Pfizer’s Lipitor edged out Bristol-Myers Squibb’s Pravachol in a head-to-head competition between the two cholesterol-lowering drugs, a new study reported last week. It appeared to be a disappointing result for study-funder Bristol-Myers. Not to worry, though. There seems to be a move afoot to make sure there are plenty of profits for all.

The study compared the health outcomes among heart-attack patients treated with either Lipitor (search) or Pravachol (search), members of a class of drugs called statins (search). Twenty-two percent of Lipitor patients died or experienced further adverse coronary events during the clinical trial compared to 26 percent of Pravachol patients. Although I’m not sure that such a small difference in a single clinical trial really proves that Lipitor is a better treatment than Pravachol, what struck me is how the study was being used as a platform for the unnecessary pushing of expensive drugs on the general public.

It is estimated on the basis of the criteria in the national guidelines that 36 million people in the United States should be taking a statin, but only 11 million are currently being treated. Worldwide the discrepancy is even more staggering; more than 200 million people meet the criteria for treatment, but fewer than 25 million take statins, wrote Dr. Eric J. Topol (search) in an editorial accompanying the study in the New England Journal of Medicine. Americans already pay about $12.5 billion for statins every year. So Dr. Topol urged this tab be pushed to almost $40 billion.

Given ever-increasing prescription drug costs and other health care costs being foisted on the public, we ought to stop, take a deep breath, and ask if its really necessary to turn America into a nation on statins. As discussed in more detail in Dr. Uffe Ravnskov’s (search) book, The Cholesterol Myths, just because you have an elevated cholesterol level (i.e., greater than 200), doesn’t mean you are at increased risk of heart disease. Atherosclerosis, the build-up of plaque in arteries, also occurs in individuals with low cholesterol levels. High cholesterol may indicate that you have some underlying health issue, but a high cholesterol level by itself isn’t necessarily a problem.

Cholesterol (search) is vital to the cells of all mammals. Our bodies produce much more cholesterol than we eat ― that’s why diet alone doesn’t always reduce cholesterol levels and why statins are used.  Statins do reduce cholesterol levels and deaths from heart disease, according to Dr. Ravnskov, but here’s the rub ― there’s no evidence the two are related. Statins seem to protect against heart disease regardless of whether cholesterol levels are high or low. Statins apparently do much more than lower cholesterol levels but no one knows what, says Dr. Ravnskov.

Isn’t it wonderful that the statins work? Shouldn’t we all take statins?, asks Dr. Ravnskov. You be the judge.

In the WOSCOP clinical trial where healthy people with high cholesterol were treated with statins, the five-year death rate for treated subjects was reduced by a mere 0.6 percent, according to Dr. Ravnskov. To achieve that slight reduction, about 165 healthy people had to be treated for five years to extend one life by five years. As statin treatment is expensive ― as much as $1,400 per year ― that efficacy amounts to a drug cost of nearly $1.2 million to extend one life by five years. It certainly would be nice if we could afford to spend so much money treating so many healthy people for such a slight result, but it’s not clear that we can. While Dr. Topol did note in his editorial the high costs of universal statin therapy, he apparently never even considered that some sort of cost-benefit analysis might be in order.

Another notable aspect of Dr. Topol’s widely reported recommendation that the statin-taking population should be tripled is that the New England Journal of Medicine opted not to disclose that Dr. Topol’s employer, the Cleveland Clinic (search), receives financial support from both Pfizer and Bristol-Myers. Dr. Topol’s expertise and reputation, combined with the fact that Pfizer’s and Bristol-Myers’ support for the Cleveland Clinic doesn’t involve statins, was the rationale for not disclosing the potential conflict of interest, a Journal spokesman told me. Regardless of whether the Cleveland Clinic is funded by Pfizer and Bristol-Myers on statin research, they still are supported financially by those companies and a prominent Cleveland Clinic employee recommended that Americans triple their use of Pfizer’s and Bristol-Myers’ products.  If that doesn’t at least appear to be a conflict, I’m not sure what is.

Statins do produce some benefits in some situations. But until we know better what those benefits and situations are, it is irresponsible to recommend a mass prescription for the public. America-on-statins may be the pharmaceutical industry’s fantasy, but we simply can’t afford it.

Steven Milloy is the publisher of JunkScience.com, an adjunct scholar at the Cato Institute and the author of Junk Science Judo: Self-Defense Against Health Scares and Scams (Cato Institute, 2001).

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