RxISK and the RIAT Act

June 14, 2013 • 3 comments

Editorial Note: Below is the press release for a potentially significant development in clinical trial publishing – the RIAT Act.  Doshi and colleagues are aiming to publish studies that companies have buried or to correct studies that are published but grossly misleading. The main reason for non-publication or misleading publication is that companies do not want you to know about adverse events on treatment. This makes RxISK and RIAT a marriage made in heaven. You can help correct the publication record by authoring a RxISK report.

Your Free RIAT Act is here and an assessment of its significance here.

Experts propose restoring invisible and abandoned trials “to correct the scientific record”

Experts are today calling for all unpublished and misreported trials to be published or formally corrected within the next year to ensure doctors and patients rely on complete and accurate information to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.

Sponsors and researchers will be given one year to act before independent scientists begin publishing the results themselves using previously confidential trial documents.

The BMJ and PLOS Medicine have already endorsed the proposal and committed to publishing restorative clinical trial submissions – 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Unpublished and misreported studies make it difficult to determine the true value of a treatment.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Medicine, will contact manufacturers of trials, asking them to signal their intent within 30 days to publish previously unpublished trials and formally correct previously misreported trials (i.e. to restore abandoned trials).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.”

In an accompanying editorial, editors at The BMJ and PLOS Medicine say Doshi and colleagues “offer a bold remedy” to help restore the integrity of the clinical trial evidence base.

They explain that the results of clinical trials “are a public, not a private, good” and that the public interest “requires that we have a complete view of previously conducted trials and a mechanism to correct the record for inaccurately or unreported trials.”

They conclude: “If we do not act on this opportunity to refurbish and restore abandoned trials, the medical research community will be failing its moral pact with research participants, patients, and the public. It is time to move from whether to how, and from words to action.”

Make Your Voice Heard

Make your voice heard!
Report your experience with prescription drug side effects

Although drug side effects are known to be a leading cause of death and disability, less than 5% of serious drug side effects are reported. Our mission is to capture this missing data directly from patients to help make medicines safer for all of us.

When you report your drug side effect, you also receive a free RxISK Report to take to your doctor or pharmacist. This report serves as a means to initiate a more detailed discussion of your treatment.

At the end of the reporting process, we also provide you with the option to take the information you have reported on RxISK and automatically create a form to send to your country’s health authority — for example, the FDA in the United States, Health Canada in Canada, and Yellow Card in the United Kingdom (more countries will be added soon).


Filed Under: RxISK Stories | 3 comments

Comments (3)

  1. http://1boringoldman.com/index.php/2013/06/16/as-it-should-be-3/#comments

    Study 329/Paxil – Seroxat – is the most infamous of all studies.

    The buck stops with the prescriber – comments – I disagree, the buck stops with GSK.
    The prescriber had no idea, at all, that Paxil/Seroxat causes aggression, violence and suicide and, although I blame my prescriber, I feel a certain sympathy that he did not do his research, but I did.
    Interesting that the patient now knows more than doctors and prescribers.
    The patient has been beavering away, but the prescribers and doctors have not been beavering away at all.
    So, Rxisk may start the doctors and prescribers to start beavering away.
    Otherwise, they are a loss, pointless and academically neutered.
    What was the point of their seven year education if they don’t know how to question.
    Sheep, sheep, sheep and bleat, bleat, bleat.
    It is so tiresome that doctors and psychiatrists do not question anything at all.
    Why?

  2. Why don’t you just tell people to stop taking the drugs. People are not rats! Stop this. The drugs are horrible and all of you know it, so what is all this noise about studies and results? Are you trying to help children and young adults? Because if you where you would not be trying to push for studies. People need to stop taking these types of drugs. Period!

  3. Wanda
    Professor Healy has said time and time again that he uses ssris, benzos and anti-psychotic drugs, but he uses them carefully and shrewdly and he would be the first to notice when the patient is going ga ga, because of his dispensing.
    It is the others in his profession who are not of his disposition and herein lies the danger and the tragic, sometimes, fatal, result.
    I agree that people need to stop taking these type of drugs – period – but when the gps and psychiatrists have been so misled and so brainwashed by the manufacturers, herein lies the problem.
    If Professor Healy could wave a magic wand and tell them all what these drugs were doing to people then I am sure he would. But, he can’t, but what he can do is to push his Rxisk.org and to spread the word and surely but calmly the world will be a better place for it.
    The trick is not to get angry. The trick is to follow the leader and then, perhaps, those accountable for the mayhem of drug abuse will become accountable.
    Follow Alltrials, RIAT, and things are slowly and surely turning around.
    What could be better.
    A lesson I learned extremely quickly, was that if I raged about GSK and I raged about my ignorant and extremely stupid gp and psychiatrist, then I could end up with the white coats coming to get me.
    Calm, calm, insight and prudence is called for with this delicate state of affairs…
    There are too many doing nothing about all this.
    There are too many moaners and groaners.
    But, take a look, and who is actually doing something,
    Stick with the trusted and ride along on the coat tails…….
    Slings and arrows come, but they go, and we all have to deal with it…….Maverick was a pretty nasty expression used by some, but, my horse was called Maverick and Maverick is a compliment because if you don’t have a Maverick around then you might as well give up……
    And, we are certainly all not going to do that, are we?
    I wonder how much more anger is out there, or do people get so whipped and beaten that they feel their voice is of no merit?

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