FDA orders label changes then withdrawal for ProHeart 6

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F.D.A. Official Chides Agency Over Treatment


Correction Appended


WASHINGTON, Dec. 5 - A federal drug safety official said Monday that her career had been sidetracked and her reputation tarnished after complaints from a drug maker led the Food and Drug Administration to suspend her from reviewing a heartworm medicine for dogs.

The reviewer, Dr. Victoria Hampshire, was eventually cleared of any wrongdoing. But Dr. Hampshire said she was angry that agency officials had failed to inform her of the accusations or give her a chance to explain herself before taking actions that, she said, hurt her career.

"Everybody jumped to the conclusion that I was guilty before they knew the answers, and no public apology was ever made," she said.

Susan Bro, a senior adviser to the agency, said: "The F.D.A. acted properly with respect to this matter. The F.D.A. considers it concluded."

In 2003, Dr. Hampshire raised concerns about ProHeart 6, a heartworm drug made by Wyeth that was later linked with the deaths of 500 dogs and illnesses in 5,000 more. Under pressure from the F.D.A., Wyeth withdrew the drug last year.

In a Nov. 29, 2004, meeting, Wyeth's chief executive, Robert A. Essner, raised concerns about Dr. Hampshire with Lester M. Crawford, then the agency's commissioner, said Dr. Hampshire's lawyer, whose account was confirmed by agency officials. The lawyer, Mark Cohen of the Government Accountability Project, a private group that represents whistle-blowers, said Wyeth had hired a private investigator to "dig up dirt" about Dr. Hampshire.

"They should at least give her the courtesy of hearing what she has to say about it before she is removed from the case," Mr. Cohen said.

Doug Petkus, a Wyeth spokesman, said the company "became aware through public information" that Dr. Hampshire had a relationship with an Internet veterinary pharmacy that marketed products that competed with ProHeart 6.

"We made the F.D.A. aware of Dr. Hampshire's affiliation, which we perceived as a potential conflict of interest," Mr. Petkus said.

Dr. Hampshire said that she used the pharmacy, VetCentric.com, because she was practicing veterinary medicine only in her spare time and did not want to buy a full array of drugs. She said the fees she received were minimal: $196 over four years.

"I don't understand at all why this was seen as a conflict," Dr. Hampshire said. "Sure, the site sold competitors to ProHeart 6. But it also sold ProHeart 6."



Correction:

An article yesterday about a federal drug safety official who said her career and reputation had been damaged by complaints from a drug manufacturer misstated her given name. The official, who has since been cleared of wrongdoing, is Dr. Victoria Hampshire, not Nancy.

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http://www.hcrenewal.blogspot.com/

http://www.nj.com/business/ledger/index ... xml&coll=1

http://www.boston.com/business/globe/ar ... ny_on_fda/

http://pharmawatch.blogspot.com/2005/12 ... s-196.html

http://pharmawatch.blogspot.com/2005/11 ... -gone.html

http://www.sciencedaily.com/upi/index.p ... assley.xml

http://today.reuters.com/investing/fina ... 17706798:1

http://www.whistleblower.org/about/pers ... rson_id=31

http://www.alertnet.org/thenews/newsdesk/N17706798.htm

http://www.medadnews.com/News/Index.cfm ... eid=292534

http://coffeehousetv.org/
This is a very short clip from an interview of Dr. Hampshire. It is listed on the left side under Now Showing.

http://www.whistleblower.org/content/pr ... ess_id=291

http://www.whistleblower.org/template/p ... age_id=140

http://www.whistleblower.org/template/p ... age_id=141

http://www.nytimes.com/2005/12/06/politics/06fda.html

http://www.healthcentral.com/newsdetail ... 07383.html

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http://finance.senate.gov/press/Gpress/ ... 112905.pdf
For Immediate Release
Tuesday, November 29, 2005
Grassley seeks correction from the Food and Drug Administration
WASHINGTON — Sen. Chuck Grassley is calling on the Food and Drug Administration
to correct its statement of last week that the agency conducted an investigation of one of its own
scientists with her knowledge despite evidence to the contrary.
Grassley said that in addition to misrepresenting the fact that its scientist was informed of
the investigation before the matter was nearly closed, the FDA denied that its internal
investigation was criminal in nature. He said that documents and emails obtained by his staff
investigators suggest otherwise. The text of a letter Grassley sent today to the Acting
Commissioner of the FDA follows this news release. The attachment to the letter is posted at
http://finance.senate.gov.
Earlier this month, Grassley publicly questioned the way that both the FDA and Wyeth
Pharmaceuticals had handled the findings of FDA employee Dr. Victoria Hampshire that led to
the recall of the heartworm medication ProHeart 6. He asked the drug maker to respond to
allegations that the company had launched an investigation to discredit the FDA scientist before
the FDA’s own internal review was started. The text of Grassley’s November 17 letter to Wyeth
Pharmaceuticals 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
Acting Commissioner
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 on
Finance (Committee), it is my duty under the Constitution to conduct oversight into the actions
of executive branch agencies. As part of the Committee's ongoing review of the Food and Drug
Administration (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 the
press related to this matter.
It has come to my attention that on November 18, a spokesperson for the FDA provided
information to a reporter from Reuters regarding the FDA's investigation of Dr. Victoria
Hampshire that was factually inaccurate. Specifically, the article quoted the FDA spokesperson
stating 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 a
criminal investigation. Information that was obtained by Committee staff through a review of
documents and interviews conducted with FDA personnel supports the position that these two
statements made by the FDA spokesperson were factually inaccurate and portrayed in a light
other than in the way they occurred.
Interviews conducted by Committee staff with Special Agents from the FDA's Office of
Internal Affairs, of the Office of Criminal Investigation revealed, among other things, that the
FDA 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 nearly
completed. Documents and emails obtained by the Committee further support both of these
facts, and show that the FDA was, at all times, aware of both of these facts. Further, Committee
staff has obtained emails that show FDA officials were aware of factual inaccuracies in their
November 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: It
uses the language that the FDA investigation of her [Dr. Hampshire] was conducted 'With your
knowledge…' 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 remains
open and the Committee is continuing to examine various aspects of this matter. While the
recent 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. I
strongly encourage the FDA to examine the attached information and correct any factual
irregularities 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 to
correct 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 your
staff have any questions regarding this matter or the documents in question, please Emilia
DiSanto or Nick Podsiadly of my Committee staff at (202) 224-4515.
Sincerely,
Charles E. Grassley
United States Senator
Chairman, Committee on Finance
Attachment
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
Chairman, Committee on Finance
Attachment

