Thursday, May 28, 2015

The Rule To Show Cause Order We Mentioned -- In Merck's Propecia® MDL -- Is For A Doctor/PI Who Led Finasteride Clinical Trials

So, it turns out (as I guessed in comments) that the non-party witness -- in the Propecia® MDL who is (allegedly, at least) "wholly failing" to comply with a lawfully-issued subpoena duces tecum is, in fact the person Merck credits with having "discovered" the prostate- reducing effects of finasteride (the generic name for Propecia), lo those many years ago.

In addition, and tellingly, the very same doctor was the PI, (or Principal Investigator in FDA parlance), on numerous large national clinical trials back when finasteride was not yet approved by FDA -- studying safety, and efficacy. The PI of any given clinical trial accepts federally-mandated oversight and signature responsibility -- for that clinical trial on (in this case) a new drug candidate, under numerous existing FDA/HHS/ORI rules.

No mention however, that she was studying its use as a baldness reducing candidate -- just a prostate reducing one.

I would be willing to bet however (as the plaintiffs plainly are, as well. . . so willing) that her research might have shown some off target (i.e., erectile dysfunction) side effects. We shall see, as ever.

But for now, here is the full memo of law in support of the potential order to show cause ruling. Pop the popcorn folks, this one just got interesting. She was served at 525 East 68th Street in New York City, back in February 2015 -- which as Google Maps explains -- just happens to be the New York Presbyterian Cornell Med Center. Must be one of the places where she conducts her (likely now unrelated) research, to this day. Onward.


Anonymous said...

Wow, interesting turn of developments... even more interesting when you consider this:

As always, thanks for the frequent updates!

Anonymous said...

Damn. Crazy update and one that I was not expecting before June 19.

Anonymous said...

It's obvious why she doesn't want to hand over these documents. They're likely very incriminating and if they surfaced it would essentially back Merck into a corner and cost them millions of dollars. This is huge.

Condor said...

I would expect that this doctor will comply prior to the scheduled June 19, 2015 hearing -- to avoid the ire of a sitting federal District Court Judge.

Having the US Marshalls show up at one's office, asking why you are thwarting the authority of the federal courts. . . is rather unseemly.

So I expect she'll deliver the documents she has -- that's what "duces tecum" means.

Thanks one and all -- and Namaste, on a Sunny Friday!

Anonymous said...

But even if we assume that this former PI had something big in her older research, would that necessarily be incriminating for her? Isn't it possible that she could have conducted the prostate research for Merck and that the onus still falls on Merck for failure to disclose what she may have known about the side-effects? Or are we assuming she got kick-backs for helping bring finasteride to market so she's in on it too?

Anonymous said...

I'm no legal expert but I do know that Northwestern University's Feinberg School of Medicine released a study a few months ago exposing the Propecia clinical trials to be “systematically biased" (see my link above). Given that and her reluctance to hand over the documents or speak to anyone it would seem pretty obvious to me that these documents will be incriminating for Merck. If not, it never would have gotten to this point.