Endoscope Maker Olympus Agrees To $646 Million Settlement Over Kickbacks, while still ignoring the elephant in the room, CJD TSE PRIONS
Health Inc.
Endoscope Maker Olympus Agrees To $646 Million Settlement Over Kickbacks
March 2, 2016·11:03 AM ET
Medical device maker Olympus Corp., already under federal investigation for
its role in superbug outbreaks, has agreed to pay $646 million to resolve
criminal and civil probes into illegal kickbacks and bribes to doctors and
hospitals.
Federal prosecutors said Tuesday that the company's settlement is the
largest ever for violations of the U.S. Anti-Kickback Statute. A portion of the
company's payout, $22.8 million, will resolve similar bribery allegations in
Latin America.
U.S. investigators said the Tokyo-based company's "greed-fueled kickback
scheme" from 2006 to 2011 used research grants, consulting deals, luxury trips,
gifts of hot-air ballooning and spa treatments and free equipment to induce
influential doctors to order more Olympus devices at prominent hospitals and
help the company keep out competitors. The devices included gastrointestinal
scopes, which have been tied to deadly outbreaks of drug-resistant
bacteria.
In one case, according to the federal criminal complaint, senior Olympus
executives agreed to pay for three doctors to spend a week in Japan "as a quid
pro quo" for a prominent California institution to switch from a competitor's
products to Olympus.
After the trip, one of the doctors thanked Olympus for "providing so much
extra entertainment that we did not expect," according to the government's
complaint.
Prosecutors declined to name any medical centers or doctors in their
complaint.
In other instance, Olympus gave a doctor $400,000 worth of free endoscopes
and other supplies for his private practice from 2006 to 2010, prosecutors said.
Olympus believed this doctor could persuade a "leading New York medical center"
to spend millions of dollars on devices, according to the government
complaint.
This strategy appeared to pay off for Olympus. Prosecutors alleged that
after a key doctor for a Midwest hospital system took a week-long trip to Japan
and received a company grant, an Olympus vice president wrote an internal email
in 2006 that said, "We have received all of the orders expected and have kept [a
competitor] completely out of the [hospital] system. Hooray!"
As part of the settlement, Olympus agreed to a corporate-integrity
agreement and the appointment of an independent monitor, Larry Mackey, a former
prosecutor in the Oklahoma City bombing cases.
"Olympus leadership acknowledges the company's responsibility for the past
conduct, which does not represent the values of Olympus or its employees," Nacho
Abia, chief executive of the Olympus Corp. of the Americas unit in Center
Valley, Pa., said in a statement. "Olympus is committed to complying with all
laws and regulations and to adhering to our own rigorous code of conduct."
As a result of the kickbacks, Olympus generated more than $600 million in
sales and reaped gross profits of $230 million, officials said. Olympus is the
leading manufacturer of gastrointestinal scopes worldwide, and it boasts an 85
percent share of the U.S. market.
"Kickbacks are illegal because they taint buying decisions," said Paul
Fishman, U.S. Attorney for the District of New Jersey, which spearheaded the
investigation. "Doctors and hospitals should decide to purchase medical devices
based solely on legitimate considerations, like quality and price. They
shouldn't be tempted and swayed by free trips, free equipment, consulting
agreements or research grant money."
Prosecutors credited the help of the former chief compliance officer at
Olympus, John Slowik, who filed a whistleblower case against the company under
seal in 2010.
In his whistleblower complaint, unsealed Tuesday after the government's
announcement, he said he was fired by Olympus for trying to end improper
practices. Slowik now stands to receive about $50 million from the settlement,
in accordance with federal whistleblower law, prosecutors said.
Patrick Burns, acting president of the Taxpayers Against Fraud Education
Fund, praised Slowik, saying he exposed illegal actions that wasted money and
threatened patient safety.
"This is exactly why we need whistleblowers — because companies cannot be
relied upon to put patients before profits," Burns said. Olympus was "funding a
massive kickback scheme that channeled millions of dollars in payola to doctors
and hospitals."
Well before Tuesday's announcement, Olympus was under fire for failing to
alert U.S. regulators and hospitals sooner about the risks of infection from its
duodenoscopes, a gastrointestinal scope that has proven difficult to clean of
dangerous bacteria because of its intricate design.
A Senate investigation released in January identified 19 scope-related
outbreaks at U.S. medical centers from 2012 to 2015 that sickened nearly 200
patients with drug-resistant infections. Thirteen of those outbreaks were
associated with Olympus scopes.
