Shadowing--the practice of pharmaceutical company representatives following physicians into examining rooms while they are consulting with patients--has been drawing more notice lately from the medical profession.
David Fassler, M.D., a psychiatrist from Burlington, Vt., and a member of the Governing Council of the American Academy of Child and Adolescent Psychiatry, has concerns about the participation in such visits by drug reps, who often pay physicians for the privilege.
"We started receiving calls from members several months ago raising questions and concerns about this practice," Fassler says. "As we began talking with our members, it became clear this was a widespread practice. Dozens of our members had been approached about becoming involved, and some had even participated."
One member told him that, in talking with a pharmaceutical company, he found that their program had been in place for five years.
Expressing its concern over the practice, the AACAP has drafted a resolution for discussion at the annual meeting of the AMA House of Delegates this month in Chicago. It is co-sponsored by the American Psychiatric Association, Fassler says.
Currently, the AMA has no position on shadowing. But the academy's resolution could set policy, focusing on informed consent and the need for appropriate guidelines to protect patient confidentiality and prevent inappropriate intrusion into the doctor-patient relationship.
On April 28, Janet Rehnquist, the outgoing inspector general at HHS, issued a 39-page guidance warning drug companies that shadowing was among a list of "suspect" pharmaceutical industry activities that may violate federal anti-kickback laws.
The guidance is not legally binding, but it's not the first time that drug industry business practices have been called into ethical, if not legal, question.
In July 2002, the Pharmaceutical Research and Manufacturers of America, in response to physician pressure, adopted voluntary guidelines for its members regarding gifts to physicians from sales representatives. Gifts are to be limited to $100 in value, according to Jeff Trewhitt, a spokesperson for the 90-member trade group. But he says those guidelines don't apply to shadowing payments, which he says are compensation for services rendered.
PhRMA has no policy on shadowing, even in the wake of the OIG admonition, says Trewhitt. "Each company will have to make that decision itself," he says. "This is not an issue we would get involved in, because it gets into competitive marketing and pricing, and we have to leave that to our member companies."
Leonard Morse, M.D., chairman of the AMA Council on Ethical and Judicial Affairs, says there is precedent for bringing observers into the room with patients.
"Having medical students and residents accompany physicians into examining rooms or offices as part of a preceptorship program is well-established," Morse says. "There are even 'doctor for a day' programs, where medical societies pair up physicians with legislators who accompany them into examining rooms for a day so they can see what physicians do. Of course, this is always done with the consent of the patient."
However, Fassler, Morse and other physician leaders take issue with drug reps shadowing doctors.
One key concern is patient pressure. Could patients feel too embarrassed to refuse a physician's request to have a drug rep participate in the visit?
"One concern we have is that patients may not always feel free to say no," Fassler says.
"This certainly could happen," Morse says. "Patients don't want to do anything to upset their doctor, so they might feel obligated to agree, even if they would personally prefer not to."
Another concern is whether the patient has truly given informed consent.
"This is not always a simple issue," Fassler says. "For example, there have been some situations involving drug reps sitting in on clinical sessions with children. There is a whole set of issues related to not only getting the parent's permission, but also the child's."
One of the most significant concerns, according to Morse, is whether patients might withhold sensitive or embarrassing information from the physician in the presence of the drug rep, even if they do agree to the rep's presence.
"Having anyone else in the room is obviously going to change the nature and dynamics of the clinical interaction between the physician and the patient," adds Fassler.
Additionally, physicians might feel sales pressure to prescribe a specific manufacturer's product, rather than one that might be more appropriate, given that the manufacturer's rep is present.
"Having reps in rooms with doctors and patients doesn't seem right, if for no other reason than they can influence what physicians prescribe," Morse says.
Doctors at GreenField Health System, a five-physician internal medicine group in Portland, Ore., also were concerned with drug rep influence--so much so that they no longer accept visits of any kind, including shadowing, from drug reps.
"We made the decision because we felt it was in our patients' best interest," explains GreenField spokesperson Steve Gordon, M.D. "When drug reps seek our attention, they do so in order to sell their products. Since our patients come to us for unbiased opinions, we felt the best way to provide this is to exclude obvious opportunities for bias."
With the implementation of the HIPAA privacy regulations in April, shadowing raises legal issues regarding patient confidentiality (see sidebar).
"Given that medical information is highly privileged, even to the point where physicians don't have access to the medical records of patients they are not treating, we have concerns about issues of patient privacy and confidentiality," says Morse.
The Queens City Physicians, a multispecialty group of 56 physicians in Cincinnati, once permitted shadowing on a limited basis but no longer does so.
"We allowed very limited shadowing programs in the past for specific conditions, such as asthma," reports Pamela Coyle-Toerner, the group's president and COO. "I'm not sure we would be opposed to such programs, but I don't think we would really offer the best environment for it.
"For one reason, given the new government regulations, the number of signatures we would be required to gather for such a thing to occur would be greatly increased," Coyle-Toerner says.
The Queens City group limits visits by charging drug reps to spend time with physicians. "We set up a program where our physicians act as consultants for a company called Physician Access Management, which we own," Coyle-Toerner says.
Physicians sign an agreement where they will see reps on a scheduled basis for a guaranteed, uninterrupted 10 minutes, she explains. The doctors are then compensated for those visits by the pharmaceutical house.
Not all drug companies like the idea. "The small players see the benefits and are cooperating," she says. "The big guys haven't done so, so we don't see them. They can still leave their drugs at the front desk, but they don't see our physicians."
Education or influence?
Fassler, the Vermont psychiatrist, opposes shadowing altogether.
"Overall, my own opinion is that physicians are better off not to be involved in drug rep shadowing programs," Fassler says. "The idea of bringing such a person into the interaction, where there is really no opportunity to benefit the patient, seems quite inappropriate.
"However, if they do, it needs to be absolutely clear to everyone what is happening and why," he says. "If there is fully informed consent, if patients really understand what is happening, and if they decide they want to participate, it's not my position to tell them that they can't."
"The concept of shadowing is relatively new as it applies to pharmaceutical representatives," notes the AMA's Morse. "As such, the council does not yet have a formal opinion on the practice. We need to consider all of the issues. For example, the pharmaceutical industry is aligned with the medical profession, and you can't have a firewall between these two groups. The issue is dealing with how and where conflicts of interest may present themselves."
Fassler notes that, despite the obvious concerns, some members of the AACAP support the idea of drug rep shadowing. "They feel it is an effective way to educate pharmaceutical representatives." Another potential benefit is that drug companies pay physicians up to $500 a day for allowing drug reps to shadow them, Fassler says.
"One of our members suggested that, rather than the physicians keeping the money paid by the pharmaceutical companies, the patients should receive it," Fassler says.
William Atkinson is a freelance writer from Carterville, Ill.