Unmasking ‘Invisible’ Drug Trials

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Publish your data, or else we will—that's the stark warning to drug companies in a new proposal released today.


Peter Doshi, a postdoctoral fellow at Johns Hopkins University in Baltimore, Maryland, and his colleagues are fed up that only about half of all clinical trials are published. They want to change that, by convincing researchers and journals to print data that have been publicly released through other means, such as litigation and Freedom of Information Act requests, but, practically speaking, are sitting dormant in the filing cabinets or computers of individual scientists.

The unusual proposal is called RIAT, for Restoring Invisible and Abandoned Trials. It was published today in BMJand also endorsed by PLOS Medicine. Doshi, who studies comparative effectiveness research, came up with the idea when his colleague, Swaroop Vedula, was analyzing reporting biases involving the drug gabapentin. Gabapentin's maker Pfizer had been sued for the way in which they marketed the drug for unapproved indications. During litigation, Pfizer had released thousands of pages involving gabapentin trials, and Vedula was poring through them. (One of the authors of the RIAT paper, Kay Dickersin, served as an expert witness against Pfizer in gabapentin litigation.) Pfizer had published only 12 of its 20 trials in gabapentin. But Doshi's center at Hopkins had the clinical study reports detailing the results of the other eight.

At the time, "it just hits me," Doshi says. "Why are we still referring to these as unpublished trials? Why aren't we publishing them ourselves?"

Written By: Jennifer Couzin-Frankel
continue to source article at news.sciencemag.org

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  1. “another step on the road towards a complete and unbiased account of the effectiveness and safety of medical interventions.”

    Another step might be; to permit anything to be sold as a medicine if its efficacy and safety is demonstrated by peer reviewed publication. If not, it cannot be sold. That should put an immediate stop to patent medicines, herbal cures, homeopathic medicines, Chinese medicines etc. Shouldn’t be too difficult to produce a watertight definition of what it means to sell something as a medicine.

    • Agreed.
      In reply to #1 by Kevin Murrell:

      “another step on the road towards a complete and unbiased account of the effectiveness and safety of medical interventions.”

      Another step might be; to permit anything to be sold as a medicine if its efficacy and safety is demonstrated by peer reviewed publication. If not, it cannot be sold. That…

    • In reply to #1 by Kevin Murrell:

      “another step on the road towards a complete and unbiased account of the effectiveness and safety of medical interventions.”

      Another step might be; to permit anything to be sold as a medicine if its efficacy and safety is demonstrated by peer reviewed publication. If not, it cannot be sold. That…

      That would also stop many so-called standard medicines – especially in certain fields such as psychopharmacology. Many drugs in such fields have a negligible effect above placebo, if any at all, and yet they are still used. Death Knell to them too, then?

      • In reply to #3 by TanyaK:

        In reply to #1 by Kevin Murrell:

        “another step on the road towards a complete and unbiased account of the effectiveness and safety of medical interventions.”

        Another step might be; to permit anything to be sold as a medicine if its efficacy and safety is demonstrated by peer reviewed publication….

        Hope so. The bill for pharmaceuticals cripples government health services, and quack pharmas consume vast amounts of money from private individuals and health insurance providers. Societies and states and deluded individuals cannot afford to waste resources on worthless products.

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