Senator Grassley: http://grassley.senate.gov/webform.htm
The Government Accountability Project (http://www.whistleblower.org/template/index.cfm)
which is assisting Dr. Hampshire legally accepts earmarked contributions
through The Network for Good (http://www.networkforgood.org/donate/)
November 19, 2006 - Iowa senator a champion of whistle-blowers
Sen. Charles Grassley has become Congress’s expert on using whistle-blowers to ferret out waste and fraud.
October 31, 2006 - Grassley Continues to Press FDA on Handling of Hampshire Case
September 20, 2006 -
outlines problems at FDA, urges reforms
June 15, 2006 Washington Post
HHS Trip for Antibiotic Data Yields Only Ire
"...... “I’m tired
of the runaround,” he said after leaving the HHS headquarters.
He said that he told the agencies’ officials that “I
know it’s probably not your intent to protect companies,
to cover for companies.”
“But I said that every time that you stand in the
way of information getting out that ought to be public, that’s
the impression you give the American people.”
June 14, 2006 -
Remarks of U.S. Sen. Chuck Grassley of Iowa at the U.S. Department
of Health and Human Services
"I’m fed up with resistance
from the bureaucracy. It’s been one excuse after another.
Practices and policies have changed from one day to the next.
Files available one day become “confidential” overnight.
A line agent isn’t allowed to tell his story, even though
line agents have been made available in other cases. The agency
says its employees will not be prohibited from cooperating with
Congress, then instructs its employees not to cooperate with Congress.
The agency won’t provide a background briefing on past regulatory
Creates Drug Fact Squad!
"According to polls, Americans
no longer trust the pharmaceutical industry. Simultaneously, there
is a crisis of confidence in the Food & Drug Administration
(FDA) as an impartial arbiter of drug safety and effectiveness.
More than half of the agency’s drug budget comes from industry
user fees earmarked for speeding up the approval of drugs. As
a result, the FDA, long established as the “gold standard”
of consumer protection against industry’s dangerous drugs,
now treats the industry as its primary client.
If we, the public, can’t
rely on either industry or the FDA to tell it to us straight,
then where can we turn for independent and reliable information
about prescription drugs?"
the Gap" newletter (page 4) Spotlight: A Conversation with
GAP President Louis Clark and Victoria Hampshire
"GAP client Dr. Victoria Hampshire
was a safety officer at the Food and Drug Administration’s
Center for Veterinary Medicine (CVM) charged with reviewing the
safety of a dog care product manufactured by Fort Dodge, a Wyeth
subsidiary. She concluded that ProHeart 6 was not safe and may
have contributed to some 500 dog deaths. Wyeth hired a private
investigator to mischaracterize information about her, and was
granted a private session with then-acting FDA Commissioner Lester
Crawford – after which she was removed from review of the
product. The FDA then launched a criminal investigation of her.
Dr. Hampshire was totally exonerated and now Senator Grassley
is investigating Wyeth and drug company efforts to target FDA
safety officers whose findings disagree with their corporate plan."
May 16, 2006
Senator Says FDA Should Stop Citing a Fraudulent Ketek Study, Seeks
Access to Information
"Sen. Chuck Grassley said
it’s “mystifying” that the Food and Drug
Administration continues to provide information the agency knows
is fraudulent about the safety of the antibiotic Ketek, and he’s
keeping the pressure on for more information about the FDA’s
initial approval and post-market surveillance of the drug."
May 1, 2006 Sen.
Grassley Slams FDA for Citing Fraudulent Safety Study
"Sen. Chuck Grassley today
released information about his ongoing
investigation of the Food and Drug Administration regarding the
drug-safety agency’s initial approval and post-market surveillance
of the antibiotic Ketek".
|April 24, 2006 Senator
Grassley’s Comments on the New GAO Report on the FDA and Post-market
Spring 2006 GAP
"Bridging the Gap" newletter GAP Client Blows Whistle
on Dangerous Dog Drug- Saving Our Pets
"FDA Veterinarian Dr. Victoria
Hampshire found a big problem with a canine heartworm drug in
2004 – it was related to the deaths of over 500 patients.
She recommended that the drug be immediately recalled from the
market. Unfortunately for her, the profitable drug’s producer,
Wyeth Pharmaceuticals, tried to counter Dr. Hampshire’s
claim by attacking her character.
What followed is a twisted story about a secret FDA/drug-company
meeting, a smear campaign, and an unjustified criminal investigation.
Luckily for Dr. Hampshire, she found support and allies in GAP
and a key U.S. Senator. In this edition’s Food & Drug
Safety update, read the chilling story of a major pharmaceutical
corporation’s underhanded campaign to discredit Dr. Hampshire
and how the FDA initially caved under corporate pressure. Story
on page 3."
