What worse, however, is the packaging of programs that are “delivered” by sales reps to hospitals and other organizations, with the promise of payment by an “unrestricted educational grant” that is provided by the company itself. If you put on my “marketing program of off-label information”, then my company will pay you to do so. It’s a common ploy in the Big Pharma industry in order to avoid the restrictions of speakers programs. What’s just as disgusting is the opinion leaders that are willing to sell their souls and do this 10, 15, even 25 times a year for $5-10000 a pop. That can be a hefty side income, particularly if you also do promotional talks and CME programs for the same company. It’s really not that unusual for these guys to roll in $200 - 300,000 a year off of one company.

So why isn’t someone doing a study like that.

Well you guess is as good as mine. My answer is that the current FDA is just completely asleep at the switch and the OIG has lost its focus and believes it can change the culture of the industry if every single company has a CIA. They are wrong. Companies have policies. And on their face they are followed. But the influence comes from marketing because everyone knows where the money is, the influence somes from the mere selection of CME speakers, you don’t have to control the content when you KNOW the speaker, the influence comes from a system where the CME business is huge and the vendors know what they have to do to stay on the money train. The decisions are subtle and technically compiant. The influence of marketing on CME remains overwhelming. I see it every day.

I also agree that marketing has too much direct and/or indirect influence in CME programs. Given that many ex-marketing types have moved over to the CME provider side, I see this as a potential source of, if not actual, bias in the design of CME programs.

Industry CME education does quite a bit of harm to patients by driving complacency of doctors and patients themselves.

Take Gleevec for instance. You probably believe that the IRIS data shows that 97% of patients treated with it go into remission. At first glance you would say, wow, we’ve done our job here, no need for any other drugs - right? No, Of the 553 patients who started out in the trial, only 66% remain (6 years later). Yes 83% of the 325 patients still on trial remain event free. 24 patients who achieve a complete molecular response lost it and 6 of those regained it. There is a huge gap in what the general public believes and what is reality. Additionally, what is not being reported and what is being downplayed in all of this is the debilitating side effects that drastically reduces quality of life, on this drug and similar drugs. No magical miracle here!

The problem with this is that some doctors and many patients are being very complacent in seeking out second TKI’s. This is a big mistake. Patients go into doctors complaining of side effects and they get told - stop complaining it could be worse! Why? because the educational material is totally skewed to downplay it.

Do you know how many years I suffered and got ridiculed? The drug companies also like to skew educational material to the patients. Some patients pick on patients for having a side effect - they believe the company so much that they think their fellow patient is a hypochondriac!

This is a big problem for the 35- 40% of this patient population who are under 40 years of age and should be seeking out more aggressive therapy.

This mis information shifts funding of research to other areas and this definitely harms the patient.

I have recently read several CME pieces on a variety of drugs and all I can say is god help us patients! For the amount of money I spend each year to stay alive I just wish people would stop screwing around with MY INFORMATION and blocking MY ABILITY to INFORMED CONSENT - do you still think this doesn’t hurt patients.

Would you like some of my cancer and live it for a while and see if you would still say the same thing?

You wouldn’t trade places would you?

The only patients who aren’t hurt by this are the ones who still believe their doctors and industry have their best interests in mind. In other words, they are naive…

Regarding what has and has not been shown, anyone who has spent time with academic researchers (who are my colleagues) has heard enough stories about skewed or suppressed data, corruption of junior faculty, attempted intimidation and/or bribery of more senior people (and departments) that there really isn’t a need for a lot more “data.” As the Supreme Court once said about pornography, it’s hard to define, but you kinda know it when you see it. Many, perhaps most, academic researchers find ways to avoid it. But there is a steady pull toward corruption which sweeps up some number. If that doesn’t add up to a negative impact on public health and patient care, then nothing does.

1) A physician who agrees to serve as an advisor to a drug company or as a PI of a drug-funded study is not a drug rep (caveat: these positions are entirely different from participating on a speakers’ bureau–which Dr. Carlat engaged in and got what was coming to him, imo). Moreover, beneficial education and enterprise are by no means mutually exclusive. There are a number of innovative commercial compounds (eg, Herceptin, Gleevec, Gardasil, to name just a few), the evidence-based use of which greatly benefits the patients who use them and, therefore, the companies who sell them.

2) In my experience, ACCME-accredited medical education communications companies (MECCs) provide probably the most stringently created CME in the biz, particularly if they employ healthcare professionals. One of the dirtier secrets in CME world that I’ve witnessed is the rubber stamping of poorly vetted programs from unaccredited MECCs by university-based CME offices.

3) Ms. Beales recommends the centralizing of vetted CME speakers and content by a government agency–because, no doubt, our government agencies do such a bang-up job on more important tasks already.

4) There are actions that can be taken to report “improper behavior” by a CME presenter–although, I do condede that they could be more formalized. It seems reasonable that the ACCME should be the organization to vet these complaints, and it does have the authority (but perhaps not the manpower) to hold a producer of CME accountable for such behavior by probationary measures or the withdrawal of accreditation altogether.

5) Re the disclosure of commercial interests by a doctor to a patient, I essentially agree with Jack2. And what is the patient supposed to do with the information once she has it. Decide that she’s not going to follow the doctor’s recommendation? Find another doctor? Perhaps, but Ms. Beales should know that informed consent is a dynamic and individualized process between a specific doctor and patient, which may or may not involve the exchange of a whole lot of information.

To Jack2’s final point, nobody has shown that industry-sponsored CME has a negative impact on patient care. In fact, it’s likely that a physician who participates in industry-sponsored CME is more well-informed than one who doesn’t–and therefore, provides better patient care.