New guidelines from the American Heart Association and the American College of Cardiology for the use of statin drugs came out on November 12. This is a very big deal for big Pharma, for doctors and for patients. Health consumers beware!
The guidelines may lead to tens of millions of healthy, low-risk people being transformed into patients--patients who need statins. "The change could more than double the number of Americans who qualify for treatment with the cholesterol-cutting drugs known as statins," according to the guideline authors, as reported in the WSJ.
Statins: what exactly do they do? Statins inhibit the production of mevalonate, a precursor of both cholesterol and coenzyme Q10, a compound believed to be crucial for mitochondrial function and the provision of energy for cellular processes.
Statins definitely lower cholesterol, and they seem to lower the risk of heart disease in those people who have already had a cardiac event. But they may also cause muscle pain and muscle weakness, liver inflammation, cognitive impairment, and increase the risk of diabetes. Furthermore, while taking a statin, you are statistically much more likely to experience one of these side effects than you are to benefit by avoiding a heart attack or stroke. That might suggest that patients need to be carefully selected for this treatment.
However, calculation of the risk-benefit equation requires adding a third element: pharmaceutical profits, and how they drive research, advertising, and the creation of guidelines.
[UPDATE Nov. 18, from NYT: Adding insult to injury, it now turns out that the "risk calculator" designed to be used with the guidelines significantly overestimates risk--by 75 to 150%. Simply being an older adult, with no other risk factors, appears sufficient to put most healthy people into a category "who can benefit from therapy". Last year, the Heart Lung and Blood Institute at NIH removed itself from development of the guidelines, soon after problems with the calculator surfaced.]
Eleven billion dollars was spent on just the two leading statin drugs in the USA in 2011, according to USAT. Lipitor (atorvastatin) was the US' best-selling drug, and Crestor (rosuvastatin) was #4. [Subsequently Lipitor lost its patent exclusivity and cheaper generic versions became available. Crestor remains on patent.]
However, Zocor (simvastatin) had been available as a generic for years; why were patients being given the much more costly, brand name drugs? Another issue re statin prescribing has to do with choosing the optimal dose; experts have recommended pushing up the dose in higher-risk patients, but it is unclear whether evidence supports this. What is the right dose? No study has shown that a particular target level of cholesterol provides protection from heart disease, which may be why specific target levels were removed from the guidelines just issued. But instead, the new guidelines suggest most patients should get intensive (high dose) therapy.
Back in April 2011, the Harvard Health Letter provided the following statistics on the dramatic increase in use of statin drugs over two decades of availability. By 2008, fully 50% of American men between 65 and 74 were being prescribed statins!
If US doctors follow the new guidelines, a doubling of those on statins will add many $billions more to Pharma's coffers. The rest of the world is befuddled by the US' addiction to prescription drugs; it will be interesting to see how doctors elsewhere react to these recommendations.
A NYT Op-Ed by doctors John Abramson and Rita Redberg lays out the serious questions surrounding the new recommendations. Here is an excerpt:
Statins are effective for people with known heart disease. But for people who have less than a 20 percent risk of getting heart disease in the next 10 years, statins not only fail to reduce the risk of death, but also fail even to reduce the risk of serious illness — as shown in a recent BMJ article co-written by one of us. That article shows that, based on the same data the new guidelines rely on, 140 people in this risk group would need to be treated with statins in order to prevent a single heart attack or stroke, without any overall reduction in death or serious illness.
At the same time, 18 percent or more of this group would experience side effects, including muscle pain or weakness, decreased cognitive function, increased risk of diabetes(especially for women), cataracts or sexual dysfunction.
Perhaps more dangerous, statins provide false reassurances that may discourage patients from taking the steps that actually reduce cardiovascular disease. According to the World Health Organization, 80 percent of cardiovascular disease is caused by smoking, lack of exercise, an unhealthy diet, and other lifestyle factors. Statins give the illusion of protection to many people, who would be much better served, for example, by simply walking an extra 10 minutes per day.
Aside from these concerns, we have more reasons to be wary about the data behind this expansion of drug therapy.
When the last guidelines were issued by the National Heart, Lung, and Blood Institute in 2001, they nearly tripled the number of Americans for whom cholesterol-lowering drug therapy was recommended — from 13 million to 36 million. These guidelines were reportedly based strictly on results from clinical trials. But this was contradicted by the data described in the document itself...