Did Wyeth attempt to discredit an FDA employee?

Did Wyeth attempt to discredit an FDA employee who came out against a Wyeth drug?

See letter below from Sen. Grassley, from http://www.medadnews.com/News/Index.cfm?articleid=292534 and a related post on Pharmawatch.blogspot.com .

Note the extensive "instructions" at the end of Grassley's letter. Great boilerplate for an inquiry or for legal discovery. This senator knows how to avoid the strategies of semantic gamesmanship, feigned confusion, stonewalling and obfuscation utilized by large organization legal departments.

-- SS


November 17, 2005
Mr. Robert Essner
Chairman, President, and CEO
North America and Global Business
Wyeth Pharmaceuticals
500 Arcola Road
Collegeville, PA 19426

Dear Mr. Essner:

As a senior member of the United States Senate and as Chairman of the Committee on Finance (Committee), it is my duty under the Constitution to conduct oversight into the actions of the government and companies that do business with the government. Over the past year, the Committee has reviewed various matters relating to the pharmaceutical industry and its relationship with the Food and Drug Administration (FDA). In previous letters to you, the Committee sought your assistance with inquiries into nominal pricing, educational grants, as well as employer sponsored education of the False Claims Act. I write today seeking your continued cooperation with a matter concerning Wyeth Pharmaceuticals (Wyeth) and FDA’s Center for Veterinary Medicine (CVM).

Recently, the Committee received allegations regarding Wyeth and events surrounding the recall of the heartworm medication ProHeart 6. Information and documents reviewed by the Committee appear to support allegations that Wyeth investigated an employee of the FDA involved in the safety review of ProHeart 6. It appears that the express purpose of the investigation was to discredit the employee and have the employee reassigned. Further, following the investigation conducted by Wyeth, the FDA initiated an internal criminal investigation into the same FDA employee. The Committee’s review of these allegations raises serious questions regarding, among other things, the appropriateness of the actions taken by both the FDA and Wyeth.

Wyeth manufactures and distributes a number of animal health care products through its division Fort Dodge Animal Health (FDAH), including at one time, the heartworm preventative drug called ProHeart 6. Originally approved in 2001 by the FDA, ProHeart 6 was a novel heartworm prevention drug for dogs. It was an injectable sustained-release drug that provided six months of coverage and was administered only by a veterinarian. As part of the FDA’s postmarket review of ProHeart 6, the FDA assigned Dr. Victoria Hampshire, V.M.D., as the Adverse Drug Event Coordinator, to monitor adverse events sent in by both consumers and veterinarians. From 2003 to 2005, Dr. Hampshire compiled the results of over 5500 adverse drug event reports (ADEs) related to ProHeart 6, including nearly 500 canine deaths. Responding to the numerous adverse drug reports, Dr. Hampshire urged the FDA to take action on ProHeart 6 in November of 2003. While this initial call to action garnered little attention within the FDA, a subsequent effort by distraught consumers in July 2004 caught the attention of Dr. Sundlof, the Director of CVM. Dr. Hampshire presented this information and subsequently brought the matter to the attention of former Commissioner Dr. Lester Crawford. Dr. Crawford, a veterinarian himself, agreed with the findings and on September 1, 2004, the FDA organized a meeting with Wyeth to review the adverse event data.

Following the presentation, CVM, the Acting Commissioner and FDA Legal Counsel agreed to recall ProHeart 6 from the market. After two days of negotiating with the FDA, Wyeth voluntarily recalled ProHeart 6 from the market on September 4, 2004.

Shortly after the recall of ProHeart 6, Wyeth sought a review of the recall decision through a meeting of the Veterinary Medicine Advisory Committee (VMAC). The FDA granted the request for a VMAC meeting and scheduled it for January 2005. It appears the timing of the VMAC would have allowed Wyeth a chance to reintroduce ProHeart 6 for the spring heartworm season if the VMAC voted to support its return to the market. In preparation for the VMAC meeting, Dr. Hampshire prepared a presentation regarding the thousands of ADEs received and worked to ensure that the advisory committee would have complete information regarding these events.

Documents obtained and reviewed by the Committee, coupled with interviews conducted by Committee staff, appear to support allegations that Wyeth investigated Dr. Hampshire and presented its findings to Dr. Crawford. Following Wyeth’s presentation, Dr. Hampshire was removed from the review of ProHeart 6 and subjected to a criminal investigation by the FDA. FDA Investigators advised Committee staff that the criminal investigation resulted in no action taken against Dr. Hampshire. Furthermore, the FDA recently gave Dr. Hampshire an award for her job performance related to ProHeart 6.