Olympus announced in January it would recall its duodenoscopes nationwide
and make repairs to better protect patients. Last year, the company disclosed it
had received a subpoena from federal prosecutors seeking "information relating
to duodenoscopes."
In the kickback case, federal officials said Olympus used a grants
committee staffed by sales and marketing executives to dole out millions of
dollars to key hospital and physician customers.
In 2007, Fishman said an Olympus vice president recommended a research
grant of $100,000 to a hospital's foundation. "Why? Because that hospital was
their '#1 account in the US' and they had, and I'm quoting, 'no intention of
losing it' to a competitor," Fishman said Tuesday.
Although prosecutors didn't identify institutions, the whistleblower's
complaint did mention some physicians and hospitals by name.
For instance, it recounted an October 2009 meeting between top Olympus
executives and a prominent doctor at the University of Southern California's
Keck School of Medicine, about the possibility of a company grant.
After the meeting, an Olympus executive in Japan emailed a counterpart in
the U.S. about his opinion on the USC grant in light of "future business
expansion (any future sales potential?)," according to the whistleblower's
complaint.
A spokeswoman for USC said she couldn't immediately comment late
Tuesday.
Olympus reported a general payment of $64,013 to USC's Keck Hospital in
2014 for "in-kind items and services," according to federal data on industry
contributions to doctors and teaching hospitals.
Overall, for 2014, Olympus issued $5.25 million in general and
research-related payments to physicians and hospitals, the federal database
shows.
Slowik, the whistleblower, said the company ran a "sham physician
consultant program" that paid some doctors more than $100,000 annually.
Prosecutors said Olympus paid one doctor $112,300 for consulting from 2006
to 2011 in order to influence the purchasing decisions of a "leading
Southeastern medical institution."
The company also used "permanent loans" or "medical loaner scopes" to
improperly give hospitals free equipment, inducing them to buy more products,
according to federal investigators.
"This practice enabled Olympus America to acquire monopoly power in certain
segments of the medical business, ultimately resulting in customers paying
inflated prices," according to Slowik's amended complaint.
This story was produced by Kaiser Health News, which publishes California
Healthline, a service of the California Health Care Foundation.
health care fraud
Medical Devices
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 ;
some old history on Endoscopy equipment and CJD TSE Prion concerns ;
1999
Subject: CJD * Olympus Endoscope
Date: Sun, 10 Oct 1999 16:41:49 –0500
From: "Terry S. Singeltary Sr."
To: GOLDSS@...
Dear Dr. Goldstine,
Hello Sir, I understand that Olympus has issued a letter to the medical
institutions and the CDC, about the dangers of _not_ being able to decontaminate
the instruments (endoscope's) via modern autoclaving techniques (boil 3 minutes
in 3% SDS or another ionic detergent and autoclave for 1 hour at 134 degrees C).
I understand that; "Olympus" has issued a warning, _not_ to attempt to
decontaminate the instrument, that they are instructed to destroy them.
(very very wise move)
Please Sir, it is imminent that I receive a copy of this letter, it is very
important. This could lead to other company's following through, and lead to
awareness of the potential health threats from human T.S.E.'s and the risks
through surgery, and not just from endoscopes. It would be most appreciated, if
you could send a copy of this document to;
Fax: xxxxx
I look forward, to hearing back from you....
Many Thanks,
Terry S. Singeltary Sr./ Mom DOD 12-14-97 hvCJD
Subject: Re: CJD * Olympus Endoscope
Date: Tue, 12 Oct 1999 15:57:03 –0500
From: "Terry S. Singeltary Sr."
To: GOLDSS@...
References: 1
Dear Mr. Goldstine, Hello again, I hope the CDC has not changed your mind,
since our phone call, about sending me the information, in which we spoke of. I
am still waiting for the information, re-fax. Someone had told me, you would not
send me the information, but I told them you would, due to the importance of it
pertaining to public safety, and the fact, you are a Doctor. I hope you don't
disappoint me, and the rest of the public, and hide the facts, as the CDC and
NIH have for years. Olympus can be part of the Truth, or you can be part of the
cover-up. We are going to find out, sooner or later.
I already know, as do many more.
Still waiting,
Kind Regards,
Terry S. Singeltary Sr.
