UMass policy limits doctor, drug maker ties

Conflict of interest rules among strictest in country

Email|Print| Text size + By Liz Kowalczyk
Globe Staff / December 24, 2007

UMass Memorial Medical Center last week adopted some of the strictest conflict of interest rules in the country, in effect sharply limiting the close ties between many doctors and the makers of drugs and medical devices.

The policy should significantly reduce conversations and meetings between physicians and salespeople, and therefore presumably reduce the appearance of influence over what drugs doctors prescribe for patients.

It prohibits doctors and other clinical staff from eating meals paid for by companies; bans all gifts, from candy to medical journals; stops drug companies from giving money directly to individual physicians and departments for educational programs; and places a complete ban on doctors joining company "speakers bureaus" to give talks about products.

"It will be a dramatic change for some physicians," said Dr. Daniel Lasser, head of family medicine and community health at UMass Memorial.

"You can find a restaurant in Worcester at least one night a week where there's a room with a speaker and a bunch of doctors. Teaching institutions have a lot of traditions and habits that are difficult to break. We see this [change] as a way to serve as role models."

Many of the practices that UMass Memorial is prohibiting are common in hospitals in Boston and across the United States. These institutions have grown dependant on hundreds of thousands of dollars from drug and device makers to pay for continuing medical education courses, consulting agreements, drug samples, meals, and trips to conferences, as well as legitimate and important research. Many are now debating how far to go in restricting these relationships.

"You don't want to chase drug company money out of the system completely," said David Rothman, a history of medicine professor at Columbia University and director of the university's Center on Medicine as a Profession. "Drug companies are not tobacco companies. We all need them."

Hospitals depend on pharmaceutical company money for research and to help turn discoveries into medical products for patients. The UMass Memorial policy still allows physicians to work as scientific consultants for companies and accept research funding, as long as the contract is related to work on specific medical issues, not marketing.

But, Rothman said, hospitals need to "sever the tie between the company and the prescribing physician."

Rothman was a coauthor two years ago of an article in the Journal of the American Medical Association that called for teaching hospitals to sharply limit the gifts and money they accept from pharmaceutical and medical device makers, and laid out a blueprint for a policy.

Since then, the Prescription Project, a Boston-based nonprofit organization working with Rothman's group, has been meeting with and pressuring hospitals to adopt stricter standards.

While many hospitals are strengthening their policies, Rothman said UMass Memorial now has one of the most restrictive and comprehensive policies. Boston University and Boston Medical Center earlier this year also adopted strict conflict of interest rules.

John O'Brien, UMass Memorial Health Care chief executive, said relationships between drug companies and some doctors are too close at teaching hospitals nationally, threatening the objectivity of doctors in caring for patients.

"This is one of the dark sides of medicine unfortunately," he said. "It erodes public confidence."

The UMass Memorial policy goes further than those at most other hospitals in several ways. It bans company-paid meals off and on campus. It also establishes strict rules for doctors who serve on committees that decide which drugs and devices the hospital should buy in bulk to treat patients. Most hospitals require doctors simply to disclose their financial relationships with companies to other committee members.

But UMass Memorial decided that doctors with consulting agreements or grants from companies cannot serve on these committees, meaning some current members may have to resign. The danger, conflict of interest specialists say, is that doctors may select a drug for the hospital's "formulary" because he or she does work for the manufacturer, not because it is the best, lowest-cost medication.

Partners HealthCare, which includes Massachusetts General Hospital and Brigham and Women's Hospital and is the largest provider network in the state, "will be tightening up" its policies, said Dr. David Torchiana, head of the Massachusetts General Physicians Organization. But, he said, he doesn't want to go overboard.

"Academic medical centers are here to advance knowledge, but discoveries have no value to patients unless they get made into products," he said.

"We don't want to kill that by enforcing an overly strict conflict of interest policy. It's a little bit of a runaway train right now: If you've ever eaten a slice of pizza supplied by a company you are irredeemably tainted," he said.

Under the UMass Memorial policy, companies may still fund continuing medical educational courses, but the money must be funneled through the UMass Memorial Foundation and cannot be earmarked for a specific topic or doctor - a compromise reached with doctors after executives said they wanted to ban company educational funding entirely. Doctors say this is a crucial source for keeping up their skills.

Companies can direct funding to a specific department, such as surgery. A special committee will review all donations over $10,000 for potential conflicts of interest.

The goal is to ensure that companies do not influence the content of courses so as to place their drug or device in a favorable light.

Sales people will no longer be able to give free drug samples directly to the physician; they must be delivered to the hospital pharmacy. This new rule will probably cut down on much of the contact between doctors and sales people, because most doctors agree to see company representatives because of the free samples, which they can dole out to patients. The samples allow a company to get a patient started on their drug and increases the chances they will use it long-term. The doctor will be able to request samples from the pharmacy.

O'Brien said it is unclear whether companies will stop paying for educational courses or donating free samples under these new rules. But, he said, the hospital is prepared to pay for much of what drug companies currently fund, although executives aren't sure of the amount.

The policy was approved last week by the "clinical performance council," which includes department heads and senior leadership. Another committee and the board of trustees are expected to give final approval by the end of February, said Douglas Brown, senior vice president and general counsel. Hospital leadership will develop an implementation plan and penalties for not complying with the policy in the spring.

The policy applies to all nurses, pharmacists, and other clinical staff, including 750 employed physicians and 100 doctors who serve on hospital committees. The hospital's goal is to expand the new rules to another 800 to 900 doctors who are in private practice but admit their patients to UMass Memorial.

"To the extent that there is this appearance out there of undue influence or taint, that does hurt overall patient care," Brown said.

"Patients should never have to question whether the care they're getting is based on sound judgment and decisions."

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