Turn the Page - Pharmaceutical Executive


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

Pharmaceutical Executive

It is in industry's interest to promote positive data and downplay the negative.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. –Janice Radak, editor-in-chief of Geriatrics
"We always get the 'Well, I didn't know,' when they probably did know," she says. "We are going to adhere to a standard of honesty and disclosure to make sure the readers know if there are any potential financial conflicts of interest."

Do editors think there need to be additional measures to ensure transparency? Lundberg says that, although they're committed to them, current measures are already onerous.

Authors are used to conflict of interest disclosure statements. Anybody who's published in an academic journal has done it for years. –Jordana Bieze Foster, editor of Applied Neurology.
Janice Radak, editor-in-chief of Geriatrics, offers: "As an editor I don't want to have to examine some author's IRS statements, but neither do I appreciate hearing, 'Oh, maybe should I disclose...?' I think a big part of the evolution of disclosure is making the researchers more aware of their ethical responsibilities."

Judy Orvos, editor of Contemporary Ob/Gyn, says another way conflict of interest disclosures may evolve is to "require not just authors, but also the writers and editors with whom they collaborate, to disclose any industry relationships relative to a manuscript's content."

One of the "rules" of journal editors is to keep various players in healthcare on their toes. At the same time, transparency is an area where we can work more collaboratively. It allows pharmaceutical companies to behave in a way that allows them to be trusted, and for that trust to be built on a background of transparency. –Fiona Godlee, editor of the British Medical Journal
At the same time, journals need to ensure these changes actually increase transparency. "Not all journals provide the ability to acknowledge contributors who may not rate as a full author, but whose contributions materially impacted the research," says Tim Bacon, president and CEO of PeerView, a publication strategy consultancy.

Clinical Trial Registries In 1978, a group of journal editors met in Vancouver to set guidelines for formatting manuscripts. They suggested authors number pages starting with the title page, leave generous margins, and double-space. But they also set formats for how to describe participants, state conflicts of interest, and discuss results.

One problem is ambiguity over what type of trial should be registered. We don't know enough about this middle ground of trials that fall between those clearly not affecting practice and those that have a primary purpose to affect practice. There's no doubt about Phase III. It's the Phase II and small randomized Phase I trials that are difficult to decide about. So we're going to get our feet wet and formulate what amounts to case law to guide us so each journal will treat articles consistently.–Harold C. Sox, MD, MACP, editor of the Annals of Internal Medicine.
Over the years, the so-called "Vancouver group" evolved into the International Committee of Medical Journal Editors (ICMJE). And it is that organization that put forward a new policy that is changing the way companies handle how they communicate research with professionals: As of July 1, 2005, all clinical trials research must be registered if sponsors want to ever publish their results in a member journal.

The idea for clinical trial registries gained steam in June 2004, when New York State Attorney General Eliot Spitzer sued GlaxoSmithKline (GSK) for withholding negative trial data on the use of Paxil (paroxetine) in children. Soon, journal editors also were demanding a new way to put drug information into context.


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