Hospitality and Pharma: Relationship on the Rocks?

Decades of mutually beneficial economic ties have bound the fortunes of hotels, restaurants, and drug companies. But in an era of Sunshine Act disclosure, renewed calls for professional ethics, and ballooning healthcare costs, that relationship may be souring.

It used to be a veritable love-fest. As recently as 2011, I was writing about a restaurant's attempt to rebrand itself as a "pharmaceutical dinner facility."  In 2010, I debated a restaurant chain owner who was calling for the Massachusetts legislature to repeal the state's 2009 gift ban so drug companies could once again wine and dine doctors at his restaurants. His lobbying turned out to be successful. The state's previously strict law was revised in 2012. Now it allows industry representatives to purchase meals of a "modest value" outside the office or hospital as long as they provide educational information about their products between courses.

However, it turns out that while hospitality industry owners are working double time to book reservations for doctors and pharmaceutical reps, their employees have an entirely different idea. They--correctly--see drug company relationships with doctors as a driving force in their rising health care costs, and they want pharmaceutical companies to stop funding educational CME programs at their hotels.

Last week I wrote about this brave stance from the hospitality worker's union Unite Here ("Hotel Workers Against Industry-Funded CME?"). The Wall Street Journal​'s Pharmalot blog got in touch with me to discuss the matter further and yesterday they posted a follow up that includes more of my thoughts on the matter and more of ACCME's self-serving response.

Looking back over the recent history of these industry dynamics, it's easy to see more workers taking this stand against business as usual. After all, they go to work every day in the middle of a money storm while simultaneously seeing their health costs rise year after year. That's a pretty good reason for them to want to stand up.

You can help them out by signing the No More Drug Money petition they are promoting and by sharing it around.

Medscape Presents: The Brintellix Show

As I wrote in part one of my Medscape review, the website gets high marks for up-to-the-minute coverage of psychiatric news, and it deserves kudos for posting a ton of textbook-like content on disorders and drugs. I wasn’t so thrilled with its "un-privacy" policy, which results in your personal info and browsing history being sold to third parties. 

Today we get into the dark side of Medscape Psychiatry, which is their industry-funded CME. 

Medscape Psychiatry CME Overview

Medscape offers four different categories of CME on its “CME and Education” page.  "Clinical Briefs" and "Journal Articles" are mostly not industry funded, whereas "Patient Cases" and "Knowledge and Practice" are generally industry products.  

Brintellix (vortioxetine) Background

To give you a little context, Brintellix is the latest antidepressant to be FDA approved. It is being marketed as a "multimodal" antidepressant because it has effects on several different receptor sites. The company has produced some interesting data showing that Brintellix may cause fewer sexual side effects than other antidepressants, and that it may help improve the slowed-down thinking that is common with depression. But it is not FDA approved for either of these potential advantages, because thus far, the data are far from definitive.

Medscape and Takeda/Lundbeck

Medscape is the largest single recipient of pharmaceutical CME grants among all U.S. medical communications companies. According to an article in JAMA, it received $20,315,730 in 2010, the last year for which such data were aggregated. I don't know how much the company is receiving from Takeda/Lundbeck for producing CME programs, but it's probably a lot. If you click through Medscape's most technologically sophisticated online courses, a high proportion are funded by this duo.

Here are some of the titles of the courses:

• Strategies for Effective Communication With Patients With Major Depression
• Strategies for Improving Symptoms in Patients With Major Depression 
• Engaging Patients as Partners in Care: The National Quality Strategy in Practice
• Cognition in Major Depressive Disorder: Improving Quality of Life
• Updates and Perspectives in Major Depressive Disorder: Highlights From 2014 
• The Pharmacology of MDD Treatment: Building a Foundation With a Focus on 5-HT

Commercial Bias in One of the Courses

All of the courses listed above are likely biased in favor of Brintellix--there wouldn't be much point in paying Medscape to produce them otherwise. Since blogging is not my day job, I chose only one of them to watch: The Pharmacology of MDD Treatment: Building a Foundation With a Focus on 5-HT.

This course begins with four multiple choice questions, which are supposed to test your knowledge before you learn. Here's one of them:

Which of the following antidepressants manipulates the most serotonin receptors at once?

vilazodone

selegiline

quetiapine

vortioxetine

The correct answer? Vortioxetine. 

This is a clever way to prime the pump, to get the audience thinking about the promoted drug.

Next, we get a slide purporting to give an overview of the history of antidepressant drug development.

The big red bubble labeled MMD refers to "multimodal drug", ie., vortioxetine. That's the latest one. The implication is that it's the most technically advanced. 

Later in the program, there are a few slides highlighting "new antidepressants." Only one antidepressant gets prominently featured on two slides:

The more crucial question is not "how many ways can one drug manipulate 5-HT" (even the manufacturer states the "clinical relevance" of the drug's many serotonin actions is "unknown") but rather "how many ways can one communication company manipulate doctors's prescribing practices?"

