Wednesday, July 2, 2008

Pfizer and CME Support: A Second Shoe Drops?

Thanks to the Pharmalot blog and Ed Silverman for this fascinating news:

Now, what Ed does not tell us is that this posture of Pfizer's--ceasing the funding of continuing ed for docs (CME) via the for-profit medical education and communication companies (MECCs to the trade)--is almost for sure a reaction to recent events on Capitol Hill; but the antecedents go back to a bit of old history that was reviewed in HOOKED.

Act One of the drama occurred in 2003, when the Office of the Inspector General, DHHS, issued a report that got the industry's attention--by threatening drug company execs with Federal prison on racketeering charges if they violated the anti-kickback law. OIG-DHHS helpfully explained to the drug companies (and to doctors, had any been listening) that in order to be in violation of this Federal statute, all you have to do is give anything of value, to a physician who receives reimbursement from a Federal program such as Medicare or Medicaid or the VA, with even the partial purpose of influencing whether or not she prescribes your product.

Having explained that every encounter between a drug rep and a physician in which a gift is given, is technically a violation of Federal law, the OIG reassured the companies that they were not out to police individual contacts with docs. Rather they were going to be looking in the future at broad issues of corporate practices, and would view certain practices as being in compliance, and others as raising red flags. One red flag behavior was paying for CME out of your marketing budget. The OIG said instead that if they ever investigated a drug company, they'd be seeking evidence that the company had erected a financial firewall between its CME funding actiity and its marketing activity.

As I went on to report in HOOKED, the industry sat up and paid attention. The budding industry attack on strict new CME guidelines issued by the national accrediation counsel (ACCME) melted away and ACCME adopted its tougher guidelines with nary a whimper from industry. Companies reportedly were working to construct the needed firewalls and to separate much more formally their marketing budget from CME support and to make the latter more obviously no-strings-attached.

However, the result of Act One was not a refusal to channel industry CME money through MECCs. Rather it was the creation of the needed firewall to be able to claim that CME and marketing were being kept separate.

Now we come to Act Two--the newly aggressive efforts in the Senate (especially) to push for a sunshine law revealing all industry payments to docs, and Sen. Grassley's recent campaign to publicize egregious cases of conflicts of interest among academic physicians. I interpret the Pfizer move to demonstrate that at least some companies have decided that the heat is now turned up too high to permit things that seemed okay even after the OIG-DHHS report, and so the companies are responding to the heat by getting out of the MECC kitchen. But it's my guess that Act One was a necessarily prelude to this more recent development.

When I initially logged onto the Pharmalot blogsite, there were two comments to the story about Pfizer, each of which raised an interesting point. The first suggested that this is not necessarily going to improve integrity in CME, but rather drive the funding stream deeper underground; Pfizer admitted that it would keep sending its money to the MECCs if they could do so via a third-party broker. (Example: Pfizer gives a professional medical society a major grant to fund a stop-smoking campaign; the professional society independently contracts with a MECC to manage the campaign; and merely by chance, the campaign urges that docs prescribe Pfizer's Chantix to get people to quit smoking.) A second commentor suggested that this development is a good thing because now instead of giving their money to slimy MECCs, the drug company will give its CME money to groups of integrity, like "university-based CME providers." I am afraid that this commentor has not been to a university-based CME event lately to see how commercial even those venues have often become when they are heavily funded by industry.

1 comment:

pharmalot said...

Hi Howard,

Good analysis and thanks for the illuminating background on this topic. You're correct that I didn't spent a great deal of time discussing the Sunshine Physicans Payments Act, although I actually did note that Pfizer's move comes after the bill emerged. There was also a link to an earlier post that discussed in more detail the recent decision by Lilly to back the bill, after it was watered down. Anyway, I enjoyed your insights and appreciated the link.