"Terry S. Singeltary Sr." wrote:
Dear Dr. Goldstine,
Hello Sir, I understand that Olympus has issued a letter to the medical
institutions and the CDC, about the dangers of _not_ being able to decontaminate
the instruments (endoscope's) via modern autoclaving techniques (boil 3 minutes
in 3% SDS or another ionic detergent and autoclave for 1 hour at 134 degrees C).
I understand that; "Olympus" has issued a warning, _not_ to attempt to
decontaminate the instrument, that they are instructed to destroy them.
(very very wise move);
Please Sir, it is imminent that I receive a copy of this letter, it is very
important. This could lead to other company's following through, and lead to
awareness of the potential health threats from human T.S.E.'s and the risks
through surgery, and not just from endoscopes. It would be most appreciated, if
you could send a copy of this document to;
Fax: xxxxxxx
I look forward, to hearing back from you....
Many Thanks,
Terry S. Singeltary Sr./ Mom DOD 12-14-97 hvCJD
=================================================================
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
>>Citation:
>> Creutzfeldt-Jakob disease: implications for gastroenterology
>> M G Bramble and J W Ironside
>> Gut 2002; 50: 888-890 (Occasional viewpoint)
>>-----------------------------------------------------------------
>>"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., Bacliff, Texas USA 77518
flounder@wt.net CJD WATCH
[scroll down past article for my comments]
snip...
were not all CJDs, even nvCJD, just sporadic, until proven otherwise?
Terry S. Singeltary Sr., Bacliff, Texas 77518 USA
Professor Michael Farthing wrote: Louise Send this to Bramble (author) for
a comment before we post. Michael
=======================================================
snip... see full text ;
2003
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
Monday, December 26, 2011
Prion Uptake in the Gut: Identification of the First Uptake and Replication
Sites
snip...see full text ;
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 ;
Sunday, January 17, 2016
Of Grave Concern Heidenhain Variant Creutzfeldt Jakob Disease
Saturday, February 13, 2016
The Risk of Prion Infection through Bovine Grafting Materials in dentistry
Thursday, February 25, 2016
U.S. Food & Drug Administration (FDA) FDA/CFSAN Cosmetics Update:
Cosmetics Program; Import and Domestic and Transmissible Spongiform
Encephalopathy TSE Prion Disease Risk Factors
***WARNING TO ALL CONSUMERS AND COUNTRIES AROUND THE WORLD***
***Note: FDA labs do not conduct BSE analysis and thus no sampling guidance
is issued for BSE. ***
Saturday, February 6, 2016
*** Secretary's Advisory Committee on Animal Health; Meeting [Docket No.
APHIS-2016-0007] Singeltary Submission ***
2026 iatrogenic CJD TSE Prion Update
“There are now FDA-approved disposable GI endoscopes for upper endoscopy, colonoscopy and for ERCP,” he said. “This will cover most clinical situations where urgent endoscopic evaluation of such a patient is needed.”
Although CJD infections are rare—about 600 reported cases in the United States every year—they have been rising in recent years (JAMA Neurol 2024;81[2]:195-197), Dr. Salameh noted, adding, “No matter how rare the disease is, it should be on our minds. People die within a year of getting Creutzfeldt-Jakob disease, and we want to be at a low threshold of suspicion when it comes to CJD.”
—Kaitlin Sullivan
iatrogenic TSE CJD/CWD, my greatest fear, here’s why…
remember, all iatrogenic cjd is, is sporadic cjd, before the iatrogenic event is discovered, traced back, proven, documented, put into the academic domain, and then finally the public domain, this very seldom happens, thus problem solved, it's all sporadic cjd, PLUS, SPORADIC CJD HAS NOW BEEN LINKED By Scientific TO ATYPICAL AND TYPICAL BSE, SCRAPIE, AND NOW CWD. ...terry
one of the old studies that has always stuck out in my mind, one that the late great Dr. Gibbs, Gajdusek, et al did way back, and to this day is still amazes me...
*** 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
remember, all iatrogenic cjd is, is sporadic cjd, before the iatrogenic event is discovered, traced back, proven, documented, put into the academic domain, and then finally the public domain, this very seldom happens, thus problem solved, it's all sporadic cjd, PLUS, SPORADIC CJD HAS NOW BEEN LINKED By Scientific TO ATYPICAL AND TYPICAL BSE, SCRAPIE, AND NOW CWD. ...terry
one of the old studies that has always stuck out in my mind, one that the late great Dr. Gibbs, Gajdusek, et al did way back, and to this day is still amazes me...
