Grassley seeks correction from the Food and Drug Administration regarding comment on Dr. Hampshire investigation
WASHINGTON — Sen. Chuck Grassley is calling on the Food and Drug Administrationto correct its statement of last week that the agency conducted an investigation of one of its ownscientists with her knowledge despite evidence to the contrary.
Grassley said that in addition to misrepresenting the fact that its scientist was informed ofthe investigation before the matter was nearly closed, the FDA denied that its internalinvestigation was criminal in nature. He said that documents and emails obtained by his staffinvestigators suggest otherwise. The text of a letter Grassley sent today to the ActingCommissioner of the FDA follows this news release. The attachment to the letter is posted athttp://finance.senate.gov.
Earlier this month, Grassley publicly questioned the way that both the FDA and WyethPharmaceuticals had handled the findings of FDA employee Dr. Victoria Hampshire that led tothe recall of the heartworm medication ProHeart 6. He asked the drug maker to respond toallegations that the company had launched an investigation to discredit the FDA scientist beforethe FDA’s own internal review was started. The text of Grassley’s November 17 letter to WyethPharmaceuticals follows today’s letter text below. The attachment to the November 17 letter is posted at http://finance.senate.gov.
November 29, 2005
Dr. Andrew C. von Eschenbach
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Dear Acting Commissioner von Eschenbach:
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 executive branch agencies. As part of the Committee's ongoing review of the Food and DrugAdministration (FDA) and events surrounding the investigation of Dr. Victoria Hampshire,V.M.D., I write today seeking a clarification from the FDA regarding facts FDA released to thepress related to this matter.
It has come to my attention that on November 18, a spokesperson for the FDA providedinformation to a reporter from Reuters regarding the FDA's investigation of Dr. VictoriaHampshire that was factually inaccurate. Specifically, the article quoted the FDA spokespersonstating that "the [FDA] investigation was conducted with Dr. Hampshire's knowledge." Further,the FDA spokesperson went on to add that the FDA investigation of Dr. Hampshire was not acriminal investigation. Information that was obtained by Committee staff through a review ofdocuments and interviews conducted with FDA personnel supports the position that these twostatements made by the FDA spokesperson were factually inaccurate and portrayed in a lightother than in the way they occurred.
Interviews conducted by Committee staff with Special Agents from the FDA's Office ofInternal Affairs, of the Office of Criminal Investigation revealed, among other things, that theFDA internal investigation into Dr. Hampshire was in fact a criminal investigation and that Dr.Hampshire had no knowledge of the internal FDA criminal investigation until it was nearlycompleted. Documents and emails obtained by the Committee further support both of thesefacts, and show that the FDA was, at all times, aware of both of these facts. Further, Committeestaff has obtained emails that show FDA officials were aware of factual inaccuracies in theirNovember 18 press release.
For example, in an email dated November 18, 2005 Mr. Mark Cohen, the attorney for Dr.Hampshire, sent an email to the FDA Office of Communications stating:
"[T]he press release that the FDA plans to release tonight is inaccurate in one regard: Ituses the language that the FDA investigation of her [Dr. Hampshire] was conducted 'With yourknowledge…' In fact, Dr. Hampshire was not aware at the time that she was being investigated.We'd ask that you correct this in the press release."
The current inquiry into events surrounding the investigation of Dr. Hampshire remainsopen and the Committee is continuing to examine various aspects of this matter. While therecent information presented to the media by the FDA did not directly harm the ongoing inquiry,the potential damage that incorrect and misleading statements could cause remains a reality. Istrongly encourage the FDA to examine the attached information and correct any factualirregularities that it presented to the media related to the November 18, 2005 article by Reuters.Please inform me immediately when this is done and in the event a decision is made not tocorrect these factual irregularities, please explain why FDA decided not to do so.
Thank you in advance for your cooperation on this matter. Should you or any of yourstaff have any questions regarding this matter or the documents in question, please EmiliaDiSanto or Nick Podsiadly of my Committee staff at (202) 224-4515.
Charles E. Grassley
United States Senator
Chairman, Committee on Finance
November 17, 2005
Mr. Robert Essner
Chairman, President, and CEO
North America and Global Business
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 emailaddress, for a person who will act as the point of contact for Wyeth Pharmaceuticals during theCommittee’s review by November 22, 2005, unless it is available sooner. All requests forcommunications, documents, records and written responses to questions should be received nolater 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 orotherwise made inaccessible to the Committee.
Charles E. Grassley
United States Senator
Chairman, Committee on Finance
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