Tissue transplant flaws exposed21st June 2006
A three-month investigation by The Associated Press has found a host of deadly problems in the U.S. tissue-transplant industry, ranging from scanty testing for potentially deadly germs to inadequate oversight and a lack of a unified system for tracking tissue between donors and recipients.
Allegations that a New Jersey company scavenged corpses without families' permission and sold body parts to tissue processors have focused new attention on the industry, which the investigation says is putting thousands more Americans at risk every day. A federal regulator noted in 2003 that Biomedical Tissue Services—the now infamous New Jersey firm—wasn’t documenting disposal of tissues deemed unsuitable for transplant, but the U.S. Food and Drug Administration (FDA) let the matter drop after the company said it had fixed the problem.
In one case, a healthy 23-year-old student died from a raging infection after receiving cartilege from a corpse that had sat unrefrigerated for 19 hours and already been rejected by two tissue banks.
Among major problems cited by the AP investigation: The FDA requires no medical training to operate a tissue bank or procure tissue; tissues aren’t tested as thoroughly as blood is for infectious diseases; the FDA hasn’t set limits on age or health of donors, or how long after death tissue can be taken; funeral homes aren’t required to report deaths to organ procurement groups, making it possible for them cut side deals to supply body parts; and reporting of tissue infections to health officials isn’t required.
"At every step—from funeral homes, where the journey often begins, to hospitals and doctors' offices, where it ends with patients receiving the eyes, bones, skin, and other parts of the dead—poor oversight invites abuse and creates danger," the AP reported, citing criticism that a 2005 overhaul of FDA regulations fell far short of what is needed.
Interpol has meanwhile launched a probe into South Africa’s tissue export industry, at the request of the FDA.
The number of tissues distributed for transplant in the United States rose from 350,000 in 1990 to 1.3 million in 2003. And tissue companies are profiting. The largest nonprofit tissue transplant organization, the Musculoskeletal Transplant Foundation Inc. of New Jersey, reported U.S. $243 million in revenues and paid its chief executive U.S. $542,212 in 2004.
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