*** 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
The TSE prion disease survives ashing to 600 degrees celsius, that’s around 1112 degrees farenheit.
You cannot cook the TSE prion disease out of meat. In fact new data now shows that exposure to high temperatures used to cook the meat increased the availability of prions for in vitro amplification.
you can take the ash and mix it with saline and inject that ash into a mouse, and the mouse will go down with TSE.
Prion Infected Meat-and-Bone Meal Is Still Infectious after Biodiesel Production as well.
the TSE prion agent also survives Simulated Wastewater Treatment Processes.
IN fact, you should also know that the TSE Prion agent will survive in the environment for years, if not decades.
you can bury it and it will not go away.
The TSE agent is capable of infected your water table i.e. Detection of protease-resistant cervid prion protein in water from a CWD-endemic area.
it’s not your ordinary pathogen you can just cook it out and be done
New studies on the heat resistance of hamster-adapted scrapie agent: Threshold survival after ashing at 600°C suggests an inorganic template of replication
http://www.pnas.org/content/97/7/3418.full
France issues moratorium on prion research after fatal brain disease strikes two lab workers
By Barbara CasassusJul. 28, 2021 , 4:35 AM
PARIS—Five public research institutions in France have imposed a 3-month moratorium on the study of prions—a class of misfolding, infectious proteins that cause fatal brain diseases—after a retired lab worker who handled prions in the past was diagnosed with Creutzfeldt-Jakob disease (CJD), the most common prion disease in humans. An investigation is underway to find out whether the patient, who worked at a lab run by the National Research Institute for Agriculture, Food and Environment (INRAE), contracted the disease on the job.
If so, it would be the second such case in France in the past few years. In June 2019, an INRAE lab worker named Émilie Jaumain died at age 33, 10 years after pricking her thumb during an experiment with prion-infected mice. Her family is now suing INRAE for manslaughter and endangering life; her illness had already led to tightened safety measures at French prion labs.
Posted in: EuropeHealthScientific Community
doi:10.1126/science.abl6587
https://www.sciencemag.org/news/2021/07/france-issues-moratorium-prion-research-after-fatal-brain-disease-strikes-two-lab
Variant Creutzfeldt–Jakob Disease Diagnosed 7.5 Years after Occupational Exposure
Variant Creutzfeldt–Jakob disease was identified in a technician who had cut her thumb while handling brain sections of mice infected with adapted BSE 7.5 years earlier. The long incubation period was similar to that of the transfusion-transmitted form of the disease.
Variant Creutzfeldt–Jakob Disease Diagnosed 7.5 Years after Occupational Exposure
TO THE EDITOR:
We report a case of variant Creutzfeldt–Jakob disease (CJD) that was plausibly related to accidental occupational exposure in a technician who had handled murine samples contaminated with the agent that causes bovine spongiform encephalopathy (BSE) 7.5 years earlier.
In May 2010, when the patient was 24 years of age, she worked in a prion research laboratory, where she handled frozen sections of brain of transgenic mice that overexpressed the human prion protein with methionine at codon 129. The mice had been infected with a sheep-adapted form of BSE. During this process, she stabbed her thumb through a double pair of latex gloves with the sharp ends of a curved forceps used to handle the samples. Bleeding was noted at the puncture site.
In November 2017, she began having burning pain in the right shoulder and neck. The pain worsened and spread to the right half of her body during the following 6 months. In November 2018, an examination of a sample of cerebrospinal fluid (CSF) obtained from the patient was normal. Magnetic resonance imaging (MRI) of the brain showed a slight increase in the fluid-attenuated inversion recovery (FLAIR) signal in the caudates and thalami (Fig. S1A and S1B in the Supplementary Appendix, available with the full text of this letter at NEJM.org). In January 2019, she became depressed and anxious and had memory impairment and visual hallucinations. There was hypertonia on the right side of her body. At that time, an analysis of CSF for 14-3-3 protein was negative. In March 2019, MRI showed an increased FLAIR signal in pulvinar and dorsomedial nuclei of thalami (Fig. S1C through S1E).
Figure 1.
Detection of Abnormal Prion Protein in Biologic Fluid Samples and Postmortem Findings.
