An OTC Cholesterol Pill? What Do You Think?
10 CommentsBy Ed Silverman // December 11th, 2007 // 10:30 pm
Earlier this week, we noted that an FDA panel will meet on Thursday to review the merits of allowing consumers to buy Merck’s Mevacor without a prescription. This marks the third time in eight years that Merck is asking an FDA panel for permission to sell its cholesterol-lowering med on an OTC basis. If the panel and the agency agree, Mevacor would become the first over-the-counter statin, the biggest-selling class of meds.
Merck argues that untold millions of Americans susceptible to heart disease and stroke who aren’t taking a statin could receive health benefits, especially since many people don’t think about their cholesterol levels if they don’t feel sick. But not everyone agrees an OTC pill is best. An FDA medical reviewer wrote in briefing documents that she isn’t convinced “there is adequate consumer comprehension of the proposed product label to ensure safe and effective use of this product.”
What do you think?
Is an OTC cholesterol pill a good idea?
- No (59%, 88 Votes)
- Yes (41%, 62 Votes)
Total Voters: 150
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Dan
I’m not a health care provider, but I have promoted statins in the past, including Mevacor.
And I’m against having any statin OTC. The treatment requires diagnostic testing, which is a protocoled and structured blood test, for a complete cholesterol analysis. Obviously, a high cholesterol patient does not experience or display any obvious indications that they would have high cholesterol. One should probably not treat high cholesterol on thier own based on speculation or for prevention at this point.
A possible exception would be if the medical community agreed that patients could test thier own cholesterol, just as many test thier own blood sugar, and then it may be appropriate for them to dictate any needed treatment afterwards, which in this case Mevacor OTC may be a suitable treatment.
Statin treatment is not as if one has a runny nose or a cough or something, which is why I have this opinion.
Outsidethe box
There are two pre-requisites for the safe OTC sale of any drug - the patient must be able to self-diagnose and the drug must be as close to totally safe as possible. I don’t know about Mevacor’s safety profile but I know for sure that patients cannot safely self-diagnose in this area.
I can see an argument for a BTC approach, requiring that the patient demonstrates professional diagnosis and follow-up before being allowed to purchase, but OTC seems too far given the combination of factors involved in the correct use of these products.
Robert DeVito
Mevicor & other statin drugs can be dangerous. I was taking Lovastatin 80mg. My feet are numb and my calves ache. I have visited 4 doctors and have neuroapathy. CAT scans show spots on my liver and kidneys. The FDA would be foolhardy to give OTC approval. What would be the correct dosage?
Anna
OTC I am not so excited about, but statins would be prime candidates for BTC therapy. Cholesterol and liver enzymes can be monitored in the pharmacy (I have worked in a German pharmacy where such service was provided) for a fraction of the cost of a doctor’s visit + lab. Oh, I am pharmacist myself, for those questioning my bias(es).
Mike Dunphy
Mevacor would be an ideal drug for the new 3rd class of drugs. This class would restrict the sale to a pharmacist who performs a short evaluation (based on a cholesterol test and a discussion with patient). The pharmacist would insist that appropriate labs be done prior to dispensing more in the future.
Very cost effective approach that would assure that the patient was taking the drug for the right reason and that safe medication practices were adhered to.
The time has come for a 3rd class of drugs (restricted to Phrmacists).
Brian
Zocor has been available BTC in the UK for several years, so the experiment has already been successfully tried. It has the potential to save a lot of people a lot of money, and increase the number of people who who are actively lowering their risk of CVD. Lets face it, its a lot easier to pop a pill than lead a healthier lifestyle!
On the other hand, if a statin was available BTC, I’m not sure that I would personally take it UNLESS my CVD risk was dangerously high, simply because I don’t think that my HMG-CoA reductase pathway is something I’d like to mess with un-necessarily. There are other ways that I’d rather try first to lower my CVD risk profile (and I already do so.) And, I am hopeful that some of the other options in the pipelines will prove fruitful.
This is just a personal choice and not necessarily one that my Primary Care Physician (if I had one) would agree with.
But, this does point out one possible problem with BTC statins: choosing to take a major drug (yes, a statin is a MAJOR drug!) every day for the rest of your life is a big decision, and people should fully understand the pros and cons. And they should be willing and able to take the necessary steps to protect themselves (Eg., occasional liver enzyme monitoring and hold the grapefruit!)
I am all in favor of giving people choices, but a choice made without proper consideration of all the facts is worse than no choice at all.
BP MD
No way! Horrible idea!!
Hank
As I recall, FDA restricted sales of “Red Yeast rice” precisely because it contained the statin that is Mevacor.
If the pharmacist is doing labs, it’s no longer OTC. But full assessment of risk factors, target levels and their rationale, discussion of any potential AEs would all have to be included.
There may be some pharamcists in the U.S. who do that, but I haven’t seen it.
Anna
Hank,
It is done very commonly by pharmacists at the VA clinics and at Indian Health Service. Blood pressure clinics, warfarin clinics and cholesterol clinics are staffed by pharmacists. Many pharmacy students also rotate through these sites.
Garden Fountain Freak
Garden Fountain Freak…
Although i totally disagree with you, i still appreciate you\’re post. (but you\’re wrong here :) )…