To make their point crystal clear, one of the experts in the video glowingly endorses Brintellix, saying that its multimodal mechanism is like packing a bunch of great medicines into one:

"Vortioxetine is a great example of this multimodal thing we were talking about. It is a serotonin reuptake inhibitor, but it also is a very strong agonist at 5-HT_1A, which we said you want to have an agonist there. It also is a powerful antagonist at 5-HT₃ which and a powerful antagonist at 5-HT₇. On paper, here is a drug that has some of these qualities we have been talking about that could make it possibly a multimodal agent almost like a built in augmentation strategy in 1 pill, which certainly would be, just practically, a little easier for patients than having to take more than 1 medicine, which we often have to do.^[3-6]"

A bit later, he goes even further, implying that Brintellix uniquely targets three common symptoms of depression:

"Again, right now, the data clearly show the 3 most common residual symptoms, even with people who have a response to an antidepressant are insomnia, cognitive impairment, and fatigue. I think those are things that are not well addressed by an SSRI alone. Thinking more sophisticated, multimodal actions whether it is 1 pill that has that built in augmentation. I think that is where the field is going."

Summing up Medscape

Since the last time I reviewed a psychiatric website, I assigned a letter grade, I'll give Medscape one as well: a B-. 

Why? It gets an A for delivering bite-sized psychiatric news clips on its non-CME page, an A- for providing free but dry drug and disorders info, and an F for failing to comply with Standard 5 of ACCME's Standards for Commercial Support in its CME courses. Among other things, Standard 5 forbids a CME program from promoting a "specific proprietatry business interest of a commercial interest", and it requires that presentations "must give a balanced view of therapeutic options." 

I'm surprised that Medscape is still resorting to these shenanigans, but I guess that's what butters their bread. 

ACCME Seeks to Hide Drug Company Disclosures in the Fine Print

In an absolutely perplexing move, Dr. Murray Kopelow and the ACCME are proposing a revision to their Standards for Commercial Support that will undermine those standards. Currently, when an education company solicits money from industry to underwrite a course for doctors, they must disclose this inherent conflict of interest, and they often do so by printing the company's logo somewhere.

As an example, in Medscape's current online course called Diagnosis and Treatment of Major Depressive Disorder: Performance Improvement, you can see very clearly on the home page that the course is paid for by Eli Lilly:

This tells you that the course is likely to biased in favor of a Lilly product, and that you should hightail your way to a different website. But since it is offering you 20 free CME credits, you might be tempted to take the course. If you do, you will at least know that you should evaluate the content very carefully for bias.

Of course, simply displaying the supporter's name is hardly full disclosure. In my opinion, the supporter should be required to provide more information, including:

--The name of the product(s) marketed by the supporter that might be relevant to depression (in this case, Cymbalta and Symbyax.) Disclosing this is crucial, because many doctors do not know exactly which products a particular company markets, and therefore may not realize how the company has a financial stake in the CME program.

--The amount of money the supporter has paid the educational company to create the CME course. The more money that is at stake, the larger is the incentive for a company to bias the program in favor of the supporter's drug. Did Lilly pay Medscape $100,000 or $1,000,000 for this course? If it was $1,000,000 (and I'm guessing this figure is closer to the true amount), a learner would reasonably become even more skeptical about the scientific validity of the course.

But instead of increasing disclosure, ACCME is proposing a decrease in disclosure. They are, quite literally, proposing that all disclosures get buried in the fine print.

You can read the proposal here. The proposed new wording is:

“The provider’s acknowledgment of commercial support as required by SCS 6.3 and 6.4 under Standard 6 of the ACCME Standards for Commercial Support must only state the name of the company supplying the commercial support, in text format only. Disclosure cannot contain corporate logos and cannot mention or describe any other units within the commercial interest’s corporate structure.”

I assume that ACCME's motivations are pure--apparently it believes that it has already succeeded in scrubbing all commercial bias from CME courses, and that there is one loose end to tie up, which is getting rid of company logos. But the organization has deluded itself. In fact, commercial bias continues to be rampant throughout the CME world, and this proposal will be a great gift to drug companies and their education company sidekicks.

Any MBA will tell you that the best marketing uses advertising that doesn't look like advertising. That way, the customer does not realize that there is a hidden agenda. Commercial CME already is advertising disguised as medical education--this new proposal will make that disguise even more impenetrable.

A MECC that BLISSfully keeps Promotion in Medical Education

Recently, medical writers from across the country have been forwarding me blatant examples of how medical education companies are currupting the basic tenets of continuing medical education. Although I've become jaded, this particular company astonished even me with their willingness to do away with the pretense that industry-funded medical education is anything other than advertising.

The company is called Brand(x) and they are based in the United Kingdom. They are mainly an advertising firm but they have a robust medical education department. Here is a screen shot from their website in which they explain their conception of "medical education."


If you can't quite make out the small print, you can reach this page by going to the home page, clicking "enter" then "services" then "med ed." Here is the definition of CME, Brand(x)-style:

In today's business environment clients increasingly recognize that to get the best results, medical education must be led by a clear understanding of what the brand stands for and be closely integrated with the promotional strategy. At Brand(x), we are uniquely placed to provide the exceptional skills, which will help shape your educational strategy and implementation so that your brand's business objectives are met.

The company has developed its own process for making sure CME promotes a drug company's brand. It's called "BLISS," an acronym for "Brand Led Integrated Support Service." Here's a screenshot showing how they make CME more BLISSful:

Recently, Dr. Murray Kopelow assured the Senate Special Committee on Aging that his organization, the ACCME, has everything under control. In fact, here is what ACCME's standards for commercial support has to say about the content of CME:

The content or format of a CME activity or its
related materials must promote improvements
or quality in healthcare and not a specific
proprietary business interest of a commercial
interest.

