The CME Police: To Protect and Serve?

Tighter rules seek to eliminate bias. But does educational value get caught in the crossfire?

By Samantha Stahl, Assistant Editor

To protect and serve is the proud motto of many a police force, and communities generally welcome a robust police presence. In the medical community, however, some bristle at what they consider to be overreach in efforts to “protect” doctors from commercial bias and thus “serve” the public good. Commercial influence in the medical world is endemic, and accredited providers are working overtime to keep educational programs balanced. While some physicians are willing to accept the increasingly strict standards, others feel that the handholding and coddling is patronizing to astute doctors who can decide for themselves if a presentation is slanted.

Is it justifiable to ban presenters from referencing a product by name? Does requesting a presentation months in advance for review mean that educational programs will no longer be up to date? Critics worry that the unfortunate answer is yes. “In short, the CME police destroy spontaneity,” says Memphis retina specialist Steve Charles, MD. “Full disclosure is great, but presentations sanitized by the CME police months in advance are not current; presentations should be up-to-the minute.”

In this feature, doctors weigh in on how adherence to the rules is hindering their educational efforts, while proponents insist that the much-maligned restrictions ultimately serve the greater good of physicians and their patients.

The Thin Blue Line

Political pressure takes the blame from some for increased awareness of commercial bias, especially after the action recently spearheaded by Senator Chuck Grassley (R-IA), says Howard Barnebey, MD, chair of the ASCRS CME advisory committee. Sen. Grassley is in the midst of a two-year investigation of conflict of interest between academic researchers and the pharmaceutical industry.

The scrutiny can also be linked to the Stark Law, says Dr. Barnebey, which went into effect in 1992 to prevent physicians from self-referring and creating conflict of interest. “Many academic institutions took the lead and attempted to distance themselves from commercial support. Although, perhaps not a direct result, many of the breakthroughs in ophthalmology came about outside of mainstream academia,” says Dr. Barnebey. Many major advances, he says, were developed by physicians working with companies who were still willing to take the risk to support innovation, citing phacoemuslification, IOLs and LASIK as examples of positive relationships between physicians and industry.

Unfortunately, in other areas of medicine outside of ophthalmology, some professional-corporate relationships crossed the line, creating the perception that all relationships with industry were for personal gain more so than improvements in patient care, Dr. Barnebey says. This perception carried over to medical education, with many believing that industry was unfairly benefiting from marketing presented under the guise of education and adding to the fiscal burden of healthcare, so the government stepped in to create pressure.

“The public, the press, Congress, physicians and policymakers are becoming increasingly aware of the dangers to the physician-patient relationship inherent in perceived commercial bias,” says David Parke, MD, executive VP and CEO of the AAO. “Bona fide scientific research shows that even modest gifts and payments to physicians by industry creates a conscious or subconscious obligation to the company. I personally don't believe in the argument that a coffee cup or pen does this, but it is tough to argue that a $10,000 or $100,000 payment doesn't have an effect.”

Murray Kopelow, MD, chief executive of the Accreditation Council for Continuing Medical Education, fights to ensure that CME is valid, truthful and free of commercial bias. He compares the process of a doctor detecting bias in a CME program to being a judge in court. “In the milieu of CME, the physician winds up being the tryer of the facts and must decide what's right and what to do for their patient. They get to have expert witnesses—the lecturers, the sage on stage.” Unlike in court, however, physicians don't have cross-examination or rebuttal witnesses, which Dr. Kopelow says is where the ACCME comes in. The standard guidelines are meant to assist physicians in their judgment process, so they aren't left to decide all alone.

In 2004, the Standards for Commercial Support—guidelines first issued by the ACCME in 1992—were revised to reflect the ubiquity of physician-industry relationships and the increased amount of money involved in comparison to the 1990s, according to Dr. Kopelow.

“These rules are created by the profession, for the profession,” says Dr. Kopelow. “They are approved by our seven member organizations, not just one organization in Chicago.” These organ izations include the American Board of Medical Specialties, the American Hospital Association, the American Medical Association and the Council of Medical Specialty Societies, among others.

In the ACCME's experience, it is not the Standards that are the problem, but how they have been applied.

Dr. Kopelow says that accredited providers have a responsibility to eliminate commercial bias without excluding valuable material. Everyone is encouraged to add in “any explosive information that came out the week before the presentation,” even if a provider usually requires that a talk be submitted weeks or months beforehand for review.

“There is no one way to apply the Standards. We ask that accredited providers are aware of conflicts of interest, give clear guidance to faculty and make sure that commercial interests do not control CME content.”

Moderating or Meddling?

