Dr. Drug Rep

To see how I made an extra $30,000 in 2002, click here. The article is published in this Sunday's New York Times Magazine. By the way, the Wyeth-sponsored "Faculty Development Programs" are still being held; a friend tells me he just went to one in Florida.

Antipsychotics for the Masses?

When it comes to antipsychotic medication, it appears that psychiatry has come full circle. The very first antipsychotic, Thorazine, was introduced in 1952, and had originally been considered to be an antihistamine, a bit like Benadryl. Eventually, we understood that it had extraordinary effects on the delusions and hallucinations of schizophrenia.

Over the years, many other antipsychotics have been introduced, and they are all effective at reducing psychotic symptoms, as their name implies. But over the past decade, they have also won FDA approval for treating bipolar disorder. Now, the companies marketing these drugs have their eyes on depression, which represents a far larger potential market than either schizophrenia or bipolar disorder. On November 21, Abilify received FDA approval as an add-on treatment for major depression (see the news item here). This follows closely on the heels of a study published a couple of weeks ago in the Annals of Internal Medicine showing that Risperdal was effective as an adjunctive depression treatment.

How effective are these drugs for depression? Not terribly. The Abilify data, for example, shows a remission rate of 26% vs. 16% for placebo augmentation, meaning that 1 out 10 patients would be expected to respond to an Abilify-induced boosting of their current antidepressant. The design of this study was somewhat manipulated in order to make sure Abilify beat placebo, a fact brought to my attention by this excellent post in Cl Psych. Nonetheless, the Risperdal data are very similar, and I'm convinced that atypicals provide a small antidepressant effect. Enough of an effect to overcome the potential side effects? That's unclear.

What is abundantly clear is that drug companies are going to be pushing both psychiatrists and primary care doctors to think of "antipsychotics" as "antidepressants." Look closely at the data before you buy the message!

Luvox CR: Let the Marketing Battles Begin

My Luvox CR posting from this past Monday somehow made its way quickly to the upper echelons of Jazz Pharmaceuticals. Lloyd Davies, the Director of Finance of the company (at least that's his title in this recent industry training event), responded to my early review of Jazz's new product with the following email:

(November 21, 2007)
"I just read your blog. There are a few factual inaccuracies that you might want to correct. 1) It's Luvox CR not SR; 2) The product has not actually been approved yet - presumably why the adverts do not mention the product; 3) Luvox CR is a once a day formulation as opposed to the old product which was twice a day. Therefore the half life might be different right? 4) I am guessing that it is "comorbid" not "comorbic" which is not a word that exists.If you want people to pay attention to what you say you should at least get your facts straight. Perhaps quality would be better than quantity. Lloyd"

I think that my response was civil, but you can be the judge:

November 21, 2007
"Mr. Davies,
Thank you for your corrections, which I have already fixed. However, regarding the half life, my understanding is that CR formulations do not change the actual half-life of the molecules upon with they are based. The major relevant example would be Effexor vs. Effexor XR. The sustained release version is advantageous because it produces fewer GI side effects, but there is no evidence that I am aware of that XR causes fewer discontinuation side effects. Regarding the relationship between half lives and once a day vs. twice daily dosing, this is a non-issue for most psychiatrists. Both Cymbalta and nefazodone are short half life antidepressants that are typically dosed once-daily with no evidence of therapeutic disadvantages. Perhaps Jazz has conducted head to head studies of Luvox vs. Luvox CR--if so, the results would be informative.
Best, Danny Carlat"

I haven't heard back yet from Mr. Davies. I'm guessing that some folks higher up in the company are mulling over the best response, from a marketing perspective. I'd also hazard a guess that the CEO is none-too-pleased with Mr. Davies' e-mail to me. Somehow, I doubt that his message was vetted through media relations at Jazz. But I could be wrong!

Nature Journal Publishes Major Article on Biased Medical Education

A few months ago, Jim Giles, a science writer for the New Scientist and Nature, called me out of the blue to ask about my opinions on drug industry-funded CME. I gave him my usual earful, and mentioned a preliminary study on CME bias that I presented at the American Psychiatric Association meeting two years ago. He asked to see the raw data, meaning the ghost-written CME articles, and it impressed me that he took this level of interest. The result is this article published in this week's issue of Nature.

The bottom line is that in 14/15 articles I reviewed, the sponsored drug received the highest number of favorable mentions. That may not be terribly surprising, but it is evidence of commercial bias, which is not allowed by ACCME standards of commercial support.

