You Know What Happens When You Assume

To nobody's surprise:

A Food and Drug Administration advisory panel recommended against the over-the-counter sale of a Merck cholesterol-lowering drug, saying that while millions of Americans could benefit from taking it, they should not begin such a regimen without a doctor's advice.

Also, to nobody's surprise, the medical establishment, as illustrated by the heavy hitters of the medical blogosphere, breathe a sigh of relief. Dr. Rangel:

For many people this issue reeks of the self-serving paternalism of the medical profession intent on preserving its monopoly on medication prescribing. Well, this is one spin on the issue but this ignores the possibility that there are real practical reasons for such a system. For one, there are real potential side effects of medications that can be life threatening and may develop in the course of normal use of a medication.


The safe use of these drugs requires monitoring of subsequent cholesterol levels (to get the correct dose) and liver enzyme levels (to check for the not infrequent side effect of liver inflammation), which - suprise - require visits to the doctor, and time, and money. If these are granted over-the-counter status, then every other medication from antibiotics to blood pressure medication to anti-depressant medications might as well be made over-the-counter, too.

Maurice Bernstein of the Bioethics Blog:

I am pleased that the panel made the right decision and ethically showed beneficence to the public. In view of the ciriticisms the FDA itself is having with regard to other drug issues currently, it is doubtful that the FDA will go against the decision of the panel.

And finally, from the original article:

None of the panel members said they were worried about serious muscle or liver function problems with Mevacor, which is one of the earlier, low-strength statins. The use of some newer, stronger statins has been associated with a potentially fatal muscle-wasting condition called rhabdomyolysis.

But several panel members said they were concerned that the availability of a low-dose statin in drugstores would cause some patients to forgo the more intensive therapy they might actually require.

Dr. Boisey Barnes, a Washington physician, raised that same issue from the floor during the panel's public testimony session. He also voiced concerns that people who buy statins over the counter would not make other, more important changes. "A healthy lifestyle, low-fat diet and exercise may achieve the same results of O.T.C. statins," he said.

Of course, I am dismayed by the conclusions these people come to (as illustrated here). But what dismays me almost as much, is the seemingly complete inability for anybody to say anything new, different, or interesting. It's the same old reasoning (however internally logical), using the same old assumptions.

I think we should be afraid whenever we see people all thinking the same way and coming to the same conclusions. When you see this, you can be sure the exact same assumption are being made. And these assumptions are often unspoken. And when unspoken assumptions are made, a lot of interesting questions are never asked nor addressed.

I would like Dr. Rangel to address what risks exactly we should be allowed to take and which ones not, and who gets to make that distinction, and why. I would like Dr. Smith to address why the law should force people who seek to improve their health only to do it under a doctor's supervision. I woud like Dr. Bernstein to address exactly which medical ethic the FDA decision protects, and to examine which ethics, if any, it contradicts, and what to do when an actions promote one ethic and cross another. I would like Dr. Barnes to address why some strategies of improving health are morally superior to others.

None of these issues are discussed or debated - they're assumed. And in assuming them, a lot of interesting questions go unanswered. In their stead, we get several cookie-cutter reports of the unsurprising and uninteresting account of how a government agency protected the interests of certain individulas, while those individuals claim that this protection is for the good of their customers. Wake me up when somebody says something interesting..

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With regard to the question

With regard to the question posed to me, I think that the main responsibility of the FDA is the protection of the public and whatever the agency does this should trump every other issue. Protection means making decisions which are ethically beneficent to the public's health and to assure that the decisions are non-malificent (that they don't, in the long run, cause harm). Other considered FDA functions such as encouraging pharmaceutical research by pharmaceutical companies through perhaps con sidering to support the companies "bottom line" cannot be ethically acceptable if there is any question of public harm by the FDA's decision. In the current case of switch of Mevacor to OTC status, it clearly would benefit the pharmaceutical company financially but to those of us in the medical profession who have dealt with evaluating and monitoring patients for statin therapy, a FDA decision to allow the switch would clearly invite harm. The documented inadequate patient treatment by physicians with statins for primary and secondary benefit should not be resolved by making the drugs OTC but through more intense education of physicians and the public. You know, I strongly disagree with TV drug commercials which end up with "Ask your doctor.." except I think a media campaign with "Ask your doctor whether you could benefit from beginning statin treatment" would be most appropriate and perhaps very effective. ..Maurice.

:roll: Wake up, then.... If


Wake up, then....

If Dr. Barnes feels that a healthy lifestyle, low-fat diet, and moderate exercise may achieve the same results as the drugs he's so worried about, the the answer is clear--it's time to forbid people from having a healthy lifestyle, eating low-fat foods, or exercising, unless they can show that they have a legal prescription from a qualified doctor!

Maurice, why then let

Maurice, why then let anybody buy any drug over the counter? If an OTC drug is concentrated enough to have a noticable effect on a patient, wouldn't it be strong enough (potentially) to cause interactions with other drugs. Why the double standard? Heck, we don't even have to worry about interactions; If I gave my then 2 year old son the doses pf cough syrup I was taking in the early stages of bronchitis, I would have killed him. In fact, I seem to remember a father who killed several of his children in precisely that manner a few years back.

