More Than Half of US Drug Safety Studies Never See the Light of Day

Before taking a prescribed medicine, patients assume that the product has undergone rigorous testing, with researchers proving it safe and effective. Of the world’s 20 largest pharmaceutical firms, more than half are in the US, and so global consumers depend on the US Food and Drug Administration to regulate drugs and report safety concerns. A survey conducted by a team at the University of California, San Francisco, suggests that more than half of all clinical trials are not published within five years of drugs going on the market, reports James Randerson for the Guardian. The researchers pointed to publication bias and Randerson explains, “Trials with statistically significant results were more likely to be published than those with non-significant results, as were those with larger sample sizes.” Such a finding could suggest that some medicines, while not causing harm, are unnecessary and merely a way for the pharmaceutical industry to pursue profit. Public data on clinical trials would allow doctors and patients to assess risks with complete information. – YaleGlobal

More Than Half of US Drug Safety Studies Never See the Light of Day

Only 43 percent of the evidence of safety and efficacy that the US Food and Drug Administration uses to approve drugs is published in scientific journals – authors of one survey say this amounts to "scientific misconduct"
James Randerson
Tuesday, September 23, 2008

Click here to read the article in The Guardian

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