Drop in on any intensive care unit and the scene looks like controlled chaos. Physicians and nurses move in and out of patients’ rooms, a transport team pushes a gurney with a new admission along the corridor and technicians ready portable respiratory equipment. Mingling with these caregivers are members of another group whose presence has become all too common, and controversial— pharmaceutical sales representatives (PSR). They might be waiting for a lull to buttonhole a resident or a nurse practitioner, or setting up a company-sponsored lunch in the unit’s break room. They have one primary objective: to persuade those who write medication orders to use their company’s products.
While this ritual gets played out in hospitals and doctors’ offices throughout the country, this freewheeling relationship between the medical community and the industry that spends billions of dollars in direct marketing to presribers has come under closer scrutiny. Now, Hopkins Hospital has joined the growing trend, adopting a policy to bring tighter restrictions on drug companies’ interactions with health care professionals.
“In too many cases, the behavior of drug sales reps around the institution was getting out of hand,” explains Beryl Rosenstein, Hospital vice president for medical affairs. “It was time to come up with a comprehensive policy that brought some control over this industry activity. This is new territory for us.”
Gone will be the flood of pens, notepads, key chains, monogrammed golf balls and free, unsolicited food. House staff, medical students and nurses will no longer be subjected to unrestricted marketing by drug sales representatives. Clinical departments will assume more control over industry-underwritten educational sessions.
According to drug industry data from 2002, the last year for which complete figures are available, pharmaceutical firms spent more than $18.5 billion to promote their products to health care workers. By contrast, $3 billion was spent on advertising to consumers. A company may spend $800 million to bring a new medication to market.
Accounts in the media and in professional journals of this growing controversy have intensified the spotlight on the issue. A study published in 2000 by the Journal of the American Medical Association concluded that prescriber practices are influenced by the interaction. And according to a study in the Archives of Internal Medicine, doctors hold lenient views about accepting gifts from the pharmaceutical industry.
The response by the medical community to this aggressive marketing strategy has been varied. Harvard University banned pharmaceutical sales reps from all its affiliated hospitals. The American Medical Association has hotly debated policies prohibiting industry “freebies,” including paying for physicians to attend educational conferences. Even the Pharmaceutical Researchers and Manufacturers of America, the industry trade group, sought to blunt criticism by issuing a voluntary code of conduct for its sales reps.
At Hopkins, meanwhile, departments such as medicine and oncology had developed their own guidelines concerning pharmaceutical reps, but they primarily dealt with corporate-sponsored educational events, such as lectures and lunches.
But in the spring of last year, a group led by Rosenstein, Brent Petty, chair of the Hospital’s pharmaceutical and therapeutics (P&T) committee, and representatives of the medical staff, nursing, pharmacy and the ethics committee sat down to discuss whether to bring greater control over the activities of the industry and its sales people. After they unanimously agreed to take action, the question became, How far to go? First, the group examined PSR policies from other academic medical institutions like the Cleveland Clinic Foundation and New York-Presbyterian Hospital.
The resulting policy, which applies only to the Hospital and not to University-owned buildings, is far-reaching and restrictive. All gifts are banned except those directly related to patient care and items of educational benefit, such as medical books, journals or unrestricted grants. New rules governing industry-sponsored educational programs stipulate that the choice of topics and speakers is solely up to Hopkins staff and no longer can be determined by a drug company or sales rep.
In addition, all “detailing,” or explanations by PSRs that describe to residents, fellows or medical students the use and benefits of the newest therapy, can now only be done in the presence of a faculty member and must be limited to drugs already in the Hospital’s formulary. Detailing of non-formulary drugs is permitted only if the discussion is requested by a faculty or staff member and is for the purpose of introducing the drug for consideration as a formulary medication.
When the new policy went before the Hospital medical board in April, it met a mixed response. A few clinical department directors bristled at the notion that their faculty could be had for a few gifts or free meals. Some directors noted that the industry provides an invaluable service by underwriting educational programs their departments couldn’t otherwise afford. They expressed alarm that the policy could irreparably harm that relationship.
Proponents, on the other hand, contended that gifts had the potential to subtly influence a physician’s choices—noting that pharmaceutical companies would not spend billions on promotional efforts that didn’t work. Some members of the board argued for a complete ban of the estimated 200 drug sales reps who visit Hopkins on behalf of 76 drug companies.
“We felt that a total ban wasn’t entirely in our best interest because we are a teaching institution,” Rosenstein says. Exposure to PSRs “in a controlled type of setting” is a worthwhile educational experience for medical students and physicians, pharmacists or nurses in training, he adds.
The medical board tabled action on the policy, and Rosenstein, Petty, and the board’s chair and vice chair, Gyn/Ob Director Harold Fox and Emergency Medicine Director Gabe Kelen, circled back to department directors to iron out objections. The main area of concern, Rosenstein says, was the provision requiring that a P&T committee member be present for every educational session. “We changed that to require the presence of a faculty member,” he says, “and restored control over these sessions to the department.”
The new policy, Rosenstein notes, does not affect interactions between pharmaceutical firms and Hopkins staff or students off site. If a drug company sponsors an educational event at a local hotel or restaurant, for instance, or offers to fly prospective customers to the Bahamas for a round of golf, the Hospital will continue to rely “on the good ethical judgment of our staff and employees as to how they respond to such invitations,” Rosenstein says.
Drug reps face penalties for violating the policy, ranging from a written warning to an indefinite suspension of their privilege to be on Hospital property. Todd Nesbit, assistant director of clinical pharmacy services, asserts that drug reps he’s discussed the new policy with understand why it’s being adopted and have not raised objections.
Kelen, who heads the medical board’s administration committee that recommended the policy, says he generally doesn’t like drug reps interjecting themselves into physician training. “They are in sales, not science, and they give a very one-sided perspective,” he notes. Nevertheless, Kelen concedes that many members of the medical board find educational value in the interactions. “The revised policy is very sound and reasonably protects patients, the institutions and education without being overly burdensome for the companies,” he stresses.