Dr. Barnebey and Laura Johnson, the director of education for ASCRS, compare the CME guidelines to the emissions controls in California: “When they were first introduced, many felt the policy would hinder development and production of cars. Ultimately, however, the result was not an impediment, but forced adaptation and change that have led to huge innovations in the auto industry.”

While CME's resulting big-time innovations may still be on the way, it's recognizable that the rules have a valid purpose.

“In medical school, I don't remember my professors saying, ‘Here are my financial disclosures.’” jokes Peter Kaiser, MD, a retina specialist at the Cleveland Clinic. “We aren't in kindergarten and are not naïve. We know who is conflicted and who is teaching.” Though he criticizes some accreditors for reading the rules “too much like a lawyer and not like a pragmatic physician,” he defends their efforts by agreeing that the ideals and goals of the rules are noble.

“You don't want people who are paid mouthpieces for industry to be out giving lectures without being policed,” Dr. Kaiser says. The primary problem, in his opinion, is that all of the best speakers have financial conflicts and a meeting without conflicted speakers wouldn't be very productive. While he appreciates that talks need to be peer reviewed and that factual information needs to be referenced, he thinks that the guidelines make too much of an assumption that doctors are “stupid” and can't decide for themselves if someone is trying to sell a product.

Dr. Kaiser points the finger at specialties like psychiatry and oncology as “the real culprits behind these big changes” because they receive hundreds of thousands of dollars from companies to say that a certain drug is better due to the massive off-label use of drugs in those professions. “Ophthalmologists aren't the bad guys,” he says. Unfortunately, regardless of who's responsible, everyone now has to play by the rules.

While the guidelines have altruistic intentions, physicians are still candid about the tedious side effects. Paul Koch, MD, of Warwick, RI. says he used to enjoy getting invitations to speak, but has begun to decline opportunities to give presentations because of the recent increase in vetting materials. One of the most common critiques of accreditors is that they require submission of presentations months in advance, meaning speakers may be giving outdated information—not entirely useful for doctors who are looking for the newest clinical innovations to apply to their own practice.

“I don't want presenters to say, “Well, three months ago a clerk made a list of things I'm allowed to tell you and these are those things,'” says Dr. Koch, who admits that the frustrating restrictions have encouraged him to submit an older talk rather than spending the time on something new that will likely be censored and watered down.

Larry Patterson, MD, of Crossville, Tenn., concedes, “It's silly for us to think lectures can't be biased. I have seen presentations that were unbelievably slanted.” However, like Dr. Koch, he has cut way back on the number of talks he gives, calling the review process “onerous” and “too much of a hassle.” He speculates that perhaps manufacturers can use the review guidelines as an opportunity to get speakers to say exactly what they want, albeit obliquely.

Dr. Charles, who has developed many innovative retinal surgery products in collaboration with Alcon, knows all too well how aggravating the restrictions can be. As the foremost authority on the products he co-developed, he is frequently asked to give lectures on their use, but often can't be as forthcoming as he would like. He feels it is crucial to completely disclose financial ties and let an educated audience determine if it impacts the talk. “I don't give the marketing speech. I want to be a scientist and a fellow physician.” If people wanted a scripted marketing lecture, brochures could be mailed out and everyone could save the money spent on airplane tickets to conferences, he says.

Pulling no punches, John Doane, MD, of Leawood, Kan., calls the requirements “draconian” and a detriment to the best communication of medical education concepts. He asks, “How does having a less qualified and experienced instructor provide for the best transfer of knowledge?” Like many of his peers, he foresees the rigid standards reducing the quality of presentations as more and more of the best speakers become disqualified because of their industry ties.

“This is a huge step back,” says Dr. Doane. “The solution is: let physicians play like big boys and girls in the sense of having the ‘experts’ disclose their interests and allow the professional listener to pass judgments of credibility.”

Influence on Industry

The ACCME put standards in place to protect physicians, but how do these rules affect industry? Opinions are mixed.

Susan Connelly, PharmD, director within Pfizer's Medical Education Group, says that most of her colleagues in industry “see any efforts made by providers to reduce bias from their programs as a benefit to the community.” The company provides support for independent education by reviewing grant requests on a quarterly basis. Pfizer has no direct involvement with the development or implementation of CME activities, “adhering to the spirit of independence,” says Dr. Connelly.

“Any perception of bias detected in the grant review process results in a denial of the grant request,” she says. Because there is a strong separation between the groups at Pfizer that handle marketing and medical education, the restrictions have zero impact on their marketing strategies, she says.

