This week’s debate between Steven Nissen, MD Cleveland Clinic and Robert Harrington, MD Duke on Industry support of education proved to be lively discussion.
The discussion and presentations ranged from industry support of research, education, and medical societies.
At one point during Dr. Nissen’s presentation he argued that the American Heart Association had made statements on a Framingham observational study on soft drink consumption and metabolic syndrome based on a relationship with Coca-Cola. Dr. Nissen also outlined another paper calling for a tax on soft drinks and the AHA’s statement, which called for “additional research to determine the impact of these types of sales taxes or excise taxes on consumption rates, and shifts in consumer choice with special consideration for disparate populations”.
The problem with his argument is that the AHA does not have a relationship with Coca-Cola. Accordingly, the AHA issued a statement clarifying that the study was observational and should be considered with other eating habits. This fact however, did not deter Dr. Nissen from insisting that the money came from Coca-Cola.
In fact, he then reasoned that the AHA was making these statements because they had accepted money from the Coca-Cola for the Red Dress campaign. He even went as far as showing a slide of Heidi Klum wearing a red dress and the Heart Truth Logo cases of Diet Coke.
When the question and answer session began, Clide Yancy, MD, President of the American Heart Association, rebutted Dr. Nissen’s statements as false and pointed out that the Heart Truth Campaign is the National Institutes of Health, Heart Blood Lung Institute and not the AHA’s.
Dr. Nissen was quoting from a incorrect internet story about Fashion Week on the blog TrendBites.com (this was unexpected, Dr. Nissen reading about fashion shows on a blog and then using this as evidence at a scientific meeting). Unfortunately the blogger incorrectly reported the story, they completely missed that Coke supports the NHLBI Heart Truth campaign, not the AHA’s Go Red for Women campaign.
Consequently, this was just one of several sweeping statements that Dr. Nissen espoused during his presentation including:
CME has a 350% return on investment; (study from 1999 on promotional education)
CME is not regulated; and
MedIQ’s sole source of income is from Pharmaceutical Companies
All CME programs are promotion
Steve Nissen: Opening
Dr. Nissen told the audience in his introduction that he “designed his talk to offend pretty much everyone in the room.” By playing a clip from the movie A Few Good Men “you can’t handle the truth” at the beginning, it was clear when he was done he was successful in his endeavor.
Accordingly, Dr. Nissen’s disclosure listed 28 companies that he is consulting for and six companies he has conducted clinical trials for. He claims that monies he receives from such work he donates to, although he has never released the amounts of funds that he has received from industry. If he gives this money to charity then he should be proud of the amounts. His disclosure also does not address when in his career he stopped accepting funds from industry that were given to him personally.
Despite all his criticism, he still acknowledged that “working with industry is vital to the development of new therapies for Cardiovascular Disease.” In fact, he in response to the slides on increased lifespan due to drugs developed by industry that medicine would not be the same today without developing new therapies with industry.” Moreover, he even admitted to “working with industry all the time,” something he would argue “is morally important.” So what was his issue?
Dr. Nissen believes that there needs to me more independent assessments of the effectiveness and safety of medicine and therapies without undue industry influence in professional societies and among physician leaders. He pointed out that such a goal is particularly true in educating colleagues where excessive industry influence may distort the benefits and risks of treatments. As an example, he walked the audience through an industry sponsored CME program supported by Merck and CME accredited by the American College of Cardiology and MedIQ, a Medical Education Company.
Anatomy of an Industry Sponsored CME Program
The program, titled “Optimizing Patient Outcomes in Acute Heart Failure,” was supported solely by Merck, and included faculty from the Cleveland Clinic and Duke. He then claimed, that MedIQ’s sole source of income was from pharmaceutical companies and he showed their supporter list. It was unclear how Dr. Nissen was so familiar with the company to have the knowledge to make such a claim, but we will let you be the judge.
What are interesting is the similarities between companies that Dr. Nissen conducts research and consults for and the supporters of MedIQ programs, including Abbott, Sankyo, Eli Lilly, GlaxoSmithKline, Pfizer, Roche, Sanofi Aventis and Takeda but not Merck. (see chart). Despite these comparisons, Dr. Nissen went on to claim that Merck’s acquisition of certain drugs and carrying out a pilot study, was a misuse of education. The drug has since been dropped from development but the CME course is still available online.
Dr. Nissen failed to point out any specific content in the program that he would find bias, only that he did not approve of the topic, supporter or the speakers.
