FDA Considers Over-the-Counter Sales for Cholesterol Drug

ap.tbo.com ^ | Jan 13, 2005 | Laura Meckler

[foolscap]

WASHINGTON (AP) - The government is considering whether a drug for a serious chronic condition - high cholesterol - should sit on drugstore shelves alongside medicines for headaches, allergies and athlete's foot. Supporters say making a low-dose cholesterol medicine available without a doctor's prescription would help get needed treatment to millions of Americans who are at risk of heart disease.

"There's a huge treatment gap," said Jerry Hansen, vice president of marketing at Johnson & Johnson-Merck Consumer Pharmaceuticals Co., a joint venture that is asking the Food and Drug Administration for permission to sell a low-dose version of Mevacor over the counter.

The drug, he notes, has been on the market for a long time and has proven quite safe.

But opponents say selling directly to the consumer allows patients to skip doctor visits, where they might be told to change their diet and exercise - both crucial in the effort to lower cholesterol.

"This is going to encourage people to take medication rather than alter other parts of their lifestyle," said Dr. Michael Schloss, clinical co-director of the Cholesterol Treatment and Research Center at New York University.

A panel of FDA scientific advisers was considering the request Thursday and Friday. The FDA usually follows the recommendations of its advisers.

The FDA turned down a similar request in 2000. In the years since, the drug companies have tested the idea through consumer surveys, focus groups and mock pharmacies, hoping to prove that average patients can figure out for themselves whether they need the drug at all and, if so, if the nonprescription strength is right for them.

But in documents released ahead of the meeting, the FDA detailed numerous flaws with these studies. For instance, the agency said, a study of how well people could understand the label that would be on the drug found that just 1 percent of people who said they could start using Mevacor "right away" were appropriate candidates for the drug. The other 99 percent did not meet the criteria or had a medical condition that made the drug wrong for them.

The drug is only meant for a slice of the population: men 45 and over and women 55 and older whose LDL - low-density lipoprotein, or "bad" cholesterol - count is between 130 and 170. They should also have at least one risk factor for heart disease, such as smoking, high blood pressure, family history of heart disease or an HDL - high-density lipoprotein, or "good" cholesterol - count of less than 40.

Certain patients, such as pregnant women, should not use Mevacor.

Mevacor was the first of the statin drugs, which lower cholesterol by limiting the buildup of artery-clogging fat deposits, reducing the risk of heart attack by about a third. As a group, statins made some $14 billion in the United States alone last year.

Still, less than half the people who could benefit take them. Over-the-counter sales are targeted at those with moderate risk who might benefit from a low-dose version of the pill.

Last year, British health officials approved the world's first nonprescription cholesterol drug, Zocor. Consumers must ask a pharmacist for the drug and answer questions to determine if it is appropriate.

Makers of Mevacor think the time is right for U.S. over-the-counter sales, and some doctors agree.

"There's a tremendous number of patients at risk for coronary disease that we're not able to reach," said Dr. Edgar Lichstein, a cardiologist at Maimonides Medical Center in New York. "We need to figure out different ways to get them this medicine."

The company says it will encourage patients to get their cholesterol checked after they begin treatment, though critics say there's no guarantee patients will do it. The company does not want the FDA to require tests of liver function, despite concerns that the drug can cause inflammation of the liver.

Officials have said they would charge about $1 for each daily 20-milligram pill if the over-the-counter sales are approved. That's less than Merck charges for the prescription version, but consumers who have health insurance would have to pay the whole thing, rather than just a co-payment.

Another drug company, Bristol-Myers Squibb Co., said last month it plans to submit a similar application for over-the-counter sales of a statin called Pravachol, but it has not yet done so.

[foolscap]

This is not a good idea.

[TommyDale]

Still, less than half the people who could benefit take them.

There is a good reason for this: Many people suffer severe muscular pain and suffer strokes after taking the drugs, because they break down muscular tissues. Their side effects far outweigh any potential benefits in many people. This is a way for the drug manufacturers to sell products to the remaining population without assistance from doctors.

[Lil'freeper]

Another Weston A. Price I-Told-You-So-Moment

OTC status for statins is a very, very bad idea.

[MRobert]

I am not aware of any problems with these types of drugs. My husband has used Lipitor for the past few years. Everything we read in the WSJ and other publications suggest they strengthen the walls of the arteries and help prevent the heart attacks that occur when there is a rupture in the walls. If a mild version was on the market I am not sure this would be a bad thing. If there have been deaths from statin use I would appreciate a link to the articles.

[TommyDale]

You may want to do some further research. All the statin drugs cause side effects. You might want to do your own search at Google.com for statin side effects.

http://www.prevention.com/article/0,5778,s1-1-75-57-3004-1,00.html

[Born Conservative]

Statins require regular monitoring of liver function. I don't think this is a good idea.

[Ditter]

I take Zetia for cholestrol is that a statin?

[Quinotto]

Absolutely, I agree with you completely. However, statins have other serious risks because of the way it inhibits the HMG-CoA reductase enzyme, an enzyme which shares the same pathways with other enzymes which, in turns are also blocked, creating the risk for skeletal muscle myopathy and even heart disease. Having these meds OTC means that most people with medicate themselves unsupervised.

[TommyDale]

Zetia itself is not a statin, but it is used IN CONJUNCTION with a statin such as Lipitor, Pravachol, etc. The side effects are the same: muscular aches, etc.

[cynicom]

Let the buyer decide.

[Ditter]

I use Zetia alone and it has brought my cholestrol down about 100 points.

[gortklattu]

---Let the buyer decide---

I agree....more OTC drugs and less government.

[cynicom]

In the past my stomach med cost 80 bucks a month. Now OTC it costs me 16 bucks. I am tired of the nanny state going to extremes to "protect" me.

[foolscap]

Let the buyer decide.

That's ok with me as long as they don't whine about the FDA when they have a problem.

[TommyDale]

Yours is not the normal regimen. You are fortunate you have not experienced the side effects. Sometimes, what some doctors call "high cholesterol" isn't really high at all. But it makes for good business to get everyone on these $100+ per month drugs, especially when doctors get kickbacks from the drug companies. The general public is being duped while a few people really may need treatment.