Cover Story
Thanks, but no thanks
By Howard Bell
Hospitals and clinics are saying no to gifts from drug and device makers.
In January, St. Mary’s Duluth Clinic Health System (SMDC) drew national attention when it went cold turkey off freebies from vendors—purging every logoed item from its 17 clinics and four hospitals. Employees collected 18,700 items, the equivalent of 20 shopping carts worth: clipboards, notepads, mouse pads, clocks, mugs, tape dispensers, surgical caps, calculators, pens, and a foam Allegra nose that says “That’s snot funny.” Instead of dropping them off the top of Mount Crumpet like the Grinch did with the Whos’ goodies, they shipped the useful stuff to a hospital with whom SMDC has had a long-standing partnership in Cameroon. “We wanted to make this a positive experience,” says Ken Irons, M.D., SMDC’s chief of neighborhood and community clinics. “Employees responded enthusiastically.”
Only a couple of years ago, vendors providing doctors with gifts was standard practice. But after a flurry of news reports drew attention to the issue, giving such items is increasingly seen as potentially promoting conflicts of interest that can damage patient trust in their doctors and in some cases compromise quality of care. As a result, hospitals and clinics are more closely scrutinizing gifts their physicians receive from drug and device makers.
SMDC isn’t the only Minnesota health system to take on this issue. In the Twin Cities, Park Nicollet, Allina, HealthPartners, Fairview, and Hennepin County Medical Center have changed or are about to change their policies concerning gifts and payments (see “Let’s Not Do Lunch”). To come up with common approaches, they have formed the Physicians Leaders Policy Forum. In addition, the University of Minnesota has created a conflict of interest task force, and Mayo Clinic is changing some of its policies.
An Issue of Perception
The trend to cut back on gifts gained momentum just two years ago, when influential physicians writing in the January 2006 Journal of the American Medical Association (JAMA) called on academic medical center faculty to set an example by no longer accepting industry gifts such as free food, trinkets, and travel money, or payments for speaking about a company’s products. They said such gifts and payments create a conflict of interest that biases physician treating and prescribing decisions—however honorable and well-intentioned a physician may be. Even small gifts with no explicit strings attached led to unconscious bias, they said, by creating a sense of obligation to reciprocate by using their product. “Individuals receiving gifts are often unable to remain objective,” they wrote. “Research suggests that the expectation of reciprocity may be the primary motive for gift-giving.” Furthermore, the authors asserted when unnecessary drugs or newer, more expensive drugs are prescribed that have little marginal benefit,
health care costs rise needlessly.
All these vendor-to-doctor gifts and payments went largely unnoticed by the public until media outlets picked up on the 2006 JAMA paper. The New York Times threw another log on the fire when it reported on a March 2007 JAMA article that said Minnesota’s and Vermont’s methods of publicly disclosing vendor-to-physician payments were ineffective and inadequate. The Times’ series and many other news reports have shed light on the more eye-popping payments and gifts physicians receive. (Physicians are reportedly paid $500 to $5,000 per talk at vendor-sponsored conferences.) They have also increased public awareness of the smaller, more commonplace gifts most physicians have traditionally accepted. Other reports have focused on major drug and device makers paying large fines and penalties and entering into “corporate integrity agreements” with the federal government to settle investigations into their relationships with physicians; and physicians in other states paying fines or being reprimanded for accepting football tickets, meals, money, and travel in exchange for inappropriately referring patients to a device maker’s clinical trials, inappropriately influencing device purchasing decisions at a hospital or clinic, for being “high prescribers” of certain drugs, for getting a particular drug on a formulary, or for influencing practice guidelines in favor of a particular drug company or device maker.
Let's Not Do Lunch
Several health systems in Minnesota have developed their own policies about what is acceptable in terms of accepting gifts and payments from drug and device manufacturers.
At Twin Cities-based HealthPartners, there truly is no such thing as a free lunch. Their physicians no longer accept food, trinkets, or other noneducational materials from vendors. Nor does HealthPartners accept free samples at primary care clinics and 80 percent of its specialty clinics, according to Brian Rank, M.D., medical director for HealthPartners Medical Group and Clinics.