Chris Cannon, MD, Harvard Cardiologist and Editor of the American College of Cardiology’s Cardiosource reviewed the content of the program and posted this statement on MedPage Today: I would like to challenge the characterization of the co-sponsored CME program that Dr. Nissen cites. He says he finds it "marketing, not education". I just reviewed the program and find the following: 5 talks – and 4 of the 5 did not mention the drug that Dr. Nissen says is being "marketed" What is covered is the pathophysiology, epidemiology, statistics on prevalence of the disease, then design and rationale of 2 NIH sponsored trials is covered at length (neither of which have anything to do with the drug made by the sponsor of this program. Then, there is a complete list of all possible interventions and treatments, each of which is covered, then there is a review of all ongoing clinical trials of all drugs in this field, and finally there is a case, where the drug is not mentioned. There are 130 slides shown in the program and 8 deal with the drug made by the sponsor, meaning 6% of this program speaks about the drug in question. This is I believe a fair balanced program and it does not meet the characterization stated by Dr. Nissen. I encourage anyone to view the program -it is excellent. http://www.cardiosource.com/cosponsoredcme/program.asp? cid=26
Overview of CME
He tried using an unpublished study (we looked it up it is from 1999) that showed promotional education and not CME – provided a 350% return on investment. This study was prior to many of the rules now governing CME. His example is as relevant as showing a miles per hour rates for NASCAR, and applying that to the speeds traveled on main street and prior to changes in speed limits on main street and not taking into account any of the new laws.
Dr. Nissen then complains about the differences between what American’s spend on drugs versus other developed countries, by outlining that CME is responsible for the difference of $90 billion. Although he thinks that the difference in what we pay is a result of commercial support of CME, the reality is there are many factors contributing to the rise in pharmaceutical prices. Moreover, topics are not just chosen by the sponsor and always designed to support their product(s). The reality is, ACCME, FDA, and grant contracts requires that a CME provider control all content, selects the topics and sends over requests for funding.
His idea that CME providers who receive industry money know that they will receive future funding only if the CME program supports the company’s goals is misleading because CME providers are contractually obligated to provide fair and balanced programming in compliance with ACCME guidelines. If CME providers hope to get paid for their activities and future projects it is in their best interest to provide non biased fair balanced programming. As a result, CME providers do not just choose speakers and topics that will please the sponsor because this will not meet their goal of fair and balanced.
In fact, the overwhelming majority of speakers today are focused on this balance, and since Dr. Nissen claims to no longer work on commercially supported CME programs, he may not be aware of the changes that have taken place in the last five years. Perhaps his lack of involvement has made him less aware of the current environment. Accordingly, he listed programs without commercial support that he felt were important topics for others to undertake such as—all of which, current CME programs discuss at great length such as:
How to choose generic drugs to save your patient and the health care system from undue expense;
Common serious adverse reactions to widely used pharmaceutical agents;
How to use optimal medical therapy to avoid stenting patients in stable angina patients; and
Which therapies commonly used are not cost effective (often CME course do not address cost in the interest of being fair balanced, but it is not uncommon to discuss the cost effectiveness of therapies).
Medical Education Companies
His presentation then moved into the claim that large and small Medical Education Companies (MECs) often locate themselves in close proximity to major drug or device makers. The states where many MEC’s are located such as Maryland, Colorado, Virginia, Georgia and Texas are hardly in close proximity to drug or device makers.
In addition, his belief that MECs select speakers and topics they know will please the sponsor is problematic because often companies have no idea who the speakers are until the program happens. It is also important to recognize that the CME provider is the sponsor, and the supporter is someone assisting in funds for CME education.
Dr. Nissen’s belief that resulting “educational products” that are offered to professional medical associations (PMA’s), such as ACC, are not objective or credible is misguided. In working with medical societies for over fifteen years, I can attest that most medical societies have committees who decide content, select speakers and review final presentations. There are checks and balances throughout the process.
One has to wonder if the same kind of scrutiny that is applied to a industry supported CME program went into Dr. Nissen’s talk if it would have saved him the embarrassment of the wrong red dress and other misstatements.
Working with our own staff and discussing with others in the industry it is clear there is a dedication to compliance with the rules, for educating physicians and seeing physicians improve their practice to help with better treatment for patients. It is shameful to castigate a class of businesses just because you may not like everything about them. America is a about free enterprise and small business, we sent men to the moon using government contractors. Why should all of a sudden everything that the private sector does be bad?
Another problem Dr. Nissen’s sees is that ACCME, which regulates CME, is “only compliance based”. Although he notes they have reasonable policies on commercial support, he feels they do not enforce them, and calls ACCME “pathetic.” He stated that “2 out of 725 providers were discredited for rules violations.” We checked and there is no indication where he came up with this number.
Searching the ACCME website there are currently 713 accredited providers, 38 organizations on probation and 32 organizations that are no longer accredited to provide CME. The ACCME has instituted new enforcement in the last few years including live monitoring of programs, mid review surveys, and complaint procedures.
Conclusion
Although Dr. Nissen believed that many CME programs are well done, his approach to critiquing CME and industry is farfetched. While I don’t think any one would disagree with him that their have been bad behavior by CME providers in the past, much work has been done in the last several years to ensure compliance with ACCME, FDA and OIG rules, including outside review, and pre-screening of faculty for conflicts of interest. In addition, CME providers are contractually obligated in their grants and contracts that their programs must be fair balanced, free from commercial bias, and meet all FDA, and ACCME rules. The ACCME has been diligent in their review of CME providers, and it is not as if the world stopped in 1999 it is 2010 and much is being done to improve CME and every year it is getting better, educating more physicians and helping patient’s live better lives.
News Coverage of Debate
MedPage Today – including Audio of the Session