OTC Lipitor is a Bad Idea

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It certainly had a nice run. In fact, the nicest of any drug ever. But the Lipitor party ends today and while Pfizer's attempt to derail generic sales by selling the drug over the counter might be a good business move, it is a bad medical move. And not even original.

In 1999, Warner-Lambert was in talks to merge with Wyeth (then American Home Products) when Pfizer swept in the next day, making Warner-Lambert an offer they could not refuse. They ended up paying $90 billion for Warner-Lambert, substantially more than the Wyeth deal was worth. They were essentially paying $90 billion for Lipitor, which, despite being launched only two years earlier had already become the leading statin on the market, passing its four competitors at lightning speed. By 2009, Lipitor was earning over $12 billion per year, accounting for about one-quarter of Pfizer's sales.

Now, with Pfizer losing a very big chunk of its revenue, they are trying quite hard to hang on to whatever they can. This makes sense, but one of their strategies does not--selling Lipitor over the counter. Merck tried to do the same thing in 2008, after Mevacor had lost patent protection. The FDA shot this down, and they should do the same here.

Some have argued that selling former prescription drugs OTC is fine, citing off-patent acid reducing drugs like omeprazole (Prilosec) and ranitidine (Zantac). This would eliminate the cost of a visit to the doctor and may save consumers some money. But this analogy doesn't add up. There is a big difference between the two.

Here are the issues involving the OTC acid reducers:
Swallow pill. Stomach feels better.

But here are some for Lipitor:
Do you really need to take it?
If so, what is the right dose?
Are you taking them to improve your HDL ratio, triglycerides, both?
What are your target numbers?
How well is your liver functioning before you start?
Does the drug cause elevated liver enzymes, and if so, what do you do?
What do you do if your muscles start to ache?

Not so simple, is it? Which is why I believe statins should only be used under the supervision of a physician. Just like antibiotics, blood pressure and asthma medications, and many others. I strongly suspect the FDA will agree with me.

If Pfizer wants to regain dominance in the statin market, they will have to invent something better.

OTC Lipitor is a Bad Idea/Medical Progress Today