HealthPartners’ physicians can accept consulting fees and honoraria but only with prior and ongoing written approval from the associate medical director of their division. Says Rank, “We ask, Does an activity create an actual or perceived conflict of interest with our patients? If the answer is yes, we don’t allow it.”
Duluth-based SMDC Health System does not allow vendors to put up displays at CME presentations or any SMDC-sponsored conference. Vendors cannot pay for specific meetings or bring in their own speakers. But vendors can give grants for education, and their support is acknowledged in program brochures. SMDC does not recognize CME credits earned at presentations that are primarily vendor-sponsored. Its physicians can speak and consult for vendors, but SMDC collects the honorariums and fees. The physician gets a per diem to cover expenses.
SMDC discourages physicians from attending vendor-sponsored seminars that include free dinners at nice restaurants. A doctor can still meet one on one with a vendor rep, but only to receive information. Meetings are by appointment and cannot occur in a patient care area. Such meetings don’t happen much anymore, according to Ken Irons, M.D., SMDC’s chief of neighborhood and community clinics, because
75 percent of SMDC’s physicians have put their names on a vendor no-call list.
SMDC hasn’t accepted free samples in seven years, except for birth control pills and inhalers for patient education. Patients who can’t afford their prescriptions get a free two-week supply from an SMDC pharmacy. Employees help them get signed up with patient assistance programs.
At SMDC and HealthPartners, physicians have responded favorably to these internal policy changes. “We’ve had little negative feedback,” says Irons. “An incredible number of physicians have thanked us. So have patients.” Likewise at HealthPartners, Rank says. “I’ve had many say to me, ‘Thank you. This is absolutely the right thing to do.’” Vendors might long for the old days, but even they appreciate having clear rules to go by, Rank says. “Our vendor relations are better now because the vendors know the ground rules. Before, the thinking was, ‘What can we do to get around them?’”—H.B.
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Even though much of the media attention has focused on a few bad apples, many physicians have become concerned that patients now perceive the entire profession to be on the take. The only solution, some have concluded, is to eliminate wherever possible the gifts and other financial influences of medical industry vendors.
The Evidence Against Gifts
There is research to support such thinking. For example, studies published in JAMA and the American Journal of Medicine between 2000 and 2005 suggest using drug samples, meeting with drug reps, and attending drug-company-sponsored CME programs can lead to inappropriate prescribing. In one 2005 study by University of Minnesota researchers, residents randomized to use drug samples were less likely to prescribe generics and more likely to prescribe brand-name drugs as compared with residents who agreed not to use samples. A study by University of Washington investigators published in the Journal of General Internal Medicine showed that more than 90 percent of physicians would dispense a sample that was different from their preferred drug choice. In a study of one Georgia clinic, use of first-line antihypertensive therapy increased from 38 percent to 61 percent after samples were banned, according to a 2002 article in Family Medicine. As the authors of the 2007 JAMA article asserted, it’s better to prescribe based on scientific evidence than by what happens to be in the sample closet.
As for gifts and free food, many physicians say such trifles don’t influence how they practice medicine. “This is a ridiculous nonissue whipped up by the press,” said one physician who responded to a Minnesota Medical Association (MMA) survey about industry gifts to practitioners (see “Doctors Disagree”). “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,” says Jeff Trewhitt, spokesman for the pharmaceutical lobby group PhRMA. Yet numerous studies published since 2000 suggest such gifts do influence physicians whether they know it or not. “I used to think it had no effect on me,” says Irons. “But we’ve realized that doctors are like everyone else. We aren’t above the effect these things can have.”
As for a gift’s value, there is no ethical distinction between gifts of different value, according to Brian Rank, M.D., medical director for HealthPartners Medical Group and Clinics, who’s helped tighten the vendor relations policies at HealthPartners. “The gift’s effect is the same,” he says, “whether it’s a pen or a $5,000 trip to Tahiti.”
