For your information and cross posting. From:
http://www.medadnews.com/News/Index.cfm?articleid=292534

We need more brave people like Doctors Andrew Mosholder, David Graham and
Victoria Hampshire to step forward. Many thanks to Senator Chuck Grassley of
Iowa for exposing this terrible injustice! Many thanks to Dr. Victoria
Hampshire, who should never have had to endure such treatment! Her integrity
speaks
for itself!

This may be small comfort to dog owners whose dogs were harmed by ProHeart6 -
however, their dogs will not have died in vain.

See also: http://www.whistleblower.org/content/press_detail.cfm?press_id=291

Jean
(Always for George - Always for the Rimadyl Dogs)
"The truth is incontrovertible. Malice may attack it and ignorance may deride
it, but in the end, there it is." Winston Churchill


QUOTE:
Floor Statement of U.S. Senator Chuck Grassley of Iowa - One-Year Anniversary
of the Finance Committee’s Hearing on the FDA and Vioxx

WASHINGTON, November 17, 2005 - Mr. President, I rise today on the
anniversary of the hearing on the worldwide withdrawal of Vioxx, the blockbuster
drug
that became a blockbuster disaster. As chairman of the Committee on Finance, I
called for this hearing a year ago. The Vioxx hearing turned the spotlight on a
troubled agency in denial. The type of problems exposed during the hearing
have proven to be not isolated but systemic.


Over the past year, my Committee staff have investigated allegations coming
from within and without the agency. Brave whistleblowers – such as Doctors
Andrew Mosholder, David Graham and others – have come forward to expose the
too
cozy relationship between the agency and the drug industry. I can tell you today
that problems exist not only within the Center for drugs, but extend to the
Centers for devices, biologics and even to veterinary medicines. I am concerned
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 company that appears too cozy with the Food and Drug Administration. Last
year, just two days after the Vioxx hearing, the drug company Wyeth met with
former Commissioner Crawford. Why did Wyeth’s CEO want to talk with the
Commissioner? Because Wyeth recently had to remove one of 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 was killing hundreds of dogs. I have in my hand what Wyeth presented to
former Commissioner Crawford. 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 targeted by Wyeth and her agency for simply doing her
job. Last week, the FDA briefed my Committee investigators on this matter. It
turns out that Wyeth succeeded in having Dr. Hampshire removed from reviewing
its drug. Dr. Hampshire’s hard work and dedication to science and drug safety
placed a bulls eye on her reputation and career. Without her knowledge, the FDA
also launched a criminal 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’s drug, which remains off the market. Unfortunately
for Dr. Hampshire, Wyeth’s efforts to discredit her did not end at the FDA. At
least one Wyeth sales representative attempted to discredit Dr. Hampshire in
the Veterinary community. Fortunately for Dr. Hampshire, the sales person’s
comments about Wyeth’s investigation of her and her alleged conflicts of
interest
were made to a former colleague of Dr. Hampshire. My letter to Wyeth today
seeks information and documents 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 the drug industry. Dr. Hampshire’s sad story is further proof that
the FDA needs a permanent Commissioner who can restore order and respect for
independence. The Food and Drug Administration cannot serve the American people
and the interests of the drug industry at the same time.

A year ago today, Dr. Graham created a firestorm when he said at the Vioxx
hearing, “I can tell you right now, there are at least five drugs on the
market
today that I think need to be looked at quite seriously to see whether or not
they belong there...”. Dr. Graham identified those five drugs – Accutane,
Bextra, Crestor, Meridia and Serevent – when asked by my distinguished
colleague,
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 on four out five of the named drugs. Less than a week after the
hearing, the Food and Drug Administration announced it was strengthening its
plan to reduce the risk of birth defects associated with Accutane. Then in
August, the agency issued a public health advisory to help make sure females do
not
become pregnant while taking this medicine and to release more information
about depression and suicidal thoughts associated with the drug.

A month after the hearing, the Food and Drug Administration issued a public
health advisory for Bextra. The agency announced it changed Bextra’s label to
provide consumers with upgraded warnings about possible heart and blood
clotting problems. Ultimately, the agency asked Pfizer to voluntarily remove
Bextra
from the market in April. Less than four months after Dr. Graham’s testimony,
Crestor was subject to a public health advisory too as part of the agency’s
efforts to notify the public of potentially significant emerging safety data.
Crestor’s label was changed to highlight important information on the safe use
of
Crestor. Eight months after the hearing, the Food and Drug Administration
convened an Advisory Committee meeting related to the safety of Serevent and
other asthma drugs. The Advisory Committee recommended strengthening 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 agency would have acted without Dr. Graham’s testimony. But I know from
experience that sunlight is the best disinfectant. The scrutiny of the last 12
months is just the kind of medicine the Food and Drug Administration needed.
Things have not turned around overnight.

Reforming this agency is a long-haul task for those of us in Congress
committed to oversight, reform and improvement. The Vioxx investigation and
hearing,
as well as other investigations, prompted me to co-sponsor two FDA reform
bills this year. Senator Dodd and I introduced the Fair Access to Clinical
Trials
Act in February and the Food and Drug Administration Safety Act of 2005 in
April. These bills represent part of a sustained effort to restore public
confidence in the federal government’s food and drug safety agency. A number
of you
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
accountability and transparency for the Food and Drug Administration. And if
enacted they would provide the agency with some much-needed authorities to
ensure
the safety and efficacy of drugs.  One big opportunity that absolutely cannot
be
missed right now is appointment of a new, full-time commissioner who is
committed to reform. This leader must recognize the problems of a culture
that’s
become too cozy with the industry. Then that leader must be tough enough to make
necessary changes happen. Mr. President, the FDA has to do a top-notch job on
ensuring the safety 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 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.













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