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On 8/24, ACCME announced 7 new policies that will go into effect as of January 1, 2008. Some of these were probably motivated by the Senate Finance Committee's critical report, but I assume that these don’t represent ACCME's definitive response (or at least I desperately hope not!). You can read the new policies yourself here, but unless you have been through an application for accreditation, as I have, don’t expect to understand what is being said. I’ve taken the liberty of translating each of their impenetrable pronouncements below, along with some commentary along the way.
New Policy # 1: If you make an agreement to provide a CME activity for a drug company, make sure to sign the document. Huh? This is new? It's a little bit alarming that this needs to be spelled out.
New Policy # 2: Drug companies are no longer allowed to tell you how to produce the CME they sponsor. Okay, I guess this is an admission that, in fact, companies had been able to directly influence CME content for all these years. I’m shocked, just shocked.
New Policy # 3: If you produce a web-based CME program, you can no longer conveniently leave off the fact that it is industry-sponsored from the first few web pages, as many providers were doing. This was a rather slimy way of roping doctors into an activity before they realized that it was just another promotional fluff piece. Thus, this policy enhances disclosure. Problem is, disclosure by itself does nothing to prevent promotional content. It only provides the illusion of objectivity.
New Policy # 4: Drug companies can’t put links to CME programs on their websites. This allows providers to more effectively hide the fact that you are about to watch a drug ad in the guise of education. Bad idea.
New Policy # 5: You know all that pesky disclosure stuff that we’ve always required you to do? Well, now we’re serious. You really have to do it. And this is a new policy…how???
New Policy # 6: We’ve changed our official definition of “commercial interest.” But don’t worry, after listening to the concerns of all the for-profit Medical Education Communication Companies, we’ve made certain that our new definition won’t disrupt business as usual. The crux here is that a “commercial interest” is not allowed to produce CME. As you can imagine, any redefinition of commercial interest generates high anxiety among MECCs. To the rest of the world, any company that makes all of their income by taking grants from drug companies and producing education that relates to their products, would be defined as a “commercial interest.” But somehow, ACCME has tweaked, massaged, nay, Shiatsued language as we know it to ensure that MECC’s remain blissfully non-commercial. This way, they can continue to make loads of money!
New Policy # 7: If you teach a CME activity, you can get two hours of CME credit for every hour of credit you teach. Excellent! That nets me 24 extra CME credits per year for writing The Carlat Psychiatry Report! Now this is policy I can get behind.
Bottom-line: The status quo finds ever more elaborate ways of maintaining the status quo.
On July 26, I sent CNS Spectrums a formal letter-to-the-editor outlining, in more genteel terms, the concerns about their commercially biased supplement on drug-drug interactions that I posted early this week here. I just received their response. It is the bland denial of wrongdoing that one might expect. There is no mention of Dr. DeVane's mysterious sea-change in his opinions about the clinical relevance of drug-drug interactions in EMSAM's competitors. Cheer up, truth fans. There is much more to this drama than meets the eye. Stay tuned.
August 14, 2007
Daniel Carlat, M.D.
Assistant Clinical Professor of Psychiatry
Tufts University School of Medicine
Editor-in-Chief
The Carlat Psychiatry Report
42 Pleasant Street
P.O. Box 626
Newburyport MA 01950
Dear Dr. Carlat:
We have had the opportunity to review your Letter to the Editor dated Thursday, July 26, 2007 regarding the Expert Roundtable Supplement “Antidepressant Drug-Drug Interactions: Clinical Relevance and Risk Management,” by Drs. Nemeroff, Preskorn, and DeVane.
We have forwarded your concerns to the faculty members, reviewed the activity planning and independent peer review processes, and examined the participant evaluations that have been received to date. Our findings include the following:
• The faculty remains comfortable with the positions they have taken in this CME activity, both in their presentations as well as how the question and answer section of the activity was addressed.
• Our independent review processes — both for MBL Communications and i3 CME — established that there was no concern of commercial bias with either the live activity or the subsequent enduring supplement.
• Evaluation reports show that 91% of the participants believe this supplement activity to be “objective,balanced and of scientific rigor”.
The ACCME’s Standards for Commercial Support were strictly adhered to and all decisions for this activity were made free of the control of the commercial interest. This includes the identification of the need, the determination of the educational objectives, the selection and the presentation of the content, and the identification of the persons that were in a position to control the content presented during the CME activity. In addition, the disclosure of commercial support was provided to the participants prior to the beginning of the activity as well as all relevant financial relationships of those planning members who had control over the content.
