Future of lucrative cholesterol drugs murky

[Celebration]

http://www.reuters.com/article/reutersEdge/idUSN0229104420080504

NEW YORK (Reuters) - Doctors are waiting for new preventive heart medicines beyond popular statin therapies, but a tough regulatory climate and fierce debate over the effectiveness of some newer drugs has clouded the future of cholesterol treatments.

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Sudden plunges in sales of newer cholesterol drugs, that had been expected to grow strongly for years, and unexpected U.S. Food and Drug Administration rejections or delays of medicines have sparked steep declines in share prices.

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Fernandez expects the FDA will start requiring outcome studies for novel cholesterol treatments -- proof that a medicine actually reduces heart attacks or strokes rather than just alters levels of blood fats.

The FDA was stung by intense criticism over drugs such as Merck & Co's (MRK.N: Quote, Profile, Research) withdrawn painkiller Vioxx and GlaxoSmithKline Plc's (GSK.L: Quote, Profile, Research) diabetes treatment Avandia, that had serious safety issues revealed long after they were approved and in wide use. The agency now appears more focused on the risk element of the risk/benefit ratio of new drugs.

"I think the FDA is beginning to understand that unless they set the bar high enough we may not fully understand how a drug works," said Dr Steven Nissen, chairman of cardiovascular medicine at Cleveland Clinic, who has been an outspoken critic of the agency and drugmakers.

[truedelphi]

1. This is good news. The Federal Agencies need to tighten the controls n/t

[DesertFlower]

2. i agree. nt

[Clear Blue Sky]

3. Harder to prove the link to reducing heart attacks.

If these drugs lower cholesterol, and if it is believed that lower cholesterol is associated with fewer heart attacks and strokes, then there is benefit. (if a=b and b=c, then a=c).

Glaucoma drops lower eye pressure but haven't been proven to preserve vision (but there is the assumption that high eye pressure causes vision loss). Ditto high blood pressure drugs.

Add drugs have risk and benefits. Hopefully the prescribing physicians assess these and make good recommendations.

[Celebration]

4. similar argument with Avandia

Shouldn't have caused heart problems, should it, because it lowered blood glucose levels in Type 2 diabetes, and high blood glucose levels are associated with heart and other ailments. But correlation does not prove causation and there are lots of problems with this drug.

I think the turning point on all this stuff was the Business Week article on the cholesterol drugs and the statistics involved. I believe it actually educated the FDA reviewers.


http://www.businessweek.com/magazine/content/08_04/b4068052092994.htm

[Clear Blue Sky]

5. I would hope that the smart folks at the FDA

could see through bogus studies and stats, but maybe not. Unfortunate as they are the last bastion of independence in the pharma world.