The (Over)Use of Statin Drugs May be Preventive Medicine Gone Awry

America is waging its war against heart disease with stockpiles of statins.

More than one of every six adults—nearly 40 million people—now takes these cholesterol-lowering drugs. Millions more could be buying them soon, since the Food and Drug Administration took the unprecedented step last year of allowing one company to market its statin to prevent heart disease—rather than to control only existing heart problems.

But some health experts are now worrying that our infatuation with statins may be spiraling out of control. Not only do many doctors question whether statins should ever be used to prevent heart disease, but some are dubious that these medications have ever been the miracle drugs they are advertised to be.

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This will be the first of a six-part series of original reporting from Rochelle Sharpe on various topics related to health, wellness, and prevention. A Pulitzer Prize-winning journalist, Sharpe has more than 25 years experience and has worked as a staff writer for The Wall Street Journal, Business Week and USA Today.

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Clearly, statins have been lifesavers for millions who suffer with severe heart problems. They also have become a lifeline for the pharmaceutical industry, generating $35 billion in sales in 2009 alone. Lipitor is now the best-selling drug in the world.

Lost in the euphoria over these drugs’ obvious benefits are warnings about statins’ serious side effects as well as persistent questions over how well these drugs work for women and the elderly.

Statins may do a fabulous job of lowering cholesterol. But lowering cholesterol does not always translate into preventing heart attacks, let alone extending lives, experts say.

Just last month, scientists raised questions yet again about statins’ benefits in a leading journal of evidence-based medical research. Writing in the Cochrane Review, these experts concluded that using statins to prevent heart disease “is not supported by the existing evidence.”

The authors analyzed the 14 most pertinent studies on the topic, 13 of which were sponsored by the pharmaceutical industry. Many of these studies’ conclusions were misleading, they wrote, with more than half not mentioning any side effects and more than a third leaving out results from clinical trials.

“Drug companies are manipulating what we know,” says John Abramson, a Harvard medical school professor and long-time critic of the drug industry’s aggressive promotion of statins.  Abramson, the author of Overdosed America, contends that our medical knowledge is being “commercially distorted.”

The debate over statins underscores just how much influence the drug industry has over health care issues. Not only do pharmaceutical manufacturers sponsor or ghostwrite many academic studies on drugs—including statins, but the companies also finance the continuing education courses that doctors take to keep up-to-date on drug usage.

In addition, the industry has had a surprising influence over the clinical practice guidelines on cholesterol, issued by the National Institutes of Health. These guidelines, last updated in 2004, were written by a panel of nine experts, eight of whom had financial ties with statin manufacturers. Physicians rely on these guidelines in their practices and those who ignore them can pay a huge price—losing incentive pay, getting rated by insurance companies as providing lower quality care, or giving malpractice attorneys ammunition against them if they should make a medical mistake.

Of course, the drug industry does not taint everything it financially supports. But research has shown that clinical trials funded by the industry are significantly more positive than other studies. A study published in the Journal of the American Medical Association concluded this may be due to biased interpretation of trial results.

As for statin research, some academics have been astounded by the misinterpretation of studies.

“The guidelines for cholesterol reduction don’t reflect the studies at all,” says Beatrice Golomb, a medical professor who leads the Statin Effects Study at the University of California in San Diego. “This is very troubling to me.”

Instead of presenting a balanced approach to preventing heart disease, the guidelines focus on getting doctors to lower LDL cholesterol, Abramson says. That approach is driven by drug company goals, he says, pointing out that the pharmaceutical industry and doctors often are seeking answers to fundamentally different questions.

Doctors want to know how to best reduce their patients’ risk of dying from heart attacks, while pharmaceutical companies are more focused on what drugs they can sell to cut cholesterol and alleviate cardiovascular problems.

The answers to these questions are surprisingly different. Statins certainly lower cholesterol. But half of all people who get heart attacks have normal cholesterol. And low cholesterol does not appear to be the key to longevity for the elderly or for women.

The famous Framingham Heart Study, which began tracking the health of 5,000 residents of Framingham, Mass., in 1948, shows that high cholesterol is significantly related to higher risks of  heart disease deaths only through age 60.

