The Clot Thickens! Bloggers Beware! Congress Requests Information from Drug Rep. Website on Anonymous Postings Concerning Early ENHANCE Study Results

February 15, 2008

Our fellow bloggers over at The Volokh Conspiracy recently posted an interesting story concerning a congressional investigation into Merck/Schering-Plough’s cholesterol absorption inhibitor VYTORIN (ezetimibe; simvastatin).  We previously reported on, among other things, a group of letters sent by the U.S. House of Representatives Energy and Commerce Committee Oversight and Investigations Subcommittee and the U.S. Senate Finance Committee to myriad public and private parties in January 2008 concerning Merck/Schering-Plough’s ENHANCE (Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression) study of VYTORIN versus ZOCOR (simvastatin) alone in reversing the atherosclerotic thickening of the carotid artery in patients with high cholesterol.  Those letters raised a concern that Merck/Schering-Plough officials might have delayed the results of the ENHANCE study so as not to affect VYTORIN’s market share. 

The most recent letter in this deepening controversy brings the online community into the fray.  Specifically, on February 11, 2008, the U.S. House of Representatives Energy and Commerce Committee Oversight and Investigations Subcommittee sent a letter to the operators of the website (a self-proclaimed “site for drug reps by drug reps”) requesting information on anonymous postings on the website about the ENHANCE study results.  The anonymous postings were made as early as March 13, 2007, which is about 9 months before Merck/Schering-Plough publicly released the trial results earlier this year.  “[H]ave a buddy at [Schering Plough Research Institute].  He says that the study is a bust,” reads one such anonymous posting.  “Heard it crashed and burned,” reads another posting.  According to the congressional letter sent to “These Web site postings are obviously troubling and raise further questions as to whether anyone within Merck or Schering-Plough knew the results of the ENHANCE trial prior to [their release].”  

The letter requests that provide the Oversight and Investigations Subcommittee (within 2 weeks of the date of the letter) “all records relating to any posting on related to the ENHANCE study, including but not limited to, names, addresses, phone numbers, and e-mail and internet protocol addresses of anyone creating such a post.”  According to the The Volokh Conspiracy,’s response was short: “[W]e do not collect any user information with anonymous posts (including IP addresses).  Therefore, we do not believe we will have any information to provide regarding these posts.”

The Oversight and Investigations Subcommittee also sent a similar letter to Merck/Schering-Plough.  That letter requests written explanations as to when Merck/Schering-Plough officials first learned of the postings and what the companies plan (or have done) to investigate the sources of the posts.  It also requests all records related to the postings.

In two other letters unrelated to the postings, the Oversight and Investigations Subcommittee also requests detailed information from FDA and Merck/Schering-Plough on, among other things, the ENHANCE study protocol.  Not to be outdone by the U.S. House, the U.S. Senate Finance Committee also sent a letter to Schering-Plough CEO Fred Hassan requesting information related to the ENHANCE study.  The letter follows up on the Finance Committee’s January 2008 letter on the same topic.

By Kurt R. Karst

Categories: Drug Development