Unapproved: Bias In Continuing Medical Education
9 CommentsBy Ed Silverman // November 20th, 2007 // 12:44 pm
Can the pharmaceutical industry be trusted to fund compulsory education without introducing bias? We all know the issue is academics, drugmakers and, of course, docs. And the Senate recently released a critical report. However, Nature reports today that new preliminary data suggests industry-sponsored courses skew training material in favor of commercial interests.
Jatinder Takhar, a psychiatrist who heads the CME office at the University of Western Ontario in Canada, grew interested in the issue after attending a CME presentation on antipsychotics that she’d audited and approved for her university. But she noticed a problem. “The slides had been changed,†she tells Nature. “The data were slanted and the presentation was more promotional and less educational†than it had been when she had approved it.
So Takhar and some colleagues developed a standardized checklist of potential problems to be used for measuring bias in CME, which they published in June in the Journal of Continuing Education in the Health Professions (take a peek). They applied their checklist to 17 company-sponsored CME events and found nine were biased and shouldn’t have been approved. Some focused only on the sponsor products and ignored rival treatments. In others, side effect info was reduced to small print, Nature writes.
Another study by Daniel Carlat, a psychiatrist at Tufts University School of Medicine, looked at printed CME materials, typically medical articles followed by a written test. He asked colleagues to remove info about the sponsor from exercises sent to his office during 2005 and 2006. He then calculated the ratio of positive to negative statements made about each drug metnioned. In 14 of 15 exercises reviewed, the drug receiving the highest ratio turned out to be made by the firm sponsoring the exercise. The paper is being prepared for submission to the American Journal of Psychiatry.
One caveat about Carlat: he publishes a CME newsletter that operates independently of industry funding, presenting a conflict of interest to his study. And Nature writes that researchers shown the findings of the two studies add that the samples Carlat looked at might not be representative of all written CME exercises. And unlike Takhar, Carlat hasn’t validated his method for estimating bias.
Drugmakers like to point out that that they tend to sponsor materials about disorders for which they sell the best med, so it makes sense that those exercises focus on the sponsors’ drugs. Yet interviews with docs involved in the exercises that Carlat evaluated reveal that, at least in some cases, the focus isn’t simply the result of a sponsor’s drug outperforming a rival med.
One exercise Carlat looked at was based on talks on bipolar disorder given at the 2005 US Psychiatric and Mental Health Congress. Anton
Porsteinsson of the University of Rochester Medical Center in New York gave one presentation and alleges that he mentioned problems with a sponsor’s drug - Abbott’s Depakote - in his talk. But these were missing from the exercise and he claims that positive results not mentioned during the talks were included.
In his opinion, “the big issue is that the article is selective.†Abbott denies claims that the presentation was distorted. A spokeswoman tells Nature that the drugmaker reviewed the material and found it to be in line with current thinking on bipolar disorder.
When asked about Carlat and Takhar’s findings, Jennifer Page, a PhRMA spokeswoman, says only that drugmaker adhere to industry guidelines. Those standards require a firewall between drugmakers and CME companies. Drugmakers can recommend speakers for events, for instance, but CME providers select the docs best suited for the job and aren’t obliged to follow a sponsor’s suggestions.
But some argue the firewall isn’t working. As other forms of promotion are scaled back, marketing is increasingly disguised as education, says Jerome Kassirer, a former editor of the New England Journal of Medicine, now at Tufts University. “It’s a reallocation of marketing money,†he tells Nature.
One doc who was employed by a drugmaker to check the accuracy of promotional material, and who asked to remain anonymous, claims that CME material is still viewed by drugmakers as part of marketing campaigns. He adds that the provider–sponsor firewall is easy to subvert, because CME providers don’t need to be explicitly told to produce biased programmes. “They know that if they don’t provide what the company wants, then they’re never going to be hired again,†he claims.
The Accreditation Council for Continuing Medical Education, which approves CME providers, acknowledges that more could be done to protect against bias. Murray Kopelow, the council’s ceo, says that next year the ACCME will launch a trial in which reviewers will check CME material and report back on problems they encounter. The council will also consider whether drugmakers could be asked to pool CME fnds for distribution by an independent
body in a bid to reduce the influence that any one firm has over an educational exercise.
