This Article Extract Reprint (PDF) Submit a response to this article Alert me when this article is cited Alert me when Comments are posted Alert me if a correction is posted Services E-mail this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to My Personal Archive Download to Citation Manager Reprints & Permissions Citing Articles Citing Articles via ISI Web of Science (4) Citing Articles via Google Scholar Google Scholar Articles by Spilker, B. Search for Related Content PubMed PubMed Citation Articles by Spilker, B. Related Collections Personal Experience ("Narrative Matters") Pharmaceuticals

Narrative Matters

The Benefits And Risks Of A Pack Of M&Ms

Physicians in hospitals should not be denied contact with sales representatives and the useful information they can impart, just because of the unfounded fears of a few. Any physician who does not want to meet with a sales representative can choose not to, without imposing his or her view on others who might have a different view.

Sales representatives perform valuable functions that promote better patient care. At a time when doctors are bombarded daily with new information and are finding it increasingly difficult to keep up to date, sales representatives provide information to physicians on new treatments, new approved uses for existing medicines, contraindications, new dosages, drug interactions, and new ways to monitor patients. They also are an important channel of information from physicians to drug companies about the use of their products, particularly about any adverse reactions physicians may have observed.

For example, in a Sep/Oct 01 Health Affairs paper examining the value of innovation in health care, David Cutler and Mark McClellan noted that new medicines known as selective serotonin reuptake inhibitors (SSRIs) have greatly expanded treatment for depression. Prior to the 1990s it was estimated that about half of the persons who met a clinical definition of depression were not appropriately diagnosed, and many of those diagnosed did not receive clinically appropriate treatment. According to Cutler and McClellan, with the advent of SSRIs, "Manufacturers...encouraged doctors to watch for depression, and the reduced stigma afforded by the new medications induced patients to seek help. As a result, diagnosis and treatment for depression doubled over the 1990s."

Do Jung and Brody believe that medical care would be improved by banning a key mechanism for transmitting information about new treatment options? And what would take the place of this mechanism?

Also, the authors fail to note that sales representatives are subject to certain rules and guidelines. The U.S. Food and Drug Administration (FDA) governs their communications with physicians and forbids the promotion of a drug beyond its approved labeling. The relationship of sales representatives and physicians is further spelled out in position statements of the American College of Physicians (ACP) and American Medical Association (AMA) that have been adopted by the Pharmaceutical Research and Manufacturers of America (PhRMA).

One position specified by the ACP provides that gifts, hospitality, or subsidies offered to physicians by the pharmaceutical industry should not be accepted if acceptance might influence or appear to others to influence the objectivity of clinical judgment. The ACP’s positions have been adopted not only by PhRMA but also by the American Diabetes Association, the American Society of Hematology, and the American Thoracic Society. The AMA guidelines adopted by PhRMA provide that textbooks, modest meals, and other gifts are appropriate if they serve a genuine educational function. "Individual gifts of minimal value are permissible as long as the gifts are related to the physician’s work (e.g., pens and notepads)," the guidelines state. Jung had a perfect right to return the pack of M&Ms, but his colleagues also have a perfect right to make their own benefit/risk decisions about the value of their relationship with pharmaceutical sales representatives.

As to the concerns expressed by Frank Davidoff, we support the policies set forth by a group of thirteen journal editors in September to ensure the independence of academic researchers who participate in industry-sponsored clinical trials. In the interest of scientific integrity and patient safety, it is essential that academic researchers who participate in clinical trials have complete freedom to participate in and approve all aspects of a trial, including any resulting publication. We encourage all authors to abide by the editors’ rules, regardless of affiliation.

Editor's Notes

 
Bert Spilker is senior vice-president of scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers of America (PhRMA) in Washington, D.C. Health Affairs solicited his response to the preceding essays.

                      What's this?