Thursday, July 23, 2015

Publishing medical trials

This week's edition of The Economist has a couple of pieces on the need to make sure that all medical trials are published. The campaign by AllTrials in the UK has made great inroads on this issue already but now investors are signing up because they realise that lost data could be affecting the way they value companies. The first piece is a leader (op-ed).

Drug testing

Trials and errors

The evidence base for new medicines is flawed. Time to fix it

Jul 25th 2015 | From the print edition

WHEN patients are prescribed a drug, they might assume it had been subject to the closest scrutiny. They would be wrong. The results of about half of all clinical trials are never published. Companies are allowed to run many tests and publish only the ones with results they like. Unsurprisingly, negative results are far less likely to appear in public.

Regulators can see the results of every trial. But that provides only so much comfort. Officials may well be convinced that a particular drug has enough value for a few patients to pass the bar for approval, but that does not tell doctors whether the drug is better to prescribe than other treatments. And the regulators have limited resources. They cannot match the sort of scrutiny that comes from making all trial results public. Independent evaluations were important in raising concerns about the heart-attack risks associated with Vioxx, a painkiller that was recalled in 2004.

At best, this bias in published results has produced a polluted evidence base. Patients have been prescribed antidepressants that look much less effective when unpublished data are taken into account. The British government’s decision to stockpile antiviral drugs in case of a flu pandemic looks less clever now that previously unpublished data have called their efficacy into question. At worst, the skew has caused demonstrable harm. Some patients may have died because data about potentially dangerous side-effects were not published; volunteers in clinical trials may have suffered harm for no reason.

Clinical trials

Spilling the beans

Failure to publish the results of all clinical trials is skewing medical science

Jul 25th 2015 | From the print edition
I’M THE one who looks the patient in the eye and tells them the trial is beneficial,” says Tim Crater, a research physician at the Hutchinson Clinic in Kansas. Dr Crater runs drug tests for large pharmaceutical firms. He says volunteers are interested in more than just the promise of payment. “A lot of people want to help, they are altruistic to a certain degree and want to advance science.” Dr Crater’s experience is typical. Those who participate in trials often believe that they are, in a small way, contributing to the advancement of medicine and that any suffering on their part will help others.

Unfortunately, this is not always the case. Though pertinent trials carried out by companies do have to be reported to those responsible for licensing drugs and medical devices, there is no obligation on firms to make them public. That means such trials cannot be scrutinised by outsiders. The licensing authorities look at them, of course, so anything approved should, in theory, be safe, and have at least some beneficial effect. But the practitioners who go on to use them do not know all the details.

Some estimates suggest the results of half of clinical trials are never published. These missing data have, over several decades, systematically distorted perceptions of the efficacy of drugs, devices and even surgical procedures. And that misperception has sometimes harmed patients.