Head to head brawl: should drug companies be trusted to conduct research trials on their own drugs?

It may seem to the casual observer that the U.K.’s Great Oxford Debate (held in September at Oxford University and covered last month in the British Medical Journal) resembled a fight between the fox and the farmer over which one of them should be in charge of the henhouse. In one corner, wearing the red silk shorts, you had physician, activist and Bad Science blogger Dr. Ben Goldacre, who argues that the financial interests of a drug company lead to distorted clinical evidence when they run research trials on their own drugs.  In this corner, in the shiny blue Spandex, you had consultant Vincent Lawton, a Big Pharma veteran (most notably as a 26-year executive with drug giant Merck Pharmaceuticals), arguing that adequate safeguards already exist to keep a drug company’s research bias nicely  in check.

With the British Medical Journal refereeing the rumble, let’s tune in for Round One, led off by Vincent Lawton:  Continue reading

Warning: clinical trials funded by drug companies may appear more truthful than they actually are

gabapentinWell, here’s a shocker: apparently, there appears to be a difference between internal drug company documents about the research trials that they fund, and the articles reporting that research that end up in medical journals. The New England Journal of Medicine calls this ‘selective outcome reporting’, but for the sake of clarity, let’s just call it ‘lying’.

At first blush, the process of getting drug research results published seems straightforward enough. Since 2005, the International Committee of Medical Journal Editors has even required all research investigators to register their clinical trials prior to participant enrollment as a pre-condition for publishing the trial’s findings in member journals.

So in a nutshell, researchers set out to run clinical trials, as they are legally required to do, on a particular drug. They have some specific purpose in mind before undertaking this research.  Will this drug ease pain? Reduce inflammation? Lower blood pressure? Treat cancer? That’s the primary outcome of the clinical trial they have in mind, which must be registered before they even begin recruiting people to participate in this study if they want to later submit their findings to a medical journal. Which of course they do.

In a study published today in the NEJM, researchers examined practices for clinical trials of a drug called gabapentin, better known by its brand name Neurontin, an epilepsy drug which was approved in late 1993 for use as an adjunctive medication to control partial seizures (meaning that it’s considered effective when added to other anti-seizure drugs). The research trials for this drug were all funded by Pfizer and Warner-Lambert’s sudsidiary drug company, Parke-Davis.

Researchers looked at 20 clinical trials of gabapentin for which there were internal Pfizer or Parke-Davis documents, 12 of which were ultimately published in medical journals. For eight of these 12 reported trials, the primary outcome defined in the ultimately published journal article differed from that described in the internal documentation protocol. Quelle surprise…  Continue reading