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Selected news articles which highlight important policy issues.

News: Weekly Archives

News for the week of 03-08-2007

New Generation of Stents Awaits FDA Approval
Wall Street Journal, 3-8-07

Editor's Notes:

As the FDA and physicians debate the relative risks of drug coated stents vs. bare metal stents, companies are already developing a new generation of coated stents that try to overcome safety concerns associated with previous models. But the FDA may slow the approval of new models until more data is available on the older models.

Exactly what causes the clotting problem [with older models] isn't clear, but it is thought that either the design of the devices (which are tiny metal scaffolds), the polymer that holds and releases the drug, or the drug itself might prevent the body's healing response from completely covering the implanted stent with tissue. That could leave a portion of the stent's surface exposed to the blood stream, where it has the potential to trigger a clot. Whether the patient takes blood thinners and how accurately the physician implants the device may also play a role.

A large question is whether safety concerns that are hanging over the current stents will apply to this new crop of devices—a prospect that could slow their journey to market. Right now there are only two drug-eluting stents on the U.S. market: Johnson & Johnson's Cypher and Boston Scientific's Taxus Express. Sales of both have slipped as a result of criticism from scientists and clinicians.

In December, the FDA convened a high-profile panel of experts to debate drug- coated stent use. After listening to two days of presentations, the committee concluded that drug-coated stents are associated with a small increase in late thrombosis (blood clots), but that the increased risk wasn't associated with an increased risk of death or heart attack.

Yesterday, at a cardiology meeting called CRT 2007, key members from that panel and the FDA continued to discuss potential new requirements in the approval process for new devices. The FDA is planning to issue guidance as early as this spring.

"We can't have had this two-day panel meeting and have heard all we heard [in December] and ignore it," says Ashley Boam, the FDA's branch chief for interventional cardiology devices and a speaker at CRT 2007. She says the agency is likely to start requiring up to five years of postapproval studies on drug-eluting stents. "However, we're sensitive toward finding a middle ground," she says.

The FDA certainly has a conundrum on its hands. Newer models may be safer, but the agency is sensitive to criticism that it is rushing new drugs and devices to market without examining them sufficiently for potential safety problems. This in turn may be driving the agency to keep asking for more data on new designs, potentially keeping safer devices off of the market longer, and resulting in needless deaths.

A better approach would be to recalibrate how the FDA and industry weight pre-market vs. postmarket testing. Pre-market testing can never find all of the potential risks associated with new drugs and devices—and only offers the public the illusion of safety.

Instead, we should put promising new drugs and devices on the market faster, but require much more extensive post-market surveillance that would help physicians and patients use new innovations with greater safety and efficiency.

This is where we should be going but, if anything, safety scares from Vioxx and anti-depressant drugs seem to be pushing us in the opposite direction.

[permanent link]



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