Saturday, January 16, 2010

Evidence For CJD TSE Transmission Via Endoscopes 1-24-3 re-Singeltary to Bramble et al

Evidence For CJD/TSE Transmission Via Endoscopes

From Terry S. Singletary, Sr flounder@wt.net 1-24-3

I have researched human/animal TSEs now for over 5 years due to the death of my Mother from the Heidenhain Variant Creutzfeldt Jakob disease, one of six - known - variants of the infamous 'sporadic' CJD.

I did a little survey several years ago about CJD and ENDOSCOPY in 2001, and then went there again when another article was released recently. However, they seemed to only be concerned with the vCJD strain and risk from endoscopy equipment.

My concerns are if vCJD can be transmitted by blood, and there are now 6 variants of the infamous sporadic CJDs that they are documenting to date, how do they know that none of these 6 variants will not transmit the agent (prion) via blood?...especially since the sporadic CJDs are the only ones documented to date to transmit via the surgical arena and now that the CWD is spreading more and more, who knows about the cattle?

I would always read this study and it would bring me back to reality as to how serious/dangerous this agent is in the surgical/medical arena. You might want to read this short abstract from the late, great Dr. Gibbs twice, and let it really sink in. And please remember while reading some of these transmission studies, that most all, if not ALL these agents transmit freely to primates. Humans, of course, are primates.

Regarding claims that:

'Well, it has never been documented to transmit to humans."

There are two critical factors to think about:

A. CJD/TSEs in the USA are NOT reportable in most states and there is NO CJD/TSE questionnaire for most victims and their families, and the one they are now issuing asks absolutely nothing about route and source of the (prion) agent, only how the disease was diagnosed. Furthermore, the elderly are only very rarely autopsied, ie looking for Alzheimer's or 'FAST Alzheimer's' OR prion disease-related factors and phenomena, such as heart failure caused by disease.

B. It is unethical and against the law to do transmission studies of TSEs to humans, they are 100% FATAL.

I suggest you read these case studies about medical arena CJD transmission very carefully:

1: J Neurol Neurosurg Psychiatry 1994 Jun;57(6):757-8

Transmission of Creutzfeldt-Jakob disease to a chimpanzee by electrodes contaminated during neurosurgery.

Gibbs CJ Jr, Asher DM, Kobrine A, Amyx HL, Sulima MP, Gajdusek DC.

Laboratory of Central Nervous System Studies, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD 20892.

Stereotactic multicontact electrodes used to probe the cerebral cortex of a middle aged woman with progressive dementia were previously implicated in the accidental transmission of Creutzfeldt-Jakob disease (CJD) to two younger patients. The diagnoses of CJD have been confirmed for all three cases. More than two years after their last use in humans, after three cleanings and repeated sterilisation in ethanol and formaldehyde vapour, the electrodes were implanted in the cortex of a chimpanzee. Eighteen months later the animal became ill with CJD. This finding serves to re-emphasise the potential danger posed by reuse of instruments contaminated with the agents of spongiform encephalopathies, even after scrupulous attempts to clean them.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8006664&dopt=Abstract




Tissue Infectivity and TSEs (brain = high / rectum = medium)

[PDF]TSE infectivity distribution in ruminant tissues

... small intestine Distal small intestine Proximal colon Distal colon Rectum ... on the basis of the most recent scientific data, the sheep tissue infectivity ...

http://www.europa.eu.int/comm/food/fs/sc/ssc/out241_en.pdf




... entire bovine intestine from duodenum to rectum

... in any other extra neural tissue

... could promote the spread of infectivity

... Abnormal prion protein could also be


http://www.europa.eu.int/comm/food/fs/sc/ssc/out215_en.pdf





Transmission of prion diseases by blood transfusion

Nora Hunter,1 James Foster,1 Angela Chong,1 Sandra McCutcheon,2 David Parnham,1 Samantha Eaton,1 Calum MacKenzie1 and Fiona Houston2

1 Journal of General Virology (2002), 83, 2897-2905. Printed in Great Britain Published ahead of print (16 July 2000) in JGV Direct as DOI 10.1099/vir.0.18580-0 Transmission of prion diseases by blood transfusion Nora Hunter,1 James Foster,1 Angela Chong,1 Sandra McCutcheon,2 David Parnham,1 Samantha Eaton,1 Calum MacKenzie1 and Fiona Houston2 1 Institute for Animal Health, Neuropathogenesis Unit, West Mains Road, Edinburgh EH9 3JF, UK 2 Institute for Animal Health, Compton, Newbury, Berkshire RG20 7NN, UK Author for correspondence: Nora Hunter. Fax +44 131 668 3872. e-mail nora.hunter@bbsrc.ac.uk Received 16 May 2002; Accepted 9 July 2002 This article is now available in the November 2002 print issue of JGV (vol. 83, 2897-2905). The complete issue of the journal may be seen in electronic form on JGV Online (http://vir.sgmjournals.org). 0001-8580 © 2002 SGM

Abstract

Attempts to detect infectivity in the blood of humans and animals affected with transmissible spongiform encephalopathies (TSEs or prion diseases) have often been inconclusive because of the limitations of cross-species bioassays and the small volumes of blood that can be injected by the intracerebral route. A model has been developed for the experimental study of TSE transmission by blood transfusion using sheep experimentally infected with bovine spongiform encephalopathy (BSE) or natural scrapie as donors and susceptible scrapie-free sheep as recipients. Donors and recipients of the same species greatly increase the sensitivity of the bioassay and in sheep large volumes of blood can be injected by the intravenous (i.v.) route. Transmission of BSE to a single animal using this approach was reported recently. This study confirms this result with a second transmission of BSE and four new cases of transmission of natural scrapie. Positive transmissions occurred with blood taken2 at pre-clinical and clinical stages of infection. Initial studies indicate that following such infection by the i.v. route, deposition of the abnormal prion protein isoform, PrPSc, in peripheral tissues may be much more limited than is seen following oral infection. These results confirm the risks of TSE infection via blood products and suggest that the measures taken to restrict the use of blood in the UK have been fully justified.

Introduction

Creutzfeldt-Jakob disease (CJD) is one of a group of related diseases known as prion diseases or transmissible spongiform encephalopathies (TSEs), a group that also includes scrapie in sheep and bovine spongiform encephalopathy (BSE) in cattle. A new variant of CJD (vCJD) in human beings in the UK (Will et al., 1996) is thought to have been the result of infection with the same agent that causes BSE in cattle (Bruce et al., 1997). The numbers of vCJDinfected people remain unknown, although, to date, over 100 clinical cases have been recordedin the UK. Amongst many sources of concern, one major question relates to the safety of blood transfusions and blood products - especially when inadvertently sourced from individuals during the long pre-clinical phase of vCJD, a time at which these individuals may act as asymptomatic carriers of the infectious agent. There is no epidemiological evidence to indicate that iatrogenic CJD has ever occurred via blood or blood products but vCJD is a new disease with a different pathogenesis and may present different risks.

The TSE disease-associated form of the prion protein (PrPSc) of the neuronal glycoprotein PrPC is often used as a marker for infectivity. Using a sensitive Western blotting technique, no PrPSc was detected in the buffy coat from one vCJD patient (Wadsworth et al., 2001). Although a novel method for detection of PrPSc in scrapie sheep blood has been described (Schmerr et al., 1997), the study was limited by a low number of samples and the technique requires further validation. Other investigators using the more conventional method of immunocytochemistry failed to demonstrate PrPSc in peripheral blood leucocytes of scrapie-infected sheep (Herrmann et al., 2002).

An alternative to PrPSc detection is direct bioassay of infectivity by inoculation of material into hosts of the same or different species. In laboratory rodents experimentally infected with TSE, a number of investigators have demonstrated infectivity in blood and blood components during the pre-clinical and clinical phases of infection (Brown et al., 1998; Diringer, 1984; Manuelidis et al., 1978). However, infectivity has not been isolated, so far, from blood components of natural animal hosts of TSEs (Hadlow et al., 1982; Marsh et al., 1973). Isolated reports of transmission of CJD to laboratory rodents by whole blood or buffy coat from human3 patients have been questioned for a variety of reasons (Brown, 1995).

A large-scale study conducted by the National Institutes of Health failed to demonstrate infectivity in blood from 13 patients with CJD, using either highly susceptible primates or rodents as bioassay hosts (Brownet al., 1994). With vCJD, no infectivity was detected in blood from two patients using mouse bioassays (Bruce et al., 2001). Many of these studies could have failed to reveal low levels of infectivity in blood because of the use of rodents as bioassay hosts, thus limiting the sensitivity by crossing a species barrier. Also, in most cases, the intracerebral (i.c.) route of inoculation was used, because it is the most efficient, but this severely limits the volume of blood that can be assayed.

Thus, where transmission from blood has been successful, infectivity was usually concentrated in some way, for example, by the use of buffy coat fractions. Transmission by the intravenous (i.v.) route has been shown to be up to seven times less efficient than following i.c. infection (Brown et al., 1999), but there have been very few attempts to transmit TSEs by whole blood transfusion. Units of whole blood from three CJD cases were transfused into chimpanzees with negative results (Brown et al., 1994) and pooled blood from three terminally ill TSEinfected mice produced disease in 1 of 20 transfusion recipients (Brown et al., 1999). Sheep infected orally with BSE show widespread deposition of PrPSc in the lymphoreticular system (LRS) (Foster et al., 1996a, 2001b), similar to that seen in human vCJD patients.

In contrast, in cases of sporadic human CJD and cattle BSE, peripheral pathogenesis does not appear to involve the LRS (Hill et al., 1999; Wells et al., 1998). Sheep were chosen as a model in which to study transmission of TSEs by blood transfusion because of the similarity of the pathogenesis with vCJD and because large volumes of blood can be transferred in the absence of a species barrier. We have transfused whole blood and buffy coat from BSE-infected sheep and natural scrapie-infected sheep into susceptible but scrapie-free recipient animals. In the first report on these experiments (Houston et al., 2000), we described a single case of BSE infection via blood transfusion.

The significance of this finding in a single animal has been questioned. However, the present report gives details of further successful transmissions from BSE and natural scrapie cases, the latter being the first conclusive demonstration of infectivity in blood of naturally infected individuals. Although still incomplete, our study indicates a frequency of transmission of TSEs in at least 10 % of the transfusion recipients. We have decided to provide an update of our results because of the potential importance of the study for human health. In addition, in the two BSE transfusion cases examined so far, deposition of PrPSc in peripheral tissues appears rather limited when compared with sheep infected by the oral route. The potential implications of this observation for pre-clinical diagnosis and screening are discussed.

SNIP...

14 Discussion

With this report we have confirmed and extended our initial observation of a single case of BSE following transfusion of blood from a BSE-infected sheep and have provided the first conclusive evidence of significant levels of infectivity in blood in a naturally occurring TSE (scrapie). The experiment may take up to 5 years to complete; however, so far we have clear evidence of disease transmission by the blood transfusion route in 2 of 24 sheep (8 %) with BSE and 4 of 21 sheep (19 %) with scrapie, with two additional animals showing clinical signs in the BSE group. If the clinically suspect BSE-transfused sheep progress as expected, this would bring the transmission rate for BSE up to 17 %, comparable with the scrapie rate.

Positive transmissions have occurred not only with samples taken from sheep at the clinical phase of disease but also with those from apparently healthy donors as early as halfway through the incubation period (Fig. 1, lane 9; no PrPSc detection in the brain of donor J2746). Each TSE is transmitting to its appropriate susceptible genotype (AXQ/AXQ for BSE and VRQ/VRQ for scrapie) and Western blot/glycoform analyses support the conclusion that donors and recipients are infected with the same strains of BSE and scrapie. Our negative controls remain healthy, although still at relatively early stages post-transfusion and our positive controls are developing clinical signs at around, or greater than, 600 days post-challenge, showing incubation periods very similar to the transfusion cases. Whole blood transfusion (400-450 ml) cases are presenting incubation periods of around 600 days, which is very similar to those resulting from i.v. injection of 0.2 g BSE cattle brain homogenate. The transfusions might be expected to be more efficient because they are a sheepto-sheep transmission with no species barrier, which contrasts with the i.v. brain infections, which is a cattle-to-sheep transmission.

A full titration of the inoculum used in the cattle BSE brain i.v. controls is under way in mice but is incomplete at the time of writing. Accurate estimation of the levels of infectivity in blood will require i.v. titration in sheep; however, the results presented here suggest that they are significantly higher than suspected previously. Another important consideration is the distribution of infectivity among different blood components. Perhaps surprisingly, most positive transmissions so far have followed transfusion of whole blood rather than buffy coat, whereas previous studies have tended to find infectivity concentrated in the buffy coat fraction. As we now have a clinical case of scrapie resulting from transfusion of buffy coat, it is clear that, in our model, infectivity is also carried by the cells in this fraction. However, these preliminary results suggest that infectivity is not confined to the buffy coat fraction and that there may also be significant levels of infectivity in the plasma and/or red cell fractions. 15

The presence of infectivity in blood suggests that it should be possible to detect PrPSc or other surrogates of infectivity by alternative methods, with obvious benefits for development of ante-mortem diagnostic tests. Early reports of the use of capillary electrophoresis to detect PrPSc in the blood of scrapie-infected sheep showed some promise (Schmerr et al., 1997); however, a recent study could not detect PrPSc in peripheral blood leucocytes of scrapie-infected sheep using immunocytochemistry (Herrmann et al., 2002). PrPC is known to be expressed only on peripheral blood mononuclear cells in sheep, in contrast to humans where it is also found on platelets and, at low levels, on erythrocytes (Barclay et al., 2002; Herrmann et al., 2001; Holada et al., 1998). Since tissues that express PrPC do not always equate with areas that accumulate PrPSc and infectivity during disease, the distribution of infectivity in blood fractions of different species clearly merits more detailed analysis.

Immunocytochemical detection of PrPSc in peripheral tissues of two of the BSE transfusion cases has shown a greatly reduced involvement of lymphoid tissues, including tonsil, in the peripheral pathogenesis compared with NPU Cheviot sheep orally infected with BSE or natural scrapie (Foster et al., 2001a). A recent report has shown that a proportion of Romney sheep in the late pre-clinical stages of infection with BSE following oral dosing (22 months post-infection) have PrPSc deposits in the CNS in the absence of any detectable involvement of peripheral lymphoid tissues (Jeffrey et al., 2001). This study also noted the relatively late and variable onset of PrPSc accumulation in the lymphoid tissues of BSE-infected sheep.

A more detailed study of BSE and scrapie transfusion cases, and positive controls, will be undertaken to determine whether lack of involvement of the LRS is a consistent feature in animals infected by the i.v. route; the results will be published at a later date. If our preliminary observations are confirmed, there may be implications for human patients with the misfortune to have received blood products from vCJD cases, because a negative tonsil biopsy as a means of reassurance might very well be unreliable. On the other hand, it also may mean that if a human patient became infected with vCJD by the i.v. route, then the peripheral tissues and blood of this secondary case may not themselves be highly infectious. In conclusion, our results so far indicate that, with more than 10 % of transfusions resulting in disease in the recipients, blood transfusion represents an appreciable risk for transmission of TSEs in sheep and, by extension, of vCJD in human beings. The relatively short and consistent incubation periods seen in positive cases suggests that levels of infectivity in the blood may be higher than suspected previously, even in the pre-clinical stages of infection, and/or that transmission by the i.v. route is highly efficient. From these preliminary results, it would appear that measures taken to safeguard the blood supply in the UK are fully justified. 16

However, further work, in particular a thorough investigation of the distribution of infectivity in different blood fractions, is required before a reliable estimate of the risks associated with contaminated blood products can be made.

Acknowledgements The authors are indebted to the UK Department of Health, European Union and DEFRA for their financial contribution to this study.

see full text:

http://www.socgenmicrobiol.org.uk/JGVDirect/18580/18580ft.pdf



also, older data pertaining to CJD/TSEs/BLOOD...TSS

Sir, -- Professor Manuelidis and his colleagues (Oct 19, p896) report transmission to animals of Creutzfeldt-Jakob disease (CJD) from the buffy coat from two patients. We also transmitted the disease from whole blood samples of a patient (and of mice) infected with CJD.1 Brain, Cornea, and urine from this patient were also infectious, and the clinicopathological findings2 are summarised as follows.

A 70-year-old man was noted to have a slowing of speech and writing and some disorientation, all of which progressed rapidly. Decorticate rigidity, forced grasping, positive snout reflex, and myoclonus appeared within 2 months. Electroencephalogram revealed typical periodic synchronous discharge, and he died of pneumonia and upper gastrointestinal haemorrhage, about 3 months after onset of the symptoms. The Brain weighed 1290g and showed severe histological changes diagnostic of CJD, including spongiform change, loss of nerve cells, and diffuse proliferation of astrocytes. There were no inflammatory cells, microglia, neurofibrillary tangles, and amyloid plaques, although virus-like particles were detected by electron microscopy.

Results of innoculation in Mice

Inocula NO* Incubation period (days)+ Brain 7/10 (4) 789 (+ or - 112) Cornea 1/6 (0) 1037 Blood 2/13 (0) 1080 (+ or - 69) Urine 5/10 (1) 880 (+ or - 55) CSF 0/10

* Number of mice with CJD change/number examined histologically. Number with amyloid plaques shown in parentheses.

+ means + or - SD

Samples were taken aseptically at necropsy. 10% crude homogenates of brain and cornea in saline, whole blood (after crushing a clot), and untreated CSF and urine were innoculated intracerebrally into CF1 strain mice (20 ul per animal). Some mice showed emaciation, bradykinesia, rigidity of the body and tail, and sometimes tremor after long incubation periods. Tissues obtained after the animal died (or was killed) were studied histologically (table). Animals infected by various inocula showed common pathological changes, consisting of severe spongiform changes, glial proliferation, and a moderate loss of nerve cells. A few mice inoculated with brain tissue or urine had the same amyloid plaques found in patients and animals with CJD.3

In our long-term experiments, inoculating materials taken from twenty patients with CJD or Gerstmann-Straussler-Scheinker's disease (GSS) into rodents, positive results were obtained in seventeen cases, including this patient. Brain tissue transmitted the disease most frequently within the shortes incubation period, except for one case where the lymph node was the most infectious. Transmission through the cornea has been noted in man4 and in guineapigs.5 Whole blood samples taken from three patients were inoculated and a positive transmission occured only in the case recorded here. Mouse-to-mouse transmission through blood inoculation was successful after a mean incubation period of 365 days.1 Transmission through urine was positive in this patient only, and negative in one other patient and in many infected animals. Transmission through the CSF from eight patients was negative, yet transmission via the CSF of infected rats was positive.1

As viraemia has been proved in guineapigs,6 mice,1,7 and lately in patients with CJD, blood for transfusion or blood products for medical use must be tested for unconventional pathogens. For this purpose, we inoculated blood products inot rodents.8 The CJD pathogen was not found in the products examined. However, this approach takes too long to be of practical value. More efficient methods must be developed to detect pathogens and to eliminate them from blood. One proposal9 is to apply membrane filtration to the pruification protocol of human growth hormone suspected of being contaminated with CJD. Similar methods are needed for blood contamination.

Department of Neuropathology, Neurological Institute, Faculty of Medicine, Kyushu University, Fukuoka812, Japan

JUN TATEISHI

1. Tateishi J, Sato Y, Kaga M. Don H, Ohta M. Experimental transmission of (bum??cannot read) subacute spongiform encephalopathy to small rodents I: Clinical and histological observations. Acta Neuropathol (Berl) 1980; 51: 127.

2. Shibayama Y, Sakaguchi Y, Nakata K, et al, Creutzfeldt-Jakob disease with demonstration of virus-like particles. Acta pathol Jpn 1982;32: 695.

3. Tateishi J, Nagara H, Hikita K, Sato Y. Amyloid plaques in the brains of mice with Creutzfeldt-Jakob disease. A?? Neurol 1984; 15: 278.

4. Duffy P, Wolf J, Colings G, DeVoe AG, Streeten B, Cowen D. Possible person-to-person transmission of Creutzfeldt-Jakob disease. N Engl J Med 1974; 290?: 692.

5. Manuelidis EE, Angelo JN, Gorgacz EJ, Kim JH, Manuelidis L. Experimental Creutzfeldt-Jakob disease transmitted via the eye with infected cornea. N Engl J Med 1977; 296: 1334.

6. Manuelidis EE, Gorgacz EJ, Manuelidis L. Viremia in experimental Creutzfeldt-Jakob disease. Science 1978: 209?: 1069.

7. Kuroda Y, Gibbs CJ Jr, Amyx HL, Gajdusek DC. Creutzfeldt-Jakob disease in mice. Persistent viremiam and preferential replication of virus in low-density lymphocytes. Infect Immun 1983; 41: 154.

8. Tateishi J, Tsuji S. Unconventional pathogens causing spongiform encephalopathis absent in blood products. J Med Virol 1985; 15: 11.

9. Tateishi J, Kitamoto T, Hiratani H. Creutzfeldt-Jakob disease pathogen in growth hormone preparations is eliminatable. Lancet (in press).


=================================


Something I submitted to GUT previously;

Subject: Re: gutjnl_el;21 Terry S. Singeltary Sr. (3 Jun 2002) "CJDs (all human TSEs) and Endoscopy Equipment"
Date: Thu, 20 Jun 2002 16:19:51 -0700
From: "Terry S. Singeltary Sr."
To: Professor Michael Farthing
CC: lcamp@BMJgroup.com
References: <001501c21099$5c8bc620$7c58d182@mfacdean1.cent.gla.ac.uk>

Greetings again Professor Farthing and BMJ,

I was curious why my small rebuttal of the article described below was not listed in this month's journal of GUT? I had thought it was going to be published, but I do not have full text access. Will it be published in the future? Regardless, I thought would pass on a more lengthy rebuttal of mine on this topic, vCJD vs sCJDs and endoscopy equipment. I don't expect it to be published, but thought you might find it interesting, i hope you don't mind and hope to hear back from someone on the questions I posed...

Here is my short submission I speak of, lengthy one to follow below that:

Date submitted: 3 Jun 2002

>> eLetter ID: gutjnl_el;21
>> >> Gut eLetter for Bramble and Ironside 50 (6): 888
>> >>Name: Terry S. Singeltary Sr. >>Email: flounder@wt.net
>>Title/position: disabled {neck injury}
>>Place of work: CJD WATCH
>>IP address: 216.119.162.85
>>Hostname: 216-119-162-85.ipset44.wt.net
>>Browser: Mozilla/5.0 (Windows; U; Win98; en-US; rv:0.9.4)
>>Gecko/20011019 Netscape6/6.2
>> >>Parent ID: 50/6/888
>>Citation:
>> Creutzfeldt-Jakob disease: implications for gastroenterology
>> M G Bramble and J W Ironside
>> Gut 2002; 50: 888-890 (Occasional viewpoint)
>> http://www.gutjnl.com/cgi/content/abstract/50/6/888
>> http://www.gutjnl.com/cgi/content/full/50/6/888
>>-----------------------------------------------------------------
>>"CJDs (all human TSEs) and Endoscopy Equipment"
>>----------------------------------------------------------------- >> >> >>
>>

regarding your article; >>
>>

Creutzfeldt-Jakob disease: implications for gastroenterology >>

>>

I belong to several support groups for victims and relatives
>>of CJDs. Several years ago, I did a survey regarding
>>endoscopy equipment and how many victims of CJDs have
>>had any type of this procedure done. To my surprise, many
>>victims had some kind of endoscopy work done on them.
>>As this may not be a smoking gun, I think it should
>>warrant a 'red flag' of sorts, especially since data now
>>suggests a substantial TSE infectivity in the gut wall
>>of species infected with TSEs. If such transmissions
>>occur, the ramifications of spreading TSEs from
>>endoscopy equipment to the general public would be
>>horrible, and could potential amplify the transmission
>>of TSEs through other surgical procedures in that
>>persons life, due to long incubation and sub-clinical
>>infection. Science to date, has well established
>>transmission of sporadic CJDs with medical/surgical
>>procedures.

Terry S. Singeltary Sr. >>CJD WATCH

Again, many thanks, Kindest regards,

Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518 flounder@wt.net CJD WATCH

[scroll down past article for my comments]

Subject: Creutzfeldt-Jakob disease: implications for gastroenterology & CJD 38 years after _diagnostic_ use of hGH (Iatrogenic CJDs & sporadic CJDs)
Date: Mon, 17 Jun 2002 16:46:46 -0700
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de

Bovine Spongiform Encephalopathy

OCCASIONAL VIEWPOINTS

Creutzfeldt-Jakob disease' implications for gastroenterology

M G Bramble, J W Ironside

Gut 2002;50:888-890

The current clinical views regarding variant Creutzfeldt-Jakob disease, and in particular transmission via endoscopy, of those representing both gastroenterology and the Spongiform Encephalopathy Advisory Committee are presented in an attempt to guide clinicians as to "best practice" given the current state of our knowledge.

See end of article for authors' affiliations

Correspondence to: Professor MG Bramble, Endoscopy Centre, James Cook University Hospital, Marton Rd, Middlesbrough TS4 3BN, UK;

Most gastroenterologists working in the UK have been aware for some time that endoscopy may be a vector for the transmission of prions from a patient incubating, but not clinically manifesting, variant Creutzfeldt-Jakob disease (vCJD) to the next individuals undergoing the same procedure on the same list. To date there are no recorded cases of iatrogenic transmission of vCJD via endoscopy but it remains a risk which will be present for many years to come. Advice to health authorities on individual cases is through the CJD Incidents Panel. However, we are aware that advice to health professionals performing endoscopy needs to be as comprehensive as current evidence will allow, without making it impossible to perform endoscopic procedures on patients who will clearly derive long term health benefits from an accurate endoscopic diagnosis and/or treatment. This article represents the current clinical views of those representing both gastroenterology and the Spongiform Encephalopathy Advisory Com-mittee (SEAC). Both authors sit on the CJD Inci-dents Panel and have been advising the Depart-ment of Health on individual cases during the last year. It is important to note that the advice given in this article may be superseded if additional information or evidence becomes available.

CJD is a member of a group of neurological disorders known as the transmissible spongilorm encephalopathies or prion diseases, which affect both animals (such as scrapie in sheep or bovine spongiform encephalopathy (BSE) in cows) and humans. The precise nature of the transmissible agents responsible for these disorders is unknown but there is increasing evidence to support the prion hypothesis, which states that the agent is composed of an abnormally folded form of a host encoded protein, prion protein. The normal prion protein (PrPc) is expressed in many tissues but occurs at the highest levels in neurones in the central nervous system (CNS) where it may act as a copper binding protein, although its precise physiological role is unknown. The abnormal form of the protein (PrPSc) accumulates in the CNS in prion diseases; the infectious agent is remarkably resistant to most forms of degradation. The association between PrPSc and the gut has been eloquently described in a previous lead-ing article1 and gastroenterologists need to understand where we are in terms of our present day knowledge of this entity.

In humans, prion diseases occur in three major categories: sporadic, acquired, and familial. All are currently untreatable and universally fatal although recent studies have indicated that a combination of drugs may be effective in experimental prion diseases2: this approach is under consideration as a clinical trial. The sporadic form of CJD affects approximately one person per mil-lion per annum in the population on a worldwide basis. CJD has also occurred as an acquired iatrogenic disorder, transmitted to other humans through direct (inadvertent) inoculation of the brain via contaminated neurosurgical instruments, via corneal and dura mater grafts, or through administration of human pituitary ex-tracts used to treat growth hormone or gonadotrophin deficiency. Variant CJD (vCJD) is a new acquired form of CJD which was first reported in 1996 affecting mainly young adults and with a unique neuropathological phenotype.3 It is now widely accepted that bovine prions passed into the human population through consumption of BSE infected bovine tissues; the transmissible agent responsible for vCJD is identical to the BSE agent (but different from the agent in sporadic CJD). The incubation period for vCJD is likely to be lengthy and may have a mean value of 10-30 years. During this time the affected person has the potential to transmit the disease to others via surgical procedures which might result in the transfer of infected tissue into the next person operated on with the same surgical instruments.

The distribution of PrPSc in the body is different in sporadic and variant CJD, reflecting the differ-ent pathogenesis of the two forms. In the case ot sporadic CJD, prion infectivity is largely limited to the CNS (including the retina) and only opera-tions involving the brain and eye have resulted in iatrogenic transmission of the disease. Gastro-intestinal endoscopy is unlikely to be a vector for the transmission of sporadic CJD as infected tissue is not encountered during the procedure. No special precautions are necessary during or after the procedure and the endoscope should be cleaned and disinfected in the normal thorough way.4

"Endoscopy on patients who are incubating vCJD may result in exposure of the instrument (and particularly the biopsy forceps) to PrPsc''

In contrast, in vCJD the lymphoreticular system throughout the body contains PrPSc at the time of death, and experimental evidence suggests that the lymphoreticular system may contain significant levels of infectivity for most of the incuba-tion period.5 To support this, in vCJD abnormal prion protein was found in the germinal centres in the wall of an appendix from a vCJD patient that was removed eight months before the onset of neurological disease.6 As lymphoid follicles and germinal centres are widely distributed in the gastrointestinal tract (and are often biopsied), it is possible that endoscopy on patients who are incubating vCJD may result in exposure of the instrument (and particularly the biopsy forceps) to PrPsc. Consequently, the question now arises, how great is the risk of secondary (person to person) transmission in endoscoping a patient incubating vCJD? There are three scenarios which gastroenterologists are likely to encounter and this editorial will attempt to guide clinicians as to "best practice" given the current state of our knowledge.

UPPER GASTROINTESTINAL ENDOSCOPY

Scenario No 1

Occasionally gastroenterologists may be requested to endo-scope a patient with known or probable sporadic CJD (usually to site a PEG feeding tube). This can be carried out in the rou-tine way provided vCJD is not suspected. If inadvertently a patient with suspected vCJD is endoscoped, the instrument used should be quarantined until the postmortem diagnosis is known. If sporadic CJD is diagnosed, the endoscope can be returned to use following thorough cleaning and decontami-nation, as is normal practice. If vCJD is diagnosed the endoscope cannot be used again and should be quarantined or sent to the National CJD Surveillance Unit in Edinburgh for research purposes. The previous advice to destroy such instru-ments represents a lost opportunity to study the risks involved in more detail. It would also be good practice to inform colleagues locally that a quarantined instrument was available for use in other endoscopy units if they too had a patient with suspected vCJD requiring endoscopy.