We would also like to note that the question and answer session is live and i3 CME has no influence on questions received from the audience. For many this is a rare opportunity to speak with the experts and questions received are not always directly related to the content.
Given the above information, it is our position that certifying this activity for AMA PRA Category I CreditTM is appropriate. Both our organizations have done due diligence in ensuring that this activity meets the standards for a certified medical education activity.
Sincerely,
Sandra T. Weaver, MS, Vice President, CME Program Development, Compliance Officer, I3CME
Darren L. Brodeur,, CEO & Publisher, MBL Communications, Inc., Publishers of CNS Spectrums, Primary Psychiatry, and Psychiatry Weekly
No, that's not Carlat getting nasty and personal again. Those are the words of one of the most well-recognized names in American psychiatry, an academic of impeccable credentials who is involved in the industry-CME charade and is getting sick of it (insert the letters "r" and "a" to complete the headline--the spelled-out version was offensive to some). He will remain anonymous.
Why is he saying such terrible things about CNS Spectrums? He is referring to one of the most corrupt CME activities to hit the stands in a long time, and believe me, it takes a lot to impress this reporter.
The article in question can be found in the May 2007 Supplement to CNS Spectrums, entitled, “Antidepressant Drug-Drug Interactions: Clinical Relevance and Risk Management,” (Nemeroff CB, Preskorn SH, DeVane LC, CNS Spect 12:5 (Suppl 7) May 2007).
According to my source, this sham article was originally a televised roundtable which was adapted by medical writers to form the basis for an industry-supported supplement. The CME company in question is i3 CME, which, my source said, wrote a "ridiculous text...parts of it were inaccurate, simplistic, and had overgeneralizations."
And yet, it was published anyway, and is accredited by the ACCME for 1 hour of Category 1 PRA credit.
The details of the science are a bit murky. But the short version is the Bristol-Myers Squibb, maker of the newly approved antidepressant EMSAM (transdermal selegiline patch), commissioned the article to convince doctors that EMSAM is safe to prescribe, even though it is an MAOI, which can produce fatal interactions with other drugs and with certain foods containing the amino acid tyramine. In order to deflect attention from this liability, the article dwells primarily on a drug-drug interaction in which EMSAM is safe: interactions involving the liver's P-450 enzyme system. Indeed, EMSAM neither inhibits nor induces these enzymes, meaning that it won't affect the levels of other medications that are metabolized in the liver.
Of course, this is an "advantage" only if drug-drug interactions are problematic for other antidepressants. The article works hard to make the case that two SSRIs, Prozac (fluoxetine) and Paxil (paroxetine), are dangerous medications because of drug-drug interactions: "To put these numbers in perspective, fluoxetine and paroxetine at 20 mg/day produce approximately a 500% increase in the AUC of CYP2D6 dependent drugs" (see page 6).
But this opinion directly contradicts what one of the authors recently wrote in a non-commercially funded article published in the journal Neuropsychopharmacology, at that time edited by Dr. Nemeroff, who happens to be the first author of the CNS Spectrums piece. According to my source, Dr. Nemeroff spearheaded this CNS Spectrums EMSAM advertisement "for the sake of selling CME time."
At any rate, in that earlier unfunded article, Dr. DeVane, the third author of the CNS Spectrums piece, wrote: "Dr. Preskorn and Dr. Werder's commentary is confusing because it frequently fails to distinguish between verifiable statements and personal opinion, includes dubious extrapolations of data (eg 'lowest effective dose of fluoxetine and paroxetine produces approximately a 500% increase in the plasma concentration of co-prescribed [CYP2D6] drugs')" (Neuropsychopharmacology 31:1594-1604, 2006).
With a sprinkling of industry money, an opinion that was once a "dubious extrapolation of data" becomes a fact. While I'm no fan of industry-funded CME, in this case there was a silver lining: old foes (Dr. DeVane and Dr. Preskorn) were reunited.
By the way, I have nothing against EMSAM, but I rarely prescribe it because most patients don't want to have to hassle with wearing a patch. Generally, if I want to prescribe an MAOI, I'll prescribe oral Parnate or Nardil.
