“Human guinea pig” asks for animal studies

BMJ 2014; 349 doi: (Published 30 December 2014) Cite this as: BMJ 2014;349:g6714
  1. Peter C Gøtzsche, professor
  1. 1Nordic Cochrane Centre, Rigshospitalet, DK-2100 Copenhagen, Denmark
  1. pcg{at}
  • Accepted 5 November 2014

A trial participant whose request for animal data had been rejected turned to Peter Gøtzsche for help. It later emerged that the information he requested didn’t exist at the start of the human trial. He describes what happened and says the social contract between patients and corporate sponsors of drug trials is broken

Patients must be respected as partners in clinical trials. They need access to information that is important to them and should be informed about the known harms of the interventions. Trials that do not inform participants adequately violate the Declaration of Helsinki. However, the participants do not always have all the facts.

For example, in 2009, the information given to participants in a Pfizer funded trial comparing celecoxib with other arthritis drugs said that it was unclear whether celecoxib increased the risk of heart disease and stroke.1 But four years before the trial, the package insert mentioned the cardiovascular risks. Pfizer had also written to doctors to advise them that celecoxib increases cardiovascular risks.2

Also in 2009, GlaxoSmithKline (GSK) started the TIDE (Thiazolidinedione Intervention with Vitamin D Evaluation) trial comparing the cardiovascular safety of rosiglitazone and pioglitazone. GSK had long known that rosiglitazone increased the risk of myocardial infarction compared with pioglitazone,3 4 but this risk wasn’t mentioned in the information to patients.5 US and European physicians weren’t willing to enrol patients, and in 2010, India’s drug controller stopped the trial and rosiglitazone was taken off the European market.2

Here, I describe another case related to a request for data on non-clinical long term toxicity studies that raises further concerns about how well participants are informed.

Participant seeks information

In 2013, a participant contacted me after he had come across an article in which I advocated open access to clinical trial data.6 He had …

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