Scenario No 2

For patients with known or probable vCJD,7 endoscopy should only be a last resort. Ultrasound guided insertion of a gastrostomy feeding tube would be preferable to a PEG feeding tube if local expertise is available. If not, endoscopy should be per-formed using an instrument already set aside for such patients. If no such instrument is available locally, one can be loaned to any hospital by the National CJD Surveillance Unit in Edinburgh (contact telephone number 0131 537 1980). If scenario No 2 becomes more common, endoscopes may need to be held regionally for this purpose.

Scenario No 3

This scenario covers patients who have been endoscoped by an instrument previously used on a patient who was not known to be incubating vCJD at the time of endoscopy but who sub-sequently went on to develop the disease. This could become the commonest scenario and it must be assumed that the patient who went on to develop vCJD was incubating the dis-ease at the time of the original endoscopy. This also means that infectious material may not have been removed completely by current methods of decontaminating endoscopes, and that subsequent patients have been exposed to the prion agent. The instrument used should therefore be quaran-tined until advice has been sought from the CJD Incidents Panel (Department of Health, Skipton House, London; contact telephone 0207 972 1761) as to the management of the situa-tion. Local infection control teams will need to be involved with contact tracing and information handling.

LOWER GASTROINTESTINAL ENDOSCOPY

It is unlikely that colonoscopy would be clinically justifiable in a patient known or strongly suspected as suffering from vCJD. However, it is quite possible that an asymptomatic patient incubating vCJD may undergo colonoscopy prior to diagnosis and this situation is essentially the same as in scenario 3. The risks of transmitting prion protein to the next patient are much greater however, due to a number of factors which relate to the amount of lymphatic tissue encountered during endos-copy and the number, site, and size of mucosal biopsies obtained by this method.

In general the risks of transmitting vCJD from one patient to another are dependent on the infectivity of the tissues involved, the amount of tissue contaminating the instrument, the effectiveness of the decontamination processes, and the susceptibility of subsequently exposed patients. Experimental studies suggest that levels of infectivity in prion diseases are highest in the CNS and retina, which are approximately two logs higher than in the tonsils and other lymphoreticular tis-sue. A recent study has also detected the abnormal form of the prion protein in rectal tissue from a patient with vCJD by western blot examination of autopsy tissues.8 The risk of transmitting vCJD through the endoscopy procedure itself is likely to be small, but contamination of the endoscope and forceps as a result of biopsy of lymphoid tissues may represent a larger (but currently unquantifiable) risk, even though only small amounts of tissue are involved.

"The risks of transmitting vCJD from one patient to another are dependent on the infectivity of the tissues involved, the amount of tissue contaminating the instrument, the effectiveness of the decontamination processes, and the susceptibility of subsequently exposed patients"

The greatest risk is undoubtedly that which ensues from biopsy of the terminal ileum where Peyer's patches may con-tain significant levels of prion protein for a patient incubating vCJD. The biopsy forceps and the colonoscope become poten-tial vectors for disease transmission under these circum-stances. Meticulous manual cleaning of the colonoscope is probably the best defence against person to person transmis-sion. The same is true of the biopsy forceps, but as disposable forceps are now available there is a strong argument for mov-ing towards the universal use of disposable biopsy forceps for mucosal samples taken at colonoscopy. Endoscopy units should now work towards a policy of using disposable biopsy forceps as the only practical way of minimising the risk which results from ileal biopsy. In addition, "random" biopsies should be kept to a minimum as lymphoid tissue is distributed widely throughout the gastrointestinal tract. Although thor-ough cleaning of flexible endoscopes ensures patient safety for "normal" pathogens, the same process may not be adequate for the PrPsc. The main benefit of the decontamination process under these circumstances is undoubtedly effective manual cleaning, as glutaraldehyde may stabilise PrPSc on the metal surface of the endoscope, with potentially adverse conse-quences. It follows that brushes used to clean the channels of the endoscope are used only once to ensure maximum efficiency and biopsy forceps should also be functioning opti-mally and discarded as soon as they appear to be under performing (tearing tissue rather than cutting it). The rubber valve protecting the biopsy channel is another item which is potentially disposable and serious consideration should be given to single use valves. Again, more research is required to determine "best practice". For rigid endoscopes, autoclaving at the recommended conditions for CJD9 is the best way of attempting decontamination.

What should endoscopists do in the short term? The answer to this question must be to ensure as far as possible that manual cleaning of endoscopes and reuseable accessories is of the highest standard. Endoscopy has a major role in patient care, and this should not be compromised unless it is absolutely unavoidable in the public interest. It is also essen-tial that endoscopes should be individually identifiable and their use traceable in any given patient population. Random biopsies should be kept to an absolute minimum (particularly of the ileum in colonoscopy) and endoscopy itself should be as atraumatic as possible, especially gastroscopy where the instrument is in contact with the mucosa covering the tonsils. Biopsy forceps should be treated as "high risk" and undergo thorough ultrasonic cleaning followed by autoclaving. As research in the UK progresses, it is likely that other procedures will be developed to inactivate prion infectivity and to remove proteins from instrument surfaces. The development of such techniques (along with more sensitive tests for prion detection) may well have an impact on future advice concern-ing endoscopy and CJD.

Depending on the final numbers of people infected with vCJD, we must assume that a significant number may undergo endoscopy before neurological symptoms appear10. It is there-fore up to every endoscopist to be aware of the dangers and follow the advice set out here. Further advice on specific cases and possible exposure incidents can be obtained from the CJD Incidents Panel (Department of Health, Skipton House, London; contact telephone 0207 972 1761).

Authors' affiliations M G Bramble, Endoscopy Centre, James Cook University Hospital, Marton Road, Middlesbrough TS4 3BW, UK J W Ironside, CJD Surveillance Unit, Western General Hospital, Crewe Road, Edinburgh EH4 2XU, UK

mike.bramble@stees.nhs.uk

Accepted for publication 19 November 2001

REFERENCES

1 Shmakov AN, Ghosh S. Prion proteins and the gut: une liaison dangereuse? Gut 2001;48:443-7.

2 Korth C, May BCH, Cohen FE, et al. Acridine and phenothiazine derivatives as pharmacotherapeutics for prion disease. Proc Nail Acad Sci USA 2001;98:9836-41.

3 Will RG, Ironside JW, Zeidler M, et al. A new variant of Creutzfeldt-Jakob disease in the UK. Lancet 1996;347:921-5.

4 Report of a Working Party of the British Society of Gastroenterology Endoscopy Committee. Cleaning and disinfection of equipment for gastrointestinal endoscopy. Gut 1998;42:585-93.

5 Hill AF, Butterworth R J, Joiner S, et al. Investigation of variant Creutzfeldt-Jacob disease and other human prion diseases with tonsil biopsy samples. Lancet 1999;353:183-9.

6 Hilton DA, Fathers E, Edwards P, et al. Prion immunoreactivity in the appendix before the clinical onset of new variant Creutzfeldt-Jacob disease. Lancet 1998;352:703-4.

7 Will RG, Zeidler M, Stewart GE, et al. Diagnosis of new variant Creutzfeldt-Jakob disease. Ann Neuro12000;47:575-82.

8 Wadsworth JD, Joiner S, Hill AF, et al. Tissue distribution of protease resistant prion protein in variant Creutxfleldt-Jakob disease using a highly sensitive immunoblotting assay. Lancet 2001 ;358:171-80.

9 Dangerous Pathogens Spongiform Encephalopathy Advisory Committee. Transmissible spongiform encephalopathy agents: safe working and the prevention of infection. London: The Stationary Office, 1998.

10 Ironside JW, Hilton DA, Ghani A, et al. Retrospective study of prion protein accumulation in tonsil and appendix tissue. Lancet 2000;355:1693-94.

http://www.gutjnl.com/cgi/content/abstract/50/6/888



========================================================


Greetings List Members,

This is _very_ disturbing to me:

snip...

The distribution of PrPSc in the body is different in sporadic and variant CJD, reflecting the different pathogenesis of the two forms. In the case ot sporadic CJD, prion infectivity is largely limited to the CNS (including the retina) and only operations involving the brain and eye have resulted in iatrogenic transmission of the disease. Gastro-intestinal endoscopy is unlikely to be a vector for the transmission of sporadic CJD as infected tissue is not encountered during the procedure. No special precautions are necessary during or after the procedure and the endoscope should be cleaned and disinfected in the normal thorough way.4

snip...

i personally believe it is irresponsible for anyone to state in this day and time, that sporadic CJDs (now at 6 variants) will not transmit the disease by this route. considering infective dose cannot be quantified, only speculated, such a statement is thus, irresponsible. to hypothosize that sporadic CJD just happens spontaneously (with no scientific proof), that the PrPSc distribution in tissues of all sporadic CJDs is entirely different than that of vCJD, without being able to quantify the titre of infection, or even confirm all the different variants yet, again is _not_ based on all scientific data, then it's only a hypothosis. who is to say that some of these variants of sporadic CJD were not obtained _orally_?

also stated:

snip...

Although thorough cleaning of flexible endoscopes ensures patient safety for ''normal'' pathogens, the same process may not be adequate for the PrPSc.

snip...

The sporadic form of CJD affects approximately one person per mil-lion per annum in the population on a worldwide basis.

who is to say how much infectivity are in some of these variants of sporadic CJDs, without confirming this? if we look at the 6 different variants of sporadic CJDs, has the infective dose for all 6 _documented_ variants been quantified, and documented as being 'measurable'?

will there be more variants of sporadic CJDs, and what of the ramifications from them?

what of other strains/variants of TSE in cattle, BSE in sheep, CWD in cattle, or any of the 20+ strains of Scrapies in deer/elk? i get dizzy thinking of the different scenerio's. what would the human TSEs from these species look like and how can anyone quantify any tissue infectivity from these potential TSE transmissions to humans, and the risk scenerio described here from this potential route? could not some of these sporadic CJDs have derived directly or indirectly from one of these species, and if so, pose a risk by the route described here?

something else to consider, in the recent finding of the incubation period of 38 years from a _small_ dose of human growth hormone;

snip...

We describe the second patient with hGH related CJD in the Netherlands. The patient developed the disease 38 years after hGH injections. To our knowledge, this is the longest incubation period described for any form of iatrogentic CJD. Furthermore, our patient was _not_ treated with hGH, but only received a _low_ dose as part of a diagnostic procedure. (see full text below).

snip...

so my quesion is, how low is 'low' in quantifing the infectious dose in vCJD, comparing to _all_ sporadic CJDs, from the different potential routes, sources, and infectivity dose?

will the titre of infectivity in every tissue and organ of all sporadic CJDs stay exact or constant, no matter what the infective dose, route and species may be? this is considering you don't buy the fact that sporadic CJDs 85%+ of _all_ CJDs, are a happen stance of bad luck, happen spontaneously without cause, and are one-in-a-million world wide, with no substantial surveillance to confirm this.

Diagnosis and Reporting of Creutzfeldt-Jakob Disease T. S. Singeltary, Sr; D. E. Kraemer; R. V. Gibbons, R. C. Holman, E. D. Belay, L. B. Schonberger

http://jama.ama-assn.org/issues/v285n6/ffull/jlt0214-2.html


and what of Dr. Prusiner et al recent work about tissue infectivity;

Prions in skeletal muscle

snip...

Our data demonstrate that factors in addition to the amount of PrP expressed determine the tropism of prions for certain tissues. That some muscles are intrinsically capable of accumulating substantial titers of prions is of particular concern. Because significant dietary exposure to prions might occur through the consumption of meat, even if it is largely free of neural and lymphatic tissue, a comprehensive effort to map the distribution of prions in the muscle of infected livestock is needed. Furthermore, muscle may provide a readily biopsied tissue from which to diagnose prion disease in asymptomatic animals and even humans.

snip...


http://www.pnas.org/cgi/content/abstract/99/6/3812?maxtoshow=&HITS=10&hits= 10&RESULTFORMAT=&author1=prusiner&author2=prusiner&titleabstract=prions+meat+ tissue+mice&fulltext=prions+meat+tissue+mice&searchid=1024346978866_6016&stored_ search=&FIRSTINDEX=0&fdate=1/1/2002



can the science/diagnostic measures used to date, measure this, and at the same time guarantee that no titre of infectivity exists from sporadic CJDs (all of the variants), from this potential mode and route of transmission?

i don't think so, this is just my opinion. this is why i get paid nothing, and these scientists get the big bucks. i just hope i am wrong and the big bucks are correct in their _hypothisis_ of this potential mode/route of transmission with endoscopy equipment, from _all_ human TSEs.

i understand we have to weigh the risks of what we know to what we don't know, to the disease we _may_ catch to what we are having the procedure for, but to categorically state at this present time of scientific knowledge;

snip...

"Gastro-intestinal endoscopy is unlikely to be a vector for the transmission of sporadic CJD as infected tissue is not encountered during the procedure. No special precautions are necessary during or after the procedure and the endoscope should be cleaned and disinfected in the normal thorough way.4"

snip...

but, to categorically state this, in my opinion, is not only wrong, but potentially very dangerous to the future of human health...TSS

SHORT REPORT

Creutzfeldt-Jakob disease 38 years after diagnostic use of human growth hormone

E A Croes, G Roks, G H Jansen, P C G Nijssen, C M van Duijn ...............................................................

J Neurol Neurosurg Psychiatry 2002;72:792-793

A 47 year old man is described who developed pathology proven Creutzfeldt-Jakob disease (CJD) 38 years after receiving a low dose of human derived growth hormone (hGH) as part of a diagnostic procedure. The patient presented with a cerebellar syndrome, which is compatible with iatrogenic CJD. This is the longest incubation period described so far for iatrogenic CJD. Furthermore, this is the first report of CJD after diagnostic use of hGH. Since the patient was one of the first in the world to receive hGH, other cases of iatrogenic CJD can be expected in the coming years.

Prion diseases are potentially transmissible. Human to human transmission was first reported in 1974, when a 55 year old woman was described who developed symptoms of Creutzfeldt-Jakob disease (CJD) 18 months after a corneal transplant.1 Since then, transmission has been reported after stereotactic electroencephalographic (EEG) depth recording, human growth hormone (hGH) and gonadotrophin treatment, and dura mater transplantation.2-5 More than 267 patients with iatrogenic CJD are known today and their number is growing.6 The most important iatrogenic cause of CJD is still contaminated cadaveric hGH. Exposure to contaminated hGH occurred before 1985, when recombinant growth hormone became available. In a recent study, incubation periods in 139 patients with hGH associated CJD were found to range from 5-30 years, with a median of 12 years.6 One of the factors influencing incubation time is genotype on polymorphic codon 129 of the prion protein gene.7 The incubation time is significantly shorter in people who are homozygous for either methionine or valine on this polymorphism.7

We describe the second patient with hGH related CJD in the Netherlands. The patient developed the disease 38 years after hGH injections. To our knowledge, this is the longest incubation period described for any form of iatrogenic CJD. Further-more, our patient was not treated with hGH but only received a low dose as part of a diagnostic procedure.

CASE REPORT

This patient presented at the age of 47 years with paraesthesia in both arms for six months, difficulty with walking for four weeks, and involuntary movements of mainly the upper extremities of two weeks' duration. He did not notice any change in cognitive function, although his twin sister had noticed minor memory disturbances. There was no family history of neurological disease. During childhood the patient had experienced a growth delay compared with his twin sister and with the average in the Netherlands. When he was 9 years old, a nitrogen retention test with 6 IU hGH over five days was performed to exclude growth hormone deficiency. Since the result was not decisive, a quantitative amino acid test was performed, which measures 30 amino acids during fasting and one, two, and three hours after growth hormone injection. No abnormal amino acid concentrations were found making the diagnosis of primordial dwarfism most likely. Therefore, no treatment with hGH was given.

On neurological examination we found a slight dysarthria without aphasia. Cranial nerve function was normal. Walking was unstable and wide based. During movements of the upper extremities myoclonic jerks were present. Sensation, muscle tone, and strength were normal. Co-ordination was impaired in all four limbs with a disturbed balance. Tendon reflexes were brisk at the arms and increased at the legs with a clonus in the ankle reflex. Plantar responses were both normal. On the mini mental state examination, the patient scored 30/30. Routine laboratory investigation, thyroid function, vitamin concentrations (B-1, B-6, B-12, and E), and copper metabolism were normal. Admission EEG examination showed generalised arrhythmic slow activity with diffuse spikes and spike waves. EEG examination two months later showed a further slowing of the rhythm with bilateral diphasic sharp waves but was not typical for CJD. Cerebral magnetic resonance imaging was normal. Cerebrospinal fluid examination showed 1 cell/3 µl, normal glucose and protein concentrations, and a strongly positive 14-3-3 protein test. The patient was homozygous for methionine on the PRNP codon 129 polymorphism. On clinical grounds, CJD was diagnosed. Within one month the patient's condition deteriorated rapidly and because of severe disturbances in coordination and progressive myoclonus he became bedridden. An eye movement disorder developed with slow saccadic and dysmetric eye movements. Temperature became unstable with peaks of 39°C without an infectious focus, for which a disorder of autoregulation was presumed. Until a very advanced stage, cognitive function was intact. The patient died five months after admission. The diagnosis of CJD was confirmed at necropsy. The brain weighed 990 g and showed clear cortical and cerebellar atrophy. Spongiosis, neuronal loss, and gliosis were found predominantly in the putamen, caudate nucleus, and basotemporal and cerebellar cortex; the cerebellum was the most severely affected of these. Vacuoles ranged from 2-12 µm. No amyloid or Kuru plaques were found. Immunohistochemical staining (3F4 antibody 1:1000, Senetek, USA) was clearly positive for prion protein accumulation in a "synaptic" distribution. Most deposition was found in the stratum moleculare of the cerebellum.

DISCUSSION

We describe a 47 year old patient who developed pathology proven CJD 38 years after hGH injections. The patient was never treated with hGH but received a small dose as part of a diagnostic procedure. The onset of CJD was signalled by prodromal symptoms of paraesthesia followed by a rapidly progressive ataxia. The disease presentation and course with predominantly cerebellar and eye movement disorders are compatible with iatrogenic CJD caused by hGH treatment.6 8

Growth hormone treatment was first described in 1958 but hGH was not produced on a larger scale from human pituitary glands until the beginning of the 1960s. In the Netherlands growth hormone extraction started in 1963 and was soon centrally coordinated. Until 1979 growth hormone was extracted non-commercially from pituitaries by a pharmaceutical company. In 1971 commercial products also became available. Our patient was one of the first to receive hGH in the Netherlands but the origin of this product was not recorded. A causal relation can therefore not be established with full certainty, but coincidentally receiving growth hormone and developing this very rare disease is unlikely. Since the clinical course in this relatively young patient is in accordance with an iatrogenic cause, we think the probability is high that the hGH injections explain the development of CJD in this patient.

The first Dutch patient with hGH related CJD died in 1990. 9 During several periods from 1963 to 1969 she received intramuscular injections of hGH. During an unknown period the hGH was derived from South America. At age 39, 27 years after starting the treatment, she developed an ataxic gait, slurred speech, sensory disorders, and myoclonus, but her cognitive function remained normal. Postmortem examination of the brain confirmed the diagnosis of CJD.9 Following the identification of this patient, a retrospective study was started to trace all 564 registered hGH recipients who were treated before May 1985. Until January 1995, none of these was suspected of having CJD.10 Since 1993 prospective surveillance for all forms of human prion disease has been carried out in the Netherlands and, apart from the patient described above, a further two patients with iatrogenic CJD have been identified, who developed the disease after dura mater transplantation.11

An incubation period as long as 38 years had never been reported for iatrogenic CJD. Huillard d'Aignaux et al7 studied the incubation period in 55 patients with hGH related CJD in a cohort of 1361 French hGH recipients. The median incubation period was between 9 and 10 years. Under the most pessimistic model, the upper limit of the 95% confidence interval varied between 17 and 20 years. Although the infecting dose cannot be quantified, it can be speculated that the long incubation period in our patient is partly explained by the administration of a limited amount of hGH. This hypothesis is supported by experimental models, in which higher infecting doses usually produce shorter incubation periods.6 Since our patient was one of the first in the world to receive hGH, this case indicates that still more patients with iatrogenic CJD can be expected in the coming years. Another implication of our study is that CJD can develop even after a low dose of hGH. This case once more testifies that worldwide close monitoring of any form of iatrogenic CJD is mandatory.

ACKNOWLEDGEMENTS

We are grateful to M Jansen PhD MD for his search for the origin of the growth hormone and P P Taminiau MD. CJD surveillance in the Netherlands is carried out as part of the EU Concerted Action on the Epidemiology of CJD and the the EU Concerted Action on Neuropathology of CJD, both funded through the BIOMED II programme, and is supported by the Dutch Ministry of Health. This surveillance would not have been possible without the cooperation of all Dutch neurologists and geriatricians. ........................................

Authors' affiliations

E A Croes, G Roks*, C M van Duijn, Genetic Epidemiology Unit, Department of Epidemiology and Biostatistics, Erasmus University Medical Centre Rotterdam, PO Box 1738, 3000 DR Rotterdam, Netherlands

P C G Nijssen, Department of Neurology, St Elisabeth Hospital, PO Box 90151, 5000 LC Tilburg, Netherlands

G H Jansen, Department of Pathology, University Medical Centre Utrecht, Heidelberglaan 100, 3584 CX Utrecht, Netherlands

*Also the Department of Neurology, St Elisabeth Hospital

Correspondence to: Professor C M van Duijn, Genetic Epidemiology Unit, Department of Epidemiology and Biostatistics, Erasmus University Medical Centre Rotterdam, PO Box 1738, 3000 DR Rotterdam, Netherlands; vanduijn@epib.fgg.eur.nl

Received 27 December 2001 In revised form 1 March 2002 Accepted 12 March 2002

Competing interests: none declared

REFERENCES

1 Duffy P, Wolf J, Collins G, et al. Possible person-to-person transmission of Creutzfeldt-Jakob disease. N Engl J Med 1974;290:692-3.

2 Bernoulli C, Siegfried J, Baumgartner G, et al. Danger of accidental person-to-person transmission of Creutzfeldt-Jakob disease by surgery. Lancet 1977;i:478-9.

3 Koch TK, Berg BO, De Armond SJ, et al. Creutzfeldt-Jakob disease in a young adult with idiopathic hypopituitarism: possible relation to the administration of cadaveric human growth hormone. N Engl J Med 1985;313:731-3.

4 Cochius JI, Burns RJ, Blumbergs PC, et al. Creutzfeldt-Jakob disease in a recipient of human pituitary-derived gonadotrophin. Aust NZ J Med 1990;20:592-3.

5 Thadani V, Penar PL, Partington J, et al. Creutzfeldt-Jakob disease probably acquired from a cadaveric dura mater graft: case report. J Neurosurg 1988;69:766-9.

6 Brown P, Preece M, Brandel JP, et al. Iatrogenic Creutzfeldt-Jakob disease at the millennium. Neurology 2000;55:1075-81.

7 Huillard d'Aignaux J, Costagliola D, Maccario J, et al. Incubation period of Creutzfeldt-Jakob disease in human growth hormone recipients in France. Neurology 1999;53:1197-201.

8 Billette de Villemeur T, Deslys JP, Pradel A, et al. Creutzfeldt-Jakob disease from contaminated growth hormone extracts in France. Neurology 1996;47:690-5.

9 Roos RA, Wintzen AR, Will RG, et al. Een patiënt met de ziekte van Creutzfeldt-Jakob na behandeling met humaan groeihormoon. Ned Tijdschr Geneeskd 1996;140:1190-3.

10 Wientjens DP, Rikken B, Wit JM, et al. A nationwide cohort study on Creutzfeldt-Jakob disease among human growth hormone recipients. Neuroepidemiology 2000;19:201-5.

11 Croes EA, Jansen GH, Lemstra AF, et al. The first two patients with dura mater associated Creutzfeldt-Jakob disease in the Netherlands. J Neurol 2001;248:877-81.


re-CJD after diagnostic use of human growth hormone

from a donor sourcing aspect, seems the record keeping here has a lot to be desired for, let us hope it has improved for recipients sake.

also, they speak of 'low dose fitting long incubation'. what about KURU still existing after some 40 years exposure had ceased. i don't believe in most instances the dose with kuru is low. just something else to ponder?


TSS


http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12023427&dopt=Abstract


1: Ann Neurol 1999 Aug;46(2):224-33

Classification of sporadic Creutzfeldt-Jakob disease based on molecular and phenotypic analysis of 300 subjects.

Division of Neuropathology, Institute of Pathology, Case Western Reserve University, Cleveland, OH 44106, USA.

snip...

The present data demonstrate the existence of six phenotypic variants of sCJD. The physicochemical properties of PrP(Sc) in conjunction with the PRNP codon 129 genotype largely determine this phenotypic variability, and allow a molecular classification of the disease variants.

snip...

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10443888&dopt=Abstract


were not all CJDs, even nvCJD, just sporadic, until proven otherwise?


Terry S. Singeltary Sr., P.O. BOX 42, Bacliff, Texas 77518 USA

http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html


Professor Michael Farthing wrote:

Louise Send this to Bramble (author) for a comment before we post. Michael

=======================================================

Subj: Reprocessing of Flexible Endoscopes and Endoscopic Accessories - an International Comparison of Guidelines Date: 9/17/02 3:28:43 AM Eastern Daylight Time
From: flounder@WT.NET (Terry S. Singeltary Sr.)
Sender: BSE-L@UNI-KARLSRUHE.DE (Bovine Spongiform Encephalopathy)
Reply-to: BSE-L@UNI-KARLSRUHE.DE (Bovine Spongiform Encephalopathy)
To: BSE-L@UNI-KARLSRUHE.DE

Bovine Spongiform Encephalopathy

Reprocessing of Flexible Endoscopes and Endoscopic Accessories - an International Comparison of Guidelines

Zeitschrift für Gastroenterologie

© Georg Thieme Verlag Stuttgart New York More about this journal

Endoscopic examinations and procedures are essential for diagnosis and treatment of gastrointestinal diseases. As a result of poor reprocessing practice microorganisms can be transmitted via endoscope. The majority of infection transmissions is due to insufficient performance of cleaning and disinfection disregarding guidelines of societies of gastrointestinal endoscopy.

A review of the literature and a comparison of European and American guidelines for reprocessing flexible endoscopes are given. Differences in the classification of endoscopic devices, on the possibility of prion transmission, recommendations on staff training and protection, quality assurance of reprocessing and evidence-based graduation of guidelines are stressed and discussed. With respect to the procedure of endoscope reprocessing, differences concerning the cleaning solution to choose, necessity of thoroughly manual cleaning and brushing of the accessible endoscope channels (even in the case of subsequent automatic reprocessing endoscopes in washers-disinfectors), disinfection solution, microbiological quality of water for final rinsing and rationale for alcohol flush of endoscope channels for better drying are mentioned.

The need for experimental investigations of the cleaning and disinfection process is stressed. In contrast to recent guidelines of European and American societies of gastrointestinal endoscopy, the now updated recommendations of the Robert Koch-Institute for reprocessing flexible endoscopes and endoscopic accessories are evidence-based and graduated.

Original Article Z Gastroenterol 2002; 40: 531-542 DOI: 10.1055/s-2002-32807 Table of Contents Leitlinien zur Aufbereitung flexibler Endoskope und endoskopischen Zusatzinstrumentariums im internationalen Vergleich Reprocessing of Flexible Endoscopes and Endoscopic Accessories - an International Comparison of Guidelines O. Leiß1, U. Beilenhoff2, L. Bader3, M. Jung2, M. Exner4 1Fachbereich Gastroenterologie, Deutsche Klinik für Diagnostik, Wiesbaden 2St. Hildegardis-Krankenhaus, Mainz 3Max von Pettenkofer-Institut der LMU München, München 4Hygiene-Institut der Universität Bonn, Bonn

Zusammenfassung

Endoskopische Untersuchungen und Eingriffe sind für Diagnostik und Therapie gastrointestinaler Erkrankungen unverzichtbar. Durch mangelhaft aufbereitete Endoskope können Mikroorganismen übertragen werden. Die Mehrzahl der Infektionsübertragungen bei Endoskopie ist auf unzureichende Reinigungs- und Desinfektionsmaßnahmen unter Missachtung aktueller Aufbereitungsrichtlinien der Fachgesellschaften zurückzuführen.

In einer Literaturübersicht werden die Leitlinien europäischer und amerikanischer Fachgesellschaften zur Aufbereitung flexibler Endoskope verglichen. Es werden Unterschiede in der Klassifikation des endoskopischen Instrumentariums, in der Bewertung der Prionenproblematik, in den Anforderungen an Personalschulung und Personalschutz, in der Betonung qualitätssichernder Maßnahmen und in der wissenschaftlichen Untermauerung und Graduierung der ausgesprochenen Empfehlungen dargestellt und diskutiert. Zu Einzelschritten der Aufbereitung werden Unterschiede hinsichtlich der einzusetzenden Reinigungslösung, der Notwendigkeit einer manuellen Bürstenreinigung der Endoskopkanäle (auch bei nachfolgender maschineller Aufbereitung), der Wahl des Desinfektionsmittels, der mikrobiologischen Qualität des zur Schlussspülung verwendeten Wassers und der Empfehlung einer Spülung der Endoskopkanäle mit Alkohol für eine verbesserte Trocknung herausgestellt und kritisch bewertet.

