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<DIV dir=ltr align=left><FONT face=Tahoma size=2><B>Subject:</B> Warning about
injection used for heartworm prevention in dogs<BR></FONT><BR></DIV>
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<P>Proheart 6, an injected drug to prevent heartworm, the<BR>common parasite in
dogs, has been temporarily withheld<BR>in the US but is still currently
available in Canada<BR>and in Europe, according to the following article.
<BR>This article tells of an FDA employee and her work to<BR>have the
above-mentioned veterinary drug banned., as<BR>well as her reasons for doing so
<BR>---<BR><BR>AP IMPACT: Sounding Alarm Over Pet Drug - New
York<BR>Times<BR>The New York Times<BR><A
href="http://www.nytimes.com/aponline/us/AP-When-the-Watchdog-Barked.html?_r=1&oref=slogin&pagewanted=print">http://www.nytimes.<WBR>com/aponline/<WBR>us/AP-When-<WBR>the-Watchdog-<WBR>Barked.html?<WBR>_r=1&oref=<WBR>slogin&pagewante<WBR>d=print</A><BR><BR>April
21, 2007<BR><BR>AP IMPACT: Sounding Alarm Over Pet Drug<BR>By THE ASSOCIATED
PRESS<BR><BR>Filed at 12:40 p.m. ET<BR><BR>BETHESDA, Md. (AP) -- The first hints
of trouble came<BR>with vague warnings from the outer reaches of
the<BR>bureaucracy.<BR><BR>She was ''pushing too hard.''<BR><BR>She was
''alarmist.'<WBR>'<BR><BR>But it was something else -- a clumsy bid to call
her<BR>off the scent of the dangerous veterinary drug she was<BR>tracking --
that really galled her. Maybe that<BR>was her last possible moment to keep
soundless and<BR>safe.<BR><BR>''When enough dogs die, this product will take
care of<BR>itself,'' a colleague said.<BR><BR>Her reply tumbled out like a
boulder that, once<BR>rolling, will no longer stop. Victoria Hampshire
heard<BR>herself say: ''I don't know what I'm doing here<BR>then.''<BR><BR>What
she was doing -- trying to do, at least -- was<BR>her job: She kept count of
side effects from animal<BR>drugs for the<BR>Food and Drug
Administration.<BR>She made tallies, analyzed numbers, and
alerted<BR>supervisors when something seemed amiss.<BR><BR>And something seemed
amiss that spring of 2004.<BR><BR>A big drug maker had crafted what seemed a
star<BR>performer in Proheart 6, a three-year-old injected<BR>drug to prevent
heartworm, the common parasite in<BR>dogs.<BR>Hampshire's numbers showed,
though, that dogs were<BR>dying at alarming rates.<BR><BR>What happened next --
and the price she paid for<BR>speaking up -- have spurred a<BR>U.S.
Senate<BR>inquiry and shined a spotlight on the complex<BR>topography of drug
safety, where interests collide<BR>like tectonic plates and squeeze decisions
from all<BR>sides.<BR><BR>On this landscape, the government's watchdogs come
in<BR>disparate breeds too. Some whimper at approaching<BR>trouble; others bark
gamely.<BR><BR>And some, like Hampshire, won't give an
inch.<BR><BR>------<BR><BR>While dogs were dying, her dad's heart was
failing.<BR><BR>Gifford Hampshire was an FDA press officer in the<BR>1960s, when
the agency firmly held the public trust.<BR>There was no Vioxx scare, little
fuss about taking<BR>money from industry.<BR><BR>His daughter Victoria --
everyone called her Tory --<BR>now worked as a veterinarian at the same agency.
