Dr Phil Hammond, broadcaster and GP returner in Bristol

Legislation reinforces need for openness in drug trials
 

Former health secretary Frank Dobson, no doubt miffed at the billions in NHS cash being mopped up by litigation, once said, ‘the only place for a lawyer in a hospital is in a bed’.

Doctors too can be simplistically anti-lawyer but they earned my grudging respect when I observed them fighting for justice for parents involved in the Bristol heart scandal.

Lawyers are responsible for turning over stones in the health service and shining a light on the parts that have been hidden for years. They may turn your blood cold, but at least part of the drive for quality and safety in the NHS is thanks to the work of lawyers.

Lawyers also have a key role to play in bringing pharmaceutical companies to account. Those involved in drug liability cases have privileged access to safety data that pharmaceutical companies would rather keep secret. As the majority of such cases are settled before trial, this information is rarely made public.

Recently, however, lawyers involved in action against a pharmaceutical company persuaded the judge to release documents that appeared to show an inappropriate analysis of clinical trial data, thus obscuring the suicide risks associated with the drug in question.

The lawyers seeking damages managed to force the release of data demonstrating an eight-fold increase in suicide risk dating as far back as 1989. This report had remained under seal in a district court in California until the judge agreed to make parts of it public. This can only have been because the lawyers felt it would benefit, rather than hinder, their clients, who are claiming a link between suicide, or suicide attempts, and the drug.

The claims of an association between their product and successful and unsuccessful suicide attempts are fiercely contested by the company, and the argument hinges on whether the company was right to include suicides, and attempted suicides, from the washout period preceding the trial. This is when subjects stop taking most or all of their other medications to avoid confusion with the trial itself. Adverse events occurring during this time cannot be attributable to the trial and so are seldom, if ever, included in the final results. The company added in the washout data, but only for the placebo wing, with the effect of masking any suicides or para-suicides attributable to the medication.

The fight goes on over whether data has been misinterpreted, and, if so, whether it was deliberately misleading. There is also some dispute as to whether the Food and Drug Administration (FDA) knew how the washout data was being used, and, if it did, whether it raised concerns prior to licensing. It is fascinating stuff, as far as these things go, and none of it would have been forced into the open if it weren’t for lawyers.

The FDA is regularly pilloried for failing to identify risks associated with the drugs it oversees, and drug companies are always going to downplay the risks of their potential blockbusters. So we need lawyers to seek the truth.

An even better solution, as evidence-based medicine guru Sir Iain Chalmers has long argued, is to force all drug companies to publish all their trials in full.1 Only then can Cochrane, NICE, and other bodies quickly and accurately assess them. In these days of openness and scrutiny, there should be no hiding place for ‘disappointing data’.

 

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  1. http://www.bmj.com/cgi/content/full/319/7215/939/a G