How drug companies get the clinical trial results they want

Posted on September 30, 2012 by Carolyn Thomas

Every prescription drug (or over-the-counter medication) in your bathroom cabinet is there because it’s been evaluated in research called a clinical trial. For a basic introduction to clinical trials, let’s turn to former editor-in-chief of the prestigious New England Journal of Medicine, Dr. Marcia Angell, who wrote the following in her frightening landmark piece called “Drug Companies & Doctors: A Story of Corruption” (New York Review of Books, 1/15/2009):

“Before a new drug can enter the market, its manufacturer must sponsor clinical trials to show the Food and Drug Administration that the drug is safe and effective, usually as compared with a placebo or dummy pill.

“The results of all the trials (there may be many) are submitted to the FDA, and if one or two trials are positive – that is, they show effectiveness without serious risk – the drug is usually approved, even if all the other trials are negative.”

Continue reading →

Battling bad science

Posted on October 22, 2011 by Carolyn Thomas

He’s back… Watch Dr. Ben Goldacre‘s irreverent and brilliant explanation of why those industry-funded miracle cure headlines can be so appallingly wrong – yes, even when the science is done by those with the letters M.D. after their names.

How did this heart drug get approved in the first place?

Posted on July 18, 2011 by Carolyn Thomas

In case you believe that the medicine you’re taking has been adequately tested on real live patients before being legally approved, you might want to consider research published recently in The New England Journal of Medicine*. A heart drug called nesiritide that for the past 10 years has been given to hospitalized patients with acute heart failure has failed to show any improvement compared to placebo.

But the drug had somehow received FDA approval in 2001 for use on these patients – after initial non-approval. Continue reading →

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

Posted on December 28, 2009 by Carolyn Thomas

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

Posted on November 13, 2009 by Carolyn Thomas

gabapentin Well, 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 →