“Human guinea pig” asks for animal studies

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.