Statin drugs are the biggest-selling drugs in the world and have been shown to significantly lower cholesterol and reduce the risk of heart attack. But data have been less clear about potential side effects, such as muscle aches and memory problems. Now, a new Web site has been launched to help change that.
The Statin Effects Survey site (www.statineffects.com) was created by University of California-San Diego researchers who are studying the full range of effects -- both good and bad -- from statins, a class of cholesterol-lowering drugs that include big brands like Pfizer's Lipitor, Merck's Zocor and others. World-wide, cholesterol-lowering drugs accounted for about $32.4 billion in sales, according to IMS Health, which tracks pharmaceutical data.
Beatrice Golomb, the UCSD assistant professor who created the statin Web site, says reliable side-effect data are lacking, in part, because studies created to gauge a drug's potential benefits are often designed differently than studies aimed at determining whether a drug causes harm.
"Studies are set up in such a way that showcases the benefits of a drug and that can inadvertently obscure harms," Dr. Golomb says.
Drug makers, however, say there already are extensive data on statin side effects. Pfizer, maker of the top statin brand, Lipitor, says 400 clinical trials of 80,000 patients have produced a "substantial amount of data by which to assess the drug's safety," says Barbara LePetri, senior medical director in Pfizer's cardiovascular group.
Unfortunately, the current system of tracking drug side effects and unexpected complications once a drug is approved and on the market isn't perfect. It's widely believed that only a fraction of drug side effects are reported under the Food and Drug Administration's Adverse Event Reporting System, or AERS. Through AERS, drug reports are collected from doctors, pharmacists, pharmaceutical companies and patients themselves, often through the www.fda.gov/medwatch/ Web site. But between 1999 and 2002, the number of adverse events being reported dropped 21 percent, due in large part to procedural changes that mean "non-serious" events are less likely to be entered into the database, either because the drug has been around for three or more years or because the product labeling already warns consumers about the issue, according to a report last summer in the Archives of Internal Medicine.
AERS is particularly problematic when it comes to statin therapy, some doctors say. For one, men are the biggest users of statins, but the Archives report noted that women are far more likely to report adverse drug effects than men. But perhaps the bigger problem is that many purported side effects of statins -- muscle aches, thinking problems and fatigue, among others -- are common complaints associated with aging. As a result, patients may talk to their doctor about mild aches, memory problems or fatigue, but many doctors just tell them it's part of getting old and don't think to report the complaint as a side effect of statin use.
There are a handful of studies designed specifically to track statin side effects. University of Pittsburgh researchers conducted a study putting 308 adults with high cholesterol on a placebo or two different doses of the drug Zocor for six months. In tests measuring cognitive functions, statin users didn't do as well as placebo users. The study was far from conclusive, but researchers noted that it provided "partial support" that statins cause minor problems in cognitive functioning.
UCSD researchers say data they've collected so far from patients on adverse effects of statins shows that nearly 60 percent reported muscle weakness or fatigue, and about half reported cognitive problems.
A spokeswoman for Merck, maker of Zocor, says the company isn't familiar with the new Web site, but says it is important that patients who are experiencing adverse effects from any drug contact their doctor, who will then provide the information to regulatory officials.
Patients interested in detailing their experiences with statin drugs for the UCSD researchers must first register with the Statin Effects Survey site, which launched last month. Dr. Golomb says all patient information is confidential. The site will attempt to collect survey data from at least 3,000 patients. Patients may be contacted about their survey but many will not. The main benefit of participating will be in helping doctors achieve a better understanding of statin side effects, says Dr. Golomb.
Dr. Golomb says she decided the Web site, which is funded by a grant from the Robert Wood Johnson Foundation, was necessary because so many patients contact her office to report statin side effects. Many of the patients she speaks with are frustrated that their complaints are ignored. "They say 'My doctor won't listen to me or my doctor says it can't be related to the drugs,'" says Dr. Golomb.
Bad Medicine
Here are some Web sites to learn about or report drug side effects.
www.fda.gov/medwatch/ Guide to reporting side effects; includes info on recent concerns
http://vaers.hhs.gov/ Site dedicated exclusively to adverse events related to vaccines
www.statineffects.com University of California-San Diego site looking at side effects of cholesterol drugs
www.medlineplus.gov Click on "Drugs & Supplements" button for info on benefits and side effects
First Published: October 3, 2006, 4:00 a.m.
