Reboxetine Ineffective, Drug Maker Suppressed Negative Studies, Report Says

<"">Reboxetine, an antidepressant sold by Pfizer that is sometimes used to treat attention-deficit hyperactivity disorder (ADHD), is ineffective, and could even be harmful, according to a new study conducted by German researchers. The issues with reboxetine indicate that pharmaceutical companies need stricter rules about disclosing clinical trial results, the researches said.

Reboxetine, sold under the brand names Edronax, Norebox, Prolift, Solvex, Davedax or Vestra, has been available in Europe for 13 years, but its approval application was rejected in the US in 2001. Unlike most antidepressants on the market, reboxetine is a norepinephrine reuptake inhibitor (NRI); it does not inhibit the reuptake of serotonin. Reboxetine was developed by Pharmacia Corp., which Pfizer acquired in 2003.

Researchers from the German Institute for Quality and Efficiency in Health Care have accused Pfizer of failing to disclose negative clinical trail results for reboxetine, after finding that eight out of 13 significant trials were never published. Their report, published in the British Medical Journal, says that published studies overestimated reboxetine’s benefit by 115 percent when compared to a dummy pill and 23 percent compared with other antidepressants. The 13 studies analyzed by the researchers involved 4,098 patients.

In addition to its ineffectiveness, the researchers found that people taking the antidepressant had a higher rate of side effects compared with those with placebo. In addition, more stopped taking the drug because of side effects compared with those taking a placebo or a different antidepressant.

“Our comparison of published and unpublished trials confirmed this assumption: the positive benefit-risk ratio of reboxetine in the published literature was changed to a negative ratio if unpublished trials were added to the analysis,” the report authors wrote. The institute has now recommended that the German health system stop paying for the drug. They also called for changes in European law to make it mandatory for all clinical trial results to be published.

Similar worries about drug makers suppressing study results led the US Congress to pass a law in 2007 creating a registry for clinical trials. However, according to a Bloomberg News report, the law does not require disclosure of trials conducted prior to September 27, 2007, or on drugs rejected by the Food & Drug Administration.

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