“Lowering cholesterol with statins does not extend life in elderly persons, even those at high risk of heart disease,” Golomb concluded in an article in Drug Safety.

High cholesterol may actually protect the elderly from catastrophic illnesses, she contends. For those over 75, low cholesterol appears to be a risk factor for strokes and deadly heart arrhythmias, she says.

Cholesterol does not appear to affect women in the same way as men, Golomb says. This complex substance, which is vital to synthesizing several hormones, including sex hormones, does not appear to be as deadly to women as in men.

Women with high cholesterol may have more heart attacks than women with lower cholesterol, she says. But they do not have more heart attack deaths or higher overall death rates.

Clearly, statins can bring enormous benefits to middle-aged men with high risks of heart disease—the very people who have participated in most of the statin drug trials.

But the extraordinary benefits of these drugs on middle-aged men have overshadowed statin risks, which are not trivial. Just last year, a study appeared in the The Lancet, a British medical journal, linking statins to increased risks of diabetes. Meanwhile, the sole clinical trial that focused exclusively on people over 70 taking statins showed a statistically significant increase in cancer—a finding that remains highly controversial.

It is unclear how many people get side effects from these drugs, but most likely it’s only a small percentage—perhaps between one percent and five percent of statin users. Those who do experience side effects, though, often find them debilitating—and irreversible.

Muscle difficulties are the most common problem, Golomb says, with many people suffering from severe muscle breakdown and excruciating pain. “I am only 44 years old, but my physical activity is like an 80-year-old,” one woman told her. Another complained: “This cholesterol drug crap is worse on my health than cancer was. It’s been 14 months and I still have problems.”

Golomb says that statins may kill some muscle cells and could interfere with the muscles’ response to physical activity. In a study of 22 professional athletes taking statins, 16 discontinued the drug because of muscle problems.

Cognitive problems, such as memory loss, are the next most common side effect, Golomb says, with women and the elderly suffering the most. Some patients experienced amnesia, while others lost their ability to read or balance checkbooks. Some were diagnosed with dementia or Alzheimer’s disease, but they quickly recovered after discontinuing their drugs.

Many doctors are not aware of these drugs’ dangers.

When Golomb asked patients how their doctors reacted to their complaints, most said they dismissed the possibility that the drugs had caused problems. Although the side effects have been discussed extensively in medical journals, some doctors told patients that statins had no side effects. Others attributed the pains as just the normal aging process. One patient said her doctor dismissed her, saying “I just didn’t like taking pills.”

Doctors are supposed to report side effects to the Food and Drug Administration. Given these attitudes, it’s no wonder that the government has a hard time getting a handle on how drugs actually work in the general population.

Half of all dire side effects, which lead to drug withdrawals or black box warning labels, are not identified until seven to 25 years after a drug’s release, Golomb says.

So, how are consumers supposed to cut through all the drug industry-sponsored material to figure out the best way to improve cardiovascular health?

Dr. Abramson suggests they return to the Framingham Heart Study, which found two interventions that helped reduce mortality in all patients: exercise and a healthy diet.

Rather than spending so much time fixing illnesses with pills, he says, the nation needs to wrest control of the health care debate away from pharmaceutical companies and focus more on prevention.

“We’re going about solving the problem of making people healthy in the wrong way,” he says.

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Contributing Writer Rochelle Sharpe is a Pulizter Prize-winning journalist with more than 25 years of health writing experience. Sharpe’s bi-monthly news feature for the Health Policy Forum focuses on issues related to health, wellness, and prevention. As a leading nonprofit health care research and consulting institute dedicated to improving human health, Altarum encourages open discussion and debate about the many challenges in health care today. All postings to the Health Policy Forum (whether from employees or those outside the Institute) represent the views of the individual authors and/or organizations and do not necessarily represent the position, interests, strategy, or opinions of Altarum Institute. Altarum is a nonprofit, nonpartisan organization. No posting should be considered an endorsement by Altarum of individual candidates, political parties, opinions, or policy positions. Read more.