Welcome to my blog, a place to explore and learn about the experience of running a psychiatric practice. I post about things that I find useful to know or think about. So, enjoy, and let me know what you think.

Monday, June 17, 2013

Quiet RIAT

RIAT stands for "Restoring Invisible and Abandoned Trials.

I don't know if it's supposed to be pronounced like "riot", or like "ree-at".

But here's the idea.

Drug companies conduct studies to get new drugs approved, and to convince people to prescribe or request those drugs once they are approved. Do the studies tell the whole story? No. Do the studies always report all the truth about the drug in question, including side effects? No. Do the studies sometimes juke their stats to make their drugs look good? Yes. Are all relevant studies published? No.

It amazes me that in an age when the government routinely spies on random dot citizen with impunity, when everyone is talking about how privacy has gone the way of the Edsel, somehow, Big Pharma has managed to retain its secrets.

But not all its secrets.

Due to things like technology and lawsuits, lots of data are now available to the general public. Specifically, the pharmaceutical industry produces Clinical Study Reports (CSRs), which are hundreds or even thousands of pages long, and include "...an unabridged and detailed summary of the planning, conduct, and results of a clinical trial...Manufacturers submit clinical study reports to the US Food and Drug Administration as part of applications for new drugs. In addition, the FDA typically also requires submission of the protocol and individual participant data. ." (Same link as above).

So when a drug company releases its CSR and data to the public realm, whether voluntarily or by legal requirement, all the information necessary to publish the study becomes available. To the whole wide world.

Now along comes RIAT, with access to 178,000-some pages of data, and says, loud and clear:

HEY! Big Pharma! You have 365 days to republish the study, accurately and fully, so the world can judge the results for itself, Yo! And if you don't republish the study within a year, we'll publish it for you, using your publicly available data, and our own judgement as to what really went on, and what to conclude from the results.

Actually, it's the BMJ, so they say it a lot more politely.

I like a lot of things about this idea. It dovetails nicely with my Open Source post. It holds pharmaceutical companies accountable for their products. It's clever. And it openly acknowledges the problems that may arise, and it accepts that there are many questions to be asked, and not always clear answers:

There's a lot more to it, and the article has a number of links to free papers with titles like, Rethinking credible evidence synthesis, and, Evidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications.

Pretty interesting. Check 'em out!

No comments:

Post a Comment