Drug companies occasionally conduct post-marketing studies to collect data on the safety and efficacy of drugs in the real world, after they’ve been approved by the US Food and Drug Administration. “However,” writes the anonymous author in an editorial in the British Medical Journal (subscription), “some of the [post-marketing] studies I worked on were not designed to determine the overall risk:benefit balance of the drug in the general population. They were designed to support and disseminate a marketing message.”
According to the whistleblower, the results of these studies were often dubious. “We occasionally resorted to ‘playing’ with the data that had originally failed to show the expected result,” he says. “This was done by altering the statistical method until any statistical significance was found.” He adds that the company sometimes omitted negative results and played down harmful side effects.
Nature says it was unable to work out who the writer was but they likely worked on diabetes and the studies criticized were from the Denmark-based pharmaceutical company Novo Nordisk."
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