Information available to the Committee appears to support allegations that Wyeth’s efforts to discredit Dr. Hampshire were not limited to the FDA. More specifically, it appears that Wyeth’s efforts to reintroduce ProHeart 6 to the market included a Wyeth sales representative presenting information to the veterinary community in an apparent effort to discredit Dr. Hampshire. Attached is a two-page letter from a veterinarian and former commissioned officer in the United States Public Health Service. According to the letter, a Wyeth sales representative in Alabama stated that Dr. Victoria Hampshire was the sole reason for the recall of ProHeart 6.

Further, the Wyeth representative stated that Wyeth investigated Dr. Hampshire and said that she pursued the withdrawal of ProHeart 6 for personal financial gain. Finally, the Wyeth representative added that once “[Dr. Hampshire] was taken care of” the number of adverse event reports being submitted for ProHeart 6 dropped significantly. As Chairman of the Committee, I request that Wyeth provide the following records and information to the Committee:

(1) State how Wyeth concluded that Dr. Hampshire had an “apparent conflict of interest.” In complying with this request, describe in detail the actions taken by Wyeth, including but not limited to whether or not Wyeth subsidized, either directly or indirectly, an investigation of Dr. Hampshire. Additionally, provide copies of all communications, documents, and records related to Wyeth’s conclusion that Dr. Hampshire had an “apparent conflict of interest,” including but not limited to, payments associated with one or more investigation(s) of Dr. Hampshire.

(2) Identify all individual(s) and/or agent(s) (including full name, title, and contact information) employed by and/or associated with Wyeth, either directly or indirectly, who were involved in any way with an investigation(s) of Dr. Hampshire. In the event that any individual(s) and/or agent(s) is/are no longer associated with Wyeth, identify that individual(s) and/or agent(s) as well.

(3) Identify all individual(s) and/or agent(s) (including full name, title, and contact information) employed by and/or associated with Wyeth, either directly or indirectly, who were involved in any way with the research supporting and the preparation of the Power Point presentation entitled, “ProHeart 6 Apparent Conflict of Interest,” dated November 19, 2004. In the event that any individual(s) and/or agent(s) is/are no longer associated with Wyeth, identify that individual(s) and/or agent(s) as well.

(4) Provide copies of all documents and records, including but not limited to communications and email, related to the Wyeth Power Point presentation entitled, “ProHeart 6 Apparent Conflict of Interest,” dated November 19, 2004.

(5) State whether or not Wyeth provided notice to the FDA that it was initiating or conducting a private investigation into an FDA employee? If so, provide the name(s) of any individual at the FDA who received notice prior to the initiation of the investigation. Provide copies of all records, including but not limited to communications and emails between Wyeth and the FDA related to the investigation of Dr. Hampshire.

(6) How many times has Wyeth investigated an FDA employee(s) and/or presented information to the FDA related to an FDA employee’s apparent conflict of interest? Additionally, describe in detail the facts associated with each investigation and/or presentation.

(7) Provide complete contact information for Mr. Clint “C.T.” Newsum, Vice President for Wyeth Pharmaceuticals. Additionally, please make Mr. Newsum available for an interview with my staff to take place no later than December 23, 2005.

(8) Provide complete contact information for Mr. Glen Kimmorely, a Senior Territory Manager for Fort Dodge Animal Health, a division of Wyeth Pharmaceuticals. Additionally, please make Mr. Kimmorely available for an interview with my staff to take place no later than December 23, 2005.

(9) Provide complete contact information for Mr. Tom O’Hare of Copiague, New York. Identify the relationship Mr. O’Hare has with Wyeth Pharmaceuticals, including but not limited to, any financial relationship. State whether or not Wyeth is able to make Mr. O’Hare available for an interview, and if so, please make Mr. O’Hare available for an interview with my staff to take place no later than December 23, 2005.

Thank you in advance for providing the name and contact information, including an email address, for a person who will act as the point of contact for Wyeth Pharmaceuticals during the Committee’s review by November 22, 2005, unless it is available sooner. All requests for communications, documents, records and written responses to questions should be received no later than December 16, 2005. In cooperating with the Committee’s review, no documents, records, data or information related to these matters shall be destroyed, modified, removed or otherwise made inaccessible to the Committee.

Sincerely,

Charles E. Grassley
United States Senator
Attachment

GENERAL INSTRUCTIONS

1. Please note that, for purposes of responding to this document request, the terms “document” and “record” should be interpreted in accordance with the general definitions attached to this letter.

2. In complying with this document request, produce all responsive documents that are in your possession, custody, or control, whether held by you or your past or present agents, employees, and representatives acting on your behalf. In addition, produce documents that you have a legal right to obtain, documents that you have a right to copy or have access to, and documents that you have placed in the temporary possession, custody, or control of any third party.

