Which Pill
for the Drug Industry?
By Amy Tsao
Business Week Online
01/13/2005
At an ethics confab, participants shared many ideas but reached
little consensus on how to revive sliding public confidence in the sector
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.
