Another Over-the-Counter Propriety Debate
A while back the FDA considered — and rejected — a proposal to allow a cholesterol-fighting statin to be sold over-the-counter. I was ambivalent about the plan; it’s easy to self-medicate for symptom relief such as headaches, athlete’s foot or coughs, but “high cholesterol” is asymptomatic and non-binary (i.e., not a simple case of “you either have it or you don’t”).
I do, on the other hand, wholeheartedly support this de-scripping proposal:
A pharmaceutical company that seeks federal approval for over-the-counter sales of a prescription diet pill that blocks the absorption of fat faces questions on the pill’s potential for creating vitamin deficiencies and encouraging abuse.
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An FDA reviewer found [orlistat] is a “safe and effective weight loss agent,” but held off on recommending whether the … advisory committees should in turn recommend to the FDA that it approve the drug for sale without a prescription.The drug acts by blocking the absorption of about one-quarter the fat a patient consumes. That fat is then passed out of the body in stools, which can be loose or oily as a result.
Remember olestra? Orlistat is almost like an olestra pill — it makes the fat you eat undigestible. The upside is that the fat can’t go into your body; the downside is that the fat goes somewhere else, as anyone who has eaten too many olestra potato chips knows.
In any case, since “overweight” is a self-diagnosable condition, like a headache but unlike high cholesterol, it seems to me that there is no reason not to de-scrip it.
Silly libertarian me:
[T]he primary concern with the drug is its potential to create vitamin deficiencies, since its use also would block absorption of fat-soluble vitamins like D, E, K and beta-carotene.
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Orlistat may also block some drugs, including cyclosporine, used to prevent rejection of kidney, liver and heart transplants. … Furthermore, just 35 percent of diabetes patients in a study correctly stated the drug was not appropriate for them to use, according to agency documents.The regulatory agency also is concerned about increased potential for abuse or misuse of the prescription-free version of the drug, especially among bulimics or binge-eaters who could develop vitamin deficiencies due to chronic use of the drug.
Given the criticism (deserved or not) of the FDA in the COX-2 mess, I somehow suspect that there is now an overarching aura of the Precautionary Principle at the FDA (i.e., always err on the side of caution). This would argue against de-scripping the drug.
Moreover, it is always a fundamental characteristic of bureaucracies to see only those who need protection from themselves, not those who don’t. Millions of people could benefit from de-scripping Orlistat. But a few diabetics, transplant patients and bulimics might incur some negative consequences from the drug. So keep it behind the pharmacist counter. Just in case.
Maybe I’m too cynical and the FDA will vote in favor of personal choice and personal responsibility. Or maybe the War on Fat will outweigh (no pun intended) the War on Self-Reliance and the “obesity crisis” will compel the FDA to “do anything” to get people to lose weight.
Stay tuned…
POST SCRIPT: If any of my medically literate readers know of a better term than “de-scripping,” then please leave a comment. “Over-the-counterizing” sounded far worse.
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On a related note, the FDA is also considering saving the planet from dropping dead by telling asthmatics to drop dead:
An advisory panel voted 11-7 Tuesday to recommend that the Food and Drug Administration remove the “essential use” status that Primatene Mist and other similar nonprescription inhalers require to be sold, spokeswoman Laura Alvey said. Final revocation of that status would mean a de facto ban on their sale.
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Wyeth Consumer Healthcare estimates that 3 million Americans use Primatene Mist for mild or intermittent cases of asthma, spokesman Fran Sullivan said.
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The over-the-counter inhalers proposed to be banned contain the drug epinephrine along with chlorofluorocarbons, or CFCs, which propel the medicine into the lungs of asthmatics.
MY TAKE: Even taking as a given the assertion that CFCs generate externalities in the form of ozone layer erosion, can the collective squirts of even all the world’s Primatene users really pose a sufficient threat to the planet to deny them the relief that the product offers? Zero tolerance for any and all CFC use is not an enlightened, externality-correcting policy. It’s overkill in the name of warm-fuzzy-feeling policy (or, if you’re an asthmatic on Primatene, a warm-fuzzy-wheezing policy).
More thoughts at Market Power, Malcontent.
Similar Posts:
- COX-2 Update: Some Sanity Returns to the Debate
- Should You Be Trusted With Your Own Cholesterol?
- More on “Plan B” and “Conscientious Objector” Pharmacists
- On Compulsory Pharmacology
- Wheat the Heck are They Thinking?
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Re: asthma and inhalers.
My albuterol inhaler does not list chlorofluorocarbons (CFCs) as being the propellent.
That would imply there are other non-CFC propellents available.
I would type out the names of the propellents used but the type is too small and each consists of about seventy letters.
Damn chemists.
Another point re: inhalers and CFCs. My experience, at least with albuterol is that all of the contents of the squirt are shot into the back of the mouth.
How does the body metabolize CFCs? For all we know it is rendered harmless by some chemical process in the body?