Drennan also notes that all clinical trials aren't created equal. "If you publish the papers that aren't well designed, you
might create misinformation."
Physicians first Publicly posting trial results can disrupt the most effective flow of information. After all, healthcare providers are important
intermediaries in interpreting clinical information for patients.
Last year, for example, NIH released results of its Women's Health Initiative, which tested the effect of hormone replacement
therapy (HRT) on heart disease and cancer. NIH decided to halt the study prematurely because of the risks found with long-term
usage of Wyeth's HRT Prempro (estrogen/ medroxyprogesterone). NIH announced the results at a press conference, and the media
ran with the story.
Because the news was simultaneously disseminated to the public and medical community, the interpretation of Prempro's breast
cancer and heart disease risks was inaccurate, says Wyeth's Doug Petkus: "It probably led to some undue concern and stress
and confusion amongst the key audience, which is patients," she says. "One possible better way to do it would have been to
communicate to physicians first, in a more direct way, and then follow that up with a more public pronouncement."
A Look Ahead
A little more than a month after Spitzer filed a lawsuit against GSK, Rep. Henry Waxman (D, CA) wrote to Secretary of Health
and Human Services Tommy Thompson asking him to persuade industry to expose more comprehensive results of pediatric clinical
studies. "Experience shows that there are strong pressures on drug companies to suppress negative information," says Waxman.
"Doctors and patients deserve to be sure they will have access to the information they need."
Waxman introduced legislation last year that would require companies to register clinical studies when they begin the research
and to provide the results when the studies are complete. The database would publish the results of Phases II through IV trials
for all drugs and medical devices, regardless of their approval status. Financial penalties may result for the responsible
person if the results aren't published to expectation. "We will continue to pursue legislation this year," says Waxman.
Others believe that transparency starts with medical journals, the traditional repository for clinical information. "Historically,
you can't get a negative result published," PhRMA's Rosen says. "Journals want to publish breakthrough treatments." Gerald
Burr, vice president of scientific communication at Wyeth, puts it another way: Leading journals often don't publish negative
clinical trial results because they just aren't that interesting.
Journal editors are combatting the imbalance. In an editorial published in September 2004 by members of the International
Community of Medical Journal Editors (ICMJE), the committee stated that it will require all studies starting in July 2005
to be registered online before being published in a member journal. ICMJE proposes using the already established site,
Today, GSK and Eli Lilly maintain clinical trial registries of their research on their websites. But the future, enforced
by the rules of publication for medical journals, may be a unified, online clinical trials registry overseen by HHS and FDA
with free public access.
Pharma is participating in these developments: "The important thing is that we have a dialogue going and all the parties that
can make this work are at the table," says Rhyne.
Accounts CoTherix named Strategem Healthcare Communications agency of record for Ventavis (iloprost), an inhalable pulmonary arterial hypertension treatment.
Launches Brandofino Publications launched Doctor's Digest, a practice management title. » HCPro launched an e-zine, Compliance Alert for Drug Sales Marketing.
People Abelson-Taylor promoted three staffers: Nicole Berg and Rachel Lomasz to senior copywriters and Angie Bauerle to senior art director. » Elsevier/ BioLink Communications' restructured sales and account management team now includes:
David Horowitz, Community Oncology, Joe Schuldner, The Oncology Report, and Timothy Wolfinger, The Journal of Supportive Oncology. » DeLor Healthcare Communications welcomes Teresa Leezer as vice president of marketing, Teresa Flynn as senior marketing manager, and Sharon Johnson and Kristin Havill, both business development managers for corporate pharmaceutical brands. » Nick Luciano is account manager at Physicians' Travel & Meeting Guide. » Tony Perraglia joins Jobson Medical Group as associate publisher of Clinician News and Clinician Reviews. And Heather Wood will be NP/PA education programs director for both publications.
Willow Duttge is a freelance writer. She can be reached at