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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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December 3, 2009

All Of You Industrial Scientists: Out Of the Room

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Posted by Derek

Continuing Education (CE) is a big issue in many medical fields and those associated with them. Licensing boards and professional societies often require proof that people are keeping up with current developments and best practices, which is a worthy goal even if arguments develop over how well these systems work.

And it's also been a battleground for fights over commercial conflicts of interest. On the one hand, no one needs a situation where a room full of practitioners sits down to a blatant sales pitch that nonetheless counts as continuing education. But one the other hand, you have the problem that's now developing thanks to new policies by the Accreditation Council for Continuing Medical Education (ACCME) and the Accreditation Council for Pharmacy Education (ACPE). Thanks to a reader, I'm reproducing below some key parts of a letter that one professional organization, the American Society for Clinical Pharmacology and Therapeutics, has recently sent out to its members:

In 2006, ACCME and ACPE adopted new accreditation policies that went into effect in January 2009. Most concerning of these new policies is the requirement that CE providers develop activities/education interventions independent of any commercial interest, including presentation by industry scientists. This requirement greatly impacts the Society as industry scientists constitute nearly 50% of our membership and contribute significantly to the scientific programming of the ASCPT Annual Meeting. . .

ASCPT has been left with two options: 1) stop providing CE credit and continue to involve scientists from industry in the scientific program of the Annual Meeting; or 2) continue providing CE credit and remove all industry scientists from the program and planning process. . .

They go on to say that this year's meeting, having already been planned in the presence of Evil Industry Contaminators (well, they don't quite say it like that), will have no CE component, and that they don't see how they'll be able to have any such in the future, since they can't very well keep half the membership from presenting their work. This is definitely a problem for a number of professional organization, particularly the ones that deal with clinical research. They intersect with the professions that tend to have continuing education requirements, but a significant part of the expertise in their fields is found in industry. The ASCPT is not the only society facing this same dilemma.

It looks as if the accreditation groups decided that they were faced with a choice: commit themselves to judging what sorts of presentations should count for CE credit (which you might think was their job), or just toss out anything that has any connection with industry. That way you can look virtuous and save time, too. My apologies if I'm descending into ridicule here, but as an industrial scientist I find myself resenting the implication that my hands (and those of every single one of my colleagues) are automatically considered too dirty to educate any practicing professionals.

To be fair, this could well be one of those situations that the industry has helped bring on itself. I've no doubt that the CME process has probably been abused in the past. (Update: see the comments section. Am I being too delicate in this phrasing? Probably comes from never having dealt much with the marketing side of the business. . .) But there has to be some way to distinguish the old-fashioned "golf-resort meeting" from a clinical pharmacologist delivering a paper on new protocols for trial designs. The last thing we need is to split the scientific community even more than it's split already.

Comments (14) + TrackBacks (0) | Category: Academia (vs. Industry) | Clinical Trials | Drug Development


COMMENTS

1. ralphbon on December 3, 2009 10:19 AM writes...

Particularly with regard to pharmacologic specialties where industry scientists are the true go-to people for faculty, I think you have a point that the described restrictions go too far.

However, your comment that the CME process has "probably" been abused "in the past" is laughable. As a medical writer who's worked in various branches of the professional medical education and communication industry, I can assure you that, golf resort restrictions notwithstanding, industry-supported CME in most areas of clinical medicine is marketing. Period.

Although companies take at least some care to avoid embarrassing paper trails, CME sponsorship is one piece of the marketing dollar pie, divvied up along with advertising, "promotional education," publication planning, personal and "nonpersonal" detailing, etc.

CME is pretty much the only way to sell a drug before it's approved, through sponsored activities with carefully vetted faculty designed to whet attendees' appetites for an agent that would intervene in a pathway highlighted by the program. After approval, CME is also a marketing avenue of choice for an agent with major off-label potential, which faculty can discuss with relative freedom, in stark contrast to promotion education, where FDA promotional rules apply.

I have neither time nor space to enumerate the ways in which CME curricula and faculty selection can be gamed, but as a past participant in such gaming, I can assured you it is. To be fair, the bias is generally well-blended with genuinely good information. And probably only a minority of doctors accept industry supported CME content without applying at least a minimally critical eye.

But in clinical medicine, industry-supported CME is marketing, and the day when sufficient controls come into play to prevent that will be the day high-minded industry dedication to continuing education mysteriously dries up.

