Saturday, April 16, 2016

More infections from dirty scopes than estimated, what about CJD TSE Prion aka mad cow type disease?


Washington - Today, Congressman Ted W. Lieu (D | Los Angeles County) introduced two pieces of legislation after a yearlong investigation he requested by the House Committee on Oversight and Government Reform found significant gaps in existing law that contributed to a nationwide problem of superbug outbreaks due to tainted duodenoscopes.

Upon introduction of his legislation, Rep. Lieu made the following statement:

“Antibiotic-resistant bacteria are a major threat to public health. I am proud to introduce these pieces of legislation today in response to the numerous superbug outbreaks happening in hospitals across the nation. Patients and hospitals deserve to know that the medical devices being used on patients can be properly cleaned and are designed effectively. Patients should not be worried that undergoing a routine medical procedure could lead to them becoming infected with a deadly superbug. What happened to the patients and families at UCLA Medical Center and hospitals across the country should not happen again.

“I am deeply grateful to the Oversight and Government Reform Committee for making this issue a top priority. This legislation is a result of their yearlong investigation into the many superbug outbreaks caused by tainted duodenoscopes across the country. I am also grateful to FDA for cooperating fully with my office and the Oversight Committee. Through diligent hard work and investigation, the Committee has identified many of the causes and solutions needed to protect patients from future superbug outbreaks.”

Rep. Lieu’s New Superbug Legislation

The DEVICE Act (Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency)

This legislation further increases patient safety by requiring device manufacturers to notify Federal Drug Administration (FDA) whenever they change the design or cleaning instructions of their devices. The bill also requires manufacturers to notify FDA whenever safety warnings are issued in foreign countries related to the design and cleaning of devices. Finally, the bill requires FDA to further regulate tests of medical devices to determine whether bacteria are present.

Upon introduction of The DEVICE Act, Rep. Elijah Cummings, Ranking Member, House Oversight and Government Reform Committee, made the following statement:

“Congressman Lieu has been steadfast in addressing this critical public health issue on behalf of his constituents and the nation. His leadership is a strong example of elected officials identifying problems and implementing solutions that the will help improve the lives of the American people.”



The Preventing Superbugs and Protecting Patients Act

This legislation improves safety for patients undergoing medical procedures by requiring that the reprocessing instructions for medical devices be scientifically validated. This ensures that the cleaning instructions for medical devices actually work. Furthermore, this is the House companion bill to the Senate bill, which, last month, Senator Patty Murray (D-WA), Ranking Member of the Senate Committee on Health, Education, Labor, and Pensions, introduced. Rep. Peter Roskam (R-IL) also introduced The Preventing Superbugs and Protecting Patients Act in the House along with Mr. Lieu.

Upon House introduction of The Preventing Superbugs and Protecting Patients Act, Senator Murray made the following statement:

“Patients should be able to trust that the medical devices used in their treatment are safe and effective, but as we saw in my home state of Washington, our medical device monitoring system too often falls short. I’m proud to be working with Representative Lieu on legislation that would provide the FDA with additional tools to review and ensure the safety of medical devices like duodenoscopes, and I’m committed to continued work to improve our medical device monitoring system and protect patients and families in Washington state and across the country.”

Legislation Background

Last year, at the UCLA Medical Center, hundreds of patients were exposed to the antibiotic-resistant bacteria (or superbug) Carbapenem-resistant enterobacteriaceae (CRE), due to tainted duodenoscopes in a routine medical procedure, and the Los Angeles Times reported three patients died related to CRE infected duodenoscopes. Shortly afterwards, another outbreak also from CRE tainted duodenoscopes occurred at Cedars-Senai Medical Center. These are two of several outbreaks which have occurred across the country. One of the causes of the outbreaks was the difficulty in cleaning the devices and a lack of scientifically verified reprocessing guidances.


Report: More infections from dirty scopes than estimated

Matthew Perrone, Ap Health Writer | April 15, 2016 | Updated: April 15, 2016 5:53pm

WASHINGTON (AP) — At least 300 patients have been sickened by life-threatening infections linked to contaminated medical scopes — more than previously estimated by federal regulators, according to figures released Friday.

