November 17,2005

Grassley Floor Statement on One-Year Anniversary of Committee Hearing on the Food and Drug Administration and Vioxx

Floor Statement of U.S. Senator Chuck Grassley of Iowa
One-Year Anniversary of the Finance Committee’s Hearing on the FDA and Vioxx
Thursday, November 17, 2005

 Mr. President, I rise today on the anniversary of the hearing on the worldwide withdrawalof Vioxx, the blockbuster drug that became a blockbuster disaster. As chairman of theCommittee on Finance, I called for this hearing a year ago. The Vioxx hearing turned thespotlight on a troubled agency in denial. The type of problems exposed during the hearing haveproven to be not isolated but systemic.

Over the past year, my Committee staff have investigated allegations coming from withinand without the agency. Brave whistleblowers – such as Doctors Andrew Mosholder, DavidGraham and others – have come forward to expose the too cozy relationship between the agencyand the drug industry. I can tell you today that problems exist not only within the Center fordrugs, but extend to the Centers for devices, biologics and even to veterinary medicines. I amconcerned and every other member of this Senate should also be concerned.

To further illustrate this problem, I am sending today a letter to another drug companythat appears too cozy with the Food and Drug Administration. Last year, just two days after theVioxx hearing, the drug company Wyeth met with former Commissioner Crawford. Why didWyeth’s CEO want to talk with the Commissioner? Because Wyeth recently had to remove oneof its most profitable veterinary drugs from the market.

So what did Wyeth do? They launched an investigation of an FDA employee, Dr.Victoria Hampshire. You see, it was Dr. Hampshire who concluded that Wyeth’s drug waskilling hundreds of dogs. I have in my hand what Wyeth presented to former CommissionerCrawford. It’s a 29-page power point with 10 pages of back up materials, dated November 19,2004. It’s marked “confidential” and says “ProHeart 6 Apparent Conflict of Interest.”In summary, it alleges that Dr. Hampshire had personal and financial conflicts of interest.

Dr. Hampshire approached my Committee staff because she was scared and felt unfairly targetedby Wyeth and her agency for simply doing her job. Last week, the FDA briefed my Committeeinvestigators on this matter. It turns out that Wyeth succeeded in having Dr. Hampshire removedfrom reviewing its drug. Dr. Hampshire’s hard work and dedication to science and drug safetyplaced a bulls eye on her reputation and career. Without her knowledge, the FDA also launched acriminal investigation against her.

This sordid story is still unraveling. But I can say that no action was taken against Dr.Hampshire and, after the investigation closed, the FDA rewarded her for her work on Wyeth’sdrug, which remains off the market. Unfortunately for Dr. Hampshire, Wyeth’s efforts todiscredit her did not end at the FDA. At least one Wyeth sales representative attempted todiscredit Dr. Hampshire in the Veterinary community. Fortunately for Dr. Hampshire, the salesperson’s comments about Wyeth’s investigation of her and her alleged conflicts of interest weremade to a former colleague of Dr. Hampshire. My letter to Wyeth today seeks information anddocuments related to Wyeth’s investigation of Dr. Hampshire and the salesperson’s comments.So a year later, we are still uncovering the cozy relationship between the agency and thedrug industry. Dr. Hampshire’s sad story is further proof that the FDA needs a permanentCommissioner who can restore order and respect for independence. The Food and DrugAdministration cannot serve the American people and the interests of the drug industry at thesame time.

A year ago today, Dr. Graham created a firestorm when he said at the Vioxx hearing, “Ican tell you right now, there are at least five drugs on the market today that I think need to belooked at quite seriously to see whether or not they belong there...”. Dr. Graham identified thosefive drugs – Accutane, Bextra, Crestor, Meridia and Serevent – when asked by my distinguishedcolleague, Sen. Bingaman. Some roundly criticized Dr. Graham’s testimony as inflammatory.Today, it is noteworthy that the agency has taken regulatory action or action is pending onfour out five of the named drugs. Less than a week after the hearing, the Food and DrugAdministration announced it was strengthening its plan to reduce the risk of birth defectsassociated with Accutane. Then in August, the agency issued a public health advisory to helpmake sure females do not become pregnant while taking this medicine and to release moreinformation about depression and suicidal thoughts associated with the drug.

