Pfizer is getting ready to take a multibillion-dollar loss this fall when it loses patent protection on the best-selling drug of all time. But don't expect them to sit back and watch Lipitor's $11 billion a year in sales go down the drain. The Wall Street Journal says the company is hatching a plan to have its cholesterol-lowering drug sold over the counter.
And if they get their way, you can bet it won't just be sold in pharmacies anymore. I'm thinking 7-11, McDonald's, and Dunkin Donuts, for starters, where Lipitor can be billed as the antidote to cholesterol-laden convenience foods.
That's not nearly as far-fetched as it sounds. Some researchers have already proposed doing exactly that. (Read about it here.)
But if there's anything as bad for you as a fast food meal on your plate, it's a statin in your body. I don't care what you've been told. These drugs are bad news.
Along with the notorious risk of muscle weakness and debilitating pain, statins have also been linked to kidney failure, liver damage, cataracts, joint and tendon problems, sexual issues, and even an increased risk of diabetes.
That's right... a drug that's supposed to keep a supposed risk factor for diabetes in check -- cholesterol -- can actually help bring the disease on.
Here's a better plan: Skip the fast food and skip the statins. Basic lifestyle changes can do a much better job of keeping cholesterol levels under control anyway.
The one bit of good news here is that Big Pharma is 0-for-2 when it comes to getting statins approved for over-the-counter sales. Merck's plan for OTC Mevacor was rejected by the feds at least three times, along with Bristol-Myers Squibb's bid for nonprescription Pravachol.
Normally, I spend a lot of time ripping FDA decisions -- and, let's face it, there's a lot to rip. But in this case, the agency has managed to get it right -- and they've already put Pfizer on notice that the bar for over-the-counter Lipitor has been set pretty high.
"They would have to provide data to show that consumers understand the treatment and recognize that cholesterol-monitoring is required," FDA spokeswoman Shelly Burgess told Bloomberg News.
That's not going to be easy, because Burgess quickly added that previous studies have shown that patients don't get it.
"Most study participants made mistakes and chose to take the proposed over-the-counter statin when they should not have done that," she was quoted as saying.
On the other hand, statins such as Zocor are already available over the counter in the U.K. -- so maybe it's only a matter of time before the FDA follows suit.