March 3, 2006
Urges More Teeth for FDA’s Post-market Drug Enforcement
“The FDA lacks the ability
to effectively police drugs on the post-market side. The agency
really needs more enforcement tools. The bill Sen. Dodd and I
introduced to establish an independent office of drug safety at
the agency will do just that. Companies that don’t comply
with their postmarket commitments would face civil monetary penalties.
Right now, the FDA has no teeth to enforce post-market drug safety
studies. That has to change.”
March 2006: Drug
Safety: Improvement needed in FDA's Postmarket Decision-making and
" What GAO Recommends
To improve the decision-making process for postmarket drug
safety, GAO suggests that the Congress consider expanding FDA’s
authority to require drug sponsors to conduct postmarket studies
when needed. GAO also recommends that FDA systematically track
postmarket drug safety issues, revise and implement its draft
policy on major postmarket safety decisions, improve the dispute
resolution process, and clarify ODS’s role in scientific
advisory committees. In its comments on a draft of this report,
FDA stated that GAO’s conclusions were reasonable. FDA did
not comment on GAO’s recommendations."
|February 1, 2006 - DVM Mag: Wyeth to comply with Senate investigation
February 2006 REVIEW
OF THE FDA’S APPROVAL PROCESS FOR THE VAGUS NERVE STIMULATION
THERAPYSYSTEM FOR TREATMENT-RESISTANT DEPRESSION
"As part of that mission,
the FDA weighs the risks and benefits of a product, in this case
a medical device, to determine if the productis reasonably safe
and effective for use."
company harasses honest regulator
GAP 12/20/05 -- U.N.
Issues Groundbreaking Whistleblower Policy
"Washington, D.C. – The Government Accountability
Project (GAP) praised the United Nations for issuing a new standard
of whistleblower protection in an anti-retaliation policy released
today as a Secretary General’s Bulletin. GAP, which was
consulted directly regarding the policy, is hailing the protections
as the benchmark for other Intergovernmental Organizations (IGOs).
The new protections take effect on January 1, 2006. While these
breakthroughs set the bar higher for whistleblower protection
for all IGOs, the group cautioned that they must be viewed in
the larger context of unfinished structural reform that awaits
U.N. General Assembly action next year."
GAP 12/7/05 -- GAP
Creates Drug 'Fact Squad'
"According to polls, Americans no longer trust the pharmaceutical
industry. Simultaneously, there is a crisis of confidence in the
Food & Drug Administration (FDA) as an impartial arbiter of
drug safety and effectiveness. More than half of the agency’s
drug budget comes from industry user fees earmarked for speeding
up the approval of drugs. As a result, the FDA, long established
as the “gold standard” of consumer protection against
industry’s dangerous drugs, now treats the industry as its
Medical and Science News 12/6/05 --
US FDA vet says agency probe harmed review process
"A U.S. Food and Drug Administration probe of a veterinarian
studying the risks of a Wyeth heartworm drug has had a "chilling
effect" on fellow government scientists and harmed their
ability to protect the public, the researcher said on Monday."
Boston Globe 12/6/05 -- Dog-drug
case renews scrutiny on FDA-- Agency transferred reviewer after
Wyeth unit questioned her
"After a Food and Drug Administration reviewer alerted
managers to a surge in safety problems with a veterinary drug,
supervisors transferred her from the case and the agency began
secretly to investigate her."
NYTimes 12/6/05 -- F.D.A.
Official Chides Agency Over Treatment
"A federal drug safety official said that her career
had been sidetracked after complaints from a drug maker led the
F.D.A. to suspend her from reviewing a heartworm medicine for
NJ.com 12/6/05 -- Regulator
opposed drug and Wyeth opposed her
" 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."
USA Today 12/5/05 -- Staffer's
move sparks probe of FDA, Wyeth
"A Food and Drug Administration scientist said Monday
that she was reassigned and, without her knowledge, subjected
to a criminal investigation by the agency because of allegations
brought by Wyeth (WYE), maker of a lucrative heartworm shot pulled
off the market last year as a result of her work."
U.S. Senate/Fiance Committee 11/ 29/ 2005 --
Grassley seeks correction from the Food and Drug Administration
"Sen. Chuck Grassley is calling on the Food and Drug
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."
|PharmaWatch Blog 11/24/05 -- Smears
and censorship: Wyeth has gone to the dogs
FDANews 11/21/05 -- Grassley
Uses Alleged Wyeth Dispute to Call for Change in FDA Leadership
"Sen. Chuck Grassley (R-Iowa), chairman of the Finance
Committee and an increasingly vocal critic of the FDA, is using
an alleged effort by Wyeth to discredit an agency investigator
as ammunition in his campaign to reform the agency's relationship
with the pharmaceutical industry and to bolster his call for a
permanent, reform-minded commissioner."