Es wird offensichtlich, dass experimentelle Untersuchungen zu Einzelaspekten der Endoskop-Aufbereitung weitgehend fehlen bzw. erst in jüngster Zeit bearbeitet wurden. Im Gegensatz zu bisherigen Leitlinien europäischer und amerikanischer Fachgesellschaften zur Endoskop-Aufbereitung sind die aktualisierten Empfehlungen des Robert Koch-Instituts zur Aufbereitung flexibler Endoskope und endoskopischen Zusatzinstrumentariums mit der verfügbaren Evidenz verknüpft und graduiert. Schlüsselwörter

Flexible Endoskope - Aufbereitung - Reinigung - Desinfektion - Personalschulung - Qualitätssicherung - Mikrobiologische Prüfungen - Hygiene Abstract

http://www.thieme-connect.com/DOI/DOI?10.1055/s-2002-32807


TSS

http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html




2009


Pre-surgical risk assessment for variant Creutzfeldt-Jakob disease (vCJD) risk in neurosurgery and eye surgery unitsHospitals should already be using a questionnaire in Annex J of the ACDP TSE Working Group Infection Control guidance to find out whether any patients who are about to undergo any surgery or endoscopy may be at increased risk of being infected with CJD. If a patient is found to have an increased risk of CJD prior to their surgery or endoscopy then special infection control precautions may need to be taken. The Department of Health has carried out an analysis [1] which explores the effect of receiving a large number of blood transfusions on a patient's risk of vCJD infection. The CJD Incidents Panel reviewed this analysis and advises that patients who have received blood components from 80 or more donors may have an increased risk of variant CJD (vCJD).

Annex J of the TSE Infection Control guidance has recently been revised, and now advises that patients who are due to have high risk surgery [2 ] or neuro-endoscopy should be asked an additional question: whether they have received transfusions of blood or blood components from 80 or more donors since 1980.

On 16 July 2009 the HPA wrote to the chief executives of NHS trusts asking them to ensure that the guidance is implemented. Detailed information and tools for implementing the guidance can be downloaded from the links below.

If you have any queries about the implementation of the guidance, please contact the HPA Centre for Infections CJD Section at cjd@hpa.org.uk or on 020 8327 6074/6411.

Background information on this new pre-surgical assessment is contained in this Letter to chief executives - July 2009 (PDF, 73 KB) written to all hospitals in England.

The new version of Annex J of the TSE Infection Control Guidance contains a new question for patients undergoing high risk surgery and neuro-endoscopy. The questionnaire in Annex J should be used to assess patients' CJD risk factors.

Clinicians carrying out the new pre-surgical assessment should read Information for healthcare staff - November 2009 (PDF, 164 KB) This vCJD Algorithm for per-surgical roles - July 2009 (PDF, 28 KB) shows suggested roles and responsibilities for infection control teams, surgical teams and blood transfusion specialists.

Information on patients' transfusion histories should be collected using the Highly transfused vCJD risk assessment form - July 2009 (Word Document, 328 KB) This form is also available as a Highly transfused vCJD risk assessment form and tool - July 2009 (Excel Spreadsheet, 2.7 MB). This may help calculate the number of blood donors to a patient. The form may be posted or emailed to the HPA Centre for Infections CJD Section cjd@hpa.org.uk.

Blood transfusion laboratories may wish to use this draft Letter to other blood laboratories - July 2009 (Word Document, 31 KB) when collecting transfusion information from other hospitals.

Pre-surgical assessment teams and patients may wish to read vCJD Information for presurgical patients - July 2009 (PDF, 29 KB) about this new pre-surgical assessment.

[1] The risk of secondary vCJD infection of patients receiving a high number of blood transfusions. Department of Health, July 2009.

[2] High risk surgery is defined as surgery involving any of the following organs or tissues (high risk tissues): brain, spinal cord, cranial nerves (specifically the entire optic nerve and only the intercranial components of the other cranial nerves), cranial nerve ganglia, posterior eye (specifically the posterior hyaloid face, retina, retinal pigment epithelium, choroid, subretinal fluid, optic nerve) and pituitary gland.

•Letter to chief executives - July 2009 (PDF, 73 KB) Added/updated: 16 July 2009

•Pre-surgical assessment Information for healthcare staff - November 2009 (Word Document, 252 KB) Added/updated: 27 November 2009

•vCJD Algorithm for per-surgical roles - July 2009 (PDF, 28 KB) Added/updated: 16 July 2009

•Highly transfused vCJD risk assessment form - July 2009 (Word Document, 328 KB) Added/updated: 16 July 2009

•Letter to other blood laboratories - July 2009 (Word Document, 31 KB) Added/updated: 16 July 2009

•vCJD Information for presurgical patients - July 2009 (PDF, 29 KB) Added/updated: 16 July 2009

•Highly transfused vCJD risk assessment form and tool - July 2009 (Excel Spreadsheet, 2.7 MB) Added/updated: 8 December 2009


http://www.hpa.org.uk/webw/HPAweb&Page&HPAwebAutoListName/Page/1247469069188


Pre-surgical assessment for vCJD risk in neurosurgery and eye surgery units. Information for clinicians

1. Introduction. 2

Box 1 High risk tissues for patients with vCJD and at risk of vCJD. 2

2. Preparation and planning. 2

Box 2. Who may be involved in assessing patients’ vCJD risks 2

3. Proposed roles and responsibilities. 3

a. Pre-surgical assessment staff 3

Box 3: Questions for patients undergoing procedures involving high risk tissues 3

b. Lead consultant for blood transfusion/consultant for the hospital blood bank. 4

c. Infection Control Doctor 5

Box 4 Infection control actions for patients with an increased risk of vCJD. 6

d. Lead consultant for vCJD risk assessment 6

e. The CJD Section at the HPA Centre for Infections 7

f. General Practitioners (or other clinician) - Informing patients 8

Box 5 Public health advice for patients 9

g. General Practitioners – action. 9

h. Health Protection Units 10

Box 6 Tissue infectivity levels for patients with, or at increased risk of, vCJD. 10

4. Evaluation. 10

5. Frequently Asked Questions. 11

a.. Which patients should be asked for their transfusion history to assess their vCJD risk? 11

b. Why not assess all patients attending for any operation? 11

c.. Should patients attending for anterior eye surgery be asked for their blood transfusion history to assess their vCJD risk? 11

d.. What should happen if a patient who has, or might have, received blood from 80 or more donors needs surgery on medium risk tissues (e.g. cataract procedure or tonsillectomy)? 11

e. What happens if a patient identified as highly transfused when assessed prior to surgery on high risk tissues or neuro-endoscopy, has an operation involving medium risk tissues at a later date? 12

f.. Should doctors try to identify prospectively all their patients who may have received blood from 80 or more donors? 12

g.. What if patients ask their doctors whether they are at increased risk because of their blood transfusion history? 12

h. How should patients who have received large numbers of transfusions, but fewer than 80, be managed? 12

i... What information should be given to patients who may receive 80 or more transfusions as part of their treatment? 13

j. Might the 80 donor exposure cut off level for highly transfused patients change? 13

k. What is the CJD Incidents Panel? 13

l... What does the CJD Incidents Panel recommend? 13

1. Introduction

This information leaflet accompanies Annex J of the ACDP TSE Working Group infection control guidance[1]. This leaflet,and related documents are available on the HPA website[2].

Annex J describes how to assess pre-surgical patients for their risk of variant Creutzfeldt-Jakob disease (vCJD) and other transmissible spongiform encephalopathies (TSE). It includes new guidance on assessing patients undergoing surgery or neuro-endoscopy on high risk tissues. This includes identifying patients who have received blood from 80 or more donors, and may have an increased risk of vCJD. This leaflet aims to give practical information on how to assess these patients, and how to manage those who have an increased vCJD risk because of their transfusion history, or have an incomplete or uncertain transfusion history.

Box 1 High risk tissues for patients with vCJD and at risk of vCJD

brain

spinal cord

dura mater

cranial nerve ganglia

cranial nerves,

specifically: the entire optic nerve

only the intracranial components of other cranial nerves

posterior eye,

specifically:

posterior hyaloid face

retina

retinal pigment epithelium

choroid

subretinal fluid

optic nerve

pituitary gland

2. Preparation and planning

--------------------------------------------------------------------------------


[1] http://www.dh.gov.uk/ab/ACDP/TSEguidance/index.htm



[2] http://www.hpa.org.uk/vCJDpresurgicalassessment



SEE FULL TEXT ;


http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1247469061870



Latest news 16 November 2009: Annex C: General principles of decontamination and waste disposal

Download

General principles of decontamination and waste disposal: ACDP TSE Working Group Annex C (PDF, 201K)

http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_108602.pdf




12 October 2009:

Alert to urological surgeons – transrectal prostatic biopsy in men at risk of variant CJD Download alert to urological surgeons regarding the equipment used for patients at risk of vCJD requiring transrectal prostatic biopsy (PDF, 28K)

http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_106909.pdf




Annex D - Transport of TSE-infected material Published: December 2003, updated: 23 January 2009

http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_087484.pdf



Transmissible Spongiform Encephalopathy Agents: Safe Working and the Prevention of Infection: Annex J

ANNEX J

Assessment to be carried out before surgery and/or endoscopy to identify patients with, or at increased risk of, CJD or vCJD

Summary of advice (revised July 2009)

Annex J provides a clear and pragmatic way of assessing CJD and vCJD risk prior to surgery or endoscopy. Growing numbers of patients have been informed that they are at increased risk of CJD or vCJD. Therefore it is recommended that all patients about to undergo any surgery or endoscopy should be asked if they have ever been notified as at increased risk of CJD or vCJD. This recommendation is outlined in paragraphs J1 and J2. In addition, patients undergoing surgery or neuro-endoscopy which may involve contact with tissues of potentially high level TSE infectivity (“high risk tissues”) should, through a set of detailed questions, be assessed for their possible CJD/vCJD risk exposure. These questions are outlined in Table J1 and paragraphs J3 to J6.

Annex J has been revised (July 2009) to include a new question to be asked of all patients about to undergo surgery or neuro-endoscopy on high risk tissues. This new question (question 4 in Table J1) has been added to identify those patients who have received blood or blood components from 80 or more blood donors. These patients are now designated as at increased risk of vCJD by the CJD Incidents Panel. Table J1 and paragraph J6 provide guidance on how to identify those patients who have received multiple blood transfusions. An algorithm, included as Appendix A, guides health professionals through the process.

Recommendation for all surgical and endoscopy patients

J1. The CJD Incidents Panel has identified a number of individuals or groups who are at increased risk of CJD or vCJD (see paragraphs J14 – J18). At a local level arrangements should be put in place to ensure that patients who have been notified they are at increased risk of CJD/vCJD are identified before surgery or endoscopy, to allow appropriate infection control procedures to be followed.

All patients about to undergo any elective or emergency surgical or endoscopic procedure should be asked the question: “Have you ever been notified that you are at increased risk of CJD or vCJD for public health purposes?”

J2. The actions to take following the patient’s response to the above question are:

SEE FULL TEXT ;

http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_102856.pdf




Update: Creutzfeldt-Jakob Disease Associated with Cadaveric Dura Mater Grafts --- Japan, 1979--2003 MMWR Weekly December 5, 2003 / 52(48);1179-1181

http://www2.niddk.nih.gov/AboutNIDDK/CommitteesAndWorkingGroups/HGH_CJD_Dec_11_2003_TAB_A.htm




Thursday, October 23, 2008

Creutzfeldt-Jakob Disease Associated with Cadaveric Dura Mater Grafts - Japan, 1979-2008 : UPDATE

http://creutzfeldt-jakob-disease.blogspot.com/2008/10/creutzfeldt-jakob-disease-associated.html



http://www.wellsphere.com/cjd-article/medical-procedures-and-risk-for-sporadic-creutzfeldt-jakob-disease-japan-1999-2008-warning-to-neurosurgeons-and-ophthalmologi/641229



Thursday, January 29, 2009

Medical Procedures and Risk for Sporadic Creutzfeldt-Jakob Disease, Japan, 1999-2008 (WARNING TO Neurosurgeons and Ophthalmologists) Volume 15, Number 2-February 2009 Research

http://creutzfeldt-jakob-disease.blogspot.com/2009/01/medical-procedures-and-risk-for.html



Sunday, May 10, 2009

Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009 (Singeltary submission)

http://tseac.blogspot.com/2009/05/meeting-of-transmissible-spongiform.html


Monday, August 17, 2009

Transmissible Spongiform Encephalopathy Agents: Safe Working and the Prevention of Infection: Annex J,K, AND D Published: 2009

http://creutzfeldt-jakob-disease.blogspot.com/2009/08/transmissible-spongiform-encephalopathy.html



Friday, July 17, 2009

Revision to pre-surgical assessment of risk for vCJD in neurosurgery and eye surgery units Volume 3 No 28; 17 July 2009

http://creutzfeldt-jakob-disease.blogspot.com/2009/07/revision-to-pre-surgical-assessment-of.html




Tuesday, August 12, 2008

Biosafety in Microbiological and Biomedical Laboratories Fifth Edition 2007 (occupational exposure to prion diseases)

http://creutzfeldt-jakob-disease.blogspot.com/2008/08/biosafety-in-microbiological-and.html


Thursday, July 23, 2009

UW Hospital warning 53 patients about possible exposure to rare brain disease

http://creutzfeldt-jakob-disease.blogspot.com/2009/07/uw-hospital-warning-53-patients-about.html



Tuesday, April 21, 2009

Doctor Antonio Ruiz Villaespesa, pathologist and CJD researcher deceased because of Creutzfeldt-Jakob Disease SPAIN

http://cjdusa.blogspot.com/2009/04/doctor-antonio-ruiz-villaespesa.html



Br J Ophthalmol 2005;89:1131-1138 doi:10.1136/bjo.2004.063495 Clinical science Scientific reports Abnormal prion protein in the retina of the most commonly occurring subtype of sporadic Creutzfeldt-Jakob disease M W Head1, A H Peden1, H M Yull1, D L Ritchie1, R E Bonshek2, A B Tullo2 and J W Ironside1 + Author Affiliations

1National CJD Surveillance Unit, University of Edinburgh, Western General Hospital, Edinburgh EH4 2XU, UK 2Academic Department of Ophthalmology, Manchester Royal Eye Hospital, Manchester M13 9WH, UK Correspondence to: Dr M W Head National CJD Surveillance Unit, Bryan Matthews Building, Western General Hospital, Edinburgh EH4 2XU, UK; m.w.head@ed.ac.uk Accepted 7 March 2005 Abstract Background: Involvement of the eye has been reported in patients with variant Creutzfeldt-Jakob disease (vCJD), but there is disagreement on whether retinal involvement occurs in sporadic Creutzfeldt-Jakob disease (sCJD).

Methods: Western blotting, paraffin embedded tissue blotting, and immunohistochemistry were used to test whether the abnormal form of the prion protein (PrPSc) accumulates to detectable levels in the eye in a case of the most common subtype of sCJD (MM1).

Results: Low levels of PrPSc were detectable in the retina, localised to the plexiform layers of the central retina. PrPSc was not detectable in other ocular tissues.

Conclusions: The abnormal form of the prion protein is present in the retina in the most common sCJD subtype (MM1), albeit at levels lower than those found previously in vCJD and in sCJD of the VV2 subtype.

http://bjo.bmj.com/content/89/9/1131.abstract


Friday, August 07, 2009

CJD Human Cornea Tissue, Recall END OF ENFORCEMENT REPORT FOR AUGUST 5, 2009

http://creutzfeldt-jakob-disease.blogspot.com/2009/08/cjd-human-cornea-tissue-recall-end-of.html


Wednesday, August 12, 2009

Unique clinicopathological features and PrP profiles in the first autopsied case of dura mater graft-associated Creutzfeldt-Jakob disease

http://creutzfeldt-jakob-disease.blogspot.com/2009/08/unique-clinicopathological-features-and.html




Tuesday, August 11, 2009

Characteristics of Established and Proposed Sporadic Creutzfeldt-Jakob Disease Variants

http://creutzfeldt-jakob-disease.blogspot.com/2009/08/characteristics-of-established-and.html



Monday, July 27, 2009

U.S.A. HIDING MAD COW DISEASE VICTIMS AS SPORADIC CJD ?

WHY DID THIS VIDEO NOT SHOW ON EVERY NEWS CHANNEL IN THE U.S.A. $$$

IT IS A DAMNING VIDEO !!!

I WATCHED THIS RECENTLY, and had never seen it. i was so mad, i was spitting nails out faster than a framing gun.

WHY DID THE CANADIAN MEDIA ONLY PRESENT THIS TO THE U.S.A. PUBLIC (thank you very much though), and why has the U.S.A. MEDIA FAILED US ???

SNIP...

SEE DAMNING VIDEO AT BOTTOM OF BLOG HERE ;

Monday, July 27, 2009

U.S.A. HIDING MAD COW DISEASE VICTIMS AS SPORADIC CJD ?

http://creutzfeldt-jakob-disease.blogspot.com/2009/07/usa-hiding-mad-cow-disease-victims-as.html



NOW, AFTER SEEING THAT VIDEO, (first watch the video) lets go back in mad cow time here in the USA, shall we.

THERE must be an independent review of this cover-up, and the infamous ENHANCED BSE SURVEILLANCE AND TESTING OF 2004, that was nothing but a cover-up, and blundered at that, and plus a REDO of the testing of no less than 1 million head of cattle tested each year, for five years, with scientist from the EU overseeing the testing protocols, surveillance, and confirmation of all cases.

this video states the 'USA had to _admit_ a home grown case of mad cow in TEXAS." fact was, they did not finally admit anything, IT TOOK AN ACT OF CONGRESS, THE HONORABLE PHYLISS FONG AND THE O.I.G., TO MAKE THEM RETEST AND CONFIRM! that my friend is fact. and only after Prof. Aguzzi, Dr. Jean-Philippe Deslys, Dr. Collinge et al slammed them over the testing of that animal. and then we had the mad cow in Texas that they just refused to test, and was sent to a pet food rendering plant. NO TEST AT ALL. you must realize, when other officials, doctors, and such from other country's confront issues about things in the USA, they must walk on ice when doing so. read inbetween the lines here ;

i wrote all these scientist and doctors and the OIG about that damn texas cow, gave them the evidence i had from TAHC. so did others, but finally fong et al did something.

a bit of history for you mel. file this away. ...

Tuesday, July 28, 2009

MAD COW COVER-UP USA MASKED AS SPORADIC CJD

http://madcowtesting.blogspot.com/2009/07/mad-cow-cover-up-usa-masked-as-sporadic.html



The most recent assessments (and reassessments) were published in June 2005 (Table I; 18), and included the categorisation of Canada, the USA, and Mexico as GBR III. Although only Canada and the USA have reported cases, the historically open system of trade in North America suggests that it is likely that BSE is present also in Mexico.

http://www.oie.int/boutique/extrait/06heim937950.pdf



Tuesday, July 14, 2009

U.S. Emergency Bovine Spongiform Encephalopathy Response Plan Summary and BSE Red Book Date: February 14, 2000 at 8:56 am PST

WHERE did we go wrong $$$

http://madcowtesting.blogspot.com/2009/07/us-emergency-bovine-spongiform.html


Saturday, January 2, 2010

Human Prion Diseases in the United States January 1, 2010 ***FINAL***

http://prionunitusaupdate2008.blogspot.com/2010/01/human-prion-diseases-in-united-states.html



my comments to PLosone here ;



http://www.plosone.org/annotation/listThread.action?inReplyTo=info%3Adoi%2F10.1371%2Fannotation%2F04ce2b24-613d-46e6-9802-4131e2bfa6fd&root=info%3Adoi%2F10.1371%2Fannotation%2F04ce2b24-613d-46e6-9802-4131e2bfa6fd



TSS

Labels: , , , , , ,

Monday, August 31, 2009

HUMAN BODY PARTS FOR SALE TO THE HIGHEST BIDDER Inside a Creepy Global Body Parts Business

SPIEGEL ONLINE - News - International ~~ August 28 2009

42.90 Euros Per Arm

Inside a Creepy Global Body Parts Business By Martina Keller and Markus Grill

The German company Tutogen's business in body parts is as secretive as it is lucrative. It extracts bones from corpses in Ukraine to manufacture medical products, as part of a global market worth billions that is centered in the United States.

Anatoly Korzhak, a pensioner and former engineer, died in Kiev on August 5, 2004. His body was picked up at 2 a.m. and taken to the forensic medicine institute in the Ukrainian capital. That same night, Korzhak's daughter, Lena Krat, received a telephone call and was asked to come to the institute immediately in the morning, where she was told she would receive further information.

It was the first time Krat was confronted with the death of a close relative. "I was so upset that I couldn't think clearly," she recalls. When she arrived at the institute in the morning, a man there said something to her about skin transplants. He was an employee of a Ukrainian company that works hand-in-hand with forensic medicine experts. She said to the man: "Leave me alone. I don't understand what you're talking about, and I don't want to listen to you."

But the employee was persistent and eventually gave her a form to sign. He told her that if she consented to skin removal, she would be helping pediatric burn victims who needed transplants. Krat signed the form. "It was as if I had been hypnotized," she says.

But now Krat, a mother of two young girls, has learned from SPIEGEL that the Ukrainian company in question sends the body parts to a German company, Tutogen Medical GmbH, which in turn apparently supplies large numbers of such parts to the American tissue market.

In addition to strips of skin, tendons, bones and cartilage are removed from the bodies. "This shocks me," says Krat. "If I had known that so much is cut out, I would never have given my consent."

A Lucrative Industry The incident in the Ukrainian capital is part of the secretive daily routine of a little-known but highly lucrative branch of the medical industry, in which companies use corpses to make medical spare parts. In doing so, they reuse almost everything the human body has to offer: bones, cartilage, tendons, muscle fascia, skin, corneas, pericardial sacs and heart valves. In the jargon of the profession, all of this is referred to as tissue.

Bones and tendons, the parts that interest Tutogen the most, are subjected to complex processing. The company degreases and cleans bones, cuts, saws or mills them into the desired shapes, then sterilizes, packages and sells the finished product in more than 40 countries around the world. With a prescription, it is even possible to order Tutogen's products through online pharmacies.

Photo Gallery: Tutogen's Global Business in Body Parts 1. HQ: Tutogen headquarters in Neunkirchen am Brand, a town of 8,000 people in northern Bavaria. Body parts extracted in Ukraine are shipped by are to Frankfurt or Nuremberg before being taken here. 2. A photo of the rundown pathology department where autopsies are conducted in the Ukrainian city Dnipropetrovsk. 3. Assistant District Attorney Josh Hanshaft holds a photograph of an X-ray showing the pelvic area of a deceased person with PVC plumbing pipe inserted where bones should have been at a Feb. 23, 2006 press conference in New York. Prosecutors allege four individuals including the head of Biomedical Tissue Services illegally extracted body parts of the deceased and sold them for profit. The case is still pending.

The market for tissue products is still small in Germany. When it comes to bones, for example, experts estimate that only about 30,000 transplants a year are used in hospitals nationwide, mainly for use in bone reconstruction for hip surgery and in spinal column surgery.

It's a completely different story in the United States. According to the American Academy of Orthopedic Surgeons, more than a million bone parts are used in transplants every year. In no other country is it possible to make so much money with body parts. If a body were disassembled into its individual parts, then processed and sold, the total proceeds could amount to $250,000 (€176,000). For a single corpse! The US tissue industry generates total revenues of about $1 billion a year, says journalist Martina Keller, a co-author of this article and the author of the German book, "Cannibalized: The Human Corpse as a Resource."

Legal and Ethical Questions

This raises the question of just how legal the process of obtaining raw materials is. And are bone products made from corpses even medically necessary? According to Klaus-Peter Günther, president of the German Society of Orthopedics and Orthopedic Surgery, they are often "not the first choice" in operations. "For us, the gold standard is still tissue taken directly from the patient in question."

Alternatives are only an option, says Günther, when the material from the patient's body is insufficient. Those alternatives include animal bones and artificial replacement parts made of ceramic material, for example -- or human donor bones.

Many hospitals collect and reuse bone fragments removed from patients who have received artificial hips. "For this reason," says Günther, "we have not had to resort to dead donors so far."

In the United States, doctors have far fewer qualms about using body parts from corpses than their German counterparts -- in such areas as spinal surgery, sports injuries and cosmetic surgery. For instance, doctors used pulverized skin particles to enhance lips and smooth out wrinkles.

Should corpses be butchered to make cosmetic procedures possible? Ingrid Schneider is decidedly opposed to the practice. For the past 15 years the Hamburg political scientist, a former member of the Investigative Commission on Law and Ethics in Modern Medicine in the German parliament, has been involved in the subject of recycling body substances. Schneider argues that the body is not a source of raw materials that can be sold at will. Given such concerns, it is not surprising that many people are deeply opposed to allowing the body of a family member to be reused, even for medical purposes.

Even if it is unrealistic to expect that all commercialization of the body could be ruled out in modern medicine, says Schneider, it is important to set boundaries. For that reason, she insists that human tissue ought to be used sparingly -- that is, only when such use is medically necessary and clearly superior to other forms of treatment.

The conviction that the body is much more than an object has also shaped the policies of the World Health Organization (WHO), the European Parliament and the European Council, the EU's body representing the leaders and ministers of the 27-member bloc. All of these bodies condemn the practice of trading in human body parts to turn a profit.

In Germany, the country's organ transplant act regulates the removal of tissue. Only those who have consented to organ and tissue harvesting are considered as donors. If a person dies and is not already a donor, his or her closest relatives can consent to donation. Paragraph 17 of the transplant act explicitly states: "Trading in organs or tissue intended for use in the medical treatment of others is prohibited." Physicians who remove tissue can only be paid suitable compensation for their efforts. The law calls for prison sentences of up to five years for violation of the trading prohibition.

Part 2: A Booming Tissue Market Tutogen paid its Ukrainian partners a fixed price for each body part. In January 2002, the company paid €42.90 for a complete femur, €42.90 for a humerus and €13.30 to €16.40 for a pericardial sac, depending on its size. Graduated prices were also arranged with the Ukrainians. Take, for example, the removal of patellar tendons with bone segments, known as "bond-tendon-bone," or BTB. When coroners supplied less than 40 BTBs on-site, Tutogen paid €14.30 apiece. For larger numbers of BTBs, the price went up: to €23 apiece for 40 or more BTBs and to €26.10 for 60 or more. For a coroner, who makes about €200 ($287) a month in Ukraine, such graduated prices must have been an incentive to remove as much body material as possible.

Thousands of pages of internal memos, faxes, supply lists and documents from the years 2000 to 2004, which SPIEGEL has obtained, suggest that not only did Tutogen process the Ukrainian body parts itself, but it also supplied the US tissue market.

Florida-based RTI Biologics, one of the US market leaders in the industry, generated $147 million in sales in 2008. The company describes itself as the "leading provider of sterile biological implants for surgeries around the world."

To that end, RTI acquired Tutogen Medical, Inc., the American parent company of the German company Tutogen Medical GmbH, last year. The acquisition was good news for RTI shareholders, because of Tutogen's large international donor network, says CEO Brian Hutchison. Put differently, Tutogen is a company that knows the ins and outs of gaining access to as many body parts as possible.

The body parts from Ukraine are shipped by air to Frankfurt or Nuremberg. From there, they are taken to Tutogen headquarters in Neunkirchen am Brand, a town of 8,000 people in northern Bavaria.

Tutogen's facilities in Neunkirchen, just a few kilometers north of Nuremberg, comprise several low, warehouse-like buildings, where about 140 employees work. All in all, it is an inconspicuous place for visitors who fly in regularly from Ukraine and the United States.

Company President Karl Koschatzky refused to respond to requests for an interview, and the company declined to answer a list of questions sent to its offices.

The Middleman Tutogen uses a middleman to organize its deliveries from Ukraine. Dr. Igor Aleshenko, a coroner by training, manages the company's relationships with the various local forensic medicine institutes. He has been working for Tutogen in Ukraine for about 10 years.

In that time, Aleshenko has become a wealthy man, and he now divides his time between his two residences, one in Kiev and one in Moscow. In 2002, Tutogen described Aleshenko as a "cost-intensive person." He too was unavailable for an interview in Kiev, nor did he respond to written questions.

In Ukraine, Aleshenko is far more than Tutogen's local contact. He is the director of Bioimplant, a company that manages tissue removal. Because of its close ties to the Ukrainian Health Ministry, Bioimplant is practically immune to overly probing government inspections of bone shipments crossing the border.

Ukrainians are kept somewhat in the dark when it comes to Bioimplant's true business dealings. According to the company's Web site, its "primary activity" is the "production of bio-implants" for use in Ukrainian patients. But what does Bioimplant really do?

Kiev, on a summer's day in 2009. Anyone seeking to pay a visit to Bioimplant's headquarters would be inclined to head to the company's official address at Patrice Lumumba Street 4/6, an office building with a number of tenants -- where Bioimplant doesn't even have its own mailbox.

A guard and a doorman greet visitors and send them to the fourth floor, where Bioimplant's offices are supposedly located. Room 305 is in a long hallway of closed doors. There is not even a sign to identify the room as being associated with Bioimplant. A young man in a pinstriped suit opens the door. He says that he hasn't been working for Bioimplant for very long, and that most of his work consists of photocopying.

According to the young man, the company leases three rooms in the office complex, but Dr. Aleshenko is not in today. Tutogen brochures and packets of sterilized corpse bones are stacked in the next room. Instead of the expected production facility, the offices are nothing but a distribution site.

Tutogen developed its business relationship with Aleshenko about 10 years ago. During a trip to Tutogen headquarters in the Bavarian countryside in November 2001, Aleshenko met with Koschatzky at the Bayerischer Hof Hotel in Erlangen, near Nuremberg. The minutes of the meeting contain a list of "new pathologies" working for Tutogen in the eastern Ukrainian cities of Dnipropetrovsk, Poltava and Zhytomyr.

Aleshenko had apparently brought along a wish list to the meeting, and his German business partners were eager to comply. According to the minutes, "TTG (Tutogen) agreed to provide 5,000 deutsche marks for investment costs in Dnipropetrovsk (Ukraine). Dr. Aleshenko will send us the necessary payment instructions."

Unkosher Discussions Some of the issues discussed at the meeting were less than kosher. For instance, the minutes state, "TTG is testing whether depilation of the corpse prior to skin removal could alleviate the hair problem (perhaps using the hot wax or cold wax method)."

A list of "pathologies currently providing (parts)," dated November 2001, already included abbreviations for 15 facilities in Ukraine. In the 2000-2001 fiscal year alone, 1,152 bodies in Ukraine were used to provide tissue for Tutogen.

But it still wasn't enough for the company, which needed more cooperating institutions, more donors and more bone parts to supply a booming tissue market.

