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CASE Medical MD Challenges FDA Ruling

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A new report by a CASE School of Medicine physician is critical of the market approval of drugs later found to pose a risk of heart attacks and strokes. ideastream's Rick Jackson reports the doctor believes the FDA missed a critical connection.

Wednesday, February 23, 2011 at 4:34 pm

Doctor Robert Blankfield says the FDA didn't test enough before approving drugs like the now recalled Avandia, Bextra, and Vioxx, used by physicians to treat sufferers of illnesses including Diabetes, Arthritis, and Migraines.

Blankfield says the FDA failed to test for one crucial property – whether they increase a patient’s fluid retention.

In his groundbreaking paper, Blankfield uses complicated mathematical analysis to show that fluid retention leads to blood flow that is – in his words - "more turbulent". He says it doesn’t raise patients’ blood pressure – which is a clear red flag - but it DOES increase the risk of heart attack or stroke.

DR. ROBERT BLANKFIELD "When the blood swirls and there are vortices, that does aggravate the cells that line the arteries - that causes them to initiate Artherosclerosis - hardening of the arteries. The end result is an increased risk of heart attacks and strokes."

Blankfield says other doctors at both CASE Medical and MetroHealth have looked at his research and agree with his test results, but he HASN”T yet shared his findings with the drugs' manufacturers. He wants the FDA to mandate additional cardiovascular safety data for all medications that cause fluid retention, including some that are currently on the market. He says the agency acknowledged his findings, but would not specify whether an investigation is warranted.

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