How Safe is America’s Donated Tissue Supply?

Wisconsin’s Bureau of Communicable Disease and Preparedness, Division of Public Health has just come out with a warning to all local health officers, tribal clinic directors and Division of Public Health regional offices.
An internal memo from the WI BCD states “[Biomedical Tissue Services, Ltd. (BTS) of Ft. Lee, NJ] used multiple funeral homes in New Jersey , New York State, and Pennsylvania to recover tissues between July 2002 and October 2005. It has been alleged that appropriate informed consent for donation from the next-of-kin was not obtained, and that consent documents and donor health history/risk assessment forms were falsified.”

In other words, BTS stole tissue from bodies from shady-dealing funeral homes, falsified the records that determine not only consent but medical history and suitability and then sold that tissue to several tissue processors and distributors including:

LifeCell Corporation of Branchburg, NJ(Which receives tissue from the Madison, WI office of Regeneration Technologies)
Lost Mountain Tissue Bank of Kennesaw, GA
Blood and Tissue Center of Central Texas in Austin, TX
Tutogen Medical, Inc., of Alachua, FL
Regeneration Technologies, Inc., of Alachua, FL(With an office in Madison, WI)

The reason? PROFIT. Tissue banking is, underneath all the “warm fuzzies” that tissue banks try to create, a profitable industry. Bodies are reduced to parts sold for dollars and cents.

Abuses such as these will continue as long as there are profits to be made in the tissue banking business; profits that slip through the federal law prohibiting the sale of human body parts and prohibit tissue banks from sharing the profits with the donor families.

There are two issues here. First and foremost is the fact that unscrupulous funeral homes were working with BTS to perform these illegal recoveries but the second issue comes from another part of the Wisconsin Department of Health Memo.

It reads: “The Wisconsin Division of Public Health has learned from CDC and FDA that tissues from BTS have been distributed by various tissue processors to all 50 states. However, we have been unable to obtain a list of the Wisconsin facilities that received the tissues in question, and therefore do not know how many (if any) state residents may have been implanted with these tissues.”

How can the Wisconsin Division of Public Health not be able to obtain a list of the Wisconsin facilities that received the tissues in question? Tissue processors and distributors keep meticulous records (as required by various regulations from the Food and Drug Administration, Centers for Disease Control and organizational regulatory bodies such as the American Association of Tissue Banks), records including which donors and tissue procurement agencies tissue comes from. The records make it possible to trace end products right back to the tissue procurement agency it came from, the people that procured it and even the location in which the procurement took place.

Obtaining a list of the recipients in Wisconsin should be as simple as calling the tissue distributors and saying “give me a list of all the tissue you’ve sold in Wisconsin that came from BTS.”

Instead, the Wisconsin Department of Public Health sent a memo saying “To identify any cases of infection or disease that may be associated with these transplanted tissues, we are requesting that local health departments inquire about a history of tissue transplantation (involving surgeries since July of 2002) when investigating cases of hepatitis B, hepatitis C, and HIV infection. If a history of transplantation is obtained, please contact Sheila Guilfoyle in the Bureau of Communicable Disease and Preparedness.”

In other words, only if a transplant recipient is later tested for and the test comes back positive for hepatitis B, C or HIV then the local health department should “inquire” about a history of tissue transplantation.

Cases such as this shouldn’t rely on incidental testing at a later date to identify at-risk or involved transplant recipients. Right now, hundreds or even thousands of transplant recipients are losing a lot of sleep wondering if they’ve been transplanted with these stolen tissue and if they’ll end up contracting potentially fatal disease from the transplant – and the best the State of Wisconsin can do is absolutely nothing but wait and see.

Even the tissue processors and distributors are taking more action than the State of Wisconsin – they’ve launched a recall of all of the tissue they’ve sold (or have in stock) that came from BTS.

Here’s my advice.

First, If you’ve received a tissue transplant involving skin, bone or tendon within the last four years, contact your physician and tell him or her that you’re worried that your tissue came from BTS. After all, you may be infected with any of a number of communicable diseases as a result and not even know it. Demand that your doctor research the transplanted tissue and don’t stop until you find out where it came from. And…get tested! HIV/Aids, hepatitis B or C, syphilis – all are possible to have contracted from the tissue (along with countless other bugs or diseases).

Second, contact the State of Wisconsin Department of Health and demand they do more than just “wait and see” – demand that they put in at least a little bit of effort to find out who received this tissue.

The FDA is saying that the tissues procured by BTS make up only a small portion of the tissue in the US supply and that infection risks are low. But, when you could be that 1 in 100, your risk is 100%.

The underlying problem with this and every other organ and tissue donation situation is profits. A human body could be worth up to $100,000 when all the transplantable parts are removed and sold. Greedy procurement agencies as well as tissue banks, funeral homes and the like are seemingly ready to gamble with your life to turn a buck.

Contact your legislators to demand more regulation of the tissue banking industry and demand that donor families receive a portion of the obscene profits tissue banks make from freely donated tissue. It’s time to make tissue banks accountable for the profits they reap (read a related Chris Truitt column here).

Lastly, contact the State of Wisconsin Public Health department and demand a full investigation. They can be reached at
Department of Health and Family Services 1 W. Wilson Street Madison, WI 53702
General Phone Number: (608) 266-1865, TTY Phone Number: (608) 267-7371.

Footnote: I gave the writer of the memo the chance to comment. His only response was “Mr. Truitt – I can confirm that the [memo you have obtained] was issued from our office at the Bureau of Communicable Disease and Preparedness, Wisconsin Division of Public Health, and was sent to local public health officials to ensure that any infections that may have resulted from these tissues are detected.”

More information on this topic can be obtained on the web at http://www.fda.gov/bbs/topics/NEWS/2005/NEW01249.html and http://www.fda.gov/cber/safety/bts030206.htm.

14. March 2006 by Chris
Categories: Health & Medical, Organ & Tissue Donation | Tags: , , , , | Leave a comment

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