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From: TSS ()
Subject: Hospitals warn patients over 'stolen' body parts
Date: September 21, 2006 at 9:23 am PST

Hospitals warn patients over 'stolen' body parts
Thu Sep 21, 2006 11:20

Hospitals warn patients over 'stolen' body parts

David Batty and agencies
Thursday September 21, 2006
Guardian Unlimited

Patients at hospitals across the UK have been warned that they have received grafts from allegedly stolen human body parts, possibly contaminated with HIV and other diseases, it emerged today.
A government healthcare watchdog yesterday named 25 hospitals in England and Wales that imported bone tissue, unaware that it may have been illegally stripped from corpses in the United States.

The Medicines and Healthcare Products Regulatory Agency (MHRA), which regulates the safety of medicines, blood and body tissues, decided to name the hospitals affected after deciding the public interest outweighed the potential breach of patient confidentiality.

The US Food and Drug Administration (FDA) last year ordered a recall of human tissues sourced by Biomedical Tissue Services, after it emerged the New Jersey-based company had failed to adequately screen and document the donors.

It appeared that bodies had been obtained from mortuaries illegally and without consent. The body of veteran BBC broadcaster Alistair Cooke was one of more than a thousand allegedly plundered by a corpse-snatching ring in New York, which then sold bones, ligaments and skin for use in transplants.

The FDA warned that many patients could have been exposed to diseases including HIV, hepatitis and syphilis, but insisted the risk of infection was minimal. Affected tissue was recalled in the US and the UK, but it emerged that up to 82 pieces of bone had been grafted onto British patients needing hip or jaw operations.

The MHRA named the hospitals affected following a request by the BBC under the Freedom of Information Act. They are:

Airedale general hospital, Keighley, West Yorkshire
BUPA Hartswood hospital, Brentwood, Essex
Derriford hospital, Plymouth Doncaster Royal Infirmary, South Yorkshire
Guy's & St Thomas' hospital, London
Mayday university hospital, Croydon, south London
North London Nuffield hospital, Enfield, Middlesex
North Staffordshire Royal Infirmary, Stoke-on-Trent
Northern general hospital, Sheffield
Northwick Park and St Mark's hospital, Harrow, Middlesex
Parkside hospital, Wimbledon
The Royal London hospital
The Royal National Orthopaedic hospital, Stanmore
S...horpe general hospital, S...horpe
Somerset Nuffield hospital, Taunton
Southend hospital, Southend
St George's hospital, London
Taunton & Somerset hospital, Devon
Torbay hospital, Devon
Warrington hospital, Cheshire
Wellington hospital, London
Wessex Nuffield hospital, Hampshire

The Welsh assembly contacted another three hospitals in Cardiff: BUPA hospital Cardiff; Llandough hospital; and university hospital of Wales Cardiff. Most of the hospitals contacted by Guardian Unlimited said they had informed affected patients of the potential risk. But some hospitals have decided not to inform patients, believing this would cause unnecessary distress given that the risk of adverse effects is minimal.

A MHRA spokeswoman said the hospitals were advised that "the infection risk was negligible". It was now up to doctors to decide what advice they should give to their patients, she added.

Southend Hospital said 18 patients were treated with bone material sourced from the US company at the centre of the scandal. A spokesman said the bone had been screened for known infectious diseases and the risk of infection was negligible. He added: "No patient has ever reported any adverse reaction following the use of bone products at Southend Hospital."

Plymouth Hospitals NHS Trust, which runs Derriford Hospital in Devon, said one of its patients had a bone tissue transplant before it was recalled in October 2005. The trust said the patient later died of unrelated causes.

A spokeswoman for the Bupa Hartswood Hospital in Brentwood, Essex said: "We have identified one patient, the bone in question was used in a grafting operation. We are confident that there is no medical issue and no risk to that patient's health."

A spokesman for Mayday university hospital, Croydon, south London, said only one patient received a graft from the company. He said: "They were called in we explained the situation. The patient in consultation with a doctor decided against another operation as the risk would have been greater than keeping the graft. They have suffered no adverse effects."

Private healthcare firm Nuffield hospitals had three hospitals affected by the body part scandal. A spokesman said three patients - one at each hospital - had received grafts and been informed of the potential risks. He said: "To date we can confirm that one patient has taken up the offer of screening."

