Who Overstated the Risk of Drug Coated Stents??

  • by: |
  • 11/12/2007
A year after safety questions about drug-coated heart stents prompted doctors to change treatment for hundreds of thousands of cardiac patients, many physicians say the medical community overreacted and should now reverse course.

The alarm was caused by medical studies suggesting that drug-coated stents might be causing deadly blood clots. But with benefit of additional data and further analysis, many doctors say drug-coated stents may not be so risky after all, at least compared with various alternatives whose drawbacks may outweigh the risks of clotting.

Because the safety fears were widespread, however, even those rooting hardest for a rebound — the companies that make stents — are not expecting a quick resurgence for the drug-coated devices. Worldwide, stent sales have fallen by about $1 billion since last year, to $5 billion this year."

The alarm was not caused by the studies but by media accounts that ignored dozens of other studies and the absolute risk of death followed by trial lawyers fanning flames of fear...

From an Oct 21 2006 article by Feder

Doctors Rethink Widespread Use of Heart Stents

..."But now stent sales are falling and some doctors are rethinking their faith in the devices, driven by emerging evidence that the newest and most common type — drug-coated stents — can sometimes cause potentially fatal blood clots months or even years after they are implanted.

The Food and Drug Administration said yesterday that it would hold hearings in early December to consider whether to issue new stent safety guidelines.

The evidence indicates that overuse of stents may be leading to thousands of heart attacks and deaths each year, whether because stents are being used in relatively mild cases where drugs should be prescribed instead, or because patients are receiving drug-coated versions where simpler, cheaper bare-metal devices might work just as well.

There is no question that stents have saved countless lives in the short term by preventing impending heart attacks or opening arteries while an attack is being treated. But neither type of stent, no matter how much better it may make a patient feel, has been shown in rigorous clinical trials to improve long-term survival compared with other forms of treatment.

“In the past we’d say, ‘Why not?,’ ” said Dr. William O’Neill, a well-known cardiologist at the University of Miami and longtime advocate of using drug-coated stents. But the new safety data, he said, amounts to “a big why not” for many patients.

The new evidence has added to a long-simmering debate over whether doctors have been too quick to prescribe stenting — whether because drugs would work as well for healthier patients or because bypass surgery might help the sickest ones live longer."



Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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