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.

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.]

Friday Flailing: Medical Gasses and the Law of the Excluded Middle

Buried

Aristotle never actually said "principium tertii
exclusi", mostly because he didn't speak Latin.

under the mass of attention and conversations surrounding the ACA last week, the FDA Safety and Innovation Act (FDASIA) contained a number of provisions that will have lasting effects in the pharmaceutical industry.  What little notice it did get tended to focus on PDUFA reauthorization and the establishment of fees for new generic drug applications (GDUFA).

(Tangent: other parts of the act are well worth looking into: NORD is happy about new incentives for rare disease research, the SWHR is happy about expanded reporting on sex and race in clinical trials, and antibiotic drug makers are happy about extra periods of market exclusivity.  A very good summary is available on the FDA Law Blog.)

So no one’s paid any attention to the Medical Gasses Safety Act, which formally defines medical gasses and even gives them their own Advisory Committee and user fees (I guess those will be MGUFAs?)

The Act’s opening definition is a bit of an eyebrow-raiser:

(2) The term ‘medical gas’ means a drug that is--

‘(A) manufactured or stored in a liquefied, non-liquefied, or cryogenic state; and
‘(B) is administered as a gas.

I’m clearly missing something here, because as far as I can tell, everything is either liquefied or non-liquefied.   This doesn’t seem to lend a lot of clarity to the definition.  And then, what to make of the third option?  How can there be a third option?  It’s been years since my college logic class, but I still remember the Law of the Excluded Middle – everything is either P or not-P. 

I was going to send an inquiry through to Congressman Leonard Lance (R-NJ), the bill’s original author, but his website regrets to inform me that he is “unable to reply to any email from constituents outside of the district.”

So I will remain trapped in Logical Limbo.  Enjoy your weekend.