The university hospital of North Staffordshire said it was contacting one patient believed to have been affected. A spokesman said: "Our records show that one item has been implanted in a patient. We are in the process of contacting the patient to give them full details and to reassure them that there is a negligible clinical risk."

But a spokesman for Guy's and St Thomas' NHS foundation trust said it had not informed the one patient affected. He said: "The patient has not been informed. Senior doctors decided this after weighing up the risk to the patient against the potential distress caused. The case happened a while back and there were no adverse reactions."

New York investigators now say that, as well as bodies being taken illegally, death certificates were doctored to make the dead out to have been younger and healthier than they actually were.

In the case of Mr Cooke, who died of cancer at 95 in March 2004, documents listed the cause of death as a heart attack and lowered his age to 85, investigators said.,,1877985,00.html

THE LEGAL TRADING AND SELLING OF BODY PARTS AND TSEs i.e. THE BODY SNATCHERS;article=2864;title=CJD%20WATCH;article=2818;title=CJD%20Voice%20Discussion%20Group

----- Original Message -----
From: "Terry S. Singeltary Sr."
Sent: Friday, September 01, 2006 10:04 PM

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

----- Original Message -----
From: Terry S. Singeltary Sr.
Sent: Friday, September 01, 2006 2:49 PM

FDA News
August 30, 2006
Media Inquiries:
Paul Richards, 301-827-6242
Consumer Inquiries:

FDA Forms Task Force on Human Tissue Safety


“The primary goal of the new task force is to identify whether any additional steps are needed to further protect the public health while assuring the availability of safe products,” said Jesse Goodman, MD, MPH, director of CBER. “The creation of this task force is part of the agency's overall plan to ensure that all human cells and tissues are as safe as possible.”

While the agency believes most firms involved in tissue manufacturing comply with the new regulations, FDA wants to explore where additional steps could help strengthen its approach to making sure firms follow required practices to prevent the transmission of communicable diseases. The agency continues to work diligently to identify and, where appropriate, take action against establishments and individuals that violate the rules. These actions may include both administrative and criminal proceedings.

“FDA is committed to rapidly identifying and stopping those establishments and individuals that risk endangering the public health by not complying with the regulations,” said Margaret O’K Glavin, Associate Commissioner of the Office of Regulatory Affairs. “We also will continue to work with professional and trade associations to support their ongoing efforts to assure quality oversight of manufacturing operations and product safety.”

“The creation of this task force underscores FDA’s recognition that compliance with the rules in place to ensure recipient safety is our highest priority,” Dr. Goodman said.

Within the next three months, the task force will develop an action plan, and where necessary, propose changes to existing policies, as well as generate a set of recommendations, identify what resources are needed to support these actions and report on how the agency can immediately implement its action plan.



I only hope that you (FDA et al) are serious? ACTIONS speak louder than words, and only monetary damages AND jail will make some companies comply. I donated my mothers brain for the research of human TSE, she died 12-14-97 from the Heidenhain Variant of Creutzfeldt Jakob Disease, and since, have regretted ever doing it due to the various controversies that have taken place since, with tissue donations. I know others that feel the same way. Either get it under control now, or risk having less and less donated tissue to work with in science and the medical donor programs. ...

Thank You,

I am sincerely,

Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518


Wed Jun 14, 2006 09:07

Greetings CJD VOICE,

IF i would have been aware of all this greed, i would have never ever donated my mother's brain for research. NIH AND PFIZER SHOULD BE HELD ACCOUNTABLE for there disgraced actions. you cant tell me they did not know. ...TSS

US scientist accused of selling tissue samples
Deal said to earn $285,000 for vials that cost millions
By Diedtra Henderson, Globe Staff | June 14, 2006

WASHINGTON -- A senior government scientist pocketed hundreds of thousands of dollars as a drug company consultant in exchange for human tissue samples that cost the federal government millions to acquire, congressional investigators said yesterday .

The House Energy and Commerce Committee report, the culmination of a one-year inquiry, was released hours before a two-day hearing began to explore the government's practices for procuring human tissue samples.
According to congressional investigators, the National Institutes of Health's Dr. Trey Sunderland agreed to collaborate with Pfizer Inc. , the world's largest drug company. Sunderland, chief of the geriatric psychiatry branch of the National Institute for Mental Health , sent Pfizer 3,200 tubes of spinal fluid and 388 tubes of plasma collected for Alzheimer's research.

