Friday, November 15, 2013

Statins: A Cholesterol Hoax?

Statins are marketed as a drug that can be taken to control the amounts of the various forms of cholesterol in our blood streams. It has been assumed that cholesterol levels are a marker for risk of cardiovascular disease. Statins are generally prescribed for patients who have cardiovascular disease or who have health indicators that suggest a high risk level. Recently, the recommended usage of statins has changed dramatically. This source states that under the new guidelines, up to a third of all adults would fall into the category of potential statin user.

"….under the new advice, one-third of U.S. adults — 44 percent of men and 22 percent of women — would meet the threshold to consider taking a statin. Under the current guidelines, statins are recommended for only about 15 percent of adults."

The number of potential statin users has been doubled and is approaching 100 million people in the US alone. What is going on? Skeptics might see this as another initiative by big pharma to enrich itself by further polluting our blood streams with their products. An article by John D. Abramson and Rita F. Redberg in the New York Times suggests that profit may be the motive.

"….the American Heart Association and the American College of Cardiology issued new cholesterol guidelines that essentially declared, in one fell swoop, that millions of healthy Americans should immediately start taking pills — namely statins — for undefined health "benefits."

"This announcement is not a result of a sudden epidemic of heart disease, nor is it based on new data showing the benefits of lower cholesterol. Instead, it is a consequence of simply expanding the definition of who should take the drugs — a decision that will benefit the pharmaceutical industry more than anyone else."

The authors then go on to suggest that those who formulated this recommendation might be paid lackeys of the pharmaceutical industry.

"The process by which these latest guidelines were developed gives rise to further skepticism. The group that wrote the recommendations was not sufficiently free of conflicts of interest; several of the experts on the panel have recent or current financial ties to drug makers. In addition, both the American Heart Association and the American College of Cardiology, while nonprofit entities, are heavily supported by drug companies."

This view fits well an "evil pharma" scenario. However, the guidelines on statin usage that have been issued also included a rather surprising recommendation. An article by Gina Kolata in the New York Times, New Cholesterol Advice Startles Even Some Doctors, provides some background.

"The new guidelines, released….by the American College of Cardiology and the American Heart Association, represent a remarkable and sudden departure from decades of advice on preventing cardiovascular disease."

"According to the new advice, doctors should not put most people on cholesterol-lowering medications like statins based on cholesterol levels alone. And, despite decades of being urged to do so, patients need not monitor their cholesterol once they start taking medication. The guidelines do not even set target levels for LDL, the so-called bad cholesterol."

What the guidelines seem to be saying is that you should take statins if you are at risk for cardiovascular disease, but risk should be based on overall health indicators such as obesity rather than on cholesterol levels. Meanwhile tens of millions of people are now taking statins solely based on cholesterol levels. This would indicate that the emphasis on cholesterol has been inappropriate.

"The chairman of the committee that developed the new guidelines, Dr. Neil J. Stone of Northwestern University, said the group was prompted to examine the idea of target LDL levels when two doctors — Dr. Krumholz and Dr. Rodney A. Hayward of the University of Michigan — asked what the evidence was for their efficacy."
"When the committee looked, Dr. Stone said, they found no evidence. It was generally accepted that lower was better, but no one had shown that an LDL of 90 milligrams per deciliter, for example, was better than 100. And the high doses and multiple drugs many patients were taking to get to target levels raised concerns."

"Dr. Lisa Schwartz, a professor of medicine at Dartmouth, said that medical systems constantly prodded doctors to report patients’ LDL levels and used the numbers to judge doctors’ performance. Referring cardiologists often insist that LDL levels be measured and then lowered."

"’Everyone adopted the targets,’ Dr. Schwartz said. ‘It drove a huge amount of testing and focusing around the LDL number. Many doctors thought it was crazy. We were prescribing higher doses of drugs for older patients, which was probably dangerous’."

Everyone seems to agree that statins are beneficial for those have or are at high risk for cardiovascular disease. Everyone—or nearly everyone— seems to have assumed that cholesterol was the culprit that needed to be controlled. However, statins provide benefits other than controlling cholesterol.

"Statins do more than just lower cholesterol, noted Dr. Valentin Fuster, director of the heart center at Mount Sinai Hospital in New York City. They also reduce inflammation and blood clotting, both of which are associated with heart attack and stroke risk. Drugs that only reduce LDL have not been shown to be effective in preventing heart attacks."

If the main interest of drug companies is selling statins to as many users as possible, and lowering cholesterol is the marketing angle for sales, how can the new guidelines be viewed as serving the wishes of the pharmaceutical industry? This source provides further insight.

"Roughly half the cholesterol panel members have financial ties to makers of heart drugs, but panel leaders said no one with industry connections could vote on the recommendations."

That is encouraging. One might even go so far as to claim that the panel responsible for the new recommendations took a courageous step in correcting a misconception related to cholesterol that has long been a part of medical tradition.

While the range of people that might be prescribed statins has grown, the focus on other indicators of cardiovascular risk rather than on cholesterol highlights the option that just living a healthier lifestyle is as good, if not better, than medication. It is not clear what this change will mean for statin sales in the long run.

We need to ask ourselves a serious question. There has never been any conclusive evidence that lowering cholesterol in an otherwise healthy person protects them from heart attacks and strokes. So how did it become "common knowledge" that cholesterol lowering medications, statins, should be prescribed? This source provides a clue:

"The US market for statins nearly tripled when the National Cholesterol Education Program revised its guidelines to recommend statins as primary prevention [2001]. Although the panel cited randomized trials to support statin therapy for primary prevention of occlusive cardiovascular disease, a report in Lancet notes, ‘not one of the studies provides such evidence.’ Journalists have questioned the interests of the doctors who made such recommendations, as eight of the nine doctors on the panel were discovered to have been paid by statin manufacturers."

Who has the resources—and the motivation—to purchase the allegiance of medical professionals, flood academic journals and the media with self-serving articles, and create a market where none needs exist?

"Evil pharma" lives—and we should not forget that it has lived for a very long time.

And we should remember that doctors don’t always know what they are talking about. Do your own research.

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