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Academics plea for politicians to tackle problem of missing data

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e7306 (Published 29 October 2012) Cite this as: BMJ 2012;345:e7306
  1. Zosia Kmietowicz
  1. 1London

Campaigners have called on the government to take action to end the “ongoing secrecy” that surrounds the reporting of clinical trials.

In a letter to the Times they write that despite drug companies being required by law to report negative as well as positive results from clinical trials, the reality is somewhat different.1

“We wish that drug companies truly were compelled to be transparent. In reality, vitally important information about drug trials continues to be withheld from doctors and the public, meaning that patients are harmed, and money is wasted,” they write.

The 28 signatories include Ben Goldacre, author of the book Bad Pharma; Fiona Godlee, editor in chief of the BMJ; Virginia Barbour, chief editor of PLOS Medicine and chairwoman of the international Committee on Publication Ethics; Clare Gerada, president of the Royal College of General Practitioners; Richard Horton, editor of the Lancet; and Iain Chalmers, founder of the Cochrane Library.

The letter says that half of all drug trials are never published in academic journals and that despite the fact that the United Kingdom has spent £500m (€620m; $800m) on stockpiling oseltamivir (Tamiflu) “Roche continues to withhold information about trials on this drug from the widely respected Cochrane Collaboration.”

On 23 October Sarah Wollaston, a GP and the Conservative MP for Totnes, raised the issue of missing data affecting the evidence base on which doctors rely in the House of Commons.2 Norman Lamb, the Liberal Democrat MP for Norfolk and minister for care services, agreed that access to all data from clinical trials was a “really important issue” and committed the government to a meeting with campaigners.

The letter says that “politicians have neglected this problem for too long” and that new legislation planned for Europe is weak and that similar legislation in the United States is largely ignored.

They conclude, “The government must publicly acknowledge the harm done to patients when information on trials is withheld, and commit to specific remedial steps. All information affecting patient care, from all clinical trials, new and old, on all drugs in current use, must be made available to health professionals. Until that happens, patients will continue to suffer unnecessarily.”

Notes

Cite this as: BMJ 2012;345:e7306

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