Physicians who request additions to hospital drug formularies are far more likely to have accepted free meals, travel funds, or speaker’s fees from that drug’s maker, according to studies by researchers from Harvard Medical School and University Hospitals of Cleveland. In 2000, JAMA published a systematic review of medical literature on gifting. Most of the studies reviewed found that doctor-vendor interactions led to prescribing fewer generics and more expensive new drugs that had no demonstrated advantage, an inability to identify wrong claims the vendor made about a medication, a positive attitude toward the rep, awareness, preference for and rapid prescribing of a new drug, and making formulary requests for medications that rarely held important advantages over existing drugs. None of the studies included in the review looked at whether these influences affected patient outcomes, however. The review concluded that vendor interactions “affect prescribing and professional behavior in a way that should be addressed at the level of policy and education.” Many Minnesota hospitals and clinics are doing just that.
Not Just an Internal Affair
Although hospitals and clinics have taken on the task, some states have passed laws regarding what physicians can and cannot accept. Minnesota’s gift ban law prohibits physicians from receiving gifts from drug manufacturers and wholesale distributors with a combined value of more than $50 per vendor per year. That includes meals. Currently, the U.S. Senate is considering the Physician Payments Sunshine Act, which would require drug and device makers to publicly disclose all gifts and payments that exceed $25, not including drug samples and clinical trial funding. February hearings on the bill included testimony about surgeons who were enticed to use particular medical devices through consulting fees, royalties, gifts, and other payments. Sometime this year, two bills will likely be introduced in the Minnesota Legislature that would place far more stringent rules on gifts and samples.
Physicians, themselves, have also responded. The AMA’s policy set in 1992 says gifts should not exceed $100 per vendor per year and should be only educational in nature. In 2006, the MMA adopted the AMA’s policy on honoraria, which says, “It is appropriate for faculty at conferences or meetings to accept reasonable honoraria and to accept reimbursement for reasonable travel, lodging, and meal expenses.” Ditto for consultants who provide “genuine services,” meaning they actually did enough speaking, consulting, or advising to merit the compensation.
Specialty societies have guidelines for vendor relationships, too. The American College of Physicians, for example, acknowledges that drug-company gifts can potentially influence clinical judgment and that “physicians must be conscious of all potential influences and their actions should be guided by the patient’s best interests.” Its policies also state that physicians who have potential conflicts of interest, whether as speakers, consultants, researchers, or investors, “must not in any way compromise their objective clinical judgment.…”
Some societies place limits on the value of gifts vendors can hand out at conferences, but these rules are commonly violated, according to a Wisconsin physician who was interviewed on behalf of NoFreeLunch, a physician organization trying to eliminate marketing influences on physician decision-making. NoFreeLunch was founded in 1997 by a New York internist and now has several hundred members. The NoFreeLunch website cites a 2005 study showing that at a 2002 American Psychiatric Association (APA) conference, more than half of the exhibitors violated either an APA or an FDA rule.
Mixed Feelings
Doctors opposed to cutting back on physician-vendor interactions say vendor reps and vendor-sponsored meetings provide important up-to-date information about the latest drugs and devices. “Reps give us a heads-up on new drugs coming that we wouldn’t read about in a journal until months later,” says Jim Rogers, M.D., a family physician at Raiter Clinic in Cloquet.
Doctors Disagree
Doctors are concerned that the recent media spotlight on relationships between physicians and drug and device makers is affecting the public’s perception of them. A 2007 email survey of Minnesota Medical Association (MMA) members found that 76 percent of the 700-plus respondents were very or somewhat concerned about patients’ perceptions of the medical profession in light of recent media coverage of industry gifts and payments to physicians.
But the MMA’s survey reveals there is no consensus about whether these gifts affect their behavior or whether the government ought to regulate gift-giving.
Fifty-five percent of respondents said gifts or payments from pharmaceutical companies are very likely or somewhat likely to influence physician prescribing behavior.
Forty-seven percent said it’s very appropriate or somewhat appropriate for the state to impose limits on the value of gifts or payments physicians may accept from a pharmaceutical company.
This sampling of respondents’ comments reveals the range of their opinions:
"The medical profession has been compromised for many years by gifts and payments. The scandal is deep and widespread … Patients have suffered. It is complex, but needs to be cleaned up.”
“One would have to be ignorant to believe these things don’t influence behavior.”