But here is what Brand (x) has to say about CME:

BLISS ensures that your medical education programmes and strategies are synergistic with your brand's promotional strategy and execution.

I guess ACCME will need to hire a few more compliance officers.

New ACCME Report: Commercial CME Support Enters Free Fall

Once a year, the ACCME (Accreditation Council of Continuing Medical Education) releases its Annual Report detailing the state of the health of the CME enterprise. It reports various things, like how many CME courses have been offered, how many physicians have taken part, etc.... But the meat of the report is always on page 8, Table 7: "Income and Expense by Organization Type".

This year, the big news (though not that newsy to those who have been following the issue) is that for the first time since financial records were reported in 1998, the size of the CME industry has contracted. In 1998, the total income for all CME activities was $888 million, and over the years, it steadily increased to a high of $2,539 million in 2007. Well, last year, the total dipped to $2,365 million, a "loss" of $174 million.

Why do I put the word loss in quotes? Because virtually this entire shortfall was accounted for by a decrease in commercial support for CME. Commercial support dropped from roughly $1.2 billion in 2007 to $1 billion in 2008. This is actually good news, because drug companies support CME in order to encourage doctors to prescribe the newest and most expensive drugs, even when these drugs have no advantages and, as often happens, have more severe side effects than older agents.

But the news is even better than this. Drug companies are wisely electing to pull their money out of the most corrupt and biased of all CME-providing entities--the for-profit Medical Education and Communication Companies. As you can see in this chart put together by my assistant who painstakingly entered years worth of ACCME numbers into an Excel spreadsheet (note to ACCME--shouldn't this data crunching be your job?), commercial support for MECCs has entered free fall mode. In 2007, drug companies forked over $594 million to MECCs in order to promote their newest and most expensive products; last year, they reduced the spigot to $463 million--a decrease of $131 million, or a 22% drop.

And believe me folks, the 2009 report will look even worse for MECCs. Pfizer has announced that it will no longer fund them. The American Psychiatric Association is ending industry sponsored symposia, all of which are administered by MECCs. The AMA, in its latest CEJA report, said that commercial funding should be allowed only if the CME provider is deemed "not overly reliant on funding from industry sources." Translation: for-profit MECCs will no longer be kosher. (I realize this second CEJA report has been sent back to committee to tweak language such as "ethically permissible" but the language regarding MECCs will likely survive). Finally, the Institute of Medicine has called for a drastic reduction in commercial support of CME.

So goodbye MECCs. Your Christmas and Hannukah lasted a long time, but it's finally winding down.

ACCME's Good Courses, Bad Courses--Mystery Solved?

According to an anonymous source, ACCME’s newly proposed “Commercial Support Free CME” did not arise directly from ACCME. Rather, the idea was hatched in response to pressure from the American Board of Medical Specialties, which apparently takes a very dim view of industry-supported CME.

Here’s the background of this increasingly complicated issue.

As I wrote in a prior post, the ACCME has floated the concept of distinguishing two different types of CMEs—a Commercial Support Free CME versus the standard "anything goes" industry-funded CME (see this report from their March 2009 Board meeting for the details.) This has struck many as a strange idea: the national certifying body presents a refined definition of superior vs. inferior education, but at the same time declares that they would happily accredit inferior education anyway.

The plot got even murkier after the American Medical Association’s Council on Ethical and Judicial Affairs (CEJA) recently released its second effort at defining the ethics of industry funding of medical education. In their first report, which was released last year, the committee proclaimed that companies should not pay for doctor’s education when those same companies stand to benefit financially from the content of the education. While that made eminently good sense, it angered a subculture of doctors who prefer not to pay for their own education, so the proposal was tabled, and the committee was directed to come up with a more palatable version of medical ethics, which they recently released. This document, like ACCME’s proposal, proposes the same surreal notion of two CMEs: one that is “ethically preferrable” (involving no commercial support) and another that is only “ethically permissable” (funded by drug companies).

Essentially, the world’s premier medical organization is saying that while we should strive for the best ethics, dodgy ethics are also acceptable—at least when a lot of money is at stake.

Well, I finally solved the mystery of the two CMEs. At the heart of this case is neither the ACCME nor the AMA, but rather the American Board of Medical Specialties (ABMS). The ABMS sets the standards for maintenance of specialty board certification. Depending on your specialty, you have to undergo an exam or other evaluation process every few years so that you can continue to call yourself a “Board-Certified” psychiatrist, cardiologist, dermatologist, and so on. Apparently, the ABMS, realizing that industry-funded CME is quickly losing the public's trust, would prefer to no longer allow doctors to submit commercial CME as part of their requirements. But in order to be able to distinguish commercial CME from non-commercial CME, ABMS needed help from the organization that accredits CME, namely, the ACCME. So they asked the ACCME to create a separate Commercial-Free CME designation. ACCME complied, and the result is the proposal and call for comments posted on their website.

I called ABMS to verify they they are the force behind ACCME's proposal, but I was told that this was a "misunderstanding." I then went to my source, who said that ABMS is backtracking because of angry comments from medical societies. Finally, I contacted ACCME to find out if the Commercial Free CME designation was, in fact, prompted by ABMS, and I am still awaiting their response.