The patient was found to be homozygous for methionine at codon 129 of the prion protein gene without mutation. An analysis of a sample of CSF on real-time quaking-induced conversion analysis was negative for a diagnosis of sporadic CJD. However, an analysis of plasma and CSF by means of protein misfolding cyclic amplification was positive for the diagnosis of variant CJD (Figure 1A and 1B). The patient died 19 months after the onset of symptoms. Neuropathological examination confirmed the diagnosis of variant CJD (Figure 1C and 1D). Western blot analysis showed the presence of type 2B protease-resistant prion protein in all sampled brain areas. The clinical characteristics of the patient and the postmortem neuropathological features were similar to those observed in 27 patients with variant CJD who had previously been reported in France.1 (Additional details are provided in the Supplementary Appendix.)
There are two potential explanations for this patient’s condition. Oral transmission from contaminated cattle products cannot be ruled out because the patient was born at the beginning of the French BSE outbreak in cattle. However, the last two patients who had confirmed variant CJD with methionine homozygosity at codon 129 in France and the United Kingdom died in 2014 and 2013, respectively, which makes oral transmission unlikely. In France, the risk of variant CJD in 2019 was negligible or nonexistent in the post-1969 birth cohort.2
Percutaneous exposure to prion-contaminated material is plausible in this patient, since the prion strain that she had handled was consistent with the development of variant CJD.3 The 7.5-year delay between the laboratory accident and her clinical symptoms is congruent with the incubation period in the transfusion-transmitted form of the disease. The ability of this strain to propagate through the peripheral route has been documented, and experimental studies with scrapie strains have shown that scarification and subcutaneous inoculation are effective routes.4,5 The last known Italian patient with variant CJD, who died in 2016, had had occupational contact with BSE-infected brain tissues, although subsequent investigation did not disclose a laboratory accident (Pocchiari M, Italian Registry of CJD: personal communication). Thus, the last two cases of variant CJD outside the United Kingdom have been associated with potential occupational exposure. Such cases highlight the need for improvements in the prevention of transmission of variant CJD and other prions that can affect humans in the laboratory and neurosurgery settings, as outlined in the Supplementary Appendix.
Jean-Philippe Brandel, M.D. Assistance Publique–Hôpitaux de Paris, Paris, France
M. Bustuchina Vlaicu, M.D. Groupe Hospitalier Nord-Essonne, Orsay, France
Audrey Culeux, B.Sc. INSERM Unité 1127, Paris, France
Maxime Belondrade, M.Sc. Daisy Bougard, Ph.D. Etablissement Français du Sang, Montpellier, France
Katarina Grznarova, Ph.D. Angeline Denouel, M.Sc. INSERM Unité 1127, Paris, France
Isabelle Plu, M.D. Elodie Bouaziz-Amar, Pharm.D., Ph.D. Danielle Seilhean, M.D., Ph.D. Assistance Publique–Hôpitaux de Paris, Paris, France
Michèle Levasseur, M.D. Groupe Hospitalier Nord-Essonne, Orsay, France
Stéphane Haïk, M.D., Ph.D. INSERM Unité 1127, Paris, France stephane.haik@upmc.fr
Supported by a grant (ANR-10-IAIHU-06) from Programme d’Investissements d’Avenir and Santé Publique France.
Disclosure forms provided by the authors are available with the full text of this letter at NEJM.org.
5 References
July 2, 2020
N Engl J Med 2020; 383:83-85
DOI: 10.1056/NEJMc2000687
Metrics
https://www.nejm.org/doi/full/10.1056/NEJMc2000687
You cannot cook the TSE prion disease out of meat. In fact new data now shows that exposure to high temperatures used to cook the meat increased the availability of prions for in vitro amplification.
you can take the ash and mix it with saline and inject that ash into a mouse, and the mouse will go down with TSE.
Prion Infected Meat-and-Bone Meal Is Still Infectious after Biodiesel Production as well.
the TSE prion agent also survives Simulated Wastewater Treatment Processes.
IN fact, you should also know that the TSE Prion agent will survive in the environment for years, if not decades.
you can bury it and it will not go away.