She<BR>grew up on a Virginia horse farm, where her mother<BR>raised basset
hounds, and learned to treat animals<BR>with compassion. She once crafted little
sleeping bags<BR>from cloth to help mice recover from surgery.<BR><BR>Her dad
was so proud of her. She'd worked hard on her<BR>government career. Then age 44,
she was smart and<BR>upstanding in everyday life too, someone who points<BR>out
undercharges and never speeds. But she wasn't<BR>timid. When she'd stare over
reading glasses, it<BR>wasn't always fun to be her focal point.<BR><BR>''I could
feel like I'd get an honest opinion from<BR>her, without brownnosing,<WBR>''
says Dr. Judith Davis, her<BR>former supervisor at the<BR>National Institutes of
Health.<BR>That meant Hampshire was not always ''a real subtle<BR>person,'' says
Dr. Linda Tollefson, who was deputy<BR>head of the FDA's Center for Veterinary
Medicine.<BR><BR>In summer 2004, Hampshire was analyzing Proheart 6<BR>side
effects for a fast-approaching showdown with drug<BR>maker Wyeth. Evenings,
she'd visit her dad at<BR>the hospital. Then she'd work into the
night.<BR><BR>She asked her dad if he wished she'd done anything<BR>differently
in her life. Be less intense and have more<BR>fun, he suggested. That evening,
she noticed an<BR>old Jaguar for sale on the roadside. She wrote a<BR>$1,000
check on the spot and drove it back to the<BR>hospital. She made a martini for
her dad and pointed<BR>to the car parked outside.<BR><BR>It would be her last
moment of comfort for a long,<BR>long time.<BR><BR>------<BR><BR>Two days after
his death, setting aside her grief,<BR>Hampshire went toe-to-toe with
Wyeth.<BR><BR>She and Tollefson clearly remember the confrontation<BR>in a
conference room at FDA headquarters. As adverse<BR>events coordinator, Hampshire
was anxious about<BR>thousands of reported autoimmune, allergic, liver
and<BR>other reactions. Almost 500 dogs had died after taking<BR>Proheart 6--
surpassing all competitors combined.<BR><BR>But Wyeth was known for strongly
defending its drugs<BR>from claims of harm. It had rallied for its
estrogen<BR>replacement and for its half of the fen-phen diet<BR>combo. Its
veterinary subsidiary, Fort Dodge Animal<BR>Health, had sold 18 million doses of
Proheart 6, worth<BR>tens of millions of dollars. It surely wouldn't<BR>give up
without a fight.<BR><BR>Many vets also liked replacing pills with
the<BR>twice-a-year shot, which put heartworm prevention back<BR>into their
hands. One vet with ties to Wyeth lectured<BR>colleagues about seizing on
Proheart 6 as a ''hook''<BR>to pull in healthy pets for profitable regular
exams.<BR><BR>As the FDA meeting unfolded, the company said<BR>Hampshire was
inflating her side-effect numbers.<BR>Things turned nastier when Hampshire said
Fort Dodge<BR>had<BR>previously expressed its own concerns over tumors.<BR>Fort
Dodge said it hadn't.<BR><BR>''Either you're lying, or I'm imagining
it,''<BR>Hampshire erupted.<BR><BR>Dr. Stephen Sundlof, FDA's veterinary chief,
grabbed<BR>her hand under the table, silencing her, Hampshire<BR>says. (He
didn't answer messages seeking comment<BR>for this story.)<BR><BR>''Tory did not
have experience dealing with animal<BR>pharmaceutical community people, who are
not different<BR>than the human pharmaceutical people. They make<BR>a lot of
money on this stuff. They will never ever<BR>admit there's something wrong,''
says Tollefson, who<BR>is now FDA's assistant commissioner for
science.<BR><BR>On Sept. 4, 2004, in the face of Hampshire's damning<BR>data,
Wyeth ordered all Proheart 6 back from vets --<BR>without conceding it was
dangerous.<BR><BR>It was perhaps the largest recall ever of a pet
drug.<BR><BR>------<BR><BR>Two months later, Wyeth's chief executive officer
went<BR>to FDA offices for a personal meeting with then-FDA<BR>Commissioner
Lester Crawford.<BR><BR>The CEO, Robert Essner, wanted to work out a
big<BR>problem: Victoria Hampshire.<BR><BR>His company had uncovered a Web site
that gave<BR>Hampshire a cut of its drug sales. Though Proheart 6<BR>was sold
there, Wyeth focused on competing drugs.<BR><BR>''We felt Dr. Hampshire had a
conflict of interest in<BR>regard to her evaluation of this product, and
we<BR>wanted the agency to be aware of it,'' says Wyeth<BR>spokesman Doug
Petkus.<BR><BR>FDA policy banned agency vets who moonlight from<BR>taking
payments by pharmacies independent of their own<BR>practices. But so many
staffers unknowingly violated<BR>the rule that it was rewritten the next
year.<BR><BR>Hampshire acknowledges using the Web site, mainly to<BR>prescribe
drugs for pets of old clients and friends,<BR>without needing to warehouse
medicines at her<BR>Bethesda home. She says she meant to drop the site
and<BR>hadn't bothered to disclose it as an outside activity<BR>that year -- a
bad decision, she now acknowledges.<BR>But an invoice shows her earnings were a
mere $160<BR>over 2 1/2 years.<BR><BR>Wyeth also accused her of inciting
complaints from dog<BR>owners like Jean Brudd, of Thornton, Colo., who
had<BR>contacted the FDA about the deaths of her two<BR>dogs.<BR><BR>In one
e-mail to Brudd, Hampshire had written that<BR>''autoimmune disease is being
reported in growing<BR>numbers'' and laid out how Brudd's friends
could<BR>submit<BR>side-effect reports.<BR><BR>Hampshire says it was her duty to
check complaints and<BR>help people navigate the FDA.<BR><BR>Wyeth wanted
