What is the British Medical Journal smoking?
In a new editorial, “Patients are urged to boycott trials that do not guarantee publication," the BMJ (along with other organizations) calls on patients to boycott clinical trials that promise, “to publish the results in full.
Tracey Brown, director of Sense About Science, an ally in this effort, is quoted in this effort saying, “Everybody agrees that clinical trials should be registered and that we should at the very least have clinical reports on what was found.”
Really? “Everybody” agrees? While there is general agreement – and strict government regulations -- on the registering of trials, the idea of publication of every trial fielded is, well kind of loony.
Should pharmaceutical companies guarantee that regulatory bodies such as the FDA and the MHRA see all important data before new products (or additional indications) are approved? Of course. And, incidentally, that’s the way it works. Any company that withholds important clinical information pays a severe price – and not just financially.
According to Iain Chalmers, of the James Lind Alliance, Paul Glasziou, professor of evidence based medicine at Bond University, Queensland, and Fiona Godlee, editor in chief of the BMJ, the withholding of trial results is important to people in trials because, “participants in clinical trials assume that they are contributing to the advancement of medical knowledge; non-publication of study results negates this reasonable assumption and betrays those who have volunteered.”
Balderdash. Note to Mr. Chalmers, Mr. Galsziou, and Ms. Godlee – patients in clinical trials do indeed provide a brave and noble service to the advancement of science whether or not any given trial results are published.
And what does this myopic triad have to say about clinical trials as intellectual property? Not surprisingly, they are silent.
Third party funders of trials certainly have the right, as part of their grant terms, demand publication. But privately funded trials also have the right to maintain the confidentiality of their findings – until they chose to submit them for regulatory review.
By furthering the anti-IP agenda of the Usual Suspects, the BMJ does a disservice to those they are trying to protect -- patients. Full publication of every trial fielded will not result in safer, better designed trials -- only in fewer trials. Cui bono BMJ?
