Wednesday, May 14, 2008

Is Pharmaceutical Promotion Protected by Free Speech?

Recently, the New England Journal of Medicine published this interesting Sounding Board article by Aaron S. Kesselheim and Jerry Avorn, both of whom are physicians at Brigham and Women’s Hospital and Harvard Medical School. They are leading proponents of efforts to limit the use of prescription data-mining, and assisted the state of New Hampshire in its ultimately unsuccessful efforts to ban the practice (see this article for some background on various legislative actions).

At issue is whether prescription data-mining and other promotional activities are considered “free speech” and thus protected by the First Amendment. This has been a major argument of the pharmaceutical industry in its ongoing litigation in several states that are considering bans.

The authors distinguish personal speech, which is strongly protected by the First Amendment, from commercial speech. Whereas any limitation on individual free speech requires that the government have a clear interest in limiting a particular person’s speech (a high legal standard that is rarely met), limitations on commercial speech are based on different standards. The main framework used by courts is called the “Central Hudson Test,” after a 1980 case in which a utility company sued New York State over regulation of their advertising.

Based on that case, courts now allow limitations on commercial speech if three conditions are met. First, the government must have a substantial interest in the issue (in the case of prescription data-mining, the government indeed has a substantial interest in the relevant issue, which is public health); second, the proposed regulation must directly advance those interests (banning data-mining reduces the potential for non-scientifically based physician prescribing behavior); and third, the proposed regulation must not be more extensive than necessary to achieve its goals (the New Hampshire courts ruled against the ban partly because it agreed with Pharma arguments that there are less restrictive ways to counteract drug company misinformation, such as programs to better educate doctors about evaluating promotional claims).

I found this a valuable article for understanding some of these issues. Happy reading!


Supremacy Claus said...

Dan: Think of the Free Speech Clause as a coin with two sides. There is the freedom to speak. The other side is the freedom to hear speech.

The prescribing database is the most accurate measure of the standard of care as of today.

The left wing ideologue academics have a vested interest in suppressing such information. They compete with it with grants and studies that take five years to complete. So evidence based standards are the medicine of five and more years ago. They have competition for grants so tough, it is far easier to go out and earn the $million than to get it from the government, only to publish useless, obsolete trash.

We could get national statistics on off label use of a medication for about $5000 from one of the prescription tracking companies. I priced it. That is a cheap measure of modern clinical care.

Off label use is the single cheapest, deepest, and most productive vein of medical innovation to mine. So a hundred year old pain killer causes bleeding as a nuisance side effect. But it is the standard of care for patients suffering severe angina in the emergency room, and reduces mortality.

Old antibiotics turn out to be the best treatment for stomach ulcers.

The over-reaching regulation of the self-dealing left wing ideologues with personal conflicts of interest threatens progress of clinical care.

As a patient, I am prepared to support direct action against these enemies of clinical care. Patients and families have full moral and intellectual justification to just kick their rear ends to save patients. To deter.

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Anonymous said...

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. An example is the large amounts of money the industry gives the FDA for various reasons- amounts so large that this accounts, according to some, for about half of the FDA’s income, upon information and belief. An example of funds received is due to the prescription drug user fee act, which began in 1992. Basically, the drug industry has been authorized and required to pay the FDA for faster approval of their pending medications. Results of this relationship between the drug industry and the FDA, one could posit, could be a contributing factor 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. Yet the FDA continues to validate what has been posited through their support from the drug industry, in ways that seem reciprocal, and as a consequence, have possibly neglected the health of the public as best as they should.
The presumed intimacy between these two organizations does in fact seem to continue to worsen. For example, and recently, a new proposal by the FDA has been introduced that would 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 with their approval to 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 by the pharmaceutical representative, and this is rather delusional, to say the least.
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, and rarely admit guilt as part of such settlements.
This FDA protocol described and proposed is 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, so it appears the FDA did not take this into consideration.
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 with accuracy and meaning 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 in such training. So this seems to further complicate 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 a possibly harmful association by suggesting such practices as this with deliberate intent and reckless disregard for public health, so it seems. Yet this situation of the FDA proposal mentioned appears to be of most benefit for the 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, but in the amendment may be restrictions in regards to public health, as speech should be accurate and objective. 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 with no regard to the science behind these meds, in large part. 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, which could be the case now with the FDA. And the health of the public is that interests what I believe we as citizens demand, and should be enforced 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