Wednesday, July 16, 2008

Pfizer and CME: Reading the Tea Leaves

On July 3, Pfizer announced that it would no longer directly fund medical education and communication companies (MECCs).

Everyone’s wondering what Pfizer’s announcement means and what the implications will be for commercial CME. It’s not clear at first glance. They will no longer fund independent MECCs. However, they will fund medical schools, hospitals, and medical societies, even when those organizations jointly sponsor programs with MECCs.

Why did Pfizer target independent MECCs? Primarily because MECCs, unlike hospitals, medical societies, and medical schools, are almost entirely dependent on drug company CME funding for their existence. The incentives to bend the rules and create biased education are enormous, much greater than the incentives operative in other institutions.

According to ACCME data, in 2006 MECCs received more commercial support ($621 million) than medical schools, medical societies, and hospitals combined ($497 million combined total). In addition, MECCs are more dependent on commercial support as a proportion of their total income. In 2006, commercial support comprised 76% of MECC income, followed by medical schools (62%), hospitals (52%) and medical societies (30%).

These proportions appear deceptively comparable, but in fact they are not, because unlike other organizations, MECCs are dependent on CME income alone. If a typical academic medical center stopped providing CME, it would cause barely a hiccup in their overall budget; if a MECC stopped providing CME, it’s Goodnight, MECC.

Trade groups representing MECCs have reacted to Pfizer’s announcement by riffling through their inexhaustible supply of spurious arguments painting them as good corporate citizens. Their favorite one: they are very very competent when it comes to paperwork. For example, NAAMECC, the North American Association of Medical Education and Communication Companies, says in their response to Pfizer that:

“The ACCME’s own accreditation data released in 2006 demonstrates that MedEd companies perform at least as well as, and in many cases better than, other provider types, including academic medical centers (AMCs) and professional and medical societies and hospitals. In fact, MedEd companies lead compliance with the ACCME
Standards for Commercial Support among all accredited provider types. In addition, 100% of the accredited MedEd companies, as a condition of ACCME accreditation, have demonstrated separation of promotion from education, which is a key criterion for establishing their independence from commercial support.”

Yes, when you receive millions in Pharma grants for CME, you can afford to hire a team of compliance experts who will make sure that your disclosure forms are worded correctly and that you've paved convincing paper trail to demonstrate a firewall between your sponsor and your CME. Luckily, Pfizer is not at all fooled by such arguments. In this fascinating interview with Medical Meetings Magazine, Pfizer’s head of CME, Mike Saxton, put it like this: “The MECC community will appropriately point out that as a group they’re more in compliance than other provider groups, but noncompliance findings are often for relatively minor issues involving paperwork and ignore more fundamental conflicts of interests that aren’t even being looked at or discussed.”

Saxton is particularly concerned about the typical MECC business model, in which executives’ salaries are tied to the amount of grant money they bring in from companies. In contrast, CME directors at medical societies and hospitals are paid a salary unrelated to the size of grants. Without the big bonuses, CME directors certainly make less money, but on the positive side, their professional incentives are closer to where they should be: creating valid and unbiased medical education for physicians. The business development practices in MECCs are very different, and according to Saxton they "create an irreconcilable conflict of interest with independence that is not currently addressed by the ACCME system at all.”

It’s an age-old problem. When you know who butters your bread, you do everything you can to keep your supplier happy. Especially when the bread and butter is all you’ve got to eat.

But enough of the sunny side of Pfizer’s decision. Here’s the dark side: they will continue to indirectly fund MECCs, as long as the grant money goes first to a medical society or medical center. What a loophole. You can already hear the great sucking sound of dozens of MECCs running to medical societies with proposals.

If the system of industry-funded CME is already a legalized form of money laundering, Pfizer’s solution exactly doubles the deception. For example, Pfizer has funded the California Academy of Family Practice to the tune of around $3 million to provide CME on smoking cessation, a program called CS2day (Cessation of Smoking Today).

Guess where much of the $3 million will go? To CME Enterprise,
a MECC which is the sister company of Avant Healthcare Marketing, a firm specializing in such things as “thought leader relationship management” and “strategic lifecycle counsel.”

Here’s how the CME money will henceforth be scrubbed and layered at Pfizer:

First layer: Grant to a “clean” medical society or academic medical center.
Second layer: Medical society gives money to a MECC.
Final layer: MECC writes check to hired guns and ghost writers.

Will medical societies achieve better oversight over the final CME outcome? Possibly. I’ll be interested in seeing what CS2day actually produces. Pfizer markets Chantix, which has been linked with a tsunami of neuropsychiatric and other side effects. We’ll see if the California Academy of Family Physicians will risk mentioning any of these.


James M. La Rossa Jr. said...

In all fairness to the players involved, perhaps it is time to acknowledge that Pfizer et al. is making a good faith attempt to influence the debate by ridding itself of direct sponsorship. To suggest that Pfizer will simply "launder" their CME through other channels shows a lack of understanding as to how this issue has proven to be both a legal and marketing liability for industry. (As has been suggested in the past, industry did not create this CME boondoggle. The FDA guidelines gave birth to this monster, and the ACCME unwittingly let it grow over the years.) What you opine is patently transparent under subpoena, and no company with the marketing expertise of a Pfizer would enroll themselves in such a foolish venture. Talk about "throwing good money after bad," as the saying goes; they are way too smart to go down that road. The most pressing question is whether the APA will clean up its roll in all this, or will it be business as usual for the capital gang? Lastly, some credit where credit is due here: It is highly unlikely that these initial reforms would have come about without DC and colleagues.

Daniel Carlat, M.D. said...

Perhaps I am a bit harsh on Pfizer. I do believe that this is a step forward, and I support it. However, the issue of the "double deception" is a real one. I'm sure the vast majority of physicians attending industry-supported symposia at medical society meetings have no idea that MECCs are involved, and in fact probably don't even know what MECCs are or how central their role is. They think that the medical society has simply received a grant from a drug company and has invited speakers themselves. That's not at all the way the system works, since most symposia begin with a relationship between a particular MECC and a thought leader. These two hash out the symposium content and decide which company will be approached to support it. The medical society has to approve the content, to be sure, but they are simply a conduit for the money, taking a good piece of it for themselves.