By Deirdre Cummings, MASSPIRG
Soon, Massachusetts’ Congressional
delegation will have a chance to make a difference on a profound
aspect of how prescription drugs affect the lives of Bay Staters –
safety. And Congressional action couldn’t come soon enough to bring
strong independent safety testing, enforcement, accountability and
disclosure to America’s drug safety system.
It won’t happen on its own. A few
years ago, when Merck, the makers of Vioxx, first learned that their
drug could cause serious health problems including heart attack and
stroke, they could have told doctors and their patients. They didn’t.
When GlaxoSmithKline, makers of the
antidepressant Paxil, learned that it was linked to an increased risk
of suicidal behavior in children, they could have sounded the alarm.
They didn’t.
These companies had the opportunity to
do the right thing by giving doctors and patients the information
they needed to make safe and informed medical decisions. They chose
not to tell the public the full story.
Instead, they decided to gamble with
the health of millions of Americans by keeping vital safety
information from doctors and patients, and they continued to heavily
promote the drugs in question. This may have helped them sell more
medicine in the short term, but the consequences have been deadly—
according to an FDA whistleblower, Vioxx alone caused an estimated
140,000 heart attacks and strokes and 55,000 deaths.
While these are two of the highest
profile cases of drug companies spinning the roulette wheel with our
health, revelations of similar problems within the pharmaceutical
industry have become too common. The bottom line is that the agency
tasked with safeguarding our medicine, the U.S. Food and Drug
Administration, isn’t getting the job done.
The good news is that Congress has an
opportunity this Spring to make our medicine safer. Our own
Congressman Ed Markey (D-Malden) coauthored The Enhancing Drug Safety
and Innovation Act of 2007, and if passed in the House version’s
strong form, will address the following problems:
One, federal law currently requires
that the FDA use an overwhelming percentage of the agency’s budget
on the process of approving new drugs, leaving insufficient funding
for reviewing and monitoring the safety of existing drugs. Congress
needs to put an end to this restriction and insist that more money be
spent on reviewing drug safety.
Two, Congress needs to give the FDA
stronger enforcement powers, including the ability to levy
substantial fines on companies that fail to complete required drug
safety tests or that conduct misleading advertising campaigns.
Three, the FDA relies on outside expert
advisors who, too frequently, are on pharmaceutical industry payrolls
or are otherwise financially tied to drug manufacturers. The FDA must
recruit and hire truly independent advisors without conflicts of
interest.
Four, current law allows drug
manufacturers to aggressively market their medicines from the minute
they hit store shelves, long before doctors, researchers, and
patients know all the dangers a drug might pose. Congress should
enact a moratorium on marketing any new drug for its first three
years, which will give the FDA more time to monitor the real-world
effects of a drug as it is used by a market larger and more diverse
than the groups studied in clinical trials.
Finally, Congress must empower and
require the FDA to shine the light on clinical trial results for all
drugs. Had doctors, patients, and researchers been given full access
to all the Vioxx studies and seen the indications that the drug could
cause serious health problems, tragedy may have been averted.
As basic as these reforms are, they
won’t come easily. Passing them will require standing up to the
pharmaceutical industry and its lobbyists, which is exactly what the
doctor ordered and what we need Congress to do.
Deirdre Cummings is the Legislative
Director for MASSPIRG, a non-partisan, non-profit public interest
organization with 50,000 members across the state.