The government spent $6.4 million to obtain the 3,500 samples that showed how Alzheimer's disease progressed in 538 subjects.

Pfizer paid Sunderland $285,000 in consulting fees related to the samples, investigators said. In total, Pfizer paid him more than $600,000 from 1998 to 2004 for outside consulting and speaking fees. Sunderland is scheduled to testify today at the hearing.

``Contrary to the House committee report, Dr. Sunderland did not receive any payments from Pfizer for human tissue samples," said Robert F. Muse, the scientist's Washington, D.C., attorney. ``He acted properly, ethically, and legally in his relationship with Pfizer."

Pfizer spokeswoman Kate Robins said the company had a transfer agreement endorsed by the NIH that permitted Sunderland to send cerebrospinal fluid from research participants with Alzheimer's, the participant's relatives who were at higher risk of developing the neurological disease, and elderly adults with normal Alzheimer's risk.

Sunderland's consulting role tapped his Alzheimer's disease expertise to look for signals in the samples that could help identify and diagnose the disease.

``The payments over a six-year period were reasonable and customary for an expert of Dr. Sunderland's stature, and reflect the fair-market value of his consulting services," Robins said.

The report said the tissue transfers, reported by a government whistleblower, raised serious questions about how the government ensures its scientists do not abuse their positions and about the agency's ability to track the valuable samples.

``NIH tells us it has no centralized inventory system that could tell the NIH director how many vials of tissues are in freezers at a particular institute," said Representative Joe Barton , Republican of Texas and House Energy and Commerce Committee chairman . ``It would really be a shame if we find out that the National Institutes of Health has more control over its paper clips and trash cans than it has over its human tissue samples."

John T. Burklow , a NIH spokesman, said the agency shares ``the committee's concerns in regard to the ethical management of human tissue samples."

Sunderland's arrangement with the drug maker -- made without NIH knowledge, according to Burklow -- occurred after the agency relaxed its ethics policy covering scientists' outside activities and ended before the agency enacted more stringent rules.

The NIH, pressured by Barton's committee, on Aug. 25 curbed outside consulting deals between its scientists and pharmaceutical and biotechnology companies.

Diedtra Henderson can be reached at

© Copyright 2006 Globe Newspaper Company.

Tuesday, June 13, 2006

OD Office of Communications
and Public Liaison

NIH Statement Regarding House Hearing on Human Tissue Samples
Attribution: John Burklow, NIH spokesman

NIH’s position on ethics is clear: any conflict of interest resulting in an individual personally profiting from official government research activities cannot be tolerated. We are committed to maintaining the public’s trust in NIH and its scientists as an unbiased source of biomedical research guidance and advice. The case under consideration concerns events that began in 1998 — after the NIH ethics rules concerning outside activities were relaxed — and that ended before the new rules were put in place. NIH has previously referred this case to the relevant authorities for appropriate action.

It is important to note that the specific consulting arrangements in question, had they been known to NIH, would not have been approved under the present or previous ethics regulations. Outside consulting connected to an NIH employee’s official government duties has always been prohibited at NIH.

NIH has undertaken a comprehensive review of its activities and conflict of interest policies in the last few years. As a result of that process, on August 25, 2005, NIH implemented comprehensive ethics rules that make it clear what NIH scientists can and cannot do in regard to outside activities. These new rules removed any ambiguity about what is allowed or not allowed. Here are two important points:

Under new NIH regulations, all NIH employees are now prohibited from engaging in outside employment with pharmaceutical companies and biotechnology companies in their private capacities — period.
Collaboration and partnership with industry can nonetheless be very valuable in scientific pursuits and NIH rules allow such activities, as long as they are undertaken through an officially approved Cooperative Research and Development Agreement (CRADA).
Although we cannot discuss this particular case because it remains under investigation, we can speak to the relevant issues that it raises.

Collaborations among scientists that involve human tissue samples are common and essential for science. There are, however, stringent rules in place to protect the participants who donated their samples, and to ensure that there is full informed consent.

We share the Committee’s concerns in regard to the ethical management of human tissue samples and the development of rigorous and uniform policies to protect the public’s trust and interests, while advancing science to address important public health problems. The thousands of scientists who work at NIH have always been and remain committed to these principles.

