Now that the pharmaceutical companies have an OTC statin in Great Britain, we focus on the US market. Apparently, several companies have interest in OTC statins here. Drug Makers Propose OTC Cholesterol Drugs

Some of the world’s biggest drug companies are working behind the scenes to convince regulators to let older cholesterol-lowering drugs be sold without a prescription in low doses, as Britain has just done.

A decision is months away, but approval by the Food and Drug Administration could significantly affect the nation’s biggest public health problem, heart disease, and greatly expand sales in the top-selling drug category.

Cholesterol drugs, or statins, raked in $26 billion worldwide – $14 billion in this country alone – last year, according to health data company IMS Health. By limiting buildup of artery-clogging fat deposits, they can reduce risk of heart attack by about one-third. The category is dominated by blockbusters Lipitor, made by Pfizer Inc., and Zocor, made by Merck & Co. of Whitehouse Station.

While doctors say the drugs are safe, less than one-half of Americans who could benefit take them, mostly those at highest risk of heart disease, other complications and death, experts say. Most of the 18 million at moderate risk, defined as having a 10 percent to 20 percent risk of such problems over the next decade, are not on medication.

I continue to consider this issue. For those who pay out of pocket, we would see a price advantage (see the next quote). The problem that I have difficulty with remains inappropriate use. Statins are not a substitute for broad risk reduction. Statins are not an after steak guilt reduction agent.

Besides compiling evidence of Mevacor’s safety and effectiveness, the venture has worked with nearly 10,000 consumers through surveys, focus groups and tests in mock pharmacies. It’s all aimed at proving to FDA that the average Joe could correctly follow the proposed package information to determine whether he is a good candidate for the nonprescription version or needs a much stronger prescription dose.

“Visits with a doctor are not required but are highly encouraged,” under the application being prepared for FDA, Hemwall said.

The company would encourage people to get follow-up tests of cholesterol levels. Hemwall said it will ask FDA not to require tests of liver function, because early concerns have proven since unwarranted.

Merck says nonprescription Mevacor likely will cost about $1 for each daily 20-milligram pill – more than what many insurance companies would charge for a co-payment on a brand-name prescription drug. Prescription Mevacor currently costs $2.10 per pill.

Launched in 1987, it had peak sales of $1.3 billion in 1994. That dropped to $31 million last year amid competition from generics and heavily advertised Lipitor.

It really is about the money. Insurance companies will support the concept, as it will decrease their costs. Many will support the concept on the basis of freedom.

I have not really decided yet. For many OTC would make sense. I hope we let Great Britain have at least a year lead time, so that we can learn from their experience.

So what do you think?

Related posts:

1. Wherefore statins?
2. Why we need CER – the short story
3. On statins
4. Do we overuse statins?
5. Why patients stop taking statins!

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