Between 2010 and 2015 more than 41 hospitals worldwide, most in the U.S., reported bacterial infections linked to the scopes, affecting 300 to 350 patients, states a memo released by U.S. Rep. Ted Lieu, D-Calif. The lawmaker stressed that those figures likely underestimate the problem since hospitals don't always test patients for the antibiotic-resistant "superbugs" that cause such infections

"I'm absolutely certain there are lots more infections out there that are not being reported just because no one is getting tested," Lieu said in an interview with The Associated Press.

Investigators for the House Committee on Oversight and Government Reform obtained the updated figures from the Food and Drug Administration as part of a year-long investigation into "superbug" outbreaks tied to the devices. A previous report by a Senate committee found 250 reports of patients sickened by contaminated scopes, though that finding came from a shorter timespan between 2012 and early 2015. Last year, the FDA reported 142 patient infections from the medical scopes made by Olympus Corp. and other companies.


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SEC charges DePinho-founded firm with misleading investors The FDA came under fire in early 2015 after several high-profile outbreaks at hospitals in Los Angeles and Seattle were linked to so-called duodenoscopes made by Olympus, a Japanese manufacturer which dominates the U.S. market. The specialized fiber-optic scopes are threaded through the digestive tract to diagnose and treat tumors and other blockages of the pancreas and bile ducts. Officials at the hospitals said they had followed the manufacturers' instructions for cleaning the devices.

"It was not hospitals or doctors who weren't cleaning the devices correctly or using them correctly, it was a fault with the devices themselves," Lieu said

Lieu, who represents sections of Los Angeles, introduced two bills Friday that would tighten regulations of reusable medical devices that require cleaning. Among other steps, companies would need to notify the FDA whenever they change the design or cleaning instructions for a device. A separate bill would require companies to scientifically confirm the effectiveness of their cleaning procedures. Sen. Patty Murray, D-Wash., released similar legislation in the Senate last month.

Despite the links to infections, the FDA previously ruled it would keep the devices on the market because they fill an important need in routine medical procedures.

The agency said late Friday it would "carefully consider" the congressional report's findings. It's already taken steps to reduce infection with the scopes, said agency spokeswoman Deborah Kotz in an emailed statement.

Duodenoscopes feature a mechanized tip with moveable instruments used to drain blockages and perform other procedures. The complex design makes the scopes extremely difficult to clean, even with mechanical processing equipment. Bodily fluids and other debris can stay in the device's joints and crevices even after cleaning and disinfection.

Lawsuits Over Contaminated Medical Scopes May Rise

A new review has found that as many as 350 people have been sickened by life-threatening infections linked to contaminated medical scopes between 2010 and 2015. The review found that 30 hospitals in the United States and 11 other hospitals around the world reported 404 bacterial infections and 44 more potential exposures linked to the scopes. Regulators say that these device reports “likely contain duplicate patient reporting,” reducing the number of affected patients somewhat. However, other sources say that those figures likely underestimate the problem since hospitals don’t always test patients for the antibiotic-resistant “superbugs” that cause such infections.

The House Committee on Oversight and Government Reform obtained the updated figures from the Food and Drug Administration under a year-long investigation into “superbug” outbreaks tied to the devices. In 2015, several high-profile outbreaks at hospitals in Los Angeles and Seattle were linked to duodenoscopes. Superbug outbreaks at UCLA’s Ronald Reagan Medical Center and Cedars-Sinai Medical Center in Los Angeles were linked to several patient deaths and multiple infections.

The devices in those cases were made by Olympus Corp., a Japanese manufacturer which dominates the U.S. market. Duodenoscopes feature a mechanized tip with moveable instruments used to drain blockages and perform other procedures. The scope infections occurred during a procedure known as endoscopic retrograde cholangiopancreatography, or ERCP. Nationally, more than 650,000 ERCP procedures are performed each year.

Olympus had redesigned its duodenoscope in 2010 in a way that makes them extremely difficult to clean, even with mechanical processing equipment. Experts found that bodily fluids and other debris could remain in the device’s joints and crevices even after cleaning and disinfection. Officials at the hospitals said they had followed the manufacturers’ instructions for cleaning the devices. An FDA warning went out in February 2015 urging all hospitals to review their cleaning procedures for these reusable scopes and consider additional steps to minimize the infection risk.

