New breed of gifts from drug makers: Good for care or crossing the line?
By Phyllis Maguire
Family physician Berdie H. Safford, MD, has had her share of expensive gifts offered by drug companies. As medical director of quality assurance for Family Care Network, a group of 45 primary care physicians in Washington, she routinely turns down opportunities for educational trips, fancy dinners and lucrative "consulting" jobs.
But two years ago, she noticed a change in the drug companies' approach. Instead of trying to entice her with a cruise, representatives wanted to know how they could help fund programs that could benefit her patients.
Dr. Safford's practice eventually accepted two unrestricted educational grants. One gave each physician in the network a "toolbox" containing educational materials for diabetic patients. The other is funding a patient survey about a new diabetes management program the group put in place a year ago. Neither effort promotes a specific product or medication.
Like Dr. Safford, many physicians have routinely declined drug company offers of exotic trips and expensive dinners. Yet many are taking a different attitude about this new breed of promotional gift, which aims to improve patient care without marketing a specific drug.
Dr. Safford, for instance, said she has no qualms about accepting gifts that help her practice improve patient care. "I personally benefit from them less than if the companies gave us pens," she explained. "This is a much more effective, ethical and patient care-based approach to marketing pharmaceuticals than inviting me to some wonderful place to relax in the sun."
Not everyone, however, is comfortable with drug companies' new promotional efforts. Some physicians say that all industry promotions—whether for patient surveys or steak dinners—drive up drug costs and compromise physician prescribing patterns.
Those concerns are likely to intensify as drug companies explore an emerging type of promotion: giving away computer hardware and software to help physicians computerize their offices at little or no expense. While many physicians argue that gifts like handheld computers improve patient care, critics worry that these promotions will only increase the potential for conflicts of interest.
One thing, however, is clear: As drug manufacturers get more creative with their marketing techniques and physicians work harder for shrinking reimbursements, more physicians appear willing to walk the fine line that separates professional ethics from drug company generosity.
A new promotional era
Across the country, physicians report a growing willingness on the part of drug companies to fund promotions that aren't tied to specific medications. A New Jersey geriatrics practice, for instance, is using an unrestricted educational grant to rent a hall and stock snacks for support groups for caregivers of Alzheimer's patients. And in South Bend, Ind., a hematology-oncology group is using a similar grant to provide diaries to cancer patients and host community programs on the role of nutrition in cancer care.
Analysts say that several factors are driving this new breed of drug company promotions. For one, physicians with more patients and paperwork are increasingly reluctant to give up evenings for a steak-dinner sales pitch or two days for an out-of-town conference. Instead of taking doctors away from their offices, these new promotions bring pharmaceutical dollars directly to physicians.
"It's ethically problematic when a company with a direct interest is the source of your funds for patients." —Arthur L. Caplan, PhD
Drug companies are also moving quickly to fill what many see as a growing economic vacuum. Business models like managed care, integrated delivery systems and physician practice management companies that once promised to finance patient care programs have fallen short. With reimbursements shrinking, physicians say that drug companies may be their only resource to pay for tools that can enhance patient care.
Nowhere is that need greater, say physicians, than in computerizing clinical care. While there is a growing body of evidence that computerization can decrease errors and enhance evidence-based medicine, few physicians have the capital to invest in the technology.
That void hasn't been lost on drug companies, which are scrambling to find ways to add electronic clinical tools to their promotional efforts. Kim D. Slocum, director of e-business strategy and alliances for AstraZeneca, explained that if handheld devices can help improve care by improving medication safety, cost shouldn't be a barrier. "If it's a question of 'priming the pump' a little bit to demonstrate to physicians that these tools are helpful, then I think it's very useful for us to provide these tools at no or minimum cost," Mr. Slocum said.
Similarly, many physicians make an economic argument for accepting industry aid. They don't have the money themselves to invest in electronic tools, they say, and would welcome any help that could enhance patient care.
Michael E. Monaco, MD, one of two internists who make up Select Healthcare PA in Overland Park, Kan., said that as an entrepreneur and a small business owner, he would "certainly accept any help that would facilitate my practice," particularly if it could help connect him to the Internet. According to Dr. Monaco, patient care promotions not only benefit patients but also correct an increasingly distorted flow of health care dollars.
"The money that used to go to physicians is now being divided by health plans and pharmaceuticals," Dr. Monaco said, "So what is wrong with that money being redirected back to the physician? That's where it was originally."
Robin T. Zon, ACP-ASIM Member, one of seven oncologists with Michiana Hematology-Oncology PC in South Bend, Ind., said that she would probably prefer to buy a handheld device herself. "But if they wanted to provide me with software for patient care," she said, "I would accept that."
Pharmaceutical grants are already "essential" to her practice, Dr. Zon said, not only to fund the group's clinical research and physician symposia, but for nurse education and community and patient programs. And she denied the notion that patient care promotions might influence her prescribing decisions.
"We prescribe enormous amounts of drugs," Dr. Zon said of herself and her colleagues. "Yet when I prescribe, never once has any company swayed me based on what they gave the practice."
On the surface, promotions geared to clinical care and patient education seem to avoid ethical pitfalls. They don't promote a particular medication, so they don't violate antikickback regulations. And clinical care promotions clearly benefit patients instead of simply padding an individual physician's vacation plans.
