Industry-funded CME: Is Commercial Content Ever Appropriate?

Dr. Robert Donnell (the writer of Notes from RW ) and I have been debating some key topics related to commercial funding of CME.

In his latest post on the issue, he focuses on a core issue. When an industry-funded program highlights the sponsor's product, does this inherently imply bias? What if the sponsor's product actually is the best treatment for the condition under discussion? To quote from his post:

What if a clinical problem under discussion has only one commercially available treatment, or one drug which is clearly superior to the alternatives? Many topics come to mind in my own areas of interest: Thromboembolism prophylaxis and the risk of heparin induced thrombocytopenia in a post cardiac surgery patient. (Arixtra, the only available anticoagulant with a clear advantage, would be featured). Improving outcome in a patient with severe sepsis: modulating the inflammatory and coagulation cascades. (Gotta be Xigris). Or how about Options for basal insulin coverage in a brittle type 1 diabetic. (Lantus and Levemir would be the clear choices). While Carlat might not think these topics worthy of CME they are common clinically important issues. I just made them up but they are typical of offerings we are likely to see more of given the recent clamor among some academics for more focused, case based CME.

There are definitely a few situations in medicine in which there is one and only one reasonable treatment, and in those cases a sponsored and an unsponsored program would have essentially the same content. But these are exceedingly rare. In psychiatry, I can think of no examples at all. In most of medicine, there are multiple competing treatments, none with any clear advantage for most patients (which is a good thing for medical choice and progress). I suppose that one policy implication of Dr. Donnell's argument is that we might create a list of those few one-best-treatment topics, and allow industry funding for these topics only. It sounds unworkable to me, given the pace of medical progress and the disagreements among academics regarding treatments of choice.

Another point from Dr. Donnell's post:

Dr. Carlat raises another point. Some of Medscape’s offerings my not be in compliance with ACCME standards. Section 5.1 reads:

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.

On the surface that is so obviously true it’s a cliché, but a literal reading of the words would restrict comments on benefits of drug treatment to coverage of generics and orphan drugs! That’s not what the ACCME intended, so there has to be room for interpretation.

I disagree. This section does not prevent industry from funding discussions of both branded and generic drugs, as long as the discussion is not slanted toward one particular agent. If there is no slant, then the CME activity does not promote a “specific proprietary business interest.” The problem is that medical education companies have become specialists in the techniques of subtly slanting programs in the direction of the sponsor’s product. Such programs, indeed, are non-compliant with ACCME standards.

While we all agree on the importance of quality educational offerings the debate over CME will go on. My take? Medscape CME may have quality problems. I differ from Dr. Carlat in that I think its offerings should be adjudicated case by case.

By “quality problems,” does he actually mean “bias problems?” The problem with the idea that the solution is to “adjudicate case by case” is that the ACCME will never have the resources to even begin to do this. Working as a volunteer, it takes me hours to unravel the mechanisms of commercial bias in a single psychiatry CME program, and I can do this only because I have a very good familiarity with the literature in the field. How can ACCME hope to monitor these programs in all the different specialties of medicine with a staff of 12, most of who are not physicians? There are literally thousands of commercially-sponsored programs per year.

As an example of how ACCME is doing, I lodged a formal complaint about a course on drug interactions in psychiatry well over a year ago, a case involving such blatant manipulation of content that one of the authors called it a “piece of commercial crap.” ACCME is apparently still examining the issue, and will not respond to emails requesting an update. They have no formal process for complaint resolution.

Case by case adjudication is, I fear, a way of ensuring that there will be no reform.

Finally, I would be remiss if I didn’t point out that identification of the payer source is not a litmus test for the quality of a CME offering. No one has demonstrated a general correlation based on high level data. Dr. Carlat offers a few interesting anecdotes. I can easily counter with some of my own. Recently I attended a prestigious accredited course with no support from device companies in which a speaker promoted numerous non evidence based uses for inferior vena cava filters. I’ve seen similar clean, pharmfree and unbalanced promotions of coronary artery bypass surgery and angioplasty. More concerning examples (all ACCME accredited) can be found here, here and here. I could trot out many others. You get the idea.

Yes, it’s true that lack of industry funding does not guarantee unbiased presentations. However, presence of such funding almost guarantees a lack of balance. Interestingly, the three activities he cites as “concerning” are programs that would never receive industry funding. They are all courses on integrative or complementary medicine, offered by UCLA, Yale, and NIH. Each covers the clinical evidence for these treatments using evidence-based teaching, but because these techniques have little commercial potential, doctors are poorly informed about them. As an example, few physicians are aware that an NIH consensus statement declared acupuncture to be effective for both post-operative nausea and post-dental procedure pain.

I'm a physician. I deserve nice things.

Medscape and my sometimes nemesis Dr. RW got a nice smackdown in this blog entry on “Billy Rubin’s Blog.”

I had never heard about this blog until my Google alert sent me the link under the keyword “industry-sponsored CME.”

I encourage you to read the entire article, which is well argued, and does a great job of being indignant without sounding mean or strident, a skill in which I could use some tutoring.

