Showing posts with label TEST Act. Show all posts
Showing posts with label TEST Act. Show all posts

Wednesday, August 8, 2012

Testing Transparency with the TEST Act

A quick update on my last post regarding the enormously controversial -- but completely unmentioned -- requirement to publicly report all versions of clinical trial protocols on ClinicalTrials.gov: The New England Journal of Medicine has weighed in with an editorial strongly in support of the TEST Act. 

NEJM Editor-in-Chief Jeffrey Drazen at least mentions the supporting documents requirement, but only in part of one sentence, where he confusingly refers to the act "extending results reporting to include the deposition of consent and protocol documents approved by institutional review boards." The word "deposition" does not suggest actual publication, which the act clearly requires. 

I don't think this qualifies as an improvement in transparency about the impact the TEST Act, as written, would have. I'm not surprised when a trade publication like Center Watch recycles a press release into a news item. However, it wouldn't seem like too much to ask that NEJM editorials aspire to a moderately higher standard of critical inquiry.

Monday, August 6, 2012

Public Protocols? Burying the lede on the TEST Act

Not to be confused with the Test Act.
(via Luminarium)
4 Democratic members of Congress recently co-sponsored the TEST (Trial and Experimental Studies Transparency) Act, which is intended to expand the scope of mandatory registration of clinical trials. Coverage so far has been light, and mainly consists of uncritical recycling of the press release put out by congressman Markey’s office.

Which is unfortunate, because nowhere in that release is there a single mention of the bill’s most controversial feature: publication of clinical trial "supporting documents", including the patient’s Informed Consent Form (ICF) and, incredibly, the entire protocol (including any and all subsequent amendments to the protocol).

How Rep. Markey and colleagues managed to put out a 1,000-word press release without mentioning this detail is nothing short of remarkable. Is the intent to try to sneak this through?

Full public posting of every clinical trial protocol would represent an enormous shift in how R&D is conducted in this country (and, therefore, in the entire world). It would radically alter the dynamics of how pharmaceutical companies operate by ripping out a giant chunk of every company’s proprietary investment – essentially, confiscating and nationalizing their intellectual property. 

Maybe, ultimately, that would be a good thing.  But that’s by no means clear ... and quite likely not true. Either way, however, this is not the kind of thing you bury in legislation and hope no one notices.

[Full text of the bill is here (PDF).]

[UPDATE May 17, 2013: Apparently, the irony of not being transparent with the contents of your transparency law was just too delicious to pass up, as Markey and his co-sponsors reintroduced the bill yesterday. Once again, the updated press release makes no mention of the protocol requirement.]