Permalink to Comment

2. Phil Stracchino on December 3, 2009 11:09 AM writes...

And another baby goes out with the bathwater. Like zero-tolerance policies, it's a simplistic solution that doesn't require anyone to go to the effort to exercise any judgment, or take any actual responsibility. They can just point at the rule and say "Don't look at me, the rule book did it." Eliminating practical real-world experience from continuing education in the field is absurd.

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3. emjeff on December 3, 2009 11:48 AM writes...

The most ridiculous part of this is how it assumes that physicians and pharmacists are complete idiots. Good thing that the employees of ACCME and ACPE are there to protect us poor stupid health professionals (all of whom have years of greuling training) from the evil drug companies. { heavy sarcasm for the humor-impaired}

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4. CMCguy on December 3, 2009 2:47 PM writes...

I know that CME can be "sales pitches in disguise" as #1 describes and it likely coordinates with whether "MD Communications Group" is part of Marketing Department verses another Department (such as Regulatory). Yes there have been abuses so is correct industry has help bring this on.

I do not believe this is the entire picture. I think both comments #2 & #3 are on target as many COI advocates often totally ignores integrity and reasoning abilities of both people in Industry and the MDs/RNs/Pharm. (Its funny that many are Politicians which IMO is "do as I say, not as I do"). Just like with R&D funding I think Pharma can provide valuable support and interactions without automatic "quid pro quo" that seems to be base assumption of some. Like so many things we in last few decades have shifted from an atmosphere of cooperation as beneficial to a more adversarial/CYA approach that spins things around without aiding much progress.

There is a related article in Fiercepharma that will be interesting to see how it play out

http://www.fiercepharma.com/story/pfizer-funds-canadian-cme-prompting-outcry/2009-12-03?utm_medium=nl&utm_source=internal

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5. MTK on December 3, 2009 4:08 PM writes...

As if somehow academics are above marketing?

They're marketing themselves, their research, and their reputations just as hard as those in industry are marketing their products.

Permalink to Comment

6. Anonymous BMS Researcher on December 3, 2009 8:08 PM writes...

My wife and I both work in different parts of the Evil Pharma Empire so we've been watching the anti-Industry crusades with considerable alarm.

Yes, sometimes industry has done questionable things in the areas of publications and CME. But some of the harshest critics of our industry have themselves failed to reveal how much THEY were paid as expert witnesses by plaintiffs' lawyers.

The following article from Mayo Clinic Proceedings is essential reading for all who are following the debate on COI policies.

http://www.mayoclinicproceedings.com/content/84/9/811.full

Permalink to Comment

7. sanjiva86 on December 3, 2009 8:31 PM writes...

It's a bit ridiculous if you ask me. There's no doubt that CME has a strong marketing aspect, but I don't think anyone can deny that a lot of good comes out of it as well. It's not like marketing is purely evil; its not hard to imagine a scenario where a complete absence of marketing would result in knowledge gaps and poor uptake of potentially life-saving interventions. There's a bit of controversy here in Canada because Pfizer has pledge a huge sum of money to the CMA for continuing medical education. Pfizer says it will be done at an arm's length, but there's obviously an ulterior motive. Nevertheless, the ultimate question is not "what's in it for Pfizer", but rather "what's in it for the patients"? I personally don't care if Pfizer's investment in physician education results in bigger profits for them, so long as having better informed and more up-to-date physicians results in optimized patient care.

Permalink to Comment

8. thomas on December 3, 2009 8:46 PM writes...

This seems really pointless. The really successful perversions of scientific conferences involve the marketing divisions selecting and cultivating status-seeking academics and turning them into shills. Industry scientists, especially drug discovery scientists, seem much less likely to make convincing and deniable marketing puppets.

What we really need is more people from all sectors willing to call out crap presentations, whether the presenters are from an evil multinational drug company or are just intellectually dishonest of their own volition.

Permalink to Comment

9. ralphbon on December 4, 2009 8:10 AM writes...

If industry wanted to help fund genuinely impartial CME, it could do so through pooled, multi-supporter donations to academic and nonprofit CME institutions. The fact that industry resists such solutions demonstrates that companies fear losing whatever tenuous influence they can impart over the message.

I agree that the degree to which this has demonstrably harmed the practice of medicine is uncertain and probably overstated by certain crusaders. Still, for anyone who glibly defends the status quo, I invite you to be the ones to explain to patients that the physicians they love and trust are having their licenses recertified largely, often wholly, on the basis of drug marketing presentations.