The TSE agent is capable of infected your water table i.e. Detection of protease-resistant cervid prion protein in water from a CWD-endemic area.
it’s not your ordinary pathogen you can just cook it out and be done
New studies on the heat resistance of hamster-adapted scrapie agent: Threshold survival after ashing at 600°C suggests an inorganic template of replication
http://www.pnas.org/content/97/7/3418.full
France issues moratorium on prion research after fatal brain disease strikes two lab workers
By Barbara CasassusJul. 28, 2021 , 4:35 AM
PARIS—Five public research institutions in France have imposed a 3-month moratorium on the study of prions—a class of misfolding, infectious proteins that cause fatal brain diseases—after a retired lab worker who handled prions in the past was diagnosed with Creutzfeldt-Jakob disease (CJD), the most common prion disease in humans. An investigation is underway to find out whether the patient, who worked at a lab run by the National Research Institute for Agriculture, Food and Environment (INRAE), contracted the disease on the job.
If so, it would be the second such case in France in the past few years. In June 2019, an INRAE lab worker named Émilie Jaumain died at age 33, 10 years after pricking her thumb during an experiment with prion-infected mice. Her family is now suing INRAE for manslaughter and endangering life; her illness had already led to tightened safety measures at French prion labs.
Posted in: EuropeHealthScientific Community
doi:10.1126/science.abl6587
https://www.sciencemag.org/news/2021/07/france-issues-moratorium-prion-research-after-fatal-brain-disease-strikes-two-lab
Variant Creutzfeldt–Jakob Disease Diagnosed 7.5 Years after Occupational Exposure
Variant Creutzfeldt–Jakob disease was identified in a technician who had cut her thumb while handling brain sections of mice infected with adapted BSE 7.5 years earlier. The long incubation period was similar to that of the transfusion-transmitted form of the disease.
Variant Creutzfeldt–Jakob Disease Diagnosed 7.5 Years after Occupational Exposure
TO THE EDITOR:
We report a case of variant Creutzfeldt–Jakob disease (CJD) that was plausibly related to accidental occupational exposure in a technician who had handled murine samples contaminated with the agent that causes bovine spongiform encephalopathy (BSE) 7.5 years earlier.
In May 2010, when the patient was 24 years of age, she worked in a prion research laboratory, where she handled frozen sections of brain of transgenic mice that overexpressed the human prion protein with methionine at codon 129. The mice had been infected with a sheep-adapted form of BSE. During this process, she stabbed her thumb through a double pair of latex gloves with the sharp ends of a curved forceps used to handle the samples. Bleeding was noted at the puncture site.
In November 2017, she began having burning pain in the right shoulder and neck. The pain worsened and spread to the right half of her body during the following 6 months. In November 2018, an examination of a sample of cerebrospinal fluid (CSF) obtained from the patient was normal. Magnetic resonance imaging (MRI) of the brain showed a slight increase in the fluid-attenuated inversion recovery (FLAIR) signal in the caudates and thalami (Fig. S1A and S1B in the Supplementary Appendix, available with the full text of this letter at NEJM.org). In January 2019, she became depressed and anxious and had memory impairment and visual hallucinations. There was hypertonia on the right side of her body. At that time, an analysis of CSF for 14-3-3 protein was negative. In March 2019, MRI showed an increased FLAIR signal in pulvinar and dorsomedial nuclei of thalami (Fig. S1C through S1E).
Figure 1.
Detection of Abnormal Prion Protein in Biologic Fluid Samples and Postmortem Findings.
The patient was found to be homozygous for methionine at codon 129 of the prion protein gene without mutation. An analysis of a sample of CSF on real-time quaking-induced conversion analysis was negative for a diagnosis of sporadic CJD. However, an analysis of plasma and CSF by means of protein misfolding cyclic amplification was positive for the diagnosis of variant CJD (Figure 1A and 1B). The patient died 19 months after the onset of symptoms. Neuropathological examination confirmed the diagnosis of variant CJD (Figure 1C and 1D). Western blot analysis showed the presence of type 2B protease-resistant prion protein in all sampled brain areas. The clinical characteristics of the patient and the postmortem neuropathological features were similar to those observed in 27 patients with variant CJD who had previously been reported in France.1 (Additional details are provided in the Supplementary Appendix.)
