Nissen questions approval process for diabetes drugs

Steven Nissen (photo [1]) of the Cleveland Clinic made a statement to the FDA that might hurt diabetes drug manufacturers--especially Bristol-Myers Squibb and AstraZeneca, which are currently in the FDA approval process with diabetes drugs. 

A top expert in the field of cardiology, Nissen urged FDA to take a more stringent approach to new drug reviews when it comes to diabetes, and to take extra steps to ensure the drugs also lower cardiovascular risk and ultimately influence lifespan. He said there are so many drugs for diabetes available today that FDA can afford to be more selective. Nissen made his comments on day one of a two-day meeting scheduled to end this afternoon.   

Nissen said that drugs that focus only on lowering blood glucose are too simplistic and that diabetes medications must ultimately reduce the risk of cardiovascular disease, as cardiovascular disease is responsible for about 75 percent of deaths in diabetic individuals. However, such a move would change the drug approval process entirely, moving approval based on surrogate endpoints toward later outcomes--and could affect drugs aimed at treating almost every disease state known.

Companies like GlaxoSmithKline and Takeda Pharmaceutical--major players in the $6 billion dollar diabetes market--are also likely to be displeased with the statements, as slower drug approval processes would likely increase manufacturing and approval costs and decrease profits. However, thus far there are no drugs on the market with a proven cardiovascular benefit for over 90 percent of diabetics, those with Type 2 diabetes. Recent controversy about Avandia [2], charged with increasing risk of heart attack, likely played a role in the planning of the meeting.

Nissen said, "If we take drugs forward that lower blood sugar but increase the risk of death and heart attack, we haven't done diabetics any favors."

- get the full story [3] from the Wall Street Journal
- read more [4] at CNN Money

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Pharma's love/hate relationship with Dr. Nissen [5]
Nissen, pharma industry have complex relationship [6]
Nissen named to Cleveland Clinic post [7]
FDA considers new trial standard for diabetes drugs [8]