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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