The United States Senate Committee on Finance issued a big wake-up call to the continuing medical education community on April 25 when it released a report saying that some purportedly independent educational programs are, in reality, veiled advertising vehicles for the pharmaceutical industry. The most severe language is in the press release that accompanied the report, which stated that the Accreditation Council for CME's oversight is insufficient to guarantee that programs are independent of drug company influence.
The report cited's own data to back up its points, noting that 24 percent of the providers reviewed by ACCME in 2005 and 2006 for compliance with the revised Standards for Commercial Support did not comply with at least one of the guidelines. The report also highlighted that ACCME relies on CME providers' self-reporteddata, and does not conduct its own investigation of programs.
Two days later, the committee followed up with a letter to the ACCME, noting its concerns. The ACCME's review process does not necessarily detect whether providers are catering to commercial supporters by favorably presenting their drugs in activities — and if providers are slanting content, they're not necessarily violating ACCME policy, the letter said. In fact, the committee's review suggests that CME providers could say that they control content and have full independence, even though they allow commercial supporters to influence content. The senators also said they found it “troubling” that the ACCME accredits providers if 80 percent of their activities are found in compliance, allowing some activities to fall below standards.
The committee is now waiting for a response to its letter to the ACCME before it determines its next steps, according to a committee spokeswoman. (For the ACCME's response, see page 15.)
While some may blame the shift to Democratic control of the Congress for the crackdown on CME, the probe actually began in June 2005 when the committee, under a Republican-controlled Congress, wrote to 23 of the largest pharmaceutical companies enquiring about their educational grants processes. Later, the committee sent follow-up letters to the pharma companies and also sent questions to the ACCME. The report is based on the information received from the drug companies and the ACCME, as well as other publicly available data.
“This isn't a political issue,” says Stephen Lewis, MA, president and CEO, Medical Education Collaborative, Golden, Colo. “It's a money and a fraud and a kickback issue.” And it's not going away.
While the report and subsequent letter to the ACCME clearly may have huge ramifications for the CME community, it's important to put these developments in context, say CME experts familiar with the national political process. “There were no action items mentioned in the report; there were no recommendations for legislation. Typically, reports coming out of congressional committees make recommendations for change; this report gives no such recommendation,” says Thomas P. Sullivan, BS, president and founder of Rockpointe, a medical communications and education agency based in Columbia, Md. In the past, Sullivan has coordinated political campaigns for clients including the National Republican Congressional Campaign Committee.
“Rarely do you see wholesale dramatic changes coming from a committee report,” adds Lewis, a former U.S. Senate staffer and press secretary. “What I've heard from committee staffers is: ‘We follow the money.'” While the CME industry brought in more than $1 billion in commercial support in 2005, according to the ACCME's data report, that's “chump change” compared to the pharmaceutical industry's total revenues of more than $200 billion per year, he says.
Despite those caveats, the SFC report signals big changes for CME. “They're looking for a bad guy and the ACCME is in their cross hairs,” Lewis says. The good news is that the government tends to trust existing structures and deal with them first. “I think they're going to try as a first step to work with the ACCME. If that route works, then great, the Feds are happy and they can say they've helped increase standards and improve education. If it doesn't work, I will guarantee you we'll see FDA or federal involvement at some level. So, this is a very critical time for the ACCME.”
The report says that whether or not the FDA has the authority to regulate CME depends on whether product messages conveyed in educational activities originated with the manufacturer. It also says some accredited CME providers still allow commercial supporters to exert improper influence on education. “In my mind, they're at least making the argument that the FDA could potentially have authority over some CME content,” Lewis says.
But, “Congress does not have a high view of the FDA now, and will probably not reward them with the additional responsibility of covering CME,” counters Sullivan. He adds that FDA oversight would require additional funding or a funding mechanism.
Many CME providers are concerned that the federal focus on CME will make pharma companies even more skittish about funding education.
“The report was surprisingly fair [and] balanced, especially as it relates to the work industry has been doing to separate education from promotion,” says Mike Saxton, Med, FACME, senior director, team leader, Medical Education Group, U.S. Medical, Pfizer Inc., New York. “I don't think industry funding will go down as a result of this particular report. I don't think people will see it as the sky is falling.”
Eli Lilly responded to the report by announcing that it would disclose its grants online. The SFC praised that decision and hoped other pharma companies would follow suit. Saxton agrees that it's a great idea. “I've been a champion of transparency for some time, as are many in industry. I think more and more companies will move in that direction. Certainly, we've been talking about this issue at Pfizer in recent months.”
Some warn that posting grant awards online could have a negative impact for pharma companies. There may be a religious group, for instance, that may be offended that a pharmaceutical company supports an HIV patient advocacy group. Companies will have to carefully consider whether to post these additional types of grants or whether to limit online postings to grants given for professional education, experts say.
While commercial support may not decrease, Saxton does think pharma companies will take a closer look at the CME process. “I do see some shifts. Does the ACCME monitoring system identify problem providers in a timely enough fashion for all of us to have confidence in the system?”
