Grassley Seeks Marketing and Safety Documents From Major Drug Maker

WASHINGTON – Sen. Chuck Grassley is asking the drug maker, Eli Lilly and Company, for information related to the risks and marketing of the anti-psychotic drug Zyprexa.

Grassley made this request in response to allegations that the company downplayed safety risks and engaged in other improper marketing practices that may be jeopardizing patients’ health. The text of Grassley’s letter follows here.

April 4, 2007
Via Electronic Transmission
Sidney Taurel
Chairman and Chief Executive Officer
Eli Lilly and Company
Lilly Corporate Center
Indianapolis , IN 46285

Dear Mr. Taurel:

As a senior member of the United States Senate and as Ranking Member of the Committee on Finance (Committee), I have an obligation to ensure that the public’s money is properly spent to provide safe and effective treatments to the vulnerable populations that are beneficiaries of the Medicare and Medicaid programs.

I am aware of several pending products liability actions regarding Zyprexa, an anti-psychotic drug manufactured by Eli Lilly and Company (Eli Lilly). Specifically, questions have been raised regarding safety information and marketing practices relating to that drug. Furthermore, I understand that Eli Lilly produced certain documents in the course of these litigations that shed light on issues of interest to the Committee.

On December 20, 2006, I wrote to Dr. David Egilman, a plaintiffs’ expert, to request information and documents related to Zyprexa. Dr. Egilman did not provide any confidential Eli Lilly documents regarding Zyprexa. Instead, Dr. Egilman responded to my request by providing the Committee with a copy of a discovery order, dated December 15, 2006, instructing him to return Eli Lilly documents in his possession to Richard D. Meadow of the Lanier Law Firm. Eli Lilly had alleged that some of its confidential documents had been disseminated without the company’s authorization. Although no one affiliated with the Committee was a party to that dispute, I decided to suspend efforts to obtain the relevant documents until that dispute was resolved.

On February 14, 2007, Judge Jack Weinstein of the U.S. District Court for the Eastern District of New York issued a decision regarding the confidential Eli Lilly documents. The court enjoined several individuals from further disseminating the protected documents and ordered them to return any such documents and copies still in their possession or control. Contrary to what was reported in Judge Weinstein’s decision, the Committee’s Chief Investigative Counsel, Emilia DiSanto, did not receive any protected documents related to Zyprexa from Mr. James Gottstein or Dr. Egilman. Nor did Mr. Gottstein or Dr. Egilman provide any protected documents related to Zyprexa to other Committee staff.

As the dispute regarding the dissemination of the documents is now resolved, I believe the time is now right for the Committee to pursue its request for the documents. I am writing to request your cooperation with the Committee’s inquiry. In that regard please provide to the Committee all documents and materials, including, but not limited to, emails, letters, reports, and memoranda, that were made available to the court-appointed Plaintiffs’ Steering Committee I and II pursuant to pretrial discovery in In re Zyprexa Prods. Liab. Litig.

Thank you in advance for assisting the Committee. I would appreciate receiving the requested documents in an electronic and searchable format by no later than April 25, 2007.

Sincerely,

Charles E. Grassley
United States Senator
Ranking Member, Committee on Finance

http://grassley.senate.gov/news/Article.cfm?customel_dataPageID_1502=3917