Now that it has been uncovered that the contaminated medical scopes may be linked to more infections than previously estimated by federal regulators, the number of personal injury lawsuits filed over these infections may rise. If you believe that you have been harmed due to contaminated medical scopes, you may be entitled to compensation. Contact a personal injury attorney and give them the facts of your case, and they will help you determine the best course of action for you going forward.


sadly, these figures are just the tip of the iatrogenic ice burg... terry


*** 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.



Monday, August 17, 2015


FDA Says Endoscope Makers Failed to Report Superbug Problems OLYMPUS


I told Olympus 15 years ago about these risk factors from endoscopy equipment, disinfection, even spoke with the Doctor at Olympus, this was back in 1999. I tried to tell them that they were exposing patients to dangerous pathogens such as the CJD TSE prion, because they could not properly clean them. even presented my concern to a peer review journal GUT, that was going to publish, but then it was pulled by Professor Michael Farthing et al... see ;



Wednesday, March 02, 2016


Endoscope Maker Olympus Agrees To $646 Million Settlement Over Kickbacks, while still ignoring the elephant in the room, CJD TSE PRIONS





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 1-24-3



Monday, December 26, 2011


Prion Uptake in the Gut: Identification of the First Uptake and Replication Sites



Saturday, February 13, 2016


The Risk of Prion Infection through Bovine Grafting Materials in dentistry



Saturday, January 16, 2016


Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products Guidance for Industry



Tuesday, May 26, 2015


Minimise transmission risk of CJD and vCJD in healthcare settings Last updated 15 May 2015



Friday, October 09, 2015


An alarming presentation level II trauma center of Creutzfeldt-Jakob disease following a self-inflicted gunshot wound to the head



Wednesday, January 06, 2016





Saturday, December 12, 2015





Thursday, March 17, 2016


Preliminary Diagnosis Creutzfeldt-Jakob Disease Confirmed in Patient that had Lumbar Puncture at Washington Regional Medical Center



Sunday, January 17, 2016


Of Grave Concern Heidenhain Variant Creutzfeldt Jakob Disease



Thursday, April 14, 2016


Arizona 22 year old diagnosed with Creutzfeldt Jakob Disease CJD



 PLEASE REMEMBER, IN 55 YEARS AND OLDER, THE RATE OF DOCUMENTED CJD JUMPS TO ONE IN 9,000. but officials don’t tell you that either. and please remember, all iatrogenic cjd is, is sporadic cjd, until the iatrogenic event is discovered, traced back, documented, put into the academic domain, and then finally the public domain, and due to lack of trace back efforts, this very seldom happens, thus most all is sporadic CJD.


now, what is sporadic CJD ???


O.05: Transmission of prions to primates after extended silent incubation periods: Implications for BSE and scrapie risk assessment in human populations


Emmanuel Comoy, Jacqueline Mikol, Valerie Durand, Sophie Luccantoni, Evelyne Correia, Nathalie Lescoutra, Capucine Dehen, and Jean-Philippe Deslys Atomic Energy Commission; Fontenay-aux-Roses, France


Prion diseases (PD) are the unique neurodegenerative proteinopathies reputed to be transmissible under field conditions since decades. The transmission of Bovine Spongiform Encephalopathy (BSE) to humans evidenced that an animal PD might be zoonotic under appropriate conditions. Contrarily, in the absence of obvious (epidemiological or experimental) elements supporting a transmission or genetic predispositions, PD, like the other proteinopathies, are reputed to occur spontaneously (atpical animal prion strains, sporadic CJD summing 80% of human prion cases). Non-human primate models provided the first evidences supporting the transmissibiity of human prion strains and the zoonotic potential of BSE. Among them, cynomolgus macaques brought major information for BSE risk assessment for human health (Chen, 2014), according to their phylogenetic proximity to humans and extended lifetime. We used this model to assess the zoonotic potential of other animal PD from bovine, ovine and cervid origins even after very long silent incubation periods.


