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Healthy Skepticism Library item: 12179

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Publication type: news

Pettypiece S.
Merck May Lose Over-the-Counter Cholesterol Pill Bid
Bloomberg News 2007 Dec 10

Full text:

Merck & Co. is seeking to overcome doctor opposition to sell the first non-prescription version of a cholesterol pill that lost patent protection six years ago.

The drugmaker is pressing the U.S. Food and Drug Administration for the third time in a decade to make Mevacor, a cholesterol-lowering medicine prescribed 15 million times last year, available on drugstore shelves. Mevacor, sold as a generic medicine since 2001, is part of a class of drugs known as statins, the most frequently prescribed type of medicine in the U.S.

The FDA is unlikely to approve nonprescription Mevacor in the face of the concerns raised by the 250,000-member American Medical Association, said Michael Obuchowski, a health-care investor with Altanes Investments LLC in New York. Patients need a physician’s help to determine if they have high cholesterol and whether they can take Mevacor safely, the AMA said in a Nov. 28 letter to the FDA.

``This is serious medication, not the kind you want to be taking over-the-counter on your own,’‘ said Steven Nissen, head of cardiology at the Cleveland Clinic, in an interview. ``Unlike a headache, high cholesterol doesn’t have any symptoms, so how do you know you have high cholesterol, or if it has improved, without going to a physician?’‘

A panel of advisers to the FDA will hear arguments and make a recommendation on Dec. 13.

Mevacor and its generic copies generated $278 million in U.S. sales last year. A retail version might increase demand and carry a higher price per pill, Obuchowski said. He hasn’t forecast revenue for an over-the-counter product because he’s skeptical Whitehouse Station, New Jersey-based Merck will win regulatory approval, he said.

Benefit to 14 Million

Selling Mevacor in stores may benefit 14 million Americans with high cholesterol not currently being treated, said Jerry Hansen, an executive director of Merck Research Labs, in a telephone interview. High levels of cholesterol can cause heart attacks and strokes.

``Cardiovascular disease is the biggest killer, and while statins have been proven safe and effective, there remains a huge treatment gap,’‘ Hansen said.

The company said the FDA panel in 2005 didn’t raise concerns about the product’s safety and that studies found it similar to a placebo in terms of risk.

Merck, having been turned down by the FDA in 2000 and 2005, said it will present new research showing consumers could use non-prescription Mevacor properly. The company said it will set up a Web site and a telephone hotline to help them.

``We believe the patient can do this with benefits,’‘ said Antonio M. Gotto Jr., a consultant to Merck and dean of the Weill Cornell Medical College, in an interview today.

Glaxo’s Alli

GlaxoSmithKline Plc promised a similar consumer education plan to win FDA approval in February for Alli, the first weight- loss pill cleared for nonprescription sale.

London-based Glaxo has licensed from Merck the rights to sell over-the-counter Mevacor for an undisclosed amount. Merck says it will receive milestone and royalty payments, though it declined to reveal the terms.

``I’m surprised Merck would really fight for it so hard,’‘ said Altanes’s Obuchowski. ``Whenever you have issues with side effects that need to be monitored, I don’t think the drug is going to go over-the-counter.’‘

Merck rose 10 cents, or less than a percent, to $60.77 in New York Stock Exchange composite trading at 4 p.m. and has gained 39 percent this year, making it the top performer in the Standard & Poor’s Pharmaceuticals Index. Glaxo’s shares fell 7 pence to 1,304 pence in London trading.

$16 Billion in Statin Sales

Mevacor’s revenue was behind other statin drugs, such as Pfizer Inc.‘s Lipitor, which had $8.8 billion in U.S. sales, according to IMS Health Inc. Statins generated $16 billion in U.S. sales last year, according to IMS, a Norwalk, Connecticut- based health research firm. Others in the class are AstraZeneca Plc’s Crestor and Bristol-Myers Squibb Co’s Pravachol.

Merck and Glaxo need new drugs to replace products losing patent protection. Merck said it will lose as much as $2 billion in sales this year when its osteoporosis drug Fosamax faces generic competition. Glaxo, hurt by a report linking its diabetes treatment Avandia to heart attacks, also needs to make up for declining sales.

Mevacor, at the 20-milligram dose, sells as a prescription drug for about $2.50 a day and generic copies cost less than $1 a day, according to the Web site Merck declined to comment on potential over-the-counter pricing.

A low-dose version of simvastatin, the chemical in Merck’s cholesterol drug Zocor, has been sold over-the-counter in the U.K. since 2004.

Side Effects

People with high cholesterol are usually diagnosed by a doctor through a blood test, then checked six months or a year later. Some patients who don’t need Mevacor would buy it over- the-counter, putting them at risk for side effects including muscle pain and weakness and liver damage, the AMA said in its letter.

``To potentially lose the benefit of physician supervision by switching statins to OTC use would, in the AMA’s view, be detrimental to the health of many individuals and to the public,’‘ the AMA said in its letter.


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