Want To Reform CME? Here Are 5 Easy Steps
12 CommentsBy Ed Silverman // April 4th, 2008 // 10:47 am
In the latest issue of Medical Meetings, Donna Beales, the CME coordinator at Lowell General Hospital, in Lowell, Massachuesetts, and the editor of Journal of Hospital Librarianships, offers what she admittedly calls a “provocative plan” for making continuing medical education more palatable for all concerned. But in her view, the consequences for failing to do anything will only lead to more trouble. This is an excerpt…
“The cat is out of the bag,” she writes, “Powerful factions of the US economy have discovered that the practice of medicine and the commercial interests of pharmaceutical and medical device companies - and opportunistic individual physicians - don’t mix. If there was any doubt whatsoever about the extent of this problem, the recent investigation of the Senate Finance Committee into the dealings of the CME industry - itself a commercial endeavor - forever banished that doubt.
“The Accreditation Council for CME’s policy updates to the Standards for Commercial Support, issued in August 2007, leave a series of gaping holes large enough to drive a snake oil cart through. It’s time for a major change. Here are five ways the CME industry can once and for all free itself from the vagaries of sleeping with commercial interests…
1 - Make physicians with commercial interests ineligible to present CME programs: “Choosing to be a physician is a noble calling. Choosing to be a drug rep may have lucrative financial returns for a doctor who is burned out with medical practice. Both are free enterprises. It’s time to choose between one or the other - teaching, or hawking. They are not one and the same. In fact, education and enterprise are mutually exclusive. It’s time for doctors to get back to the business of doctoring, and for those with aspirations toward the world of commerce to depart the profession for greener pastures.
“If we’re worried that we won’t attract anyone to teach due to the lack of financial gain, then it’s time to look at the whole structure of CME. No other educational program in the US is free of charge to participants. Perhaps it’s time to entertain the possibility that participants themselves should defray some of the increasing costs that will inevitably result from a real split between industry and medical education. Attorneys and accountants often pay for their own continuing education course work. If lawyers can afford to do it and bean counters can afford to do it, surely doctors can manage, too.”
2 - Prohibit medical education and communications companies from any participation in CME: “Medical education and communication companies have no place in education. They may be legally separate from their parent companies on paper, but it’s a sure bet that the parent company’s drug company clients hold sway and pull the strings on what happens at the teaching level.”
3 - Centralize the vetting of speakers and content: “The requirements regarding content validation and disclosure of faculty financial relationships with commercial interests are a good start, but the actual execution of these mandates leaves plenty to be desired. Since the speaker disclosure document is not a legal and binding contract, and because the wording on most of these speaker agreements around commercial interests is vague and open to interpretation, right away a problem exists.
“In a perfect world, all lecturers would be honest and open about their financial dealings. In the real world, this is often not the case. Ties may be unreported or underrepresented, and who is the wiser? Unless a CME program is run by the IRS, it is patently impossible for you to determine if the speaker’s disclosure of financial relationships is accurate without asking for a copy of the individual’s tax returns. This is hardly realistic. Not many people willingly open their personal finances to public scrutiny. Vetting is best handled by a singular, unbiased agency with the time, materials, and personnel to deeply explore speaker commercial ties and to assess content for potential bias. A government agency is a likely choice for this process.”
4 - Create a structure to report improper behavior on the part of any presenter: “No structure is in place to track and report any problems with CME program lecturers or content…No one is held accountable for lapses, save for the individual CME programs themselves. This is short-sighted and punitive, and it creates a disincentive for getting to the bottom of any incidents involving speakers. Again, a centralized agency for overseeing speakers would be of help in addressing potential concerns.”
5 - Lobby to make “plain language” disclosure to patients a legal requirement: “Put the power in the hands of those who need it most - patients! Make it a legal requirement for physicians to fully disclose in simple, uncomplicated language any and all ways they are involved in commercial dealings, such as when they hand out samples or prescribe, or when they opt for specific procedures that involve devices from which they might benefit.”
Hat tip to The Carlat Psychiatry Blog
Jack2
QUOTE: In fact, education and enterprise are mutually exclusive.
I strongly disagree with this sentiment. I believe part of the reason America’s university system currently ranks as the best in the world stems from its private enterprise routes and (comparatively) little government regulation.
QUOTE: Make it a legal requirement for physicians to fully disclose in simple, uncomplicated language any and all ways they are involved in commercial dealings, such as when they hand out samples or prescribe, or when they opt for specific procedures that involve devices from which they might benefit.
