New Rules on Conflicts Proposed

More financial disclosure, ban on promotions suggested at UW

By John Fauber and Susanne Rust of the Journal Sentinel

Major changes to conflict-of-interest rules, including a ban on doctors giving promotional talks for drug companies, have been recommended by a task force of doctors and health professionals at the University of Wisconsin-Madison.

In addition to banning so-called dinner talks, the group said, doctors should be required to disclose specific amounts, to within $1,000, of money they receive from drug and medical device firms.

The task force of 15 doctors and other health care professionals acknowledged that financial relationships with industry companies can undermine patient trust and threaten the integrity of the medical profession.

"People need to trust their doctors and know that when they provide care, they are only acting with their best interests at heart," said James Stein, a UW cardiologist and co-chairman of the task force.

The recommendations come as UW and other medical schools have been under intense scrutiny over the pervasive influence of drug companies that have poured huge amounts of money into academic medicine. Critics say the money is used to increase sales of expensive, brand-name drugs as well as pricey medical devices.

The Journal Sentinel last month began publishing stories about conflicts of interest among UW doctors. The newspaper also has reported on drug company funding of professional courses offered to doctors though the university's continuing medical education department.

If implemented, the recommendations would represent a solid conflict-of-interest policy, said Jerome Kassirer, a distinguished professor at Tufts University School of Medicine and former editor of the New England Journal of Medicine.

"It's one of the better ones I've seen," he said.

Will changes happen?
The big question is whether the recommendations will stick as they go through the process of adoption.

In addition, the recommendations do not fully address drug company funding of continuing medical education, or CME. Observers say that continuing medical education has been used by the industry to market expensive brand-name drugs, in part by promoting non-approved uses for the drugs.

"The one missing piece is CME," Kassirer said. "That's too bad."

Eric Campbell, an associate professor of medicine at Harvard Medical School, said the banning of dinner talks is a big step.
"Very few places have done that," said Campbell, who researched conflicts of interest in medicine.

He said he is not surprised by the recommendations, given the bad publicity UW and other universities have received over drug company payments to doctors.

"When the spotlight of impropriety is shone on an institution, they either create a set of policies or they establish an office," he said. "This has been the deep dark secret between universities and companies for years."

Campbell noted that federal legislation dealing with disclosure of drug company payments is coming soon, and many universities are trying to change policies before that happens.

Just as important as any new policies, he said, is enforcement. It is one thing for a university to demand disclosure of payments, he said. It is another to actually check a disclosure against a doctor's tax return.

The recommendations go beyond the issue of just requiring disclosure, banning gifts and discouraging doctors from attending promotional events, said Steve Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic.

"It's as tough as anything I've seen out there," said Nissen, who has spoken out on conflicts of interest in academic medicine.
Nissen said he, too, believes that the issue of drug company funding of continuing medical education needs to be reformed.

"The criticism of it is on target," he said. "What they call education often is promotion."

Full review planned
Robert Golden, dean of the UW School of Medicine and Public Health, said a three-person commission has been appointed to look at the entire Office of Continuing Professional Development, including financing and academic standards for continuing medical education. He said he expects a report in the next three months.

Golden and Jeffrey Grossman, president of the UW Medical Foundation, said they hoped all the recommendations could be implemented before the start of the next academic year. Ultimately, the board of directors will have to approve the recommendations.

Initially, the new policies would apply to about 1,200 faculty physicians who work for the UW Medical Foundation.
Golden said he did not expect a "substantial gutting" of the recommendations. He said he hoped that other health affairs schools and the entire university would adopt the policies.

Grossman said he also would like to see a set of national standards.

"These local solutions to some extent are not adequate," he said.

One area that likely will have a big impact on UW doctors is the money they make giving talks to other doctors. University doctors are sought by drug companies because of the influence they wield. They can earn as much as $2,500 for a two- or three-hour engagement at an upscale restaurant.

Unknown fees
The newspaper found that in 2007 more than 40 UW physicians were paid to work as speakers or authors by drug or medical device companies, records show.

The doctors earned annual fees ranging from less than $5,000 to undisclosed amounts exceeding $20,000, according to records.
One of the biggest criticisms of UW's conflict of interest policy is that for years, doctors have been able to merely check ranges of income. It's a practice that critics say allows them to conceal large amounts of money. For instance the top reporting category is $20,000. So when a doctor checks that amount, the university does not know if the actual amount is $20,000, $200,000 or $2 million.

More than 30 UW physicians exceeded $20,000 in 2006 and 2007, records show.


-The recommendations would ban ghostwriting, a practice in which doctor are paid to put their names on papers that are written by other people, such as those working for a drug company.

-All gifts - including food, travel and entertainment - would be prohibited.

-Doctors would be required to report income from educational events, including whether the money came from a drug company.

-Health care providers would be strongly discouraged from attending non-accredited, promotional events. The task force said a complete ban was rejected as unenforceable.

-Doctors would be allowed to continue as consultants to drug and device companies, such as serving on a board or advisory committee. The group conceded that such work may have promotional or commercial goals and should be "strongly discouraged."

-UW personnel could work as investigators for clinical trials or other industry-sponsored research. They also would be allowed to hold stock and other equity, although the holding must be reported.
In addition, they could receive royalty payments, but they would not receive payments from products used at UW. And they must inform their patients in writing.

-Some conflicts of interests may be subject to conditions, including transferring a patient to another doctor or having an independent colleague corroborate any prescription or implantation of a device.

-The task force said signs should be posted in all UW clinics informing patients that their doctors may have paid relationships with the drug industry.