An anonymous author who works in the pharmaceutical industry wrote several anonymous editorials in this weeks British Medical Journal in which they claim:
“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 writer the process begins as doctors are recruited to find patients who will demonstrate the best results for the company. The doctor is told exactly what to tell patients they should expect and that information is meant to plant the seed of support in the patients mind.
What’s worse, the whistleblower claims that the studies are often molded to fit the expectations of the drug company.
“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.”
Negative results are then omitted when it comes to harmful side effects since post-marketing studies do not face the same public scrutiny of pre-approval studies.
The other notes that the false reports are based on a company’s desire to make money over the ten-year period in which their drug is under control of strict patent laws.
Nature examined the authors work and believes they may come from a diabetes background as the editorials focus on post-marketing studies involving insulin drugs meant to fight diabetes.
News of bait-and-switch campaigns involving “post-marketing” studies are nothing new, researchers for years have complained about these so-called “studies” which attempt to overturn accepted problems with drugs that were discovered in pre-study tests.
In the meantime, the companies involved in the authors attacks such as Norvo Nordisk continue to stick behind their products, claiming that their studies involved real-world case studies.