Hospitals tighten rules on gifts, meals, education from pharma
Conflict of interest policies go under revision
By Stacey Butterfield
From the May ACP Hospitalist, copyright © 2008 by the American College of Physicians
At hospitals around the U.S., pants may be getting a little looser and desks a little less cluttered thanks to new policies restricting interactions between physicians and the pharmaceutical industry.
The changes to conflict of interest policies are occurring primarily at academic medical centers and affect everything from free food and trinkets to funding for continuing medical education. Pharma-funded lunches have become a thing of the past at many academic medical centers, including Yale, Stanford and Boston University, and one hospital has gone so far as to send every item that carries a drug logo to Africa.
“The whole idea is to try to get academic medical centers to reduce the potential for conflicts of interest, especially for the trainees.”
Many of the recent efforts to build barriers between the pharmaceutical industry and hospital staffs can be traced back to a 2006 policy proposal for academic medical centers that was published in the Journal of the American Medical Association.
“The whole idea is to try to get academic medical centers to reduce the potential for conflicts of interest, especially for the trainees,” said Troyen A. Brennan, FACP, lead author of the paper and Aetna’s chief medical officer.
Kenneth Irons, MD, with the pharma items collected at SDMC Health System.
Much of the motivation behind the new policies was the same for nonacademic medical centers as for academic medical centers, according to Kenneth Irons, MD, chief of community clinics for SMDC Health System in Duluth, Minn., the organization that purged all its pharma trinkets.
“We wanted to make sure, for our patients, that we eliminated the perception that we were significantly under the influence of the pharmaceutical industry,” he said. “We wanted to make sure that the information that we were using in our prescription decisions was as unbiased as possible.”
Going above and beyond
Pressure from outside the medical establishment also has had something to do with the changes, noted David L. Coleman, FACP, who led policy revisions at Yale and Boston University. Several state legislatures are looking at bans or limits on gifts to physicians, and pending federal legislation would require disclosure of any gift or payment worth more than $25.
“I thought it was better that the profession seize the initiative and not leave it up to state legislatures,” he said.
Many of the medical centers have gone beyond what the government is likely to require of them, however. Bans on free lunches and gifts are almost universal among hospitals that have made the changes, and others have eliminated all pharmaceutical displays and severely curtailed funding of educational activities. Samples are another targeted area—some hospitals now preclude detailers from meeting with individual physicians to drop off medications, while others are still struggling with the issue.
“The most complex issue we encountered was that of samples,” said Barbara E. Barnes, FACP, associate dean for continuing medical education at the University of Pittsburgh School of Medicine. Particularly challenging was setting a single standard for all 20 hospitals and 500 outpatient sites of the University of Pittsburgh Medical Center. “The needs of a clinic co-located in our major teaching hospital were much different than a rural health clinic that was remote from a pharmacy,” she said.
Samples are also likely to be the only aspect of the changes that concerns patients. Otherwise, public response to the new policies has been overwhelmingly favorable, hospital administrators said. “We’ve seen editorials in the paper and had favorable endorsements from the papers themselves,” said Dr. Barnes.
Will new rules affect prescribing?
Response from the pharmaceutical industry has been a little more mixed. Dr. Coleman said that most of the pharmaceutical reps he consulted about the changes were supportive because they are also interested in maintaining a healthy, appropriate relationship between medicine and industry.
Ken Johnson, senior vice president of Pharmaceutical Research and Manufacturers of America (PhRMA), took a dimmer view. “Hospitals that restrict interactions between representatives of America’s pharmaceutical research companies and physicians ignore the commitment of doctors to quality health care,” he said in a prepared statement.
"It’s an insult to health care providers to suggest that they would prescribe medications based on who gave them a slice of pizza or a pen."
“Despite what critics say, it’s an insult to health care providers to suggest that they would prescribe medications based on who gave them a slice of pizza or a pen,” the statement continued.
Some physicians at academic medical centers have also had trouble accepting that idea, according to Dr. Coleman. “None of us like to admit that we’re subject to bias,” he said. “That’s not something that any physician wants to believe about themselves.”
But, in addition to research that has shown the effects of industry interactions on prescribing, the sheer existence of the freebies is evidence against them. “We know the reason companies do all this is that it works. It influences prescribing,” said Dr. Coleman.
What is less clear is the effect that the new conflict of interest policies will have on prescribing habits. “That’s the question that we’re all hoping to answer. Unfortunately, it’s not easy to answer it,” Dr. Coleman said.
Robert Restuccia, executive director of the Prescription Project, a nonprofit organization that promotes the ideas in the 2006 JAMA paper, is optimistic. “Ultimately, the impact of this is going to mean more evidence-based scientific prescribing and that the quality of care will improve for patients,” he said.
