Experts call for oversight of tissue recovery industry
Sandra Chapman/13 Investigates
Buying or selling human tissue is against federal law, but thousands of companies nationwide - including some funeral homes - are cashing in on tissue harvesting. It's a fast growing medical industry with very little oversight.
13 Investigates brought you exclusive details of how unsafe, stolen tissue made its way into Indiana patients. Now there's a local call for change.
Anyone, anywhere can claim the title of a "tissue banking specialist." In New York, prosecutors say a group of funeral home workers discovered it's a lucrative business. A single body can bring in up to $250,000.
"Presently there are no requirements. God only knows how these people learned to do this," said Robert Katz a professor of law at IUPUI. Katz specializes in non-profits and healthcare. Based on his research, he says it's time to put limits on tissue recovery.
"Where things start to get shady is the tissue that gets into the system from funeral homes," he said.
Former Marion County Coroner and neurosurgeon Dr. Karl Manders agrees. He's spent 50 years on the cutting edge, implanting tissue allografts to treat chronic pain.
Without apology, Manders told Eyewitness News, "Take it away from the funeral homes. It should be done in a situation which has significant controls."
Eyewitness News sat down with the Indianapolis businessman who blew the whistle months after purchasing a Brooklyn funeral home.
Robert Nelms is convinced harvesting would face more scrutiny in a hospital. Recalling the level of secrecy he found in the funeral industry, "nobody wanted to get involved. Nobody wanted to tell because you're considered a 'man' if you just keep your mouth shut," he said.
Nelms found missing funeral files, missing money and eventually a trail to the illegal harvesting ring. He described what X-rays of exhumed bodies showed: "PVC pipe that was being placed into the humans to replace the bones."
Based on a timeline of FDA documents obtained by Eyewitness News, the tissue-processing company at the center of this scandal, BTS - Biomedical Tissue Services, escaped proper oversight and sanctions for nearly four years.
Now Nelms is critical of the FDA. "They have let a lot of things slip through the cracks and a lot of innocent people got hurt for it," he said.
Starting in September 2003, an FDA inspection revealed BTS "did not maintain destruction records of human tissue...unfit for transplantation" and no donor files for 2002 and 2003, including donor screening, testing and recovery.
In November 2004 records showed BTS failed "to follow written procedures for prevention of cross contamination."
Then in October of last year, government inspectors said: "donors were not screened...for certain diseases," and that "donor eligibility records were not accurate."
That inspection led to the largest nationwide tissue recall.
But it was too late for William Thomas, who received a batch of the tissue months earlier in May of 2005. Now Thomas is the first Indiana implant patient to test positive for Hepatitis C. He can't believe how many people overlooked the dangerous risk.
"I shouldn't have received those parts," Thomas said, as he prepares to undergo 12 months of treatment.
Despite the FDA's own alarming inspections and the criminal investigation, BTS continued operating until the FDA finally shut it down back in March.
Professor Katz says requiring certification wouldn't cost Indiana taxpayers a dime. He says a change in law could simply require potential tissue bank specialists to pay for their own training. That's the process now used for lifeguards here in Indiana.
Katz also believes harvesting should be limited to not-for-profits like the Indiana Organ Procurement Organization. The FDA declined comment, citing the ongoing investigation.
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