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Congress Turns Up Heat On MRK And SGP Over Enhance Study

CNBC.com

This press release and letters to the CEOs of MRK and SGP from the House Energy and Commerce Committee just arrived in my inbox:

Committee on Energy and Commerce

Rep. John D. Dingell, Chairman

For Immediate Release: January 22, 2008

Dingell, Stupak Continue ENHANCE Trial Inquiry

Question Merck, Schering-Plough on Advisory Board and Employee Stock Sales

Request Information, Records from CMS

Washington, D.C. – Rep. John D. Dingell (D-MI), Chairman of the Committee on Energy and Commerce, and Rep. Bart Stupak (D-MI), Chairman of the Oversight and Investigations Subcommittee, today wrote to the CEOs of Schering-Plough Corporation and Merck & Co, Inc., and to Kerry N. Weems, Acting Administrator of the Centers for Medicare and Medicaid Services (CMS), requesting information about the ENHANCE study trial. The ENHANCE study compared the brand-name drug Vytorin to the generic drug simvastatin, both of which are used to treat patients with high-cholesterol. The study results show that Vytorin, which is a combination of Zetia and the generic simvastatin, resulted in no significant difference when compared to simvastatin alone.

The Committee on Energy and Commerce began an investigation into the ENHANCE trial on December 11, 2007. The investigation was launched following concerns that, although the ENHANCE trial ended in April 2006, the data had not yet been released. The results were recently released on January 14, 2008.

January 22, 2008

Mr. Fred Hassan
Chairman and CEO
Schering-Plough Corporation
2000 Galloping Hill Road
Kenilworth, NJ 07033

Mr. Richard T. Clark
Chairman, President, and CEO
Merck & Co., Inc.
One Merck Drive
P.O. Box 100
Whitehouse Station, NJ 08889

Dear Mr. Hassan and Mr. Clark:

Under Rules X and XI of the Rules of the U.S. House of Representatives, the Committee on Energy and Commerce and its Subcommittee on Oversight and Investigations are continuing their investigation into Vytorin and the ENHANCE trial.

Since the Committee’s initial letter dated December 11, 2007, we have discovered that, in addition to the ad hoc advisory board convened after the trial’s conclusion, there may have been a scientific advisory committee or advisory board created at the outset of the ENHANCE trial that was to periodically meet to discuss the ENHANCE trial, and that it may include a European and U.S. component. We wish to determine whether such an advisory board exists and also whether there was a Data Safety Monitoring Board associated with the ENHANCE trial.

We have also discovered that a Schering-Plough officer, Carrie Smith Cox, sold significant numbers of shares of Schering-Plough in the time between the end of the ENHANCE study and the release of the results on January 14, 2008. This raises questions as to whether this sale was related to any knowledge of the study’s results.

Your press release of January 14, 2008, stated, “Key secondary imaging endpoints showed no statistical difference between treatment groups.” The press release did not, however, provide specific data related to these secondary endpoints.

Therefore, in addition to our prior requests, we ask that Schering-Plough and Merck provide the Committee answers to the following questions:

1. Was there an advisory committee, board, or panel of any sort, either within the United States, Europe, or both, with the charge of meeting periodically to discuss the ENHANCE trial?

2. Was there a Data Safety Monitoring Board associated with the ENHANCE trial?

3. Have you decided to discontinue direct-to-consumer advertisements for Vytorin, or have you decided to reduce your advertising for the drug?

4. Did any corporate officer have knowledge of the results or any preliminary results of the ENHANCE trial prior to the public release of results on January 14, 2008?

We also ask that Schering-Plough and Merck provide the following:

1. Names and qualifications of all persons on any aforementioned committee created to discuss the ENHANCE trial;

2. All records, including but not limited to, minutes and transcripts relating to all meetings of any advisory committee, board, or panel created to meet periodically to discuss the ENHANCE trial;

3. All records of communications between the members of any aforementioned committee to Schering-Plough, Merck, or Dr. John Kastelein;

4. Names and qualifications of all persons on a Data Safety Monitoring Board for the ENHANCE trial;

5. All records, including but not limited to, minutes and transcripts relating to all meetings of a Data Safety Monitoring Board;

6. All records of all briefings to corporate officers of Schering-Plough or Merck relating to the ENHANCE trial;

7. All records of stock sales by Schering-Plough and Merck corporate officers between April 2006 and January 2008, inclusive;

8. All financial and contractual records relating to the division of revenue from Vytorin between Schering-Plough and Merck, including, but not limited to, the percentage of revenue allocated to Zetia versus simvastatin;

9. Results of secondary analyses of the ENHANCE trial, specifically the secondary endpoints detailed in “Kastelein JJ, Sager PT, de Groot E, Veltri E. Comparison of ezetimibe plus simvastatin versus simvastatin monotherapy on atherosclerosis progression in familial hypercholesterolemia. Design and rationale of the Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression (ENHANCE) trial. Am Heart J. 2005 Feb;149(2):234-9.”; and

10. The original ENHANCE trial protocol.

Please deliver the responses to our questions and copies of the requested records to the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, Room 316, Ford House Office Building, by no later than two weeks from the date of this letter. Please note that for the purpose of responding to this request, the terms “record” and “relating” should be interpreted in accordance with the attachment to this letter. After review of the records, we may require additional records and/or staff interviews with study investigators and corporate officials.

Thank you for your prompt attention to this matter. If you have any questions related to this request, please contact us or have your staff contact John F. Sopko or Paul Jung of the Committee staff at (202) 226-2424.

Sincerely,

John D. Dingell
Chairman

Bart Stupak
Chairman
Subcommittee on Oversight and Investigations

cc: The Honorable Joe Barton, Ranking Member
Committee on Energy and Commerce

The Honorable John Shimkus, Ranking Member
Subcommittee on Oversight and Investigations

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