http://healthjournalclub.blogspot.com/2009/10/do-people-with-high-cholesterol-live.html

http://shearlingsplowed.blogspot.com/search?q=FDA+transparency

“18 USC § 371. Conspiracy to commit offense or to defraud United States

If two or more persons conspire either to commit any offense against the United States, or to defraud the United States, or any agency thereof in any manner or for any purpose, and one or more of such persons do any act to effect the object of the conspiracy, each shall be fined under this title or imprisoned not more than five years, or both.”

Seems to me that per Condor’s earlier post mentioned above that MERCK CEO Clark has indicated that he has already conspired to defraud the US. Thus it seems that it’s a question of whether an act to effect the conspiracy has been commited yet or not. It’s possible that simply not having stopping criteria for futility might fulfill this.

Salmon

I neglected to add that in the case of the Vytorin Improve-IT study that it’s not only unethical in respect to patient safety but in my opinion it’s also a way for Merck to unjustly enrich themselves.

If they know the results are negative and if released will likely result in decreased prescribing then they are making sales including those paid for by the US gov’t that they shouldn’t be. To me this is fraudulent and I would assume that this additional information would be of interest to Senator Grassley as ranking member of the Finance Committee.

Salmon

I will note that — in my opinion — the results of IMROVE-IT, even if completed, won’t be published until late 2014 or 2015. The analysis on that conjecture has been “out there” since November of 2009 — simply by piecing together the already public data.

So — with Vytorin (albeit in smaller studies, with largely only surrogate endpoint analysis) running on an 0-for-3 track record (ENHANCE, SEAS and ARBITER 6 - HALTS). . .

When does the professional independence of the prescribing doctor kick in to say — enough, already?

Great stuff, Ed!

Namaste

http://shearlingsplowed.blogspot.com/2010/01/merck-provides-updated-mid-2013.html

The most important information is that Merck’s CEO seems to have implied that the study will not be stopped even if they know the drug will not improve outcomes.

Clearly this is unethical as there are safer (i.e. no rhabdomyolysis et al.) and effective drugs currently available.

Allowing unethical studies to run (it happens all the time) is unacceptable and FDA regulations need to be changed.

Also did you know that that the FDA can’t stop a study for inadequate informed consent as this is left to the institutional review board.

Consequently there are studies where there is a known risk was death and yet the informed consent does not mention it and the FDA is helpless to stop the study. In light of posts such as the following

http://www.pharmalot.com/2008/12/time-bomb-the-clinical-trial-gold-rush-in-india/#comment-457515

Regulations to prevent trial subject endangerment must also be strengthened.

The FDA has the legal obligation to ‘protect the public health’. I believe we the interested and knowledgable readers of this blog should let FDA Commissioner Hamburg that these policy of doing nothing to protect patients are unacceptable and need to be changed.

Her address is:

Commissioner Margaret A. Hamburg, M.D.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
OFFICE OF THE COMMISSIONER
10903 New Hampshire Avenue
WO1-2217
Silver Spring, MD 20993-0002

and her is e-mail.

margaret.hamburg@fda.hhs.gov

I would also cc Senator Grassley.

Senator Chuck Grassley
135 Hart Senate Office Building
Washington, D.C. 20510-1501

If you e-mail Commissioner Hamburg you can copy Senator Grassley by cutting and pasting the e-mail into the following webform.

http://grassley.senate.gov/contact.cfm

I would however advise letters instead.

Salmon