Monday, October 12, 2009

CME Outfitters: Guilty of Pro-Seroquel Bias, According to ACCME

In ACCME's testimony before the Senate Special Committee on Aging on July 29 of this year, Dr. Murray Kopelow, the chief executive of ACCME, defended the integrity of the embattled organization in part by pointing out that they have beefed up their enforcement of anti-commercial bias policies.

He said that he has begun to give extra "scrutiny" to organizations that "receive a large amount of commercial support," and said that 10% of all ACCME providers are now on probation.
But how well does ACCME actually regulate the bad apples of CME--generally speaking, those for profit MECCs who are completely dependent on commercial support for their very existence and who consistently bend the Standards of Commercial Support in order to maintain the flow of money?

In a fascinating post by Bernard Carroll on Health Care Renewal, we get a close-up view of ACCME's new commitment to enforcement, which while showing some signs of life is severely lacking in bite.

Dr. Carroll had filed a formal complaint on December 23, 2008 about a web-based round-table discussion of the use of antipsychotics in depression, which was chaired by Charles Nemeroff (the disgraced psychiatrist who resigned under pressure as chair of psychiatry at Emory after the New York Times reported that he lied to the University about payments from GlaxoSmithKline, promising officials that he would limit his earnings to the required $10,000/year from promotional talks, then going on to earn $170,000 that year alone.)

Nemeroff's program was produced by CME Outfitters and was funded by Astra Zeneca, maker of Seroquel, an antipsychotic which was recently approved for add-on treatment of depression.
After its investigation, according to Dr. Carroll, the ACCME determined that the program did, indeed, violate its standards. In particular, the course was commercially biased in favor of the sponsor's treatment because it downplayed negative side effects of Seroquel while giving short shrift to alternative, safer depression treatments.

So far, so good. The monitoring system appears to be working. Or is it?

Dr. Carroll asks a series of questions that will prod ACCME to think about the logical next step.

--If this accredited CME program was corrupted by commercial bias, shouldn't the ACCME force CME Outfitters to contact all the physicians who participated in the course in order to explain to them that they were given biased medical information?

--Shouldn't the CME credit obtained through this program be revoked?

--Shouldn't CME Outfitters be required to ascertain whether patients were harmed as a result of their biased education (for example, how many patients were put on Seroquel for depression and later developed obesity, diabetes, or heart disease as a result?).

--Will ACCME publically list its sanctions against CME Outfitters and other MECCs who have aired commercially biased CME? Or are we going to have to depend on the occasional blogger to reveal these egregious cases?


These are all crucial questions, and Dr. Carroll is awaiting a reply. Aren't we all?

8 comments:

Michael S. Altus, PhD, ELS said...

Danny,

What is the evidence for your assertion that for-profit MECCS that completely depend on commercial support CONSISTENTLY bend the Standards of Commercial Support?

Anonymous said...

That's a very nice list of questions, but I have a feeling that whoever in ACCME would have the responsibility to pursue the answers would think, "Too much bother and trouble. Leave things and the issue will go away."

You would imagine there is a break down of individual responsibilities within ACCME, specific people with specific positions and responsibilities. From this post I know about Dr. Murray Kopelow, the chief executive of ACCME.

Perhaps naming others and sending specific requests to those individuals in ACCME, as well as documenting their responses, here, say, could move things along a little more decisively.

Daniel Carlat, M.D. said...

Michael--Show me a MECC produced, single company sponsored program in psychiatry that is NOT biased. I don't think I can recall any.

SteveM said...

Dan,

Dr. Carroll asks some great questions. Unfortunately, the only real leverage lies with FDA and/or litigation. (Assuming APA is spineless and/or indifferent.)

And the symbiotic relationship between Big Pharma and FDA precludes litigation. FDA sanctioned Seroquel for depression, so legally it doesn't matter how the physician learned about the therapy. And like the bizarre Cymbalta side effect profile, the Seroquel injured patient is shit outta luck because FDA said it's OK.

If litigation is out, then that leaves the FDA Drug Marketing office and/or the Psychopharmacologic Drugs Advisory Committee as avenues for redress. Bang the drum in front of those guys and see if they would insert themselves into a corrective process.

I'm a chump so they won't listen to me. That said, if I were an M.D. that bitched at this site, I'd be writing 2 letters of invective to FDA DDMAC and the Advisory Committee for every morsel of bile I posted here. You guys doing that?

Steven Reidbord MD said...

--Shouldn't the CME credit obtained through this program be revoked?

I'm the CME Committee chair at my medical center, and want to comment on this one point. Revoking CME credit is a sticky issue. Suppose a proposed CME activity looked good on paper (and thus was approved) but turned out to be bad in reality. Do we deny CME credit for the docs who unwittingly attended? They're apt to argue that they spent time and money to attend based on their faith that ACCME, the state oversight agency, and our particular institution all vouch for the quality of the CME we provide. Suppose a doc claims to have found it personally educational despite our post-hoc concern?

Do colleges revoke credit (or degrees) if soon thereafter they lose accreditation? Is that a good analogy?

skillsnotpills said...

Regarding the above reply by Dr Reidbord, I respectfully disagree that something cannot be recanted or dismissed if the premise was misleading or in frank error.

Yes, a degree could be rescinded if it turned out the training was not fully accredited or legitimate.

I once met a patient who's training for a technology position was not accepted as the source of the education turned out to have fraudulant elements. He was at least offered the opportunity to access retraining courses that he had to turn down due to monetary restrictions at that time.

Tell that to him this could not happen. Tell that to physicians who legitimately thought the CME information was objective and unbiased and was provided for sole educational interests, only to find out later it only was provided for profit margins and reinforced the use of a product or service that later caused harm to the patients he/she thought were served in best interests.

I am surprised Dr Reidbord would offer such a position.

Sincerely,
skillsnotpills, board cert psych MD

Steven Reidbord MD said...

Skills,

You misquote me. I said it was sticky issue, not that it "cannot be recanted" or "could not happen."

Suppose you go to a legitimate CME event, but it turns out you happen to know everything presented, i.e., you don't learn anything. Do you still get CME credit? Of course you do. Docs who attend a CME event reasonably expect credit for having done so, even if it doesn't turn out to be terribly educational.

I'm not saying CME credit couldn't be revoked in certain extreme cases, just that these issues may be more nuanced that they appear at first glance.

This is a digression anyway. Never mind. ;-)

skillsnotpills said...

Dr Reidbord:

If you feel I misquoted you, then all I can say is sorry, but that is how I interpreted your comment, so your rebuttal is heard and acknowledged.

I am also commenting now to note to the readers here I am going to be at the US Capitol, White House, and other buildings of influence on Wednesday, Nov 4 from 10AM to 2PM to protest the coming legislation allegedly called Health Care Reform. I will be having my SICK OUT that day, holding up a sign saying "SICK of these intrusions and if Health Care legislation passes I am OUT."

I can only hope by doing this, letting others know at least one doctor is not accepting of the alleged representation at hand going on in Washington DC, others may be interested and willing to participate or find their own personal and responsible ways of protesting poor choices and actions that interfere and ruin their efforts at providing or receiving care. And I say this at sites like this because that seems to be their message by such blogs.

These are serious times, people, and we need to show others we care and we hope by saying no in ways that can and hopefully will be heard so genuine changes can occur in positive, productive ways.

Thank you for the opportunity to encourage real empowerment!

Sincerely,
skillsnotpills
(you'll know who I am if you are in DC on the 4th)