ScienceDaily 11/18/05 -- Grassley
renews calls for FDA reform
"Problems exist not only within the Center for drugs,
but extend to the Centers for devices, biologics and even to veterinary
medicines," Grassley, R-Iowa, said in remarks delivered on
the Senate floor late Thursday.
"I am concerned and every other member of this Senate
should also be concerned," he said."
|GAP: 11/18/05 -- Senator
Grassley Investigates charges of FDA and Wyeth misconduct
"Yesterday on the Senate floor, Senate Fiance Committee
Chairman Charles Grassley (R-Iowa) announced that he is investigating
charges that Wyeth Pharmaceuticals smeared an FDA safety officer
who negatively reviewed one of Wyeth's animal care products, and
that the FDA subsequently removed her from that product's review.
Dr. Victoria Hampshire , the safety officer, "concluded that
Wyeth's drug (Proheart6) was killing hundreds of dogs," according
to Sen. Grassley. Dr. Hampshire is represented by the GAP."
here to read Sen. Grassley's floor speech
here to read Sen. Grassley's letter to Wyeth
here to read letter sent to FDA's Dr. Sundlof from veterinarian
ABC News 11/17/05 -- Senator
says Wyeth targeted FDA reviewer
(same article can be found at: http://www.fen-phen-eresource.com/dog.cfm)
"Drug maker Wyeth tried to discredit a Food and Drug
Administration scientist who linked the company's withdrawn heartworm
treatment to the deaths of hundreds of dogs, a U.S. Republican
senator charged on Thursday."
GAP: 11/17/05 -- GAP
Praises new MDB Whistleblower Policies
"The Government Accountability Project (GAP) today praised
breakthroughs in whistleblower protection included as part of
greater accountability and transparency standards signed into
law Monday, November 14."
GAP: 9/29/2005 --GAP
Coalition Praises Committee's Decision to Strengthen Whistleblower
"In a letter to House Government Reform Committee Chair
Tom Davis (R.-Va.), a coalition of 20 good-government organizations
from across the partisan and ideological spectrum praised his
committee for a vote scheduled today to give jury trial rights
to government whistleblowers. The bill, H.R. 1317, would amend
the Whistleblower Protection Act (WPA) to give federal government
workers access to courts, akin to the free speech breakthrough
for corporate whistleblowers in the 2002 Sarbanes-Oxley Act. UPDATE:
The bill passed through committee, 34-1."
PRNewswire 8/4/05 -- FDA
Ignores its Whistleblowers, New Report Says
"For over two weeks, the news service has been publishing
the whistleblowers' allegations that an FDA computer containing
trade secret data was lent by an FDA device review manager to
an outside candidate for a division director vacancy. The candidate
allegedly used the laptop to promote his candidacy in front of
an internal employee panel, who complained about the secrets'
exposure, according to the whistleblowers."
AHRP 6/8/05 -- Grassley
Pushes FDA: Transparency, Accountability & Independence / Whistleblowers
are essential Witnesses
"WASHINGTON - Sen. Chuck Grassley is questioning the
make-up of the new drug and safety board set up by the Food and
Drug Administration to provide independent review of FDA-approved
In a letter sent to the acting commissioner of the nation's
drug safety agency, Grassley asked for assurances that the board
could act in an unbiased way given its composition and said the
deliberations of the panel should be more transparent in order
to improve accountability at the Food and Drug Administration."
GAP: 6/6/05 -- Watching
the Office of Special Counsel
"The Office of Special Counsel (OSC) is the government
agency in charge of protecting whistleblowers working within the
federal government. Scott Bloch, the current Special Counsel,
has come under heavy scrutiny by GAP and other watchdog groups
regarding disturbing allegations of purging the OSC of internal
critics and arbitrarily dismissing personnel complaints to reduce
heavy backlogs. He has also refused to protect workers fired or
harassed due to sexual orientation, reversing a long standing
OSC practice. Find out about steps GAP has taken to raise awareness
of this issue by clicking on our Office
of Special Counsel page."
blames Dr. David Graham for warning about prescription drugs; medical
McCarthyism now in full swing
GAP 5/31/05 -- Medical
Whistleblowers Speak out
"..... One of the lessons, says Lenzer, is that "ties
between drug regulators and industry may influence new drug approval."
Graham said at the roundtable that the FDA was in "a collaborative
relationship" with industry, and that the FDA gets money
from drug companies through the Prescription Drug User Fee Act
"to approve new drugs and approve them more quickly."
A senior official at the FDA, said Graham, had told him, "industry
is our client."
"The pharma-FDA complex has to be dismantled,"
he said, "and the American people have to insist on that,
otherwise we're going to have disasters like Vioxx that happen
in the future."