According to an internal planning document dated June 17, 2002 (the file is titled "Raw Tissue Requirements"), Tutogen needed the following parts for the coming fiscal year:

* 2,920 shafts of the femur,

* 3,000 iliac crests,

* 1,190 patellar tendons,

* 3,750 kneecaps,

* 10,200 femoral muscle fascia (or fascia lata),

* 50 cranial bones,

* 70 Achilles tendons.

Aleshenko, who Tutogen apparently paid directly for the tissue parts, is believed to have funneled part of the money to coroners in Dnipropetrovsk, Kiev, Kharkiv and other Ukrainian cities. According to an internal list of "paid incoming goods," Tutogen's Ukrainian partner received roughly €350,000 between January and August 2001.

The investment must have paid off. Online pharmacies charge between €367 and €854, depending on the size, for a Tutoplast Spongiosa Block (Bone Substance). According to the price lists used at the time, the Ukrainians received between €23 and €26.10 for the original body part, again depending on the size. Even if Tutogen were paying twice as much for the raw material today, it would still be a bargain.

Part 3: Tissue and Organ Harvesting

Not surprisingly, Tutogen could afford to be generous to its Ukrainian partners. That generosity included large quantities of equipment the company routinely sent to its hardworking coroners.

According to the internal documents, in the 2000-2001 fiscal year Tutogen shipped 6,000 scalpels, 2,600 pairs of sterile gloves, 500 surgical gowns, 15 hacksaw blades for autopsies and many other items to Ukraine -- at a total cost of €40,000 in "donor expenses without tissue," as the Tutogen bookkeepers noted fastidiously. Tutogen paid its Ukrainian partners roughly €500,000 for the body parts during the same period.

The US Food and Drug Administration (FDA) currently lists 20 facilities in Ukraine that are authorized to supply body parts for the US market. But no matter which of these facilities one clicks on in the FDA database, all share the same contact information: the telephone number of Tutogen Medical GmbH in northern Bavaria.

One of the facilities on the list is the forensic medicine institute in Krivoy Rog, an industrial city in southeastern Ukraine, with a population of about 700,000. According to the FDA database, the Krivoy Rog site is authorized to supply bones, cartilage, fascia, ligaments, pericardial sacs, sclera (the white of the eye), skin and tendons.

Tissue and Organ Harvesting The whitewashed, Spartan structure housing the forensic medicine institute is on the edge of the hospital grounds. Frosted glass windowpanes behind latticed windows discourage prying eyes. Visitors immediately notice the cloying odor of corpses upon entering the building. The director of the institute is unavailable, even though his car is parked on the hospital grounds. A doctor wearing a denim jacket assumes the task of getting rid of anyone inquiring about the institute's collaboration with the German company.

Instead, he tells the reporters to contact the district attorney's office and points to a sign above the door, which reads: "No Admittance without Authorization." Does that include Tutogen, the reporters ask? "No, Tutogen is not unauthorized here," the man says, indicating that the conversation is over.

The former director of the city's forensic medicine department, Vladimir Bondarenko, is slightly more forthcoming. A retiree, he meets with visitors at a street café. Tissue harvesting began at his department about 10 years ago, says Bondarenko.

"It was illegal," he says. "The family members should have been told about what was happening with the bodies," but they had no idea. "When the deceased is lying in the coffin, the family members see nothing but the face. What they don't see is that the bones of the legs or arms have been removed."

The Ukrainian tissue transplant act includes a provision stating that family members must consent to tissue donation if the deceased did not already do so while still alive. However, there are indications that this was often not the case. Ukrainian authorities in Krivoy Rog and several other cities are conducting investigations into suspected illegal tissue and organ harvesting.

The case of the deceased father of Kiev resident Lena Krat, for example, was examined in connection with an investigation identified by the file number 50-3793, begun on Jan. 4, 2005. The investigation included all incidents that took place between May and September 2004. The names of 10 deceased persons are listed in the files. Their family members stated that they "did not consent to the removal of anatomical material."

According to the court order authorizing the proceedings, "family members were deceived, in that they were told that only a small part of the deceased would be removed, such as a bone or tissue fragment. In actual fact, almost all bones and tissue were removed. ... All of the material is taken to Germany."

A Legal Twist Despite the evidence, the Kiev district attorney's office closed the proceedings in July 2005, "for lack of a statutory offense." Curiously, the document states, as grounds for dropping the case, that the Bioimplant employees had not violated the transplant act, because they had not transplanted material from corpses, but had merely removed it so that it could be processed into "bio-implants." As a result of this legal twist, the recycling of corpses has been allowed to continue to this day.

Kiev, the forensic medicine institute on Orangery Street: A long, brick building, from which doctors wearing light-green aprons occasionally emerge to smoke cigarettes outside the front door. Family members stand next to the entrance, waiting for the release of their dead relatives. There is a display of coffins and wreaths in front of a funeral parlor across the street.

Vladimir Yurchenko is the director of the institute. He points to the room where bodies are processed for Tutogen. It is on the ground floor and sealed off to outsiders. Why? "Because that's what the US health authorities require," says Yurchenko.

Kiev's senior forensic pathologist explains the process. Bioimplant obtains the relatives' consent, and company employees also come to the institute to harvest the body parts. Yurchenko's staff members assist in the process, for which they receive additional compensation. Once bones and other parts have been removed, wooden sticks are inserted into the body so that it retains its shape until the funeral.

The harvested bones, tendons and pieces of cartilage are stored in zinc-plated metal boxes in a refrigerated room in the basement. "The tissue parts are brought up once every few weeks, when a truck comes and takes them away," says Yurchenko. Karl Koschatzky, the secretive Tutogen executive from Bavarian, also turns up occasionally.

Part 4: 'A Source of Raw Materials' According to Yurchenko, about 8,000 corpses a year are delivered to the forensic medicine department. Of that number, more than 5,000 are potential bone donors, but family members only consent to harvesting from about 150 bodies. If the two facilities in the capital already provide parts from about 150 bodies each, as Yurchenko says, and if a total of 20 facilities in Ukraine are registered with the FDA -- and, therefore, are collaborating with Tutogen -- it can be assumed that the German company obtains its body parts from large numbers of Ukrainian corpses. "All we are for the rich countries is a source of raw materials," says Yurchenko.

In May 2004, Tutogen signed a five-year contract with Bioimplant, which describes the process as follows: The Ukrainians transfer harvested tissue to Tutogen in Germany to have it processed into products. But this processing is costly. How does the Ukrainian company pay for the expensive processing? The answer is deceptively simple: with the bones, from Ukrainian corpses, that have been processed into products in Germany. This is the currency accepted by both parties to the arrangement.

What the agreement does not state is that the Germans were not producing products for Bioimplant, but were ordering substantial amounts of raw material from the Ukrainians every month.

At times, much larger numbers of body parts from Ukraine and other countries were arriving in Neunkirchen than Tutogen could even process. A document titled "Inventory, Raw Material Storage 1," dated March 2000, reveals the scope of this excess material. According to this inventory document, Tutogen warehouses already contained 688 patellar tendons, 1,831 kneecaps, 1,848 fibula, 2,114 fascia and 1,196 foot bones, or a total of more than 20,000 body parts.

In June 2002, Tutogen employees wrote the following comments in the minutes of a meeting: "Warehouse problems. More tissue than necessary continues to be delivered. Solutions are needed to address this problem."

The company documents also include references to the kinds of solutions Tutogen had in mind. According to an internal memo dated April 2002, a Ms. R. noted "that there is no longer any storage capacity in the deep freezers. Efforts must be stepped up to ship tissue to the USA."

According to a document dated June 2002, which lists the "Raw Tissue Requirements for USA Needs," the US partners required the following monthly supply:

* 119 iliac crests,

* 667 pieces of fascia lata,

* 267 kneecaps,

* 243 shafts of the femur.

Did Tutogen Break the Law? Apparently, the deliveries to the United States were not only sent to the parent company in Florida, Tutogen Medical Inc., which could have been explained as a way of shifting the problem within the company, but also to RTI, the company's US competitor at the time.

In a table detailing a shipment from Lugansk in Ukraine, delivered on Dec. 7, 2001, a sum of €62,000 is quoted, but the recipient is identified as "TM/RTI."

If Tutogen was indeed shipping unprocessed tissue to the United States, this could constitute an act of engaging in illegal tissue trade, provided a profit was generated as a result.

In a memo dated April 4, 2002, a Tutogen employee issued the following cautionary statement: "We should avoid shipping unprocessed raw material to TMUS (Tutogen USA), so as not to create the impression of engaging in the tissue trade."

The German Institute for Cell and Tissue Replacement, another major bone producer, categorically rejects such practices. Director Hans-Joachim Mönig insists that "obtaining raw tissue from one country and passing it on to third parties is against the law. In our view, this constitutes the crime of trading in tissue."

To date, its collaboration with Aleshenko and the Kiev Health Ministry has worked exceedingly well for Tutogen. All investigations against Tutogen's Ukrainian partners in Krivoy Rog, Kiev and Dnipropetrovsk have been suspended.

But that could change. Last year, the public prosecutor's office in Krivoy Rog launched a new investigation.

Once again, forensic medicine employees, as the public prosecutor's office states in response to SPIEGEL's inquiry, are suspected of "having used coercion and fraud to obtain the consent of family members for the removal of tissue and other anatomical material for purposes of transplantation." Seventeen family members of the deceased have already testified.

On Jan. 9, 2009, the district attorney's office submitted the case to the relevant district court, where the case is still underway.

Lena Krat, the Kiev woman who was persuaded to release her father's body for tissue harvesting in 2004, would be pleased to see those responsible finally brought to justice. "Those people are truly guilty," she says, "and I am outraged that these terrible things are still taking place."


http://www.spiegel.de/international/europe/0,1518,645375,00.html





DER SPIEGEL (9/2001) - 24.02.2001 (9397 Zeichen)USA: Loch in der MauerDie BSE-Angst erreicht Amerika: Trotz strikter Auflagen gelangte in Texasverbotenes Tiermehl ins Rinderfutter - die Kontrollen der Aufsichtsbehördensind lax. Link auf diesen Artikel im Archiv: http://service.spiegel.de/digas/find?DID=18578755"

Its as full of holes as Swiss Cheese" says Terry Singeltary of the FDA regulations. ...



http://service.spiegel.de/digas/servlet/find/DID=18578755





http://usdameatexport.blogspot.com/2008_01_01_archive.html




2001


Last, but not least. The illegal/legal harvesting of body parts and tissues will come back to haunt you. Maybe not morally, but due to NO background checks and human TSEs, again it will continue to spread.



http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf






Tutogen Medid,U.S.,Inc.

December 9, 2002

Dockets Management Branch (HFA-305)
Food and Drug Administration5630 Fishers Lane,Rm. 1061Rockville, MD 20852

RE: Docket No. 02D-0266, CBER 150. Draft Guidance for Industry: Preventive Measures toReduce the Possible Risk of Transmission of Creutzfeldt-Jakob disease (CID) andVariant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular andTissue-Based Products (HCT/Ps); Availability. Pages 42789--42790 FR Dot. 02-158981

Tutogen Medical Inc. (“Tutogen”) appreciates the opportunity to comment on the draft documentissued by the FDA in June 2002 entitled: “Preventive Measures to Reduce the Possible Risk ofTransmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease(vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) ” Inparticular, we wish to use this venue to respond to your request for data assessing the impact ofthe recommendations contained therein to reduce the risk of CJD and vCJD on the availability ofHCT/P.


snip...


1. # of Tissue Banks reporting 63

2. # of tissue donors recovered (HCT/P domw population) 18,021

3. # of Bone allografts dlstributed in U.S. 675,370

4. Volume of Skin grafts distributed in U.S. 11,222 ft2

1Excerpt Corn “Background” statement contained in the American Association of Tissue Banks MembershipDirectory 2001-2002.


snip...


II. Impact of donor deferral upon the availability of HCT/ps: During the year 2001, Tutogenprocessed 3,500 donors recovered by our contract recovery agencies from various locationsincluding Europe. In the 12 months from July 1, 200l to June 30, 2002, Tutogen distributed atotal of 21,639 musculoskeletal allograft products to patients in the U.S. Based upon the dataabove, this represents approximately 3% of the total number of bone allograft productsdistributed by AATB accredited Banks in the United States.
The implementation of the FDA’s proposed guidance would immediately reduce the number ofavailable HCT/P donors by approximately 10% in the U.S. due to country of origin exclusion.The direct impact to Tutogen would be an approximate 50% reduction in our donor base orapproximately 10,820 musculoskeletal allograft products. Therefore, the impact of this proposalfrom the FDA upon Tutogen would be greater than upon any other U.S. based tissue bank.Among the remaining 16,271 HCT/P donors (approximately) recovered by other AATBaccredited organizations annually, a large percentage would be eliminated under the proposedFDA rule that would disqualify any donor who has visited a listed country for a cumulativeperiod of 6-months or more. Not only would frequent travelers be considered deferred donors,but a large share of military veterans and their immediate family members due to being stationedoverseas. Tutogen does not have verifiable data concerning these figures, however, it is notinconceivable that this would adversely impact the donor pool by at least an additional 6% ormore, based on the blood bank industry experience, this would translated to a 976 HCT/P donors.The combination of Tutogen’s and the rest of the tissue banks would total approximately 2,726HCT/P donors. .

III. Musculoskeletal allografl tissue has been scientijiiaUy classified as low risk forCVZWCJD transmission. As with other AATB certified organizations, Tutogen allograftproducts are used across a multitude of medical applications. Currently, none of TutogenHCT/Ps in the United States are so-called high-risk tissue such as dura mater or corneas (refer toAppendix 1).
Not all tissue has the same infectivity risk. The HCT/Ps utilized by Tutogen in allografiproducts, distributed in the US, are classified as Category IV tissue (i.e., “No detectible @Jo-)infectivity”) by the World Health Organization in its March 19972 study.Tutogen has not processed or distributed in the United States high-risk Category II tissue such asdura mater since June 2000. Tutogen has never processed or distributed comeal tissue.Therefore the effect of any donor deferral ruling by the FDA on HCT/Ps limited to high-riskCategory II tissue, will not have any effect upon Tutogen’s ability to continue providing HCT/Psin the United States as shown in the table above.

2 World Health Organization, Emerging and other Communicable Diseases Report of a WHO consultation onmedicinal and other products in relation to human and animal transmissible Spongiform Encephalophathies.

2


IK Tutoplast safe@ claims are supported by a long-hktory (25 consecutive years) ofsuccessful allograft implants:

Tutogen HCT/Ps are recovered following a very stringent donor selection criterion in accordancewith AATB standards and FDA regulations. The current industry standard concerning CJDsignificantly reduces the risk of harvesting tissue from a potentially infected HCT/P donor.All Tutogen HCT/Ps are processed using a proprietary system known as the Tutophst 8 process.Tutogen’s single donor tissue processing methods (no pooling of donors) have been shown toensure viral/bacterial inactivation in controlled studies. The Tutopht 8 process has beenvalidated, specifically for the inactivation of prions and other transmissible agents. Twoindependent studies have confirmed that the Tutophst 8 process is capable of removinginfectious Prion agents from sol? tissue as a result of treating soft tissue with sodiumhydroxide. ‘4

Recommendations:

Tutogen recognizest hat the spread of bovine spongiform encephalopathy, or mad cow disease,has prompted debate concerning the possible modification of recent deferral criteria Tutogenurges the FDA to continue inviting scientists, physicians and patient groups to participate in thispolicy discussion. Physicians must be given accurate information about the benefits and risks,both real and theoretical associatedw ith HCT/P transplantations o that they can effectivelyeducate every patient when an HCT/P transplant is needed.

While Tutogen also recognizes that studies about the potential for transmission of TSEs inanimal models continue, however, evidence is still lacking of such transmission among patientswho have received human tissues, blood transfusions and clotting factor concentrates. Tutogenrespectfully requests that the Food and Drug Administration, before any final ruling, addressissues sited herein, by limiting its definition of deferred donor to those cases where high-riskCategory II tissue is being implanted (e.g., dura mater, corneas), and/or to those cases wheretissue recovery and processing methods being used pose additional risks.

Conclusion:

The very low incidence of human CJDMXD and our current screening criterion already poses alow risk that an infected donor may enter the process. The Centers for Disease Control andPrevention reports that the incidence of CJD is one case per million people each year.3Robert Koch Institut in Berlin (Department of the German FederalI nstitute of Health) Diringer H, Braig H,Infectivity of unconventional viruses in duramater,The Lancet, February 25, 19894L aboratorieso f RBM, Ivrea, Italy and expert opinion by Dr. Masullo (NurosurgeonM) asullo, 1994, Estimate ofthe theoretical risk of transmission of Creutzfeld-Jacob Disease by human duramater grafts manufactured by theTutoplast process.R MB, Studienbericht1, 994, Determination of the clearance factor for unconventional slowviruses during the processing of duramater.

3


Based upon the track record of safety, quality, and clinical effkacy of mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000055/!x-usc:mailto:TutopZast@%20and theproduct approval protocols adhered to by Tutogen, and already audited by the FDA, relating tothe import of HCT/Ps into the U.S. from Europe, we do not believe that there is any additionalrisk associated with HCT/Ps recovered and processed by Tutogen. Given the scientific dataavailable today, Tutogen does not believe that a blanket ruling to defer HCT/P donors fromspecific counties would reduce CJD and vCJD risk in cases where a validated recovery andprocessing procedure is being used. Indeed, the impact of a deferred donor ruling as presentlyproposed would significantly reduce the availability of HCT/Ps in the United States (up to 20%or more based upon the data contained herein) without a commensurate and measurable riskreduction in CJD and vCJD transmission.

Very truly yours,
Wade S, Tetsuka
Tutogen Medical U.S., Inc.General Manager
P.J. PardoTutogen Medical U.S., Inc.Director,Regulatory Affairs/ Quality Management



Appendix 1: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000055/!x-usc:mailto:Tutoplast@P rocessedA llografks Distributed
Spinal / TraumaSulzer SpineTech,Minneapolis MNOphthalmologyIOP, Inc., Costa Mesa, CAENTUrologyMentor Corp., SantaBarbara, CADentalSulzer Dental, Carlsbad, CASpinal Fusion, ACL,Rotator Cuff repairGlaucoma patch, eyebrowslings, enucleationwraps, poterior segment,eyelid spacersTymp~oplasty,CholesteomaR esectionPelvic Floor repair,urinary incontinencePeridontal implantsFemur, Ulna, Radius,Humurous with cuff,anterior cruciateligament.Sclera, Pericardium,Fascia LataSclera, Pericardium,Fascia TemporalisFascia Lata,Pericardium,D ermisCancellousb onec hipsfrom femur, ulna, radius4,000 grafh8,000 grafts2,000 grafls9,000 grafts17,000 grafts


http://www.fda.gov/ohrms/DOCKETS/dailys/02/Dec02/121002/02d-0266.pdf





From: TSS
Subject: Possible body parts theft ring uncovered (spreading TSEs from stolen body parts perfectly legal in Texas after 4 hours)Date: December 24, 2005 at 7:36 am PST
Dec. 23, 2005, 11:44PMPossible body parts theft ring uncoveredSkin and bones are alleged to have been sold secretly

By TOM HAYSAssociated Press

NEW YORK - Michael Bruno's life had been uncomplicated: He was an immigrant who worked hard, spoke his mind and succumbed to kidney cancer two years ago at 75.

"Typical Italian cab driver," recalled his son, Vito. "He had an opinion about everything."
It's only after death that his story became ghoulish.

Authorities believe his body and those of hundreds of other people — including famed British broadcaster Alistair Cooke — were secretly carved up in the back rooms of several funeral parlors citywide to remove bone, skin and tendons, without the required permission from their families. Authorities allege the body parts were then sold for a profit.

Worse, health officials fear some of the stolen body parts were diseased, and could infect patients who received them in skin grafts, dental implants or other orthopedic procedures — a risk concealed by paperwork doctored with forged signatures and false information.

"It's not just disrespectful to my father," said Vito Bruno, who has sued one of the funeral homes. "It's an absolutely hideous crime against other people."

In the Cooke case, authorities confirmed this week that investigators contacted the late broadcaster's family after finding paperwork indicating his bones had been removed and sold by a Fort Lee, N.J., tissue bank, Biomedical Tissue Services, before he was cremated. Cooke, best known as the host of PBS's Masterpiece Theatre, died from cancer last year at 95 in Manhattan.
Violation of FDA rulesThe family insists it never signed off on the procedure, and that someone had falsified documents by changing his cause of death to heart attack, and by lowering his age to 85. Harvesting bones from cancer patients violates rules by the Food and Drug Administration.
A state grand jury in Brooklyn has been hearing evidence against at least a half dozen funeral homes in the borough and against Biomedical Tissue Services. Authorities allege that they illegally profited by conspiring to sell stolen body parts, and say indictments could be handed up early next year.

The scandal's reach extends beyond the New York City area. In the fall, the FDA ordered a recall of products produced by tissue processors in Texas, New Jersey, Florida and Georgia, all customers of Biomedical Tissue Services.

Health officials advised physicians that patients who were implanted with the tissue should be tested for HIV, hepatitis and other infectious diseases. The officials said they believed the health hazards were minimal, and no infections have been reported since the FDA warning.
But past cases have demonstrated dire risks. In 2001, a Minnesota man died after a knee surgery from an infection traced to cartilage from an infected donor. A year later, health officials in Oregon announced that several patients were infected with hepatitis C after receiving donated organs and tissue from a single corpse.

Authorities say the Brooklyn case stems from a deal struck between a dentist who started Biomedical Tissue Services, Michael Mastromarino, 42, of Fort Lee, and Joseph Nicelli, 49, an embalmer and funeral parlor operator from Staten Island.

Alleged harvesting schemeInvestigators suspect Nicelli helped secure access to tissue and bones from funeral directors for $500 to $1,000 a body. Mastromarino allegedly would remove the body parts, then ship them to processors paying thousands of dollars per order.

Attorneys for Nicelli and Mastromarino did not respond to numerous phone messages left by the Associated Press, but have previously denied that their clients did anything wrong. A phone number listed for Biomedical Tissue Services was disconnected.


http://www.chron.com/disp/story.mpl/nation/3545690.html


Dec. 23, 2005, 11:05AM

Authorities Probe Theft of Body Parts

By TOM HAYS Associated Press Writer© 2005 The Associated Press

NEW YORK — Authorities are investigating allegations that hundreds of bodies were illegally carved up in funeral homes around New York City and sold for parts without the permission of the families of the deceased.

Corpses _ including that of famed British broadcaster Alistair Cooke _ were used to harvest human bone, skin and tendons which were then sold for a profit, authorities allege.
Worse, health officials fear some of the stolen body parts were diseased, and could infect patients who received them in skin grafts, dental implants or other orthopedic procedures _ a risk concealed by paperwork doctored with forged signatures and false information.
"It's not just disrespectful to my father," said Vito Bruno, who has sued one of the funeral homes after his father Michael's corpse was desecrated. "It's an absolutely hideous crime against other people."

In the Cooke case, authorities confirmed this week that investigators contacted the late broadcaster's family after finding paperwork indicating his bones had been removed and sold by a Fort Lee, N.J., tissue bank, Biomedical Tissue Services, before he was cremated. Cooke, best known as the host of "Masterpiece Theatre," died from cancer last year at 95 in Manhattan.
The family insists it never signed off on the procedure, and that someone had falsified documents by changing his cause of death to heart attack, and by lowering his age to 85. Harvesting bones from cancer patients violates rules by the Food and Drug Administration.
A daughter, Susan Cooke Kittredge, said the family was "shocked and saddened" by the news.
"That people in need would have received his body parts, considering his age and the fact he was ill when he died, is appalling to the family, as is that his remains were violated," she said.
The probe _ first reported by the Daily News in October _ has generated other gruesome stories. In one instance, the corpse of a Queens grandmother that investigators exhumed last month had nearly all the bones removed below the waist and replaced with PCV pipes.
A grand jury in Brooklyn has been hearing evidence against at least a half dozen funeral homes in the borough and against Biomedical Tissue Services that they illegally profited by conspiring to sell stolen body parts. Authorities say indictments could be handed up early next year.
The brewing scandal's reach extends far beyond the New York City area.

In the fall, the FDA ordered a recall of products produced by tissue processors in New Jersey, Florida, Georgia and Texas, all customers of Biomedical Tissue Services. Since the announcement, authorities in Canada have determined that about 300 potentially tainted products were imported there, and used for dental surgery on at least two patients.
Health officials advised physicians that patients who were implanted with the tissue should be tested for HIV, hepatitis and other infectious diseases. The officials said they believed the health hazards were minimal, and no infections have been reported since the FDA warning.
But past cases have demonstrated dire risks.

In 2001, a Minnesota man died after a knee surgery from an infection caused by a bacterium traced to cartilage from an infected donor. A year later, health officials in Oregon announced that several patients were infected with hepatitis C after receiving donated organs and tissue from a single corpse.

Authorities say the Brooklyn case stems from a deal struck between a dentist who started Biomedical Tissue Services, Michael Mastromarino, 42, of Fort Lee, and Joseph Nicelli, 49, an embalmer and funeral parlor operator from Staten Island.

Investigators suspect Nicelli helped secure access to tissue and bones from funeral directors for $500 to $1,000 a body. Mastromarino allegedly would remove the body parts, then ship them to processors paying thousands of dollars per order.

Attorneys for both Nicelli and Mastromarino did not respond to numerous phone messages left by The Associated Press. A phone number listed for Biomedical Tissue Services was disconnected.

The Brooklyn case demonstrates the potential pitfalls of allowing funeral homes and tissue banks to do business without stricter oversight, said Annie Cheney, author of the upcoming book, "Body Brokers: Inside America's Underground Trade in Human Remains."

"The fact that these people were supposedly able to get away with this for so long is shocking," she said.

http://www.chron.com/disp/story.mpl/ap/nation/3544706.html


Dec. 23, 2005, 10:35AM

Allegations of body part sales investigated

Associated Press

NEW YORK — Authorities are investigating allegations that the body of British broadcaster Alistair Cooke — among hundreds of others — was illegally carved up in the back room of a funeral home and sold so its parts could be used in transplants.

Officials confirmed this week that investigators found paperwork indicating Cooke's bones had been removed and sold by Biomedical Tissue Services, a Fort Lee, N.J., tissue bank, before he was cremated.

Cooke, longtime host of PBS' "Masterpiece Theatre" and known around the world for his "Letter From America" shows on the BBC, died from cancer last year at age 95 in New York.
His family said it never agreed to the bone removal and that someone falsified documents by changing Cooke's cause of death to heart attack and by lowering his age to 85.

A day after his death, Cooke's bones were allegedly sold for about $7,000 to two transplant companies. The family was supplied with what they were told were his ashes, and scattered them in Central Park.

A daughter, Susan Cooke Kittredge, said the family was "shocked and saddened" by the news.
"That people in need would have received his body parts, considering his age and the fact he was ill when he died, is appalling to the family, as is that his remains were violated," she said.
A phone number listed for Biomedical Tissue Services was disconnected.


http://www.chron.com/disp/story.mpl/nation/3544620.html


TSS


----- Original Message -----

From: "Terry S. Singeltary Sr."
To:
Sent: Tuesday, December 20, 2005 4:25 PM
Subject: Re: THE LEGAL TRADING AND SELLING OF BODY PARTS AND HUMAN TSEs IN THE USA


----- Original Message ----- From: "Terry S. Singeltary Sr." To: Sent: Tuesday, December 20, 2005 4:25 PM Subject: Re: THE LEGAL TRADING AND SELLING OF BODY PARTS AND HUMAN TSEs IN THE USA

##################### Bovine Spongiform Encephalopathy #####################

Subject: Biomedical Tissue Services (BTS) THE BODY SNATCHERS and mad cow disease i.e. CJD and other dangerous pathogens Date: December 20, 2005 at 2:05 pm PST

Greetings BSE-L et al;

well, the 'dear unlucky john recipient' letters are in the mail, while these company's are laughing all the way to the bank. ...TSS

Biomedical Tissue Services (BTS) THE BODY SNATCHERS and mad cow disease i.e. CJD and other dangerous pathogens

Body snatchers tied to allograft firms? Alleged New York-area ring investigated for selling parts to corpse tissue harvesters. October 7, 2005: 2:54 PM EDT By Aaron Smith, CNN/Money staff writer

NEW YORK (CNN/Money) - A Brooklyn funeral home and a New Jersey company that harvests body parts from corpses are being investigated for their alleged roles in a body snatching ring that sold parts to companies specializing in medical grafts, sources close to the investigation said Friday.

The Brooklyn district attorney's office declined to comment on the investigation. But sources close to the investigation acknowledged that it has been going on for about one and a half years, focusing on Michael Mastromarino of Biomedical Tissue Services Ltd. of Fort Lee, N.J., who allegedly harvested body parts illegally from the Daniel George funeral home in Brooklyn.

The firms that bought the allegedly black-market tissue have not been accused of any wrongdoing. Human tissue is usually obtained from non-profit tissue banks. In the U.S., it's illegal to buy and sell human tissue.

Wendy Crites-Wacker, spokeswoman for Regeneration Technologies (down $0.66 to $7.28, Research), a company in Alachua, Fla., said her company has severed all ties with Biomedical Tissue Services, their former source for some of the body parts used to make medical grafts, or allografts.

"We had previously terminated the relationship with Biomedical Tissue Services and we are cooperating with the appropriate authorities on this issue," said Crites-Wacker, who declined to say when the termination took place.

Crites-Wacker also said that her company's BioCleanse process, in which bones and tendons are sterilized through a melange of chemicals, temperature and pressure, ensures that its products are safe.

Two other allograft companies have been identified as customers of Biomedical Tissue Services: LifeCell Corp. (down $2.82 to $17.33, Research), of Branchburg, N.J. and Tutogen Medical Inc. (down $0.15 to $4.06, Research) of West Paterson, N.J.

LifeCell Corp. had issued a Friday statement saying it had voluntarily recalled some human tissue products after questions were raised about Biomedical Tissue Services.

"Specifically, the company recalled all lots of product that were produced using tissue from Biomedical Tissue Services (BTS)," LifeCell said in a release.

LifeCell, which markets products made from human tissues that are used in surgical procedures, said it recalled certain AlloDerm, Repliform and GraftJacket products on Sept. 30.

