Will Vioxx fallout affect medical device industry?

  As physicians and pharmaceutical companies exchanged verbal bullets with each other about drug safety, medical device manufacturers crouched low to avoid getting hit by the crossfire.
  In the wake of the withdrawal from the market of the painkiller Vioxx in September, some physicians and members of Congress were calling for a better system to monitor the safety and effectiveness of pharmaceuticals after the Food and Drug Administration has cleared them for marketing. A potential problem for medical device manufacturers is that some of the most vocal critics of the current system suggest that regulators revise the way medical devices are monitored as well.
  The clamor stemmed from a number of well-publicized incidents involving big-name drugs, the most recent being Vioxx, the painkiller from Merck & Co. that has been linked to heart attacks. Two previous incidents were also cited: •

• The withdrawal from the market in 2001 of the cholesterol drug Baycol (cerivastatin) by Bayer AG over concerns that the drug caused serious muscle conditions. Critics charge that Bayer knew of a possible link between the drug and the muscle condition soon after the drug was introduced in January 1998, but that the company failed to confirm it or notify doctors of the potential link until much later.
• The failure of GlaxoSmithKline to report studies linking its anti-depressant Paxil with incidences of suicide among children and teenagers.

  Conflicts of interest
  In its Dec. 1 issue, the Journal of the American Medical Association published an editorial and series of articles on the issue. In an editorial titled “Postmarketing Surveillance: Lack of Vigilance, Lack of Trust,” JAMA’s editors lobbied for a restructuring of the way the U.S. responds to drug-safety concerns.
  The editors said that the current postmarketing surveillance (which relies on field reports of adverse drug reactions) is laden with shortcomings, including:

• Reliance on voluntary reporting of adverse events by physicians and other healthcare professionals.
• Poor quality of submitted reports, often with inadequate documentation and detail.
• Underreporting of adverse outcomes.

  But these problems pale in comparison to the potential for conflicts of interest in the current surveillance process, according to the editors.
  “[T]he major problem with the current system for ensuring the safety of medications is that drug manufacturers are largely responsible for collecting, evaluating, and reporting data from postmarketing studies of their own products. This approach has many inherent problems. For instance, it appears that fewer than half of the postmarketing studies that manufacturers have made commitments to undertake as a condition of approval have been completed, and many have not even been initiated. Moreover, despite the mandatory adverse event reporting system for companies subject to the FDA’s postmarketing safety reporting regulations, drug manufacturers may be tempted to conceal available data that may signal the possibility of major risks.

  Medical devices thrown in
  JAMA proposed that an independent board be created to track the safety of drugs after they have been put on the market. (Indeed, the FDA has asked the Institute of Medicine of the National Academy of Science to study the current system of postmarketing surveillance.) But the editors went one step further, suggesting that this agency be charged with overseeing postmarketing surveillance for drugs and devices.
  “This agency should be given full authority to ensure compliance with regulations and sufficient funding to establish an effective national active surveillance system with a prospective, comprehensive, and systematic approach for monitoring, collecting, analyzing, and reporting data on adverse events. Above all, the agency must be completely independent of influence from the pharmaceutical industry, biotechnology firms, and medical device manufacturers.”

  Device oversight unnecessary
  “It’s frustrating that medical devices got thrown in almost as an afterthought,” says Mark Brager, spokesman for the Advanced Medical Technology Association (AdvaMed), speaking with IMDA Update. “All of the case studies [JAMA] mentioned are pharmaceutical-related. There has been no evidence of any parallel problem in the medical technology industry.” In fact, says Brager, more than 99 percent of medical technology recalls are done voluntarily by manufacturers -- a statistic to which the FDA often points as proof that the current system works.
  Brager also points out many problems with medical devices – such as manufacturing or sterilization problems with particular lots – can be addressed relatively easily. Even user errors and design flaws can be addressed without pulling a product from the market. “But if a drug is causing adverse events, you can’t change its formula and make the problem go away.” That’s why standards for postmarketing surveillance of drugs should be separate from those of medical devices, he says.
  Finally, Brager believes that medical devices simply don’t lend themselves to the same kind of postmarketing surveillance as pharmaceuticals. “A drug is a compound; it’s static; it doesn’t change. But on average, a new model or iteration of a device comes on the market every 18 months, because technology is constantly improving.” Chances are, by the time a postmarket study of a medical device were to be completed, the device itself would already have been modified, making the study irrelevant.
  “We’re monitoring the situation to ensure that anything arising from the Vioxx fallout isn’t painted with a broad brush to affect medical device manufacturers.”

Copyright © 2004 IMDA