God Save the Queen!…

Posted on Wednesday 31 October 2012

Some days, it’s a pleasure to wake up and read the news. This is one of them…

The respected British Medical Journal (BMJ) will refuse to publish research papers on drugs unless the clinical trial data behind these studies is made available for independent scrutiny. The requirement to make anonymised patient-level data available "on reasonable request" will apply to all clinical trials of drugs and medical devices from January 2013, the BMJ said in an editorial.

The move increases the pressure on drug companies to lift the lid on data secrets amid growing criticism that lack of disclosure hampers the ability of doctors and medical researchers to assess the true value of products. Patient-level data, which sits behind the published results of clinical trials, is a potential treasure trove for scientists wanting to test drug company claims and expose product deficiencies. Companies have been reluctant to release this information, but GlaxoSmithKline set a precedent this month by announcing that it would make such data available from its trials.

Clinical trial data for all drugs in current use Must be made available for independent scrutiny
by Fiona Godlee editor in chief
British Medical Journal, London WC1H 9JR, UK
October 29, 2012

The drug industry does many good things. It produces medicines that can improve health and save lives. It creates jobs and stimulates economic growth. Sadly it does bad things too. Persistently and systematically over decades it has withheld and misreported data from clinical trials. As a result, a whole range of widely used drugs across all fields of medicine have been represented as safer and more effective than they are, endangering people’s lives and wasting public money. Such wilful distortion is scientific misconduct. It is not something we can forgive because of the good things drug companies do. As Ben Goldacre says in the introduction to his new book Bad Pharma, “Drug companies around the world have produced some of the most amazing innovations of the past fifty years, saving lives on an epic scale. But that does not allow them to hide data, mislead doctors, and harm patients.” Hats off then to GlaxoSmithKline, which announced last month that it would allow access to anonymised patient level data from its clinical trials. An independent panel will assess all requests, and the company’s chief executive officer, Andrew Witty, says access will be granted on the basis of a reasonable scientific question, a protocol, and a commitment from the researchers to publish their results. Trial data collected since 2007 will be placed on a password protected website. Earlier data, not yet available in standard digitised formats, will be made available on “an ad hoc basis.”

Whether researchers will find it as easy to get past the panel as Witty suggests we will have to wait and see. It will be particularly important to know how many requests are turned down and for what reasons. And amid the plaudits, a moment of doubt. Surely what this apparently brave and benevolent action really serves to highlight is the rank absurdity of the current situation. Why aren’t all clinical trial data routinely available for independent scrutiny once a regulatory decision has been made? How have commercial companies been allowed to evaluate their own products and then to keep large and unknown amounts of the data secret even from the regulators? Why should it be up to the companies to decide who looks at the data and for what purpose? Why should it take legal action (as in the case of GlaxoSmithKline’s paroxetine and rosiglitazone), strong arm tactics by national licensing bodies (Pfizer’s reboxetine), and the exceptional tenacity of individual researchers and investigative journalists (Roche’s oseltamivir) to try to piece together the evidence on individual drugs?

Goldacre’s book makes it clear that the reasons are complex and there are no simple solutions. But there is no doubt that medical journals could do more. Rather than no longer publishing industry funded trials, as some have suggested, they could leverage their power and publish only where there is a commitment to make the relevant anonymised patient level data available on reasonable request. The International Committee of Medical Journal Editors has so far declined to take such a step. The BMJ will require this commitment for all clinical trials of drugs and devices—whether industry funded or not—from January 2013…

The open correspondence on bmj.com aims to hold specific individuals and organisations to account. Their actions are preventing independent scrutiny of the results of clinical trials and putting patients’ lives at risk. We also hope it will contribute to a sea change in the public mood. Goldacre’s book presents an opportunity to raise awareness of a scandal too long ignored by those in power. We should seize this moment with both hands.

Open data: seize the moment
by Trevor Jackson, deputy editor, BMJ
British Medical Journal 2012 [Published 31 October 2012]

One of the most popular videos on TED.com is a mini-lecture by the writer, doctor, and academic Ben Goldacre, called “What doctors don’t know about the drugs they prescribe” (http://tinyurl.com/9y8chac). In the video, Goldacre (whose latest book, Bad Pharma, does much to expose the damage caused by withheld and misreported data from clinical trials) says that in drug trials funded by pharmaceutical companies “positive findings are around twice as likely to be published as negative findings.” Since it was posted two months ago, the video has attracted over 387 000 views. Does this suggest that the public is waking up to one of the biggest scandals in clinical research: that big pharma does not make all the clinical trial data for all drugs in current use available for independent scrutiny?

Certainly BMJ editor Fiona Godlee, who has led an ongoing campaign for open data, hopes that we are on the brink of a “sea change in the public mood.” In an editorial this week (doi:10.1136/bmj.e7304) she asks, “Why aren’t all clinical trial data routinely available for independent scrutiny once a regulatory decision has been made? How have commercial companies been allowed to evaluate their own products and then to keep large and unknown amounts of the data secret even from the regulators? Why should it be up to the companies to decide who looks at the data and for what purpose?”

The past fortnight has seen a number of initiatives that might help to make this moment a tipping point in the United Kingdom. The first came from general practitioner and Conservative MP Sarah Wollaston, who last week raised in the House of Commons the issue of missing data affecting the medical evidence base (doi:10.1136/bmj.e7306). In response, Norman Lamb, the minister for care services, agreed that access to all data from clinical trials was a “really important issue.” He committed the government to a meeting with campaigners.

The second initiative was a letter to the Times this week, signed by 28 campaigners—including Fiona Godlee and Ben Goldacre. The letter called on the government to act to end “ongoing secrecy” surrounding the reporting of clinical trials (doi:10.1136/bmj.e7306). “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 wrote.

The third initiative is part of the BMJ’s own open data campaign. As David Payne, editor of bmj.com, reports (doi:10.1136/bmj.e7303), the BMJ has this week launched a dedicated website aimed at persuading Roche, the manufacturers of oseltamivir (Tamiflu), to give doctors and patients access to the full data on the influenza drug. The site (www.bmj.com/tamiflu) displays emails and letters dating back to September 2009, when Cochrane researcher Tom Jefferson asked Roche for the unpublished dataset used in a 2003 analysis of oseltamivir. The site’s aim is to persuade Roche to fulfil a public promise it made in 2009 to release full clinical trial reports, in response to an investigation by the BMJ, Tom Jefferson, and his Cochrane colleague Peter Doshi. The latest addition to the site is a letter from Fiona Godlee to John Bell, regius professor of medicine at Oxford University and a Roche board member, urging the company to disclose the full data (doi:10.1136/bmj.e7305). Jefferson and Doshi explain more about the open data campaign in this week’s BMJ podcast (www.bmj.com/podcasts).

Can the momentum of the UK campaigners help push for change in Europe and beyond? As Fiona Godlee says at the end of her editorial, “We should seize this moment with both hands.”

hat tip to Jamzo
    October 31, 2012 | 5:32 PM

    Great to have some good news for a change. That said, I can’t tell you how much I appreciate the work you do here. As a 66-year-old-and-still-working psychiatrist myself, I sometimes feel very lonely and very embarrassed by what has happened to my profession. Your passion plus elbow grease helps me know that I’m not alone and that there are at least a few of us who care about good science and good service to those who put their lives in our hands.

    October 31, 2012 | 9:37 PM

    Thanks Gene,

    Beautifully said…

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