Source: Nature Or try this link.
I. Know
Hi Ed,
No, most of the pharma companies can’t be trusted. Yes, they do influence content. Sometimes, they even prepare the slides. In fact, many times the commercial teams are completely responsible for CME activities and set them up without even letting any physician or scientist even knowing about it. When they do tell them, all they want is a rubber stamp for ewhta they’ve already put in motion. The fox is watching the henhouse!!!!
I. Know
Jim
The Takhar study may be confounded by the fact that faculty often manipulate the content of talks to make points they want to introduce and then don’t run the new talks by the CME provider to allow them to adjust for fair balance or appropriate disclosure.
If “I know”, Takhar, and Carlat think that in the current environment (post-Neurontin judgement) pharma companies have the slightest interest in manipulating a CME meeting, lay down, put a nice cool compress on your forehead and see if the fever breaks.
Laughing out loud
Jim, you’ve got to be kidding me. Pharma companies surely don’t want to be caught for skewing data in CME events they sponsor, but they definitely have a vested interest in skewing the data favorably towards their product, and don’t hesitate to strong-arm or coerce the providers into approving biased information when they can.
Let’s put it this way, Professional sports referees are regulated more strongly than CME events.
I’ve seen it myself, time and time again. I can’t count the number of times we have had to explain to a pharma client that they aren’t allowed to be involved in CME content development, and many times, with the same client over and over again.
Do you really think that Pharma would pay money to “educate” doctors about certain types of products if the outcome is that their brand isn’t at (or very near) the top of the list in efficacy/safety (as claimed by the content/speaker)??
Heck, just because the slide deck or content gets approved, doesn’t mean that the speaker can’t go a bit “off topic” with the material.
Chris
LOL - it sounds as if you may be a provider or otherwise involved. Of course pharma companies want favorable mentions and more, if possible. It’s the role of the provider to adjudicate on appropriate content though isn’t it? As Jim says, any pharma company that risks manipulting the meeting is putting a huge amount at stake for little to no benefit. It’s not really a mystery who is behind providing CME is it? The benefit is in association as much as anything.
CV MD
Hey Jim,
You’ve got to be dreaming! Grip reality! CME frequently means “off-label” promotion that is run by a highly-paid vender and delivered by over-paid experts in the pockets of Big Pharma. I used to give talks, but won’t any more. I don’t want some under-educated marketing kid telling me what to say on my slides just to make more money!
CV MD
Chris
CV MD - how patronising. The highly-educated ‘experts’ for years have been more than happy to take $$$ from ‘under-educated’ marketing kids. Presume you returned your honoraria?
CV MD
Hi Chris,
Believe it or not, some MDs still have some ethics left. Not all MDs are willing to be the pawns of Big Pharma!
CV MD
Chris
CV MD - I know that, and also suspect that if anyone else was listening to this they’ve tuned out by now. However, your message, like many others on here, oversimplified the role of the industry. And it also disparaged those in marketing. Yes, I was that soldier. So I think you are not adding to others’ understanding by disparaging the marketing guys in the way you did. They do other stuff too - some of which is unrecognized and undervalued - and yes, they try to get an edge for their product, which every other person responsible for P&L does in every other industry, except of course that almost all other are more heavily regulated and so are somewhat easier to operate within. Whether pharma marketing people are less principled than others, I do not know but do have strong opinions. Are they under-educated check writers? What do you think?
Ann
Speaking from an insider’s view, we pharma reps & managers controlled, 99% of the time, everything for a CME event.
We picked the docs to speak
We coached docs on off-label
We coached docs on our marketing
We picked the topic
We picked the materials
We picked all invitees
The only thing we used the third party CME vendor for was payments. This is the reality of the system.
Payments always came out of “marketing” budgets because the CME row on our budget spread sheets always read $0.00.
It is ALL nothing but marketing, marketing, marketing.