“CME guidelines are an avenue to establish a consistent and fair system of medical education. They provide an unbiased framework to ensure the independence of CME activities,” says Alastair Douglas, director of Medical Education and Meeting Services for Alcon, who agrees that the rules are a benefit to industry. Alcon supports over 5,000 educational programs each year, and Mr. Douglas says they have no plans to reduce that number because of the restrictions.

But the rules aren't entirely a bouquet of roses for industry, argues one anonymous source. “On one side of the equation, the rules underestimate the audience a bit. They also dismiss the potential synergies between industry and medicine.” The source says that the real hazard for industry is that companies invest money to sponsor a program without fully knowing what they're getting in return. A CME company will approach a pharmaceutical company to sponsor, but oftentimes the proposal provides little detail in an effort to firewall commercial incentive.

“Industry hasn't always been a saint and the restrictions are there for that reason. There are programs that are wrought with bias, but then there are also cases where CME is completely medically accurate. Those are the win-wins, but I think the restrictions have gotten so draconian that it's throwing the baby out with the bath water,” the source says.

Pre-Presentation Assessments

Dr. Parke is a strong believer that these rules have value.

“I think we need to let the numbers speak for themselves. In the last four years, the percent of AAO Annual Meeting attendees who found papers to be commercially biased has dropped 25% with these newer rules,” he says, based on the Academy's survey of meeting attendees.

Dr. Parke says that the few complaints the AAO has received in regard to the restrictions come from people he suspects don't understand the rules and incorrectly assume that financial relationships disqualify good speakers from participating. “How could it be a hindrance to a learner to know that the presenter speaking on drug X is a paid speaker for the company that makes drug X? The Academy doesn't say you can't participate in the program if you have a conflict—we want knowledgeable people to participate.”

He disagrees with those who argue that financial disclosure rules stifle presentations about innovative therapies and devices. “I don't see that at all. In fact, we intentionally seek out such material for inclusion in our programs.” In order to maintain balance, Dr. Parke says that the AAO does pro/con presentations to give the audience multiple points of view.

Debra Rosencrance, the AAO's VP of meetings and exhibits, insists that the regulations haven't made it more difficult to find quality presenters, but worries that if the rules head in a stricter direction, there could be a problem. Because there are over 4,000 presenters at the AAO's Annual Meeting, they do not review all presentations ahead of time, only those that the program committee feels could be at high risk for bias—either a speaker who has been warned in the past or topics about a new procedure or one with only one treatment option. Monitors in the presentation rooms alert bias and attendees are asked to evaluate bias at the event's conclusion. Any presenter who is flagged for giving a biased talk receives a warning letter from the Annual Meeting secretary.

Ms. Rosencrance is optimistic that most medical meetings have always worked hard to ensure that presenters were giving the best options for patient care. “It's unfortunate, like in so many other cases, that it's the few who weren't that caused the majority of the issues,” she says.

For ASCRS's annual Symposium and Congress, all abstracts are subject to peer-review early on, secondary review prior to the meeting and potential monitoring of the live event, according to Ms. Johnson and Dr. Barnebey. “The principles of ASCRS are education and innovation to improve patient care. Many times, the best educators are innovators and innovators tend to have relationships with companies,” they explain. ASCRS has addressed the potential for bias through increased faculty training, peer review and monitoring of materials.

Contemplating the Future of CME

The influence these restrictions will have on education further down the road is difficult to judge. Dr. Parke foresees the rules becoming more uniform and clinically relevant to encourage compliance.

“Those who make the rules are not going to claim that the problem has suddenly gone away, so we can forget about it, when the issue is still very much in the public's eye,” Dr. Parke suggests. He says that the CME standards are just as valuable to industry as they are to physicians, since they provide guidelines for corporate behavior so companies can avoid “reading about themselves on the front page of the New York Times.”

But many still fear for the vitality of medical education, envisioning a future dominated by courses that are factually correct and well balanced, but with little intellectual stimulation. Will CME restrictions hit a tipping point where the programs become so watered down that the rules have to ease up? Or will physicians in search of thought-provoking educational programs simply look elsewhere?

“We are capitulating to ‘political correctness’ rather than doing anything to improve the quality of anyone's presentations,” says Richard Mackool, MD, of Astoria, NY. He protests the fact that he can discuss specific products during a presentation, but is banned from putting the product name in the title—even if it is the primary subject of the presentation.

“How is the potential attendee to know whether or not he or she wishes to attend my presentation? Why on earth should we disguise what we are really talking about?” It is standard applications such as these that leave Dr. Mackool questioning the future of medical education. He believes that if the restrictions continue, two types of meetings will emerge: those with CME credit but little real education, and those without CME credit and genuine teaching.

Dr. Koch agrees: “Very soon there will be two tiers of meetings, one for credits and one for learning.” OM