By Amy Tsao Following a controversy-filled 2004, the medical community starts the new year faced with a daunting challenge -- how to restore public trust in drugs, the companies that make them, and the regulatory system that governs the producers. The current thinking is that more information is the cure. By disclosing how drugs are tested, debacles can potentially be prevented, and trust reestablished.
Perhaps. But just how that task will be accomplished seems to stir up more questions than answers. That was clear during an influential policy summit Jan. 10-11 organized by Fordham University's Center for Ethics Education. Representatives from academia, medical journals, the drug industry, patient advocacy groups, hospitals, lawyers, and government agencies gathered to discuss ways to strike the proper balance between the industry's financial interests and public safety.
"DEFENSIVE POSITION." Lately, high-profile problems have been hitting drugmakers right and left. For one, a recent report documented an increased risk of cardiovascular problems in users of popular arthritis pain medication featuring Cox-2 inhibitors. Following the report's release , Merck (MRK) decided on Sept. 30 to pull Vioxx from the market -- too late, critics said. Pfizer (PFE) chose to keep selling its own arthritis treatments, Celebrex and Bextra.
But both companies saw their stocks plunge as the potential for expensive lawsuits escalated. Further confusing consumers, even the relative risk-to-benefit ratio of common painkillers such as Aleve has been called in question.
"We're all here because of the problems and scandals we've had," says Greg Koski, senior scientist at the Institute for Health Policy at Massachusetts General Hospital. "We're in a defensive position."
SENTIMENT SHIFT. The meeting, held near New York's Lincoln Center on the Fordham campus, saw plenty of spirited discussion. Representatives from drugmakers contend that the primary solution proposed -- releasing the details of early-stage trials -- would be of limited benefit to the public while also harming companies' ability to compete. Other participants predicted logistical and financial nightmares in managing all the information. Aside from the certainty that changes are afoot, a consensus on how to build a more transparent system seemed distant.
Public sentiment about drug regulation has shifted dramatically over the last decade. Theresa Toigo, director of the office of special health issues at the Food & Drug Administration, notes that in the late 1980s, when the U.S. HIV/AIDS epidemic was peaking, patient groups accused the agency of being too slow to approve new drugs. Cancer-patient advocacy groups have made similar criticisms.
Lately, the discourse has shifted in the opposite direction. Many argue that regulators are approving drugs too hastily. Some claim that the FDA has been co-opted by industry, since Congress created a fee-based system to encourage more expeditious drug approvals in 1992. In any case, "even the perception of conflict of interest must be addressed," says Toigo.
ELUSIVE RESULTS. The popular solution for the system's woes are registries that would list information about clinical trials being undertaken by industry and academia. If all parties signed on, registries would provide a record of what studies were begun and when. In theory, that would keep pharmaceutical players from sweeping studies with poor results under the rug.
Consequently, an onslaught of registries of various kinds is coming. Drug industry trade group PhRMA announced plans for a voluntary registry of trials in September. Prominent medical journals, including the prestigious New England Journal of Medicine, have in recent months set policies requiring studies submitted for publication to be registered from their inception. And some drugmakers are setting up their own registries.
Full-fledged databases containing trial results would be the ideal solution, but that would be significantly harder to pull off, given companies' and researchers' wariness about revealing intellectual property. Still, plaintiffs' lawyer Alan Milstein, of Sherman, Silverstein, Kohl, Rose & Poldolsky, argues that such a database might have saved Jesse Gelsinger, the 18-year-old who died in 1999 while participating in an experimental gene therapy study at the University of Pennsylvania. "Results of previous experiments could have been known," says Milstein, and those studies might have affected Gelsinger's decision to participate in the study. The Pennsauken (N.J.)-based lawyer represented Gelsinger's family.
REVEALING "ADVERSE EVENTS." However, disclosure of research findings, whether by individual researchers or giant businesses, has always been a touchy subject. "All of this gets into the broader issues of how we as scientists share information and increase knowledge," says John Schneider, chairman-elect of the council of scientific affairs at the American Medical Assn. Schneider supports a registry that, at minimum, would include information on what type of studies are under way and who is conducting them. The AMA suggest that trials have specific numeric identifiers.
Improvements to the process of tracking side effects that turn up after a drug is on the market are also overdue. Drugmakers tend to keep negative trial data to themselves -- as shown again by the recent Washington Post revelations that companies conducted studies of antidepressants in kids but did not publish the results, which showed an increased suicide risk among teens taking such medication.
"Dealing with adverse events is a high priority," says Bernard Schwetz, director of the Office of Human Research Protections, a division within the U.S. Health & Human Services Dept. "Not enough has been done about it."
INTERPRETER WANTED. The value of all this information also depends on how accessible it is. Many fear that such registries and databases will be undecipherable morasses. "We can have all the data in the world, but someone needs to analyze it," says Larry Hirsch, executive director of medical communications at Merck Research Laboratories.
The job of interpreting data is already taken, in large part, by the FDA. A third-party interpreter or curator of the data, however, would be useful in helping the public make sense of it, says Robert Rubin, professor of medicine at Harvard Medical School.
Trying to set up such a system in a period of crisis isn't optimal timing. But the researchers, regulators, and industry players know they can't afford to let public confidence continue its slide. Tsao is a reporter for BusinessWeek Online in New York