The Office of the Director, the central office at NIH, is responsible for setting policy for NIH, which includes 27 Institutes and Centers. This involves planning, managing, and coordinating the programs and activities of all NIH components. The Office of the Director also includes program offices which are responsible for stimulating specific areas of research throughout NIH. Additional information is available at

The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit

NIH may destroy human brain collection

By Steve Mitchell
Medical Correspondent

Washington, DC, Mar. 24 (UPI) -- The National Institutes of Health may discard part or all of a rare collection that includes hundreds of human brain samples from patients that suffered from a disorder similar to mad cow disease -- unless another researcher or institution takes them on, United Press International has learned.

Several scientists said the collection, which is held by the NIH's National Institute for Neurological Disorders and Stroke in Bethesda, Md. -- and includes brains and other tissue samples from people afflicted with the brain-wasting illness Creutzfeldt Jakob disease -- is irreplaceable and could even provide insight into treatments for the fatal disorder. Currently, there is no cure for CJD and patients typically die within a year after symptoms begin.

However, NIH officials in control of the collection's fate told UPI the remaining samples are of little scientific value and may be disposed of if researchers outside the agency do not claim it. That position stands in sharp contrast with CJD experts who thought the collection should be preserved.

"It's invaluable," said Dr. Paul Brown, former medical director of the NIH's Laboratory for Central Nervous System Studies, whose expertise is in CJD and mad cow disease (also known as bovine spongiform encephalopathy, or BSE).

The collection is badly in need of organization and no one is certain how many brains or other tissue samples it contains, said Brown, who worked with the collection since its inception in the 1960's until his retirement last year. There could be brains, blood, spinal fluid and various other tissues from 1,000 people or more, he said. Some of the specimens would be of scientific use today, he said.

"This collection has the unique value of stretching back to the beginning of when these diseases were discovered," Brown told UPI, noting that the first samples were obtained in 1963. "It would be as though you had in your hands the possibility of finding out when AIDS started."

Bruce Johnson, a former technician at the CNSS lab who worked extensively with the collection before he retired in 2003, told UPI he was told "in two years they (NIH officials)are going to destroy it, if nobody wants it."

Eugene Major, acting director of the basic neuroscience program at the NIH, said no specific timeframe had been established.

"We have not set a firm deadline date," Major told UPI. "We are working very hard with investigators that we know in order to be able to make sure that whatever we deem is valuable is potentially kept here." Some samples already have been determined not to have any research value and have been "removed and disposed of," he said.

Others samples have been given out to Dr. David Asher at the Food and Drug Administration and Pierluigi Gambetti at the National Prion Disease Pathology Surveillance Center in Cleveland, Ohio.

Major maintained the remaining collection was not particularly valuable for research. "Whatever had been collected here that has not already been distributed to responsible investigators who could use them really has very little remaining value," he said.

Neither Asher nor Gambetti returned phone calls from UPI, but Brown said he thought Asher had received only a dozen or two samples at most and Gambetti had not received much at all.

Neil Cashman, a brain-disease researcher at the University of Toronto's Center for Research in Neurodegenerative Diseases -- who has tried to obtain the collection from the NIH -- said it was priceless.

"It would be like destroying an art museum," Cashman told UPI. "There's all this information and insight that's locked up in these tissues and if it's destroyed it will be lost forever."

The Memorial Institute for Neurodegenerative Diseases Inc., a non-profit organization consisting of more than 40 university and institute researchers from the United States, Canada, United Kingdom and France, also thinks the brain collection is invaluable.

"It is the opinion of the Board of Directors ... of The MIND Inc., that the ... brain bank should not be broken up nor destroyed," said Harry E. Peery, MIND's executive director, in a letter to UPI. "We believe that this collection is of inestimable research value and should be kept intact."

The institute, at the University of Saskatchewan in Saskatoon, applied for possession of the collection in early 2004, but received a letter from the NINDS indicating the fate of the collection had not yet been determined.

"We have heard nothing further since that time" and continue to be interested in acquiring the complete collection, Peery said.

CJD belongs to a group of rare, brain-wasting disorders that are little understood, incurable and fatal. This includes mad cow disease in cows, chronic wasting disease in deer and elk. The most infamous of these illnesses in humans is variant CJD, which people can contract from eating beef products infected with the mad-cow pathogen.

