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Inverse benefits due to drug marketing undermine patient safety and public health
Date:1/13/2011

drugs. Or relying on statins to lower cholesterol versus having a proven impact on the hard endpoint of decreasing heart disease incidence.
  • Exaggerated safety and efficacy claims as many as 140,000 cases of serious coronary disease in the U.S. might have been caused by rofecoxib, a COX-2 inhibitor, that was broadly marketed as safer and more effective than standard nonsteroidal anti-inflammatory drugs.
  • "Disease mongering" Osteopenia, once considered a non-disease state in patients who had not lost enough bone density to be diagnosed with osteoporosis, has now turned into a disease itself, in hopes of convincing physicians and patients that biphosphonate drug treatment will prevent their "disease" from progressing.
  • Encouraging unapproved uses three of five prescriptions for antipsychotics are for off-label use, even though 75 percent of those prescriptions lack evidence of benefits but expose patients to harm. Recent examples include gabapentin and olanzapine.

    "While we looked only at marketing directed toward physicians, direct-to-consumer advertising plays a critical role in driving demand for a drug by patients who fall outside the group that might truly need it, and pressuring physicians to prescribe it more readily," said Brody. "European countries are now debating whether to join the U.S. and New Zealand in allowing DTC advertising and we hope that our work could help inform that discussion."

    Brody and Light recommend a series of remedial actions, including: restrict writing usage guidelines to groups free of commercial conflicts of interest; independently fund and design trials focused on safety and efficacy; and create a neutral agency (e.g., a branch of the National Institutes for Health) to conduct drug trials, including comparative effectiveness research to improve evidence-based prescribing.

    The authors point to recent efforts such as the National Physicians Alliance's Unbranded Doctor Campaign and
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  • Contact: Olivia Goodman
    olivia.goodman@gabbe.com
    212-220-4444
    University of Texas Medical Branch at Galveston
    Source:Eurekalert

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