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Drug
Company Harasses Honest Regulator
by Louis Clark
January
21, 2006 MinutemanMedia.org In Washington D.C., corporate lobbyists have become
freer over the years to buy influence while operating with fewer limitations.
The line between bribes and campaign contributions has become too murky, with
junkets to golf resorts, flights on private jets, and lavish entertainment
having become a useful means to influence important public policies. A deeper
examination of the "Beltway" culture, however, would find thousands of
government regulators who work hard to ensure that justice is blind, no person
or company is above the law, and the nation's public policies are implemented
with integrity. Unfortunately, these dedicated public servants are under attack
by the same private interests whose lobbyists buy influence with Congress and
top government officials. A case that exemplifies this point is that of Dr.
Victoria Hampshire, a safety officer at the Food and Drug Administration's
Center for Veterinary Medicine (CVM).
Dr. Hampshire was charged with reviewing the safety of a lucrative dog care
product manufactured by Fort Dodge, a subsidiary of drug company behemoth
Wyeth Pharmaceuticals. She concluded that ProHeart 6, a heartworm drug
was not safe and contributed to well over 500 canine deaths. Rather than remedy
the drug, Wyeth set out to discredit Dr. Hampshire, apparently hiring a private
investigator to dig up dirt on her in order to force CVM to remove her from the
drug review process. Wyeth was granted a private meeting with Dr. Lester
Crawford, then-Acting FDA Commissioner, in which it presented 29-slide
PowerPoint show about Dr. Hampshire's purported "conflict of interest" as a
veterinarian -- a trumped-up charge based on her selling of about $200 worth of
animal drugs on the Internet over the course of three years. Following this
meeting, she was removed from responsibility for regulating ProHeart 6 without
being given the chance to respond to Wyeth's charges. She was also subsequently
subjected to an FDA sting operation and secret criminal investigation. That
probe completely exonerated Dr. Hampshire, but she was still kept away from any
further involvement with Wyeth products. Concerned about Dr. Hampshire's
situation and similar stories, Sen. Charles Grassley (R-Iowa) wrote Commissioner
Crawford, stating "it appears that there is a systemic problem with the
pharmaceutical industry filing complaints against FDA employees and advisory
panel members in an attempt to exclude those with dissenting views so that [the
regulated companies] can obtain favorable results from [regulators]."
In a major address on the Senate floor last November, the Iowa senator went on
to declare, "Brave whistleblowers have come forward to expose the too cozy
relationship between the [FDA] and the drug industry -- Dr. Hampshire's hard
work and dedication to science and drug safety placed a bulls-eye on her
reputation and career -- The FDA cannot serve the American people and the
interests of the drug industry at the same time."
Even after the government investigation cleared Dr. Hampshire, Wyeth continued
its campaign to discredit her to others within the veterinarian community.
Fortunately, ProHeart 6 is no longer on the market, her regulatory safety
concerns have won the day, and the Senate is formally investigating this entire
affair.
Disturbed by CVM management's failure to grant her fundamental due process --
the right to confront her accusers -- Dr. Hampshire reluctantly accepted a
transfer to another FDA center. Hopefully, Dr. Hampshire will eventually regain
all of her previous responsibilities. But a larger problem looms over this
country. Her case is just one example of a pattern of unacceptable practices.
The chilling impact of this sort of corporate greed, influence, and intimidation
threatens the ability of our government to operate incorruptly. Few government
employees will subject themselves to possible private surveillance and criminal
investigations that place their careers in jeopardy. The pharmaceutical
industry, like many others, realizes that most regulators will look the other
way or downplay problems rather than suffer such personal agony.
The status quo is not acceptable. The American people must write letters, speak
out, vote in protest, petition, and organize in defense of their civil servants.
The price of public service for government employees should not be a choice
between fearful acquiescence in the face of undue influence or martyrdom.
Citizens must remind their leaders -- both elected and unelected -- that the
people's government is not for sale to the highest bidders or nastiest
intimidators.
Louis Clark -
http://www.cjonline.com/stories/012106/opi_clark.shtml is president of the
Government Accountability Project in Washington, D.C. GAP focuses on providing
protection for federal employees who "blow the whistle" on wrongful actions by
their employers. GAP's website is
www.whistleblower.org and email address is:
info@whistleblowers.org
Our appreciation to Jean Townsend and TheDogPress.com for sending this inside look and personal commentary on the state of one government agency.
I have been in contact with Dr. Victoria Hampshirel of the FDA Center for Veterinary Medicine over the past several years - via telephone and e-mail. I have always found her to be professional, helpful, and a person who just wants to do a good job. It infuriates me that this could happen to her - This may explain to my friends and colleagues why I do not trust the Pharmaceutical Companies - and likewise when it comes to Lobbyists and politicians. In my opinion - greed and politics go hand in hand.
Jean Townsend - Johns Island, SC
LuSwinton@aol.com
(Always for George - always for the Rimadyl Dogs)
B.A.R.K.S. - Be Aware of Rimadyl's Known Side-effects
Be informed of animal drug dangers
related links: Drug Company Threats Prescription Inserts Heartgard Failed
Other informative links Adverse Reactions Recalls Pro Heart 6 and Rimadyl Settles