As I proimised here, I now provide the balance of Senator Chuck Grassley's public letters, to date, to Fred Hassan, relative to the ENHANCE study failure. All of the answers to these NEW questions are due back to Senator Grassley's Staff by Monday. Yep -- this coming Monday. So, we should learn a lot more about Schering-Plough's so-called "49 Plan" by mid-next week.
March 31, 2008
Fred Hassan
Chairman and Chief Executive Officer
Schering-Plough Corporation
2000 Galloping Hill Road
Kenilworth, NJ 07033
Richard T. Clark
Chairman, President, and
Chief Executive Officer
Merck & Co. Inc.
1 Merck Drive
Whitehouse Station, NJ 08889
Dear Messrs. Clark and Hassan:
As Ranking Member of the United States Senate Committee on Finance (Committee), I have an obligation to the more than 80 million Americans who receive health care coverage under Medicare and Medicaid to ensure that taxpayer and beneficiary dollars are spent in a fiscally sound manner. This includes the responsibility to conduct oversight of the medical and pharmaceutical industries to ensure that Medicare and Medicaid dollars are spent appropriately on safe and effective drugs and devices.
I continue to be troubled by reports that Merck and Schering Plough (M/SP) were delaying results of the ENHANCE trial. This study examined whether Vytorin provides better health benefits than generic simvastatin -- a drug that is far less expensive than Vytorin. The ENHANCE trial was completed in April 2006, but the results were not released for almost two years.
I am pleased to see that M/SP finally released the long awaited results of the ENHANCE trial at this weekend's American College of Cardiology (ACC) meeting. However, I am troubled to learn that after careful analysis of the ENHANCE results, medical experts are now calling Vytorin the cholesterol fighter of last resort.
According to reports today on CNBC, at least one prominent cardiologist is now referring to Vytorin as an "expensive placebo." Medical professionals should have had the facts about Vytorin much earlier so they could make informed decisions about the care that they provide to patients.
Delaying the release of the results from the ENHANCE trial not only affected medical decisions, but also imposed financial burdens on patients as well as the federal government. Since the ENHANCE trial was completed in 2006, the federal government has paid M/SP hundreds of millions of dollars for Vytorin.
Additionally, I am not the only one troubled by the delay in the release of ENHANCE.
During their review of documents submitted by M/SP, my Committee staff found emailsbetween Schering Plough employees and Dr. John Kastelein, the primary investigator of the ENHANCE trial. Those emails are seminal in documenting Dr. Kastelein's concerns about M/SP's delay in releasing the results of ENHANCE. Last July, Dr. Kastelein wrote to a Schering Plough executive:
". . . .Is it correct that SP has decided not to present at AHA, but to await the two other, completely unvalidated, endpoints, which analysis is going to take us straight into 2008??!!??
If this is true, SP must have taken this decision without even the semblance of decency to consult me as PI of the study. I can tell you that if this is the case, our collaboration is over. . . This starts smelling like extending the publication for no other [than] political reasons and I cannot live with that. . . ."
That next day, Dr. Kastelein wrote again to a Schering Plough executive:". . . .I have been travelling half the globe in the last 6 months to a number of large and important meetings at the strong wish of Merck to chair them or to present ezetimibe data. At every single one of them I was cleared to say that ENHANCE would be presented at AHA. There is no reason whatsoever to include femorals; you will be seen as a company that tries to hide something and I will be perceived as being in bed with you!. . . ."
I am also troubled that M/SP may be placing marketing interests above science. For instance, in an M/SP marketing review done just last December, it appears that advancing sales, not science, was the priority. Page 8 of the document details messaging adjustments for 2008 such as "Incorporate 'lower is better' into message flow" and "incorporate switch message -- SNAG (simvastatin not at goal). Another slide show created by your respective companies last year noted that, "History has shown that ZETIA is extremely sensitive to promotion, with consistent share growth demonstrated when fully promoted."
Further, it was reported in the media that M/SP launched an ongoing Public Relations blitz called the "49 plan," designed to wine and dine doctors and convince them to prescribe Vytorin. In recent days, I have learned that M/SP budgeted at least $3.5 million for the "49 plan." This seems like a great deal of money for free lunches and dinners.
In addition, while the health benefits of Vytorin appear similar to a cheaper generic, the difference in cost to the patient and to the Medicare and Medicaid programs is significant. For instance, at a Wal-Mart pharmacy in Iowa City, generic simvastatin costs $54.54 for a month's supply. On the other hand, Vytorin costs $112.46 -- more than twice as much. Thus, I remain troubled that M/SP failed to report any results from the ENHANCE trial until January 2008 while trying over the last year or two to get doctors to switch their patients to Vytorin from other, less expensive statin drugs.
Accordingly, I request that M/SP respond to the following questions and requests for documents. In answering, please repeat the question and follow each question with the appropriate response and documentation as requested.1. Please provide the names and titles of all Key Opinion Leaders (KOL) for ENHANCE, Vytorin, and/or Zetia.
2. Please provide a list of all payments, if any, made to these KOLs during the period of November 2007 to the present. For each payment to a KOL provide thefollowing:
a) Name of physician
b) Date of payment
c) Payment description (CME, honorarium, research support, etc.)
d) Amount of payment
3. In addition to the $3.5 million budgeted for the "49 plan," how much was budgeted for the marketing and advertising of Vytorin since the ENHANCE trial was completed in April 2006, including direct-to-consumer advertising?
In cooperating with the Committee's review, no documents, records, data, or other information related to these matters, either directly or indirectly, shall be destroyed, modified, removed, or otherwise made inaccessible to the Committee.
I look forward to hearing from you by no later than April 14, 2008.
Sincerely,
United States Senator
Ranking Member,
Committee on Finance
[Emphasis supplied.]
Next week should provide an interesting ride.
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