A month after the hearing, the Food and Drug Administration issued a public healthadvisory for Bextra. The agency announced it changed Bextra’s label to provide consumers withupgraded warnings about possible heart and blood clotting problems. Ultimately, the agencyasked Pfizer to voluntarily remove Bextra from the market in April. Less than four months afterDr. Graham’s testimony, Crestor was subject to a public health advisory too as part of theagency’s efforts to notify the public of potentially significant emerging safety data. Crestor’slabel was changed to highlight important information on the safe use of Crestor. Eight monthsafter the hearing, the Food and Drug Administration convened an Advisory Committee meetingrelated to the safety of Serevent and other asthma drugs. The Advisory Committee recommendedstrengthening the labels for Serevent too, but the agency has yet to act. Only one drug –MERIDIA – has not been the subject of any action by the FDA.

American consumers are the beneficiaries of these actions. I don’t know if the agencywould have acted without Dr. Graham’s testimony. But I know from experience that sunlight isthe best disinfectant. The scrutiny of the last 12 months is just the kind of medicine the Food andDrug Administration needed. Things have not turned around overnight.

Reforming this agency is a long-haul task for those of us in Congress committed tooversight, reform and improvement. The Vioxx investigation and hearing, as well as otherinvestigations, prompted me to co-sponsor two FDA reform bills this year. Senator Dodd and Iintroduced the Fair Access to Clinical Trials Act in February and the Food and DrugAdministration Safety Act of 2005 in April. These bills represent part of a sustained effort torestore public confidence in the federal government’s food and drug safety agency. A number ofyou have co-sponsored these bills with us and I urge everyone to consider them again today.

Enactment of these bills will be another meaningful step toward greater accountabilityand transparency for the Food and Drug Administration. And if enacted they would provide theagency with some much-needed authorities to ensure the safety and efficacy of drugs. One bigopportunity that absolutely cannot be missed right now is appointment of a new, full-timecommissioner who is committed to reform. This leader must recognize the problems of a culturethat’s become too cozy with the industry. Then that leader must be tough enough to makenecessary changes happen. Mr. President, the FDA has to do a top-notch job on ensuring thesafety of the products it regulates. And where the FDA lacks the tools and resources to do so, Congress has to step in and help.

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 onFinance (Committee), it is my duty under the Constitution to conduct oversight into the actionsof the government and companies that do business with the government. Over the past year, theCommittee has reviewed various matters relating to the pharmaceutical industry and itsrelationship with the Food and Drug Administration (FDA). In previous letters to you, theCommittee sought your assistance with inquiries into nominal pricing, educational grants, as wellas employer sponsored education of the False Claims Act. I write today seeking your continuedcooperation with a matter concerning Wyeth Pharmaceuticals (Wyeth) and FDA’s Center forVeterinary Medicine (CVM).

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

Wyeth manufactures and distributes a number of animal health care products through itsdivision Fort Dodge Animal Health (FDAH), including at one time, the heartworm preventativedrug called ProHeart 6. Originally approved in 2001 by the FDA, ProHeart 6 was a novelheartworm prevention drug for dogs. It was an injectable sustained-release drug that provided sixmonths of coverage and was administered only by a veterinarian. As part of the FDA’s postmarketreview of ProHeart 6, the FDA assigned Dr. Victoria Hampshire, V.M.D., as the AdverseDrug 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 eventreports (ADEs) related to ProHeart 6, including nearly 500 canine deaths. Responding to thenumerous adverse drug reports, Dr. Hampshire urged the FDA to take action on ProHeart 6 inNovember of 2003. While this initial call to action garnered little attention within the FDA, asubsequent effort by distraught consumers in July 2004 caught the attention of Dr. Sundlof, theDirector of CVM. Dr. Hampshire presented this information and subsequently brought the matterto the attention of former Commissioner Dr. Lester Crawford. Dr. Crawford, a veterinarianhimself, agreed with the findings and on September 1, 2004, the FDA organized a meeting withWyeth to review the adverse event data.

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

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

Documents obtained and reviewed by the Committee, coupled with interviews conductedby Committee staff, appear to support allegations that Wyeth investigated Dr. Hampshire andpresented its findings to Dr. Crawford. Following Wyeth’s presentation, Dr. Hampshire wasremoved 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 actiontaken against Dr. Hampshire. Furthermore, the FDA recently gave Dr. Hampshire an award forher job performance related to ProHeart 6.