Although vCJD has infected more than 154 people worldwide, only one case has ever been detected in the United States -- in a Florida woman who is thought to have contracted the disease while living in the United Kingdom. However, the NIH brain samples have never been screened for vCJD -- something Johnson thinks is critically important.

"No one has ever looked to see if any American (in the collection) in the past had variant CJD," Johnson said. "You think it would be required that they do that. You think it would be a Congressional mandate that they test these brains: 'Let's see if we've got this disease in our country.'"

Johnson noted at least one brain in the collection he personally had examined -- from a French woman collected in 1971 -- showed evidence of possible vCJD infection, but the sample needed further study to be sure.

Other samples in the collection include the brains of patients who were only 16 years old when they were diagnosed with CJD. This would be unusual for sporadic CJD, because generally it strikes those over age 60. Variant CJD, on the other hand, typically occurs in patients in their 20s or younger.

"I thought it was absolutely vital (to test these brains)," Johnson said. "Maybe there's a dozen cases in there of variant CJD."

Major disagreed. "There's really no reason to do that," he said. "The effort it would take to screen those samples ... would not give us any new insights into variant CJD beyond what it is we already know."

Johnson said he was frustrated with the NIH administration's lack of interest in preserving the collection or testing for vCJD. "They don't understand," he said, "they honest-to-god don't understand what it's all about."

Patient advocates also objected to the possible destruction of the brains.

Terry Singeltary, whose mother died of a type of CJD called Heidenhain variant in 1997, said he is outraged and families of other CJD victims probably will be, too.

"A lot of these families went through a lot of heartache and a lot of trouble to get these brain samples to the NIH," Singeltary told UPI. "Now they're just going to discard them because they're not of scientific use? That's just asinine. That stuff is valuable information."

Graham Steel, vice-chair of the Human BSE Foundation in the United Kingdom, told UPI, "The potential loss of such important tissue samples would be a massive blow for TSE (the group of diseases that includes CJD and BSE) research in the United States. This should not be allowed to happen."

Singeltary noted there currently is no cure for these diseases. "If you don't have any answers yet, why would you throw these specimens away?" he asked.

He added that more sensitive tests are just becoming available and could help determine the origin of some of the CJD cases. "We've all been sitting around waiting for more sensitive tests to get validated because we want answers," he said.

"You know, it must be an embarrassment," Johnson said. "Some Senator is going to eventually say 'What is NIH doing about mad cow disease?' And people are going to scratch their heads and say 'not much'." He added, "What's going to happen (is) one of these senators or their wife is going to develop spontaneous CJD one day and ... there's going to be hell raised and they're going to ask, 'Why isn't NIH working on this?'"



NIH sends mixed signals on CJD brains

By Steve Mitchell
Medical Correspondent

Washington, DC, Apr. 7 (UPI) -- A National Institutes of Health official who told United Press International the agency might destroy its collection of brains from human patients afflicted with a condition similar to mad cow disease reportedly has told the head of a patient-advocate group the collection would be preserved.

The official, Eugene Major, acting director of the basic neuroscience program at the NIH, has not responded to e-mail or a phone call from UPI seeking clarification of his remarks, and the official status of the collection remains unknown.

As reported by UPI on March 24, the collection is stored in freezers by the NIH's National Institute for Neurological Disorders and Stroke in Bethesda, Md. It contains brains and other tissue samples from hundreds of people who died from the brain-wasting illness Creutzfeldt Jakob disease, as well as tissues from an untold number of experimental animals.

The consensus of scientists in this field is the collection, which dates back to 1963, is invaluable for research and could even provide insight into treatments for the fatal disorder. Currently, there is no cure for CJD and patients typically die within a year after symptoms begin.

Florence Kranitz, president of the non-profit advocacy group CJD Foundation, told UPI she had "a very long conversation" with Major, in which he told her the remaining tissues in the collection would not be destroyed.

"He reassured me in no uncertain terms," Kranitz said, noting constituents of the foundation and other CJD advocacy groups had been expressing concerns to her the tissues would be destroyed.

Kranitz, who has personal reasons for wanting the collection preserved -- her husband died of CJD in 2000 -- said she plans to meet with Major at the end of April to discuss the issue further.

CJD belongs to a group of diseases collectively known as transmissible spongiform encephalopathies, or TSEs, that includes mad cow disease in cows, chronic wasting disease in deer and elk, and scrapie in sheep. All TSEs are incurable and fatal.