*** We recently observed the direct transmission of a natural classical scrapie isolate to macaque after a 10-year silent incubation period,


***with features similar to some reported for human cases of sporadic CJD, albeit requiring fourfold long incubation than BSE. Scrapie, as recently evoked in humanized mice (Cassard, 2014),


***is the third potentially zoonotic PD (with BSE and L-type BSE),


***thus questioning the origin of human sporadic cases.


We will present an updated panorama of our different transmission studies and discuss the implications of such extended incubation periods on risk assessment of animal PD for human health.




***thus questioning the origin of human sporadic cases***







*** Title: Transmission of scrapie prions to primate after an extended silent incubation period




item Comoy, Emmanuel - item Mikol, Jacqueline - item Luccantoni-Freire, Sophie - item Correia, Evelyne - item Lescoutra-Etchegaray, Nathalie - item Durand, Valérie - item Dehen, Capucine - item Andreoletti, Olivier - item Casalone, Cristina - item Richt, Juergen item Greenlee, Justin item Baron, Thierry - item Benestad, Sylvie - item Hills, Bob - item Brown, Paul - item Deslys, Jean-Philippe -


Submitted to: Scientific Reports Publication Type: Peer Reviewed Journal Publication Acceptance Date: May 28, 2015 Publication Date: June 30, 2015 Citation: Comoy, E.E., Mikol, J., Luccantoni-Freire, S., Correia, E., Lescoutra-Etchegaray, N., Durand, V., Dehen, C., Andreoletti, O., Casalone, C., Richt, J.A., Greenlee, J.J., Baron, T., Benestad, S., Brown, P., Deslys, J. 2015. Transmission of scrapie prions to primate after an extended silent incubation period. Scientific Reports. 5:11573.


Interpretive Summary: The transmissible spongiform encephalopathies (also called prion diseases) are fatal neurodegenerative diseases that affect animals and humans. The agent of prion diseases is a misfolded form of the prion protein that is resistant to breakdown by the host cells. Since all mammals express prion protein on the surface of various cells such as neurons, all mammals are, in theory, capable of replicating prion diseases. One example of a prion disease, bovine spongiform encephalopathy (BSE; also called mad cow disease), has been shown to infect cattle, sheep, exotic undulates, cats, non-human primates, and humans when the new host is exposed to feeds or foods contaminated with the disease agent. The purpose of this study was to test whether non-human primates (cynomologous macaque) are susceptible to the agent of sheep scrapie.


***After an incubation period of approximately 10 years a macaque developed progressive clinical signs suggestive of neurologic disease.


***Upon postmortem examination and microscopic examination of tissues, there was a widespread distribution of lesions consistent with a transmissible spongiform encephalopathy.


***This information will have a scientific impact since it is the first study that demonstrates the transmission of scrapie to a non-human primate with a close genetic relationship to humans.


***This information is especially useful to regulatory officials and those involved with risk assessment of the potential transmission of animal prion diseases to humans.


Technical Abstract:


Classical bovine spongiform encephalopathy (c-BSE) is an animal prion disease that also causes variant Creutzfeldt-Jakob disease in humans. Over the past decades, c-BSE's zoonotic potential has been the driving force in establishing extensive protective measures for animal and human health.


***In complement to the recent demonstration that humanized mice are susceptible to scrapie, we report here the first observation of direct transmission of a natural classical scrapie isolate to a macaque after a 10-year incubation period.


***Neuropathologic examination revealed all of the features of a prion disease: spongiform change, neuronal loss, and accumulation of PrPres throughout the CNS.


***This observation strengthens the questioning of the harmlessness of scrapie to humans, at a time when protective measures for human and animal health are being dismantled and reduced as c-BSE is considered controlled and being eradicated.


***Our results underscore the importance of precautionary and protective measures and the necessity for long-term experimental transmission studies to assess the zoonotic potential of other animal prion strains.



***Our study demonstrates susceptibility of adult cattle to oral transmission of classical BSE. ***


***our findings suggest that possible transmission risk of H-type BSE to sheep and human. ***


P.86: Estimating the risk of transmission of BSE and scrapie to ruminants and humans by protein misfolding cyclic amplification


Morikazu Imamura, Naoko Tabeta, Yoshifumi Iwamaru, and Yuichi Murayama National Institute of Animal Health; Tsukuba, Japan


To assess the risk of the transmission of ruminant prions to ruminants and humans at the molecular level, we investigated the ability of abnormal prion protein (PrPSc) of typical and atypical BSEs (L-type and H-type) and typical scrapie to convert normal prion protein (PrPC) from bovine, ovine, and human to proteinase K-resistant PrPSc-like form (PrPres) using serial protein misfolding cyclic amplification (PMCA).


