Wednesday, February 27, 2008

Medscape--Brought to you by Lexapro

It's sad to watch a company selling its soul. Medscape used to be a source of reasonably trustworthy medical information with a few drug company ads thrown in to help pay the bills. Gradually, however, the promise of ever increasing riches became too alluring. It began selling disease-specific "resource centers" to the highest bidder (see my prior post here), earning millions from companies keen to control which articles are fed to doctors believing they are receiving medical education. At least these resource centers have a pretense of legitimacy, and if you dig around you can usually find something of value.

How things have changed. Today when I opened my email's inbox I received an email from Medscape. On the subject line: "Reasons to Choose Lexapro First." Eloquent in its simplicity. When I opened the email, I received nothing more than an advertisement for Lexapro (pasted above).

Yes, it appears that Medscape has found a new buyer for its Depression Resource Center. Kaching.

Tuesday, February 26, 2008

Brilliant Saturday Night Live Spoof of Drug Ad

For a bit of comic relief, take a look at this Saturday Night Live spoof of Seasonale, the birth control pill that prolongs periods to every 3 months. Hint: SNL's new product is called Annuale. Before watching the spoof, you might want to watch the original Seasonale commercial, since the satire plays on the original ad themes.

Monday, February 25, 2008

Bad News on the Election Front

For those looking for relief from the Obama-Clinton tiffs, I unfortunately have some bad news about the American Psychiatric Association election: Alan Schatzberg beat Donna Norris.

As I covered in a prior post, Norris heads the task force charged with scrutinizing the conflicts of interests of potential DSM-5 committee members. Schatzberg, on the other hand, is a great champion of industry-funded CME. He is on the clinical advisory board of "neuroscienceCME," a new MECC portal owned by CME Outfitters. This company produces a blizzard of CME in different formats, each funded by a single drug company whose product shines more brightly than its competitors in the neuroscienceCME version of reality. Schatzberg is also the editor-in-chief of the new journal, "The International Journal of Sleep and Wakefulness," which is produced by the MECC CECentral, funded entirely by Cephalon, and is a blatant full journal advertisement for Provigil. BUT WAIT, THERE'S MORE! Schatzberg is co-chair, along with star hired gun Charles Nemeroff, of a series of fancy CME meetings traveling across the country on behalf of Bristol-Myers Squibb and Otsuka, makers of Abilify. Entitled Current Concepts and Approaches in Treatment Resistant Depression, these meetings were created in order to highlight recent data showing that Abilify has some mild effectiveness as an augmenter of antidepressants.

But the election news was not all bad. David Fassler was elected as the secretary-treasurer and Dilip Jeste as trustee-at-large. Neither of them accepts industry money and Dr. Jeste made a conscious decision one year ago to sever his industry connections because of his concerns regarding industry influence.

Friday, February 15, 2008

Spinning and Spinning for Cymbalta

I was browsing the January issue of the Journal of Clinical Psychiatry in order to get ideas for the "Research Updates" section of The Carlat Psychiatry Report, and I happened upon two articles, one for those intrepid counter-detailers out there, and the other for Lilly drug reps.

The first one, "Time to Rehospitalization in Patients with Major Depressive Disorder Taking Venlafaxine or Fluoxetine," is an article important for evaluating the long term usefulness of Effexor, but one which, I can guarantee you, will not show up in the hands of your Effexor rep. In this study, depressed patients in a Taiwan psychiatric hospital were discharged with instructions to continue either Effexor or Prozac, depending on which medicine made them better in the hospital. The two groups were compared to see whether Effexor would better protect patients from rehospitalization than Prozac. The results? About 45% of patients in both group were eventually reshospitalized. For patients on Effexor, the average time to rehospitalization ("survival time") was 223 days, and for patients on Prozac, it was 222 days. What does this prove? Not much, since patients were not randomly assigned to treatments. However, it's certainly no endorsement of Effexor's vaunted superiority over SSRIs. As the authors (who have no pharma relationships) state: "Our findings do not support the notion that venlafaxine, a dual reuptake inhibitor, is associated with less relapse/tachyphylaxis."