Any well-intentioned requirement in this area will just turn into another form for people to sign without reading while sitting in the doctor’s office.
Has anyone actually shown a systematic bias in industry-sponsored CME? I don’t know how to prove something like that numerically, since it’s so subjective, but perhaps someone thought of something. The CPE I’ve take tends to focus on topics of interest to industry, but as best as I can tell, the actual information presented is correct. I’d like to see an informed study on this.
Former pharma Marketing Exec
By now of course it will be no surprise that I think this is an excellent idea.
In most areas where I have work I have insisted that everything be handled with a truly UN RESTRICTED educational grant. This means that the chair and board of any CME event, designed and wholly owned their own content. However, this does not happen routinely. Yes, I only awarded unrestricted educational grants to topics in the disease category of concern for the products in the company’s portfolio’s but we never insisted that our drugs be featured. We were mandated to ensure that the statement “funding for this CME event was provided by and un restricted educational grant from…”
Jack2 - I would have to agree that we do have quite a lot of industry sponsors in our universities. I really have no problem with consumer goods (non medical) providing funding to universities. Although I have to tell you I am annoyed with how “Channel one” works in elementary and high schools - it is just plan wrong in my opinion, to subject these kids to such commercializing through their education. They get enough of it, when they are in school they should be free from that.
To your point, there have been studies that show information that doctors receive from these events are believed to be actual scientific information, when in fact in some, SOME, cases it isn’t.
For more information on Dr. Avorn, who has done some of those studies and has a good book out go to here:
http://powerfulmedicines.org/pages/2/index.htm
Jeff
All you have to do is truly make the Grant Committee independent of the pharma companies.
Dan
Peter Rost once said that it is quite a challenge to find a doctor without commercial or financial interest in a pharma company, so this would be challenging.
B. Martin, MD
I frankly think Ms. Beales’s rantings come from a place of ignorance.
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.
Justice in Michigan
The current alliances between industry and academia are a relatively new development historically. Indeed, it may already be a passing phase in some areas, since CROs have been more malleable to industry’s wishes.
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.
Cancer Patient
Comments to B. Martin,
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…
Bob Freeman
I have no fundamental disagreements with Ms. Beales’ recommendations. I used to make unrestricted grants to universities directly and honored the “hands off” pledge.
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.
Been there
Of all professions that require CME, only physicians get it free, courtesy of pharma. When MDs, who are among the most wealthy of health care providers, are required to actually pay for their CME, Pharma will lose it’s control and and finally fair balance will be the norm. There are whole cottage industries built around CME, from Med Ed companies to caterers. Why would pharma spend billions on CME if there was no ROI???
Justice in Michigan
You nailed it, Been There.
Chris
I work directly in this area and the corruption I see month after month is so disheartening. I keep telling myself that with dedication I can foster a change but marketing involvement is simply too deep and the greed to great. The simple reality is that marketing controls the amount of money that will be spent and regardless of how groups are structured the folks in the grant department know what marketing wants and they know who holds the money. The first poster makes a very good point about why there isn’t more objective data on the point. And there should be because it would not be too difficult. For example, there are a few obvious steps for a study that would almost certainly yield very interesting results. First, take 5 to 10 very large blockbuster type medicines and consult with physicians to determine the off-label issues or vulnerabilities in the label that the drug maker may want to exploit or shield. Second, run a series of searches on the internet and read relevant sites and journals to find ads for CME programs where those products are mentioned. Third, look to see if the issue in question is mentioned in some what or if the speakers in the program are related to the issue in question — e.g., clinical investigators … Finally, look at the disclosures and sponsorhip info. What a search like this will find is that there are an enormous number of CME programs where there is a single drug focus, where there is one company supporting the program and where the topics and speakers shop a direct correlation to off-label issues. And the CME speakers will by and large be the same physicians the company uses for promotional speaking engagements. In short, you would see why and how companies use CME — to get a story out that they can’t get out directly because of promotional regulations.
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.
FBP MD
CME should stand for Covert Marketing Expense. In my experience in Big Pharma, the Marketing teams have been unwilling to keep their hands out of this area. they want to control everything - the topics, the messages, the speakers, the questions. Theyveto and censure things they don’t like. They eliminate speakers they don’t trust. if the CME company doesn’t do what they want, they don’t hire them again. In addition, the speakers are paid big bucks and want to be invited back.
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.