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From: TSS ()
Subject: Stolen body parts used on Australian patients could possibly transmit dangerous pathogens such as CJD i.e. mad cow disease
Date: June 22, 2006 at 9:43 am PST


Stolen body parts used on Australian patients

Gerard Ryle

June 22, 2006

MEDICAL products made from human body parts stolen from funeral homes in New York have been implanted into Australians.

Last night the Therapeutic Goods Administration (TGA) was urgently trying to contact 46 patients through their doctors to warn them in what is one of the biggest health scares of its kind.

The move came about after the Herald presented evidence to the watchdog that the material had arrived, after the agency's own inquiries failed to uncover the truth.

One of the people whose tissue was stolen was Alistair Cooke, the BBC broadcaster whose weekly Letter From America helped shape British and Australian views of the US for half a century.

The bones, ligaments and skin - many of them aged and, due to the potential for infection, unsuitable for transplant - were traded to legitimate firms, which transformed them into products used to cure back pain, incontinence and other medical conditions.

The material implanted into Australian patients was brought in under a scheme that allows patients, in consultation with their doctors or dentists, to obtain products not yet approved for use here.

The TGA did not know if all the doctors and dentists had gone ahead with the treatments using the product called AlloDerm.

The TGA said it would be up to individual doctors to decide if their patients needed blood tests to detect possible infections.

This contradicts US Food and Drug Administration (FDA) recommendations that anyone who received the stolen tissue be tested for HIV, hepatitis C and syphilis. The FDA determined that, in some instances, blood samples designed to ensure the human tissue was disease-free had not come from the people from whom the tissue had been obtained.

AlloDerm is manufactured by one of the five companies which innocently received the stolen parts, LifeCell Corporation of Branchburg, New Jersey.

LifeCell, co-founded by an Australian researcher, Stephen Livesey, has strong links to the taxpayer-funded Australian Stem Cell Centre in Melbourne, which innocently received at least three pieces of product manufactured from the stolen tissue.

Dr Livesey is the centre's chief scientific officer. He also maintains links to his former company, LifeCell. He said the material sent to his centre was for research purposes only and it had not been used on patients.

"We have a licence agreement with LifeCell to use the material for research purposes and the material that was sent to us was specifically for that, for research purposes," he said.

"None of that material was for clinical use, and none of that material was implanted into people."

When the stolen body parts scandal first broke, the TGA said it had begun an investigation "immediately on receipt of US advice in October 2005" to see if any of the material had been imported.

In March, the agency stated it had conducted a thorough, nationwide check and found that none of the products had been imported into Australia.

The TGA now admits that advice to the public was wrong. Their experts had looked at the wrong company and had failed to even check the FDA website, which lists product lots sent to the US, Korea and Australia.

The TGA said yesterday that it had begun another, urgent, investigation and had started contacting doctors.

AlloDerm, made from human cadavers, is one of the LifeCell products recalled in the US.

Dr Livesey said AlloDerm was never commercially distributed in Australia despite a LifeCell press release, dated August 15, 2000, that indicated that the product was to be distributed here.

He said the press release merely announced to the US stockmarket a distribution agreement with another US company.

The alleged desecration of bodies from funeral homes in Brooklyn, Rochester, New Jersey and Philadelphia is part of a continuing New York Police Department investigation that has scandalised America.

The police claim a former dentist and three associates secretly removed bones, skin, tendons and veins from corpses bound for cremation or burial. They then sold them through a US company called Biomedical Tissue Services.

In some cases, the bones were replaced with plastic pipes before the bodies were stitched up and returned to their families.

LifeCell and four other companies caught up in the scandal have stated that it is unlikely that anyone who received the material was infected because of safety measures taken during the processing of the human tissue.

But lawyers representing victims in the US disagree.

"Potentially we know that AIDS and hepatitis can be transmitted," said Sanford Rubenstein, a lawyer representing some of the victims.

In the US, recycling dead humans is a billion-dollar business, documents submitted to regulatory authorities show.

There are hundreds of different products derived from dead humans. Gels made from human skin are injected to smooth wrinkles, to puff up lips, or to fatten pen!ses.

An ounce of bone putty, used in spinal surgery, can sell for more than an ounce of gold. Skin, tendons, heart valves and veins and corneas are listed at thousands of dollars. Add bone from the same body and, by some estimates, one cadaver can be worth more than $US200,000 ($270,000).

FDA records show that some material from the other four companies caught up in the scandal was also sent overseas. But they do not identify if any of it came to Australia.