There are two potential explanations for this patient’s condition. Oral transmission from contaminated cattle products cannot be ruled out because the patient was born at the beginning of the French BSE outbreak in cattle. However, the last two patients who had confirmed variant CJD with methionine homozygosity at codon 129 in France and the United Kingdom died in 2014 and 2013, respectively, which makes oral transmission unlikely. In France, the risk of variant CJD in 2019 was negligible or nonexistent in the post-1969 birth cohort.2
Percutaneous exposure to prion-contaminated material is plausible in this patient, since the prion strain that she had handled was consistent with the development of variant CJD.3 The 7.5-year delay between the laboratory accident and her clinical symptoms is congruent with the incubation period in the transfusion-transmitted form of the disease. The ability of this strain to propagate through the peripheral route has been documented, and experimental studies with scrapie strains have shown that scarification and subcutaneous inoculation are effective routes.4,5 The last known Italian patient with variant CJD, who died in 2016, had had occupational contact with BSE-infected brain tissues, although subsequent investigation did not disclose a laboratory accident (Pocchiari M, Italian Registry of CJD: personal communication). Thus, the last two cases of variant CJD outside the United Kingdom have been associated with potential occupational exposure. Such cases highlight the need for improvements in the prevention of transmission of variant CJD and other prions that can affect humans in the laboratory and neurosurgery settings, as outlined in the Supplementary Appendix.
Jean-Philippe Brandel, M.D. Assistance Publique–Hôpitaux de Paris, Paris, France
M. Bustuchina Vlaicu, M.D. Groupe Hospitalier Nord-Essonne, Orsay, France
Audrey Culeux, B.Sc. INSERM Unité 1127, Paris, France
Maxime Belondrade, M.Sc. Daisy Bougard, Ph.D. Etablissement Français du Sang, Montpellier, France
Katarina Grznarova, Ph.D. Angeline Denouel, M.Sc. INSERM Unité 1127, Paris, France
Isabelle Plu, M.D. Elodie Bouaziz-Amar, Pharm.D., Ph.D. Danielle Seilhean, M.D., Ph.D. Assistance Publique–Hôpitaux de Paris, Paris, France
Michèle Levasseur, M.D. Groupe Hospitalier Nord-Essonne, Orsay, France
Stéphane Haïk, M.D., Ph.D. INSERM Unité 1127, Paris, France stephane.haik@upmc.fr
Supported by a grant (ANR-10-IAIHU-06) from Programme d’Investissements d’Avenir and Santé Publique France.
Disclosure forms provided by the authors are available with the full text of this letter at NEJM.org.
5 References
July 2, 2020
N Engl J Med 2020; 383:83-85
DOI: 10.1056/NEJMc2000687
Metrics
https://www.nejm.org/doi/full/10.1056/NEJMc2000687
Cervid CWD TSE PrP Transmission to Humans, has it already happened and being masked as sporadic CJD, What if? July 2026 Review
https://chronic-wasting-disease.blogspot.com/2026/07/cervid-cwd-tse-prp-transmission-to.html
https://prpsc.proboards.com/thread/224/cervid-transmission-humans-july-review
April 2026
Texas CWD TSE PrP Continues To Climb July 2026
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https://chronic-wasting-disease.blogspot.com/2026/05/texas-cwd-tse-prion-cases-climb-to-1377.html
https://chronic-wasting-disease.blogspot.com/2026/05/texas-cwd-tse-prion-cases-climb-to-1377.html
MONDAY, JUNE 1, 2026
NATIONAL PRION DISEASE PATHOLOGY SURVEILLANCE CENTER CJD SURVEILLANCE TABLES OF CASES EXAMINED NPDPSC Last updated March 31st, 2026
February 14, 2001
Diagnosis and Reporting of Creutzfeldt-Jakob Disease
Terry S. Singeltary, Sr
Author Affiliations
JAMA. 2001;285(6):733-734. doi:10-1001/pubs.JAMA-ISSN-0098-7484-285-6-jlt0214
To the Editor: In their Research Letter, Dr Gibbons and colleagues1 reported that the annual US death rate due to Creutzfeldt-Jakob disease (CJD) has been stable since 1985. These estimates, however, are based only on reported cases, and do not include misdiagnosed or preclinical cases. It seems to me that misdiagnosis alone would drastically change these figures. An unknown number of persons with a diagnosis of Alzheimer disease in fact may have CJD, although only a small number of these patients receive the postmortem examination necessary to make this diagnosis. Furthermore, only a few states have made CJD reportable. Human and animal transmissible spongiform encephalopathies should be reportable nationwide and internationally.
https://jamanetwork.com/journals/jama/article-abstract/1031186
iatrogenic Transmissible Spongiform Encephalopathy TSE Prion PrP
Terry S. Singeltary Sr.
posted by Terry S. Singeltary Sr. at
12:58 PM
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