Editorial Note: This is a press release for a potentially important development in medicine. You can access your copy of the RIAT Act here and an assessment of its likely significance here.
Restoring invisible and abandoned trials (RIAT) “to correct the scientific record”
Sponsors and researchers will be given one year to act before independent scientists begin publishing the results themselves using previously confidential trial documents; group calls for restorative authors and participating journals to join the effort.
Experts are today calling for all unpublished and misreported trials to be published or formally corrected within the next year to ensure doctors and patients rely on complete and accurate information to make decisions about treatments.
The BMJ is backing their call as part of its ‘Open Data’ campaign – to ensure clinical trial data is publicly available for independent scrutiny – and will discuss it in more detail at a meeting in London on Friday 14 June 2013.
Unpublished and misreported studies make it difficult to determine the true value of a treatment. Around half of all clinical trials for the medicines we use today have never been published – and a whole range of widely used drugs have been represented as safer and more effective than they are, putting patients at risk and wasting public money.
The authors of the declaration, led by Peter Doshi, a postdoctoral fellow at Johns Hopkins University School of Medicine, will contact manufacturers of trials, asking them to signal their intent within 30 days to publish previously unpublished trials and formally correct previously misreported trials (i.e., to restore abandoned trials).
They propose that if anyone who declares an intention to publish or correct does not do so within one year, all publicly available data for such trials should be considered “public access data” that others are allowed to publish.
This declaration, they say, “offers sponsors and trialists an opportunity to publish or formally correct their studies”—or otherwise see those abandoned studies published or republished by others.
New freedom of information policies means the public, and the authors, have access to around 178,000 pages of previously confidential trial documents and clinical study reports for widely used drugs for depression, heart disease, epilepsy and influenza. Some trials remain unpublished years after completion, while others have been published but have been shown to contain inaccuracies.
They say they are committed to seeing the findings from abandoned trials published – and misreported trials corrected and republished – and they set out a method for responsibly restoring invisible and abandoned trials (RIAT).
“We see RIAT as a collaborative, global effort, and over the next year we hope to discuss and debate our proposal at appropriate venues,” they write.
As such, they call on others to join them as volunteers “in place of those who should have but did not make trial reports visible and accessible.” And they ask medical journal editors to endorse the concept of restorative authorship to “help the effort to complete and correct the scientific record.”
Contacts:
Peter Doshi, Postdoctoral Fellow, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
Tel: +1 617 407 3019
Email: pnd@jhu.edu
Fiona Godlee, Editor-in-Chief, BMJ, London, UK
Tel (via BMJ Press Office): +44 (0)20 7383 6529
Email: edickinson@bmjgroup.com
This is great! Looks like a real challenge to the drug companies rather than pecking at the crumbs they have thrown “voluntarily.” I’m glad the BMJ people aren’t afraid to hang out with Healy as a co-author … that’s a good sign right there.
Already one American journal editor has written in to the BMJ offering to print some of these investigations – Thomas N. Ward of Headache, the Journal of Head and Neck Pain, from Dartmouth Medical School in New Hampshire:
http://www.bmj.com/content/346/bmj.f2865/rr/649992
Neurontin, Topamax, Depakote … they’ve all been liberally prescribed for migraine headaches as well as every other human affliction. Might be a good place to start. Hopefully there are more folks in the Ivy League med schools who are willing to risk becoming a Pain in the Neck to Healthcare Inc.!
Will all this expected transparency have a meaningful outcome? Will pharmaceutical companies accept or be forced to accept responsibility for the deaths of so many who were prescribed killer drugs? Or will they still shift that responsibility on to misinformed GPs and patients? Will PILs with endless lists of possible side effects absolve them of all crimes against humanity?
Dear Chris – it could do more than that, if the results lead to a loud enough outcry. Both the FDA and the European EMA have the right to deny or revoke approval for a medicine if its risks outweigh its advantages over other products. And once in a blue moon they actually do it. The EMA has rejected a diet pill called Belviq (lorcaserin) that’s been approved in the USA, because the side effects are so serious compared with the modest amount of weight loss it can deliver. And the FDA looks ready to reject two proposed hot-flash remedies on the same grounds. They are repackaged versions of two existing pills, Paxil and Neurontin, that are now off-patent. (That’s only a partial victory; the drugs are already being widely used for menopausal hot flashes, and doctors can still prescribe them off-label.)
If missing trials on brand-new drugs could be investigated this way we might really give some drug company a big public hit in the wallet. Maybe Belviq or better yet “Brintellix” (vortioxetine), the proposed new antidepressant from Takeda & Lundbeck. I am no scientist but that thing looks like the pharma equivalent of a dirty bomb to me … likely to make some happy and others suicidal, make this one sleepy and keep that one up all night, and god know what else. I wonder if anyone halfway independent has taken a look at the studies so far?
Amazingly, after more than 2 decades, the ADA has never advocated for investigation of rDNA synthetic insulin–used by all Type 1 diabetics. The original mantra was “it’s just like the human body makes” . . . but no proof was required. The only requirement seems to be that it (rDNA insulin) lowered blood glucose and didn’t kill the patient immediately. Natural products–created in nature–are no longer available to American diabetics; but no investigation or validation requirements are on the horizon. Interestingly, “dead-in-bed syndrome” and “hypoglycemia unawareness” have entered the vernacular (10 years ago medicine was denying that either of these existed) . . . but conveniently, the onus can still be placed squarely on the patient or the disease–never the insulin.
Are the scientists promoting RIAT going to look wa-a-a-a-a-y back. A look at the very narrow “science” that garnered FDA approval of rDNA insulin to this non-scientist’s eyes looks very sketchy. But I’ve tried for 15 years to get anyone–scientist, doctors, regulators, advocates to take another look at the “science”. Sadly, no one has the time or interest.