Monday, August 24, 2009


What, Me Worry?

A fascinating study recently showed that a substantial number of docs have little or no idea what applications of drugs have or have not been approved by FDA.

One can imagine multiple reasons--from indifference to ignorance to the success of borderline-legal promotion to industry-sponsored CME, etc.. And, of course, off-label rx'ing has never been unusual. But the degree of pure lack of knowledge adds an interesting angle.

Thanks to Fierce Pharma for the tip:


  1. All the more reason to stamp out preemptive laws and medical malpractice caps.

    This survey tells us we need to do our homework before taking any prescribed medication. Unfortunately, most people would never think of doing any such research. They believe their doctor is on top of things and the medicine prescribed will help, not hinder.

    ThePopTort: The Ugly Truth Behind Medical Malpractice Caps

  2. Actually, we need to do our homework before taking any prescription drug, having any medical procedure, going to any doctor or hospital and, most importantly, before voting for any politician. It is our political "leaders" who are responsible for the laws that promote such inequities. Perhaps we should be able to sue the lawmakers for pain and suffering... No Caps.

  3. OK, to be the D's advocate.....

    What if we do our homework and discover that a drug or device has not been approved for a particular condition for which our doc rx'd it (a very common experience).

    We ask our doc about it, and s/he says that FDA approval is not the basis of medical practice--clinical experience, his own and others, shows the use to be safe and effective as far as s/he is concerned.

    If we otherwise trust our docs, is there anyone out there who would opt out of a treatment _only_ because it has not been FDA approved?

    If so, do you also not use any supplements?

  4. To El Diablo,

    If my doctor prescribes me a drug that is not FDA approved for the use he is prescribing it for then I say - "SHOW ME THE DATA"! Produce the evidence that is the rationale for this course of treatment for me. Provide me with a risk versus benefits analysis. Now, if the doctor doesn't want to do that, then you have a "flag on the play". The question is then, how can you go forward, when your "counselor" which is exactly what the doctor is, (he is providing you with information much like a lawyer, much like an accountant) doesn't want to provide you with the right information?.

    This is why preemption cannot work. Preemption undermines the ability of the patient to legally pursue their medical adviser. Preemption sets up the dangerous precedent of "victim/patient versus big pharma", it completely debases the patient/physician relationship and alienates the patient from being able to access informed decision making and knowledge empowered self advocacy in order to improve their health outcomes. If the doctor cannot answer your questions, then do not take the drug - it is your body - work it out!

    When I do use supplements I do my research and look at any human trials and study the logic and rationale. So far, I am very impressed with the information on Vitamin D...

  5. Hi Former,

    OK, let's take it a few more steps. Your doc (an honorable and excellent clinician) says that, as far as s/he knows, there are no formal studies that support the indication in question. Some day there probably will be, but that day has not come. But, in the meantime, there is clinical experience--his/her own and others'--which suggests excellent results. S/he says it is perfectly fine for you to wait for the day when/if there is more data. That's up to you. In the meantime, you are taking risks either way--by going with what s/he suggests or not going with it.

    Is having such data an absolute prerequisite to your going with the suggestion? How much is "enough"?

    Re: vitamin D, you are right that we certainly have data now we didn't have, say, five years ago. Or at least it wasn't much publicized. Again, how do you decide, as an individual patient, when there is "enough" data? Clearly, FDA-approval is not the answer. As far as I know, FDA has not approved the various reasons why many are now being advised to up their vitamin D intake.



  6. To make it even more interesting, your doc suggests that the reason there aren't more studies is that the manufacturer of the drug in question is deliberately holding off on funding the studies that would probably show the benefit. They are doing so, s'he says, for the same reason that Warner Lambert/Pfizer did not pursue further indications for Neurontin--in order to "keep them in reserve" to hype Lyrica as the drug of choice once Neurontin went generic.

  7. Dear El Diablo,

    It really has to do with what the doctor is using as data to base his/her rationale on. If the doctor has first hand experience with patients, then I want to know the facts. How did the doctor get that first hand experience anyway? What prompted the "experiment"? Knowing the background information would help me in the decision making process.

    Who was the first patient this was tried on and why?

    Your example about Neurontin is pretty good. But there has to be some small pilot cohort data somewhwere and I would need to know about that and study it. Quite frankly, I have had to alter drug treatment for myself when I had dealth with some conditions in the past. But I spoke with independent experts and sought out independent data.

    As for vitamin D, that is true, FDA have not approved it, but there is much independent information backing it.

    I would say access to independent information is key. FDA approval isn't enough for me.

    Sometimes you do have to take risks and bravely go where no one has gone before, but you have to know the facts and understand what you are getting into.

    Some people would say that we can never know all of the risks. Perhaps, but that doesn't mean we do not have an obligation to know what the potential for certain risks are.

    Do not get me wrong, I am not opposed to a doctor being creative and trying something different. But it is my responsibility to have my quesitons answered and be "engaged" in the decision making process.

    By the way, I have opted out of treatment in the past for an FDA approved Drug and device and I am quite pleased with my decision. My doctor later confirmed with me that I made a good call, it was the right decision for me.

  8. Great answer. Bless you.


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