Reading the RIAT Act

June, 14, 2013 | 6 Comments


  1. 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:

    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.!

  2. 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?

  3. 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.

  4. […] A failure to be converted to a ‘Responsible’ way of looking at the data underpins the stand-off between GSK and the RIAT team attempting to restore Study 329 to what it should have been. Study 329 is GSK’s most famous clinical trial. RIAT stands for Restoring Invisible and Abandoned Trials (see Reading the RIAT Act). […]

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