Shed a little light.Byline: The Register-Guard Congress should require the pharmaceutical industry to stop manufacturing half-measures and excuses to avoid publishing complete results of clinical drug trials. Currently, members of the public - including doctors - can easily get their hands on scads of glowing reports demonstrating the safety and effectiveness of new drugs. But findings from clinical trials that indicate a drug is ineffective or potentially harmful are often suppressed sup·press tr.v. sup·pressed, sup·press·ing, sup·press·es 1. To put an end to forcibly; subdue. 2. To curtail or prohibit the activities of. 3. or buried bur·y tr.v. bur·ied, bur·y·ing, bur·ies 1. To place in the ground: bury a bone. 2. a. To place (a corpse) in a grave, a tomb, or the sea; inter. b. in obscure publications. Recognizing that such selective reporting compromises credibility and public health interests, a coalition of 12 leading medical journals announced that beginning next July, they will no longer publish the results of clinical trials that have not been registered in a public database. The New England Journal of Medicine The New England Journal of Medicine (New Engl J Med or NEJM) is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It is one of the most popular and widely-read peer-reviewed general medical journals in the world. said patients and doctors need complete information to make informed decisions on drug use. Advance registration makes it much harder for a company to conceal conceal, v to hide; secrete; withhold from the knowledge of others. negative trial results. The influential medical journals carry enough clout to produce a strong incentive for companies to register their trials. Sensing which way the wind was blowing, the drug industry's powerful trade group, Pharmaceutical Research and Manufacturers of America Pharmaceutical Research and Manufacturers of America (PhRMA) is an industry trade group representing the pharmaceutical research and biotechnology companies in the United States. , jumped in with an announcement that it was launching a Web site where members could voluntarily post summaries of trial results. The new policy at the medical journals and the PhRMA Web site are welcome improvements, but they fall well short of what's needed, for obvious reasons. Hundreds of medical journals worldwide would have to join the Big 12 to plug holes in the publication policy. An indus- try-sponsored voluntary plan does nothing to address criticism that financial self-interest drives drug companies' decisions about when to release complete results. That's why all eyes need to focus on legislation awaiting introduction next week in the U.S. House and Senate that would require drug companies to publicly register clinical trials and post the results on a government-run Internet site, clinicaltrials.gov, which is operated by the National Institutes of Health. The bills are sponsored by two Massachusetts Democrats, Sen. Edward Kennedy and Rep. Edward Markey, joined by Democratic colleagues in the Senate and House. The proposed legislation gives the Food and Drug Administration authority to fine drug companies that fail to comply and would withhold with·hold v. with·held , with·hold·ing, with·holds v.tr. 1. To keep in check; restrain. 2. To refrain from giving, granting, or permitting. See Synonyms at keep. 3. federal funding for researchers who didn't follow the rules. The pharmaceutical industry has long been loathe to reveal negative drug trial information because it can hurt stock prices and create a competitive disadvantage. But the issue gained traction Traction Definition Traction is the use of a pulling force to treat muscle and skeleton disorders. Purpose Traction is usually applied to the arms and legs, the neck, the backbone, or the pelvis. this year after British drug manufacturer GlaxoSmithKline was accused of suppressing trial results that suggested its antidepressant antidepressant, any of a wide range of drugs used to treat psychic depression. They are given to elevate mood, counter suicidal thoughts, and increase the effectiveness of psychotherapy. Paxil provided little benefit to adolescents and may have contributed to suicidal su·i·cid·al adj. 1. Of or relating to suicide. 2. Likely to attempt suicide. thoughts. It's ridiculous to place the interests of drug companies in their stock prices above the interests of patients and doctors in knowing the full risks of a specific drug. Congress should make quick work of passing the Kennedy-Markey measure. |
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