May 7th, 2008
Statin era over?
The era of statins, drugs like Zocor and Lipitor which lower cholesterol levels, may be ending.
The FDA’s decisions over the last week to reject Merck’s Cordaptive and Isis’ Mipomersen, coupled with a demand that the makers prove the drugs improve heart outcomes, looks like a turning point.
Past approvals of statins were based mainly on the drugs’ lowering LDL cholesterol levels. Lipitor’s market success was based on studying high dosages to get big drops in the number.
But now, with Zocor a generic called simvastatin, Lipitor going generic in the next few years, and the failure of the ENHANCE study to prove a direct link between the number and longer life everything is being re-thought.
No one will admit this publicly, but cost may also be an issue. Doctors continue to prescribe Vytorin despite the ENHANCE study results, and if statins are really having minimal impact on outcomes, why give them more patent protection?
Personally I just came from my daily half-hour workout. I take simvastatin along with time-released niacin which is supposed to raise good cholesterol, and a baby aspirin. Each morning I add a blood pressure pill.
My father’s first heart attacks came when he was years younger than I am, and I feel fine. But is that due to the statin, the blood pressure medicine, or the exercise? (The picture shows my local YMCA from the air.)
Ironically Cordaptive from Merck was not a statin at all, but a combination of niacin and laropiprant designed to enable people to take higher doses of niacin. I take just half a gram of niacin per day. Cordaptive was being studied to enable doses of up to 2 grams per day.
Mipomersen was initially studied as a way to treat a rare genetic condition which causes astronomical cholesterol levels. The rejection was for its use to treat “routine” high cholesterol.
Still, all these drugs seem to do is manipulate numbers, for LDL and HDL cholesterol. Do they help people live longer?
Until that question is answered the FDA’s approval window will likely remain closed. But you’ll still see me each morning at the Y.
Dana Blankenhorn has been a business journalist since 1978, and has covered technology since 1982. He launched the Interactive Age Daily, the first daily coverage of the Internet to launch with a magazine, in September 1994. See his full profile and disclosure of his industry affiliations.
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| 05/07/08
