Drugmakers Prefer Silence On Test Data
"Obviously it needs an enforcement mechanism attached to it," said Abbey S. Meyers, president of the National Organization for Rare Disorders. "I can guarantee you, however, that 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 countered 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. Alan Goldhammer, PhRMA's associate vice president for regulatory affairs, said he had heard anecdotally that companies are now fully complying with the law.
But Theresa Toigo, director of the FDA's Office of Special Health Issues, painted a different picture. "Many pharmaceutical trials are not participating in ClinicalTrials.gov or are not fully participating," she wrote in a recent report in the Journal of Biolaw and Business. Responding to assertions by PhRMA that the 2002 data do not reflect the current situation, she said, "It's not like we've seen a big increase in the monthly submissions of privately sponsored protocols."
Sen. Edward M. Kennedy (D-Mass.), who helped create the registry in 1997, plans to seek revisions to enforce the registration requirement and to find a way to report study results.
Meyers and Paul Kim, a former Kennedy staff member who now works for the law firm Foley Hoag LLP, said the original purpose of the registry was to link patients who wanted to join clinical trials with the researchers.
The law required companies to register all effectiveness trials, known as Phase 2, 3 or 4 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.
Some companies have boasted to stockholders of having many ongoing studies in the pipeline but not listed any with the registry. Forest Laboratories Inc., which recently touted results for an Alzheimer's disease drug called memantine and last month published a children's depression study showing positive results for its antidepressant Celexa, has no trials registered. Company spokesman Charles Triano said the law does not require companies to register trials if other drugs are available for the same disease.
Triano said the company did not need to list its trials of memantine, a new class of Alzheimer's drug, because the FDA had not given it the "fast-track" status reserved for breakthrough medicines and deadly diseases with limited treatments.
The FDA's Toigo said the law required companies to register trials whether or not medicines exist for the disease. "It doesn't say anything about existing drugs on the market," she said.
Although 246 pharmaceutical and biotech companies had ongoing trials in the database Friday, about half listed just one. GlaxoSmithKline had five, but spokesman Rick Koenig said many of the company's trials are not listed under the company's name. "We didn't understand that to be a requirement or the sort of information that is of use to a patient looking into where that patient might enroll in a trial," he said.
Toigo said the FDA's 2002 guidelines called for companies to include their names.
Journal editor DeAngelis, who is helping spearhead an editors' initiative to get all trials registered, said a government-enforced registry would be vastly superior to any system of private incentives. "It will come as a surprise to the vast majority of your readers," she said about the law's requirements. "I had personally assumed it was only for federally funded clinical trials."
Toigo said her analysis of industry compliance, which she hopes to complete by the end of the year, will examine whether more than 2,000 trials submitted to the FDA by companies seeking approval for medicines in 2002 had been properly listed.
Companies are hesitant to register trials because they want to control data, said Kay Dickersin, a professor at Brown University who has sought such data for two decades. 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."
One way to increase registration, said Dickersin, is for patients to insist trials be registered before participating. Drummond Rennie, a professor at the University of California in San Francisco, added that physicians who conduct trials for companies "should examine their consciences" before agreeing to let trials be kept secret.
"If I buy a camera and the thing falls apart, it's a lemon, I shrug and say I'm never going back to that firm," said Rennie, who is also deputy editor at JAMA. "But if I get a drug and it makes me worse, it can kill me or maim me.
"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," he said. "They owe us more information."
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