Risky Statin Drugs- Reshelved by the FDA

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Risky Statin Drugs- Reshelved by the FDA
An Over-the-Counter Prescription for the Future
FDA shelves off-the-shelf statins - for now
Ever since June of 2003, when the FDA approved the prescription-only heartburn drug Prilosec drug for over-the-counter sales, drug makers have been chomping at the bit to secure this same lucrative treatment for the wildly popular (read: over-prescribed) "statin" drugs for cholesterol control. Thankfully, the FDA voted against such a transition last month...
But get this: They shot it down because the proposed labels for the drug didn't adequately articulate who should and shouldn't take it - not because they know the drugs are too dangerous to patients' hearts and livers to be popping like breath mints. A few labeling changes and a new application later and it'll only be a matter of time before the limp-wristed FDA buckles and we'll get shelves full of "Mevacor OTC" and other risky statins.
Why, you're asking?
A bunch of reasons - all of them revolving around money. For one, it means a bundle in tax revenue on full-mark-up sales of these drugs, which surely won't be covered by health insurance in their over-the-counter form. This means that states with sales taxes in place will lobby for the approval of these less-potent (but still dangerous) medications, putting pressure on the FDA from a second front. The Feds will find a way to milk this revenue stream somehow or another.
Secondly, if the success of non-prescription Prilosec is any indication, de-regulating any mass-appeal prescription drug will increase demand and production - which means more revenue rolling in from corporate taxes on the major drug manufacturers. And by taking insurance companies out of the equation, the profit pie gets split one less time.
Proponents of the plan say people who won't go to the doctor but who nevertheless need treatment will now be able to get it, while opponents say that de-prescriptionizing drugs takes doctors out of the equation (not always a bad thing).
How do doctors feel about this potential transition? Without a huge, costly, and time-consuming survey, it would be impossible to know how rank-and-file doctors feel about the issue. Some might perceive that the move marginalizes them in the health-care process, while others (given today's outrageous malpractice insurance rates) might be relieved that patients are taking the liabilities for treatment on their own shoulders...
I'm torn on the issue, and here's why: If people self-diagnose and buy an over-the-counter statin, they may be taking the drugs needlessly (like most who take them), but they'll be taking a less potent - and ostensibly, less poisonous - version of the medication. On the other hand, those who go to the doctor invariably leave his office with a full-strength prescription...
This is a lose-lose situation. Since the paradigm is false - that cholesterol is a toxin rather than an indicator of good or bad health, depending on the blood report - the patient is treating a non-disease with a toxic drug with or without the blessing of a doctor. This is not medicine; it is mayhem.
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Bloated Ballet
I've written before about the modern trend toward "fat acceptance" instead of contending with the obesity problem in meaningful ways like sensible nutrition. But until recently, this has been a largely American phenomenon. After all, we're the nation with the most fast-food restaurants, disposable income, and the most sedentary jobs...
But in neighboring Cuba, there's now a whole new take on this trend: Fat as art.
Since 1996, that island nation's Danza Voluminosa (Voluminous Dance) ballet company has featured performers that would crush the average Bolshoi ballerina into pulp - some weighing more than 300 pounds. No, this isn't a parody show, and it isn't something out of a Kurt Vonnegut short story. It's REAL ART. And according to a recent AP piece, the players are capable of an astonishing range of dance moves, though naturally the leaps, pirouettes, and Grand Jettes are relatively scarce.
As you might expect, the troupe caters to a plus-sized audience. And though Cuba hardly endures an obesity epidemic like its Northern neighbor, they are beginning to see an increase in some of the health challenges associated with an overweight population.
It's too early to tell if the idea will catch on here in the states, but I wouldn't be surprised. After all, we tend to gravitate toward both fat and mediocrity (look at your Congress, for instance), so it should only be a matter of time, right?

Never dancing around the point,
William Campbell Douglass II, MD

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