LifeCell's stock price slid about 5 percent this morning, and a Piper Jaffray analyst attributed the slump to a New York Daily News story that first reported on the investigation.

"We believe this morning's weakness in LifeCell's shares is related to a news article that alleges LifeCell inadvertently received tissue from an illegal body-snatching ring," said Raj Denhoy of Piper Jaffray, in a written report.

LifeCell said in the statement all other tissues supplied by Biomedical Tissue Services remain "on hold until the discrepancies in the donor documentation can be resolved."

Denhoy said that LifeCell did not appear to do anything illegal and that "LifeCell itself was the victim of fraud," referring to allegations that Biomedical Tissue Services forged death certificates and family consent forms.

Denhoy said that LifeCell receives tissue from 30 sources, "so the loss of one will likely not impact the underlying business," though increased regulatory scrutiny could drive down the stock price.

"While LifeCell and the other tissue companies appear to have done nothing wrong, this event could increase regulatory and media scrutiny of the business," said Denhoy, who rates the company market perform. "We recently downgraded LifeCell shares on competitive concerns and today's revelations may pressure the stock further."

Eric Franz, the attorney representing funeral home owners Debora Johnson and Robert Nelms, said his clients "did not participate in any criminal conduct whatsoever."

Attempts to reach Mastromarino and his company Biomedical Tissue Services were unsuccessful. The Daily News reported that Mastromarino declined to comment.

Regeneration Technologies produces heart valves, bone and tendon implants and bone paste, which is used to plug holes. LifeCell specializes in AlloDerm, a "dermal matrix" made from human skin that is used in grafts. Tutogen focuses on bone and dental implants.

--from staff and wire reports

http://money.cnn.com/2005/10/07/news/midcaps/corpse/?section=money_latest


FDA News FOR IMMEDIATE RELEASE P05-77 October 26, 2005 Media Inquiries: Julie Zawisza, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Provides Information on Investigation into Human Tissue for Transplantation The Food and Drug Administration (FDA) is notifying the public of its investigation of human tissue recovered by Biomedical Tissue Services, Ltd. (BTS) of Ft. Lee, NJ, and sent to tissue processors. Some of this tissue may have been implanted into patients from early 2004 to September 2005. The tissue was recovered by BTS from human donors who may not have met FDA donor eligibility requirements and who may not have been properly screened for certain infectious diseases. At this time, the implicated tissues from BTS include human bone, skin, and tendons. These products represent only a small percentage of the overall U.S. tissue supply.

While no adverse reactions related to these tissues have been reported to FDA at this time, because of the potential lack of proper screening of the tissue donors, some recipients of the tissues may be at increased risk of infections that could potentially be transmitted through tissues. FDA and the Centers for Disease Control and Prevention (CDC) believe the risks from these tissues are low because the tissues were routinely processed using methods that help to reduce the risk of infectious disease; however, the actual infectious risk is unknown.

FDA's requirements to determine donor eligibility include important steps to ensure that donors do not harbor infections that could be transmitted to recipients. These steps include reviewing the donor's medical history and other factors, physically assessing the donor, and testing for relevant communicable diseases that may place the donor at an increased risk of infections that could then unintentionally be transmitted to recipients through the tissues.

The following tissue processors received tissue from BTS:

LifeCell Corporation of Branchburg, NJ Lost Mountain Tissue Bank of Kennesaw, GA Blood and Tissue Center of Central Texas in Austin, TX Tutogen Medical, Inc., of Alachua, FL Regeneration Technologies, Inc., of Alachua, FL These firms already have voluntarily recalled all unused tissue remaining in inventory and are working cooperatively with FDA to ensure that the implanting physicians whose patients may have received the products are properly notified. Physicians who implanted tissue from BTS should have been contacted at this time by the receiving health care facility.

FDA and CDC recommend that implanting physicians inform their patients that they may have received tissue from a donor for whom an adequate donor eligibility determination was not performed. While the overall infectious risk is likely low, FDA and CDC recommend that physicians offer to provide patients access to appropriate infectious disease testing. The relevant communicable diseases for which a tissue donor is required to be tested are HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus, hepatitis C virus, and syphilis. Physicians who still have concerns or questions about the source of the tissue should contact the health care facility where the procedure was performed. FDA will continue its investigation into this matter and will issue further public health updates, as needed.

Patients and physicians should report any infectious disease possibly related to a tissue transplant to the processing firms, who then should notify FDA. Patients and physicians who wish to notify FDA directly of such infectious disease should report via FDA’s MedWatch reporting program at http://www.fda.gov/medwatch.

http://www.fda.gov/bbs/topics/NEWS/2005/NEW01249.html


Recall of Human Tissue

DATE RECALL INITIATED:

October 13, 2005

PRODUCT:

Human Tissue for Transplantation

MANUFACTURER:

Biomedical Tissue Services, Ltd Fort Lee, New Jersey

REASON:

Biomedical Tissue Services (BTS) was recently made aware that there is the possibility that tissue has been procured from donors without proper medical/social histories. BTS is performing a voluntary recall of any unused tissue from its consignees.

The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

Updated October 18, 2005

http://www.fda.gov/cber/recalls/btstis101305.htm


Tutogen Medical Tissue Recall

Frequently Asked Questions and Answers

Q: What prompted this recall?

A: Tutogen was unable to verify donor consent for certain tissue provided by one of its recovery agency suppliers (BioMedical Tissue Services of Fort Lee, NJ). Tutogen, along with several other tissue processing companies, received allograft material from BioMedical Tissue Services. One of these other processing companies notified Tutogen that they were having difficulty in reaching persons taking the consent information or next of kin for BioMedical tissue donors. Upon receiving this notification, Tutogen immediately initiated a review and investigation of all donor consents received from BioMedical Tissue Services. Tutogen also experienced problems in contacting consent takers, witnesses and next of kin shown on the documentation provided by BioMedical Tissue Services. We further attempted to contact Dr. Michael Mastromarino, CEO and Executive Director of BioMedical Tissue Services, to assist in this matter, but without success. Although Tutogen does not believe that there are any safety concerns related to this tissue, the company elected to initiate a voluntary recall of products incorporating the BioMedical tissues, on ethical grounds.

Q: What tissue products are being recalled?

A: Specific serial/lot numbers of Tutogen’s Puros® Allograft Cancellous Particles (marketed by Zimmer Dental) and a small quantity of Tutoplast® Fascia Lata (marketed by Mentor Corporation and Innovative Opthalmic Products, Inc.) are involved in this recall.

Q: How much allograft tissue did BioMedical Tissue Services provide to Tutogen?

A: The quantity of tissue received from BioMedical represents a small fraction (about 2%) of all tissue processed by Tutogen.

Q: What did Tutogen do to notify customers of the recall?

A: Upon completion of its donor documentation investigation, Tutogen notified the FDA of our intent to initiate a voluntary recall. We immediately identified all BioMedical tissue, from raw material stock through finished goods and field distribution, and quarantined all material within our control. Customer shipment information was assembled and a recall letter was prepared and approved by the FDA. Initially, Tutogen alerted all customers of record via telephone, describing the reason for the recall, providing serial numbers of product shipped to them and indicating the process for the return and replacement of affected product.

Simultaneously, copies of the recall letter and distribution information for the affected product was sent to each customer by facsimile. This same information was then provided to customer accounts by certified mail. At the request of the FDA, Tutogen sent a recall follow-up letter to affected customers, including FDA mandated language regarding patient notification and access to disease testing.

An additional letter was prepared and mailed to those customers that had not received any of the products manufactured using BioMedical tissue and were not affected by the voluntary recall. In the interim, the company prepared and issued a press release concerning this recall and participated in numerous conference calls, throughout the U.S. and Canada, with surgeon groups, industry organizations (such as the American Association of Tissue Banks) and professional associations (such as the American Association of Oral and Maxillofacial Surgeons and the American Academy of Periodontology).

These prior communications were supplemented by a scientific dissertation mail-out that described the Tutogen Tutoplast® process, which subsequently led to the preparation of a technical monograph detailing this process and its qualification history. The monograph may be accessed on this website by selecting the link entitled, "The Tutoplast® Process: A Review of Efficacy".

Q: How can I tell whether I received any of the affected product?

A: All customers of record, that received products manufactured utilizing tissue provided by BioMedical, were notified and should have received an individualized list of all product serial numbers shipped to them. Affected product may also be quickly identified by visually checking the alpha-numeric designator beneath the product barcode label (see samples, shown below).

The affected product alpha-numeric code begins with the letters "BM" or "BT".

Q: How should I go about returning affected product that may remain in my inventory stock?

A: Once any affected product has been identified, place it in a shipping container and mark the outside of the container with "BMRECALL". Address the package to:

Tutogen Medical

13709 Progress Boulevard

South Wing

Alachua, FL 32615

Biomedical Tissue Services

Biotissue Recovery Services

Call UPS at (800) PICK UPS and request a package pick-up. Forward the package to Tutogen, via UPS ground, using account number Y6X706. This shipping account number is reserved for the return of recalled items and is for one-way service to Tutogen, from U.S. accounts. Only product affected by this recall will be accepted for return.

Canadian customers should contact Zimmer Dental Corporation Customer Service at (800) 265-0968 or (905) 567-2073 for return instructions.

Q: What is the risk to patients that have already received recalled implants?

A: The FDA and CDC have indicated that they believe the overall risk of disease transmission by these products is low, but unknown. Because Tutogen’ s Tutoplast® tissue preservation and sterilization process is extremely rigorous and has passed significant challenge testing, we believe that all tissue distributed by Tutogen, including that from BioMedical Tissue Services, is safe and effective for its intended use. In addition, comprehensive physical examination and serology testing is routinely performed on all donors processed by Tutogen.

Q: What types of evaluations are performed on donors processed by Tutogen Medical?

A: Consent for donation, along with a detailed medical/social history, is obtained from each donor or their next of kin by hospital, medical examiner, funeral home or recovery agency personnel. The recovery team identifies the donor and conducts a detailed physical evaluation of the body. This examination incorporates an extensive assessment checklist for characteristics that would disqualify a donor from further consideration and addresses tissue appearance and condition during the retrieval process. The recovery team also collects a donor blood sample and forwards it to a third-party CLIA certified laboratory for disease testing, using FDA approved test methodology. The serology test results, along with the previously mentioned donor documentation, is examined by Tutogen’s Quality Assurance Department and a staff Medical Director (a licensed physician). Only after these thorough reviews are completed and release is granted by the Medical Director, is donor tissue allowed to enter the Tutoplast® process.

Q: What testing is done on the donor serology sample?

A: Tutogen requires that the following serology testing be performed and found to be "negative" or "non-reactive", prior to accepting any donor tissue for processing:

Hepatitis B surface antigen (HBsAg)

Hepatitis B core antibody (HBcAb – IgG +IgM)

Hepatitis C Virus antibody (HCV Ab)

Hepatitis B and C Nucleic Acid Testing (HBV and HCV NAT)

Human Immunodeficiency Virus I and II antibodies (HIV I and II Ab)

HIV I – p24

Human T-Lymphotropic Virus I and II (HTLV I and II Ab)

Syphilis – Rapid Plasma Reagin (RPR/STS)

Q: Who will pay for the cost of disease testing for my patients?

A: Although Tutogen does not feel that the products manufactured using BioMedical tissue pose a safety concern, out of respect for your patients’ welfare and as a service to you, Tutogen has elected to bear the cost of the appropriate infectious disease testing.

Q: What process has Tutogen put in place to accomplish the disease testing"?

A: We have made arrangements with ViroMed Laboratories (division of LabCorp), a respected, CLIA and FDA certified organization, to conduct this testing. Should you choose to inform those patients who received the affected implants, we suggest that you offer them the opportunity to be tested for the specified infectious diseases. Additionally, we recommend that you maintain a record of notification for each patient, which would indicate their acceptance or rejection of the testing offered and be signed/dated by that individual. For those patients that elect to undergo testing, both U.S. and Canadian customers should follow the process delineated, below.

1. Provide Tutogen Medical with the name and mailing address of the patient. Only patients that received implants utilizing tissue provided by BioMedical Tissue Services are eligible for this pre-paid testing. This information will be verified in our Tissue Utilization Record (TUR) database, or you may provide documentation confirming the patient’s implant, if no TUR was previously forwarded to Tutogen.

2. Let the patient know that a test kit will be sent to him or her by ViroMed Laboratories within the next few days and will include instructions on how to proceed.

3. Instruct the patient to set up an appointment with and take the test kit to their Primary Care physician. Alternatively, the patient may elect to visit a LabCorp service center as indicated in item # 7, below.

4. Following the instructions provided with the kit, the Primary Care physician or professional healthcare office staff member should obtain a blood sample from the patient and forward it to ViroMed Laboratories in the postage-paid mailer that will be included in the kit.

5. ViroMed Laboratories will perform the appropriate disease testing and forward the results to the patient’s Primary Care physician. If a confirmatory test is necessary, ViroMed Laboratories will automatically perform this additional testing and include those results in the final test report.

6. Upon receipt of the ViroMed data, the Primary Care physician should contact the patient and discuss the final results of the testing with him or her.

7. In the event that your patient does not have a Primary Care physician, he or she may go to a "walk-in" clinic to have a blood sample taken or to be referred to a LabCorp service

center near them and have this blood sample drawn and forwarded to ViroMed Laboratories for testing. The attending physician may call ViroMed Client Services, at (800) 582-0077, to arrange for a test kit or to obtain instructions for handling the sample. These patients must have their eligibility verified by Tutogen. LabCorp or ViroMed will provide all associated test kit supplies. A list of service center locations is available on the LabCorp website (www.labcorp.com ) under the "Patient Service Center Locator" link.

If you have a patient that has already presented for infectious disease testing, a reimbursement request for costs not covered by the individual’s insurance carrier can be made by forwarding the invoice, showing the net responsibility of the patient, or a receipt, marked "Paid" to:

Tutogen Medical, Inc.

Accounts Payable

13709 Progress Blvd., Box 19

Alachua, FL 32615

The invoice should clearly show the name and address of the facility performing the disease testing and be annotated with the name of the patient ’s dentist/oral surgeon and practice name, as well as the identifier, "BMRECALL".

Q: What testing will be performed on each patient’s blood sample?

A: The recommended testing is for HIV I and II, Hepatitis B virus, Hepatitis C virus and syphilis. All test results will remain confidential, between patient and doctor.

Q: Is Tutogen still receiving tissue from BioMedical Tissue Services?

A: No. Upon initiating the voluntary recall, Tutogen suspended the acceptance of any tissues from BioMedical Tissue Services and has officially terminated its relationship with them.

Q: How can a situation such as this be prevented in the future?

A: At this point, there is no simple answer to this question. Tutogen adhered to all of its standard screening, inspection and processing procedures and there was no deviation or departure from its quality assurance systems. All processing companies rely on the FDA registered and state licensed recovery agencies to comply with established regulations and industry guidelines. Tutogen is currently evaluating a number of potential additional safeguards, but no mechanisms have been identified that would provide a foolproof solution. In addition, we are working very closely with the Food and Drug Administration and American Association of Tissue Banks to devise workable options that might preclude recurrence.

http://www.tutogen.com/recallQandA.pdf


Recall of Human Tissue Products

DATE RECALL INITIATED:

October 14, 2005

PRODUCT:

Human Tissue For Transplantation

MANUFACTURER:

Regeneration Technologies, Inc Alachua, Florida

REASON:

Regeneration Technologies, Inc. (RTI) is conducting a voluntary recall of all tissue received from BioMedical Tissue Services (BTS; Ft. Lee, New Jersey) as a result of information regarding the accuracy of donor screening documentation. RTI informed its consignees that a lack of assurance of donor identity as well as the risk of infectious diseases also exists. Consignees are asked to contact the manufacturer to arrange for product return.

The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

Updated October 18, 2005

http://www.fda.gov/cber/recalls/rtitis101405.htm


FDA News FOR IMMEDIATE RELEASE P05-77 October 26, 2005 Media Inquiries: Julie Zawisza, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Provides Information on Investigation into Human Tissue for Transplantation The Food and Drug Administration (FDA) is notifying the public of its investigation of human tissue recovered by Biomedical Tissue Services, Ltd. (BTS) of Ft. Lee, NJ, and sent to tissue processors. Some of this tissue may have been implanted into patients from early 2004 to September 2005. The tissue was recovered by BTS from human donors who may not have met FDA donor eligibility requirements and who may not have been properly screened for certain infectious diseases. At this time, the implicated tissues from BTS include human bone, skin, and tendons. These products represent only a small percentage of the overall U.S. tissue supply.

While no adverse reactions related to these tissues have been reported to FDA at this time, because of the potential lack of proper screening of the tissue donors, some recipients of the tissues may be at increased risk of infections that could potentially be transmitted through tissues. FDA and the Centers for Disease Control and Prevention (CDC) believe the risks from these tissues are low because the tissues were routinely processed using methods that help to reduce the risk of infectious disease; however, the actual infectious risk is unknown.

FDA's requirements to determine donor eligibility include important steps to ensure that donors do not harbor infections that could be transmitted to recipients. These steps include reviewing the donor's medical history and other factors, physically assessing the donor, and testing for relevant communicable diseases that may place the donor at an increased risk of infections that could then unintentionally be transmitted to recipients through the tissues.

The following tissue processors received tissue from BTS:

LifeCell Corporation of Branchburg, NJ Lost Mountain Tissue Bank of Kennesaw, GA Blood and Tissue Center of Central Texas in Austin, TX Tutogen Medical, Inc., of Alachua, FL Regeneration Technologies, Inc., of Alachua, FL These firms already have voluntarily recalled all unused tissue remaining in inventory and are working cooperatively with FDA to ensure that the implanting physicians whose patients may have received the products are properly notified. Physicians who implanted tissue from BTS should have been contacted at this time by the receiving health care facility.

FDA and CDC recommend that implanting physicians inform their patients that they may have received tissue from a donor for whom an adequate donor eligibility determination was not performed. While the overall infectious risk is likely low, FDA and CDC recommend that physicians offer to provide patients access to appropriate infectious disease testing. The relevant communicable diseases for which a tissue donor is required to be tested are HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus, hepatitis C virus, and syphilis. Physicians who still have concerns or questions about the source of the tissue should contact the health care facility where the procedure was performed. FDA will continue its investigation into this matter and will issue further public health updates, as needed.

Patients and physicians should report any infectious disease possibly related to a tissue transplant to the processing firms, who then should notify FDA. Patients and physicians who wish to notify FDA directly of such infectious disease should report via FDA’s MedWatch reporting program at http://www.fda.gov/medwatch.

Additional information is available on FDA’s web site at http://www.fda.gov/cber/recalls.htm and by calling 1-800-835-4709.

####

http://www.fda.gov/bbs/topics/NEWS/2005/NEW01249.html


Recall of Human Tissue Products

DATE RECALL INITIATED:

October 11, 2005

PRODUCT:

Human Tissue for Transplantation

MANUFACTURER:

The Blood and Tissue Center of Central Texas Austin, Texas

REASON:

Central Texas Regional Blood and Tissue Center is voluntarily recalling tissue products as the firm is unable to confirm information provided by BioMedical Tissue Services (BTS; Ft. Lee, New Jersey). Consignees are asked to contact the manufacturer to arrange for product return.

The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

Updated October 18, 2005

http://www.fda.gov/cber/recalls/blotis101105.htm


Recall of Human Tissue Products

DATE RECALL INITIATED:

October 12, 2005

PRODUCT:

Human Tissue for Transplantation

MANUFACTURER:

Tutogen Medical, Inc. Alachua, Florida

REASON:

Tutogen Medical is conducting a voluntary recall of all materials that were manufactured utilizing BioMedical Tissue Services (BTS; Ft. Lee, New Jersey) donor tissue. This action is being taken because Tutogen is unable to satisfactorily confirm that donor eligibility had been properly obtained by BTS. Tutogen informed its consignees that there is a lack of assurance that appropriate donor identification, donor screening, and medical history data collection was performed and, therefore, a risk of infectious disease exists. Consignees are asked to contact the manufacturer to arrange for product return.

The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

Updated October 18, 2005

http://www.fda.gov/cber/recalls/tutotis101205.htm


Withdrawal of Human Tissue Products

DATE WITHDRAWAL INITIATED:

October 10, 2005

PRODUCT:

Human Tissue for Transplantation

MANUFACTURER:

Lost Mountain Tissue Bank Kennesaw, Georgia

REASON:

Lost Mountain Tissue Bank, Inc. (LMTB) has initiated consignee notifications for all tissue products processed and/or distributed from donors procured in the New York area by Biomedical Tissue Services (BTS; Ft. Lee, New Jersey). LMTB was informed of some discrepant and possibly fraudulent information in donor documentation. LMTB is notifying all relevant hospitals and medical professionals of the market withdrawal of all tissue products beginning with the letters “GL” or “T” in the tissue identification number (ID#).

The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

Updated October 18, 2005

http://www.fda.gov/cber/recalls.htm


DATE RECALL INITIATED:

September 30, 2005

PRODUCT:

AlloDerm, Repliform, and GraftJacket

MANUFACTURER:

LifeCell Corporation Branchburg, New Jersey

REASON:

LifeCell Corporation initiated a voluntary recall of certain AlloDerm, Repliform, and GraftJacket product from the marketplace on September 30, 2005. The recall was prompted when internal quality processes raised questions about the donor documentation received from one tissue recovery organization. Specifically, the company recalled all lots of product that were produced using tissue from Biomedical Tissue Services (BTS). Life Cell promptly notified the FDA and all relevant hospitals and medical professionals. All other BTS inventory remains on hold until the discrepancies in the donor documentation can be resolved. LifeCell works with more than 40 other tissue recovery organizations that are not affected by this recall.

The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

Updated October 12, 2005

http://www.fda.gov/cber/recalls/tislife093005.htm


Compliance Program Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 7341.002

http://www.fda.gov/cber/cpg/7341002tis.htm


TSS

----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Thursday, October 27, 2005 9:55 AM Subject: THE LEGAL TRADING AND SELLING OF BODY PARTS AND HUMAN TSEs IN THE USA

##################### Bovine Spongiform Encephalopathy #####################

From: TSS () Subject: THE LEGAL TRADING AND SELLING OF BODY PARTS AND HUMAN TSEs IN THE USA Date: October 27, 2005 at 8:40 am PST

WASHINGTON FDA investigating human tissue sales WASHINGTON - The Food and Drug Administration said Wednesday that it is investigating a New Jersey-based company that sold human tissue to processors for eventual implantation into people, because it may not have been properly screened for infections. The New York Daily News reported earlier this month that the district attorney's office in Brooklyn, N.Y., is investigating the company, Biomedical Tissue Services of Fort Lee, N.J., on allegations that the company illegally bought body parts from funeral homes to sell to tissue processors. An FDA spokeswoman would not comment on those allegations. The tissues include human bones, skin and tendons and constitute only a small portion of the U.S. tissue supply, the FDA said. They were implanted between early 2004 and September 2005. The Blood and Tissue Center of Central Texas in Austin received some.

http://www.chron.com/cs/CDA/ssistory.mpl/nation/3419112


FOR IMMEDIATE RELEASE P05-77 October 26, 2005 Media Inquiries: Julie Zawisza, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Provides Information on Investigation into Human Tissue for Transplantation The Food and Drug Administration (FDA) is notifying the public of its investigation of human tissue recovered by Biomedical Tissue Services, Ltd. (BTS) of Ft. Lee, NJ, and sent to tissue processors. Some of this tissue may have been implanted into patients from early 2004 to September 2005. The tissue was recovered by BTS from human donors who may not have met FDA donor eligibility requirements and who may not have been properly screened for certain infectious diseases. At this time, the implicated tissues from BTS include human bone, skin, and tendons. These products represent only a small percentage of the overall U.S. tissue supply.

While no adverse reactions related to these tissues have been reported to FDA at this time, because of the potential lack of proper screening of the tissue donors, some recipients of the tissues may be at increased risk of infections that could potentially be transmitted through tissues. FDA and the Centers for Disease Control and Prevention (CDC) believe the risks from these tissues are low because the tissues were routinely processed using methods that help to reduce the risk of infectious disease; however, the actual infectious risk is unknown.

FDA's requirements to determine donor eligibility include important steps to ensure that donors do not harbor infections that could be transmitted to recipients. These steps include reviewing the donor's medical history and other factors, physically assessing the donor, and testing for relevant communicable diseases that may place the donor at an increased risk of infections that could then unintentionally be transmitted to recipients through the tissues.

The following tissue processors received tissue from BTS:

LifeCell Corporation of Branchburg, NJ Lost Mountain Tissue Bank of Kennesaw, GA Blood and Tissue Center of Central Texas in Austin, TX Tutogen Medical, Inc., of Alachua, FL Regeneration Technologies, Inc., of Alachua, FL These firms already have voluntarily recalled all unused tissue remaining in inventory and are working cooperatively with FDA to ensure that the implanting physicians whose patients may have received the products are properly notified. Physicians who implanted tissue from BTS should have been contacted at this time by the receiving health care facility.

FDA and CDC recommend that implanting physicians inform their patients that they may have received tissue from a donor for whom an adequate donor eligibility determination was not performed. While the overall infectious risk is likely low, FDA and CDC recommend that physicians offer to provide patients access to appropriate infectious disease testing. The relevant communicable diseases for which a tissue donor is required to be tested are HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus, hepatitis C virus, and syphilis. Physicians who still have concerns or questions about the source of the tissue should contact the health care facility where the procedure was performed. FDA will continue its investigation into this matter and will issue further public health updates, as needed.

Patients and physicians should report any infectious disease possibly related to a tissue transplant to the processing firms, who then should notify FDA. Patients and physicians who wish to notify FDA directly of such infectious disease should report via FDA’s MedWatch reporting program at http://www.fda.gov/medwatch.

Additional information is available on FDA’s web site at http://www.fda.gov/cber/recalls.htm and by calling 1-800-835-4709.

####

http://www.fda.gov/bbs/topics/NEWS/2005/NEW01249.html


a bit of history;

The Eyes have it/CJD * and they could be stealing them from YOUR loved one, hence the spread of CJD (aka MADCOW DISEASE) will spread...

############ Creutzfeldt-Jakob Disease #############

Greetings list members, I was impressed that someone is listening, considering the timing of when I broke the story in Nov. and this was posted in Dec., what a coincidence. Thanks for listening. I find it rather frightening of the fact sporadic CJD as well as vCJD can

transmit infectivity this way. Makes me wonder about blood? Kind Regards, Terry S. Singeltary Sr., Bacliff, Texas USA

http://mad-cow.org/~tom/dec99_news.html#bbb


Testimony of Bess Believeaux, Lions Eye Bank of Central Texas (Submission to the Jan. 18/19 meeting of the TSE Advisory Committee)

http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_16.pdf


TSS Submission to the same Committee;

http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf


Tissue Banks International (TBI), Gerald J Cole

http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_13.pdf


re-use contact lenses

http://mad-cow.org/~tom/dec99_news.html#bbb



TSS

Link: Reported by Terry S. Singeltary Sr. son of CJD victim 28 Nov 99 THE EYES HAVE IT, CJD...


#################### https://lists.aegee.org/bse-l.html ####################

#################### https://lists.aegee.org/bse-l.html ####################



http://mad-cow.org/~tom/dec99_news.html#bbb




American, 39, dies of dura mater implant
April 19, 2000
By RONALD CAMPBELL The Orange County Register

A tissue implant in 1992 helped cure Karen Bissell of numbness in her hands and legs. Six years later, it probably killed her. Bissell, 39, died Sept. 21, 1998, of Creutzfeldt-Jakob Disease, or CJD, a rare neurological condition. Scientists believe she was one of about 110 people worldwide who acquired the disease since 1987 from contaminated tissue transplants.

After Bissell's death, the company that provided the tissue launched a voluntary recall, while maintaining there was no conclusive proof the implant killed her.

The disease erupted in June 1998. In her last days, Bissell did not even know that she was being moved from a Denver hospital to a hospice. "The doctor told me she did not know what was happening, and she was not in any pain," said her mother, Eleanor Bissell. "I'm thankful for that." A friend memorialized her as "an angel to everyone she touched when she walked on Earth and now an angel to all as she resides in heaven."

Bissell will get a much-longer epitaph in the medical and legal literature. The scientists who investigated her death are preparing an article for a medical journal � at least the fourth such article tying CJD to transplants of dura mater, the outer lining of the brain. Because of the growing medical evidence, the U.S. Food and Drug Administration issued guidelines last October to prevent the spread of CJD through dura mater transplants.

CJD is a rare disease, striking one person in a million. Most victims are 55 or older. When CJD strikes a younger person, "we try to see if we can find some kind of exposure," said Colorado State Epidemiologist Richard Hoffman, who investigated Bissell's death. "In this case, there was a fairly glaring possibility as to where the person acquired it." Hoffman discussed Bissell's case in general terms, without naming her. The Orange County Register independently verified her identity.

In 1992, Eleanor Bissell recalled, her daughter complained of numbness in her hands as well as numbness and a tingling sensation in her legs. A physician diagnosed Arnold-Chiari malformation, an obstruction of nerves entering her brain. He operated to relieve the obstruction and used a package of dura mater from a German processor to patch the dura he had cut. The surgery bought Bissell six years of good health.

She was the youngest of four daughters. Never married, she remained close to her parents, often sharing their house in a Denver suburb. After 15 years of working at Lowry Air Force Base, however, Bissell decided in the fall of 1997 that she wanted a change. She got a job with the U.S. Department of Agriculture in Miami.

In June 1998, home for vacation, Bissell complained of blurry vision and headaches. The next month, the symptoms worsened, and she began a long round of visits to doctors, in search of answers. Finally, on Aug. 26, she flew to Denver.

"First she was using a cane when she got home," her mother recalled. "Then she was using a walker. Then she was using a wheelchair." From cane to walker to wheelchair was a journey of 10 days. "Day by day, she just went down, down," Eleanor Bissell said. "Each day it got a little bit worse."
The doctors in Miami had not been able to figure out what was h
appening. The Denver doctors while conducting a test saw brain cells literally being destroyed as they watched, and made their diagnosis.