Six rounds of serial PMCA was performed using 10% brain homogenates from transgenic mice expressing bovine, ovine or human PrPC in combination with PrPSc seed from typical and atypical BSE- or typical scrapie-infected brain homogenates from native host species. In the conventional PMCA, the conversion of PrPC to PrPres was observed only when the species of PrPC source and PrPSc seed matched. However, in the PMCA with supplements (digitonin, synthetic polyA and heparin), both bovine and ovine PrPC were converted by PrPSc from all tested prion strains. On the other hand, human PrPC was converted by PrPSc from typical and H-type BSE in this PMCA condition.


Although these results were not compatible with the previous reports describing the lack of transmissibility of H-type BSE to ovine and human transgenic mice,


***our findings suggest that possible transmission risk of H-type BSE to sheep and human.


Bioassay will be required to determine whether the PMCA products are infectious to these animals.














Zoonotic Potential of CWD Prions


Liuting Qing1, Ignazio Cali1,2, Jue Yuan1, Shenghai Huang3, Diane Kofskey1, Pierluigi Gambetti1, Wenquan Zou1, Qingzhong Kong1 1Case Western Reserve University, Cleveland, Ohio, USA, 2Second University of Naples, Naples, Italy, 3Encore Health Resources, Houston, Texas, USA


*** These results indicate that the CWD prion has the potential to infect human CNS and peripheral lymphoid tissues and that there might be asymptomatic human carriers of CWD infection.




***These results indicate that the CWD prion has the potential to infect human CNS and peripheral lymphoid tissues and that there might be asymptomatic human carriers of CWD infection.***




P.105: RT-QuIC models trans-species prion transmission


Kristen Davenport, Davin Henderson, Candace Mathiason, and Edward Hoover Prion Research Center; Colorado State University; Fort Collins, CO USA


Conversely, FSE maintained sufficient BSE characteristics to more efficiently convert bovine rPrP than feline rPrP. Additionally, human rPrP was competent for conversion by CWD and fCWD.


***This insinuates that, at the level of protein:protein interactions, the barrier preventing transmission of CWD to humans is less robust than previously estimated.




***This insinuates that, at the level of protein:protein interactions, the barrier preventing transmission of CWD to humans is less robust than previously estimated.***







Transmissible Spongiform Encephalopathy TSE PRION update January 2, 2014


*** chronic wasting disease, there was no absolute barrier to conversion of the human prion protein.


*** Furthermore, the form of human PrPres produced in this in vitro assay when seeded with CWD, resembles that found in the most common human prion disease, namely sCJD of the MM1 subtype.




*** These results would seem to suggest that CWD does indeed have zoonotic potential, at least as judged by the compatibility of CWD prions and their human PrPC target. Furthermore, extrapolation from this simple in vitro assay suggests that if zoonotic CWD occurred, it would most likely effect those of the PRNP codon 129-MM genotype and that the PrPres type would be similar to that found in the most common subtype of sCJD (MM1).***



*** The potential impact of prion diseases on human health was greatly magnified by the recognition that interspecies transfer of BSE to humans by beef ingestion resulted in vCJD. While changes in animal feed constituents and slaughter practices appear to have curtailed vCJD, there is concern that CWD of free-ranging deer and elk in the U.S. might also cross the species barrier. Thus, consuming venison could be a source of human prion disease. Whether BSE and CWD represent interspecies scrapie transfer or are newly arisen prion diseases is unknown. Therefore, the possibility of transmission of prion disease through other food animals cannot be ruled out. There is evidence that vCJD can be transmitted through blood transfusion. There is likely a pool of unknown size of asymptomatic individuals infected with vCJD, and there may be asymptomatic individuals infected with the CWD equivalent. These circumstances represent a potential threat to blood, blood products, and plasma supplies.



Tuesday, April 12, 2016


The first detection of Chronic Wasting Disease (CWD) in Europe



Monday, April 11, 2016





Terry S. Singeltary

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