Information available to the Committee appears to support allegations that Wyeth’sefforts to discredit Dr. Hampshire were not limited to the FDA. More specifically, it appears thatWyeth’s efforts to reintroduce ProHeart 6 to the market included a Wyeth sales representativepresenting 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 inthe United States Public Health Service. According to the letter, a Wyeth sales representative inAlabama 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 shepursued the withdrawal of ProHeart 6 for personal financial gain. Finally, the Wyethrepresentative added that once “[Dr. Hampshire] was taken care of” the number of adverse eventreports being submitted for ProHeart 6 dropped significantly.

As Chairman of the Committee, I request that Wyeth provide the following records andinformation to the Committee:

(1) State how Wyeth concluded that Dr. Hampshire had an “apparent conflict of interest.” Incomplying with this request, describe in detail the actions taken by Wyeth, including but notlimited to whether or not Wyeth subsidized, either directly or indirectly, an investigation of Dr.Hampshire. Additionally, provide copies of all communications, documents, and records relatedto Wyeth’s conclusion that Dr. Hampshire had an “apparent conflict of interest,” including butnot 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 inany way with an investigation(s) of Dr. Hampshire. In the event that any individual(s) and/oragent(s) is/are no longer associated with Wyeth, identify that individual(s) and/or agent(s) aswell.

(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 inany way with the research supporting and the preparation of the Power Point presentationentitled, “ProHeart 6 Apparent Conflict of Interest,” dated November 19, 2004. In the event thatany individual(s) and/or agent(s) is/are no longer associated with Wyeth, identify thatindividual(s) and/or agent(s) as well.

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

(5) State whether or not Wyeth provided notice to the FDA that it was initiating or conducting aprivate investigation into an FDA employee? If so, provide the name(s) of any individual at theFDA 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 tothe investigation of Dr. Hampshire.

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

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

(8) Provide complete contact information for Mr. Glen Kimmorely, a Senior Territory Managerfor Fort Dodge Animal Health, a division of Wyeth Pharmaceuticals. Additionally, please makeMr. 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. Identifythe relationship Mr. O’Hare has with Wyeth Pharmaceuticals, including but not limited to, anyfinancial relationship. State whether or not Wyeth is able to make Mr. O’Hare available for aninterview, and if so, please make Mr. O’Hare available for an interview with my staff to takeplace 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 thisletter.

2. In complying with this document request, produce all responsive documents that are in yourpossession, 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 legalright to obtain, documents that you have a right to copy or have access to, and documents thatyou 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 extentpossible, 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 theenumerated request and identifying the responsive document(s).

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

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 thecircumstances 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 orinformation, not produced because it has not been located or discovered by the return date, shallbe produced immediately upon location or discovery subsequent thereto.

GENERAL DEFINITIONS

1. The term “Wyeth” means Wyeth Pharmaceuticals, its corporation, its board of directors, or oneor 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 naturewhatsoever, regardless of how recorded, and whether original or copy, including, but not limitedto 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 andintra office communications, electronic mail (E-mail), contracts, cables, notations of any type ofconversation, 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, pressreleases, 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 anyattachments 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 orrepresentations 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, orvideotape. A document bearing any notation not a part of the original text is to be considered aseparate document. A draft or non-identical copy is a separate document within the meaning ofthis term.

3. The term “records” is to be construed in the broadest sense and shall mean any written orgraphic material, however produced or reproduced, of any kind or description, consisting of theoriginal and any non-identical copy (whether different from the original because of notes madeon or attached to such copy or otherwise) and drafts and both sides thereof, whether printed orrecorded electronically or magnetically or stored in any type of data bank, including, but notlimited to, the following: correspondence, memoranda, records, summaries of personalconversations or interviews, minutes or records of meetings or conferences, opinions or reportsof 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, taperecordings, video recordings, e-mails, voice mails, computer tapes, or other computer storedmatter, magnetic tapes, microfilm, microfiche, punch cards, all other records kept by electronic,photographic, or mechanical means, charts, photographs, notebooks, drawings, plans, inter-officecommunications, intra-office and intra-departmental communications, transcripts, checks andcanceled checks, bank statements, ledgers, books, records or statements of accounts, and papersand things similar to any of the foregoing, however denominated.

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

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

6. The term “communication” means each manner or means of disclosure or exchange ofinformation, regardless of means utilized, whether oral, written, electronic, by document orotherwise, 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.