The next article, on the other hand, will be parlayed into a "teaching point" by your Eli Lilly rep, although there's precious little to teach. Entitled "Switching to Duloxetine from Selective Serotonin Reuptake Inhibitor Antidepressants: A Multicenter Trial Comparing 2 Switching Techniques," this Lilly-funded study identified 368 depressed patients who had not responded to at least 6 weeks of SSRI treatment. These patients were then randomly assigned to either abruptly switching to Cymbalta, or gradually switching to Cymbalta. They were then maintained on Cymbalta for 10 more weeks to see if they would respond. Before we get to the results, think carefully about the design of this study, and what questions one might reasonably be able to answer, or to not answer.

This was not a double-blind study: in fact, both patients and doctors knew that the participants were being switched to Cymbalta. Furthermore, there was neither a placebo arm, nor an SSRI continuation arm. This is crucial, because patients who don't respond to a medication after 6 weeks may well respond if continued on the same medication for an additional 10 weeks. Thus, if these patients improve after a switch to Cymbalta, we have no idea how to interpret this. It might mean that Cymbalta is better. But it might also mean that the 10 extra weeks of being in treatment worked its nonspecific placebo-related magic. After all, with enough time, many people become less depressed, no matter what treatment they receive. Thus, the design of the study allows no meaningful evaluation of Cymbalta's effectiveness. The only potentially useful information here relates to the technical issue of how to conduct a switch from an SSRI to Cymbalta. As it turns out, an abrupt switch works fine and is well-tolerated. And that's all you can conclude from the study.

However, if you read only the abstract (which is as far as most readers will venture) you'll get the uncanny sensation of having been teleported to Eli Lilly's website:

"Conclusion: Switch to duloxetine was associated with significant improvements in both emotional and painful physical symptoms of depression and was well tolerated and safe, regardless of which of the switch methods was used."

If it reads like copy written by a Lilly employee, it's because it was: Dr. Perahia, the first author, works for Lilly in England. One might have hoped that the editors of the Journal of Clinical Psychiatry would have caught this bit of blatant promotionalism before it went to press. Because of this awful oversight, now Lilly will likely end up paying the journal thousands of dollars to purchase article reprints for its drug reps--someone's head will roll!

Monday, February 11, 2008

New MGH Psychiatry Academy: Take the Money, Say Nothing

In 2004, Massachusetts General Hospital's psychiatry department partnered with Primedia Healthcare and began soliciting millions of dollars from the drug industry to fund its CME programs. Called the "MGH Psychiatry Academy," this new program sent out glossy brochures to psychiatrists across the country announcing that "CME reform has arrived," and describing itself as a "revolutionary way to experience self-paced, unbiased and clinically applicable CME...."

The true "revolution" was the astonishing sums of money the Academy was able to rake in. The initial rumors had it that companies were required to pony up a cool million for whatever indirect influence they were to receive. Eli Lilly's grant registry website reveals that in 2007, they gave a total of $1.65 million, in three separate installments. Several other companies signed on as well, so this was about an $8 million cash cow for somebody. But for whom? Primedia was farming out the CME work to obscure vendors, such as "Trinity Healthforce Learning" and "CM Communications Group." A year ago, I made some half-hearted efforts to email the people at these companies who were responsible for producing the CME, but I received no response. It now appears that "CM Communications Group" is defunct, or at least it has dropped its web presence.

At any rate, in an apparent effort to make the Psychiatry Academy seem less crassly commercial, MGH fired Primedia, and has announced a 25 year "strategic alliance" with Reed Elsevier, an eminent medical publisher. But again, nothing is exactly what it seems in a world where so much money is being processed and where perceived legitimacy is crucial to the institutions involved. Reed Elsevier is farming the CME work out to another division, called Reed Medical Education. Reed Medical Education specializes in organizing huge meetings in oncology and other topics, and posts this price list of different ways that drug companies can give them a whole lot of money to be a part of a single medical meeting. Being a "cornerstone supporter" costs $195,000, "foundation supporter," $135,000, "leadership supporter," $95,000, and so on. Lord only knows what degree of influence over the medical mind each level of support might provide. Nor do we have any idea what the new MGH Psychiatry Academy price list is--remember, the price list above was for one meeting, while the MGH program encompasses dozens of live meetings and more web-based programs.