ACCME's lack of monitoring is one of the system weaknesses flagged by the SFC, and the committee's concern is shared by many CME professionals on both the industry and provider side.
With its constrained resources, the ACCME is no doubt considering how it can efficiently address this issue, says Saxton. Perhaps this is another opportunity for collaboration, where industry might be able to play a role in helping to monitor the system for inappropriate influence, he says. Commercial supporters, he points out, review thousands of grant proposals, which could become a powerful resource for the ACCME, a means to catch problems way before the actual activities or the accreditation review period. “We just haven't had enough of a dialogue about what might be an appropriate mechanism that would provide additional objective data to the ACCME on the front end,” Saxton says.
Some providers suggest that the ACCME should send observers to activities. “There should be random unannounced monitoring — like some providers do for live activities,” says Sondra Moylan, MS, president, American Academy of CME, Skillman, N.J.
A major concern for the SFC is whether CME offers pharma companies a vehicle foroff-label uses and contributes to increases in off-label prescribing. These criticisms anger many in the CME community, who underscore that discussion of cutting-edge medicine, including unapproved and off-label uses, is critical to physician education and to improving the public's health.
“I am ashamed that American physicians have been reduced to weak-kneed and mindless practitioners, unable to determine on their own what drug to prescribe; able to be swayed into prescribing drugs with questionable efficacy or for an off-label use surreptitiously promoted by the drugs' maker,” stated Jonathan J. Stotler, MAOM, senior director, Institute for Advanced Health Education, Union, N. J., in a written to response to the report. “My own personal health rides on the use of a drug not approved for my condition. There are bad apples as in any industry; however, this does not outweigh the fact that physicians have a moral obligation to prescribe evidence-based medicine for their patients whether the use of the compound they prescribe is on or off label.”
In the 1992 Standards for Commercial Support, providers had to require speakers to disclose discussion of off-label uses. This requirement was dropped from the updated Standards, issued in 2004 because the ACCME considered it superseded by its content validation policy. Issued in 2002, this policy said that clinical care recommendations made in CME activities must be based on evidence accepted within the medical profession.
Should the ACCME reinstitute the off-label disclosure requirement? The consensus seems to be no. Rather, CME professionals say providers should focus on content validation and evidence-based medicine.
“It's a constraint that's not necessary,” says Saxton. “It suggests that the best source of science is the FDA's label. Many in the academic world would beg to differ with that point of view and think the ACCME could reinforce the scientific integrity by continuing its emphasis on level of evidence and content validity as the solution, rather than go back to identifying whether things are in or out of label.”
Murray Kopelow, MD, chief executive, ACCME, believes that content validation is “mission-critical for CME. We've always felt that the content validation policy and Standard 5.1 [which states that CME activities must promote improvements in healthcare and not the proprietary interests of drug companies] are amongst the most important of our requirements. We've already started asking our providers over the last year to describe for us their process for validating the content of CME.”
Another controversial aspect of the report is its focus on for-profit education companies as CME providers. Nowhere in the report are other types of providers, such as academic medical centers, hospitals, or specialty societies, mentioned.
“It is disappointing that despite its probe, the committee doesn't seems completely cognizant of the CME system in this country and its many nuances,” says Karen Overstreet, EdD, RPh, FACME, president, Indicia Medical Education, LLC, North Wales, Pa.; and president, North American Association of Medical Education and Communication Companies. “For example, the report fails to recognize that most CME is developed by providers other than MECCs, and that MECCs are at least as — if not more — compliant with the Standards for Commercial Support, according to ACCME data.”
Despite the high marks MECCs get from the ACCME, there will be fallout from the SFC report, CME experts say. For one thing, pharma companies may become more leery of awarding grants to accredited MECCs whose parent companies focus on promotion. “If the parent organization's core mission isn't healthcare-related, does that raise a question about whether to support that accredited provider?” Saxton asks.
But Saxton and many CME professionals point out that conflicts of interest exist across the provider spectrum, as CME offices' parent organizations, whether hospitals, academic centers, specialty societies, or MECCs, have financial relationships with the pharmaceutical industry.
“The real issue here is conflict is organizational conflict of interest,” says Saxton. “The Senate report is going to renew the emphasis on that level of conflict of interest.”
MM's poll about the Senate Finance Committee CME report drew 242 responses at press time. See charts on this page, 12, and 14 for the numbers breakdown. Here are a few of your comments.
“I predict that ACCME will respond as in the past with additional requirements while continuing to be lax in the enforcement of existing requirements. (Sigh.)”
“The Senate should prohibit all industry support of CME. After the initial shock, we'd all be better off.”
“Most of the important advances in research are coming from industry. To ignore that would be medieval.”
“Are they going raise our taxes so that CME can be paid for with government subsidies?”
To take our survey, visit meetingsnet.com/medicalmeetings. For more comments, watch for the July/August issue and visit our Web site (above), click on “More News,” and scroll down to “Senate CME Report Sparks Controversy.”