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?”