Drug firms banished from medical talks

There's a good way to figure out when a drug company plans to introduce a new product.

When pharmaceutical company scientists show up at medical meetings to give talks about diseases that most people never have heard of — disorders such as female sexual dysfunction or cardio metabolic syndrome — it is likely that a new drug is coming, said James Stein, a cardiologist at the University of Wisconsin School of Medicine and Public Health.

But such talks, which Stein and others say can be used to create a buzz for new drugs, may be coming to an end.

The ongoing controversy over drug industry influence in continuing medical education has taken a sharp twist: Pharmaceutical industry employees will not be allowed to make medical education presentations later this year at the one of the largest medical meetings in the world, the American Heart Association's annual Scientific Sessions.

The policy was set by a national organization that accredits the heart association's continuing medical education programs as well as the programs of other medical organizations. It applies to the medical meetings of all those groups.

The development, which has fired up the medical community, came up last week at a National Institutes of Health meeting in Bethesda, Md. There it was learned that the heart association would not be allowed to let drug industry employees make educational presentations for doctors at its upcoming annual meeting.

The association is taking the action because of a relatively new interpretation on a policy of the Accreditation Council for Continuing Medical Education, the national body that accredits medical education courses.

The development has drawn strong reactions, including comments made at the recent NIH meeting.

"The policy is blood-curdling," said Keith Yamamoto, executive vice dean of the University of California, San Francisco School of Medicine. "This is conflict-of-interest considerations run amok."

Francis Collins, director of the NIH, said it was seriously distressing.

"It is a breathtaking sweep to squash something that is really important to us, the science going on in the private sector," he said at the meeting.

PART OF A PLAN

However, others said the decision is long overdue.

There is good reason to block drug company employees from making such presentations, the University of Wisconsin's Stein said in an interview. And the policy also should include doctors who work as consultants and paid speakers for drug and medical device companies, said Stein, a professor of medicine.

The goal of continuing medical education programs should be fairness and balance, he said, but when industry employees give talks, it often is part of a strategic marketing plan, which means they are not allowed to say anything bad about their company's product, he said.

Often presentations of industry employees are done to create interest for newly defined disorders and drugs that have yet to receive FDA approval, he said.

"They build up excitement often bordering on hype," Stein said.

Drug and medical device companies regularly use continuing medical education as a way to promote off-label uses for their products, he added.

And just because a pharmaceutical industry scientist or doctor may know more about a drug than others in the field doesn't mean that person is the best one to be teaching other doctors about it, he said.

Adriane Fugh-Berman, a critic of industry funding of medical education, said the policy is a reasonable move that should be applied to doctors who work as speakers and consultants for drug companies as well as employees.

"I don't think industry employees should be giving CME," said Fugh-Berman, a physician and associate professor of physiology and biophysics at Georgetown University.

She said they should not be in the position of evaluating potential therapies when they have a financial stake in such matters. Beyond that, it is human nature for a researcher to put a positive spin on information about a drug the researcher has studied.

"It's not impugning the integrity of anyone who works for industry," she said. "There are good scientists who work for industry. It's about evaluating the science."

On June 25, Georgetown University and the organization PharmedOut, which Fugh-Berman heads, will hold a daylong conference on whether the drug industry should fund continuing medical education.

Reflecting the strong feelings on both sides of the controversy were the former editors of the country's top two medical journals.

George Lundberg, former editor of the Journal of the American Medical Association, said the people who should be doing medical education are the ones who are the most informed on the issues.

"To rule out people who may know the most is ill-advised and counterproductive," he said.

However, Jerome Kassirer, the former editor of the New England Journal of Medicine, said the move is a good step toward cleaning up continuing medical education and eliminating financial bias from such education.

"That has been difficult to do," he said.

SPONSORSHIP PROFITABLE

Drug industry sponsorship of continuing medical education has been under fire in recent years.

Drug companies can use their sponsorship of medical education to increase market share and maximize their return on investment, Lewis Morris, chief counsel for the Office of Inspector General in the Department of Health and Human Services, said at a U.S. Senate hearing last year.

He noted a study showing that every dollar spent by a drug company on doctor education activities generated $3.56 in increased revenue.

Critics say doctor education had become a vehicle for aggressive promotion of drugs and medical devices. Drug companies now spend more than $1 billion a year to fund doctor education.

Clyde Yancy, president of the American Heart Association, said the association was aggressively appealing the decision.

"We were told we could not integrate the science [from industry employees] into any sessions ...," he said at the NIH meeting last week. "We could not invite speakers to be on our programs unless they were in a separate venue. And we could not portray the work unless it was in a separate geographic location from other CME."

In fiscal 2008-'09, the heart association got about $11 million from the pharmaceutical and medical device industry, including $1.7 million directly for continuing medical education, according to an association spokeswoman.

One solution would be to allow industry doctors and scientists to make presentations that are not part of continuing medical education programs.

However, that implies that industry's science is inferior, said Rose Marie Robertson, chief science officer for the heart association.

Robertson said the policy likely will affect fewer than 100 abstracts and presentations that would be available for medical education credit at the association's next annual meeting, which will be held in Chicago in November. That's out of about 3,000 such abstracts.

The rule also will affect the upcoming Endocrine Society meeting later this month, society President Robert Vigersky said.

Employment in the pharmaceutical industry is a serious conflict of interest that should preclude investigators from speaking in or influencing the content of doctor education activities, he said.

"We have decided to no longer provide CME credit for any oral/abstract or poster presentation sessions at our meetings because many of these scientific reports do come from industry," Vigersky said in a statement

The policy is the result of interpretation the Accreditation Council issued last year. It came up in a question-and-answer session involving its standards for commercial support and independence.

It said employees of commercial interests can't serve as planners or speakers for accredited CME activities if the content relates to business lines or products of their employer.

"ACCME is not against science," said Murray Kopelow, a physician and chief executive of the council. "We have no right to silence anyone."

He said the council stands for doctor education that is independent from industry, and allowing industry employees to give medical education talks is not compatible with that goal.

Kopelow said it is perfectly acceptable for industry employees to give talks in settings that don't involve continuing medical education.

The policy applies to all medical groups that offer accreditation council-approved continuing medical education, he said.