- The Washington Times - Monday, January 20, 2003

CHICAGO (AP) Some doctors are letting drug company sales representatives sit in while they treat patients a practice called "shadowing" that is being questioned by at least one professional group.
An organization of psychiatrists says it intends to ask the American Medical Association to review the ethics of the practice.
Sales reps have been known to sit in doctors' offices and examining rooms and observe routine checkups, various treatments and diagnostic tests, even child psychiatric therapy. Some doctors are paid hundreds of dollars in return.
Some, if not all, of the pharmaceutical companies require the doctors to obtain the patient's consent.
The companies say these preceptorship programs, as they are formally known, are purely educational, allowing sales reps to learn more about doctors' jobs and better serve physicians who use their products. But critics see the efforts as an unethical marketing attempt that violates the privacy of the doctor-patient relationship.
It is not clear how widespread the practice is, but the participants include major pharmaceutical companies like Eli Lilly and Co.
Lilly spokesman Ed Sagebiel said the practice began at Lilly at least five years ago and involves doctors of many types throughout the country. Mr. Sagebiel said Lilly's reps are told just to observe, not participate. Lilly's policy says participating doctors must obtain patient consent.
But critics say confidentiality and consent are especially problematic when psychiatric patients and children are involved. Some question whether parents can adequately represent their children's wishes.
The American Academy of Child and Adolescent Psychiatry plans to raise the issue at the AMA's annual meeting in June in Chicago.
Dr. David Fassler, a Vermont psychiatrist and member of the academy's governing council, said he wants the AMA to come out against the practice unless patients have "full knowledge and informed consent."
"It seems quite inappropriate to have nonclinical personnel present during therapy sessions," Dr. Fassler said. "I'm also concerned that patients may not always feel free to say no when asked by their doctor if something like this would be OK."
The AMA does not have a policy on shadowing, but one is needed especially if doctors are being paid, said Dr. J. Edward Hill, chairman of the AMA board of trustees.
"I would be extremely concerned about that being an ethical behavior," he said. "We don't want anybody interfering with the patient-physician relationship, whether it's a pharmaceutical representative or anybody. That's such a sacred trust."
While the extravagant freebies that drug companies have lavished on doctors have come under increased scrutiny in recent years, the industry's presence in examining rooms is less well-known. But some recent cases have raised concern among doctors and prompted calls for an end to the practice.
In one of those cases, a Lilly sales rep in Maryland sat in on a psychiatric therapy session involving children.
In another case, Parke-Davis, now part of Pfizer Inc., is accused of illegally marketing the epilepsy drug Neurontin for unapproved uses through tactics that included sitting in on patient visits. The charges were contained in a whistleblower lawsuit filed last year in Boston. The case has prompted an investigation into Parke-Davis' marketing practices in 47 states.
David Waterbury, an assistant attorney general in Washington state who is overseeing the Parke-Davis probe, said that even if sales reps are not overtly marketing, their presence would probably make a doctor reluctant to recommend another company's drug to a patient.
"If the person's there from 'X' company, is the doctor going to have a lot of discussions about the virtues of 'Y' company's drug? I think not," Mr. Waterbury said.
Lilly pays doctors $250 for one half-day session or $500 for allowing a sales rep to accompany a doctor all day, Mr. Sagebiel said.
Doctors may be paid directly or their fee can be donated in the physician's name to a medical school or a charity, he said.
Mr. Sagebiel said paying doctors is appropriate because they are providing a valuable service. "It helps the reps have a hands-on observation to the challenges of a physician and helps them to be a better partner."
Dr. Bill Arnold, an Indianapolis psychiatrist, said he has been paid to take part in several such programs involving Lilly and others. He defended the practice as a way to give sales reps exposure to medicine the way it is practiced.
"They've heard about schizophrenia and heard about Alzheimer's; here it is live," Dr. Arnold said. "They're going to market their products anyway, so instead of them trying to beat down my door, why not have them learn about what the market's really like?"
Dr. Arnold said the money is minimal given the amount of time shadowing takes away from his practice: "It's not a lucrative thing to do at all."
A Pfizer spokesman declined to comment on the Neurontin case.

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