When Merck and Schering-Plough released data from a clinical trial of cholesterol medication Vytorin showing that it worked no better than a much cheaper generic, the companies were widely accused in the media of deliberately delaying the release of the findings for 20 months in order to boost profits — prompting the U.S. Senate Finance Committee to investigate. The result: the SFC has widened its inquiry into pharmaceutical industry funding, including CME grants, to see if these monies are being used as a marketing vehicle.

In January, Senator Charles E. Grassley, [R-Iowa] ranking member, SFC, sent letters to the American Heart Association and the American College of Cardiology probing their relationships with pharmaceutical companies. The letters asked for details about industry funding the groups received from January 2003 to the present, including meeting support and program grants. Grassley also requested information on the societies' policies for accepting funding, asked whether or not the associations allowed companies to place restrictions or provide guidance on how funding would be spent, and if so, how such arrangements were handled. Although the letter does not specifically reference CME activities, it does mention that the SFC has been investigating industry funding of CME.

Grassley also sent letters to Merck and Schering-Plough, asking for information concerning payments made to the American Heart Association and the American College of Cardiology, including funding for CME. The last of the letter's nine requests says: “Please provide a list of all payments for CME regarding cardiovascular risk management and/or cholesterol control and/or Vytorin from January 2004 to the present.” The companies were asked to submit details, including CME activity topics, the names of sponsoring groups, and the amounts paid.

This latest probe comes 10 months after the SFC issued a report on CME, which concluded that some CME activities were, in fact, marketing vehicles for pharmaceutical companies. A subsequent letter to the Accreditation Council for CME expressed concern that the ACCME's oversight was insufficient to guarantee CME's independence from drug company influence.

During the two-year investigation, the SFC sent information-request letters to pharmaceutical companies and the ACCME, but did not directly contact medical societies. The CME report focused on the SFC's concerns about the financial ties between medical education and communication companies and industry. Now, the SFC is focusing the spotlight on nonprofit groups.

“Senator [Max] Baucus [D-Mont.] and I released a committee report last April on continuing medical education. We found that there are risks of kickbacks, veiled advertising of drugs, efforts to bias clinical protocols, and off-label promotion. We continue to monitor this issue, and I'm also taking a hard look at medical associations to make sure they stay independent and free of industry influence,” said Grassley in a written statement to Medical Meetings.

Data Delays

The trial (called ENHANCE) that ignited the latest investigation, studied the efficacy of cholesterol medication Vytorin, a combination of two drugs, Zocor and Zetia. According to the press release issued by the drug's manufacturers Merck and Schering-Plough, the trial showed Vytorin did reduce levels of LDL, or bad cholesterol, but had little effect on the buildup of plaque in the arteries, which is considered a predictor of heart attack and stroke. The implication is that the patients taking Vytorin, a pricey combination drug, would have done just as well on a much less expensive generic statin. While Merck and Schering-Plough were widely faulted in the media for delaying the release of the results, they responded that they needed time to analyze the results.

Grassley's investigation of the AHA and the ACC was also prompted by a New York Times article from June 28, 2006, “Charities Tied to Doctors Get Drug Industry Gifts,” which traced the relationship between nonprofit groups and pharmaceutical companies, concluding that some medical charities and foundations are basically fronts for pharmaceutical marketing efforts. In his letter to the heart associations, Grassley wrote: “Based upon reporting in The New York Times, I have come to understand that money from the pharmaceutical industry shapes the practices of nonprofit organizations which purport to be independent in their viewpoints and actions. Specifically, it is alleged that pharmaceutical companies give money to nonprofits in an attempt to garner favor in ways that increase sales of their products.”

Nothing to Hide

The inquiry doesn't seem to be generating great concern in the CME community or in the two groups targeted. The Alliance for CME posted a link to the letters and the press release on its Web site, along with this comment: “The Alliance does not believe that this investigation is directly targeting CME activity at this time.” When asked to elaborate, the Alliance responded: “It would not be appropriate for the Alliance to speculate about the impact of the letters on the pharmaceutical industry or medical specialty societies at this time.”

The American Heart Association agreed. “The requests for information are not related to CME activities in particular and we have no reason to think that there is an issue with our CME activities, which adhere to the Accreditation Council for CME's Standards for Commercial Support,” said Daniel W. Jones, MD, president, American Heart Association, Dallas, in a written statement to Medical Meetings. “The AHA not only adheres to ACCME standards for its CME activities but we are fully transparent about our relationships with the pharmaceutical industry.” The AHA has listed all industry contributions to its National Center budget on its Web site since 2004.

The American College of Cardiology also responded that it has strong policies in place regarding commercial support. “We are constantly evaluating these policies in order to further minimize any appearance of industry influence,” said Joseph S. Green, PhD, vice president, professional development; and chief learning officer, American College of Cardiology, Washington, D.C. “We are already in the process of complying with the Accreditation Council for CME's new accreditation criteria, strengthening our firewalls related to grant funding for CME, and seeking additional staff to support our accreditation efforts.”

Stay on Alert

As for whether this inquiry has implications for the wider CME enterprise, especially given the recent SFC report on CME, Green said that CME providers need to be scrupulous.

“All professional societies need to be meticulous in regard to their relationships with industry and have appropriate policies in place so that their educational standards are never compromised by industry relationships,” he said.

Societies might also consider having an ethics committee composed of members review their policies and procedures, he added. “These [government] inquiries tend to be based on perception rather than reality, but it is our job to make sure we do not even appear to [have conflicts of interest] with industry.”

Clinical Trial Conundrum

The latest U.S. Senate Finance Committee investigation into pharmaceutical industry funding, prompted by the delay of clinical trial data regarding cholesterol drug Vytorin, raises issues for physician education. While there is a big push in the CME community for evidence-based content, what happens when some of the evidence is undisclosed or distorted?

In The New York Times article, “Data About Zetia Risks Was Not Fully Revealed,” December 21, 2007, Harlan Krumholz, MD, a cardiologist at Yale University School of Medicine, commented: “We keep telling people we want to practice evidence-based medicine, and what we keep finding out is that much of the evidence is obscured.”

How can CME professionals ensure that content is evidence-based when data might be manipulated or hidden? We asked the two organizations targeted by the SFC in the latest inquiry to comment.

“The American Heart Association has advocated strongly for the inclusion of clinical trials in a national database accessible to practitioners and the public so that all clinical trial data becomes part of the evidence base,” said Daniel W. Jones, MD, president, American Heart Association, Dallas. Companies are supposed to list new trials on a government Web site, but companies do not face stiff penalties for failing to comply and can delay disclosure for years by saying that they're still analyzing data, according to The New York Times.

Disclosure isn't the only issue. “The American College of Cardiology and the scientific community would rather have unbiased trial sponsors than industry sponsors; however, public funding for clinical trials is lacking,” said Joseph S. Green, PhD, vice president, professional development; and chief learning officer, American College of Cardiology, Washington, D.C. “Currently, we do our best to present the trial data in a scientific meeting or publish it in a medical journal to ensure a balanced review.”

Toward that end, the results from the Vytorin trial, called ENHANCE, will be presented at the ACC's annual conference in March. “The ACC made the decision to allow a complete scientific presentation, review, and discussion of the data in the ENHANCE trial,” said Green.

More On/Meetingsnet.com

  • For more on the Senate Finance Committee's CME report, visit meetingsnet.com and search for “CME in the Cross Hairs.” For more on the relationship between CME, evidence-based medicine, and hidden or distorted clinical trial data, search for #8220;True Lies.”