Drug company officials don't refer to patient care promotions as "gifts," but as "health promotion services" or "value-added programs." Yet the industry's enormous office-based promotional budget ($3.6 billion in 1999, according to IMS Health, a health care research company) funds these programs. And all patient care programs indirectly help drug makers' bottom lines.
Only drug companies that market diabetes medications, for instance, develop patient care programs for diabetics. Educational programs typically stress health management and compliance, factors that typically include the continued use of medications. And drug makers offer promotional gifts and grants much more readily to large medical groups than to small practices. At the same time, any industry-physician partnership that involves electronic tools like handhelds could be an added boon to drug companies.
While pharmaceuticals already get population prescription data from pharmacy benefit management firms, shared data from handheld devices would give drug companies a faster, more complete picture of a physician's prescriptions.
As drug makers embrace electronic gifts, some have a clear link back to a product. Many groups and clinics, for instance, can better manage their Coumadin patients because of CoumaCare, a software and educational program provided free by the drug's manufacturer, DuPont Pharmaceuticals Company.
Most electronic gifts, however, are not related to a particular product. Schering-Plough, for instance, provides free Web sites to physicians through its MyHealth.com division. And handheld devices would give physicians access to information on all medications, not just those manufactured by one drug maker.
Organized medicine offers plenty of ethical advice on gifts. Since 1990, the College has "strongly discouraged" individual physicians from accepting gifts or subsides and urged them to refuse anything they would feel uncomfortable disclosing to their patients or the general public. (See the College's "Ethics Manual, Fourth Edition," www.acponline.org/ethics/index.html#manual.)
The AMA's guidelines state that gifts of substantial value, travel expenses, cash and lavish entertainment are unethical, while those that are "related to a physician's work," serve "a genuine educational function" and entail "a benefit to patients" are appropriate. (See section E-8.061 of the "Code of Medical Ethics," http://www.ama-assn.org.) The AMA has further suggested that gifts or subsidies that meet those criteria should have a value of $100 or less.
Some worry that at a retail price of $400 and up, handheld devices cost more than current guidelines allow. And public demand for lower drug costs have placed gifts to physicians under new scrutiny. Last summer, the AMA convened a new "National Educational Campaign on Gifts to Physicians" program to look at the impact of promotions geared to physicians.
"Physicians have to take a strong position in favor of ethical guidelines or they'll be faulted for being part of the problem," said Alan R. Nelson, MACP, special advisor to the College's Executive Vice President and chair of the new AMA program. "As one politician told me, 'If it wasn't for physician payola, the cost of drugs wouldn't be so high.' "
Ethicists say that pharmaceutical gifts, even when they benefit patients, erode the public's trust in physicians. "It may be better than putting money into dinners and junkets," Arthur L. Caplan, PhD, director for the Center of Bioethics at the University of Pennsylvania said about patient care promotions. "But it's still ethically problematic when a company with a direct interest is the source of your funds for patients. The more you yield to the economics, the more you're falling into a business model that undercuts arguments for professionalism."
Some physicians are frustrated that the profession has to increasingly rely on handouts. They decry a payment system that makes the economic argument for promotions so compelling.
"Why aren't we being paid enough to provide those services ourselves, instead of getting freebies from a drug company that we're then beholden to either subconsciously or directly?" asked R. Scott Hanson, ACP-ASIM Member, a general internist with South County Walk-in and Primary Care Inc., in Narragansett, R.I.
Others have concerns about how drug companies will use data acquired through these promotions. "You've got to worry about what kind of information they are trying to get," said John D. Halporn, ACP-ASIM Member, a general internist with the Bowdoin Medical Group in Brunswick, Maine. "Is it a way to just win your gratitude? Or is it also a way to understand your prescribing habits and practice style to better target drug promotions to you?"
Proceed with caution
Drug makers are aware of these concerns and are already considering ways to get electronic tools to physicians with the fewest ethical problems.
One approach may be to distribute handhelds through a third party, diluting the value of any one company's gift by involving several corporate partners. That's the route being taken by iScribe Inc., an e-health care company that gives physicians handhelds with electronic prescribing capabilities free of charge. (Physicians can pay a small subscription fee to add more functions to the device, like the ability to capture charge data with ICD-9 codes.)
A dozen different corporate partners are underwriting the distribution, according to David L. Levison, iScribe's president and chief executive officer. They include PBMs, retail pharmacy chains and several pharmaceuticals.
Another alternative is to charge physicians a nominal fee for electronic tools. That is being considered by Aventis Pharmaceuticals, which is now developing MyDoc Online, an Internet-based messaging software system for physicians that allows patients to schedule appointments, order refills, get lab results and request billing information and referrals.
Aventis is considering charging physicians a subscription fee of about $20 a month for the service. However, it might waive or reduce that monthly fee based on the number of transactions (like refills) that physicians conduct through the site. (Aventis would get a small fee for every transaction.) Even with a modest subscription, Aventis will heavily underwrite the system, making it virtually—if not technically—a promotional gift to physicians.
The MyDoc Online pilot program is being developed at Austin Regional Clinic, a multispecialty group with 125 physicians. Norman H. Chenven, MD, the group's executive vice president, said the clinic will follow ethical guidelines in collaborating with Aventis. "We won't endorse or promote their products," he said, "and we won't walk around with Aventis logos on our white coats, like we're pro basketball players."
"I don't believe in situational ethics, and I think guidelines should emanate from an ethical position that can't really change," Dr. Chenven said. "But you end up trying to be creative to get what you need and still stay within professional guidelines—and that's a balancing act."
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