- The Washington Times - Wednesday, June 13, 2007


A federal agency’s review of the billion-dollar body-parts industry calls for more inspections, but specialists in the field say it ignores the problems that led to two recent scares involving human tissue destined for transplant.

An internal task force report yesterday recommends the Food and Drug Administration require more extensive tracking of non-organ tissue such as tendons, bones and heart valves — from the cadavers where they are retrieved to the patients where they are implanted.

The in-house review also advocated what is essentially the doubling of FDA inspections of companies that remove and handle body parts.

The FDA said it has begun what one official called a “blitz” of inspections — a total of 153 — and no serious problems were uncovered. The booming body-parts industry now has more than 2,000 companies registered, but the FDA has typically done fewer than 300 inspections a year.

Yesterday, the agency’s tissues chief, Dr. Celia Witten, pronounced the industry safe and said government oversight was working for the more than 1 million medical procedures involving non-organ body parts: “Today’s report finds no significant industrywide problem in the recovery of human tissues.”

But specialists in the industry say those recommendations would not have prevented two recent well-publicized scandals over the safety of cadaver tissues that were transplanted. Thousands of Americans who had routine procedures like knee and back operations were urged to get tested for HIV and hepatitis last year because of concerns about the tissues they received.

The most egregious case involved charges that bones and other tissues were stolen from funeral home cadavers, including that of “Masterpiece Theatre” host Alistair Cooke.

The FDA task force’s recommendations wouldn’t bar funeral homes from recovering body parts, don’t require background checks and certification or immediate inspections of new companies that set up shop in the tissue business. They also wouldn’t prevent fraud, critics said.

The task force was made up of FDA employees who met in secret.

While some of the proposals are good, the report “doesn’t provide the extra layer of protection. It doesn’t address the issue that started the whole thing,” said former FDA lawyer Areta Kupchyk, an analyst in the tissue industry.

“If this is the end of it, they’ve missed some opportunities” to improve tissue safety, said Robert Rigney, executive director of the American Association of Tissue Banks. He says his own organization has stiffer standards than the FDA‘s.

If improperly screened and processed, cadaver tissues can lead to infections, including the AIDS virus or hepatitis, or even death in transplant recipients.

A three-month investigation by the Associated Press last year detailed many gaps in oversight by the FDA, especially when it came to company inspections.

In a telephone press conference yesterday, the FDA emphasized that it had inspected all 153 companies that recover cadaver parts. Roughly 2,000 more are registered to handle tissue in various ways.

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