Thursday, September 1, 2011

Pharma, Science, and Drug Reps--an Update

I commend to your attention a blog post and the related comments--
http://go.neiglobal.com/Blog/tabid/83/EntryId/16/Are-future-psychiatric-treatments-doomed-Be-careful-what-you-ask-for-you-just-might-get-it.aspx

Dr. Stephen M. Stahl, "award-winning author and psychiatrist" according to the website, founded the Neuroscience Education Institute and is a paid consultant and/or speaker for numerous pharmaceutical firms. He wrote the initial post bemoaning the activities of "pharmascolds" and accusing them of causing drug companies to be putting less research effort into finding valuable new paychiatric drugs because of the grief they are causing the industry.

This led Dr. Danny Carlat, of Carlat Psychiatry Blog and a well-known critic of Pharma, to comment that Dr. Stahl was not quite correct on a number of his facts, and that the real reasons why there are not more new and powerful psychiatric drugs now on the market is because the drugs being promoted by the industry don't work very well, and the companies prefer financially less risky me-too drugs over genuine innovation.

So that has led to a lot of back-and-forth commentary and I don't want to get involved in who said what to whom or who called whom what name, but I do want to pull out a couple of comments from the blog that struck me as illuminating.

First: One of the regular bloggers on Dr. Stahl's site is Dr. Debbi Ann Morrissette, a medical writer who I gather is employed by their firm. Dr. Morrissette took issue with a number of Dr. Carlat's objections to Dr. Stahl's statement. Here is a part of her comment:

CARLAT ASSERTION:3. Drug companies have introduced many psychiatric medications over the last two decades, but they have made the business decision to invest heavily in me-too agents, some of which, such as Pristiq and Invega, are embarrassingly blatant patent-extenders with no clear advantages over existing agents. Perhaps if companies had invested more resources into developing truly novel compounds, they wouldn’t be in the pickle they are in.

FACT: THE SUBSTANCE P ANTAGONISTS WERE NOVEL, AS WERE THE CRF1 ANTAGONISTS, NEUROKININ 2, NEUROKININ 3, BETA 3 AGONISTS, AND MANY OTHERS THAT FAILED TO SHOW CONSISTENT EFFICACY. AGOMELATINE IS NOVEL AND FACES AN UNCERTAIN FUTURE IN THE US BECAUSE OF POTENTIAL HEPATOTOXICITY. OVER A DOZEN NOVEL MECHANISMS WERE ADDED ON TO ANTIPSYCHOTICS TO TEST COGNITIVE IMPROVEMENT, FROM 5HT6, TO NICOTINIC AGONISTS, AMPAKINES, MANY MORE. THE FACT IS THAT INDUSTRY IS PUNISHED FOR PURSUSING TRULY NOVEL COMPOUNDS AND REWARDED FOR ME TOOS.


Okay, so let me see if I get this. Here is a highly trained medical writer trying to defend the drug industry from the supposedly uninformed anti-psychiatry rants of Dr. Carlat. She lists a variety of novel compounds being studied recently by the drug industry, that involve molecular mechanisms different from existing psychiatric drugs. (Real innovation--so far, so good.) She then lists the unfortunate fate of these compounds in clinical trials--they don't work very well, or they cause nasty adverse reactions. She then makes the astounding claim, that on this basis, "industry is punished for pursuing truly novel compounds and rewarded for me toos."

If you consider discovering a new chemical, subjecting it to clinical trials, and finding out that it does not perform as well as you have hoped "punishment," then you seem to be saying that normal, routine clinical research is punishment--which makes Pharma's claim that that's the business they are in rather odd. Are you saying that Pharma ought to be "rewarded" by being allowed to sell useless and dangerous drugs for huge profits? Pharma is indeed "rewarded" when it makes and markets me-too drugs, but the reward is solely economic; by definition, patient care is not significantly advanced. So are you saying that Pharma is really all about profits and not about patient care? Funny, that's what the pharmascolds have been saying.

Second: Here is a comment signed "Former Pharma sales rep":

As a former sales representative for a major international pharma company, I learned firsthand clinician and patient attitudes toward the pharma companies. Patients eyed pharma reps suspiciously in waiting rooms, the front-desk staff treated us miserably, and the doctors refused time with us. Even my acquaintences, some of whom owed their lives to modern pharmaceuticals, could not understand why pharmaceutical companies promote their products or sell them at any significant price. All education efforts, sales efforts, or marketing was considered questionable. As sales representatives, we had a hard time recruiting attendance for educational events because by this time, we were prohibited from providing lunch to go with the presentation. Soon, sales reps were banned from most clinics in the area, and we could no nothing more than drop off copies of clinical studies with scowling front-desk staff. It wasn't long before my entire sales team was laid off due to shrinking sales budgets. Any luxury item is heavily promoted and nobody complains. But a drug that saves lives is expected to be available for free and without sales or marketing behind it. I feel that the clinics in my sales territory did get what they asked for. The absence of up-to-date drug information and education from live representatives.
I am unable to say whether this is an accurate report of the status of being a drug rep in today's world, or some combination of bellyaching and sour grapes, or some of each. But if this is even partly true then I think the important take-home message is the incredible attitude shift that has occurred in this whole field since I started doing the research for HOOKED a little more than a decade ago. Back then the drug rep business was flying high, physicians rolled out the red carpet for reps, and the whole crew was fat and sassy and thought critics of these arrangements were completely crazy. If things have changed as much as "former rep" says, can we pharmascolds actually be responsible? As Dr. Carlat suggests in his reply to Dr. Stahl, it would seem odd that a bunch of generally powerless folks like us could have somehow engineered such a huge change. But hey, we'll take it.

This former rep says that the downside of these changes has been "The absence of up-to-date drug information and education from live representatives." Is that so? Of course this is nonsense in terms of the reps being a reliable source of up-to-date information, or that docs don't have far better evidence-based sources than reps. But that would take us back into far too many previous posts on this blog about how the industry thinks marketing is education.

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