Shouldn't we unwashed, un-medically trained masses be prevented from the dangers of all drugs?

To me the entire premise of the FDA is seriously flawed: it acts as a gatekeeper making the fundamental decisions about acceptable medical care for millions of people who face criminal sanctions if they disagree. Now, I am pretty risk adverse, so I carefully study a drug's track record before I agree to take it. However, if I were dealing with a life-threatening difficult to treat illness, I would probably far less risk averse. In fact, I want to be left free to be the ultimate arbitrer of what is acceptable risk in my medical care.

By preventing me from exercising my freedoms, by essentially preventing me from seeking medical care that does not meet their criteria, the officers at the FDA are interfering with my access to medical care. I consider this a serious violation of the Hippocratic oath's dictum of "Do no harm."

You speak of protecting the public, as if it is some entity. It is not: the public is a mass of individuals, each with different needs, ailments, reactions to treatment. When they are all made subject to the same restrictions to treatment, some benefit, and some are harmed. Of couse, those being harmed are not those making the decisions, so there is no interest on the part of decision makers to limiting harm. Quite the opposite, the simpler their rules, the easier it is for the decisionmakers to manage their jobs. This sets up the immoral situation where those harmed have no legal recourse other than to be denied the medical care they desire.

:cool: Emoticons!

:cool: Emoticons! Cool!

Trent, I have addressed paternalism in medicine in a recent post.

Tarran, your straw man argument reduces the prescription medication system to that of a restriction of access to health care that leads to harm. However, you never explain nor give specific reasons as to why you believe this is so. This is not something that you can assume because as Trent clearly states, you know what happens when you ass-u-me.

If I want to improve my health then I make an appointment with a physician. I go to the appointment, get my cholesterol tested (plus possibly a screen for diabetes and other tests). I give a history that may give my doctor clues to other possible health conditions (thyroid disorders or heart disease) that I may have but I have not recognized the slight symptoms. I will then get a physical that will be a screen for other unrecognized health conditions (heart murmurs, enlarged liver and spleen, etc). The visit will usually be covered by insurance and if my cholesterol is too high or there are other conditions that are discovered during the course of the visit my doctor will write a prescription for medications to treat these conditions. My doctor will then give me advice on diet and exercise and maybe home monitoring of things like blood pressure and will schedule a follow up visit to monitor my treatment and future follow up lab tests. The benefits of such a comprehensive approach to health care is clearly better than simply going to the pharmacy and buying some Mevacor to take.

However, please explain to me how the process that I have described above represents an undue "restriction" on the freedom to treat medical conditions and improve one's health. Please do not use the reason that a doctor visit is an "inconvenience". An inconvenience is not an undue burden or restriction on access to health care by the patient. There are many incontinences in life that do not represent significant restrictions on freedom and liberty.

Your belief that IF the FDA requires prescriptions on most medications then ALL medications should require a prescription is a fallacy of over-generalization. Just because a certain medication could potentially be harmful is not the only reason the FDA uses for deciding the prescription status of a medication (this is an over-simplification on your part). The FDA uses a benefit-potential harm analysis when evaluating OTC medications. For almost all OTC medications the FDA has determined that not only is the risk of adverse side effects very low when used as indicated but that patients have clear-cut indications for the uses of these medications and can self medicate based on symptoms of mild and usually self limiting conditions (acute mild cough, fever, congestion, mild-moderate pain, allergic symptoms, constipation etc.). Statin medications for lowering cholesterol are different in that they are used to treat a symptom-less and often chronic condition that usually coexists with numerous other comorbidities and even normal usage can result in a life-threatening condition. It is the combination of all these factors that lead the FDA to its decision.

A bit of a tangent -- but,

A bit of a tangent -- but, have you heard what may happen to vitamin supplements via the WTO?


Dr. Rangel, Paternalism

Dr. Rangel,
Paternalism rests on the assumption that you know better than I know what I should do for my own health, and thus it follows automatically that you have the right to act as gatekeeper for my medical decisions. It seems to me that this leads to the idea that if anyone can claim that they are better able to make any decision for me better than I can for myself, then the burden is on me to prove that they cannot. Otherwise, they can claim unlimited rights to make any decisions for me, about any area of my life. I object to paternalism because there is absolutely no basis for you to claim that you have any right to act as gatekeeper or overseer of any decision about any aspect of my life. It doesn't matter if you know better than I do or not. I also object to medical paternalism on personal grounds. When I needed to make a fairly major medical decision within the last few years, I consulted three different physicians, all highly trained experts. How many distinct opinions did I get? Three. The last doctor, after telling me what he thought, simply said "It's really up to you what you want to do." That's the way it's always been. My doctors do give me good advice, but in the end the tough choices are always mine alone. No one can make them for me. So, why can't I just seek out the advice I believe I need and make the decision that's best for me? Doctors themselves admit that they can't make the really tough choices for us- they can only give us options. So why give them so much power?

[...] Chris Rangel, et al.

[...] Chris Rangel, et al. I will hopefully get to that tomorrow. In the meantime, let me move this from Lisa Casanova up from the comments [...]