“I find samples of meds to be invaluable in my practice. Patients greatly appreciate them as well.”
“I think that the fanaticism on this issue has reached a point bordering on the ridiculous…. The evidence of physicians being adversely affected by pharma reps is systematically being repudiated.”
“This is a cancer for our profession. These payments are a clear conflict of interest. We seem to be unable to limit it ourselves (shame on us). We need laws to help us avoid this grave conflict of interest.”
“It should be up to our profession, not the government, to deal with this issue.”
“Pharmaceutical company interaction with physicians is necessary and important, but must be disclosed and within certain guidelines.”
“The media should be focusing on preventive medicine, Medicare problems, and the uninsured, not on trivial issues like this.”
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Drug reps bring lunch, information, and samples to the Raiter Clinic three days a week, according to Rogers. He says the lunches bring staff together during their hectic days and the samples help them determine whether a medication will work for a patient. “The samples are usually for meds we don’t have generic choices for,” he adds. Even so, Rogers says he has mixed feelings about vendor visits. He doesn’t go on the golf outings. At the lunches, he says, “I keep standing, give them one minute, then take the food. The cold, hard fact is the more time you spend with them, the more you use their product.” Rogers says he also tears out drug ads interspersed in prescription pads before using the pads. “It’s my little reminder to myself to not be swayed.”
Les Forgosh, M.D., and his partners at St. Paul Cardiology plan to keep accepting lunches and samples for many of the same reasons. “Samples are a cost-effective way to determine if a patient will tolerate a drug before they go out and buy it themselves,” he says. “And free food is good for staff morale, which translates into better patient care.”
Busy residents find the lunches educational and practical, too. A resident responding to the MMA survey said, “I have limited time for reading and learning about new medications or approaches. Doing it over a meal just makes sense.”
But SMDC, HealthPartners, and other groups say more objective sources of information than drug representatives are readily available—including online resources such as The Medical Letter and The Pharmacy Letter, evidence-based peer-reviewed journals that are unbiased, or at least less-biased because they accept no advertising, grant money, or donations. SMDC’s electronic medical record is linked to The Medical Letter and The Pharmacy Letter. In addition, SMDC pharmacists research drugs before they are added to the formulary. They also brief physicians on medication management issues, for example, how to manage patients on warfarin.
Icebergs Ahead
Gifts and payments for consulting or speaking are just one iceberg in the ethical ocean doctors must navigate. And it’s probably not the biggest one. What vendors value most is access to academic medicine’s research and development agenda—to the clinical trials, resources, and talent that fuel the engine of medical innovation. A mutually beneficial symbiosis between the two is essential but also rife with the potential for conflicts of interest. Not crossing that ethical line is what the University of Minnesota’s conflict of interest task force is addressing.
The task force, created last fall, will submit recommendations to the medical school dean later this year. Biotechnology researchers as well as vendor reps are on the task force’s subcommittees—as they should be, according to Denis Clohisy, M.D., an orthopedic surgeon who co-chairs the task force. “Industry is our partner,” he says. “We work together to create new drugs and devices.” Coming up with a list of potential conflicts is a critical first step, according to Clohisy. But the challenge is to determine “how to manage these potential conflicts so that patients are still benefiting from new drugs and devices and we’re not stifling research and innovation.” Mayo Clinic has already addressed some of these concerns. For example, Mayo physicians who receive vendor money for research cannot also receive money from that company for speaking engagements.
As for gifts and payments to individual doctors for speaking, consulting, advising, or just listening to a promotional talk, laws may eventually standardize the rules and hospitals may draw up new policies. However, physicians will likely keep questioning whether the vendor relations issue has been overblown. Some may think vendor gifts and payments don’t pose a problem, but what if patients think otherwise? Whether the problem is real or perceived is somewhat moot when perception can be as harmful as reality. “Preserving trust and credibility in the physician-patient relationship,” says HealthPartners’ Brian Rank, “is a cornerstone of medicine that’s easier to keep than try to win back.” Physicians, it seems, may have to get used to saying, no thanks. MM
Howard Bell is a medical writer in Onalaska, Wisconsin.