Healthy Skepticism Library item: 16683

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Wilson D
Steps to Greater Accountability in Medical Education
The New York Times 2009 Oct 20
http://www.nytimes.com/2009/10/21/business/21medic.html?_r=1

Full text:

To remain certified, most of the nation’s 700,000 doctors are required periodically to take continuing medical education courses. But for years, critics have said that too many of those courses are little more than drug company marketing in the guise of education.

Sponsorship by the pharmaceutical industry pays an estimated half of the cost of such programs in the United States, which exceeds $1 billion a year. And critics have argued that the national nonprofit group that accredits the course providers has not done enough to fight drug industry influence in the classroom. On Tuesday, the head of the accrediting group said he was poised to begin taking stronger action.

Dr. Murray Kopelow, chief executive of the Accreditation Council for Continuing Medical Education, said he would make public “within weeks” a previously confidential listing of classes and companies that violated rules against commercial bias.

And at the urging of a prominent critic who successfully filed a complaint alleging bias in a specific course, Dr. Kopelow said his group was reviewing a proposal that would require educators to notify doctors and furnish corrective materials whenever it is later found that the class material was biased in favor of a drug firm.

“That’s clearly an option,” he said. “We require freedom from bias, and we can make it explicit.”

The accrediting group is taking its steps as pressure builds from Congress, the Institute of Medicine and the American Medical Association to curb conflicts of interest in medical education. Critics say industry influence can skew treatment, raise costs and harm patients. Skeptics might still not expect a flood of disclosures from Dr. Kopelow’s group, which itself is financed by the educational companies whose work it accredits.

Dr. Kopelow told the Senate committee on aging in July that the accrediting group had completed action on only 12 inquiries or complaints about commercial bias in 2008 and 2009, and found five of them violating rules among more than 100,000 classes in all – a relatively low rate that critics have cited as proof that his group is not yet taking the problem seriously enough.

But in an interview on Tuesday, Dr. Kopelow said the five findings of violation were “a large number compared to what we’ve done in the past.” Medical education, he noted, is largely self-regulated.

A council spokeswoman, Tamar Hosansky, said the only violations to be posted on the Web site would be those initiated and resolved since February, when the council notified providers that it reserved the right to make the information public.

And by next year, Dr. Kopelow said, the council may require companies to inform the teachers and students when their classes are found to violate standards of bias.

Such disclosure has been urged by Dr. Bernard Carroll, a former chairman of psychiatry at Duke, now semiretired in California, in following up a complaint he filed last year about an online program on antipsychotic treatments for major depressive disorder. The council upheld his complaint last month and ordered the education company to pull the program off the Internet.

The program, conducted online, had been led by Dr. Charles Nemeroff, an Emory University psychiatrist who last year was removed as department chairman and lost federal grant financing for failing to report income from 16 drug companies.

Dr. Carroll said that the program concealed unfavorable data and side effects of drugs made by AstraZeneca, which sponsored it, and played down alternatives to those drugs. In his complaint, Dr. Carroll wrote that the program “appears to make a mockery” of standards against bias.

In an e-mail message Tuesday night, Dr. Nemeroff defended the program. “The program was peer-reviewed and found to have fair balance,” he wrote. He also said that he had no notice of the investigation or an opportunity to respond to the complaint.

Dr. Carroll said that while it was not the worst instance of bias he had seen, he wrote a 13-page letter about the program, listing 26 problems. And in interviews and postings on his blog, Health Care Renewal, Dr. Carroll faulted the accrediting council for taking nine months to resolve the complaint, allowing the program to rerun and failing to notify doctors who had taken it. “They’re more interested in protecting the providers than watching what gets put out there as education,” Dr. Carroll said in an interview.

In the September ruling, the council’s monitoring director, Paul Frisch, wrote to Dr. Carroll to say that the program was “found to be commercially biased” and cited “the absence of contrasting therapy data and the downplaying of drawbacks related to the therapy.”

The council notified CME Outfitters, a private medical education company based in Rockville, Md., to remove the program from the Internet.

Jan Perez, a managing partner of CME Outfitters, said in an e-mail message on Tuesday that the company was “very disappointed” with the bias finding and was not given adequate opportunity to respond to the allegations. “We continue to maintain that the activity was fair and balanced,” she wrote, noting that the company continues to hold an “accreditation with commendation” rating from the council.

Ms. Perez said CME Outfitters had never before been the subject of a complaint or inquiry.

At a conference last week in Baltimore about drug industry collaboration with continuing medical education, officials with some of the nation’s 725 accredited providers worried that drug companies were cutting back on their financing.

The American Medical Association is scheduled to vote next month on a proposal to discourage industry financing of continuing education. Pfizer and GlaxoSmithKline recently said they would stop financing for-profit medical education companies and direct their aid instead to universities and nonprofits.

“It’s a period of experimentation,” Michael Saxton of Pfizer said at the conference.

The Institute of Medicine, the health arm of the National Academy of Sciences, said in April that continuing medical education must be “free of industry influence.”

Dr. Bernard Lo, a professor of medicine and medical ethics at the University of California, San Francisco, who was chairman of the institute group that issued the report, said in an interview on Friday that the drug industry could still pool its money to support doctor education without promoting products.

“The key phrase was ‘free of industry influence,’ ” he said. “We didn’t say free of industry funding.”

As for the emerging standards against bias in those classes, Dr. Lo said: “There’s a lot more that needs to be done. You have to not just have standards, but enforcement of the standards.”