Rare Peek in to Internal FDA Furor

Quick Hits: Transvaginal Mesh Pulled, New Weight Loss Drug & More

The latest question before the FDA concerns the use of ARBs (angiotensin receptor blockers), when used primarily to manage hypertension.

Dr. Thomas Marciniak, FDA official, says the use of ARB-drugs seem to be linked somehow to an increase in the risk of lung cancer. Other FDA officials disagree and don’t want to promote/demand any further clinical or epidemiological studies.

What makes this issue interesting? Marciniak works for the FDA and has brought his concerns to the public, whose internal discussions are usually kept tight to the vest within the Agency. Literally millions of hypertensive patients are currently take ARBs. Sales of ARBs were $7.6 billion in the US last year. The FDA seems to be arguing over this matter as drug companies increase their profits and are not so interested in the long term effects that have a direct relationship to lung camcer.

The Wall Street Journalhas some very awkward “quotes” from Dr. Unger about the lack of “enthusiasm” for a regulatory decision limiting or banning ARBs even if there were a 30% increased risk of cancer, as Marciniak postulates. The Wall Street Journal seems to support Marcinak’s David vs. Goliath stance.

This is a chance to see what happens when the FDA cannot make a decision. I’m also sure this lack of decision-making happens more often than the consumer wants to know about.

–MedShadow Staff

 

 


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