At the very least, the efforts have increased the transparency of interactions with pharma and heightened awareness among physicians about potential conflicts, the experts said. “It has raised more sensitivity about accepting gifts and the importance of consummating appropriate agreements to support consulting and other relations with industry,” said Dr. Barnes.
Raising the bar
Leaders at academic medical centers also hope the changes will set an example for their students and trainees. “It has changed the teaching environment so that we don’t have pharmaceutical reps detailing their products at a housestaff luncheon or a fellows’ luncheon,” said Dr. Coleman.
That’s one of the main reasons that academic medical centers were targeted for the initial effort, according to Dr. Brennan. “The idea was that the academic medical centers are influential in two ways. They influence the behavior of a lot of other major medical centers but they also affect the way people are trained. I think that’s the important thing,” he said.
Academic medical centers also face a particular responsibility and challenge in setting the standard for relations with pharmaceutical companies because of their research roles, Dr. Coleman said. “We have a special need to do clinical research, and if we get it wrong with regards to the marketing relationships, it has potential to also damage our ability to do good clinical research.”
Research is one of the areas where many of the medical centers are still looking at their policies. Funding for educational activities and paid consultancies and speaking engagements are other topics that the guideline developers have yet to fully tackle. As study continues on those aspects, advocates of the changes hope to capitalize on their successes in academic medical centers. “We have also started to work with non-academic medical centers. We’re seeing more and more hospitals that are freestanding looking at these [policy changes] from the perspective of cost and quality,” said Mr. Restuccia.
Currently, cost is the one downside of the revised policies, the administrators said. Someone has to pay for the food that used to be free, whether it’s individual employees, clinic physicians or the health system. But the bigger hit comes in funding educational activities.
Dr. Irons of SMDC estimated that the elimination of pharmaceutical displays from CME cost the health system $30,000 to $40,000 a year, and Philip Pizzo, MD, dean of Stanford University School of Medicine, said that his school has given up about $1 million in annual industry financing.
That’s money that pharmaceutical companies will have available to spend on alternative forms of marketing, which Mr. Restuccia expects will include additional online advertising and funding of CME as more hospitals build barriers to physician/pharma interactions.
“My sense is that the pharmaceutical industry will remain entrepreneurial and creative in how they approach this and that we will have to be creative in thinking about how to counter what we think is detrimental,” he said.
Build your own barrier
Several recent academic papers have offered guidelines for the revision of conflict of interest policies (see the February 2006 Academic Medicine and the Jan. 25, 2006, Journal of the American Medical Association), but some experts who have been through the process had additional suggestions on how to smoothly and effectively limit interactions between physicians and the pharmaceutical industry at any hospital.
Follow their lead. “There are a number of examples out there of other institutions that have developed these policies. Rather than reinvent the wheel, I would certainly look at them,” said David L. Coleman, FACP, chair of the department of medicine at Boston University. Yale (where Dr. Coleman used to work), Stanford and the University of Massachusetts are frequently cited examples of schools that have led the way on this issue.
Get feedback. Changes are less likely to raise the ire of physicians and other staff if they have had a chance to consult on the new policies, the experts said. At the University of Pittsburgh, new conflict of interest proposals were under discussion from May 2006 until February 2007. “We did make modifications based on feedback. I think that generated a lot of goodwill in terms of our community knowing that their feedback was taken seriously,” said Barbara E. Barnes, FACP, associate dean for continuing medical education at the University of Pittsburgh School of Medicine.
Tackle one thing at a time. “For practical reasons, I would separate research from marketing in formulating these guidelines,” said Dr. Coleman. Because the issues surrounding research and relationships with pharmaceutical companies are more complicated, focusing initial policy changes only on marketing can make it easier to develop a consensus and enact a policy quickly.
An SMDC Health System staffer sorts through collected items.
Do some marketing of your own. When SMDC Health System in Duluth, Minn., decided to get rid of all pens and other items with pharmaceutical logos, their marketing department came up with a clever way to attract public attention and get staff buy-in. “For every item that staff turned in, they got their name put into a drawing for prizes,” said Kenneth Irons, MD, chief of community clinics. Staff won prizes like vacuum cleaners (to go with the “Clean Sweep” theme), and more than 18,000 items were donated to charity.
Replace what you’ve eliminated. “One of the things that everybody was concerned about was how do you learn about new medications when you don’t have the pharmaceutical industry providing you their biased information,” said Dr. Irons. In response, SMDC has provided their physicians with electronic access to The Medical Letter and Pharmacist’s Letter, as well as scheduling regular talks by the pharmacy department.
Just do it. “Bite the bullet and do it. I’ve talked to a number of outside groups and they’ve been wanting to do this, but they’ve always been afraid to do it,” said Dr. Irons. Staff quickly adapt to the changes, and many even appreciate not having so much unhealthy food available, he said. “We’ve really had minimal negative complaints. I think that most people will find the same thing.”
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