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Healthy Skepticism Library item: 19767

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.


Publication type: Journal Article

Christensen M, Knop FK
The unobtainable placebo: control of independent clinical research by industry?
The Lancet 2012 Jan 7; 379:(9810):30


Independent researchers might end up compromising—or even abandoning—their research design because of the unwillingness of some pharmaceutical companies to deliver placebo drugs or devices. We believe that this could be a major way for the pharmaceutical industry to control scientific information about their drugs.
In an example known by us, a drug company was approached by researchers with the aim of obtaining placebo medication (in a specialised injection pen for patients with diabetes) for an independently financed trial to investigate the effect of a marketed drug. 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.
In a second example, 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 yet another example, the drug company plainly refused to deliver the placebo. We do not think these examples are unique.
In the situations above, the only way forward short of compromising the design with an unblinded trial is to have the placebo manufactured elsewhere. This can be extremely costly and cumbersome1—or even impossible. Is it acceptable that drug companies with an established placebo-manufacturing process (for their own marketing authorisation trials) can choose whether they wish to sell placebo to independent researchers?
By contrast with publicly sponsored research, industry-sponsored research often focuses on profitable areas and future profits instead of areas where important health improvements could result.2 The industry’s reluctance to do relevant head-to-head trials1, 3 contributes to the fact that the drug of interest is often found to be superior.4, 5 These issues make independent clinical research highly necessary.
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.


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As an advertising man, I can assure you that advertising which does not work does not continue to run. If experience did not show beyond doubt that the great majority of doctors are splendidly responsive to current [prescription drug] advertising, new techniques would be devised in short order. And if, indeed, candor, accuracy, scientific completeness, and a permanent ban on cartoons came to be essential for the successful promotion of [prescription] drugs, advertising would have no choice but to comply.
- Pierre R. Garai (advertising executive) 1963