Governmental Affairs Committee to Hold Hearing onTissue Banks: The Dangers of Tainted Tissue and the Need for Federal Regulation

WASHINGTON, D.C.—Senate Governmental Affairs Committee Chairman Susan Collins (R-ME) and Ranking Member Joe Lieberman (D-CT) will hold a hearing on Wednesday, May 14, 2003, to examine the risks associated with tissue transplants and why the Food and Drug Administration (FDA) has failed to implement much-needed safety regulations on tissue banks.

In 1997, the FDA acknowledged the health risks involved with tissue transplants and the need for better federal oversight of the industry. Similar to blood transfusions and organ transplants, tissue transplants can transmit communicable diseases such as HIV and hepatitis. Unlike the government’s stringent oversight of the nation’s blood banks and organ donor programs, there are scant federal regulations governing how transplant tissues are processed and distributed.

Four years ago, the Permanent Subcommittee on Investigations, which Collins chaired, found that despite the health risks to unsuspecting transplant recipients, effective FDA regulation of the tissue bank industry remained nothing more than a promise. Then, only months after the subcommittee’s hearing on tissue banks on May 24, 2003, 23-year-old Brian Lykins underwent elective surgery to repair a knee injury. Within days, he died. The cause of death: transplanted tissue contaminated with a deadly bacterium. An investigation later found that Brian’s tissue donor had been dead for 19 hours and the corpse had not been refrigerated during that time. During a lawsuit file by Brian’s parents, Cryolife, the company that processed the tissue, cited the lack of federal regulations in its defense. At Wednesday’s hearing, Brian Lykins’ parents will speak publicly for the first time since their son’s death on November 11, 2001.

WHEN: 9:30 a.m., Wednesday, May 14, 2003

WHERE: Room SD-342, Dirksen Senate Office Building

WITNESSES: The Lykins Family; Dr. Jeanne Linden, Director, Blood and Tissue Resources, New York State Department of Health; Dr. Steven Solomon, Outcomes Bureau, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention; Dr. Jesse Goodman, Director, Center for Biologics Evaluation and Research, Food and Drug Administration.