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Regulator opposed drug and Wyeth opposed her
Tuesday, December 06, 2005
BY ED SILVERMAN
Star-Ledger Staff
Last January, Victoria Hampshire was unexpectedly reassigned from her job at the Food and Drug Administration, where she was a safety officer overseeing veterinary medicines.

The move followed conflict-of- interest charges brought by Wyeth, which a few months earlier had recalled a heartworm drug for dogs. Known as ProHeart-6, the medicine generated some 5,500 side-effect reports, including more than 500 deaths.

Hampshire had urged the FDA to act on the reports, and was about to present her findings to an agency advisory committee that was slated to review the recall. Wyeth, meanwhile, told FDA officials Hampshire ran a part-time business promoting rival medicines.

"I was a little in shock," said Hampshire, who yesterday spoke publicly for the first time since the episode was disclosed last month by U.S. Sen. Charles Grassley (R- Iowa), who is investigating the relationship between the FDA and the pharmaceutical industry.

"I was terrified by all this and sought to get the heck out of there," said Hampshire, 45, who now works in the FDA's Center for Devices. "But what I want is for the public process to be protected. I want people to be able to find out about a drug's risks."

In a telephone interview, Hampshire acknowledged running a part- time software and consulting business, which included processing a "minuscule" number of prescriptions for veterinarians. But she said she disclosed this to the FDA and didn't promote other drugs.

"I did some moonlighting, which the agency knew about. As part of that, I contracted with an outside prescription service. But I didn't own it," she said. "All I filled were 23 prescriptions for 14 clients, totaling $196."

A Wyeth spokesman, Doug Petkus, said the drugmaker learned of Hampshire's business through "public information," and was concerned it "could impact her independence and objectivity, and might prejudicially influence her evaluation" of the drug.

Grassley has accused Wyeth, based in Madison, of attempting to discredit Hampshire in order to revive a drug that was used by thousands of pet owners. Last year, ProHeart-6 generated $32 million in sales.

Hampshire's attorney, Mark Cohen of the Government Accountability Project, said Wyeth conducted an investigation that allegedly included hiring a private eye to fill prescriptions through Hampshire. In addition, a Wyeth sales rep allegedly told a vet she was to blame for the recall, according to documents released by Grassley.

Meanwhile, the FDA launched a criminal investigation in response to Wyeth's allegations, according to Grassley. Hampshire has since been told charges won't be filed.

Ultimately, the FDA advisory committee, which met last January, did not recommend returning ProHeart-6 to the market.

An FDA spokeswoman didn't respond to repeated requests for comment.

"The FDA sent a very serious statement," Hampshire said. "I was suddenly reassigned after receiving laudatory remarks from supervisors. It had a chilling effect on my colleagues, whether intended or not. They saw if they were doing their jobs aggressively, bad things might happen to them."

[morgan]

I saw this in the news and it just didn’t seem to make sense. The more I googled it the more it smells.

Wyeth maintains that it simply gave the FDA potentially troubling
information it found on a Web site about a possible conflict of interest involving
Hampshire." She was selling competitors product. Which she admitted.

Dr. Hampshire sets as a kind of administrative judge, and is selling a competitors product, her ruling eventually caused the withdrawal of the Wyeth product, and she never discloses this to the FDA or parties concerned. She thinks this is ethical, at best it gives the smell of unprofessionalism.

It raises the possibility of many concerns, did Wyeth have any idea as to her involvement, whether it was $200 or $200,000, it was reported to the FDA. If Wyeth had investigated they would have discovered it was only $200, it seems obvious this was cursory incident, they found the web page and reported it..

Dr. Hampshire brought this on herself, without full disclosure her actions are suspect. She should have reported this to the FDA and all parties concerned to avoid even the look of impropriety.

The conclusion to order the withdrawal of the product also seems suspect.

Mortality rate of proheart is approximately 0.0025 percent of the doses sold in veterinary clinics (approximately 2.5 per 100,000 doses).

http://evidencebasedvet.com/forum/viewt ... t=proheart


"It's a very low reaction rate in terms of millions and millions of doses that have gone into protect dogs against heartworm,"

Its safer than penicillin for humans, Severe penicillin hypersensitivity with anaphylactic shock is very rare and occurs mostly in connection with parenteral administration (5 to 10 cases on 10,000 treated subjects).

www.infomed.org/100drugs/peniadre.html

Something is very wrong here.

Bemused.