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Originally published February 4 2008

Why Merck Lost Its 3rd Bid to Sell Mevacor Over the Counter

by Teri Lee Gruss

(NaturalNews) An expert panel working with the FDA recently voted 10 to 2 against approving Merck's statin drug Mevacor for over-the-counter (OTC) sales. The FDA could potentially ignore this recent vote and approve Merck's request but this is not a likely scenario considering the results of a recent Merck sponsored study designed to assess the public's ability to appropriately decide if the 20mg dose of Mevacor would benefit them.

This is the third time in 7 years that Merck has attempted to gain FDA approval to sell its statin Mevacor OTC.

Dr. Sidney Wolf, director of the Health Research Group at Public Citizen, participated in the hearings and said that the Merck SELECT study "shows that up to 93 percent of the people deciding on their own to purchase Mevacor should not take the drug". According to Dr. Wolf, overall an average of 75% of the study participants inappropriately self diagnosed a need for statins.

Most media coverage of the SELECT study quoted that 25% of the 1,500 study participants incorrectly self-diagnosed a need for statins but when Dr. Wolf, along with other experts independently examined the data they found:

"21.5 percent of people deciding on their own to purchase OTC Mevacor had a less risky cardiovascular risk profile than the threshold (5 percent or higher risk of coronary heart disease (CHD) in 10 years) for which there is evidence that the drug would be of any benefit to them".

"29 percent of women who made the assessment in the SELECT study, and they were candidates for the drug, were actually younger than 55".

Data from the SELECT study also found that "almost 30% of people previously diagnosed with heart disease, diabetes or stroke would buy OTC Mevacor". According to the FDA this group of people need to be under a physician's care.

The results of this study show that an alarming portion of the population would needlessly put themselves at risk for the adverse side effects of statins including depletion of coenzyme Q10, muscle cell damage, liver damage, cognitive dysfunction, birth defects and long term risk for cancer.

Dr. Wolf included in his testimony the comments of Dr. Frank Davidoff, former Editor of the Annals of Internal Medicine: "In effect, approving statins for OTC primary prevention would amount to a huge uncontrolled experiment, in which neither the benefit nor the risk side of the equation are known". Dr. Davidoff was a former member of the committee that evaluated Merck's bid for OTC approval of Mevacor and was "one of the 20 members opposing the OTC switch in 2005".

In contrast, a Merck spokesperson optimistically said that the latest study shows "overwhelmingly favorable results that consumers can self-assess and make the appropriate decision to purchase over-the-counter Mevacor". Merck representatives argued that OTC availability of Mevacor would offer a "major public health benefit".

Current conventional risk factors for heart disease include smoking, low HDL, high blood pressure and a relative who developed cardiovascular disease (CVD) at an early age. The medical profession is advised to look for the presence of at least one of these risk factors before prescribing statins.

Total cholesterol and LDL, the very lipids that statins lower, are not independent risk factors for CVD. You will not find them on the American Heart Association list of CVD risk factors. Irresponsible advertising (both to the public and the medical profession) perpetuate the notion that lowering total cholesterol and LDL will prevent a large portion of the population from dying of CVD.

The "Lipid hypothesis" of heart disease fails to acknowledge a large body of scientific evidence that shows that half of people that suffer heart attacks have "normal" or low levels of total cholesterol and LDL. Nor has the "Lipid Hypothesis" been successfully tested in the female and elderly population, groups commonly prescribed statins.

At a time when there is increasing evidence that the incidence of adverse and serious side effects in statin users are under reported, to say that the OTC sale of Mevacor would be a benefit to public health is extraordinarily irresponsible.

Joel Kauffman, PhD in Organic Chemistry from MIT and author of Malignant Medicine, writes that "The benefits of the statin drugs in reducing mortality are exaggerated, being only about 0.3% per year from the most favorable trials reported. This is not as great as the benefits of omega-3 supplements. Indeed lovastatin (Mevacor) increased the all-cause mortality rate in its two reported trials".

According to Public Citizen, in 2006 Mevacor sales fell to "less than 0.25 percent of the overall market for lovastatin because of generic competition. OTC approval would temporarily grant exclusive OTC sales status to Merck for three years."

Based on Merck's own study results, OTC statins would put a large segment of our population at risk of very serious side effects without any health benefits. And yet the company continues to say (with a straight face) that Mevacor OTC would provide a major public health benefit, a claim that even the FDA apparently won't back.

Hats off to Dr. Sidney Wolf at Public Citizen and Dr. Joel Kauffman for providing the public with unbiased information regarding the misuse of statins.


Testimony before the FDA Endocrinologic/Metabolic and Non-Prescription Drugs Advisory Committees, December 13, 2007 by Sidney M. Wolfe, M.D. Director, Health Research Group at Public Citizen

Testimony on the public health dangers of making lovastatin (MEVACOR) available over-the-counter (HRG Publication #1829)


Malignant Medicine, Joel Kauffman PhD, p. 101

About the author

Teri Lee Gruss, MS Human Nutrition

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