Over-the-counter sales of cholesterol drugs

Counter Service

Last week I received an e-mail from a friend that read, “Did you know the FDA just voted down OTC sales of cholesterol drugs?”

At first glance it might seem that someone at the FDA was on the right track for once. And in a way that’s true. But there’s more to it than that. Much more. And before this story finally runs its course, the health of many thousands of Americans could be put at risk.

As they say, the “pursuit of giant drug corporation profits” is in the details.

Terrible synonyms

Here’s what happened last week: An FDA advisory panel voted to recommend that the agency should not allow over- the-counter (OTC) sales of Mevacor, a choloesterol-lowering statin drug.

The proposal to make Mevacor available without a doctor’s prescription was put forward as a joint effort of Johnson & Johnson and Merck, who we’ll call “JJM” for today’s purposes. Executives at JJM may have felt both confident and uneasy at the same time about their proposal. On one hand, health officials in the UK approved OTC sales for the statin drug Zocor last year. But on the other hand, the FDA has been under fire lately for letting certain popular drugs sell like gangbusters for years until – oops! – finding out that the drug companies weren’t entirely forthcoming about dangerous adverse side effects.

Then again, maybe neither of these aspects came into play. Maybe the panel looked over the evidence and simply refused to ignore the obvious: OTC sales of statin drugs is a terrible idea. Feel free to replace the word “terrible” in that last sentence with “disastrous,” or “reckless” – anything along those lines will do.

Counting the ways

The primary problem with making statins available over-the- counter is that it takes doctors completely out of the loop for a drug that’s designed to be used indefinitely. And this is one drug that needs to be monitored by a health professional for these four key reasons:

In some patients, statins increase enzyme activity in the liver. Liver damage can occur if this increase is pronounced, but symptoms don’t occur until the damage is underway. When a doctor monitors liver function, damage can be avoided. (This may have been a sticking point for the OTC proposal for Mevacor: According to a CBS news report, JJM didn’t want the FDA to require patient screening for liver function.)
One of the most common side effects of statin use is muscle pain. In some patients statins actually cause muscle cells to break down. When this happens, a protein called myoglobin is released into the bloodstream, which can trigger the third problem
Myoglobin impairs kidney function and can even lead to kidney failure.
Statin use depletes antioxidants in general and Coenzyme Q10 (CoQ10) in particular. CoQ10 fuels cellular energy production and repairs free-radical damage to the heart muscle. When CoQ10 is deficient, heart health is put at a disadvantage. This is why many doctors recommend a CoQ10 supplement when they prescribe statin drugs.

Are we there yet?

The advisory panel that considered the Mevacor proposal consisted of 23 medical professionals. Their vote: 20-3 against allowing OTC sales.

In football, that score would be considered a blowout (just ask Peyton Manning). And while the rejected proposal may have been a setback for JJM, the drug industry knows that this was just one game in a long season.

Bristol-Myers Squibb is currently preparing a proposal to request OTC status for the statin Pravachol. At this point, Pravachol’s chances don’t look too good, but drug company executives have been playing this game for a long time. They know that if they simply keep asking again and again and again, sooner or later attitudes will change, timing will eventually work to their advantage and somewhere down the line an advisory panel will probably cave in and say, “Oh okay, why not? Let’s try it.”

A Reuters report about the Mevacor rejection quoted Dr. Frank Davidoff, editor emeritus of the Annals of Internal Medicine. Dr. Davidoff said that making statins available OTC is “the right thing to do, but I don’t think we’re there yet.”

Dr. Davidoff seems to know that the day will come when “we” are going to be there.

Sources:
“FDA Panel Rejects Merck OTC Drugs” Lisa Richwine, Reuters, 1/14/05, reuters.co.uk
“Cholesterol Drugs Without Rx Eyed” CBS News, 1/13/05, cbsnews.com