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Needed: Safer drugs and medical devices
It is long past time for Congress to strengthen our nation's safety laws regarding drugs and medical devices.
Over the past two years, numerous deaths and injuries have been linked to certain prescription medications and medical devices.
Common to these cases is the fact that the manufacturers--and the Food and Drug Administration, which approved the products--downplayed
a problem or kept it from the public for months or years.
Some drugs carry risks that should have been detected and publicized earlier (see Common drugs, hidden dangers). In some cases, the drugmaker withheld safety risks from the public.
Consumers face unnecessary risks because of weak laws and a seeming lack of will by FDA leadership to challenge the pharmaceutical
industry. Critics both inside and outside the agency say the emphasis has shifted in recent years to approving drugs--in some
cases new therapies,but mostly "me too" drugs that mimic ones already being sold--at the expense of safety monitoring once
they are on the market.
Flaws in the drug-safety system were dramatically exposed in 2004, when the arthritis pain medication Vioxx was removed from
the market. An estimated 139,000 heart attacks, strokes, and other serious complications had been linked to the drug, which
was heavily marketed by Merck even though the company and the FDA had known of the safety risks since 2000, when the first
study of the drug raised concerns.
Similarly, GlaxoSmithKline, maker of the antidepressant Paxil, had studies dating back to 1998 showing an increased risk of
suicide in children and teenagers. GSK never published that information. It was not until October 2004 that the FDA at last
required the strongest safety warning on Paxil and other antidepressants.
Little has been done to prevent such problems. The FDA's new "independent" Drug Safety Oversight Board is composed entirely
of members from government agencies, mostly the FDA itself. Deliberations are closed to the public. And the board has no power
to compel a drugmaker to conduct postmarket safety studies; it can only make recommendations.
It's up to Congress to plug gaps and give the FDA the tools it needs. Two bipartisan bills, introduced in 2005 by Senators
Charles Grassley (R-Iowa) and Christopher Dodd (D-Conn.), would bring significant changes.
Neither bill has received a hearing, and similar efforts in the House of Representatives have likewise stalled.
• S. 470 would require drugmakers to register and make public their clinical drug trials to help researchers, physicians,
and patients learn of potentially harmful side effects. Currently, negative studies can be hidden from public view.
• S. 930 would give the FDA authority to require drug manufacturers to conduct further safety studies of new drugs on the
market, change warning labels, and require that ads be clearer about the risks and benefits.
• Separate proposals would impose a two- or three-year moratorium on ads for new drugs, allowing time for any serious adverse
side effects to emerge after a drug hits the market and is widely used.
The bills before Congress are common-sense reforms that will not slow the introduction of lifesaving drugs and therapies.
They ensure that doctors, researchers, and patients know more, and they let the FDA take meaningful action.
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What you can do
For more information on Consumers Union's prescription-drug-safety efforts, go to www.ConsumersUnion.org and click on "Prescription for Change."
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Madison Avenue revisited
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