While Bissell lay dying, Hoffman and investigators for the Centers for Disease Control and Prevention and the FDA scoured her medical records. They learned of the 1992 dura mater transplant, traced it to the German manufacturer and to a donor who, Hoffman said, died of a neurological illness. An autopsy had been done, but not a microscopic examination of the brain, which might have revealed CJD.

"I don't think we can conclusively say that the donor did or did not have (CJD)," Hoffman said. But he believes the transplant was "the most likely source of exposure."

The investigation of Bissell's death prompted the American parent of the German dura mater processor, New Jersey-based Tutogen Medical Inc., in mid-1999 to voluntarily recall all dura mater processed in Germany before 1994. Little was returned. In addition, Germany imposed new requirements for dura processing that the company said cost it $350,000 in revenue and $210,000 in profit.

Manfred Kreuger, Tutogen's chief executive, expressed "our deepest sympathy to the woman's family." But, he added, "to suggest that the dura mater was the cause of her condition is, frankly, unfounded." Tutogen was denied access to Bissell's medical records, Kreuger said. But a review of the donor's records showed that while "he certainly had some neurology abnormalities" and depression, he died from heart disease.

He said he believes Tutogen's dura mater "is a very safe product." Tutogen recalled its dura anyway, the company said in a May 1999 report to the Securities and Exchange Commission, because it "cannot rule out with absolute certainty" that its dura killed Bissell.


http://www.mad-cow.org/00/may00_news.html#ccc2



TUTOGEN

http://www.tutogen.com/


TutoplastTM

bone, bone-patellar tendon-bone

* alkaline treatment for prions (tissues are treated with 1N sodium hydroxide for 1 hr at room temperature)

-fascia

-pericardium

-dermis

* because this treatment also affects collagen in a time dependent manner it CANNOT BE USED ON BONES, TENDONS, OR LIGAMENTS WITHOUT A SIGNIFICANT REDUCTION IN BIOMATERIAL PROPERTIES.


http://www.clearant.com/latestnews/im47200211271552.PDF


TUTOGEN MEDICAL INC - Annual Report (Small Business Issuers ...


http://sec.edgar-online.com/tutogen-medical-inc/10ksb-annual-report-small-business-issuers/2001/12/20/Section2.aspx





-------- Original Message --------
Subject: Re: A NEW BRUNSWICKER REPORTED DEAD OF CJD AFTER BRAIN SURGERY (7 CJD cases possible in N.B., officials say)
Date: Fri, 26 Sep 2003 17:11:39 -0500
From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To: BSE-L@uni-karlsruhe.deReferences: <3f71d32b.5000506@wt.net> <3f72fb5f.5030205@wt.net> 3F743CE8.8070804@wt.net

European Journal of Epidemiology 16 (4) p.353-355 April 2000Kluwer
Creutzfeldt–Jakob Disease in health professionals in SlovakiaMitrová Eva1 and Belay Girma1
1.Institute of Preventive and Clinical Medicine, Limbová 14, 833 01Bratislava, Slovakia


Creutzfeldt–Jakob disease (CJD) is the most important humantransmissible spongiform encephalopathy (prion disease), recognised insporadic, genetic but also iatrogenic forms. The identification of 8health care workers in a group of 114 definitive CJD patients inSlovakia suggested the possibility of professionaly acquired CJD andinduced the investigation of potential endo- and exogenous risk factors.In CJD-affected health professionals special attention was paid to adetailed occupational history, including a possible professional contactwith CJD patient and to the findings characteristic for iatrogenic CJD:early cerebellar symptomatology, long duration of the disease, absenceof typical EEG finding and homozygosity of PRNP gene at codon 129.Analysis of epidemiological, clinical and molecular biological data ininvestigated group of CJD-affected health professionals gave no evidenceof an occupational risk for CJD.

Creutzfeldt–Jakob disease, Health professionals, Iatrogenic
PDF(63K)
BibTex
EndNode
Copyright© 2000 Kluwer Academic Publishers All rights reserved


http://reo.nii.ac.jp/journal/HtmlIndicate/Contents/SUP0000001000/JOU0001000164/ISS0000002345/ART0000025322/ART0000025322_abstract.html




comments from Tom about these cases;

Comment (webmaster): 7% of sporadic CJD in health professionals is waytoo high to occur by chance, despite the tone of the abstract. Now thefirst thing Dr. Mitrova would have done is rule out familial CJD of theform E200K, which has a very extensive cluster in Slovakia, though theabstract does not really say what was sequenced besides codon 129 of theprion gene. Little credence can be given to the idea that acharacteristic pattern exists for iatrogenic CJD, which is a totalhodge-podge after the dominant forms, growth hormone and dura mater, aresubtracted.
One very real possibility in Slovakia is that the high numbers of E200Kcases, prior to diagnosis, has led to a secondary epidemic in healthcare workers. This source would be missed by epidemiology because onlyexposure to clinical E200K (hospice workers) would be considered.
One clear-cut case of a health worker at occupational risk is theorthopedic surgeon who removed dura mater from sheep brain for thecompany in Germany selling dura mater for human transplants.

Until Germany conducts a Prionics-type survey of its sheep, we will haveno real idea of the prevalence of scrapie there. The whole dura matertragedy unfolding in Japan may have resulted from sheep dura mater beingused instead of human cadaver. If so, this unfortunate 'experiment'would prove transmissibility of scrapie to humans (though who woulddoubt this in a scrapie dura mater brain transplant?).

Spinal dura contains elastin and collagen gene products, which wouldallow the species origin of the transplant to be determined even decadeslater (if it is not resorbed). Thus it is still possible to determine iscausing the Japanese dura mater outbreak.

The other related case of a possibly affected caregiver is ahusband-and-wife pair who contracted sporadic CJD within a few years ofeach other:

http://www.mad-cow.org/00/aug00_last_news.html#ddd


i'd say this doctor has seemingly misrepresented medical informationthat was readily available to him from official Health Canada web sites andprominent previous alerts that he and his hospital would have previouslyreceived.

Tutogen Medical, Inc. was formerly known as Pfrimmer-Viggo GmbH+Co,Erlangen, Germany). Their Canadian distributor is listed as CenterpulseDental Canada (hmmm) where in the US it is Tutogen Medical Inc.[Productlines: Dental, Spine, Membrans, Sports Medicine, Bone (more hmmm) ]


http://www.tutogen.de/pages/kontakt/vertreiberadressen.html


what would you call this Health Canada statement ...


"The April 2001, edition of "Neurology" published details of the first case of classical Creutzfeldt-Jakob Disease (CJD) associated with the use of Tutoplast Dura. Following the publication of this news, Health Canada took action to obtain further information on the current surgical need for the use of Tutoplast Dura in Canada. It wrote to orthopaedic, neurosurgical and otolaryngological professional associations seeking advice on the importance to their members of the continued availability of Tutoplast duramater. The Canadian Neurosurgical Society (CNSS) responded by conducting a survey of their members. Of those who replied, 61% supported discontinuing the use of donor dura mater.

On April 10, 2002, Health Canada suspended the medical device licence for Tutoplast Dura. The suspension means that the importation and sale of this medical device is no longer permitted in Canada. Tutoplast Dura manufactured before 1992 was processed with a less concentrated disinfectant solution than material manufactured after October 1992.

The disinfectant used initially, which was in accordance with what was known regarding prion diseases at the time, was a ten times weaker solution of sodium hydroxide than was used starting in 1992. Tutoplast Dura (manufactured by Tutogen Medical GmbH of Germany) was first sold in Canadain January, 1982."

On the company's website in Germany, it seems they have now gone over to Tutomesh ... from bovine pericardium " that is prepared using theTUTOPLAST® procedure thus eliminating antigenic properties"


http://www.tutogen.de/pages/produkte/indikation/detail/tutomeshhernen.html


Some previous experiences in Japan:

"The most recent recipient of a dura mater graft among the 43 graft-associated CJD patients was a woman aged 65 years at the time ofonset of CJD. She had two neurosurgical procedures in 1991 to repair acerebral arterial aneurysm (one in September and one in October); duramater grafts were used during both operations. In February 1994, 28 months after the second operation, she developed progressive dysphagia, dysarthria, and unsteady gait, followed within a few weeks by dementia. In April 1995, she developed generalized myoclonic jerks and akinetic mutism. An electroencephalograph showed a 6- to 10-Hz background rhythm with the periodic synchronized slow activity complexes typical of CJD. Examination of the cerebrospinal fluid revealed a normal protein level and cell count. A magnetic resonance imaging scan showed marked cerebral and cerebellaratrophy. The patient died in October 1995, and no autopsy was performed.

Neither the brand nor year of processing of the dura mater grafts used inthis patient in 1991 could be determined. However, the hospital in which both neurosurgical procedures were performed opened in 1989 and reported using only two brands of dura mater grafts in 1991, LYODURA{Registered} andTutoplast (Pfrimmer-Viggo GmbH+Co, Erlangen, Germany). The investigation suggested that in this patient, the use of LYODURA{Registered} processed before May 1987 was unlikely but could not be ruled out.


http://www.cdc.gov/mmwr/preview/mmwrhtml/00049829.htm


... Even stringent donor screening and processing of each dura separately to avoid possible cross-contamination may not completely eliminate the potential for an infectious graft. In addition, the treatment of dura with NaOH may not inactivate all of the infectious agent that may be present(6). Therefore, surgeons should be aware of the possibly inherent risk for CJD transmission by dura mater grafts and may want to consider the alternative use of autologous fascia lata, fascia temporalis, or synthetic substitutes (4). "


http://www.hc-sc.gc.ca/english/media/releases/2003/cjdbk.htm


September 2003

Information

Tutoplast Dura mater

Health Canada is the national authority that regulates the safety, efficacyand quality of therapeutic products (such as medical devices) used inCanada. It derives its statutory authority over therapeutic products fromthe Food and Drugs Act and Regulations.

Tutoplast Dura mater is a medical device that was available in Canadabetween January 1982 and April 2002 for use in various surgical treatments,including neurosurgery.

The term "medical device" covers a wide range of products used in thetreatment, mitigation, diagnosis or prevention of a disease or abnormalphysical condition. Some examples include pacemakers, artificial heartvalves, hip implants, synthetic skin, medical laboratory diagnosticinstruments, test kits for diagnosis and contraceptive devices.

The Medical Devices Bureau of the Therapeutic Products Directorate (TPD) atHealth Canada is the national authority that monitors and evaluates thesafety, effectiveness and quality of diagnostic and therapeutic medicaldevices in Canada. The Medical Devices Bureau enforces the Medical DevicesRegulations, which aim to ensure to the extent possible, the safety,effectiveness and quality of medical devices in Canada. This is donethrough a combination of pre-market review, post-approval surveillance andquality systems in the manufacturing process.

In Canada, certain medical devices must have a Medical Device Licencebefore they can be sold. To determine which ones need a Licence, allmedical devices have been categorized based on the risk associated withtheir use. This approach means that all medical devices are grouped intofour classes with Class I devices presenting the lowest potential risk(e.g. a thermometer) and Class IV devices presenting the greatest potentialrisk (e.g. pacemakers).

Prior to selling a medical device in Canada, manufacturers of Class II, IIIand IV devices must obtain a Medical Device Licence. Although Class Idevices do not require a Licence, they are monitored through EstablishmentLicences.

What is Tutoplast dura mater?

Dura mater is a tissue that covers and protects the brain and spinal cord.Commercially processed dura mater, obtained from human donors, has beenused in the surgical treatment of many conditions in Canada since the 1970s.

Tutoplast Dura manufactured before 1992 was processed with a lessconcentrated disinfectant solution than material manufactured after October1992. The disinfectant used initially, which was in accordance with whatwas known regarding prion diseases at the time, was a ten times weakersolution of sodium hydroxide than was used starting in 1992.

Processed dura mater is regulated as a class IV medical device. TutoplastDura (manufactured by Tutogen Medical GmbH of Germany) was first sold inCanada in January, 1982.
The April 2001, edition of "Neurology" published details of the first caseof classical Creutzfeldt-Jakob Disease (CJD) associated with the use ofTutoplast Dura.

Following the publication of this news, Health Canada took action to obtainfurther information on the current surgical need for the use of TutoplastDura in Canada. It wrote to orthopaedic, neurosurgical andotolaryngological professional associations seeking advice on theimportance to their members of the continued availability of Tutoplast duramater. The Canadian Neurosurgical Society (CNSS) responded by conducting asurvey of their members. Of those who replied, 61% supported discontinuingthe use of donor dura mater.

On April 10, 2002, Health Canada suspended the medical device licence forTutoplast Dura. The suspension means that the importation and sale of thismedical device is no longer permitted in Canada.

Physicians were advised at the time to place any existing Tutoplast productin a secure location and immediately inform the manufacturer or distributor.

This action was based on the following considerations:

Advice received through Health Canada's consultation with the CanadianNeurosurgical Society The recommendations of a leading Canadian expert onprion illness (Dr. Neil Cashman). The availability of adequate alternativematerials that can be used instead of commercially-processed dura materobtained from human donors.

The Canadian distributor of Tutoplast Dura conducted the recall of theproduct as per Health Canada's request.

The day following the suspension of the licence (April 11, 2002), HealthCanada initiated an Import Alert with Canadian Customs.

Health Canada informed international partners of the suspension and recallaction through the National Competent Authority Report system. HealthCanada forwarded copies of the medical device suspension letter and of theSafety Advisory to the German authorities for information pertaining to themanufacturer Tutogen Medical GmbH in their jurisdiction.

Health Canada sent a letter to health care professionals on April 11, 2002,advising them:

Not to use Tutoplast Dura manufactured by Tutogen Medical GmbH in anysurgical procedure, as it is no longer licensed for sale in Canada. Toplace any remaining stocks of Tutoplast Dura in a secure location so thatit can no longer be used and immediately inform the manufacturer ordistributor who sold the product.

Individuals who want more information on the recall may leave a message onthe Medical Devices Hotline at 1-800-267-9675. A Health Canada officialwill return the call.

Last Updated: 2003-09-24

TSS


Terry S. Singeltary Sr. wrote:

I was amazed at the comment the doctor made about this in an article yesterday. i had to send a note to him.....tss

snip...

Dr. Dow said he doubted that the woman had died of an infected brain patch. And while there is a theoretical risk that the disease could be spread through instruments contaminated with prion proteins from a patient with CJD, he added to my knowledge there has been no proven case of a neurosurgical instrument contaminated with protein from a patient with CJD causing infection in another patient.

snip...

end


http://www.theglobeandmail.com/services/site/help.html#webstaff



what do you call this;

1: J Neurol Neurosurg Psychiatry 1994 Jun;57(6):757-8

Transmission of Creutzfeldt-Jakob disease to a chimpanzee by electrodes contaminated during neurosurgery.

Gibbs CJ Jr, Asher DM, Kobrine A, Amyx HL, Sulima MP, Gajdusek DC.

Laboratory of Central Nervous System Studies, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD 20892.

Stereotactic multicontact electrodes used to probe the cerebral cortex of a middle aged woman with progressive dementia were previously implicated in the accidental transmission of Creutzfeldt-Jakob disease (CJD) to two younger patients. The diagnoses of CJD have been confirmed for all three cases. More than two years after their last use in humans, after three cleanings and repeated sterilisation in ethanol and formaldehyde vapour, the electrodes were implanted in the cortex of a chimpanzee. Eighteen months later the animal became ill with CJD. This finding serves to re-emphasise the potential danger posed by reuse of instruments contaminated with the agents of spongiform encephalopathies, even after scrupulous attempts to clean them.

PMID: 8006664 [PubMed - indexed for MEDLINE]


http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8006664&dopt=Abstract



7 CJD cases possible in N.B., officials say Brain-wasting ailment confirmed in woman who died in July, after she had neurosurgery

RICHARD FOOT CanWest News Service

Thursday, September 25, 2003 ADVERTISEMENT

Click here to find out more!

New Brunswick health officials have warned seven former hospital patients they may have contracted Creutzfeldt-Jakob disease during neurosurgery in Moncton, N.B., following the death of a woman this summer from the rare but fatal brain-wasting illness.

The woman died on July 31, about six weeks after undergoing neurosurgery at Moncton Hospital, where doctors noticed she was showing symptoms of the disease.

On Monday, autopsy results of her brain tissue confirmed she died of classical Creutzfeldt-Jakob disease, or CJD.

Only about 30 Canadians are diagnosed each year with classical CJD, which is a related but separate illness from the human form of mad cow disease, called variant-CJD.

"I want to make it very clear that this is not a case of mad cow disease,'' Gordon Dow, the hospital's chief of infectious diseases, said yesterday in Moncton.

How the woman contracted classical CJD remains a mystery. It's also unclear what specific type of infection she had.

If she died of sporadic CJD, her death poses no risk to the seven other patients. However, officials cannot rule out the chance she died of a less common form called iatrogenic CJD.

This is contracted when the disease is mistakenly passed from one person to another, through shared surgical instruments or through brain tissue transplants. The woman may have been infected during a brain tissue transplant on her spinal cord in 1992, when doctors implanted a tissue graft taken from the brains of human cadavers.

The type of implant used in 1992, known as Tutoplast dura mater, was banned by Health Canada last year because of concerns that it could transmit CJD.

The woman returned to hospital for a second operation in June this year, and died shortly afterwards. The instruments used in her operation have since been incinerated, but of the seven patients warned in the wake of the woman's death, two may have been exposed to those instruments before they were destroyed. Five others received similar brain tissue transplants in the early 1990s.

© Copyright 2003 Montreal Gazette


http://canada.com/national/story.asp?id=AD81755E-B1B4-4F27-ACCE-E6D809057C60


Terry S. Singeltary Sr. wrote:

Brain-wasting disease confirmed in N.B. woman

By LUMA MUHTADIE Globe and Mail Update

A New Brunswick woman died in hospital from Creutzfeldt-Jakob disease, health officials in Moncton announced on Wednesday.

Officials stressed that the case of so-called “classical” CJD cannot spread from person to person, and is not connected to the variant of the disease, which has been linked to mad cow or bovine spongiform encephalopathy.

“This is not a case of mad cow disease,” Gordon Dow, chief of infectious diseases at Moncton Hospital, told the press conference.

However, health officials said that tests were inconclusive as to whether the disease developed spontaneously in the 55-year-old woman (as it does in about 30 Canadians a year) or whether it was iatrogenic, meaning it resulted from an infection acquired during a medical procedure.

In 1992, doctors in Moncton grafted a patch made from tissue taken from a human corpse onto the woman's brain. She returned to the Moncton Hospital in June for a secondary neurosurgical operation, and in a follow-up consultation on June 18, possible CJD was diagnosed. She died on July 31 and the diagnosis of CJD was confirmed through an autopsy on Monday.

Health Canada banned the use of brain-tissue patches taken from human corpses last year due to CJD fears.

Dr. Dow said he doubted that the woman had died of an infected brain patch. And while there is a theoretical risk that the disease could be spread through instruments contaminated with prion proteins from a patient with CJD, he added “to my knowledge there has been no proven case of a neurosurgical instrument contaminated with protein from a patient with CJD causing infection in another patient.”

He said it would be very useful to know if the patient represented a sporadic form of CJD, in which case there would be “absolutely no risk to anybody else” or if she acquired the disease from the graft she received in 1992, “whereby potentially, other patients could have been exposed to the same graft.”

As a safety measure, the Moncton Hospital quarantined all neurosurgical and spinal instruments in the region, later narrowing the quarantine to only those instruments used in the woman's more recent operation.

The hospital also searched the charts of all patients who received graft surgery within one year on either side of the woman's original surgery -– or from 1991 to 1993 -– to identity all potential recipients of the same graft. Seven individuals were found and informed that they were at a small risk of infection.

CJD is a degenerative disease of the central nervous system that initially alters the personality or makes social interaction difficult, but quickly progresses into problems with speech, memory and vision. It eventually leads to motor problems such as stiffness, paralysis and twitching.

“During this rapid deterioration, patients quickly become confined to bed in a mute, paralyzed state -- probably in a semi-comatose state -- with very little insight or understanding ... or sensation of their illness and subsequently die,” Dr. Dow said.

It generally takes six months from the onset of symptoms until death. There is currently no treatment available for CJD.


http://www.theglobeandmail.com/servlet/story/RTGAM.20030924.wcreu0924/BNStory/Front


spontaneous my @ss..... how can these people continue to believe that 85%+ of all CJDs happen from nothing (a spontaneous happening without route and source). this is total BSeee and they cannot prove this. it is only wishful thinking by scientist and there politicians that advocate this myth $$$

TSS

Terry S. Singeltary Sr. wrote:

######## Bovine Spongiform Encephalopathy #########

New Brunswicker reported dead of Creutzfeldt-Jakob Last Updated Wed, 24 Sep 2003 12:25:17

MONCTON - A New Brunswick resident has died of Creutzfeldt-Jakob disease after brain surgery, CBC has learned.

Sources tell CBC News that this case was not the CJD variant caused by eating tainted beef and is not related to bovine spongiform encephalopathy, or mad cow disease.

Diagnosis of the disease cannot be confirmed until after death.

Public health authorities are expected to hold a news conference later Wednesday to release more details.

* FROM APRIL 13, 2002: Health Canada bans 'brain patch' linked to brain disease



From: TSS (216-119-130-124.ipset10.wt.net)Subject: BRAIN PATCH STILL IN USE $ (re-dura/CJD) $ LESS THAN ONE MONTH TO GO FOR COSMETICS/BSE/BeijingDate: March 27, 2002 at 6:04 pm PST

POSTED AT 2:08 AM EST Tuesday, March 26[space]Brain patch still in use despite risk[space][space] Advertisement[space]

By CAROLYN ABRAHAM From Tuesday's Globe and Mail

Canadian patients still receive brain-tissue patches taken from human corpses, despite a World Health Organization call to ban them because of the risk of transmitting a fatal brain-wasting disease similar to bovine spongiform encephalopathy (mad-cow disease).

The WHO recommended in 1997 that grafts of human dura, tissue harvested from the outer lining of cadaver brains, should be used only if a surgeon has no other means to patch and close an incision.

But based on a recent survey, the Canadian Neurosurgical Society estimates that surgeons stitch these human-tissue patches into the brains of 200 patients a year.

Scientists, meanwhile, fear that the incurable Creutzfeldt-Jakob disease can contaminate these tissue grafts, especially since the infection is known to survive extreme sterilization measures. Grafts are produced by companies that collect the dura from cadavers.

One type, the German-made Lyodura, a brand that is no longer in production, has been linked to 115 CJD deaths worldwide, four of them in Canada over the past decade.

"There are so few things that we know can transmit CJD, why the hell not just eliminate one possibility?" said Neil Cashman, a neurologist at the University of Toronto Centre for Neurodegenerative Disease.

Dr. Cashman, also a member of the CJD National Surveillance Team, said the benefits of using these tissue grafts in brain operations are not worth the potential risks.

Britain banned their use in 1989. Japan, where more than half the Lyodura-linked deaths have occurred, halted its use in 1997. But in Canada, as in the United States, there have been no similar restrictions.

Health Canada spokesman Ryan Baker said, however, that federal officials are now considering whether there should be.

"Health Canada is currently reviewing the potential risks of human-derived dura substitutes," Mr. Baker said.

No government official would speak about the use of the brain patches because Health Canada is being sued by the family of a 14-year-old boy who died of CJD in 1999 after receiving a Lyodura implant in 1988. Warnings that the product could be tainted with CJD had been published a year earlier.

According to Mr. Baker, there are seven licensed products on the market to patch the tough outer membrane of patients' brains after an operation. Four are synthetic and two are derived from bovine heart tissue. Only one, he said, comes from human cadavers ? a product called Tutoplast that is made by New Jersey-based Tutogen Medical Inc.

Rick Moulton, president of the Canadian Neurosurgical Society, said Health Canada contacted his organization last fall trying to find out how many patients receive the human dura patches and how brain surgeons would react to banning them.

"We actually support a complete ban on all human dura [grafts]," Dr. Moulton said. "In part because there is no way to test the product for CJD and there is no way to test the patient who receives it."

The society represents 130 of the approximately 170 neurosurgeons in Canada.

Dr. Moulton, also head of the division of neurosurgery at St. Michael's Hospital in Toronto, said the "gold standard" is to patch the dura with the patient's own tissue, taken from the skull or thigh.

Paul Brown, a senior investigator with the U.S. National Institute of Neurological Disorders and an expert on CJD and its related diseases, said some surgeons have felt that "none of the alternatives are as good as human dura."

He also said that manufacturers who have a clean record feel they should not be punished for the cases that have been linked to one company.

Dr. Brown explained certain procedures can reduce risks, such as ensuring that no brain tissue is collected from a donor who suffered neurological problems, that specimens are not pooled in one container to avoid contaminating others, and that the tissue undergoes special and proper sterilization.

CJD, usually a rare disorder that hits one in a million elderly people, strikes about 26 people a year in Canada. It can develop sporadically, with no explanation, it can be the result of a genetic mutation and it can be spread to the brain through medical procedures, such as tissue implants or contaminated surgical tools.

CJD is also linked to the neurodegenerative BSE, in which misshapen proteins devour the brain, leaving the tissue resembling a sponge after death.

Public Citizen, the national U.S. group founded by consumer advocate Ralph Nader, petitioned the U.S. Food and Drug Administration last August for a complete ban on the use of donated human dura tissue in surgery.

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POSTED AT 3:07 AM EST Wednesday, March 27[space]Patients want answers on brain patch


By CAROLYN ABRAHAM
From Wednesday's Globe and Mail

Anxious patients who underwent brain surgery in the past dozen years are trying to find out if they received a brain tissue patch that has since been linked to a lethal, neurodegenerative disease.

Calls to doctors, hospitals and The Globe and Mail indicate that while there is no way to tell whether a patient received a tissue graft contaminated by the brain-wasting Creutzfeldt-Jakob disease, people still want to know if they are at risk.

"I have received calls from families whose members received a Lyodura [brain-tissue] transplant who also want to know what they can do. But the answer is, there is no answer," said Neil Cashman, a neurologist at the University of Toronto's Centre for Neurodegenerative Diseases.

Unless a person has actually begun to develop symptoms of CJD, such as trembling, loss of balance and dementia, no examination can reveal if they may be infected, said Dr. Cashman, who is also a member of the CJD National Surveillance effort.

Still, Health Canada is recommending that "anyone who received Lyodura or anyone who has concerns about their surgery should consult their physician," said Health Canada spokesman Ryan Baker.

But Mr. Baker added, "If we hear about a case of CJD, we will trace it to its origins."
Lyodura, processed from the brain coverings of human cadavers and produced by the German multinational medical supply giant B. Braun Melsungen until 1996, has been associated with 115 deaths in 11 countries ? including four in Canada.

The caseload has raised questions about the safety and sources of tissues harvested from human corpses for medicinal use, and the abilities of the health system to protect patients.
Hundreds of Canadians received Lyodura patches in the 1980s when surgeons stitched closed the dura, the brain's outer lining. But how many are at risk remains a mystery because no one knows which lots might have been infected with CJD, a condition that can incubate for 30 years.
One man, for example, who read on the weekend about the risks associated with Lyodura, learned from a Montreal hospital this week that he had in fact received this brand of tissue implant in 1988.

The man, who asked not to be identified, said hospital officials are now digging in their archives to determine which lot his Lyodura came from. The man said the hospital had also received the same request from another concerned patient.

Health Canada issued a recall of two lots of Lyodura in 1987 that had been linked to a CJD death in the United States. But U.S. health authorities warned later that year that the risk of CJD was not limited to any particular lot number, but applied to all Lyodura tissue grafts produced before 1987.

This is because the U.S. officials had found that, unlike other companies, B. Braun had been collecting dura brain matter from corpses and pooling all the tissue in one container, increasing the risk that one CJD-tainted specimen could contaminate all the others.

The investigation also learned that the company had no records on individual donors, making it impossible to trace the source of a possible infection.

Then it was reported in 1994 that the company had paid hospital autopsy workers $18 for each brain membrane harvested from a cadaver. German officials were quoted as saying that the tissues were sometimes collected without permission of the donor's families or hospital administrators.

However, Ermias Belay, a medical epidemiologist following the Lyodrua cases for the U.S. Centers for Disease Control, noted, "Not everyone who got Lyodura will get CJD. The risk is not 100 per cent."

In Canada, at least one family has settled out of court after filing a suit against B. Braun and others in connection to Lyodura. The family of Dominique Roy-Regimbald, a 14-year-old who died in 1999 after receiving the tissue graft in 1988, now has a suit before Quebec provincial court.

Other people with relatives who died of CJD after undergoing brain surgery are also haunted by questions.

Marianne Pope, whose 62-year-old mother died of CJD in May, 1991, contacted The Globe this week, saying she and her sister, brother and father were looking for answers.

Their mother, Margaret Sandercott, had undergone surgery at a London, Ont., hospital in November, 1988, to remove a tumour in her inner ear. They are now trying to find out from records whether she received a human tissue graft, or Lyodura, in the process.

"She lost all brain function less than three years after that operation," said Ms. Pope. "We've always been pretty convinced that she somehow contracted it through the operation.
"We feel there is way more of this out there than people realize."


http://www.globeandmail.com/servlet/RTGAMArticleHTMLTemplate/C/20020327/wxlyod?hub=homeBN&tf=tgam%252Frealtime%252Ffullstory.html&cf=tgam/realtime/config-neutral&vg=BigAdVariableGenerator&slug=wxlyod&date=20020327&archive=RTGAM&site=Front&ad_page_name=breakingnewsaca


Last updated at: (Beijing Time) Tuesday, March 26, 2002

BSE-related Cosmetics' Sale BannedChinese establishments that sell imported cosmetics which might spread mad cow disease have less than one month to clear their shelves of the potentially deadly products.


Chinese establishments that sell imported cosmetics which might spread mad cow disease have less than one month to clear their shelves of the potentially deadly products.

The Ministry of Health and the State General Administration of Quality Supervision and Inspection and Quarantine issued a statement early this month to ban the import and sale of such cosmetics before April 20.

Enterprises urged to withdraw products immediately At present, many shops still stock cosmetics containing cattle or sheep brain tissues, nerve tissue, internal organs, placenta, blood or their extracts from dozens of countries and regions where mad cow disease (bovine spongiform encephalopathy, or BSE) has been found.

Enterprises that have already imported cosmetic products containing such components are urged to immediately report them to the health authorities and withdraw.