In the CNS Spectrums parallel universe, however, patients appear to be yearning for a patch. The article ends with the following promotional comment by Dr. Nemeroff: “I have had more and more patients say to me, “I really think that I would like to try selegiline transdermal system. I do not like taking pills.”
Carlat Blog Verdict: CNS Spectrums: The very definition of a "throwaway" journal.
Recenly, Dr. Michael Posternak, a member of the Editorial Board of The Carlat Psychiatry Report, asked me if perhaps I had gotten a bit too personal in some older posts. He was referring specifically to this post in which I defended Joe Biederman during that blue June period when he was getting bashed by the Globe and several other parties. In that post, I made a couple of flippant remarks about "Charles 'bling bling' Nemeroff" and about the MGH Child Psychiatry Department being a "department in which psychiatrists can barely find the water fountain without industry support."
I was trying to be humorous, but I'll admit these come across as mean. And as someone who has been the object of many personal attacks, I know that it never feels particularly good, even when lobbed from the Wild Wild West of the Blogosphere. Therefore, I offer this post as my sincere apology to Dr. Nemeroff, and to MGH.
On Tuesday I posted about Wyeth/Solvay's subtle bifeprunox advertisement masquerading as a CME activity in Psychiatric Times. Their karma has caught up with them, as the FDA just rejected their application for approval of the new antipsychotic.
According to reports, FDA was unimpressed with two acute-treatment controlled studies, both of which showed that bifeprunox performed more poorly than existing atypicals. You can read a review of these efficacy trials here. One study compared bifeprunox 20 mg/day with risperidone 6 mg/day. After 6 weeks, bifeprunox lowered PANSS scores by 11.3, wherease risperidone posted a more robust symptom reduction of 15.6 (statistical significance was not reported). In a second study, bifeprunox with slammed even more harshly by Zyprexa (olanzapine). Also a 6-week study, bifeprunox 20 mg/day yielded a PANSS improvement of 13.8 vs. Zyprexa 15 mg/day's 22.0. In that trial, only Zyprexa significantly separated from placebo.
As a psychiatrist, I'm not too disappointed, because bifeprunox is essentially a me-too version of Abilify (aripiprazole). Like Abilify, bifeprunox is a partial dopamine receptor agonist, meaning that it can either block or stimulate dopamine receptors. Thus, bifeprunox appears to be a less effective version of Abilify (though no head to head trials have been reported). We don't need it.
The supplement to the latest issue of Psychiatric Times is yet another variation on the use of CME to promote products. Entitled "Reaching New Heights in the Management of Schizophrenia: Current and Emerging Therapies," it is supported by Solvay and Wyeth Pharmaceuticals. It is based on an industry-sponsored symposium given at the 2006 U.S. Psychiatric Congress, and you can view a video of that symposium here.
If you casually read through this article, which is designated for 1.5 AMA PRA Category 1 Credits, you get the sense that it doesn't endorse the use of any particular antipsychotic. In fact, the first part of the article reviews the confusing array of recent studies, with names like the CAFE studies, the CATIE trials, and the CUTLASS trial, and seems to conclude that it's hard to draw any firm conclusions. Next, there's a robust section on "Safety and Tolerability," focusing on the metabolic disadvantages of Zyprexa and Seroquel, but also touching on the prolactin-raising disadvantage of Risperdal, and the EPS liabilities of first generation antipsychotics.
If there is any obvious conclusion here, it is that current treatments have a lot of problems, and that we desperately need something new. Well, just prior to the conclusion there is a section entitled "New Drugs in the Pipeline." And the first non-approved drug mentioned is bifeprunox, which is a me-too knock off of Abilify. Bifeprunox is manufactured by Solvay and will be marketed in the U.S. by Wyeth (read about it here). These are the two companies that paid for the production of this article.
Thus, the promotional logic of this "educational" activity is as follows:
1. Recent studies of antipsychotics yield conflicting findings, and there is no clear winner.
2. There are safety problems with all existing antipsychotics.
3. We need a new medication.
4. That new medication is bifeprunox.
I suggest that the article be slightly re-titled, "Reaching New Heights in the Management of Psychiatic Prescribing: Pre-Release Flimflammery."
Is it possible? Did I actually read the following sentence in the ACCME's initial response to the Senate Finance Committee?
"Alternate funding models will be considered, (eg., pooled funding, limits, sources) including discussions on the value, or impact, of no commercial support."
