First, Merck is asking the FDA for the third time to permit lovastatin (Mevacor), the first HMG-CoA reductase inhibitor (or "statin"), to be sold over the counter. It seems twice is not enough. It's like telling a child "no" but they keep coming back, "Really, Daddy?" No! "Pretty please, daddy?" Not only no, but hell no!
So Merck is saying "pretty please?" and feels patients can understand a package insert like the one they use in Spain that says:
"Due to the inclusion of butylhydroxyanisol as excipient this may produce irritation of eyes, skin and mucous membranes."Do they really think Americans will read this stuff? Ask yourself, do men read assembly instructions for a new kitchen appliance or ask for directions when lost? Of course not! Why would we read some stupid package insert from an over-the-counter medication? Does anyone read an acetaminophen (Tylenol) package insert? "Marge, just give me those damn pills!"
But seriously, the drug interactions with lovastatin alone are significant. Lovastatin is metabolized in the liver, and interacts with anticoagulants and antiarrhythmic drugs like Amiodarone, and can cause some rip-roaring myositis (inflammation of the muscles) in patients who might be taking other cholesterol-lowering medications like niacin or fibrates.
And heck, with simvastatin (formerly Zocor) available for $4 for 30 pills at Walmart by prescription and is likely cheaper, do Americans really need this?
Worse still, doctors have enough problems tracking prescribed medications on their patients. Will we really know what medications a patient is taking when all of these other medications want to be circulated over the counter?
Speaking of Zocor...
What's up with Merck and Schering-Plough withholding their results of the ENHANCE trial that compares, head to head, the combination drug Vytorin (simvastatin + ezetimibe) to simvastatin or placebo? This morning the WSJ Health Blog reports that the US House of Representatives Energy and Commerce Committee and Subcommittee on Oversight and Investigations is concerned "with the delay in releasing the results of the study, the timing of the ENHANCE trial registration (on ClinicalTrials.gov), and the apparent manipulation of trial data." (Letter here).
Since when has our Congress cared so much about scientific endeavors such as this? I mean, this is one of tons of other cholesterol trials out there. Are they really interested in the delay or could there be another political motive? Could it be because Michigan Democrat Bart Stupak was left off Schering-Plough's political donation list when Rep. John Dingell got $5000 or because Merck left Michigan off its contribution list entirely in 2006? Is Congress now suddenly interested if drug companies might be massaging their data just to get the results they want? Or have the Democratic House members been raising these questions because they just shorted Merck and Schering-Plough's stock?
I guess we'll have to wait for the March ACC meeting to find out.
Addendum 13 Dec 2007 19:50 CST: Three strikes, they're out. The FDA rejects Merck's bid.