Friday, May 23, 2008

PhRMA Endorses Transparency Bill; CME Loophole Persists

The drug industry’s main trade group, PhRMA, just announced that it will support a congressional bill that would publicly post all drug company payments to physicians. The bill, the Physician Payments Sunshine Act, was initially resisted by drug companies, but recently Eli Lilly announced its support of the legislation, and both Merck and AstraZeneca have followed suit. Given these developments, and given that the bill has substantial support in the House and Senate, it is virtually certain of passage.

What would this bill actually do, and what are the implications in terms of scaling down the extent of corruption in industry-supported medical education?

You can view The Prescription Project’s fact sheet on the bill here, and coverage of the latest developments from the excellent Politico website here. Essentially, the bill forces drug companies to report any payments or gifts to physicians, as long as they are valued at more than $500. This would include payments for speaking, consulting, travel reimbursement, and various other activities. Payments for clinical research and the value of drug samples would be exempt from disclosure requirements.

It's a great start, but unfortunately, the bill misses one of the largest sources of industry payments to physicians: payments to third party medical education communication companies (MECCs). This is the money laundering scheme used by industry to make drug advertising look like objective continuing medical education. A drug company awards a MECC an “unrestricted educational grant” for a conference on, say, antipsychotics. The MECC then hires physicians as faculty members who can be counted upon to say good things about the sponsor’s drug. The checks to these physicians are then nominally written by the MECC, although the drug company is the actual source of the money. These payments typically begin at $1000 and head skyward from there. And this doesn’t include additional thousands for reimbursement of lavish travel expenses. In 2006, drug companies funneled $1.2 billion into this sleazy shell game. In its current form, the Physician Payments Sunshine Act will allow these payments to go completely unreported, because it focuses only on direct financial transfers between drug companies and doctors.

On the positive side, all non-CME, explicitly “promotional” talks will be subject to the bill’s provisions. This means that patients will be able to look up their doctors on the Physician Payments website, and find out exactly how much money they accepted from which companies, to do what. I predict a rapid depleting of the speakers bureaus of drug companies, because most doctors will be too ashamed to have this information made public. Only the most mercenary of the hired guns will remain, and they will rapidly lose their credibility as their audience members connect the dots between their financial incentives and the promotional content of their talks.

But in what could well become a case study for the Freakonomics column in the New York Times, the bill actually creates strong financial incentives to further distort medical education, precisely the opposite of what is intended. This is because hired guns who do not want to be exposed will simply shift from promotional talks to CME talks, where the third party MECC umbrella will continue to hide them from the “sunshine” of the bill’s requirements. The drug companies will follow the speakers, and we will see commercial support of CME mushroom. Good news for the MECCs. Bad news for medical education.

Luckily, the bill’s language is still being tweaked, and I hear rumors that Senator Claire McCaskill, one of the co-sponsors, is pushing for inclusion of a provision requiring disclosure of CME payments.

Stay tuned.


Anonymous said...

I think a lot of CME programs are of very high quality, and a lot of speakers have integrity and put a lot of work in delivering good quality clinically relevant presentations. Not all are of equal quality, but it is unfair to paint this with too wide of a brush.

Daniel Carlat said...

I agree. But at least in psychiatry, the majority of the industry CME programs I've examined have been blantantly promotional, and this is simply not the intent of category 1 CME.

Anonymous said...

To call MECC-sponsored CME a "money laundering scheme" is simply inaccurate and particularly unfair to those who diligently strive to produce fair and balanced CME. First, money laundering is conducted to conceal the source and ultimate destination of money--something that doesn't happen in CME. We know where the money's coming from (pharma) and who it's going to (the identified speakers). Also, last time I checked, producing pharma-funded CME is not illegal (although, you may believe it should be). Second, "lavish" travel arrangements for CME speakers have gone the way of the dodo bird, for a number of reasons. If nothing else, pharma and MECCs don't want to spend any more on these third-party expenses than you want them to.

Now it's probably worthwhile to set a reasonable (and published) cap on the CME faculty honoraria, depending on the duties performed (eg, content development, speaking), to prevent a few academicians from committing veritable extortion on MECCs to participate in these programs.

Supremacy Claus said...

"This is the money laundering scheme used by industry to make drug advertising look like objective continuing medical education."

If this statement describes a violation of this statute:

then, Dan should review this discussion:

Supremacy Claus said...

A law should remedy a harm. Where is the fact of any harm from the current state?

I still await.

Without the fact of a harm, a bill like this is called oppression.

Candidates have to provide their tax returns. Why not require all doctors to post their tax returns? If the tax return shows drug company payments of less than 2%, influence is unlikely. If it exceeds 10% of income, the doctor may be more dependent. Low income doctors would be more influenced.

Why not? Because the tax return is no one's business. The bill is an invasion of privacy. In the absence of a fact of substantive harm, there is no compelling government interest in this invasion of privacy.

It will be left to private doctors to sue the left wing ideologues. The professional societies are collaborating with this government oppression. They are left wing traitors to clinical care, and enemies of clinical care.

Once that determination is made solidly, the doctors should take the gloves off and defend clinical care against its enemies and their left wing collaborators.

Anonymous said...

With all due respect, you have connected a disparate set of dots into your own, very opinionated line of thought. Here's some continuing education for you:
1- CME, as delivered by accredited providers, is not the corrupt cesspool of tainted ideas that you make it out to be. Despite some well documented abuses and, yes, many others that aren't exposed, it's mostly good.
2- Your constant reference to MECCs as the purveyor of all these false teachings is inaccurate, and this is evidenced in the ACCME statistics. Among the many other "culprits" are academic teaching centers, hospitals, medical schools and professional associations, all of whom derive a substantial portion of their revenue from industry support.
3- Money laundering?
4- Lavish travel and excessive honoraria are proscribed in CME. Still, a speaker's contribution to a live CME event consists of hours of lecture preparation and valuable time away from practice followed by travel and actual delivery of the lecture(s). If you, as a physician, do not find that to be worth one or two thousand dollars a day, or sometimes more, then you are to be commended for your altruism.
5- Your experience that, "...the majority of the industry CME programs I've examined have been blantantly promotional" may be more a function of the state of science in psychiatry. You won't find physicians in other specialties making such a statement.

Anonymous said...

As the clinical director of a MECC, I'm here to tell you that over the past few months, I've SUCCESSFULLY (1) argued with faculty to provide REFERENCES, and told them that if they didn't come up with credible sources, their presentations would be gutted; (2) worked with faculty to revise cases so that the funder's drug did NOT come off as the savior of the world; (3) inserted levels of evidence tables of treatment recommendations into all activities, including psychiatric topics; and (4) focused on barriers to care.

It's DEFINITELY not the easy way out, but it's the right way to present CME. This MECC has (ahem) managed funders' expectations [and that's the polite way to say that we told them to back off], and refused projects that even have a whiff of promotion attached to it.

Our faculty has universally thanked us for our commitment to quality, and the occasional expert who has failed to comply will not be working with us again.

We're not alone - I know of other MECCs that have a similar attitude.

And why are we taking this stance? Because we are ALL healthcare consumers - patients - and we need to help OURSELVES, our families and friends, and everyone else obtain the best possible healthcare.

No - MECC's aren't perfect, but neither are any other class of CME provider. MECCs DO seem to be the lightning rod these days, and that's not the end of the world. But gutting the entire industry because of a few bad apples is unnecessary.

Anonymous said...

Furthermore, if the CME programs that you've reviewed are "promotional" then blame the ACCREDITING body (ie the ACCME)..all CME programs, regardless of their funding source, must be reviewed and approved in order to qualify for Category 1 credit.