Women and Heart Disease: Selling Statins

by Judy Norsigian and John Abramson

Today’s “Go Red for Women Day” campaign to increase awareness of heart disease and stroke should be called “See Red for Women Day.”

Despite being endorsed by some of our most trusted institutions like the American Heart Association and the National Heart, Lung, and Blood Institute, this event isn’t just about protecting your health.  It’s also about exploiting your concerns about health.

Remember that it was only a few years ago that post-menopausal women and their doctors were being told that hormone replacement therapy would help women live longer and prevent heart disease, stroke, and Alzheimer’s Disease.  And for women unconvinced by these promises, celebrity icons of female allure, like Lauren Hutton, were hired to make the case a different way.

Women with access to the best health care—better educated, wealthier, receiving more preventive care —were the most likely to be among the many millions of women without menopausal symptoms who took hormones believing they were protecting their health. But these women probably weren’t aware that, notwithstanding the definitive recommendations of many experts, there hadn’t been a single gold standard clinical trial showing these near-miraculous claims to be true. The Women’s Health Initiative finally debunked these grandiose claims and led to the reduction in hormone use that is almost certainly the reason for the recent drop in breast cancer incidence.

Back to the present and the Go Red for Women campaign with its slogan,   “Fight the Number 1 Killer of U.S. Women.” Yes, heart disease is the number one killer, but at some point, hopefully at a ripe old age, all of our hearts will stop beating. For women under the age of 75, cancer claims 78 percent more women’s lives than heart disease.  Yes, you should “know your numbers,” as the Go Red campaign suggests, but not the ones you’re probably thinking of – your cholesterol levels and the thresholds set by the National Cholesterol Education Program’s guidelines for starting a cholesterol-lowering statin drug.

These guidelines recommend that women without heart disease who have two or more risk factors and a “moderately high” risk of heart disease be “offered” statin therapy, if their bad cholesterol (LDL) level is 100 or higher.  The experts who formulated the guidelines insist that their recommendations are based on scientific evidence from recent clinical trials.

But it’s just like the hormone replacement therapy story. The experts who wrote the guidelines cite seven studies that they claimed show cholesterol-lowering statins to be beneficial for such women with a 10-20 percent risk of developing heart disease in the next 10 years. But, as one of us (JA) pointed out in a recent peer-reviewed article in the respected British medical journal the Lancet, there has never been a single clinical trial showing that statin therapy is beneficial for women who don’t already have heart disease or diabetes. Not one. Even the guideline authors admit that clinical evidence to support their recommendations is “generally lacking” and that their recommendations are made by “extrapolation of data from men.”

We think this is exploitation not extrapolation.

Women are different from men in many ways, including heart disease risk. Furthermore, the experts who have access to the results of all the major clinical trials know whether the combined data really show whether statins benefit women who don’t already have heart disease or diabetes.  But the experts aren’t saying. With 13 out of 14 of these studies sponsored by drug companies that market statins, one would have expected widespread publicity if the data do, in fact, show a significant benefit for women.

There are much more important numbers for women to focus on, such as: how many times a week they exercise (ideally at least several times); how many servings of fruits and vegetables we eat daily (ideally five or more); how often we eat red meat (ideally less than a pound a month); how many grams of trans fats we eat (ideally 0); and how often we smoke (ideally never) or drink (ideally not more than two alcoholic drinks in a day).

Taking statin pills certainly requires less effort than living a healthier lifestyle. And taking a statin would almost certainly lower your cholesterol numbers.  But there’s no evidence that it would achieve the real goal: reducing your risk of heart disease or improving your overall health.

With this much confusion, we’d like to be able to turn to our doctors for advice. But they, too, are influenced by the drug companies’ spin as well as pressure to follow the guidelines’ exaggerated recommendations. They also may be unaware of the growing evidence pointing to adverse effects of these drugs.

Complicating the statin issue even more for women, the five studies of statins that examined the risk of breast cancer found a 33 percent higher rate in women taking statins than in those taking placebos. There were not enough women in these studies to make this increase statistically significant, but clearly more research is needed here.  In fact, a large clinical trial based at the University of California, San Diego, is now quantifying the extent to which statin users experience a variety of adverse effects.

Pfizer, one of the sponsors of the “Go Red for Women” campaign and the maker of the best-selling drug of all time – the cholesterol-lowering drug Lipitor—may want you to think that taking statins is the best way to avoid heart disease. But what you can do for yourself is much more important than what any pill can do for you.

This op ed was originally published in the 2/2/07 edition of the Atlanta Journal-Constitution, in response to the American Heart Association’s “Go Red for Women Day” campaign.

Judy Norsigian is the executive director of Our Bodies Ourselves. John Abramson served as a family physician for 22 years and is the author of “Overdosed America: The Broken Promise of American Medicine.”