http://www.washingtonpost.com/wp-dyn/content/article/2007/12/11/AR2007121102284.html
Now there are several reasons that I should be in favor of this:
- It seems to be giving PhRMA the fits.
- The sponsor of the legislation, council member David Catania, seems to be a very nice fellow who is getting a solid reputation for his involvement in the pharmaceutical marketing issue nationally.
- It seems to be giving PhRMA the fits.
The drug rep problem in medicine could be solved overnight. Tomorrow, all physicians could wake up and discover that they possess an interesting ethical organ, known as a spine. (They could also, if they are of the male persuasion, discover that they have a couple of other organs that might be relevant, which I will not go into here.) Utilizing this new-found piece of anatomy, we could decide that from now on we will get our information on drugs only from reliable, non-commercial sources, and that we will make do without the corrupting influence of the cornucopia of gifts from the industry. The industry would immediately lay off all the reps, since if no doctor is willing to see them they are useless.
Problem solved, and no licensure apparatus needed.
Obviously this will not happen overnight, so the licensure thing would be worth thinking about if 1) it might move us incrementally closer to that Promised Land; or 2) it would be of sufficient symbolic value that it would energize and enlighten the masses for the remainder of the work to be done. I admit that I am not sufficiently imaginative to see either of either of those other consequences coming to be. Licensing reps just doesn't have that energizing zing that a really useful symbolic act can have. And it seems unlikely to do anything of substance to make the drug rep problem any more manageable in the short run.
Now, I have been wrong before. I initially was wary of the legislative proposals to outlaw data-mining of prescription information, which has been a big issue among my esteemed colleagues in the National Physician's Alliance (http://npalliance.org/). I now see that those policy measures have in fact been more useful than I imagined they would be, even if only for rallying physicians. So maybe somebody can talk me into switching sides on the DC City Council. But I remain to be convinced. And just because something gets PhRMA's knickers in a knot is not a sufficient reason to favor it, as tempting a criterion as that is.
3 comments:
Have to disagree labeling this idea as being dumb. Most reps have no medical training of any type, further damaging is thier lack of consideration of the complexity of medicine in general, with a complete lack of focus on th benefits of the patients for which thier promoted meds are intended for with the assistance of thier physicians.
It may not be the best idea, but it's better than no incetive to install these concepts into the pharma reps.
Licensing drug reps? Absolutely!! One of many reason that pharma reps have lost credibility, value and respect in the medical community is that these so called "professionals" have no clue about medicine. Placing a new college grad with a marketing degree and expecting them to educate and provide information beneficial to a physician and his treatment choices is ridiculous. They quote the company canned 30 sec blurb, smile pretty and hope their Domino's pizza will win the sale. It's no suprise that doctors don't give reps detail time....they have nothing of value to offer the Dr or his patients except free samples. And what makes me so knowledgeable on the subject. I am a licensed health care provider, former medical hospital trainer and veteran pharma rep. What was once a highly regarded and worthwhile profession is now comic relief.
The FDA and Its Damaging Lack of Citizen Protection
The Food and Drug Administration originated in its primitive form several decades ago to ensure the health and safety of the citizens of the United States. However, their focus seems to have changed the past few decades, as they appear to have formed a pathological alliance with the pharmaceutical industry through the money the industry gives the FDA for various reasons, amounts so large that this money accounts for about half of the FDA’s income, upon information and belief. Results of this relationship, one could posit, have been the progressive and recent approval of unsafe drugs and lack of regulation and monitoring of the pharmaceutical industry that the FDA is obligated to perform, and have failed to do so as much as they should for our benefit, as these unfortunate events have occurred quite often in a progressive matter that is of concern to many.
And the presumed intimacy between these two organizations does in fact seem to continue to worsen, as illustrated with the new proposal by the FDA to allow the pharmaceutical industry’s drug sales reps to discuss their products with prescribers off-label, which means that the FDA may allow and accept the industry possibly creating harm to patients with this proposal due to uncertainty associated with unapproved uses of a drug promoted in this way. Yet the FDA claims that this proposal would enhance the education and knowledge of the prescriber.
A prescriber, upon their own discretion, can in fact prescribe a drug off-label, but historically, however, representatives from the pharmaceutical industry have been prohibited from suggesting this type of activity. In fact, it is a federal offense for such reps to speak off-label about the drugs they promote, and more pharmaceutical companies are being penalized for this behavior in the past in the form of monetary settlements with the Department of Justice. The drug companies that have allowed such criminal offenses, through vicarious liability at times, perhaps, never admit guilt as part of such settlements.
This FDA protocol that is now being considered, called, “Good Reprint Practices”, would require pharmaceutical sales representatives to use what may not truly exist, which is truthful and authentic clinical trials when and if they do speak off-label to prescribers. This in itself lacks etiology for such discussions by drug reps, as many clinical trials may be flawed due to the trials being possibly manipulated by the pharmaceutical companies of the meds involved in such trials, such as by a third party. Additional trial deception involves ghostwriting and invalid authors of such trials, and this is one of many concerns of this FDA protocol. These facts can be validated and have been discovered by others.
Furthermore, this proposal is flawed in that most pharmaceutical reps lack clinical training and the ability for most drug representatives to analyze the unique statistical data regarding this issue accurately is unlikely, for the most part, I surmise. Remember that most drug reps have no medical or clinical training in any objective way, and, in my experience, have no interest is such training. This complicates the idea of this off-label concept due to the ignorance of the reps of the complexities of these once reliable and dependable methods of proof. In addition, the relaxation of previous restrictions regarding off-label promotion could prove to be a catalyst for reps to embellish statements to prescribers for their own benefit in regards to their promoted meds. So, our previous safety association, the FDA, appears to be evolving into our harmful association by suggesting such practices as this with deliberate intent and reckless disregard for public health, so it seems. Yet this situation appears to be of most benefit for drug companies. It’s unbelievable this proposal ever came into existence, with the delusional fallacy that it would be of benefit to patient health, most likely. Furthermore, this may complicate existing patient medication errors, such as in the elderly or dosing for children, complicated by the fact that many are unable to understand label instructions on their med. So there are enough problems with prescribing, and adding this FDA proposal would just make the situation worse. We as citizens are no longer the concern of the FDA, one could conclude.
However, there is freedom of speech. Perhaps another alternative would be to have clinically trained people discuss such issues with prescribers, instead of the drug reps, who, unlike those academically enriched, have the objective of increasing the market share of their promoted meds. Because historically, medications have in fact proven to be beneficial for other disease states other than what a certain med was initially indicated for upon approval. Regardless, awareness needs to happen by the citizens involving tactics that are possibly deceptive such as this and many more activities by the pharmaceutical industry that one could argue are in fact somewhat covert and tacit. As citizens, we have the right to insist of the pharmaceutical company to maintain focus on the interest of others besides themselves. And the health of the public is that interest, and should be demanded by the FDA more than it appears to be presently.
“As far as we can discern, the sole purpose of existence is to kindle a light in the darkness of being.”
---- Carl Jung
Dan Abshear
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