Monday, September 22, 2008

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?”


Anonymous said...

Just like having Phil Grahm write a commentary piece for the general media that there is no financial crisis going on, it's just all in our whining little heads.

It is nothing less that amazing and obscene how people will just lie and think everyone will just buy it and move on.

Sort of, like what an addict does?

Anonymous said...

Do Cervero and He have spines, are their legs made of jelly? What kind of reputation do they want in the future when the truth is widely accepted? Bit like being Moody's rating agency for a Wall St Investment Bank - the AAA ratings are so accepted while the game's still going on, but one day...