The body parts industry, which suffered two recent scams, is now under investigation by the Food and Drug administration of United States. According to official reports, the billion-dollar industry was examined by an in-house review board resulting in a call for a doubling of FDA inspections.
From the FDA itself, there has been a series of inspections, and accordingly, the 153 searches, have uncovered no morbid secrets.
AdvertisementThe body parts industry, which is essentially the business of harvesting organ and non-organ parts for transplant, has now more than 2000 companies dealing within it.
This Tuesday, the FDA's tissues chief, Dr. Celia Witten, pronounced the industry safe and claimed the government oversight was working for the more than 1 million medical procedures involving non-organ body parts: "Today's report finds no significant industry wide problem in the recovery of human tissues", Witten was quoted.
Yet, 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.
One of the most public cases involved charges that bones and other tissues were stolen from funeral home corpses, including that of "Masterpiece Theatre" host Alistair Cooke. According to critics, the FDA task force's recommendations would not stop funeral homes from recovering body parts, do not require background checks and certification or immediate inspections of new companies that set up shop in the tissue business. They also would not prevent fraud.
The task force was comprised of FDA employees who met in secret. According to former FDA attorney Areta Kupchyk, an expert in the tissue industry, 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." Says Robert Rigney, executive director of the American Association of Tissue Banks:"If this is the end of it, they've missed some opportunities to improve tissue safety".
If improperly screened and processed, cadaver tissues can cause lead to infections, including the AIDS virus or hepatitis, or even death in transplant recipients.
A three-month investigation by a newspaper last year detailed many gaps in oversight by the FDA, especially when it came to company inspections.
The agency hopes to inspect 484 companies by the end of this year, including processing plants, according to Dr. Jesse Goodman, director of FDA's Center for Biologics Evaluation and Research. 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.
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. 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.
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