At any rate, the new and improved MGH Psychiatry Academy's first brochure just arrived in my mail box, and the reputation clean-up operation has begun in earnest: there is no financial disclosure mentioned. Multiple CME symposia are advertised in various areas of psychiatry lucrative to industry, and yet there is no mention of industry support, and no mention of personal financial disclosures of any participating lecturers.

Pharmaceutical support of a psychiatry department at this level is embarrassing, and Reed Medical Education has come up with its own, elegant solution: no disclosure at all.

Saturday, February 9, 2008

Wall Street Journal Picks up Sloan-Kettering Story

Jacob Goldstein and the Wall Street Journal Blog ran the story on Sloan-Kettering's decision to ban industry funding of CME and generated an entertaining debate in the comments section. I recommend that interested readers take a peek. You'll find the usual polarities in this contentious topic, including both those who cheer on Sloan-Kettering for its ethical stand, and those who warn that this is a dangerous trend and will lead to poorly educated doctors.

But my favorite comment was posted by "Get Real CME Companies," a person who has worked in the CME system for 20 years. The writer's description of how porous the so-called firewall is between drug companies and the "independent" medical education companies that produce the CME is so accurate and trenchant that I can't resist reprinting it below in its entirety:

"I love all the comments by the CME vendors about how great the system is and how the rules require independence. I have never read such a load of crap in my life. Yes, the rules require independence. Who enforces it? If you work in CME you know the answer very well NO ONE. As the recent investigation by the Senate Finance Committee found the ACCME has no teeth whatsover. But more importantly, the rules are loosely structured and basically an entire approach has developed that works around the rules. And it’s not very sophisticated but certainly very devious. Marketing teams will generate a list of medical topics they think are important, things that they supposedly get questions about. Inevitably, certain off-label uses of their product will be on the list because as I said of course they get lots of questions about that. That list of questions or topics will be used by the companies grants department to award grants. Now the CME vendors are very smart folks, it’s an incredibly profitable business. They will submit grants and they will note in the request who the chairperson of the event will be and inevitably it will be the lead investigator from a hot off-label study. It’s a shocker but that grant request will be awarded while hundreds of others will be rejected. So the CME vendors learn over time what exactly they need to do to get the money. Pharma companies don’t need to exercise any control. All the control they need happens right up from when the grant decision is made. It’s a giant game incredibly profitable for pharma and the CME vendors alike. And there is no one minding the store. I have worked in this area for 20 years and what I have seen happen in that time frame makes me sick. CME has become just another marketing tool. Many of the CME vendors are the same companies who do the marketing programs, they just have a CME arm! I applaud Sloan-Kettering. And I applaud this blog for picking it up. I frequently look at about 4 or 5 different pharma related blogs and did not see this anywhere. It’s a great development and I hope it sets a trend. Pharma and CME have had too many years to clean up their act. It’s time for more dramatic change. Please keep focused on this story, it’s huge."

Thursday, February 7, 2008

Sloan-Kettering to Commercial CME: "You're Outta Here!"

Memorial Sloan-Kettering Cancer Center, which is ranked the second best cancer center in the nation by U.S. News and World Report, has just achieved another impressive distinction--it has banned commercial funding of CME throughout the institution. In a fascinating article, Dave Kovaleski of Medical Meetings Magazine describes a process that began in July 2006, when the hospital's physician in chief, Robert Wittes, MD, decided to take this bold action in order to keep medical education "purely educational."