Does any of this really matter? Who cares who came up with the idea, or who pressured whom? It matters because we all deserve to know exactly where our major medical organizations stand on issues that are crucial to the public health. And the education of physicians is one of the most crucial issues of all.

ACCME's Existential Crisis

ACCME (the Accreditation Council for Continuing Medical Education) knows what it needs to do, but it is having a very hard time bringing itself to do it.

The pharmaceutical industry funds over half of all the education U.S. doctors receive, which is an embarrassment to our medical establishment and a danger to patients. Whenever I tell my patients that drug companies are in charge of most medical education, they react the same way--they shake their heads in an "are you serious?" expression of disbelief.

ACCME knows this system is inherently wrong but it also know that most of its income is dependent on the system.

Its latest effort to distance itself from the corrupted system over which it presides is to create a new category of "Commercial Support Free (TM)" CME. It's a strange proposal. It implies, of course, that CSF-CME (as I'll abbreviate it) is an essentially different kind of medical education from industry-supported CME. After all, if it were not different, then there would be no point in creating a separate category.

And how is CSF-CME different? It is presumably better in some way, because it is not tainted with the biasing influence of industry. As the industry-friendly journal Medical Marketing and Media has put it, the new designation is an official "Good Housekeeping Seal" for CME.

But herein lies the rub. The entire mission of the ACCME is to accredit only the cream of the crop of medical education. If it is now proposing to create a platinum category of truly unbiased CME, then what does this mean for industry CME? That it isn't very good. And now ACCME has boxed itself into a difficult position. If it is creating a second class citizen category of "not-as-good" medical education, why accredit it at all?

Perhaps this is a way for the organization to gradually transition toward a ban on commercial funding, a ban which the Board of Directors has announced is not in the cards any time soon. Thus, CSF-CME may be part of a 5 year plan to gradually wean CME off of industry funding. Here's how it would work. You create a category of the "best" CME, and, under the theory that "if you build it, they will come," you hope that doctors will naturally gravitate away from the phony tin courses and toward the platinum courses. This would hasten the shift of drug company money away from CME, and would make the eventual ban on industry funding a little less painful.

But, like gradually peeling off a bandaid, it won't really make it less painful for the MECCs--it will just make it more protracted, and more like slow torture. It's much better to simply rip the bandaid off in one fell swoop. The pain is harsh but brief, and we can all move on.

FDA's Indictment of Psychiatric CME

As covered in the business section of Tuesday’s New York Times , an FDA advisory committee has accused the agency of doing too little to warn physicians about the dangers of prescribing newer antipsychotics to children.

The committee reviewed data showing that more than 389,000 children and teenagers were treated last year with Risperdal, the majority of them 12 years old or younger. Risperdal is one of five newer atypical antipsychotics, drugs which comprise the bulk of antipsychotic prescriptions to both adults and children in the U.S.

While the atypicals have been extravagantly profitable for drug companies, a series of recent studies have shown that they are no more effective than older generic antipsychotics, and that some incur a higher risk of weight gain and blood lipid abnormalities. The most recent of these studies focused specifically on children with schizophrenia and schizoaffective disorder. In that study, the atypical drugs Risperdal and Zyprexa were no more effective than the generic molindone, and the children on the newer agents suffered significant weight gain—13 pounds on Zyprexa and 9 pounds on Risperdal over only 8 weeks of treatment. Molindone caused less than a pound of weight gain.

So who is to blame for the excessive enthusiasm for atypical antipsychotics in children? The FDA says: “Not us.” When asked why physicians were not learning enough about side effects, Thomas Laughren, the director of the agency’s division of psychiatry products, said that the FDA has done its job by requiring appropriate warnings on the drug labeling. According to the article:

"Dr. Laughren of the F.D.A. said the agency could do little to fix the problem. Instead, he said, medical specialty societies must do a better job educating doctors about the drugs’ side effects."

Hmmm. Now that is going to be a tall order, considering that over half of all medical education courses in the U.S. are funded by drug companies. The medical specialty societies reap millions per year in “industry supported symposia,” which are CME courses certified by the medical societies, paid for by drug companies, and which are subtle advertisements for the sponsor’s drugs.

What is the FDA doing about this corruption of medical education? Absolutely nothing. Instead, they have given this responsibility to an agency called the ACCME. The ACCME is independent of the FDA, and is funded almost entirely by organizations that have a vested interest in continued drug company funding of CME. Because of this, it has presided over an incremental approach to regulation that has moved at glacial speed. Meanwhile, children on antipsychotics are becoming obese.

It is time for the FDA to get involved in regulating doctors’ education. I suggest that they immediately form a task force to investigate why the ACCME is moving so slowly to get industry influence out of medical education.

Let’s get real about this issue. Our health, and our children’s health, are at stake.

Using CME to Build Market Share: The Evidence

In this prior post, I discussed this dodgy literature review recently commissioned by ACCME which concluded that there is "no evidence to support or refute the hypothesis that CME activities are biased." I began by detailing how Cervero and He, the authors of this review, managed to dismiss the results of 29 damning studies by pulling the old "outcome switcheroo."

Today, let's look at one of the few empirical studies that has actually measured industry CME bias, and see how Cervero and He tweak it.

