A cure worse than the disease
When FDA oversight falters, tissue implants can do more harm than good
Five years ago, Warren King, a sports physician, reconstructed the right knee of a patient using a tendon sent to him by CryoLife, a Georgia-based company. The patient quickly developed an infection so serious the implant had to be removed. Tests showed the implant, obtained from a cadaver, had caused the infection. But CryoLife, one of many so-called tissue banks, denied it. "They denied it even when the evidence was overwhelming," King says. The logical step would have been for King to go to the authorities, but he wasn't sure who that would be. "I didn't know the Food and Drug Administration was involved in regulating tissue banks," he says.
Well, the FDA is involved--sort of. Last month the FDA asserted its authority by shutting down most of CryoLife's human-tissue business. And since then, CryoLife has faced ever increasing troubles. Patients who received implants have sued. The Securities and Exchange Commission began investigating the company for possible accounting and insider-trading irregularities, following lawsuits by shareholders who claim that CryoLife misstated the extent of its problems. Company stock has plummeted from a high of $45 a share to as low as $1.40. At week's end, CryoLife said it had been allowed to resume shipment of some tissue products. Still, the company laid off 105 workers, and those who are left are scared of losing their jobs. "It has devastated everybody," one employee says.
But for some patients, the FDA's action is too little, too late. Alan Minvielle of Santa Cruz, Calif., had knee surgery in April 2001 with a CryoLife implant. He developed an infection that ate away so much of his knee, he recently had to have the whole joint replaced. And it wasn't soon enough to save 23-year-old Brian Lykins of St. Cloud, Minn., who died last November after the infection from his knee surgery caused heart failure. "Is the FDA late?" King asks. "There's no question about it."
Unexamined. In fact, a closer look by U.S. News shows that despite FDA oversight, the fast-growing tissue-bank industry has largely gone unscrutinized. The FDA often does not know when companies distribute contaminated tissue. It doesn't approve facilities before companies begin selling products, and it hasn't set requirements on how to treat tissue implants before transplantation. Until recently, it didn't even know the names of all the tissue banks in operation in the United States. Indeed, an industry-sponsored organization--not the FDA--has set the standards for how tissue banks manage their day-to-day operations.
Moreover, although infections pose the greatest risk when a patient receives a tissue implant, the FDA does not require companies to report when they occur. Lacking a centralized database, it is difficult for health officials to spot a cluster of infections coming from one company and thus stop the company from releasing contaminated tissue. It took the FDA at least five months, for instance, to learn that tissue from the South Texas Blood and Tissue Center in San Antonio, which distributed tissue in Texas and California, had infected a patient in late 2000 with E. coli. The agency also realized that the company had taken some of the tissue from the infected donor off the market, but not all of it. The FDA demanded that the tissue bank withdraw the rest of the tissue.
advertisement
