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Saturday, June 11, 2005
Hard to swallow Maine shouldn't let drug makers keep safety secrets
Copyright © 2005 Blethen Maine Newspapers Inc. | ||||
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And how is it that doctors who prescribed the antidepressant Paxil to children and teenagers were kept in the dark about studies that showed the drug might actually increase kids' suicidal thoughts? The answer lies in weak laws that do not require the pharmaceutical industry to make public its clinical drug trial studies -- studies that in the case of Vioxx and Paxil included early indications of safety problems and deadly risk but were downplayed or hidden by drug makers for years. Compounding this problem is the never-ending deluge of drug advertisements that bombard us every day. More than $23 billion is spent by the industry each year to get us to buy -- and doctors to prescribe -- brand-name drugs that are not necessarily proved more effective or safer than existing drugs but are marketed as if they were. The result of this lack of public safety information and overdose of public relations information? Millions who took Vioxx were unnecessarily exposed to increased risk of heart attack or stroke, and many families needlessly suffered because they had no idea that the Paxil they were giving to their children might actually cause more harm than good. Maine is poised to stand up for patients and doctors in this lopsided battle. LD 1618 would require drug companies to disclose the results of their own studies -- even if the studies show a drug to have a possibly dangerous side effect. The bill also gives our state the ability to make sure drug companies comply with federal advertising requirements. By passing this legislation, Maine would be standing up to drug company practices that not only harm our pocketbooks but could harm our health. Such was the case with Vioxx, a pain reliever found to have a higher risk of heart problems than similar drugs. Designed as a "niche" drug to relieve pain for people with ulcers and other gastrointestinal problems, a massive marketing campaign by drug maker Merck helped vault Vioxx to annual sales of $2.5 billion before the drug was removed from the market in September. Reports show that Merck was aware of the risk for years but continued to market the drugs heavily to physicians, with sales representatives told not to initiate discussions of safety risks with doctors. In the case of Paxil, a 2004 lawsuit against maker GlaxoSmithKline revealed the company had studied the effects of Paxil in adolescents and learned that both children and adolescents taking the drug were "twice as likely to show behaviors that may be associated with suicide than children on sugar pills." At the same time, the company's drug representatives were telling doctors and health care professionals that Paxil worked well in children. Since the studies were unpublished, there was no way for health care providers to learn the truth. What can we do to end these harmful tactics? A critical first step is enacting LD 1618, a bipartisan bill to ensure we have basic information about a drug's safety. By making clinical drug trials public and available, doctors and consumers will no longer be kept in the dark about a drug's safety. And our attorney general will have the power to make sure drug companies tell us the whole truth about drugs in their advertisements. It is important that doctors and patients have the latest information about drug effectiveness and safety. We all lose in a one-sided system that relies on drug ads that provide incomplete information to promote expensive and sometimes more dangerous drugs. Arthur L. Lerman, D-Augusta, and James J. Campbell Sr., R-Newfield, are members of the Maine House of Representatives. |
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