This study is old (1988) and therefore precedes ACCME's current regulations on commercial support. Nonetheless, it is one of only three studies in the literature to measure the effect of industry CME on prescribing practices, and it was included in the Cervero review. The reference is: Bowman MA and Pearle DL, Changes in drug prescribing patterns related to commercial company funding of continuing medical education, The Journal of Continuing Education in the Health Professions, 1988;8: 13-20.

In a nutshell, researchers evaluated the effects of three industry-sponsored courses at Georgetown University. Each course focused on blood pressure medications, two on calcium channel blockers, and one on beta blockers. According to the authors, the drugs discussed in the courses were "basically similar, with only modest differences in benefits, side effects and cost, i.e., none of the drugs should have major advantage over the others in terms of cost, safety or efficacy."

All physicians taking the courses were asked by the researchers to estimate their use of these drugs over the past month. They were given this questionnaire both before the courses and 6 months afterwards. Researchers were interested in determining whether physicians increased their use of the drug manufactured by the sponsoring company.

Here are the results for the three courses. First, we'll start with the course on calcium channel blockers sponsored by the makers of Procardia (generic name nifedipine). As you can see in the table below, Procardia was already the most popular drug among these doctors, accounting for 47.9% of all new prescriptions of calcium channel blockers during the month before the course. Six months after the course, Procardia's market standing improved to 53.5% of prescriptions. Cardizem (diltiazem), at the time Procardia's arch rival, also improved its standing a bit, but less than Procardia. Calan (verapamil) lost out.

In this case, Pfizer (maker of Procardia) profited from the course, though not dramatically. This course was taught in the late 1980s, when Procardia’s patent expiration was just over the horizon (this happened in 1991). Cardizem was aggressively nipping at Procardia's heels with its own array of CME offerings. With this program, Pfizer's goal was to fend off Cardizem and to maintain their market leading status, and they were successful.

Effect of Procardia-Sponsored CME on Relative Standing of Competing Drugs (percentages indicate proportion of new prescriptions)

Next up, we have another course on calcium channel blockers, but this one was sponsored by Cardizem. As you can see below, when the manufacturer of Cardizem paid for CME, the education had a remarkably different effect on prescribing habits than when Procardia sponsored the same topic. Six months after the course, prescriptions for Cardizem shot up, from 31.4% of the total to 50.1%. Meanwhile, Pfizer's Procardia dipped down to only 29.3%. Clearly, speakers were chosen on the basis of their enthusiasm for Cardizem, and they were able to communicate this to the physicians quite effectively.

Effect of Cardizem-Sponsored CME on Relative Standing of Competing Drugs (percentages indicate proportion of new prescriptions)

Finally, the course on beta-blockers easily met the marketing objectives of the makers of metoprolol, which enjoyed by far the largest prescription boost among all beta-blockers discussed in the course:

Effect of Metoprolol-Sponsored CME on Relative Standing of Competing Drugs (percentages indicate proportion of new prescriptions)

Now, I would say that this study, as old and methodologically limited as it is, constitutes real evidence that industry sponsorship biases CME in favor of the sponsor's product. But Cervero and He--the artful tweakers--portray things differently. In their sketchy description of the Bowman and Searle results, they selectively mention the least impressive findings. For example, in the beta blocker study, their lukewarm summary is that "the sponsor’s drug increased although the number of physicians prescribing the drug for new prescriptions was not statistically significant." But as it turns out, most other differences were statistically significant.

Then they slam the discussion section. Pointing out that these CME courses predate some of ACCME's current standards, they object that "some of the reasons that the authors offer for why prescriptions increased are not allowed under current guidelines." Hmmm. The authors suggest five different explanations that might account for increased prescribing of the sponsoring company’s products. Let's quote each point, and see if any of them are, indeed, not allowed under current guidelines:

"First, the speakers may have favored the company drug in their discussion. The university’s guidelines were designed to prevent this, but do not guarantee success, as evidenced in another study which compared actual content of Courses I and III of this study (5). The sponsoring company’s drug was more frequently mentioned than its competitor’s products for Course I; for both courses the reported clinical effects of drugs made by the sponsoring company noted tended to be positive rather than negative."

Are Cervero and He implying that biased course content was allowed in 1988, but is no longer allowed in 2008? Actually, rules prohibiting bias have not changed in 20 years. Lack of bias is the essence of accredited CME.

The discussion continues:

"Second, the participants may have had contact with drug sales representatives at the course who gave them information."

Okay, fair enough. Drug reps are no longer allowed to have contact with doctors at CME events.

"Third, the sales representatives may have contacted course participants after the course was over."

This is definitely permitted now, and in fact it is precisely how companies leverage the marketing benefits of CME. The medical education companies say that they need participants' contact information to properly evaluate the quality of its courses. But you and I know the real reason they get this information--to pass it on to the sponsoring drug company, which then transmits it to their reps. The reps find out which CME activity you've taken, and can then tailor their pitch to coincide with the promotional--I mean, educational--points of the program. In marketing, this is called "synergy."

"Fourth, the provision of money by the company may have been part of a larger campaign for the drug. The physicians may have been subjected to other sources of information, such as drug advertising, on the same drug."

What? Are they saying that in 1988, drug companies were actually allowed to coordinate their CME programs with their overall promotional message? Surely, that is not permitted now.