3. No documents, records, data or information requested by the Committee shall be destroyed, modified, removed or otherwise made inaccessible to the Committee.

4. If the document request cannot be complied with in full, it shall be complied with to the extent possible, which shall include an explanation of why full compliance is not possible.

5. In complying with this document request, respond to each enumerated request by repeating the enumerated request and identifying the responsive document(s).

6. Each document produced shall be produced in a form that renders the document susceptible of copying.

7. If any document responsive to this request was, but no longer is, in your possession, custody, or control, identify the document (stating its date, author, subject and recipients) and explain the circumstances by which the document ceased to be in your possession, or control.

8. This request is continuing in nature. Any document, record, compilation of data or information, not produced because it has not been located or discovered by the return date, shall be produced immediately upon location or discovery subsequent thereto.

GENERAL DEFINITIONS

1. The term “Wyeth” means Wyeth Pharmaceuticals, its corporation, its board of directors, or one or more of its divisions, subsidiaries or affiliates, or related entities, including, but not limited to, Fort Dodge Animal Health.

2. The term “document” means any written, recorded, or graphic matter of any nature whatsoever, regardless of how recorded, and whether original or copy, including, but not limited to the following: memoranda, reports, statistical or analytical reports, books, manuals, instructions, financial reports, working papers, records notes, letters, notices, confirmations, telegrams, receipts, appraisals, pamphlets, magazines, newspapers, prospectuses, interoffice and intra office communications, electronic mail (E-mail), contracts, cables, notations of any type of conversation, telephone call, meeting or other communication, bulletins, printed matter, computer printouts, teletypes, invoices, transcripts, diaries, analyses, returns, summaries, minutes, bills, accounts, estimates, projections, comparisons, messages, correspondence, press releases, circulars, financial statements, reviews, opinions, offers, studies and investigations, questionnaires and surveys, and work sheets (and all drafts, preliminary versions, alterations, modifications, revisions, changes, and amendments of any of the foregoing, as well as any attachments or appendices thereto), and graphic or oral records or representations of any kind (including without limitation, photographs, charts, graphs, microfiche, microfilm, videotape, recordings and motion pictures), and electronic, mechanical, and electric records or representations of any kind (including, without limitation, tapes, cassettes, discs, and recordings) and other written, printed, typed, or other graphic or recorded matter of any kind or nature, however produced or reproduced, and whether preserved in writing, film, tape, disc, or videotape. A document bearing any notation not a part of the original text is to be considered a separate document. A draft or non-identical copy is a separate document within the meaning of this term.

3. The term “records” is to be construed in the broadest sense and shall mean any written or graphic material, however produced or reproduced, of any kind or description, consisting of the original and any non-identical copy (whether different from the original because of notes made on or attached to such copy or otherwise) and drafts and both sides thereof, whether printed or recorded electronically or magnetically or stored in any type of data bank, including, but not limited to, the following: correspondence, memoranda, records, summaries of personal conversations or interviews, minutes or records of meetings or conferences, opinions or reports of consultants, projections, statistical statements, drafts, contracts, agreements, purchase orders, invoices, confirmations, telegraphs, telexes, agendas, books, notes, pamphlets, periodicals, reports, studies, evaluations, opinions, logs, diaries, desk calendars, appointment books, tape recordings, video recordings, e-mails, voice mails, computer tapes, or other computer stored matter, magnetic tapes, microfilm, microfiche, punch cards, all other records kept by electronic, photographic, or mechanical means, charts, photographs, notebooks, drawings, plans, inter-office communications, intra-office and intra-departmental communications, transcripts, checks and canceled checks, bank statements, ledgers, books, records or statements of accounts, and papers and things similar to any of the foregoing, however denominated.

4. The terms “relate,” “related,” “relating,” or “regarding” as to any given subject means anything that discusses, concerns, reflects, constitutes, contains, embodies, identifies, deals with, or is any manner whatsoever pertinent to that subject, including but not limited to documents concerning the preparation of other documents.

5. The terms “and” and “or” shall be construed broadly and either conjunctively or disjunctively to bring within the scope of this document request any information which might otherwise be construed to be outside its scope. The singular includes plural number, and vice versa to bring within the scope of this document request any information which might otherwise be construed to be outside its scope.

6. The term “communication” means each manner or means of disclosure or exchange of information, regardless of means utilized, whether oral, written, electronic, by document or otherwise, and whether face to face, in a meeting, by telephone, mail, telexes, discussions, releases, personal delivery, or otherwise. Documents that typically reflect a “communication” include handwritten notes, telephone memoranda slips, daily appointment books and diaries, bills, checks, correspondence and memoranda, and includes all drafts of such documents.