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FDA report urges more oversight of body parts industry
The federal agency said it has already begun what one official called a "blitz" of inspections.
WASHINGTON -- A federal agency's review of the billion-dollar body parts industry calls for more inspections, but experts 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 Tuesday 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 already 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 less than 300 inspections a year.
On Tuesday, 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 experts 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 corpses, 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 comprised 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 attorney Areta Kupchyk, an expert 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 FDA's.
If improperly screened and processed, cadaver tissues can lead to infections, including AIDS 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 Tuesday telephone news conference, 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.
"We generally saw no unsafe or deceptive practices," said FDA enforcement director David Elder.
The agency hopes to inspect 484 companies by the end of this year, including processing plants, said Dr. Jesse Goodman, director of FDA's Center for Biologics Evaluation and Research. "That's quite an uptick" since 2003-2004 when less than 300 were inspected both years, he said.
However, the FDA often falls short of its inspection projections. The agency estimated it would inspect 463 tissue firms in 2005, but only ended up checking on 270, according to FDA budget documents.
One of the chief complaints about FDA's oversight by critics like U.S. Sen. Chuck Schumer of New York is that certification and specific training of tissue-recovery operators isn't required.
"Barbers are required to go to school and pass a test but someone who does [tissue] recovery doesn't have to do anything but say where they live," Kupchyk said. "I think that's appalling."
Witten said the FDA rules require "proper education and training." Those rules, however, do not spell out what that is.
The issue of who cuts body parts out of cadavers made headlines in late 2005 with the investigation of Biomedical Tissue Services (BTS) of New Jersey, accused of plundering corpses for body parts that were sold as tissues for transplant. Among the victims was Cooke, the 95-year-old PBS TV star who died of cancer in New York.
Seven funeral home directors have already pleaded guilty and tens of thousands of body parts removed by BTS were recalled. About 10,000 people are believed to have received tissues from the company.
Last August, new alarms went off when the FDA closed a North Carolina body parts procurer for poor record-keeping. That operator, Philp Guyett had pleaded no contest to embezzlement involving problems with a willed body scandal in California in the late 1990s. Yet he was still able to start a business to recover tissue from cadavers.
One victim of the BTS scandal, Alicia Dawes who received a bone implant, said she wanted a ban on tissue recovery at funeral homes and some kind of background check on companies that harvest cadaver tissue.
"There is just too much money in body parts for profit," said Dawes, of Medford, Ore. "You're going to find the same thing happening over and over."
Dawes has not become ill from her implant, but she has been told to be tested for the AIDS virus and hepatitis.
The FDA says it is reviewing recommendations from the task force, including:
-- A more extensive tracking system that ends with the recipient of the transplanted tissue. Currently, tracking stops with the doctor or hospital that does the transplant. As a result, it has been difficult to warn patients who may have received improperly processed cadaver parts.
-- Requiring companies that use tissue parts to audit their suppliers regularly. In an interview the FDA's Goodman said his agency has reiterated to doctors and tissue banks that they are responsible for making sure that their suppliers comply with the law and are safe.
-- Hiring a microbiologist to resolve scientific questions about tissue safety.