Drugmakers favour silence on test data
violated government law by failing to disclose the existence of
clinical trials to a government database, writes Wai Lang
Chu.
The US Food and Drug Administration (FDA) has revealed that a substantial number of clinical trials are not being disclosed to a government database blatantly violating federal law.
The revelation has gained a greater urgency after ongoing investigations by Eliot Spitzer, the attorney-general of New York who claimed GlaxoSmithKline suppressed negative results of trials that tested the safety and efficacy of Seroxat/Paxil (paroxetine), its leading antidepressant drug.
His campaign to investigate pharmaceutical company practice has since continued with an accusation that Forest Laboratories had been illegally promoting its products for unapproved, 'off-label' usage.
Concerns are mounting that doctors and patients do not have access to information about failed drug trials, which prompted leading journal editors to call for a database of company trials last month. But now it has emerged that in the US this requirement for a database has been existence for some time, at least for some disease.
The commitment resides in a law introduced in 1997, but is thought to have been ignored by companies as it does not list penalties or explicitly give the FDA authority to crack down on violators.
The statute requires companies to register all phases of the studies, for serious and life-threatening diseases. In 2002, the FDA defined "serious" diseases broadly, including everything from AIDS and cancer to arthritis, depression and diabetes.
Although some companies say they are amenable to wider disclosure, the patient advocacy group that fought the hardest to create the requirement predicted it would never be enforced.
Abbey Meyers, president of the National Organisation for Rare Disorders told The Washington Post: "Obviously it needs an enforcement mechanism attached to it."
"I can guarantee you the full force of the drug industry will stop it. They don't want you to know about clinical trials that fail. They are afraid what it will do to their stock price. A lot of trials are for drugs already on the market, and it would ruin their sales if the news got out."
The Pharmaceutical Research and Manufacturers of America (PhRMA) responded to this comment stating that the registry had initially been slow to list industry-sponsored trials, and that companies started supplying the information after the FDA issued its guidance.
In a recent report in the Journal of Biolaw and Business, Theresa Toigo, director of the FDA's office of special health issues claimed that pharmaceutical trials were not taking part in the government database, ClinicalTrials.gov. She responded to PhRMA claims that the 2002 data did not reflect the current situation by saying: "It's not like we've seen a big increase in the monthly submissions of privately sponsored protocols."
And Kay Dickersin, a professor at Brown University told the newspaper: "Companies are hesitant to register trials because they want to control data."
"Some are worried that trade secrets will leak out, or that a competitor will poach on patient networks. Others don't want patients to petition them for medicines on "compassionate grounds."
Dickersin suggested one way to increase registration was to for patients to insist trials be registered before participating. Drummond Rennie, deputy editor at the Journal of the American Medical Association (JAMA) added physicians who conduct trials for companies "should examine their consciences" before agreeing to let trials be kept secret.
"We give pharmaceutical companies a lot of tax advantages and a whole lot of support in the Congress and a good business environment and patent protection."
"They owe us more information," he said.
