UCSF v. Beth Israel on FDA on heart device safety

Docs from BI, working with the Food and Drug Administration, released a study this week suggesting that medical device makers are providing weak evidence to support the efficacy and safety of products, in particular cardiovascular devices like stents and implanted defibrillators.

The study was release earlier to counter a similar study in the Journal of the American Medical Association that faulted the agency for approving devices based on limited and potentially biased data.

Just prior to the release of the new study, FDA officials announced that they would strengthen the device review process.

The New York Times reported that the BIDMC “study found that more than 40 percent of the studies used to approve cardiovascular devices had lacked high-quality data about either the treatment or safety goals of the study.”Researchers also concluded that 25 percent of trials had failed to adequately follow patients enrolled in studies.”

Dr. William H. Maisel, a cardiologist at the Beth Israel Deaconess Medical Center who was involved in the study, said the review did not find a correlation between lower-quality data and problems related to the devices. However, he said he thought the potential for such links existed.

But, the JAMA study out of the University of California faulted the FDA review process and “concluded that the F.D.A. had approved cardiovascular devices based on data that ‘lacked adequate strength.’”

Their conclusion Premarket approval of cardiovascular devices by the FDA is often based on studies that lack adequate strength and may be prone to bias.

According to AP: The new studies, published in separate medical journals, cap a year of scrutiny and criticism for the FDA’s medical devices division. In August, the head of that division resigned, months after scientists under his leadership alleged they were pressured to approve certain products. The year began with congressional investigators saying the FDA should take immediate steps to make sure the riskiest devices are approved through the most stringent process.

Docs from BI, working with the Food and Drug Administration, released a study this week suggesting that medical device makers are providing weak evidence to support the efficacy and safety of products, in particular cardiovascular devices like stents and implanted defibrillators.

The study was release earlier to counter a similar study in the Journal of the American Medical Association that faulted the agency for approving devices based on limited and potentially biased data.

Just prior to the release of the new study, FDA officials announced that they would strengthen the device review process.

The New York Times reported that the BIDMC “study found that more than 40 percent of the studies used to approve cardiovascular devices had lacked high-quality data about either the treatment or safety goals of the study.”Researchers also concluded that 25 percent of trials had failed to adequately follow patients enrolled in studies.”

Dr. William H. Maisel, a cardiologist at the Beth Israel Deaconess Medical Center who was involved in the study, said the review did not find a correlation between lower-quality data and problems related to the devices. However, he said he thought the potential for such links existed.

But, the JAMA study out of the University of California faulted the FDA review process and “concluded that the F.D.A. had approved cardiovascular devices based on data that ‘lacked adequate strength.’”

Their conclusion Premarket approval of cardiovascular devices by the FDA is often based on studies that lack adequate strength and may be prone to bias.

According to AP: The new studies, published in separate medical journals, cap a year of scrutiny and criticism for the FDA’s medical devices division. In August, the head of that division resigned, months after scientists under his leadership alleged they were pressured to approve certain products. The year began with congressional investigators saying the FDA should take immediate steps to make sure the riskiest devices are approved through the most stringent process.

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One thought on “UCSF v. Beth Israel on FDA on heart device safety

  1. This kind of news is so distressing for those of us who have had cardiac stents implanted. Distressing – but alas, not surprising.

    Since my own heart attack, I’ve been learning more than I ever wanted to know about the limitlessly inappropriate influence of corporate money on health care quality. I take a fistful of cardiac drugs every day now, and I have no clue which were prescribed for me based on flawed research funded by the very drug companies whose drugs were being ‘studied’, or based on tainted medical journal articles commissioned by industry-funded medical ghostwriters and signed off by unethical academics who fraudulently claim to be authors of research they didn’t do.

    And worse, neither do any of my doctors.

    The Canadian Medical Association Journal, for example, last year reviewed 19 published scientific papers written on the subject of drug eluting stents. All seven of the studies that were funded by the device manufacturers recommended “continued widespread use” of these stents, compared to just three of the 12 independently-funded studies.

    Now heart attack survivors are learning that heart patients with implanted stents, either drug-eluting or bare metal, actually have poorer 5-year outcomes than patients who were treated with meds only.

    Yet Dr. Maisel now tells the New York Times that his study “did not find a correlation between lower-quality data and problems related to the devices?”

    Earth to Dr. Maisel: bad research equals bad medicine.

    More at http://ethicalnag.org/2009/09/04/ghostwriting1/

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