Major previously told UPI some samples already have been destroyed and others have been given to researchers at the Food and Drug Administration and the National Prion Disease Pathology Surveillance Center in Cleveland.

Major said the remaining collection "has very little remaining value" and could be destroyed if another entity does not claim them.

Bruce Johnson, a former NIH scientist who retired at the end of 2003, said he had been told the collection would be destroyed in two years if no one took the samples from the NIH.

In response to hearing that Major had failed to confirm to UPI the brain collection would not be destroyed, Patricia Ewanitz, who lives in Port Jefferson Station, N.Y., and is founder of the advocacy group CJD Voice, said, "The brain tissue might not be indispensable to the National Institutes of Health but it is absolutely necessary to the families who thought enough of science to donate the brains, brain tissue and blood in hopes of someday finding an answer to why their loved one died."

Ewanitz, whose husband died of CJD in 1997, added, "It now seems like such a joke."

Terry Singeltary, whose mother passed away from a type of CJD in 1997, said the NIH should use the samples for scientific research, not just store them in freezers.

Both Singeltary and Ewanitz said they would feel more reassured if Major verified in writing the collection will not be destroyed.

"I would go further and ask Major what he plans to do with them," Singeltary said. "If the samples are just going to sit up there and go bad, then they should give them out to researchers looking for cause and cure."

The revelation the NIH might destroy part or all of the collection sparked an outcry from patient advocates, consumer groups and scientists.

Advocates have been contacting their members of Congress, urging them to investigate and prevent the NIH from destroying the brains. Consumer groups also have gotten involved and scientists have taken steps to obtain the collection or have urged Major not to destroy the samples.

Felicia Nestor, who serves as a consultant to Public Citizen, told UPI she had contacted certain legislators and at least one was considering looking into the situation. Nestor asked the legislator's name be withheld.

Kranitz said Major also told her he plans "to advertise in professional neurological journals and by whatever means necessary to make it known" to researchers in the field the tissues are available.

Major previously said, however, that efforts to inform researchers of the availability of the collection were already underway and included informing NIH grantees. He added he had personally notified researchers at scientific meetings, but no TSE researcher contacted by UPI was aware of this.

"I was never informed," said Laura Manuelidis, an expert on these diseases and section chief of surgery in the neuropathology department at Yale University. She said the first she had heard of the situation was in UPI's March 24 report.

Manuelidis also said she contacted Major, expressing interest in the specimens, but so far has not received a response.

"I sent a letter to (Major) on (March 25) about our interest in these specimens, but he has not replied," she told UPI in an e-mail.

Neil Cashman, a TSE expert at the University of Toronto, who said he was not aware the samples might be destroyed, has lobbied colleagues at the University of British Columbia -- where Cashman is scheduled to move to this summer -- to help draft a letter requesting the collection.

The Memorial Institute for Neurodegenerative Diseases Inc., a non-profit organization consisting of more than 40 university and institute researchers from the United States, Canada, the United Kingdom and France, requested the collection in January, 2004. So far, the institute has not been informed of a decision by the NIH.

Asked if Major had told him whether the collection would be preserved, MIND Executive Director Harry Peery said, "We have heard nothing further from Eugene Major or anyone else at the NIH regarding the brain collection."



THE LEGAL TRADING AND SELLING OF BODY PARTS AND TSEs i.e. THE BODY SNATCHERS;article=2891;title=CJD%20WATCH;article=2864;title=CJD%20WATCH;article=2818;title=CJD%20Voice%20Discussion%20Group;article=2864;title=CJD%20WATCH

Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)

[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirement for the Disposition of Non-Ambulatory Disabled Cattle


Interview: Clearant's CEO on tissue safety
WASHINGTON, Sept. 1 (UPI) -- United Press International this week interviewed Clearant's CEO Alain Delongchamp about the company's technology for sterilizing human tissue implants, in light of the recent announcement from the Food and Drug Administration that it formed a task force to review the agency's regulations for ensuring such tissues are safe and free of disease.

FDA's move apparently was spurred by the recent case involving Donor Referral Services (DRS) of Raleigh, N.C., in which the agency deemed tissues collected and distributed by the firm were potentially infected with HIV and other infectious diseases. The DRS case follows the highly publicized case last year involving Biomedical Tissue Services, in which similarly risky tissues were distributed.

