http://www.healthyskepticism.org/reports/2003/0728.htm

Drug firms increasingly barred from exam rooms

Azucena Sanchez-Scott had just finished chemotherapy treatment for breast cancer, and she was worried about the side effects. Her nails and hair were falling out, hot flashes plagued her, even sleep was difficult. So she went to her oncologist for reassurance. As she undressed in the exam room, he looked on.

Sanchez-Scott's doctor didn't say who the man was, only that he was ''observing my work,'' she said. At one point, when a hot flash hit, the doctor asked the salesman to operate Sanchez-Scott's pocket fan so she could lie down for the exam. She grew increasingly uncomfortable about the stranger's presence, but it wasn't until she questioned the receptionist afterward that she discovered the visitor was a drug company representative. Eventually, she sued the doctor and Alza for invasion of privacy, a suit that was settled in 2001. Executives at Alza, now a subsidiary of Johnson & Johnson, would not comment on the case. The doctor could not be reached.

''I still feel hurt,'' said Sanchez-Scott, now 50, a family and marriage therapist who lives in Los Angeles. ''The drug rep didn't have anything to do with me or my care, and he was allowed to come into my exam room.

Sanchez-Scott's lawsuit was one of the first public challenges to a standard, long-term practice that has come under growing fire in the past year: Pharmaceutical companies paying doctors a fee of several hundred dollars a day to allow salespeople to shadow them as they see patients, a practice called a preceptorship. Drug companies and some doctors say it is an important educational tool, but others believe it is an invasion of patients' privacy and a ploy by drug companies to promote their products.

The Lahey Clinic in Burlington no longer allows preceptorships except in unusual cases, according to hospital executives and allergists there who have done them. Boston Medical Center will severely ''limit if not prohibit'' preceptorships when it adopts a new policy on relationships with the drug industry next month, said Karen Murphy, the hospital's compliance officer, although she's not aware of any specific instances of shadowing. Drug giant Schering-Plough Corp. suspended its preceptorship program earlier this year because of concerns about strict new federal patient privacy laws that went into effect in April.

Last month, the American Medical Association passed a resolution saying doctors should not allow drug company representatives to shadow them ''without the full knowledge and informed consent of patients'' -- something drug companies that still pay for preceptorships say they're already careful to obtain.

Even so, some state medical organizations are going further. The Maryland Psychiatric Society this spring decided the practice was unethical with or without a patient's consent.

''The patient is in a vulnerable position,'' said Dr. Carol Watkins, a Baltimore-area psychiatrist who has been on a crusade to get drug representatives and doctors to stop preceptorships. ''By even asking for permission, you're taking advantage of your influence over the patient.

All of this is occurring as federal prosecutors increasingly investigate -- and win multimillion-dollar settlements from -- drug companies for paying doctors illegal inducements to prescribe their medications. The federal cases haven't focused on preceptorships. But documents unsealed last year in one case against Parke-Davis, now Pfizer Inc., suggested that some representatives use shadowing more to sell drugs than to learn.

David Franklin, a former Parke-Davis medical liaison, saved voice-mail messages, including one in which a sales representative bragged that he had persuaded a doctor to prescribe Neurontin during a preceptorship.

''While the patient was dressing, the doctor and I one-on-one would discuss the patient and therapeutic options. I certainly felt that me being there, I had some influence on that medical decision.''

Former sales representatives who have shadowed doctors said the purpose was not so much to make a sale that day but to build a relationship with the physician so that he or she would be more receptive to doing business in the future.

Normally, doctors will speak to sales reps on the fly, for 10 minutes between patients. But a preceptorship gives a sales representative up to eight hours with a physician, during which the two talk about their families and hobbies.

''It's another way to build a relationship with the doctor and hopefully build business,'' said Christina Brabazon, 41, a Schering-Plough sales representative during the mid-1990s, who said she was sometimes introduced to patients as a drug representative and sometimes as a medical student.

Barbara Miller, 33, who had been saleswoman for two different major pharmaceutical companies until last year, saw 100 patients during mandatory preceptorships in which she was rarely introduced as a drug company employee.

''I have tremendous respect for the pharmaceutical industry, but this was one part of my job I absolutely hated,'' she said. ''I've sat in on every type of exam imaginable. I think of my grandmother. I wouldn't want her being examined and then have it be the topic of coffee talk at Starbucks.''

Miller testified before the AMA last month, but said she signed confidentiality agreements upon leaving her jobs and can't reveal the names of her former employers.

Even with the practice under growing scrutiny and new federal privacy rules that make it more cumbersome for doctors to obtain patients' written permission, many companies and doctors defend the educational value of shadowing. The practice, they say, allows salespeople to experience firsthand patients' concerns about and reactions to medications, not just read about them in medical journals.

Stephen Wieder, a psychiatrist in Newburyport, has allowed drug company representatives to be present as he prescribed medication for depressed patients on about 25 occasions. He approaches patients in the waiting room, tells them a drug company sales representative is there for training, and asks whether it's acceptable for him or her to sit in. If the answer is no, he drops his request. If yes, he asks the patient to sign a consent form.

That patients may be hesitant to refuse their physician's request for fear of offending him or receiving substandard care is a legitimate concern, Wieder said. But his practice style, he said, is collaborative rather than authoritarian. He said he gives patients choices about their treatment, and he doesn't believe they'd be reluctant to say no to a preceptorship, which he says are extremely valuable for sales representatives.

''The pharma reps have no idea about the complexity of what is seen in the psychiatric practice,'' said Wieder, who said he won't do another preceptorship until his lawyer makes sure his consent form complies with privacy laws.

Wieder said the representatives try to promote their drugs indirectly after seeing patients, though they rarely speak during sessions. ''They might ask why I chose drug X or drug Y and not their drug,'' he said.

''I welcome the question. There's always a reason. I tell them if there's a downside to their medicine.'' Dr. James MacLean, an allergist in Salem, agreed that shadowing helps educate drug company representatives and said he enjoys teaching them. But he said he grew uneasy about the practice given the new privacy laws and because he's concerned that the fees drug companies pay doctors are helping push up the cost of prescription drugs.To make sure the preceptorships are educational, AstraZeneca requires representatives to prove they've met certain learning objectives and limits representatives to one preceptorship per product per year. Eli Lilly and Co. has a similar rule, and will pay the doctor $100 for an hour, $250 for a half-day, $500 for a full day, or donate the fee to charity in the doctor's name.

Dr. Jerrold Rosenbaum, chief of psychiatry at Massachusetts General Hospital, which runs educational seminars for hundreds of drug company representatives every year, does not allow them to shadow doctors at the hospital. ''That strikes me as over the top,'' he said. ''It's hard to argue that the incremental educational benefit of being in the consulting room outweighs the potential breach of confidentiality and exploitation of the patient.''

Sanchez-Scott said she thought of her mother, who doesn't speak English and who also was diagnosed with breast cancer, when deciding to sue. She said she signed a confidentiality agreement prohibiting her from discussing the settlement.

''She's used to seeing doctors as professionals, and she might not want to say no without knowing what she's getting into,'' she said.

After she left her oncologist's office, she called the doctor to ask him why he let the sales representative in the room and to tell him she didn't want to see him anymore. He apologized, she said, and said she was the only patient who ever complained.

Her lawyers said Alza paid the doctor $500 for the ''mentorship program'' but that he eventually returned the money. Now, she always asks for a gown during exams, and if something makes her uncomfortable, she immediately speaks up.