This is an instructive case study of how a large institution can wean itself off industry CME support and end up with a stronger educational program. Thomas Fahey, M.D, who chairs the CME committee, has overseen the transition and says that "I don't think there's any evidence to show that the extra money made CME better." In fact, Fahey feels that the new environment "keeps the focus where it should be--on education--and that comes across to participants."

The hospital had received 25% of its CME budget from industry, and in order to make up the shortfall they "de-fancified" their programs. For example, they shifted conferences from hotels to hospital conference rooms, they stopped paying for physicians' lunches, and they recruited more internal faculty members to speak. Apparently, it is still possible to convince physicians to educate their colleagues without the incentive of a fat check. They also increased the fees physicians must pay for some courses by 10-20%.

And what has been the response? Are physicians boycotting these meetings because they are too cheap to pay for their own education, as many defenders of commercial CME warn is inevitable? No. Attendance has remained steady and there have been no complaints.

Obviously, Sloan-Kettering is a particularly well-funded institution, and it can draw on stellar faculty to give CME, both of which make its industry-free transition smoother than it will be for other hospitals. Nonetheless, it provides a encouraging example of what is possible when the leadership decides that it's time do the right thing.

Tuesday, February 5, 2008

Counter-detailing for Kevin, M.D.

As part of my "march of shame" as penance for a year of tweaking the data for Wyeth, I visited Kevin, M.D. and his colleagues at their medical practice in Nashua, New Hampshire today and did some counter-detailing. I provided the information, and Kevin graciously provided the delicious pizza.

I spoke about a practical approach to diagnosing and treating depression and anxiety, and shared three articles that I guarantee you will never get from a drug rep, and which you will never see discussed in an industry-funded CME program, unless it's from a competing company. Here they are:

1. Forest Pharmaceuticals has in the past claimed that Lexapro is more effective than Celexa, and they continue to imply that Lexapro is the best tolerated of all SSRIs. You won't see any of their hired guns discussing this paper, an analysis of the clinical trial data which concluded that there are no meaningful differences between the two drugs.

2. Wyeth Laboratories has marketed Effexor XR as being more effective than SSRIs. But this new paper reviews 93 trials comparing dual reuptake antidepressants with SSRIs, and concludes that any difference between these classes is so tiny as to be clinically insignificant.

3. Eli Lilly claims that Cymbalta "offers relief from both the emotional and painful physical symptoms associated with depression." But a new meta-analysis reports that Cymbalta's analgesic effects in depression are statistically no better than placebo, and virtually equivalent to the analgesic effects of the SSRI Paxil.

None of these articles constitute the final word on these controversial issues, but they all deserve to be read and discussed as part of an unbiased and balanced approach to medical education. Good luck convincing your neighborhood medical education communication company (MECC) of that!

Monday, February 4, 2008

New Survey: 81% of Doctors See Commercial Bias in CME

In a unique survey of 1200 randomly selected American physicians, Medical Meetings Magazine reports that 81% of respondents perceive at least least some commercial bias in CME programs. You can read the entire article here.

When asked what factors most contributed to commercial bias, the most frequently cited reason was industry funding of the activity, followed closely by the presence of faculty financial relationships with industry.

While these survey results are about as surprising as finding sand at the beach, let's hope that the ACCME and AMA take note, both of which still strongly support industry-funded CME.

Saturday, February 2, 2008

You Can Do It!

Just a quick post as I wait for a shuttle to La Guardia, after having testified yesterday before the New York State Assembly Health Committee. They are considering a package of bills that would curtail some to the excesses of pharmaceutical marketing, and I was asked to retell the story of how I had been paid to get doctors to prescribe more Effexor.

The AARP (American Association of Retired Persons) was out in force, and they quoted the following disturbing e-mail that they had somehow obtained through their channels. I'm not sure which company was involved, but it is a pep talk from a sales manager to drug reps out in the field:

"Our goal is 50 or more scripts per week for each territory...If you are not achieving this goal, ask yourself if those doctors that you have such great relationships with are being fair to you. Hold them accountable for all of the time, samples, lunches, dinners, programs, and past preceptorships that you have provided or paid for and get the business!! You can do it!"

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