Replacement Parts
How the FDA allows faulty, and sometimes dangerous, medical devices onto the market
The scientific community has become increasingly concerned about data corruption, noting the large financial stakes investigators often have in the products they are testing. Unlike with capital-intensive drug research, the inventor of a medical device may also be the product's lead investigator, as well as the company CEO. Even with less severe conflicts, ethical questions remain. Just before the FDA approved the ProteGen sling, for instance, members of Boston Scientific's urological advisory board submitted a paper for publication by the American Urological Association saying the sling material was "a safe, biocompatible substance." The abstract failed to mention, although such disclosure was required, that two of the research doctors had received compensation--approximately $320,000 combined--from Boston Scientific.
The growing worry is that in hopes of a big payday or out of fear of losing their jobs, researchers with vested interests will rejigger tests to get the "right" results or hide data that raise concerns about the product. But even when investigators speak up about problems, the company paying for the research does not always want to listen. At least that was what two prominent doctors say happened when they tested an implantable weight-loss device and didn't like what they found.
The gastric LAP-BAND, made by California-based Inamed Corp., has been billed as a safe and easy weight-loss device for thousands of morbidly obese Americans. The band is inserted, wrapped around the middle of the stomach, and then tightened, making an hourglass shape that causes patients to feel full sooner. But the results of this procedure did not impress two researchers who conducted U.S. clinical trials between 1996 and 1998.
More than one third of the implants, the doctors say, had to be removed because of complications, and another third of the patients didn't lose anywhere near the weight advertised or necessary. Harvey J. Sugerman, chief of general and trauma surgery at the Medical College of Virginia and one of BioEnterics' research leaders, says the company discouraged him from publishing his data and attempted to circumvent the three-year trial mandated by the FDA. The company petitioned the FDA for approval after two years--without submitting the disagreeable data, he said. The FDA panel rejected the company's PMA application only after Sugerman presented his data without invitation.
Robert McIntyre Jr., who helped run another trial of the device at the University of Colorado-Denver, said he believed the company wanted early approval so it could "make the safety profile look better, so the true complication rate would not be discovered." Patricia Choban, one of the panel of experts brought in by the FDA to evaluate the LAP-BAND, agreed. "The data at three years was only going to get yuckier," she said. Despite these objections, the FDA granted BioEnteric's PMA application the following year. The FDA did demand new post-market trials, however. So far this year, the agency has received 469 adverse-event reports. One death, 34 injuries, and 446 malfunctions have been reported since January 2001. An FDA official says the agency is "very concerned" about these reports. The company has denied doing anything improper. Spokesman Peter Nicholson said that although the data from the U.S. studies were "not strong," other data were and the adverse events span many years.
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