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.
The uncertainty is roiling investors looking to cash in on what has traditionally been the most lucrative arena of the pharmaceutical sector.
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.
"Today investors are probably feeling like a successful investment in a new lipid franchise is something that's going to take a long time to materialize," said Leerink Swann analyst Seamus Fernandez.
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The FDA was stung by intense criticism over drugs such as Merck & Co's withdrawn painkiller Vioxx and GlaxoSmithKline Plc's diabetes treatment Avandia, that had serious safety issues revealed long after they were approved and in wide use.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.
Nissen was also in the middle of the debate over extensive use of the new cholesterol medicines Vytorin and Zetia -- sold in a joint venture by Merck and Schering-Plough Corp -- after delayed results of a failed study led to plunging sales and patients' questioning their medicines.
Though few will argue against a focus on patient safety, many cardiologists fear a more conservative FDA will delay new therapies that could cut the risk of heart attacks and strokes further than the 30 percent seen with statins such at Pfizer Inc's Lipitor and AstraZeneca's Crestor.