Q: How does your product work?

A: Basically what we've done is, we've been able to define conditions that allow us to use gamma irradiation to completely sterilize these orthopedic tissue implants from any bacteria or any virus that could be in them. Prior to Clearant coming to fruition with this new sterilization process, no one had been able to give a high enough dose of gamma irradiation energy to achieve a full degree of sterilization from bacteria and viruses because every time someone tried ... you ended up inflicting damage upon the implant and reducing its quality or integrity.

What we've been able to discover are methods that prevent us from inflicting any damage on the implant while at the same time being able to give a dose of energy that's high enough to fully eradicate bacteria and viruses from those implants that come from human cadavers.

Q: How would your product help with the current situation involving Donor Referral Services?

A: Basically, with the use of the Clearant process, you pretty much eliminate any possibility of having any bacteria or any virus from being transmitted to a recipient of a medical implant.

The situation recently is a very typical risk management situation where the risk is clearly identified by the FDA. The risk being that infections can be transmitted. And when you have a situation like this, generally speaking, any kind of textbook risk management situation would tell you that you should design methods to control the risk or eliminate the risk.

I suspect the agency is considering tightening up the regulations around where, and in which settings, the cadavers could be harvested from. In another area that would provide a similar broad positive impact on public health would be requiring that validated sterilization processes be required for these implants.

Q: Is your technology or a similar process required by FDA regulations on tissue collection and distribution?

A: It's not required. Current good tissue practices allow manufacturers to make the implants with a final terminal sterilization step or without.

Q: Do you think there's any resistance from the agency in having something like that in their regulations?

A: No, I don't think so. When the original good tissue practices were written opening the door to methods to sterilizing tissue implants, I have never sensed there was any resistance on the part of the agency for requiring sterilization. It may be something that will come about at some point.

Q: What are your sales now for your sterilization technology?

A: We have a number of tissue banks that have licensed our process and have just begun to use the Clearant process, so our sales are less than $1 million per year, but it's a growing number of people.

Q: Do you know if any of the tissue banks that got some of the tissue in this latest incident used your process?

A: None of them (did(.

Q: Can you tell me the names of some of the banks that are using it?

A: Tissuebank International is one. Another one is Donor Community Institute in Nashville, Tenn. Another company is Cryolife. So we have a number of companies that have licensed our technology.

Q: Did you see any increased interest in your technology after the Biomedical Tissue Services incident last year?

A: We did from the surgeons. There was an increased number of phone calls from surgeons to Clearant as of that time, which has led us to now have some tissue implants manufactured by some of our existing partners that we distribute directly to surgeons. That's an effort we launched in the summer of this year, which was largely in response to surgeons in various hospitals who had called and asked us for information at first about the Clearant process.

Once we gave them information, they asked how they could source the implants from us and at the time we were not directly distributing to hospitals and we were referring these leads to our partners. Over time, that situation changed. Now we work with our partners and have a dedicated inventory that we also directly distribute to hospitals and surgeons who want them.

Q: Have you noticed an increase in calls coming in now after the Donor Referral Services incident?

A: Today, I've had several surgeons emailing me. They usually say things like, 'What does it mean, does your process help?'

Q: Are there any other competitors that offers anything similar to your technology?

A: There's one company (that) certainly has a process that seems to work well. They're called Regeneration Technologies Inc., in Florida. It's a different process entirely from ours, but based on claims they've made and presentations of data, it seems that it also eliminates the risk of bacteria from those tissue implants. Now we've never seen data from Regeneration Technologies about elimination of viruses, so I can't comment on their technology regarding virus inactivation.

In our case, we do eliminate both bacteria and viruses, such as HIV, hepatitis B, hepatitis C, West Nile virus and other viruses.

Q: How about Creutzfeldt Jakob disease?

A: No. Unfortunately, we don't eliminate the risk of prion or CJD transmission.

Q: What's in the future for your company and your product?

A: Basically, expanding the amount of direct distribution that we're doing. I think the environment is very receptive. Recent events continue to just make surgeons more aware that having a method that sterilizes very broadly against any kind of infectious disease being transmitted while maintaining fully the performance integrity of the tissue is highly desirable. We just started launching this direct distribution program in July of this year and we're already planning to expand it.


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