Permalink to Comment

10. storytellerdoc on December 4, 2009 9:15 AM writes...

Great site. And good food for thought from your perspective. Clearly, the answer is not black and white.

Happened upon your site while checking out medblogs since I just started my own two weeks ago.

I will follow

Permalink to Comment

11. CMCguy on December 4, 2009 3:05 PM writes...

#9 ralphbon I like the pooling concept although would suggest just because academic and nonprofit CME may not necessarily be totally "impartial" so would favor a consortium/collaborative approach from many stakeholder sources that defines, presents and certifies the CME course content.

As to your invitation I would be happy to be telling patients that their MDs are keeping up-to-date/aware of advances and that indeed relate some/most of their continuing education is sponsored by drug/device companies. Most Practitioners are often likely to be overwhelmed in daily and non-medical activities so are lucky if they get to pick up a medical journal occasionally. Unfortunately MDs can seem to get stuck with "Knowledge gained during Residency" level so those that do make the effort by taking advantage of "free/discount opportunities" I trust are able to gain the value and discern the marketing.

Permalink to Comment

12. Still Scared of Dinosuars on December 7, 2009 11:29 PM writes...

Why not just make MDs pay for their own education? CME has just become another entitlement they expect the world to give them upon attaining their vaunted degrees.

Permalink to Comment

13. Pharmachick on March 29, 2010 3:59 AM writes...

Derek,
i know this is ~4 moths out of date ... haven't lurked for ages ... but *very* apropos of your post:

Our Med School was deeply grateful to host a Senior Scientist from a Big Pharma Co. (we're a long way from CT, so this was a Big Deal for us) for a talk early this year. The talk was supremely well attended and was audio-taped/video-ed/directly piped into our hospital campuses.. etc.

We were lucky to secure said speaker (even our Dean was happy) ... but afterwards i came in for much flak from our Med Cont. Ed people about not plugging them in ... I tried hard prior by sending multiple e-mails to Dept. Chairs, Clin Co-ords etc, starting at least 6 weeks in advance. But up until the VIP turned up .. they insisted on treating the visit as if it was some "random Assist Prof/Stats/Trials Design guy .. so why would we as ***clinicians*** even care"

It all turned out well in the end (because I'm super-anal about making the most of our limited opportunities and taping, videoing etc) ...

BUT to answer your [general] question ... CME at our institution is soooo badly organized, that one hardly even wants to be involved, let alone be responsible for organizing [internationally respected] person/s to talk, most especially when the initial reaction is"so what?, no good to us!" ... of course it's usually followed by "OMG, why didn't you tell us of the calibre of Person X? We would have had them perform Grand Rounds or something!"

Permalink to Comment

14. M Taylor on April 16, 2013 7:30 PM writes...

Re: Mayo Clinic Proceedings paper, new URL

"Conflicts of Interest, Authorship, and Disclosures in Industry-Related Scientific Publications: The Tort Bar and Editorial Oversight of Medical Journals"
L. Hirsch
Mayo Clinic Proceedings, Volume 84, Issue 9 , pg. 811-821, September 2009

http://www.mayoclinicproceedings.org/article/S0025-6196%2811%2960491-6/fulltext

Disjointed ramblings:

Industry researchers are the topic expects regarding their own products - typically the only ones with access to the bulk of the research data and results, and I suspect 95+% operate in a well-intended manner, so it would be clearly an overall loss to lose their participation and attendance. So how can you limit the damage of the 1-5% who succumb to economic or ego vested interests?

One thing that struck me with the Canadian situation was that Pfizer was given 2 out of 6 of the committee seats, which left me unclear whether this meant that there were no other industry representatives.

Competing economic interests at least being a very crude form of verification mechanism due to the competing interests.

It seems to be dancing around the issue of how can you introduce effective, yet fair and balanced _accountability_ to CME presenters of all stripes and biases, and industry researchers / reps in attendance.

Additionally, two prime topics for policy in pharmaceutical circles would be discussions prior to regulatory approval, and off-label suggestion / recommendation.


I think it was #3 @emjeff and #8 @thomas suggest that self-policing could resolve it. I believe that is a risky assumption.

As CME material is intended to be _new_ rather than remedial, you cannot reasonably expect the target audience to have enough a priori knowledge or the time to verify the accuracy of the presented material. The entire point of CME being to keep practitioners, not topic-specialists or researchers, up to date on new developments in a time efficient manner.

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