"Fifth, the participants may have been generally impressed with the course, and, knowing it was partially underwritten by the company, have been favorably disposed to the company, and, as a result, to the company’s drug."

This remains one of the key marketing strategies underlying CME.

The bottom line: This study provides empirical evidence that industry-funded CME encourages doctors to prescribe the sponsor's drug, even when it has no compelling advantages over competing products.

Why Cervero and He did not incorporate this information into their conclusion is one of life's many mysteries.

Literature Review Shows that Commercial CME is Hopelessly Biased--Really!

Recently, ACCME commissioned and funded this literature review to determine, once and for all, whether or not commercial support biases CME. The paper, written by Ronald Cervero and Jiang He of University of Georgia, concludes that "to date there is no empirical evidence to support or refute the hypothesis that CME activities are biased."

While the finding may sound bland, such are the stakes in the epic drama accompanying the dying breaths of industry-funded CME that the Cervero and He non-conclusion is being used by MECCs (and by some misguided medical societies) as ammunition in their fight for the money. For example, you'll find the Cervero paper featured in letters to ACCME from both NAAMECC and AAFP (American Academy of Family Practice).

But Cervero’s sleepy conclusion is actually fraught with its own drama. Because if you were to read the original articles upon which this conclusion is based, you’ll find that this conclusion is wrong—and not just a little wrong. It is so far off the mark that one wonders if they made some sort of MS Word error, and accidentally pasted in the conclusion from an entirely different paper.

I don’t know much about the authors, but they appear to be well regarded academics in the world of continuing education. I assume they take no money from drug companies or their surrogates, although I haven’t done any serious investigating. I’ll give ACCME the benefit of the doubt here, imagining that it would be highly embarrassing if these authors had some undisclosed conflicts of interest.

Here’s what I assume has happened here. Cervero and He realized very quickly that this is no ordinary literature review. Not to be overly dramatic, but this is a $1.2 billion paper, the project of their lives.

If they had concluded what they should have concluded—namely, that the evidence is overwhelming that industry funding biases CME—they would have been responsible for the immediate disappearance of commercial CME.

$1.2 billion—gone!

Who can blame them for having treated each paper they reviewed as though it were ticking with radioactivity. Don’t get overly involved. Keep your distance. Be very, very cautious.

In this post, I’ll begin the slow and excruciating process of deconstructing the Cervero and He review. No fancy footwork here. I’ll simply plod through each the 10 studies they reviewed so that readers can make up their own minds.

First, the authors searched Medline and other databases for articles relating to commercial funding of CME. They identified 2000 potential articles, but rejected most of them because they were either not directly related to CME or did not discuss original data, which is fair enough. They ended up with 10 papers.

They begin their review with the famous paper by Wazana published in JAMA in 2000 entitled: “Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?" Wazana reviewed 29 studies of industry/physician interaction (two of which focused exclusively on accredited CME), and concluded that in most cases these interactions led doctors to favor the sponsor's drug, even when it posed no advantages. Wazana concluded that: “The present extent of physician-industry interactions appears to affect prescribing and professional behavior and should be further addressed at the level of policy and education.”

Wazana provides a tsunami of evidence that commercial bias affects how doctors make clinical decisions, both in CME and other settings. But Cervero and He see this rather differently: “An important point is that none of the 29 studies used patient outcome measures, and therefore there is no evidence about the positive or negative impact of the prescribing practice changes.”

But wait a minute! ACCME didn’t ask the authors to assess whether industry funding harms patients, they asked them to “analyze the research literature about the relationship between commercial support and bias in CME.” Which is exactly how they start, by reviewing Wazana. But once it is clear that Wazana demonstrates bias, Cervero and He revise their mission by raising the bar. Now they are saying, essentially: “Okay, we’ll concede your point that commercial CME is biased, but that’s not the real issue. The crucial issue is whether the bias harms patients, and none of your 29 articles have shown that.”

How unfair is that? It reminds me of a technique often used in industry-funded CME articles: when the data begins to imply a positive conclusion for your competitor, you shift the emphasis to a different outcome variable.

But okay, let’s play along here a bit, because this is a favorite argument of industry CME defenders: "It’s one thing to demonstrate bias, but unless you can show that this leads directly to doctors making bad decisions that harm patients, you have no argument."

Why is this absurd? Because if lack of demonstrated patient harm constituted ACCME’s criteria for accreditation, every drug advertisement in every medical journal would potentially qualify as a CME activity. Drug ads are biased—nobody would argue this point. But they do provide accurate information. And they have never been shown to lead to patient harm. So why not accredit drug ads?

Accredited medical education is “accredited” precisely because it is held to a higher standard than drug promotion. That standard is lack of bias, and not lack of patient harm.

Of course nobody has shown that drug ads or CME events have actually harmed a patient. Why? Because it’s an impossible study to do.

Here’s what would be required. Enroll 1,000 physicians into a study in which half of them are randomized to industry-sponsored CME and half to independent CME. Their patients, of course, would have to be enrolled as well, because the outcome of interest is patient harm.

Imagine that a researcher presents you with papers to sign, and gives you the following disclosure: “This is a study to see if patients whose doctors are educated by drug companies will have more or less heart attacks than patients whose doctors pay for their own education. Your doctor will be randomly assigned to either drug company sponsored education or independent education. Neither you nor your doctor will know which group you are assigned to. You will receive free care for the duration of the study.”