One excerpt:

Oddly--well, actually, not oddly at all--the real argument running beneath these rationalizations is virtually never spoken of. It's pretty simple, actually, and Doctor Rubin, despite his immense respect and affection for the vast majority of his colleagues, has heard that silent-yet-powerful argument since his early days in med school. The "argument," such as it is, is this: I am a physician and that entitles me to nice things. Trinkets, such as free hors d'oeuvres at the cocktail hour following the day's professional meetings, fancy dinners on the tab of the local drug rep, tax-deductible trips to "educational conferences" in the Bahamas--all this is part of the trappings of the lifestyle of a doc. Such is the mentality that resists seeing the obvious conflict-of-interest in industry sponsorship of CME; the defense of the indefensible rests on an emotional response, not a rational one. Until that mentality, that sense of entitlement changes, you can count on organized physician opposition to the meek suggestion that, you know, perhaps we might want to reconsider our relationship with groups whose job it is to make money, given that our job is theoretically to heal patients.

Can CME be both Biased and Accurate? Of Course!

I enjoy reading Notes from RW, the blog of Robert W. Donnell, MD, a hospitalist in Arkansas who writes frequently for Medscape. While the two of us disagree robustly about the propriety of industry-funded CME, he argues his points rationally. In his current blog entry, he takes me to task for my recent comments slamming Medscape's CME offerings. His main point is that I haven't demonstrated that the industry-funded CME articles in Medscape are inaccurate. To quote Dr. Donnell:

Concerning the Invega article, cited in his post on Medscape’s “CME corruption”, Carlat wrote "Has Janssen--I mean, Medscape--said anything inaccurate in this puff piece? No." That, we are to believe, is not important. In Carlat’s way of thinking the fact that the CME article is favorable to a product of the sponsor is damning enough without regard to the accuracy of the piece.

It's not that I believe accuracy is "not important." In fact, I believe accuracy is vitally important for CME. Unfortunately, however, accuracy does not protect CME articles from commercial bias.
The clearest argument is to compare drug advertisements with CME. The FDA regulates all industry advertisements for accuracy. Drug ads are required to make accurate claims about both the efficacy and the side effects of the sponsors' products. When ads are inaccurate, the drug companies can count on receiving nasty letters from the FDA such as this one, which scolded Pfizer last year for presenting inaccurate information about their antipsychotic Geodon.

Medscape's CME article on Invega is accurate, but is nonetheless promotional and commercially biased, because it focuses on the one clinical situation in which Invega offers an advantage over its competitors. It does not discuss advantages of other antipsychotics, nor does it discuss the many potential disadvantages of using Invega.

Likewise, Janssen produces advertisements for Invega which are accurate, but commercially biased. For example, here is a link to an advertisement for Invega .

It reads, in part:

"Powerful Efficacy for Many Patients Experiencing Symptoms of Schizophrenia

Including:

Patients who may benefit from a change in therapy

Powerful symptom control
In all 3 pivotal studies, INVEGA demonstrated significant improvements in PANSS total scores at all doses (3 mg, 6 mg, 9 mg, 12 mg ) versus placebo (P<0.001)."

There is nothing inaccurate here. Invega, like all FDA-approved antipsychotics, is efficacious for symptoms of schizophrenia. It does, indeed, demonstrate improvement in PANSS vs. placebo in all 3 pivotal studies. Nonetheless, this accurate medical information is commercially biased, because it is organized around the advantages of the sponsor's product and does not discuss the features of its competitors. For example, the ad does not mention that Invega performed poorly relative to Zyprexa in some of its FDA trials.

This advertisement could not possibly qualify as a CME article, because it breaks the two content rules of the ACCME's Standards for Commercial Support. Rule 5.1 states:
"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." By contrast, advertisements are crafted specifically to serve a company's business interest.

Rule 5.2 states:
"Presentations must give a balanced view of therapeutic options." Again, Janssen's drug ads are accurate but they do not give a balanced view of therapeutic options for schizophrenia. Nobody would expect such a balance--after all, these are ads.

However, the Janssen-funded CME article is supposed to give a balanced view, but it does not. Not only is the entire article organized around Invega's clinical advantages, but it ignores its two most conspicuous disadvantages: hyperprolactinemia and extrapyramidal symptoms (EPS). Instead, the article highlights weight gain and diabetes--side effects of great relevance to Invega's competitor Zyprexa.

(As an aside, Dr. Donnell defends another Medscape CME article which I criticized for an exceedingly gentle description of Zyprexa's side effects. That one, of course, was sponsored by Zyprexa's manufacturer, Eli Lilly. In Janssen's Invega article, by contrast, Zyprexa's side effects are described with vigor: The recent CATIE [study] highlighted the increased risk and incidence of metabolic consequences in patients with schizophrenia, which was associated with the use of a variety of atypical antipsychotic medications as well as specific modifiable risk factors.[10] In particular, the study noted the effects of specific antipsychotic medications on weight gain/obesity and metabolic endpoints. For example, the superior efficacy of olanzapine was tempered by its propensity to cause metabolic problems and greater weight gain than the other treatments, with an average increase of 2 pounds per month, as well as an increased risk for other metabolic effects vs the other agents.[17] In fact, the American Diabetes Association (ADA), American Psychiatric Association (APA), American Association of Clinical Endocrinologists, and the North American Association for the Study of Obesity together issued a consensus statement highlighting the relationship between specific atypical antipsychotics and the development of weight gain, diabetes, and hyperlipidemia.)

The bottom line is that accuracy is a minimum requirement of both CME articles and drug ads. In my experience, it is rare for industry-sponsored CME to be blatantly inaccurate. Instead, accurate statements are strung together strategically in order to encourage the use of the sponsor's product--and to discourage use of the competitor's.