Researchers Report a New Placebo Effect: Manipulating Clinical Trials 2

Two Danish diabetes researchers claim that the pharmaceutical industry may be manipulating independent clinical research by controlling access to placebo drugs or devices. In a letter published in the Lancet, Mikkel Christensen and Filip K Knop write that “this could be a major way for the pharmaceutical industry to control scientific information about their drugs.”

They cite an example in which researchers sought to obtain a placebo diabetes medication in a specialized injection pen “for an independently financed trial to investigate the effect of a marketed drug.” Here’s what happened:

Before considering delivery of placebo, the company asked for a full protocol to be scrutinised by an opaque system of evaluation committees. After more than 6 months, the company finally agreed to supply placebo devices provided that the protocol was changed according to their suggestions. The researchers were also obliged to allow the company access to the resulting trial report for 4 weeks before submission for publication.


Christensen and Knop briefly mention two other cases. In one, “a drug company charged an extraordinary amount of money for providing a simple placebo tablet, effectively preventing the planned clinical trial from going ahead.” In the second case, the company “plainly refused to deliver the placebo.”

The Danish researchers write that obtaining alternative placebos may be “extremely costly and cumbersome—or even impossible.”

They conclude:

In our opinion, the pharmaceutical industry has an obligation to provide placebo to match their marketed drugs without prior assessment and approval of protocols. This process would facilitate the generation of commercially unbiased research, possibly improve the life and welfare of patients, cut health costs, and help rebuild the credibility of the pharmaceutical industry. Unfortunately, the present situation shows that, without a legal obligation to provide placebos to match their marketed drugs, the pharmaceutical industry has de-facto control over drug trials.

Yale’s Joe Ross sent the following comment to CardioBrief:

If these accusations are true, the scientific community should be profoundly disappointed. Good clinical trial research requires cooperation between industry and physician investigators and having effective and affordable placebos is just one part of the process. Industry should be looking for ways to facilitate good, independent research, not to obstruct it.

 

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2 comments

  1. Would it make sense for clinical trial researchers to simply refuse to undertake trials of drugs if the manufacturer refuses to provide placebo equivalents? That seems like the strongest influence that could be applied: no one will trial their drugs unless they change their behavior. Since they can’t bring a drug to market without a trial, might that serve as a big incentive to shape up?

    • Not sure this makes much sense, Nmill. The companies have no problem finding investigators to run trials that they initiate and pay for. So your proposal would just leave all clinical research entirely in the hands of industry.

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