Turn the Page - Pharmaceutical Executive


Turn the Page
Changes in ethics and expectations are driving the way pharma interacts with medical publishers.

Pharmaceutical Executive

This new study will be more well-received because it will show product managers how to optimize their promotional mixes. They can go to the individual product level and see how the brand and its competitors are doing with regard to promotional effectiveness. This could be the best tool for the industry to use its money effectively on promotion—we'll know in the next few months if it's going to happen. –Art Wilschek, director of worldwide ad sales for the New England Journal of Medicine
"It is in industry's interest to promote positive data and downplay the negative," Radak says. "The issue is that the general public wants simple answers and industry wants to provide [them]—even though the simple answer may not be appropriate."

"When only some of the trial results are reported, they tend to be the positive ones," says Harold C. Sox, MD, MACP, editor of the Annals of Internal Medicine. "Then doctors and patients have an inflated view of how good the intervention is."

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In some ways, registries may create a cost-effective repository for negative or insignificant results. "Some physicians would like to see the data even if it didn't come to a conclusion," says Paul Weislogel, executive vice president of publishing for Lippincott Williams & Wilkins. "No journal could support a journal of negative results. That's not in the best interest of pharma and that's not necessarily in the best interests of journals—it's another way that publishing and pharma are closely linked."

Fiona Godlee, editor of the British Medical Journal, sees transparency as a way for pharma and journals—which have traditionally maintained a combative relationship—to work together: "One of the 'rules' of journal editors is to keep various players in healthcare on their toes," Godlee says. "At the same time, transparency is an area where we can work more collaboratively. It allows companies to behave in a way that allows them to be trusted, and for that trust to be built on a background of transparency."

At least twice, the authors of manuscripts we accepted for publication told us they had no financial disclosures to make. Then, as we were going to production we discovered they had very serious financial disclosures. We always get the "Well, I didn't know,' when they probably did know. –Diana Mason, RN, editor of the American Journal of Nursing
Coming out of the GSK case, there was much industry support for the idea of clinical trial registries. Eli Lilly and AstraZeneca, and organizations such as PhRMA—and most recently, the International Federation of Pharmaceutical Manufacturers and Associations—created registries on their Web sites. But that wasn't industry's first experience with the practice. Under the FDA Modernization Act of 1997, FDA established the National Library of Medicine registry ( http://www.clinicaltrials.gov/) and required registration of all clinical studies for life-threatening diseases. It was largely designed to make patients more aware of clinical trials they could participate in.

ICMJE doesn't mandate a specific database with which companies must register their trials—so long as registries are publicly accessible and free. But when it talks about registries, it is generally referring to clinicaltrials.gov/. Because of that, editors often refer to registries' dual goal of increasing transparency and building a clinical trial patient-recruitment tool.


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