Some large department stores claim they have already withdrawn the imported cosmetics.
In North Star Shopping Centre, only Lan Ono, a cosmetic brand from Australia which is famous for its wool oil cosmetics and is free of mad cow disease, is on sale.

Some cosmetics still flourishingHowever, in many small and medium-sized markets in Beijing and other cities, such cosmetics are reportedly still flourishing.

Some market managers claim they are waiting for a list of the banned cosmetics before clearing their shelves, as they do not know which ones should be pulled.

Consumers are also waiting for such a list to know which cosmetics to avoid.

The Ministry of Health will distribute a list. However, it will not be until after April 20, according to Zhang Yinfa, a ministry official.

The ministry will also check a list of cosmetics it previously approved to see which of them contain suspected tissues, he added.

"It will be a hard task because there are nearly 10,000 imported cosmetics already approved in China,'' said Zhang.

To some, the ban will not make much difference to consumers and enterprises.
For example, Meng Jun, deputy manager of the cosmetics sale department in Beijing Xidan Plaza, said the majority of marketable cosmetics are made of plant tissues -- a fashion in the cosmetic industry -- and, therefore, the ban will not have a great influence on the sale of cosmetics.

Consumers should remain cautiousBefore the list comes out, consumers should remain cautious when buying cosmetics, and check products' contents, experts suggest.

In China, cosmetics imported legally and sold have Chinese characters displaying their contents and usage.

Since the first case of mad cow disease was detected in Britain in 1985, BSE cases have cropped up in many European countries, including Ireland, Switzerland, France, Belgium, Luxembourg, the Netherlands, Germany, Portugal, Denmark, Italy, Spain, the Principality of Liechtenstein, the Slovak Republic, Finland and Austria.

China Bans Cosmetics from Countries Suffering from 'Mad-Cow' DiseaseA bulletin released jointly by the Ministry of Health and the State General Administration for Quality Supervision and Inspection and Quarantine noted that the cosmetics containing the material extracted from brains, nerve cells, inner organs, placentas and blood of cows and sheep which came from countries or regions suffering from "mad-cow" disease will be banned to import and sell.

Cosmetics containing the material extracted from brains, nerve cells, inner organs, placentas and blood of cows and sheep which came from countries or regions suffering from "mad-cow" disease will be banned to import and sell, noted a bulletin released jointly by the Ministry of Health and the State General Administration for Quality Supervision and Inspection and Quarantine. In Detail


http://english.peopledaily.com.cn/200203/26/eng20020326_92835.shtml


TSS



To: Mad Cow USA madcow@lists.iatp.org
From: flounder9@verizon.net
Date: 2006-06-01 15:20:59
Subject: Fw: Brief Report: Investigation into Recalled Human Tissue for Transplantation --- United States, 2005--2006


----- Original Message -----

From: "Terry S. Singeltary Sr."
To:
Sent: Wednesday, May 31, 2006 4:13 PM
Subject: Brief Report: Investigation into Recalled Human Tissue forTransplantation --- United States, 2005--2006


##################### Bovine Spongiform Encephalopathy#####################


MMWR Brief Report: Investigation into Recalled Human Tissue forTransplantation --- United States, 2005--2006Posted: 5/30/2006


Brief Report: Investigation into Recalled Human Tissue forTransplantation --- United States, 2005--2006


On September 29, 2005, a human tissue-processing company discoveredinaccuracies in donor records forwarded from a tissue-recovery firm andnotified the Food and Drug Administration (FDA). An FDA investigationdetermined that the recovery firm, Biomedical Tissue Services, Ltd. (BTS)(Fort Lee, New Jersey), recovered tissues from human donors who might nothave met donor eligibility requirements and who were not screened properlyfor certain infectious diseases. In October 2005, BTS and the fiveprocessors* that had received the tissues, working with FDA, issued a recallfor all tissues recovered by BTS. The continuing FDA investigationdetermined that information for some donors (e.g., cause, place, or time ofdeath) was not consistent with death certificate data obtained from thestates where the deaths occurred. The investigation also determined that BTShad failed to recover tissues in a manner that would prevent contaminationor cross-contamination and failed to control environmental conditionsadequately during tissue recovery. These failures were violations of theCurrent Good Tissue Practice Rules? (effective May 25, 2005), which requiremanufacturers to recover, process, store, label, package, and distributehuman cells, tissue, and cellular and tissue-based products (HCT/Ps) toprevent introduction, transmission, or spread of communicable diseases. InJanuary 2006, FDA ordered BTS to cease manufacturing and to retain allHCT/Ps.
The tissues recovered by BTS had been sent to five processors, whodistributed them through one or more sub-distributors or directly toclinicians and health-care facilities. CDC learned that, during June2002--October 2005, approximately 25,000 BTS-recovered tissue products weredistributed to all 50 states and internationally. Most of these tissueallografts were bone or demineralized bone matrix; others included skin andsoft tissue (e.g., tendons or fascia lata). Before distribution, tissueswere disinfected by tissue processors to reduce or eliminate contaminationwith bacteria, fungi, or viruses.


During September--October 2005, the five tissue processors recalled allproducts that had been produced from BTS tissues. Each of the processors andrelated distributors issued letters to consignees (i.e., health-carefacilities or clinicians) to notify them of the recall and request return ofunused products. The letters included a recommendation by FDA and CDC thattransplant recipients be notified of the recall and offered access totesting for the communicable diseases for which donor screening is required:human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis Cvirus (HCV), and syphilis.


In March 2006, FDA determined that, in some instances, blood samplessubmitted for disease screening had not come from the persons from whom thelinked tissues had been obtained. This finding cast doubt on the bloodsample--screening status of the tissue donors, and FDA and CDC issued anupdate§ that strongly recommended health-care providers offer patientsaccess to or referral for testing for HIV, HBV, HCV, and syphilis. CDCrecommendations¶ for testing persons who received BTS tissues call forpatients whose tissue implants have been in place >6 months to be offeredthe following tests: HIV antibody, antibody to hepatitis B core antigen,antibody to hepatitis C virus, a non-treponemal syphilis test (i.e., rapidplasma reagin [RPR] or Venereal Disease Research Laboratory [VDRL]), and atreponemal syphilis test (i.e., Treponema pallidum particle agglutination[TP-PA] or any enzyme-linked immunosorbent assay [ELISA] test). Patientswhose tissue implants have been in place <6 href="mailto:mmwrq@cdc.gov">mmwrq@cdc.gov.


Date last reviewed: 5/25/2006


http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5520a6.htm



Body snatchers tied to allograft firms?

Alleged New York-area ring investigated for selling parts to corpse tissue harvesters.

October 7, 2005: 2:54 PM EDTBy Aaron Smith, CNN/Money staff writer


NEW YORK (CNN/Money) - A Brooklyn funeral home and a New Jersey company that harvests body parts from corpses are being investigated for their alleged roles in a body snatching ring that sold parts to companies specializing inmedical grafts, sources close to the investigation said Friday.

The Brooklyn district attorney's office declined to comment on the investigation. But sources close to the investigation acknowledged that it has been going on for about one and a half years, focusing on Michael Mastromarino of Biomedical Tissue Services Ltd. of Fort Lee, N.J., who allegedly harvested body parts illegally from the Daniel George funeral home in Brooklyn.
The firms that bought the allegedly black-market tissue have not been accused of any wrong doing. Human tissue is usually obtained from non-profittissue banks. In the U.S., it's illegal to buy and sell human tissue.

Wendy Crites-Wacker, spokeswoman for Regeneration Technologies (down $0.66to $7.28, Research), a company in Alachua, Fla., said her company has severed all ties with Biomedical Tissue Services, their former source for some of the body parts used to make medical grafts, or allografts.

"We had previously terminated the relationship with Biomedical Tissue Services and we are cooperating with the appropriate authorities on this issue," said Crites-Wacker, who declined to say when the termination took place.

Crites-Wacker also said that her company's BioCleanse process, in which bones and tendons are sterilized through a melange of chemicals, temperatureand pressure, ensures that its products are safe.

Two other allograft companies have been identified as customers ofBiomedical Tissue Services: LifeCell Corp. (down $2.82 to $17.33, Research),of Branchburg, N.J. and Tutogen Medical Inc. (down $0.15 to $4.06, Research)of West Paterson, N.J.

LifeCell Corp. had issued a Friday statement saying it had voluntarily recalled some human tissue products after questions were raised about Biomedical Tissue Services.

"Specifically, the company recalled all lots of product that were produced using tissue from Biomedical Tissue Services (BTS)," LifeCell said in a release.

LifeCell, which markets products made from human tissues that are used in surgical procedures, said it recalled certain AlloDerm, Repliform and Graft Jacket products on Sept. 30.
LifeCell's stock price slid about 5 percent this morning, and a Piper Jaffray analyst attributed the slump to a New York Daily News story that first reported on the investigation.

"We believe this morning's weakness in LifeCell's shares is related to a news article that alleges LifeCell inadvertently received tissue from an illegal body-snatching ring," said Raj Denhoy of Piper Jaffray, in a written report.

LifeCell said in the statement all other tissues supplied by Biomedical Tissue Services remain "on hold until the discrepancies in the donor documentation can be resolved."

Denhoy said that LifeCell did not appear to do anything illegal and that"LifeCell itself was the victim of fraud," referring to allegations that Biomedical Tissue Services forged death certificates and family consent forms.

Denhoy said that LifeCell receives tissue from 30 sources, "so the loss of one will likely not impact the underlying business," though increased regulatory scrutiny could drive down the stock price.

"While LifeCell and the other tissue companies appear to have done nothing wrong, this event could increase regulatory and media scrutiny of the business," said Denhoy, who rates the company market perform. "We recently downgraded LifeCell shares on competitive concerns and today's revelations may pressure the stock further."

Eric Franz, the attorney representing funeral home owners Debora Johnson and Robert Nelms, said his clients "did not participate in any criminal conduct whatsoever."

Attempts to reach Mastromarino and his company Biomedical Tissue Services were unsuccessful. The Daily News reported that Mastromarino declined to comment.

Regeneration Technologies produces heart valves, bone and tendon implants and bone paste, which is used to plug holes. LifeCell specializes in AlloDerm, a "dermal matrix" made from human skin that is used in grafts. Tutogen focuses on bone and dental implants.

--from staff and wire reports

http://money.cnn.com/2005/10/07/news/midcaps/corpse/?section=money_latest


Order to Cease Manufacturing and to Retain HCT/Ps

January 31, 2006

CERTIFIED MAILRETURN RECEIPT REQUESTED

Michael Mastromarino, D.D.S.CEO & Executive Director of OperationsBiomedical Tissue Services, Ltd.2125 Center Avenue, Suite 300Fort Lee, NJ 07024-5874

Dear Dr. Mastromarino:

The Food and Drug Administration (FDA or the agency) conducted an inspection of your establishment, Biomedical Tissue Services, Ltd. (BTS or Establishment), at 2125 Center Avenue, Suite 300, Fort Lee, New Jersey07024, which manufactures human cells, tissues, and cellular and tissue-based products (HCT/Ps), between October 4 and 27, 2005. At the conclusion of the inspection, the FDA investigators issued you a FormFDA-483, Inspectional Observations. In addition to the inspection, the agency conducted a concurrent investigation of several funeral homes that provided you with potential donors of HCT/Ps for recovery. Our review of the information and records examined and collected during the inspection and investigation reveal that significant violations of Title 21, Code ofFederal Regulations (21 CFR), Part 1271, issued under the authority ofSection 361 of the Public Health Service Act (PHS Act) [42 U.S.C. 264],exist at BTS. The agency has determined that these deviations, because of their serious nature, constitute a danger to health. This Order to Cease Manufacturing and to Retain HCT/Ps relates exclusively to conduct occurring on or after May 25, 2005, the effective date of these regulations. We note that the FDA retains authority to pursue other actions and remedies.
Therefore, pursuant to 21 CFR 1271.440(a)(1) and (3), both you individually, and your Establishment, 1) must immediately cease all manufacturing until compliance with the regulations in 21 CFR Part 1271 has been achieved, and2) must retain all HCT/Ps recovered on or after May 25, 2005 that are inyour possession until they are disposed of as agreed by the agency or until the safety of the HCT/P is confirmed. Pursuant to 21 CFR 1271.3(e),"Manufacture" means, but is not limited to, any or all steps in the recovery, processing, storage, labeling, packaging, or distribution of anyHCT/P, and the screening or testing of the HCT/P donor.

Deficiencies noted include, but are not limited to, the following:
You failed to implement the standard operating procedures (SOP or SOPs) that you have established for all steps that you perform in determining donor eligibility, as required by 21 CFR 1271.47(a), and you failed to review the certificate of death for each donor, a relevant medical record, regarding risk factors for, or clinical evidence of, relevant communicable disease agents and diseases, as required by 21 CFR 1271.75(a). More specifically,your standard operating procedure entitled "Donor Identification" requiresthat, when recovering HCT/Ps at a funeral home, you review the death certificate to confirm the eligibility of the donor. However, you recovered HCT/Ps from at least eight donors, obtained from --- different funeral homes, located in ------ different states, in which you failed to review valid death certificates. The documents purporting to be the certificates of death for these donors were collected from BTS during our inspection, are not authentic death certificates issued by the state, and are inaccurate. For example:

You confirmed the eligibility of donor ------------, who donated HCT/Ps at afuneral home in ----------. The donor is listed on the BTS version of the certificate of death as being 63 years of age, having died of acutemyocardial infarction due to coronary artery disease, at ----pmon ------------, whereas the State of ---------------issued certificate of death lists this donor as being 69 years of age, having died of multi-organ failure, due to liver dysfunction, which in turn was due to thrombosis, at ----pm on ------------------;

You confirmed the eligibility of donor --------------, who donated HCT/Ps ata funeral home in ----------------. The donor is listed on the BTS version of the certificate of death as being 44 years of age, having died of blunt trauma in a motor vehicle accident, at ----am on ----------------, where as the State of -----------------issued certificate of death lists this donoras being 48 years of age, having died of congestive cardiac failure due to atherosclerotic cardiovascular disease, at ----am on ------------------;

You confirmed the eligibility of donor -------------, who donated HCT/Ps at a funeral home in ---------------. The donor is listed on the BTS version of the certificate of death as being 70 years of age, having died of cardio-pulmonary arrest due to acute myocardial infarction, at ---- pmon ------------------, whereas the State of ---------------------issued certificate of death lists this donor as being 74 years of age, having died of complications from the intravenous administration of medication due to aradical resection of a -----------------------------------------------------------------, at ----pm on ---------------------;

You confirmed the eligibility of donor ------------------, who donatedHCT/Ps at a funeral home in ---------------. The donor is listed on the BTS version of the certificate of death as having died of cardio-pulmonaryarrest due to atherosclerotic heart disease, at ----pm on -----------------, whereas the State of -------------issued certificate of death lists this donor as having died of cardio-pulmonary asystole due to sepsis and shock, at ----pm on --------------;

You confirmed the eligibility of donor ---------------, who donated HCT/Psat a funeral home in ----------------------. The donor is listed on the BTS version of the certificate of death as being 45 years of age, having died of blunt trauma due to a motor vehicle accident, at ----pm on ---------------, whereas the State of ----------------------issued certificate of death lists this donor as being 41 years of age, with a cause of death which was undetermined pending additional studies, at ----pm on -------------------;

You confirmed the eligibility of donor -------------, who donated HCT/Ps ata funeral home in -------------. The donor is listed on the BTS version ofthe certificate of death as having died of cardio-pulmonary arrest due toacute myocardial infarction, at ----pm on -----------------, whereas theState of ------------------issued certificate of death lists this donor as dying of probable ventricular fibrillation due to -------------------failure, as a consequence of -------------------- disease, at ----amon ----------------------;

You confirmed the eligibility of donor -------------, who donated HCT/Ps ata funeral home in ------------. The donor is listed on the BTS version ofthe certificate of death as being 58 years of age, having died of acutemyocardial infarction, at ----am on ----------, whereas the State of ---------------------issued certificate of death lists this donor as being 50 years of age, having died of diabetes mellitus and hypertension due to cardio-vascular disease, at ----pm on ---------------------------; and
You confirmed the eligibility of donor --------------, who donated HCT/Ps ata funeral home in ----------------. The donor is listed on the BTS version of the certificate of death as being 63 years of age, having died of acutemyocardial infarction, at ----pm on ------------, whereas the State of -------------issued certificate of death lists this donor as being 79 years of age, having died of pneumonia due to a myocardial infarction, at ----pm on -----------------.
You failed to implement the SOPs that you have established for all steps that you perform in determining donor eligibility, regarding your assessment of risk factors for, or clinical evidence of, relevant communicable disease agents and diseases, as required by 21 CFR 1271.47(a).

Furthermore, you failed to create and maintain accurate records, as required by 21 CFR1271.55(d)(2) and 21 CFR 1271.270(a).More specifically, your "Documenting the Recovery" SOP requires that, if the donor had been admitted to a health care facility immediately prior to death, you were to document the date and reason for admission; check the appropriate boxes regarding availability of donor history, physical, and discharge summary; check the appropriate box regarding surgeries; check the appropriate boxes regarding availability of lab results (including blood cultures, x-rays, and lung biopsies); and check the appropriate boxes regarding documentation of HIV, Hepatitis and Tuberculosis infection. However, your Medical Evaluation forms fordonors -----------------, ---------------, -------------------, -------------, ---------------, and -------------------- (who donated HCT/Psin ---------- different funeral homes located in ---------- different states), do not contain any of this information. Instead, you incorrectly stated that these donors were ? not admitted to a health care facility immediately prior to death?,? which statements are contradicted by the state-issued certificates of death for each of these donors.

You failed to create and maintain accurate records, as required by 21 CFR1271.55(d)(2) and 21 CFR 1271.270(a). More specifically:

The Medical Evaluation forms created and maintained by you for the following six donors are inaccurate in that you state that the donors were ? not admitted to a health care facility immediately prior to death?.? In so doing, you also failed to adhere to the following SOPs:

Documenting theRecovery SOP; Quality Assurance Audit of Donor Records SOP; QualityAssurance Check-Off Form; and Audit Check List. These six donors donated HCT/P at -----different funeral homes, located in -------- different states. More specifically:

the State of --------------issued certificate of death for donor ----------------- states that at the time of her death she was a patient at ------------------- Hospital;the State of ------------issued certificate of death for donor ------------------ states that at the time of his death he was a hospital inpatient at ---------;

the State of --------------issued certificate of death for donor ----------states that at the time of his death he was a patient at --------------------- Hospital;

the State of ----------------issued certificate of death for donor ---------- states that at the time of her death she was a patient at ------------- Hospital;

the State of ---------------------issued certificate of death for donor ---------- states that at the time of his death he was a patientat -------------- Hospital;

and the State of ---------------issued certificate of death for donor --------------- states that at the time of her death she was a patient in the emergency room of ----------------- Hospital.
The records created and maintained by you for donor --------------- are inaccurate in that you state in your Certifying Physician Interview formthat the donor was a 44 year old male who died as a result of a blunt traumato the head region in a motor vehicle accident;

your Circumstances of Death form states that the donor was a 44 year old male who was involved in amotor vehicle accident, sustained blunt trauma, and expired at the scene of the accident prior to medical intervention; and your Donor Physical Assessment form includes an incorrect schematic of the donor, showing fractures to the anterior and posterior portions of the skull, together with bruises or contusions to the anterior and posterior portions of the neck. These records are contradicted by the State of --------------------issued certificate of death, which states that the donor died of natural causes (congestive cardiac failure, resulting from atherosclerotic cardiovasculardisease), at his home, at the age of 48. The only other significant condition which is listed as contributing to the death of the donor in theState of --------------issued certificate of deathis -----------------------. In creating and maintaining these inaccurate records, you have also failed to adhere to your "Documenting the Recovery"SOP, your "Quality Assurance Audit of Donor Records" SOP, your Audit CheckList, and your Quality Assurance Check-Off form.

The records created and maintained by you for donor ---------------- are inaccurate in that you state in your Certifying Physician Interview form that the donor was a 45 year old female who suffered blunt trauma in a motor vehicle accident, and died at the scene of the accident prior to medical intervention; your Circumstances of Death form states that the donor was a 45 year old female who was involved in a motor vehicle accident, sustained blunt trauma to the head region, and expired prior to medical intervention;

and your Donor Physical Assessment form includes an incorrect schematic of the donor, showing fractures to the anterior and posterior portions of the skull, together with bruises or contusions to the anterior and posterior portions of the neck. These records are contradicted by the State of --------------issued certificate of death, which states that the donor died at her home, at the age of 41, was -----, and with an undetermined cause of death, pending additional studies. There were no other significant conditions listed as possibly contributing to the death of the donor in the state-issued certificate of death. In creating and maintaining these inaccurate records, you have also failed to adhere to your "Documenting theRecovery" SOP, your "Quality Assurance Audit of Donor Records" SOP, your Audit Check List, and your Quality Assurance Check-Off form.

The records created and maintained by you for donor ------------- are inaccurate and incomplete in that your Certifying Physician Interview form for this donor fails to indicate the cause of death; your Circumstances of Death form for this donor incorrectly states that the donor was a 70 year old female, and fails to indicate the cause of death;

your Medical/Social History Interview form incorrectly states that the donor never received an organ transplant; and your Donor Physical Assessment form for this donor fails to show on the schematic that the donor had a surgical procedure to her ------------------------ immediately prior to her death, and also fails to show that the donor had undergone a ------ transplant. These records are contradicted by the State of ------------issued certificate of death, which states that the immediate cause of death of this donor was due to complications related to the intravenous administration of medication due to a ------------------------------------------------------------------------------------------------------. The donor is also listed on the State of ----------------issued certificate of death as having undergone a status post-cadaver -------- transplant for ------------- disease, and as having died at the age of 74. In creating and maintaining these inaccurate records, you have also failed to adhere to your "Quality Assurance Audit of Donor Records" SOP, your "Documenting the Recovery" SOP, your Audit Check List,and your Quality Assurance Check-Off form.

The records created and maintained by you are inaccurate as concerns the identity of the funeral home from which donors -------, ----------------, and ----------------------were obtained and at which HCT/P recovery procedures were performed for these donors. In your Donor Demographics forms for these donors you state that their recovery location was a funeral home in -----------, -------------, and you also state that the director of the funeral home provided you with a positive identification of these three donors. However, in an affidavit provided to the agency by the director of the funeral home, while he estimates that his funeral homes have provided between --- and ---- donors to BTS, they did not provide BTS with these three donors. In creating and maintaining these inaccurate records, you have also failed to adhere to your "Quality Assurance Audit of Donor Records"SOP, your "Documenting the Recovery" SOP, your Audit Check List, and your Quality Assurance Check-Off form.
You failed to implement the SOPs you established for donor eligibility determinations specifically for documenting and confirming the identity ofthe donors' next of kin, including your Donor Medical Social History Interview SOP, your Quality Control Review of Donor Records SOP, your Quality Assurance Audit of Donor Records SOP, your Audit Check List, and your Quality Assurance Check-Off form, all as required by 21 CFR 1271.47(a), and you failed to create and maintain accurate records, as required by 21CFR 1271.55(d)(2) and 21 CFR 1271.270(a), in that you have inaccurately and incompletely recorded the donors' next of kin information.

Morespecifically:

The records created and maintained by you for donor ------------ are inaccurate and incomplete in that your information on the donor's spouse differs from that found in the State of -------------issued certificate of death. More specifically:

while your Consent for Donation of Anatomical Gifts form for this donor lists the donor's spouse as the consenting next of kin, the donor's spouse is incorrectly listed as another individual, residing at an entirely different address than the donor;

while your Medical/Social History Interview form for this donor lists the interviewee as the donor's spouse, the interview form incorrectly identifies the donor's spouse and residential address;

your Circumstances of Death form for this donor also incorrectly identifies the spouse; and the BTS version of the certificate of death for this donor is incomplete in that it does not list any surviving spouse, and does not indicate whether the donor was married.
The records created and maintained by you for donor ------------- are inaccurate and incomplete in that your information on the donor's spouse differs from that found in the State of --------------issued certificate of death. More specifically:

while your Consent for Donation of Anatomical Gifts form for this donor lists the donor's spouse as the consenting next of kin, the donor's spouseis incorrectly listed as another individual, residing at an entirely different address than the donor;

while your Medical/Social History Interview form for this donor lists the interviewee as the donor's spouse, the interview form incorrectly identifies the donor's spouse and residential address;

your Circumstances of Death form for this donor also incorrectly identifies the spouse;

andthe BTS version of the certificate of death for this donor is incomplete in that it does not list any surviving spouse, and does not indicate whether the donor was married.

You failed to implement the SOPs you established for donor eligibility determinations, as required by 21 CFR 1271.47(a), and to assure the timely refrigeration of donors and recovery of HCT/P, as required by 1271.180(a). You failed to recover HCT/P in a manner that does not cause contamination or cross-contamination during recovery, to adequately control environmental conditions, and to provide proper conditions for operations, all as requiredby 21 CFR 1271.145, 21 CFR 1271.195(a)(1), and 21 CFR 1271.215. Furthermore, you failed to create and maintain accurate records, as required by 21 CFR1271.55(d)(2) and 21 CFR 1271.270(a).Your SOPs require that donors be refrigerated within ----- hours and that HCT/P excision begin within ----- hours post cardiac asystole. However, you did not meet these standards for the following donors:

your Donor Demographics form for donor ------------- states that the donor was "? refrigerated within --- hours and tissue excision began within ----hours post cardiac asystole" and that the donors refrigeration time was at ----am on -----------, which, according to the State of --------------------issued certificate of death's time of death (----pmon ----------------), is more than 33 hours post-cardiac asystole. Also, according to your Tissue Recovery Log form for this donor, HCT/P excision of the donor began at ----pm on --------, almost 48 hours post-cardiacasystole. As a result, your Donor Demographics form is inaccurate; and
your Donor Demographics form for donor ---------------states that the donor was "?refrigerated within ----hours and tissue excision began within ----hours post cardiac asystole" and that the donors refrigeration time was at --------------------------------------------, which, according to theStateof -------------------------------------------------------------------------------------------------issued certificate of death(---------------------------------------------), is almost 48 hours post-cardiac asystole. Also, according to your Tissue Recovery Log form for this donor, HCT/P excision of the donor began at ----pm on -------------, more than 54 hours post-cardiac asystole. As a result, your Donor Demographics form is inaccurate.
You failed to implement SOPs you established to assure that HCT/P recovery takes place in a suitable environment, as required by 21 CFR 1271.180(a). You failed to recover HCT/Ps in a manner that does not cause contamination or cross-contamination during recovery, and you failed to adequately control environmental conditions and to provide proper conditions for operations,all as required by 21 CFR 1271.145, 21 CFR 1271.195(a)(2), and 21 CFR1271.215. Furthermore, you failed to create and maintain accurate records,as required by 21 CFR 1271.55(d)(2) and 21 CFR 1271.270(a). Your SOP requires that the HCT/P recovery site ensure a maintained and controlled,closed airflow system so that there is no direct access to the outside ofthe building. However, you recovered HCT/P from donors ----------and ------------ at a funeral home in ------------, ---------- that is not equipped with any refrigeration units in which to hold the deceased. The embalming room where HCT/P recovery took place was equipped with an exhaust fan that delivered air to the adjacent garage/outside. There was no air filtration system in the room. Moreover, you recorded in your Nonstandard Tissue Recovery Site Assessment form for these donors that the recovery site ensured a maintained and controlled, closed airflow system so that there was no direct access to the outside of the building.
You failed to implement SOPs you established for donor eligibility determinations, specifically to confirm whether an autopsy was performed, as required by 21 CFR 1271.47(a). In particular, your Quality Control Review of Donor Records SOP requires that "[t]he team leader will assure a physical exam was performed and the information documented on the recovery paper work is included in the donor chart?" and your Physical Assessment of a Cadaveric Donor SOP requires that the team leader physically check the donor in their entirety. Furthermore, you failed to create and maintain accurate records,as required by 21 CFR 1271.55(d)(2) and 21 CFR 1271.270(a). Your Donor Demographics forms for donors -------- and ----------------------- stat that no autopsies had been performed on these donors, and the Donor Physical Assessment forms for these donors provide schematics of the donors which fail to show that autopsies had been performed. These documents are contradicted by the State of ----------------issued certificates of death for these donors, which confirm not only that autopsies were performed on these two donors, but also that the autopsy findings were available to complete the cause of death. The fact that an autopsy had been performed should have been obvious to you upon your physical assessment of the donors at the time of HCT/P recovery.The above-identified deficiencies are not intended to be an all-inclusive list of violations by you and your Establishment. Nevertheless, they indicate serious noncompliance with many of the regulations under 21 CFRPart 1271, which are designed to protect against the risks of communicable disease transmission. Of particular concern are the serious deficiencies involving:

1/ your failure to create and maintain accurate records;

2/ your failure to implement SOPs for all steps in determining donor eligibility;

3/ your failure to recover HCT/Ps in a manner that does not cause contamination or cross-contamination during recovery; and

4/ your failure to adequately control environmental conditions. These deficiencies involve donors from numerous funeral homes located in different states. Based on the fore going, the agency finds that there are reasonable grounds to believe that HCT/Ps manufactured by you are violative because they were manufactured in contravention of the regulations under 21CFR Part 1271 and, therefore, the conditions of manufacture of the HCT/Ps do not provide adequate protections against the risks of communicable disease transmission. Moreover, these deficiencies, including your failure to createand maintain accurate records, are so serious and widespread that FDA finds there are reasonable grounds to believe that they present a danger to public health.

This letter confirms the telephone conversation on January 31, 2006, in which notice was given that, pursuant to 21 CFR 1271.440(a)(3), you individually, and your Establishment,

1) must immediately cease all manufacturing, as defined in 21 CFR 1271.3(e), until compliance with the regulations in 21 CFR Part 1271 has been achieved, and

2) must retain allHCT/Ps recovered on or after May 25, 2005 that are in your possession until they are disposed of as agreed by the agency or until the safety of the HCT/P is confirmed. Instructions were given at that time not to recover or ship HCT/Ps. Neither you, nor your Establishment, can resume operations without prior written authorization from FDA. Any shipment of HCT/Ps inviolation of this order constitutes a violation of section 368 of the PHSAct [42 U.S.C. § 271], for which criminal penalties may be imposed.