Not only would this be an impossible study to recruit for, but no institutional review board (IRB) on the face of the earth would approve it. Why? Because they would rightly maintain that the goal of this study—to decide whether industry should continue to fund medical education—is not worth the potential danger to patients.

Next post: Cervero’s take on the Bowman and Pearle study…or, “so what if a CME course made Diltiazem number one…what’s wrong with that?”

ACCME’s Latest Proposal: Docs on Speaker’s Bureaus should not teach CME

The ACCME has proposed a new policy that may actually do something significant about preventing bias in industry-sponsored CME. To quote from the proposal:
“Persons paid to create, or present, promotional materials on behalf of commercial interests cannot control the content of accredited continuing medical education on that same content.”

ACCME had been hearing about situations in which medical writers were paid to write promotional material for drug companies, and then were hired by MECCs to write CME for the same companies. In addition, often physicians are on speakers bureaus and advisory boards and are then also allowed to deliver CME content funded by the same companies. Obviously, this defeats the purpose of the firewall between CME and marketing. A firewall is essentially worthless if writers are allowed to shuttle back and forth between marketing and CME.

With this new policy, ACCME is saying to doctors: “If you want to be on speakers bureaus and advisory boards of drug companies, that’s fine. But you can’t double dip. You can’t then also get paid by the CME companies that are taking grants from those same companies.”

Of course this is a necessary policy, and many readers will find it amazing that this loophole even exists.

The ACCME has its heart in the right place, but is in an impossible situation. Its mission is to make sure continuing medical education leads to improvements in patient care that reflect the best medical science. But once the drug industry discovered ways to produce CME via the strategy of funding third party companies to do their bidding, ACCME became involved in a futile struggle against the inexorable logic of the market. When a system is structured to allow huge financial incentives to create biased education, the education will, in fact, become biased.

Nonetheless, over the past 15 years or so, ACCME has been gamely trying to swim against this current and has instituted progressively stricter versions of its Standards for Commercial Support. First, they required disclosure of industry ties. But this didn’t change the bias, and may have simply whitewashed the process. After this requirement, industry funding of CME skyrocketed.

Then, seeing that simply disclosing conflicts of interest did nothing to stem the tide of industry bias, they required that companies institute systems for identifying and neutralizing that bias. But the only thing that got neutralized was this new Standard. Companies gamed the system by using their drug company grants to hire “independent reviewers” who didn’t have ties to industry. These reviewers’ job description was to sign a form stating that every industry-funded CME activity crossing their desk was “fair balanced.” The bias continued, and industry funding grew some more.

Next, ACCME told MECCs that they could no longer get any advice from drug companies about topics or speakers to use. This didn’t affect anything, because MECCs don’t need to hear from sponsoring companies to figure out what topics they are interested in funding, or which speakers can be counted on to say good things about their products. There’s this new thing out called “Google” that allows MECCs to learn all this information on their own.

The latest proposal—no more double-dipping—is simply ACCME’s latest efforts to slap some duct tape over the porous firewall between MECCs and industry. Who could possibly argue against this? The MECCs are, and, once again, are making themselves look very bad in the process.

Among the various specious arguments I’ve heard against this policy, the most astonishing is the censorship argument. By forbidding doctors on company speakers bureaus from writing accredited CME, so the argument goes, ACCME is “censoring” them. At Policy and Medicine, for example, Tom Sullivan, president of the MECC Rockpointe, says that “banning certain authors from writing books and giving talks doesn't seem to accord with freedom of speech, but that is exactly what the ACCME is proposing.”

Come on folks. Let’s get real. ACCME is not preventing anybody from saying or writing anything they want, anywhere, at any time. They are simply withholding a lucrative seal of approval from speech that does not meet their requirements. When Good Housekeeping Magazine withholds its seal of approval from a shoddy product, they are not preventing the company from making it. The shoddy product can still be sold; the company just can’t use the seal to market the product.

Similarly, ACCME is saying that medical communication produced by people who take marketing money from drug companies no longer meets its standards for high quality CME, and it will no longer accredit such communication. MECCs are still free to provide it, print it, circulate it in conferences, but it won’t be accredited information. How is this “censorship?”

The real issue is whether the new rule will have any effect on commercial bias in CME. I’m skeptical, if only because MECCs have shown themselves so adept at coming up with regulation work-arounds in the past. They will presumably have to groom a new generation of writers and speakers who have not taken money directly from industry. That’s not hard to do. All it takes is a lot of money and a little patience.

Clearly, the only real solution is to end commercial support for CME, and ACCME is actually requesting comments on this very proposal. Who knows? Maybe they are finally tired of participating in this perennial dance of making rules that can’t stick. Only Murray Kopelow knows for sure!

Using ACCME's New Rules for Bias and Profit

In bmartin’s pro-industry-CME blog Pathophilia, there is an interesting post about the newly proposed ACCME rules intended to stamp out commercial bias while still allowing commercial support. Bmartin parses out the wording of ACCME’s proposal in order to try to divine the organization’s actual intentions, and finds much to ridicule.

You can detect a heavy dose of financial anxiety in this post. It’s an attempt to read the tea leaves in ACCME’s new policy, in the hopes that it will not actually mean any significant changes in the current system. But bmartin ends on a decidedly pessimistic note, predicting that the regulations will lead to less industry funding, and ultimately, to the disappearance of ACCME itself.

