Congress Airs Accounts of Human Tissue Misuse

Scores of tissue banks that collect human skin, bone and eyes have been operating without any government or private oversight, and federal inspectors have little idea whether some disturbing incidents are isolated cases or widespread problems, investigators told Congress Thursday.

At issue are the safety of body parts created with human tissue and the importance of treating the donor’s family with honesty and the body with respect.

Among the problems noted Thursday: operators who run multiple tests on recovered tissue in hopes that a second test will find material is healthy when the first did not; tissue banks that pool material from several donors despite medical risks of one person’s tissue contaminating another’s; and operators who mishandle cadavers after removing bones and skin.

“We have no idea what the magnitude of the problem is,” said Sen. Susan Collins, R-Maine, chairwoman of the Government Affairs investigations subcommittee.

She joined others on the panel in calling on the Food and Drug Administration to drastically increase its inspections and suggested that new regulations may be needed that go beyond those now under review by the FDA. Those rules, which are not yet final, give the agency power for the first time to shut down tissue banks that do not meet standards.

Both the FDA and the inspector general for the Department of Health and Human Services said the FDA does not have enough money to regularly inspect all tissue banks.

Collins pointed to the Pacific Coast Tissue Bank in Los Angeles, which received two warning letters more than a year ago about multiple violations of current law. Despite the serious concerns, the FDA has not yet returned for another inspection.

Until this year, when tissue banks were first required to register with the government, the FDA did not even know how many tissue banks were operating in the United States. Now some 350 banks have registered, and at least 100 of them have never been visited by government inspectors.

While most Americans are familiar with organ donation, few know much about tissue donation. Donated skin can heal burn victims, ligaments can repair knees, and bone can be used in hip replacement surgeries. The number of tissue donors rocketed from 6,000 in 1994 to about 20,000 by 1999; unlike organs, there is no acute shortage of donated tissue.

Another difference: Organ donation is run exclusively by nonprofit organizations who connect the donor directly to the surgeon. Donated tissue is recovered by one agency and then often handled by a separate processing company, which turns the material into usable body parts.

An increasing number of for-profit companies are now competing with nonprofits for this processing business. The stiff competition, experts told the panel, can result in use of medically questionable tissue by firms that have a financial interest in producing as much material as they can.

“These organizations often operate from profit motives that supersede the public interest,” said Dr. William Minogue, board chairman for the Washington Regional Transplant Consortium, the organ bank serving the Washington area. “These entities need access to human tissue in order to generate revenue and are under shareholders’ pressure to increase market position to maximize profits.”

Minogue’s organ bank also screens for tissue donation and refers these cases to a nonprofit processor. He said that a competing local tissue bank, which works with a for-profit firm, has tried to increase business by working to persuade hospitals and families that they can lower medical standards and therefore, accept more donors.

The hearing touched on a number of other financial, medical and regulatory issues in tissue banking. Among them:

--Seventy-four tissue banks have met standards to be accredited by the American Association of Tissue Banks, but at least 20 banks now operating have had their accreditation withdrawn. The association will not identify them.

--Most donor families believe that their loved one’s parts will be used for something medical, but sometimes it is used for cosmetic purposes. Donated skin, for instance, is typically used for burn victims, but can also be used for elective surgeries. And companies that process skin are under no obligation to give those who need it most higher priority.

--Once tissue is processed, it is packaged and marketed like any other medical supply and “treated more like a commodity than a donation,” said the HHS inspector general, concluding that the industry does not show proper respect for donors and families.