Within five (5) working days from the receipt of this Order to Cease Manufacturing, you may request a hearing on the matter in accordance with 21CFR Part 16 (copy attached), to Mary A. Malarkey, Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, 1401 Rockville Pike, HFM-600, Rockville, MD 20852 (telephone:301-827-6190). Failure to request a hearing within the specified time period constitutes a waiver of the right to a hearing. You may also wish to inform yourself with respect to the agency's guidelines regarding electronic media coverage of its administrative proceedings, which can be found at 21 CFRPart 10, Subpart C.


Sincerely,


----- signature -----


Jesse L. Goodman, M.D., M.P.H.DirectorCenter for Biologics Evaluation and Research
Effective Date: 31 January Time: 11:25 AM Eastern

Updated February 1, 2006

http://www.fda.gov/cber/compl/bts013106.htm




TSE i.e. CJD and the legal stealing of tainted tissue


http://www.rense.com/general62/don.htm



http://creutzfeldt-jakob-disease.blogspot.com/2008_01_01_archive.html



http://mad-cow.org/~tom/dec99_news.html#bbb




TSS


#################### https://lists.aegee.org/bse-l.html####################




http://lists.iatp.org/listarchive/archive.cfm?id=119823




From: TSS
Subject: Dubious transplant recipients sue companies
Date: March 4, 2006 at 5:52 pm PST
Dubious transplant recipients sue companies

By PENNY BROWN ROBERTSAdvocate staff writer Published: Mar 4, 2006
Hundreds of Louisianians may have body parts transplanted inside them that were looted from corpses — some riddled with cancer or infected with syphilis or hepatitis.

A class-action lawsuit made public Friday in Baton Rouge federal court alleges that a New York medical supply company sold illegal — and unscreened — tissue and bone to Our Lady of the Lake Regional Medical Center and other unnamed hospitals in the state. Darrel Bourque of Gonzales says surgeons notified him in January that tissue transplanted in his neck during spinal surgery a year ago came from that supply company — Biomedical Tissue Services.

They urged the petrochemical industry supervisor to undergo blood testing to see if the transplanted tissue was infected with syphilis, HIV or hepatitis.

Although the tests haven’t shown anything, Bourque said in an interview Friday that he’s worried that, “There’s still the possibility something could have been there.”

“I have a lot of depression and a lot of anger. I don’t really know what the future holds,” Bourque said. “I’m worried about whether or not I’ll still be able to get insurance coverage for further illnesses that may come about.”

The lawsuit estimates the defective tissue has been implanted in hundreds of Louisiana patients since 2002. In addition to damages, it seeks to establish a comprehensive medical monitoring program and treatment of any future disease or complication related to the implants.

In an advisory issued Friday, the U.S. Food and Drug Administration “strongly” recommends health-care providers inform patients who received tissue implants from Biomedical Tissue Services that they “may be at increased risk for communicable disease transmission and to offer them testing. While FDA believes the risks from these tissues are low … the actual infectious risk is unknown.”

Baton Rouge lawyer Philip Bohrer said Friday the class-action lawsuit is intended to protect Louisiana victims from the potential “long-term consequences of what’s happened to them.”
Several patients outside the state who got transplants of the tissue in question already have tested positive for hepatitis and syphilis, according to news reports.

“I believe unfortunately that many people in our community may be victims of this practice,” Bohrer said. “The people who received this contaminated tissue are at risk for the rest of their lives, and initial blood test or screening cannot rule out future diseases, such as cancer, leukemia or other diseases with long latency periods that may have been in the tissue they received.”
Biomedical Tissue Services owners Michael Mastromarino and Joseph Nicelli and others are accused of secretly carving up bodies from funeral parlors and city morgues in three states and forging death certificates and organ-donor consent forms to make it appear as if the bones, skin, tendons, heart valves and other tissues were removed legally.

Some of the corpses were those of people who had not given consent; others didn’t meet federal donor eligibility requirements because they were infected with syphilis, AIDS or hepatitis or had cancer or heart disease. Among the cadavers they allegedly raided for parts was that of former PBS “Masterpiece Theatre” host Alistair Cook, who died of cancer in 2004 at the age of 95.
Last month, the FDA shut down Biomedical Tissue Services. Those involved have pleaded innocent to charges of enterprise corruption, body stealing and opening graves, unlawful dissection, forgery and other counts.

Staten Island lawyer, Mario Gallucci — who is representing Mastromarino and Biomedical Tissue Services — said Friday he was not aware of the Louisiana lawsuit.

Mastromarino “finds it unfortunate but does sympathize with all of these people who received the tissue,” Gallucci said. “He is just as taken aback as all these people are that he was misled. Hopefully, the distribution companies have done what they were supposed to do in sterilization, processing and release of this tissue. Dr. Mastromarino is traumatized by the prospect that his life’s work may have been tainted by the processing of this tissue.”

According to prosecutors, Mastromarino is a former dentist and oral surgeon who went into the tissue harvesting business after losing his license. He was sued for malpractice by several patients — one of whom claimed he deserted them in the middle of surgery.

Also named as defendants in the Louisiana lawsuit are Florida-based Regeneration Technologies and Memphis-based Medtronic Sofamor Danek USA, which allegedly distributed the millions of dollars worth of tissue, bone and organs. The lawsuit alleges the companies violated industry standards, their own internal safety and testing procedures, and possibly state and federal laws.
The lawsuit does not blame Our Lady of the Lake Regional Medical Center, other hospitals or any local surgeons, saying none of them was aware that the body parts “consisted of the stolen human tissue obtained by BTS, or that RTI failed to follow its own safety protocols.”

Our Lady of the Lake Regional Medical Center spokeswoman Catherine Harrell said Friday that 27 of its patients are known to have gotten such transplants. She said the hospital bought the tissue in question from Tennessee-based SpinalGraft Technologies.

Harrell said that once the hospital was notified of a nationwide recall of the tissue, it “immediately” returned its remaining supply to the manufacturer.

The hospital also notified surgeons of the situation “so that the physicians could communicate with their patients about the situation and really answer any questions the patients had.”
She said the doctors should have notified all their patients by now.

The American Association of Tissue Banks estimates there are more than 1 million tissue transplants annually in the United States. The FDA began regulating the billion-dollar industry in 1993 and now has strict regulations requiring examination of the cadaver, testing for disease-causing agents, interviews with the donor family and reviews of medical records, lab test results, coroner and autopsy reports and other relevant records.

In 2005, the agency added screening for diseases such as syphilis, West Nile, SARS and the neurological condition Creutzfeldt-Jakob to tests already required for HIV and hepatitis.
The Louisiana case has been assigned to U.S. District Judge Frank Polozola. No hearing dates have been set.


http://www.2theadvocate.com/news/2406461.html



25 Apr 2002 :
Column WA58 Bovine Embryos and Live Cattle: Imports from North America
The Earl of Caithness asked her Majesty's Government:

When the ban on the importation of embryos and live cattle from North America will be lifted; and [HL3912] What is the scientific evidence for the imposition of a ban on the importation of embryos and live cattle from North America. [HL3913]

Lord Whitty: Her Majesty's Government have not imposed a ban on imports of bovine embryos and live cattle from North America.

The European Parliament and European Council introduced legislation in May last year laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (TSEs). The legislation was introduced in response to the recommendations of the Office International des Epizooties (OIE—the international animal health organisation) and advice from the Commission's scientific comittees. The legislation (and the transitional measures which came into effect in October last year) includes requirement that imports into the EU of bovine embryos and live cattle must be accompanied by certification confirming that the feeding of ruminants with protein derived from mammals has been banned and that the ban has been effectively enforced. Some exporting countries, such as Canada and the USA, are currently unable to meet these new requirements.


http://www.publications.parliament.uk/pa/ld199900/ldhansrd/pdvn/lds02/text/20425w04.htm


BSE: US Export of Specified Risk Material
Lord Kennet asked Her Majesty's Government:


Whether the United States contends that under the provisions enforceable by the World Trade Organisation the European Union may not ban the import into Europe from the United States of "specified risk material" (that is, material at possible risk of BSE infection).

Lord Donoughue: Yes. But their position on the Specified Risk Material legislation is based on the assumption that the United States can safely be regarded as a "BSE free" country. Their case for such treatment has not been accepted by the EU Commission's Scientific Veterinary Committee.
http://www.publications.parliament.uk/pa/ld199798/ldhansrd/vo971215/text/71215w02.htm
Baroness Masham of Ilton: My Lords, as blood products which infected haemophiliacs with HIV came from the USA, is the Minister confident that something else nasty may not come again from imported blood from the USA? Is he aware that there are ways of cleaning blood to make it safer? I know that that is done in Vienna, in Austria. Will the Minister look into that? Following the question asked by the noble Lord, Lord Clement-Jones, about people using their own blood, I am sure that, when this Statement goes out into the wider community, people will want to know that information.


http://www.publications.parliament.uk/pa/ld199900/ldhansrd/pdvn/lds03/text/31217-09.htm


However, the Bio Products Laboratory who produce plasma products did export surplus products, under the Income Generation Regulations for the NHS, and used the income for the benefit of the health service.[21]


http://www.publications.parliament.uk/pa/cm200001/cmselect/cmpubacc/207/20703.htm#n21


43. Do you sell any of it abroad at all?(Mr Gorham) No. The only circumstances in which we would export blood would be if there was an approach to the British Government and the British Government felt that it was appropriate to support an international emergency or something like that. We do supply the British Forces. We occasionally help out our colleagues in Wales and Scotland and they would reciprocate with us if that was appropriate. At the moment it is more or less totally contained within the United Kingdom.


http://www.publications.parliament.uk/pa/cm200001/cmselect/cmpubacc/207/1012904.htm


Blood and Blood Products

Mr. Hinchliffe: To ask the Secretary of State for Health what estimate he has made of the number of persons who have been inoculated with blood or blood products over the past three years in the United Kingdom. [61681]

Ms Jowell [holding answer 2 December 1998]: It is estimated that about one million people in the United Kingdom receive blood and blood products every year.


http://www.parliament.the-stationeryoffice.co.uk/pa/cm199899/cmhansrd/vo990210/text/90210w02.htmstationeryoffice.co.uk/pa/cm199899/cmhansrd/vo990210/text/90210w02.htm


Human vaccine prepared in animal brains


http://www.mad-cow.org/00/nov00_late_news.html#fff


http://www.whale.to/v/singeltary7.html


http://www.mad-cow.org/00/may00_news.html


http://www.mad-cow.org/00/jul00_dont_eat_sheep.html#hhh


RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I_______________________________PRODUCTHuman Tissue for Transplantation, Recall # B-0432-6:a) Tricortical Wedge (R) 1.5 x 2.5 cm,Freeze Dried Irradiated;b) Tricortical Wedge ( L ) 1.7 x 3.0 cm,Fresh Frozen Irradiated;c) Cancellous Crushed 60.0 cc, Freeze Dried,Irradiated;d) Cancellous Crushed 30.0 cc Freeze Dried,Irradiated;e) Achilles Tendon OA ( R ) Fresh FrozenIrradiated;f) Achilles Tendon OA ( L ) Fresh FrozenIrradiated;g) Lumbar;h) Cancellous Crushed 30.0 cc Fresh Frozen,IrradiatedCODEa) Tissue 04091-002;b) Tissue 04113-003;c) Tissues 04091-008, 04101-008, 04103-002,04103-003, 04105-003;d) Tissues 04091-005, 04091-006, 04091-007,04101-006, 04101-007, 04102-004, 04102-005,04104-003, 04104-004, 04104-005, 04105-002,04109-003, 04109-004, 04120-004, 04124-003,04124-004, 04138-002, 04138-003, 04140-002,04143-002, 04143-003, 04146-001, 04152-001;e) Tissues 04101-003, 04123-004;f) Tissues 04101-004, 04123-003;g) Tissues 03049-001, 03051-001, 04091-001,04102-001, 04103-001, 04104-001, 04105-001,04106-001, 04107-001, 04108-001, 04109-001,04113-001, 04120-001, 04122-001, 04123-001,04124-001;h) Tissue 04108-002RECALLING FIRM/MANUFACTURERRecalling Firm: Central Texas Regional Blood & Tissue Center, Austin, TX, bytelephone on October 4, 2005, and by letter dated October 11, 2005.Manufacturer: Biomedical Tissue Services, Fort Lee, NJ, firm initiatedrecall is ongoing.REASONHuman tissues, procured from donors without adequate donor eligibilitydeterminations, were distributed.VOLUME OF PRODUCT IN COMMERCE51 allograftsDISTRIBUTIONTX and COPRODUCTHuman Corneal Tissues for Transplantation, Recall # B-0380-6CODETissues: CI044108 OD and CI044108 OSRECALLING FIRM/MANUFACTURERMichigan Eye Bank, Ann Arbor, MI, by letter dated November 22, 2005, and byfacsimile dated November 28, 2005. Firm initiated recall is complete.REASONHuman Corneas, collected from an ineligible donor, were distributed.VOLUME OF PRODUCT IN COMMERCE2 tissuesDISTRIBUTIONMI, CA and Germany_______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced,Recall # B-0617-6;b) Red Blood Cells (Apheresis) Leukocytes Reduced(distributed as split product), Recall # B-0618-6;c) Platelets Leukocytes Reduced, Recall # B-0619-6;d) Fresh Frozen Plasma, Recall # B-0620-6;e) Cryoprecipitated AHF, Recall # B-0621-6;f) Plasma Cryoprecipitate Reduced, Recall # B-0622-6;g) Recovered Plasma, Recall # B-0623-6CODEa) Unit numbers: 1136792, 1040212, 1011245;b) Unit numbers: 1048247-1, 1048247-2;c) Unit numbers: 1040212, 1011245;d) Unit number: 1136792;e) Unit numbers: 1040212, 1011245;f) Unit number: 1040212;g) Unit number: 1011245RECALLING FIRM/MANUFACTURERHoxworth Blood Center, Cincinnati, OH, by letter dated September 6, 2005.Firm initiated recall is complete.REASONBlood products, collected from a donor considered to be at increased riskfor variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE12 unitsDISTRIBUTIONOH and FL_______________________________END OF ENFORCEMENT REPORT FOR MARCH 1, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00941.htmlPRODUCTRecovered Plasma, Recall # B-0643-6CODEUnit numbers: R170537, R165863, and R158308RECALLING FIRM/MANUFACTURERPuget Sound Blood Center, Seattle, WA, by facsimile on October 7, 2003. Firminitiated recall is complete.REASONBlood products, which were collected from an unsuitable donor based on riskfactors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE3 unitsDISTRIBUTIONAustriaEND OF ENFORCEMENT REPORT FOR FEBRUARY 22, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00940.htmlPRODUCTa) Product is 1.0 cc Regenaform® RT. SINGLE PATIENTUSE ONLY. Recall # Z-0481-06;b) OPTEFORM Allografts of varying sizes. SINGLE PATIENTUSE ONLY. Recall # Z-0482-06;c) Product is OPTEFORM Allograft Paste of varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0483-06;d) OPTEFORM® RT Moldable Allograft of varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0484-06;e) Osteofil + RT Allograft Paste in varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0485-06;f) Osteofil Allograft Paste (Bio) of varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0486-06;g) Osteofil IC Syringeable of varying sizes. SINGLEPATIENT USE ONLY. Recall # 0487-06;h) Osteofil ICM Moldable Strip of varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0488-06;i) Osteofil RT, ICM Allograft Paste of varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0489-06;j) OSTEOFIL® DBM Paste of varying sizes. SINGLEPATIENT USE ONLY. Recall # Z-0490-06;k) OsteoPack 3 FZ 22cc. SINGLE PATIENT USE ONLY.Recall # Z-0491-06;l) Regenafil IC. SINGLE PATIENT USE ONLY.Recall # Z-0492-06;m) REGENAFORM RT Allograft Paste, 1cc. SINGLEPATIENT USE ONLY. Recall # Z-0493-06;n) Product is REGENAFORM® Allograft Moldable Blocks,of varying sizes. SINGLE PATIENT USE ONLY.Recall # Z-0494-06;o) Product is RTI Allograft Paste of varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0495-06;p) Product is REGENAFIL® Allograft Paste, Syringe,0.5cc. SINGLE PATIENT USE ONLY. Recall # 0496-06;q) Product is 1.0cc flowable paste from donorapproved for distribution in Italy. SINGLEPATIENT USE ONLY. Recall # Z-0497-06;r) Product is OPTEFIL Allograft Paste of varyingsizes. SINGLE PATIENT USE ONLY. Recall# Z-0498-06;s) Product is OPTEFIL Allograft Paste, Syringeof varying sizes. SINGLE PATIENT USE ONLY.Recall # Z-0499-06;t) Product is OPTEFORM® Allograft Full Disc,5 x 90mm, 32cc, Frozen. SINGLE PATIENT USEONLY, Recall # Z-0500-06;u) Product is 2.0 cc Opteform® RT. SINGLEPATIENT USE ONLY. Recall # Z-0501-06CODE2879130 2879131 2879132 2879133 2879134 2879135 2879136 2879137 28791382879139 2879350 2879351 2879352 2879353 2879354 2879355 2879440 28794412879442 2879443 2879444 2879445 2879446 2879447 2879448 2879449 28794502879451 2879452 2879453 2879454 2879455 2879456 2879457 2879458 28794592886780 2886781 2886782 2886783 2886784 2886785 2886786 2886787 28867882886789 2886950 2886951 2886952 2886953 2886954 2886955 2886956 28869572886958 2886959 2962280 2962281 2962282 2962283 2962284 2962285 29622862962287 2962288 2962289 2963820 2963821 2963822 2963823 2963824 29638252963826 2963827 2963828 2963829 2963910 2963911 2963912 2963913 29639142963915 2963916 2963917 2963918 2963919 2963990 2963991 2963992 29639932963994 2963995 2963996 2963997 2963998 2963999 2965900 2965901 29659022965903 2965904 2965905 2965906 2965907 2965908 2965909 2965910 29659112965912 2965913 2965914 2965915 2965916 2965917 2965918 2974861 29748622974863 2974864 2974865 2974866 2974867 2974868 2974869 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3035951 3035952 3035953 3035954 3035959;2984056 2984062 2984064 2984065 2984067 2986825 2986827 2986829 29953212995322 2995323 2995324 2995325 2995326 2995327 2995328 2995329 29953302999692 2999693 2999694 2999695 2999696 2999697 2999698 2999699 29997002999924 2999925 2999926 2999927 2999928 2999929 2713387 2718732 27187362718737 2718738 2559751 2559752 2559753 2559754 2559755 2559756 25597572559758 2559759 2559760 2560031 2560032 2560033 2560034 2560035 25600362560037 2560038 2560039 2560040 2560271 2560272 2610521 2610522 26105232610524 2610525 2610526 2610527 2610528 2610529 2610530 2610541 26105422610543 2610544 2610545 2610546 2610547 2610548 2610549 2610550 26105812610582 2610583 2610584 2610585 2610586 2610601 2610602 2610603 26106042610605 2610606 2610607 2610608 2610609 2610610 2610611 2610612 26106132610614 2610615 2610616 2610617 2610618 2610619 2610620 2610761 26107622610763 2610764 2610765 2610766 2610767 2610768 2610769 2610770 26667402666741 2666742 2666743 2666744 2666745 2666746 2666747 2666748;2956993 2956994;2667541 2667542 2667543 2667548 2667981 2667983 2667984 2667985 26679872667988 2667989 2669552 2669553 2669554 2669556 2669559 2669633 26696362669639 2669640 2669965 2669967 2669968 2669969 2669981 2669983 2669985RECALLING FIRM/MANUFACTURERRegeneration Technologies, Inc., Alachua, FL, by letter on October 14, 2005.Firm initiated recall is ongoing.REASONThe tissue was collected from donors for whom there is no verifiableidentity or consent. The medical records and social histories of the donorscannot be ascertained. The devices which incorporate these donor bonetissues undergo processing, including sterilization, which has beenvalidated to inactivate and/or remove all viral diseases for which humantissue donors are tested.VOLUME OF PRODUCT IN COMMERCE5,320DISTRIBUTIONNationwide and InternationallyEND OF ENFORCEMENT REPORT FOR FEBRUARY 15, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00939.html_______________________________PRODUCTSource Plasma, Recall # B-0584-6CODEUnits VL53767, ZZ031076, ZZ030881, ZZ03046, VL151413, VL151144, VL50837RECALLING FIRM/MANUFACTURERBioLife Plasma Services LP, Shreveport, LA, by facsimile dated October 6,2003. Firm initiated recall is complete.REASONSource Plasma, collected from a donor who was at increased risk for variantCreutzfeldt-Jakob Disease (vCJD), was distributed.VOLUME OF PRODUCT IN COMMERCE7 unitsDISTRIBUTIONNCEND OF ENFORCEMENT REPORT FOR FEBRUARY 1, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00937.html_______________________________PRODUCTRed Blood Cells, Recall # B-0552-6CODEUnit number: 4426304RECALLING FIRM/MANUFACTURERFlorida's Blood Center, Inc., St. Petersburg, FL, by facsimile on July 8,2005. Firm initiated recall is complete.REASONBlood product, collected from a donor who may have been at increased riskfor new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.VOLUME OF PRODUCT IN COMMERCE1 unitDISTRIBUTIONFLEND OF ENFORCEMENT REPORT FOR JANUARY 25, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00936.htmlRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I_______________________________PRODUCTHuman Tissue for Transplantation, Recall # B-0322-6a) Alloquent CC Allograft (8, 9 & 10 mm);b) Achilles Tendon;c) Cancellous Bone 4-10 mm (15 & 30 cc);d) Patella Tendon-Hemi;e) Iliac Crest Wedge (14-17mm, 11-13mm,<10mm, href="mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000055/!x-usc:http://deposit.ddb.de/cgi-bin/dokserv?idn=993774407&dok_var=d1&dok_ext=pdf&filename=993774407.pdf">http://deposit.ddb.de/cgi-bin/dokserv?idn=993774407&dok_var=d1&dok_ext=pdf&filename=993774407.pdf


http://www.gtp.org.tw/Files/Download/2008613134233.pdf


Wednesday, January 02, 2008

Risk factors for sporadic Creutzfeldt-Jakob disease


http://creutzfeldt-jakob-disease.blogspot.com/2008/01/risk-factors-for-sporadic-creutzfeldt.html


Sunday, December 16, 2007

Risk factors for sporadic Creutzfeldt-Jakob disease


http://creutzfeldt-jakob-disease.blogspot.com/2007/12/risk-factors-for-sporadic-creutzfeldt.html


Monday, December 31, 2007

Risk Assessment of Transmission of Sporadic Creutzfeldt-Jakob Disease in Endodontic Practice in Absence of Adequate Prion Inactivation


http://creutzfeldt-jakob-disease.blogspot.com/2007/12/risk-assessment-of-transmission-of.html


New Jersey mayors and rabbis arrested in money laundering probea.. Daniel Nasaw in Washington b.. guardian.co.uk, Thursday 23 July 2009 17.31 BST c..

Two New Jersey mayors and more than two dozen political figures and religious leaders were arrested today as part of a massive international money laundering scheme that includes illegal traffic in human body parts.Among those arrested following a two-year investigation were Hoboken mayor Peter Cammarano III, Secaucus Mayor Dennis Elwell, Jersey City deputy mayor Leona Beldini, officials in the state capital and several rabbis. Federal law enforcement officials this morning also were searching the offices of the New Jersey state department of consumer affairs. Details of the charges were sparse today. The Wall Street Journal reported that the investigation included a probe of an international body-part trafficking ring. One of the people arrested is accused of dealing in human organs. State legislator Daniel Van Pelt was accused of taking $10,000 in bribes from a government informant to facilitate a real estate development, the Asbury Park Press reported. Many of the arrested come from a gritty, urban area of New Jersey directly across the Hudson River from New York City that in recent years has attracted young professionals driven out of New York by high real-estate prices.The detained clergymen came from a enclaves of Syrian Jews in New Jersey and in Brooklyn, New York. Their connection to the politicians was unclear Thursday morning.One northern New Jersey man arrested in the wide-ranging investigation, Levy Izhak Rosenbaum, was charged with conspiring to traffic human organs, the Record newspaper of Bergen County reported.Cammarano, Hoboken mayor, was apparently unaware he was sought in the probe, spending yesterday evening tending bar at a Hoboken festival and celebrating his 32nd birthday. "I would like to thank everyone today for the birthday wishes," he wrote on Twitter about 1am on Wednesday. "Hope everyone had a great time at the opening night for St Ann's feast."


http://www.guardian.co.uk/world/2009/jul/23/new-jersey-corruption-money-laundering


Mayors, rabbis arrested in NJ corruption probeThu Jul 23, 2009 3:17pm EDT

NEW YORK (Reuters) - Two northern New Jersey mayors, several rabbis and other politicians were arrested on Thursday in a federal investigation into public corruption and international money laundering, U.S. authorities said.Among the approximately 30 people arrested were Hoboken Mayor Peter Cammarano, who took office 23 days ago, Secaucus Mayor Dennis Elwell, state Assemblyman Daniel Van Pelt and Jersey City Deputy Mayor Leona Beldini, according to the U.S. Attorney's Office in Newark.Also arrested in the money-laundering investigation were several rabbis in New York and New Jersey, the federal prosecutor's office said.The international money-laundering was "high volume," it said.Local television showed images of rabbis and the two mayors taken into federal custody in Newark, New Jersey.No further details were immediately available from authorities. A news conference was scheduled for later on Thursday.Court appearances for those arrested were to begin in the early afternoon.(Reporting by Ellen Wulfhorst; editing by Mohammad Zargham)

http://www.reuters.com/article/newsOne/idUSTRE56M3QU20090723


Feds Target Politicians and Rabbis in Massive Corruption, Money-Laundering Case in New Jersey and New YorkAtlanta, Ga. 7/23/2009 03:24 PM GMT (TransWorldNews - Top Story) Federal authorities have arrested at least 30 people, including mayors, rabbis and politicians, in New Jersey and New York as part of a corruption and money-laundering investigation.Those arrested included Hoboken Mayor Peter Cammarano and Secaucus Mayor Dennis Elwell.According to federal authorities several rabbis in the two states were also detained.There have been reports that suggest some of those arrested on Thursday were involved in organ trafficking, having accepted cash payments to locate organs for those in need of transplants. ###


http://www.transworldnews.com/NewsStory.aspx?id=104213&cat=5


Saturday, January 26, 2008

CJD HGH BODY SNATCHERS


http://creutzfeldt-jakob-disease.blogspot.com/2008/01/cjd-hgh-body-snatchers.html



THE LEGAL TRADING AND SELLING OF BODY PARTS AND TSEs i.e. THE BODY SNATCHERS


http://disc.server.com/discussion.cgi?disc=167318;article=2864;title=CJD%20WATCH


http://disc.server.com/discussion.cgi?disc=7498;article=2818;title=CJD%20Voice%20Discussion%20Group


http://lists.iatp.org/listarchive/archive.cfm?id=119823


STOLEN BODY PARTS


http://www.google.com/search?hl=en&q=stolen+body+parts&btnG=Search



Friday, August 07, 2009

CJD Human Cornea Tissue, Recall END OF ENFORCEMENT REPORT FOR AUGUST 5, 2009


http://creutzfeldt-jakob-disease.blogspot.com/2009/08/cjd-human-cornea-tissue-recall-end-of.html



Update: Creutzfeldt-Jakob Disease Associated with Cadaveric Dura Mater Grafts --- Japan, 1979--2003
MMWR Weekly December 5, 2003 / 52(48);1179-1181



http://www2.niddk.nih.gov/AboutNIDDK/CommitteesAndWorkingGroups/HGH_CJD_Dec_11_2003_TAB_A.htm



Thursday, October 23, 2008

Creutzfeldt-Jakob Disease Associated with Cadaveric Dura Mater Grafts - Japan, 1979-2008 : UPDATE


http://creutzfeldt-jakob-disease.blogspot.com/2008/10/creutzfeldt-jakob-disease-associated.html


http://www.wellsphere.com/cjd-article/medical-procedures-and-risk-for-sporadic-creutzfeldt-jakob-disease-japan-1999-2008-warning-to-neurosurgeons-and-ophthalmologi/641229



Thursday, January 29, 2009

Medical Procedures and Risk for Sporadic Creutzfeldt-Jakob Disease, Japan, 1999-2008 (WARNING TO Neurosurgeons and Ophthalmologists) Volume 15, Number 2-February 2009 Research



http://creutzfeldt-jakob-disease.blogspot.com/2009/01/medical-procedures-and-risk-for.html



Wednesday, August 12, 2009

Unique clinicopathological features and PrP profiles in the first autopsied case of dura mater graft-associated Creutzfeldt-Jakob disease


http://creutzfeldt-jakob-disease.blogspot.com/2009/08/unique-clinicopathological-features-and.html



Sunday, May 10, 2009

Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009 (Singeltary submission)



http://tseac.blogspot.com/2009/05/meeting-of-transmissible-spongiform.html



Tuesday, August 11, 2009

Characteristics of Established and Proposed Sporadic Creutzfeldt-Jakob Disease Variants


http://creutzfeldt-jakob-disease.blogspot.com/2009/08/characteristics-of-established-and.html



TSS>>>>>>>>>>>> * FROM MAY 9, 2001: Possible Creutzfeldt-Jakob case reported in
>>> Windsor>>>>>> Classical CJD, which occurs naturally in a small number of people, can>>> be transmitted by transplants of human tissue.>>>>>> The disease affects the central nervous system.>>>>>> It occurs in the world population at a rate of about one case per>>> million people per year – about 30 cases are diagnosed each year in>>> Canada. Most cases die within months.>>>>>> Written by CBC News Online staff>>>>>> http://www.cbc.ca/stories/2003/09/24/moncton030924>>>>>> it would be most interesting how this hospital has handled the>>> quarantining>>> of the surgical instruments and the operating/surgical arena after this>>> surgery>>> and the finding of CJD in the patient. were the instruments used on>>> this>>> victim used on any other persons and can they trace all tools ???>>>>>> TSS>>>>>>

########### http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html>>> ############>>>>>>>>>

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