THE WATCHDOG'S POSITION IN MARCH

A nationwide investigation has determined that no Australian company is importing suspect bone or tissue samples.

THE REVISED POSITION YESTERDAY

The TGA is contacting treating doctors … there are 56 approvals [for implicated batches of AlloDerm] for 46 patients.

Stolen tissue - how body parts were shipped to Australia
1. Potentially infected human tissue is stolen from corpses lying in funeral homes in New York. Police describe a secret "cutting room", equipped with surgeon's lights and a mechanical lift that is used to haul up bodies from the family viewing rooms below.

2. The tissue is shipped by Biomedical Tissue Services to LifeCell Corporation, a human tissue processor based in Branchburg, New Jersey. Four other US tissue processing companies also received the material.

3. At LifeCell, the stolen material is transformed into medical products called Alloderm, Graft Jacket and Repliform. These products are used to treat skin conditions and in cosmetic surgery.

4. The products are then shipped to hospitals and surgeries around the US and implanted into patients. Some was shipped to Korea and Australia, after being innocently ordered by doctors and dentists.

5. At least three pieces were innocently sent to the Australian Stem Cell Centre in Melbourne. The centre, a taxpayer-funded organisation, has a licence from LifeCell to use the material "for research purposes". The centre says none of the material that it received was implanted into patients.

6. The Health Department watchdog, the TGA, is now trying to contact doctors who may have supplied 46 patients with “implicated batches of AlloDerm”.

http://www.smh.com.au/news/national/stolen-body-parts-shippedhere/2006/06/21/1150845247843.html?page=fullpage#contentSwap3

No stolen body parts in Australia: US firm
Chantal Rumble
June 23, 2006

AN AMERICAN company that innocently used stolen human body parts to make tissue grafts has denied that any contaminated goods were used to treat Australian patients.

In a letter to the Therapeutic Goods Administration, LifeCell said the only contaminated tissue grafts shipped to Australia had been intended for research and all had been returned.

David Shriver, the company's regulatory and clinical affairs director, wrote: "We are not aware of any patient in Australia that has ever received a LifeCell product processed with (contaminated) tissue."

The product, called Alloderm, was one of several recalled in the United States in September after manufacturers discovered they had been supplied with stolen body parts for production.

An investigation conducted at the time by the TGA found no Alloderm containing stolen body parts had been used in Australia, but new evidence this week prompted the watchdog to urgently contact 13 doctors who had gained special approval for its use on 46 patients.

Last night, however, the TGA again played down concerns. "It appears likely that no Australian patient has received any of this product involved in the stolen body parts scandal in the US. We expect to be able to confirm that this is the case tomorrow," a spokesman said.

Made from human skin, Alloderm can be used in reconstructive and cosmetic surgery and as a graft to treat burns.

Australian Medical Association president Mukesh Haikerwal said the delay in informing doctors and patients of any risk was regrettable. He said patients must seek advice as the stolen body parts would not have been properly screened for diseases, such as HIV and hepatitis.

Health Minister Tony Abbott yesterday sought advice on whether the TGA could have better handled the issue.

http://www.theage.com.au/news/national/no-stolen-body-parts-in-australia-us-firm/2006/06/22/1150845313506.html

Body parts did not need approval by US
Gerard Ryle and Ruth Pollard
June 23, 2006
Page 1 of 2 | Single page

THE US Food and Drug Administration did not give pre-market clearance for the medical product that has been caught up in a stolen body parts scandal, because the manufacturer was not required to apply for one.

The news came as the NSW Government accused a federal health watchdog of withholding vital information as it scrambled yesterday to contact doctors who might have used the potentially dangerous skin-graft product.

The health watchdog, the Therapeutic Goods Administration, said that anyone who had been treated with the US product, called AlloDerm, should consult their doctor. This followed revelations in the Herald that some batches of the product, manufactured between early 2004 to September 2005, were made using human body parts stolen from funeral homes in New York.

The TGA said it had written to 13 doctors and dentists who were given approval to use AlloDerm on 46 patients in Australia. It is not known how many of the patients actually got the suspect product.

"They won't give us the names of the doctors or the patients, and obviously we are very concerned about the issue from a patient safety perspective," said the NSW Health Minister, John Hatzistergos. "[The TGA is] obviously trying to downplay the significance of this issue, but to patients involved it is quite important. There would not have been a recall if there were not concerns."

In a sign that the Federal Government shared NSW's concerns, the federal Health Minister, Tony Abbott, said yesterday that he had "asked for advice on how precisely the TGA has handled this issue and whether it could have been handled better".

