For-Profit Tissue Banks Outside Government Control
By Todd Zwillich
Originally published by Reuters Health, May 25, 2001
WASHINGTON (Reuters Health) — An exploding for-profit industry of storage and processing of transplantable human tissue is operating outside of the control of government inspectors, officials told lawmakers Thursday.
Investigators and regulators told members of a Senate investigative panel that advances in tissue transplantation have driven the tissue banking industry too rapidly for federal rules and the inspectors charged with enforcing them to keep up. The result, they said, is an industry that routinely bends ethical and medical standards in a rush to satisfy demand.
"The standards of practice have not kept pace with the growth and development of the industry,'' said George F. Grob, an investigator with the office of the Inspector General at the Department of Health and Human Services.
Recent advances in surgical technology have greatly expanded the potential uses for donated human tissue in treating human ailments. Doctors can now transplant human skin, bone, cartilage, ligaments, and corneas to treat a host of problems ranging from burns to cancer.
Human tissue transplants totaled more than 750,000 last year, double what they were 5 years ago, according to the American Association of Tissue Banks (AATB). The number of donors has nearly tripled during that time.
Along with the growing demand for transplant-based cures has come a rapid increase in the number of tissue banks. Federal rules mandate that the banks test all donated human tissue for HIV and hepatitis viruses, but currently require little else. A report released by Grob's office showed that the Food and Drug Administration (FDA) has inspected only 118 of the 350 tissue banks now registered with the agency.
AATB Chief P. Robert Rigney said that even he was unaware that so many tissue banks were operating in the US. "That number would indeed surprise me,'' he told lawmakers.
Dr. Valerie J. Rao, the chief medical examiner for Lake County, Florida, told panel members that she was forced to ban tissue bank representatives from her lab because of repeated ethical violations, including cases where tissue has been harvested before proper medical examinations could be performed. One local tissue bank routinely accepted donations that had not been properly screened for diseases, she said.
The Chicago Tribune reported last year that local tissue banks had paid money directly to medical examiners for each body they made available for tissue harvesting.
AATB has a voluntary program to accredit private tissue banks that adhere to the organization's practice standards for testing and handling human tissue. The organization currently has 74 accredited members.
Only two states—Florida and New York—have laws requiring the routine inspection and licensing of tissue banks.
"There are literally scores of tissue banks that have been operating with no oversight whatsoever,'' said Sen. Susan M. Collins (R-Maine), who chairs the investigative subcommittee of the Committee on Governmental Affairs.
New rules soon to be finalized by FDA require tissue banks to screen all donors to make sure that tissue is disease-free and will also mandate 'good tissue handling' practices. But agency officials told the committee that the personnel and the $4.5 million they have on hand to run inspections is too little to police the banks in the US.
"There are not enough resources to inspect tissue banks biannually, which ideally is where we would like to be,'' said Dr. Kathryn Zoon, the director of the FDA's center for biologics evaluation and research.
Despite the expected new FDA regulations, some lawmakers suggested enacting stricter reforms of the tissue banking industry. Sen. Carl Levin, a Michigan Democrat, said that his state avoids profiteering by using one single, non-profit organization for handling all tissue collection. The set-up operates in a similar manner to regional organ distribution networks.
"The last thing we want is a bidding war for human tissue,'' said Levin, the subcommittee's current ranking member.
