AAOS Bulletin - August, 2006

Allograft issues concern FDA, Congress

By Jeanie Kennedy

Several developments relating to allograft harvesting and safety practices have occurred during the past few months. Brief recaps on the Biomedical Tissue Services (BTS) allograft tissue recall, the introduction of a “Safe Tissue Act” in Congress and a House subcommittee hearing follow.

CDC report on BTS recall

This past October, the AAOS issued a patient safety member alert after hearing from the Food and Drug Administration (FDA) about a recall of human allograft tissue procured from Biomedical Tissue Services. Each of the five tissue processors (Regeneration Technologies, Inc., LifeCell Corporation, Tutogen Medical Inc., Central Texas Regional Blood and Tissue Center, and Lost Mountain Tissue Bank, Inc.) that received tissue from BTS issued letters to health care facilities or physicians in September through October of 2005.

Approximately 25,000 allografts were distributed nationally and internationally. Most allografts were bone or demineralized bone matrix and generally subjected to radiation, greatly decreasing the probability of disease transmission.

On May 26, 2006, the Centers for Disease Control and Prevention (CDC) posted a synopsis of their investigation into the matter. Fortunately, all of the five tissue processors implicated in the recall were accredited by the American Association of Tissue Banks (AATB), which requires that they meet stringent processing methods and testing for viral and bacterial disease transmission. Incidences of disease transmission associated with this recall have yet to be confirmed.

Four employees of BTS were indicted in New York on charges of unlawful dissection, enterprise corruption, opening graves and falsifying business records. The FDA and investigators found discrepancies in donor ages and causes of death, in addition to forged donor consent forms. Federal charges are pending while federal and state authorities finalize their investigations.

The BTS case is the first high-profile case to be charged following the finalization of the FDA current good tissue practice rule in May of 2005. The FDA is expected to put its full authority behind pending federal charges. The AAOS Washington office will continue to follow all tissue-related matters and to interact with members of Congress, the AATB, the CDC and the FDA on this issue.

The CDC report Investigation into Recalled Human Tissue for Transplantation—United States, 2005–2006 can be found online.

Safe Tissue Act

Several funeral homes associated with BTS tissue procurement are located in Brooklyn, N.Y., and the surrounding regions. After the FDA confirmed its investigation of improper donor screening and eligibility in the BTS cases, Sen. Charles Schumer (D-N.Y.) expressed outrage and introduced the “Safe Tissue Act” on April 7, 2006. The legislation aims to provide more oversight in tissue-banking regulations. An identical bill that would require the inspection of tissue establishments once every two years was introduced in the House. Currently, AATB-accredited tissue banks are inspected once every three years.

Language in the bill would also require periodic audits by the FDA to determine donor eligibility and to ensure that medical history information is accurate and not obtained in a fraudulent manner. Further components of the legislation would develop a model consent form for potential tissue donors and provide that the Secretary of Health and Human Services accredit tissue establishments. Currently, accreditation of tissue banks is voluntary and provided through the AATB. Lastly, because tissue may not be sold, the legislation calls for reasonable payments for human tissue and tissue-based products. Tissue processors currently charge a processing fee, a practice that has been debated in the popular press for many years.

Legislative hearing

In related news, the House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing on alleged payments for tissue samples on June 13–14, 2006. Trey Sunderland, MD, chief of the geriatric psychiatry branch at the National Institute of Mental Health at the National Institutes of Health (NIH), invoked his Fifth Amendment rights when queried by subcommittee members about alleged sales of 3,200 samples of spinal fluid and 388 vials of plasma collected for Alzheimer’s disease research.

According to a report by the subcommittee, Dr. Sunderland is believed to have personally received $285,000 for tissue from Pfizer, Inc. After a thorough investigation, however, Pfizer was found to have acted appropriately and is not being implicated in any wrongdoing.

Subcommittee members are also concerned about the lack of a central database to track tissue samples used within the NIH. The subcommittee hearing generated much discussion about the appropriateness of the NIH staff entering into consulting arrangements. The NIH is conducting an internal investigation that is not yet public on possible violations of the Department of Health and Human Services ethics rules. House representatives contend that accountability must be restored to the NIH’s research programs. The cost to taxpayers of lost research samples is estimated at $6 million.

The subcommittee report can be found online.

Jeanie Kennedy is the manager of regulatory affairs in the AAOS Washington, D.C., office. She can be reached at jkennedy@aaos.org or (202) 548-4148.

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