Giles is right that the instrument I used, called the Commercial Bias Inventory (CBI), has not been tested for reliability, but I'm now working with two psychiatrist colleagues, Ingrid Li at Tufts and Robert Kelley at Cornell, to validate the CBI. Once it's validated, we're going to blindly rate a number of CME articles and report our findings. If anyone else out there is interested in collaborating with us in this research, let me know (drcarlat@comcast.net).

Luvox CR and All That (Yawn) Jazz

Jazz Pharmaceuticals is running two-page spreads in the psychiatric journals advertising...well, it's hard to figure out what. The headline reads: "Anxiety disorders often present first, before other comorbid conditions." Then there are two blurbs, one about social anxiety disorder (SAD), and the other about obsessive compulsive disorder (OCD). No drug is mentioned.

So you have to google Jazz Pharmaceuticals and social anxiety disorder to find out that Jazz bought the rights from Solvay to market a "new" product, Luvox CR. According to press releases, it is close to FDA-approval for both SAD and OCD and will be released sometime in the first quarter of 2008. What a bummer--not that we have to wait, but that it is being foisted on us at all.

Luvox is another SSRI, and actually the first ever used by psychiatrists, having been approved in 1984 for the treatment of OCD. It has very little going for it. Its half-life is about 15 hours, and it causes more drug-drug interactions than any other SSRI. Before, Luvox was a pretty useless drug; come next year, we'll have a pretty useless drug that lasts even longer than the original.

Jazz Pharmaceutical's advertising slogan is "Innovation that performs." With Luvox CR, there's precious little innovation, and the only performance is a level of marketing chutzpah that is guaranteed to turn off prescribers.

Some Great Blogs to Peruse

Nice to have some good news to report--namely, that I've added three great blogs to my blogroll.

1. The Psych Central Blog by John Grohol. John is a great psychologist and web expert who I know personally. While I've known about his famous Psych Central website for a long time, I only just started reading his blog. He's been posting at a furious pace (unlike me) and everything he writes is interesting and fresh. I'm not really sure how he does it, I just know I'm jealous.

2. PostScript, the new blog by Kate Peterson and The Prescription Project. These are more or less weekly postings covering the world of excessive drug industry influence in medicine. They are thorough, informative, and beautifully written. These are not rants pounded out in the middle of the night, unlike some blogs I know!

3. Hooked: Ethics, Medicine, and Pharma, by Howard Brody. Dr. Brody is an ethics expert and author of the book Hooked, which argues eloquently that we physicians need to reclaim our integrity. Don't blame Pharma, people, it's up to us!

How Money Doth Breed CME Niches!

First, my apologies for the sparsity of posts lately--I ran behind on some newsletter work and I have to keep my subscribers happy.

I just received a flyer from an outfit called "CME Peer Review" (look them up on the web here), a new company which has wormed its way into a brand new niche in the commercial CME world--"independent content validation."

This is NOT their marketing copy, but it might as well be:

THE PROBLEM: OK, you're making money hand over fist by providing drug company-sponsored "medical education" (nudge-nudge, wink-wink). It's a sweet gig, getting million-dollar grants to hire medical writers to scribble out pseudo-newsletters. Donald-me-no-Trumps, these are FAT profit margins...and all yours! So what's the problem? A new "regulatory environment," that's what. Suddenly, everyone from the New England Journal of Medicine to the Senate Finance Committee is whining about "conflict of interest" and "commercial bias." Haven't they read Nietzche?! You are beyond such fairy tales as truth and morality, but in order to maintain your uber status, you must play the game.

THE SOLUTION: At CME Peer-and Jeer Review, our "turn-key system helps you ensure your CE activities are valid, aligned with the public interest and compliant with regulatory guidance and accreditation standards" (that's lifted verbatim from their actual marketing copy!). Got an article sponsored by Pfizer pushing more docs to prescribe Geodon? Choose from our "ever-expanding independent network of reviewers" to find just the shill to give your article the seal of approval. Don't worry, we have a patented system of laundering our reviewers--they're spic and spam and ready to deploy our CME SCRUB DOWN (TM) process for your CME activity.

CLIENT TESTIMONIALS:

"We encountered a difficult situation in which management had already spent the sponsor's grant on a $100,000 rehab of his office shower. Then, at the last minute, we found out the activity was hopelessly biased. We called CME Peer-and-Jeer Review and our problems were solved--what a quick turn-around! Thanks, guys!"

"Your team found an issue in one of our activities--it was subtly promoting a competitor's drug! By helping to bring the activity back in line with the sponsor's agenda, you helped us secure double our original grant for next year. We feel so much more confident about our income stream, thanks to you."

CME Peer-and-Jeer Review: Your CME SCRUB DOWN specialists!