"The initial advice I have received from the Health Department is that there is no appreciable risk to any Australian patient," Mr Abbott said in a statement.

However, the Herald understands that the TGA will not know until later today the results of a new investigation it is conducting into how much of the product arrived, and when. After the first investigation, in March, the TGA stated that none arrived. It now concedes that advice was wrong.

AlloDerm was manufactured by the New Jersey company LifeCell Corporation. Made from human cadavers, it is mainly used in dental and plastic surgery procedures.

The company was one of five US tissue processing companies that innocently received the stolen human tissue.

LifeCell's 2005 annual report reveals that, in the US, AlloDerm is not treated in the same way as medical devices or biologics, which usually have to undergo potentially long, expensive and uncertain pre-market approvals: "The FDA permits companies to make their own initial determination regarding the regulatory status of their products. Such determinations are subject to FDA review at any time.

Gerard Ryle and Ruth Pollard
June 23, 2006
Page 2 of 2

THE US Food and Drug Administration did not give pre-market clearance for the medical product that has been caught up in a stolen body parts scandal, because the manufacturer was not required to apply for one.
The news came as the NSW Government accused a federal health watchdog of withholding vital information as it scrambled yesterday to contact doctors who might have used the potentially dangerous skin-graft product.

The health watchdog, the Therapeutic Goods Administration, said that anyone who had been treated with the US product, called AlloDerm, should consult their doctor. This followed revelations in the Herald that some batches of the product, manufactured between early 2004 to September 2005, were made using human body parts stolen from funeral homes in New York.

The TGA said it had written to 13 doctors and dentists who were given approval to use AlloDerm on 46 patients in Australia. It is not known how many of the patients actually got the suspect product.

"They won't give us the names of the doctors or the patients, and obviously we are very concerned about the issue from a patient safety perspective," said the NSW Health Minister, John Hatzistergos. "[The TGA is] obviously trying to downplay the significance of this issue, but to patients involved it is quite important. There would not have been a recall if there were not concerns."

In a sign that the Federal Government shared NSW's concerns, the federal Health Minister, Tony Abbott, said yesterday that he had "asked for advice on how precisely the TGA has handled this issue and whether it could have been handled better".

"The initial advice I have received from the Health Department is that there is no appreciable risk to any Australian patient," Mr Abbott said in a statement.

However, the Herald understands that the TGA will not know until later today the results of a new investigation it is conducting into how much of the product arrived, and when. After the first investigation, in March, the TGA stated that none arrived. It now concedes that advice was wrong.

AlloDerm was manufactured by the New Jersey company LifeCell Corporation. Made from human cadavers, it is mainly used in dental and plastic surgery procedures.

The company was one of five US tissue processing companies that innocently received the stolen human tissue.

LifeCell's 2005 annual report reveals that, in the US, AlloDerm is not treated in the same way as medical devices or biologics, which usually have to undergo potentially long, expensive and uncertain pre-market approvals: "The FDA permits companies to make their own initial determination regarding the regulatory status of their products. Such determinations are subject to FDA review at any time.

"We believe our AlloDerm, Repliform, Cymetra and GraftJacket products generally satisfy the FDA's requirements to be considered 'HCT/Ps' eligible for regulation solely as human tissue. Accordingly, we have not obtained prior FDA clearance or approval for commercial distribution of these products."

However, the company said it was required to comply with the FDA's donor-screening rules and other rules, such as infectious disease testing. It also said that once on the market, the products were subject to "pervasive and continuing regulation by the FDA", which could issue fines and other penalties.

The associate professor of ethical practice at the University of Sydney, Merrilyn Walton, said the stolen body parts issue had highlighted the need to ensure people gave proper consent to the donation of organs and tissues.

"The law is supporting the need to have access to tissues and organs for medical research," she said. "What we need to ensure is that there is transparency in the process, trust in the regulators and informed consent of the individuals."

But Mukesh Haikerwal, the president of the Australian Medical Association, said Australia had a closely controlled, integrated system of organ and tissue retrieval and harvesting. "The way that human material is treated here is very much through the hospital systems, and it very rarely gets out of that mortuary hospital environment," he said.

"The last thing we need is to scare people off or … make them feel that they will have organs harvested when they didn't want to."

http://www.smh.com.au/news/national/body-parts-did-not-need-approval-by-us/2006/06/22/1150845316146.html

http://www.smh.com.au/news/national/body-parts-did-not-need-approval-by-us/2006/06/22/1150845316146.html?page=2

the mad cow body snatchers

http://disc.server.com/discussion.cgi?disc=167318;article=2892;title=CJD%20WATCH






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