While I wish I could agree with bmartin, unfortunately I see this as very good news for industry support. Anybody who owns a CME company and has undergone accreditation and reaccreditation (as I have) knows that there is really nothing new in this “new” guidance. Any company will be able to demonstrate compliance with each of these and yet still produce promotional and biased CME. Let’s take each of these elements point by point and apply it to a recent promotional CME article produced by Medscape (see here for more details, and see Bernard Carroll's excellent investigative journalism on Medscape here and here).

1. Needs assessment will have to be identified by neutral organizations. Not a problem! You want to keep the flow of money coming from Janssen to help it promote Invega? Many non-industry funded organizations will report that practitioners have a need to learn more about the appropriate use of antipsychotics. Bingo—you’ve just done your needs assessment.

2. Practice gaps will have to be identified by neutral organizations. Same non-issue as number one. Any reasonable organization will identify adequate treatment of schizophrenia as a “practice gap.” For example, the AHRQ produced this document which can be cited to support the need for education about how to use atypical antipsychotics. Medscape will argue that focusing an article on treating a schizophrenic patient with liver disease (which just happens to be the specialty of Invega, its sponsor’s medication) fills an identified “practice gap,” and ACCME won’t argue with them.

3. The curriculum must be specified by a bona fide organization. This is a hard one…let me see…okay, how about psychiatry’s specialty board, the American Board of Psychiatry and Neurology, Inc., which publishes these “core competencies” in psychiatry. Go to the “Somatic treatment” section and you’ll find the following recommended curriculum for psychiatrists:

“Somatic treatments, including:
a) Pharmacotherapy, including the antidepressants, antipsychotics, anxiolytics, mood-stabilizers, hypnotics, and stimulants, including their:
i) Pharmacological actions
ii) Clinical indications
iii) Side effects
iv) Drug interactions including over-the- counter, herbal, and alternative medications
v) Toxicities
vi) Appropriate prescribing practices including age, gender, and ethnocultural variations
vii) Cost-effectiveness”

I think this is broad enough to support any CME activity, no matter how blatantly promotional, as long as it relates to some aspect of pharmacotherapy.

4. It must be verified as “free of commercial bias.”

This is a redundancy, since this is already a centerpiece of ACCME Standards for Commercial Support. The organization will never have the resources to monitor the thousands of industry-supported CME activities hatched yearly.

So don’t fret, bmartin—in fact, I would argue that this is a cause for great joy. ACCME is handing you the perfect mechanism for a commercial CME whitewash. Use some of that industry money to celebrate.

ACCME Gets Serious with "New Paradigm"

Given AMA's recent decision to slow down on CME reform, these new guidelines proposed by ACCME are more than welcome. The ACCME is focusing on the epicenter of commercial bias, which is the choice of topics to be covered in CME programs. As I have detailed in my last two posts, the cutting edge technique for ensuring that CME contains promotional content is to choose topics that are in line with the sponsor's commercial interests. The resulting course may be a scientifically accurate portrayal of a carefully pruned topic, showing no obvious "bias" within that topic area. But it is promotional nonetheless, just as drug company advertisements are promotional even though the FDA oversees them to ensure scientific accuracy.

The new guidelines will not allow MECCs to choose the topics; instead, they will chosen in consultation with relatively unbiased government agencies and medical societies. The one aspect of the "new paradigm" that is a head scratcher is the stipulation that CME be "free of bias." That's been a requirement for years, but has never been enforced. It appears that the organization has beefed up enforcement efforts--the say they have put 10% of providers on probation for breaches of their Standards of Commercial Support, up from 1% in the past.

We'll all have to stay tuned.

ACCME's "New" Policies, Translated

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.

ACCME Considers Banning Commercial Funding of CME

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.

Welcome to The Carlat Psychiatry Blog

I decided to start this blog in order to follow up on some buzz generated by a recent New York Times op-ed in which I recommend that industry-sponsored CME activities no longer receive accreditation from the ACCME.

I've received dozens of responses, mostly supportive. A recurring theme of these comments is: don't blame only the drug companies, blame the doctors too. The Times printed this letter to the editor saying exactly that.

It's true, everybody who stands to gain is complicit in this enterprise. The companies get a uniquely effective marketing vehicle, the medical education communication companies (MECCs) get millions in educational grants, the ACCME gets funding to continue its mission, hired-gun physician speakers get cash, prestige, networking opportunities, impact, etc...., and the doctors who attend the programs get free education. Who in their right mind would want to spoil the party?

Our patients, for one. Industry-supported CME always downplays the dangers of any product being sponsored. Sometimes, these dangers are trivial, as in the case of SSRIs. Other times, these dangers include diabetes, obesity, and high cholesterol, as in the case of Zyprexa.

The point is that we can never trust commercial CME, because of its inherent conflict of interest: it is education designed to encourage the audience to use more of the sponsor's product.

Please join me in my crusade. If you have seen any examples of obvious commercial bias in educational activities, let me know. Together, we can sniff out the worst offenders, and report them to the ACCME, to the Senate Finance Committee, which released this report , and to whoever else has an interest in improving the ethics of medicine in America.

Thanks very much for your interest.