Yes, it's definitely there on page two of the letter, which was posted on the ACCME website late Friday (read it here). Granted, this is only one of several courses of action being considered, but the fact that the possibility is being seriously debated is most heartening.
Stay tuned.
A series of posts in both Pharmalot and from former Pfizer top executive-turned-whistleblower Peter Rost illustrate another CME scandal in the making. But it's so complicated, even I, one of the more CME-obsessed bloggers on the web, can barely sort it all out.
The major culprit is Pfizer's HIV/AIDS marketing division, which has been desperately trying to market an aging protease inhibitor called Viracept, which has steadily lost market share over the years to competing drugs. The marketing division at Pfizer came up with a "POA", or plan of action, relying heavily on using various forms of company sponsored education to convince prescribers that Viracept, while no more effective than its competitors, is at least safer. In the old days, before company-sponsored CME became the preferred marketing tool for changing physician behavior, Pfizer's pathway to corruption would have been straightforward. Simply create a series of promotional slides that present studies with suspect data and methodology, and make exhuberant pro-Viracept claims. This runs afoul of FDA regulations, which stipulate that any advertising content has to be accurate. Well, Pfizer apparently did make these false claims, and an internal whistle-blower is now telling all.
What's so complicated about this? It's just false advertising, a shady marketing practice which occurs occasionally in all industries. So far, Pfizer's response has been appropriate: They've fired three top sales directors in the HIV/AIDS sales division, and they will be investigating what went wrong. But another layer of corruption involves a second type of industry education: accredited CME courses. As documented in this Pharmalot posting, and as I've written about in an earlier posting here, the Pfizer sales force had frequently hired the Connecticut cardiologist Dr. Sandip Mukherjee to talk up Viracept in promotional programs. According to an anonymous Pfizer regional manager, Dr. Mukherjee's talks "provides a very positive supportive message on the use of Viracept as part of a viable and safe component of HAART therapy." Basically, Dr. Mukherjee could be counted on to say that Viracept had a relatively benign lipid side effect profile. Fine. There's nothing illegal about hiring a speaker to do advertising for you.
But they screwed up, because the regulations propping up industry-CME activities are so complicated, and change so frequently, that various Pfizer employees just couldn't keep track of all the paper work, and tripped on it.
The first screw up involved confusion about whether Boston Medical Center could use Dr. Mukherjee for a CME certified program. A trail of redacted e-mails shows complete confusion and disarray in the Pfizer camp, which led to an odd scenario in which Mukherjee apparently gave a pro-Viracept lecture at BMC, which was advertised as a CME activity, but which was actually a standard promotional talk. The second screw-up has something to do with how Dr. Mukherjee was paid. Pfizer, responding to criticism that high payments to hired-gun physicians may tempt them to bias their presentations, recently capped such payments at a maximum of $50,000 per year. The problem is that some physicians are so good at increasing prescriptions of Pfizer products that drug reps all over the country want to use them, and their "cap" gets reached too quickly. This is exactly what happened with Dr. Mukherjee, whose cap was reached in October, meaning that he could not be hired again until January of the next year. But Peter Rost posted internal emails showing that Mukherjee's cap was mysteriously "lifted," allowing him to give extra talks: "They have just adjusted Dr. MacArthur's cap so I am holding great hope that Dr. Mukherjee will be next. Please hold on through the week and hopefully we will have good news soon." The next email presents that news: "Good news, Dr. Mukherjee's cap should be lifted next week, so [name redacted] keep the Nov. 15 talks scheduled with him. We may need to reach out to Tom to see if he can cover the honoraria for one of the talks. I will letyo u know when it is official." We don't know who "Tom" is or which bucket of money he is in charge of, but this smoking gun does not reflect well on the integrity of Pfizer's honorarium policy.
The bottom line: When your marketing plan is always teetering on the edge of corruption, you're gonna get burned. It's only a matter of time.
On 8/24, ACCME announced 7 new policies that will go into effect as of January 1, 2008. Some of these were probably motivated by the Senate Finance Committee's critical report, but I assume that these don’t represent ACCME's definitive response (or at least I desperately hope not!). You can read the new policies yourself here, but unless you have been through an application for accreditation, as I have, don’t expect to understand what is being said. I’ve taken the liberty of translating each of their impenetrable pronouncements below, along with some commentary along the way.
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