For years now, statins, the cholesterol-lowering drugs, have been a major pillar of the drug industry. After all, Pfizer's ($PFE) Lipitor is the best-selling drug of all time. Even off patent, it is now generating huge returns for generic makers. They are so ubiquitous that the FDA is suggesting patients be able to get them without a prescription.
But a little cloud is forming over the category. Links to muscle injury were already documented, and now there is a growing body of evidence tying their use to the development of diabetes. The FDA in February told statins makers to add that possibility to labels. Now, a new study draws that connection tighter while making it clearer who is at risk.
The study, published in the Lancet medical journal Thursday, says the benefits still outweigh the risks, but found those people already at risk for diabetes are significantly more likely to develop the disease if they are taking statins. The findings add that is only the case for people with risk factors for diabetes to the knowledge pool, The Wall Street Journal reports.
The study, one of those massive number crunchers, was underwritten by AztraZeneca ($AZN), the maker of one of those drugs, Crestor.
Before this study, doctors didn't know how to evaluate the risk among their patients, cardiologist Dr. Eric Topol tells the newspaper. Topol believes while the benefits outweigh risks, patients need to know they exist and decide with their physicians which way to go.
The debate is important for drugmakers because, as The Wall Street Journal points out, this category of drug generated $38.7 billion in sales last year, IMS Health data show, making it the third-largest category of drugs.
- read the Wall Street Journal story
How worrisome is the statin-diabetes link?
Experts debate preventive use of statins
Docs riled by FDA's proposal to open up drug access
FDA tightens up use of high-dose Zocor