Transparency of pharma's clinical trials—who conducts them, where the results are published, and what information is promoted—has
been a growing concern in recent years. That concern reached a tipping point when New York State Attorney General Eliot Spitzer
filed a lawsuit against GlaxoSmithKline (GSK) in June 2004 for withholding negative trial data on Paxil (paroxetine).
Now, as the industry faces legislation and implementation of requirements set forth by leading medical journals, companies
must carefully chart their next steps along the path of transparency.
In the Works
Some thought leaders say plans to increase the transparency of pharma's research were already in the works, even before Paxil.
With more information out there about its products, industry wants to provide customers with the option to receive drug information
straight from the horse's mouth.
PhRMA, for example, began talking about clinical trial transparency in 2001, but didn't launch its clinical trial database
until 2004. "It's been an ongoing process, which is often not recognized," says spokesperson Court Rosen.
GSK's Mary Anne Rhyne also says that her company has advocated clinical trial registries in the past. Back when Sir Richard
Sykes was CEO of Glaxo Wellcome, he called for clinical trial registries in scientific journals and even had a trial register.
But, says Rhyne, the controversy over Paxil "helped convince people that that was the way to go."
In theory, full disclosure is ideal. But when crafting communications policies regarding dissemination of clinical trial results,
companies need to examine the challenges that full disclosure poses to them—and to their customers.
Register All Trials
Defensive intelligence Companies should aim to balance the public's need to know with industry's right to keep strategic intelligence private.
"It's a matter of helping physicians, while also protecting the investments," Rosen explains. PhRMA handles this issue for
its member companies by publishing only the results of Phases III and IV clinical trials on its website for drugs already
on the market. "Early trials aren't relevant to what meds a doctor can prescribe," Rosen explains. "Companies also have highly
proprietary, extraordinarily expensive information in clinical trials, particularly the exploratory ones that you just don't
want to give your competitor."
GSK takes a similar approach. The company publishes all clinical research, after the drug is launched. GSK also registers
its trials on Clinicaltrials.gov/ a website developed by NIH and the National Library of Medicine that provides information about clinical research, but doesn't
include results. "The demand for information is so great that we've tried to follow the side of transparency," says Rhyne.
Appropriate expectations Some executives say publicizing early-stage results can fuel patients' hopes for a drug years before it becomes available—if
it ever becomes available at all.
"If you start putting every trial out there and the public is going to see it, it's going to create chaos," says Kathleen
Drennan, vice president and managing director of Iris Global Clinical Trial Solutions and the editor-in-chief of Contemporary Clinical Trials. She is concerned about the false hopefulness related to drugs that haven't been approved. "It's going to create chaos in
the public domain, which is going to create chaos in the medical domain," she says.