Hampshire reassigned and threatened to<BR>sue her, says agency manager
Tollefson, though Wyeth<BR>denies it.<BR><BR>In the end, Crawford ''thought it
best ... to protect<BR>Tory to get her out of it completely,'<WBR>'
explains<BR>Tollefson, who was briefed after the top-level<BR>meeting.<BR>She
says she and Sundlof, the center head, agreed to<BR>transfer
Hampshire.<BR><BR>Tollefson says they also wanted to keep her from being<BR>a
''distraction'<WBR>' when the recall was reviewed,<BR>because they too were
troubled by the drug's safety<BR>record.<BR><BR>Crawford didn't respond to
interview requests for this<BR>story. In 2005, he abruptly quit the FDA and
later<BR>admitted hiding stocks he owned in medical and<BR>food companies it
regulated. He was fined about<BR>$90,000.<BR><BR>But former FDA lawyer Daniel
Troy, also at the<BR>Essner-Crawford meeting, defends how it was
handled.<BR>''At the same time the FDA is actually getting smashed<BR>and bashed
by the news media on conflicts of interest,<BR>here there was an allegation of
conflict of interest,<BR>and the FDA took it seriously,'' he
says.<BR><BR>------<BR><BR>One morning two months later, Hampshire was working
on<BR>Proheart 6 data when she was called in to the<BR>veterinary director's
office without explanation.<BR><BR>There, in a bright office decorated with a
folksy<BR>painting of dairy cows, Tollefson waited with an FDA<BR>manager of
market reviews. Hampshire figured they<BR>needed help as the FDA prepared to
reconsider the<BR>Proheart 6 recall.<BR><BR>But Tollefson inhaled sharply, as if
steeling herself.<BR>Then she wiped a tear from her eye. Hampshire had<BR>known
Tollefson since working at the health<BR>institutes;<BR>they were friendly, but
she'd never seen anything like<BR>this.<BR><BR>''Wyeth has pulled all the plugs
at the level of<BR>commissioner,<WBR>'' Tollefson told a stunned
Hampshire.<BR>They were transferring her to the vaccines building<BR>to care for
the rats and monkeys.<BR><BR>She pleaded for her job. They refused to give
details<BR>but reassured her that this would all blow over. She<BR>was likened
to a cop who'd shot somebody in the<BR>line of duty.<BR><BR>''I haven't shot
anybody,'' she protested. ''I've done<BR>my job.''<BR><BR>She left the office in
tears.<BR><BR>Her shame deepened when a committee of FDA advisers<BR>took up the
Proheart 6 recall three weeks later in<BR>January 2005. She wasn't allowed to
talk to them,<BR>and they voted just barely, 8-7, to keep the drug off<BR>the
market for the time being.<BR><BR>The next month, an agency inspector from
Internal<BR>Affairs asked to see Hampshire. He told her she was<BR>under
investigation over Wyeth objections to her<BR>outside<BR>activities. He referred
obscurely to a ''sinister<BR>plot.''<BR><BR>A prosecutor had already ruled out
most criminal<BR>charges. But the inspector made her sign a statement<BR>saying
she could be fired and, if she lied, charged<BR>with perjury. He reminded her
about the jailing of<BR>domestic guru<BR>Martha Stewart<BR>over a financial
conflict.<BR><BR>------<BR><BR>Hampshire dragged herself through the next
several<BR>months, feeling she'd been cast, weak and worthless,<BR>into a hole.
A colleague worried she was headed<BR>for a breakdown.<BR><BR>She was sent to an
interim FDA office job within the<BR>capability of ''anybody with half a
brain,'' she says.<BR>She didn't know where the investigation would<BR>lead. She
didn't know who might be bent on ruining her<BR>career, but she looked for a
better job somewhere. She<BR>saw -- or imagined -- warning signs and
potential<BR>enemies everywhere. She hoped for protection from<BR>members of
Congress she contacted.<BR><BR>She fretted at home. ''To take this much stress
home<BR>and not to sleep for weeks is not worth it,'' she<BR>says. Even her two
children noticed changes in her.<BR><BR>Then, out of the blue, there was a
flicker of light.<BR>In April 2005, she landed a better job in the
FDA<BR>itself, at a separate office that evaluates devices<BR>for the human
heart. ''It sounded to me like she<BR>really hadn't done anything wrong,''
explains her new<BR>supervisor, Dave Buckles.<BR><BR>That July, more relief
came: Hampshire was told she<BR>was cleared by agency investigators. ''A
valued<BR>employee'' is how FDA spokeswoman Julie Zawisza now<BR>describes her,
but she won't discuss the transfer and<BR>investigation.<BR><BR>Tollefson now
believes the affair was mishandled.<BR>''Everybody saw that we reassigned Tory,
no<BR>explanation was ever given -- not a good one -- so the<BR>message<BR>to me
was very clear: If you do your job right and<BR>you're questioned, you lose your
job.''<BR><BR>Although Wyeth has been sued on behalf of dozens of<BR>people
whose pets took Proheart 6, the company hopes<BR>to be vindicated too. It has
kept selling the drug<BR>in Canada, Europe and elsewhere, and it has
approached<BR>the FDA with more data for a possible U.S. comeback.<BR><BR>In
June 2005, a Wyeth manager made a sales call at an<BR>Alabama veterinary
practice, where he openly blamed<BR>Hampshire for the Proheart 6 recall,
according<BR>to a confidential letter written by a vet there to the<BR>FDA. The
Wyeth employee boasted that the company had<BR>her investigated by private
detectives, and<BR>she had been ''taken care of,'' according to the<BR>letter
obtained by The Associated Press. He then<BR>predicted the drug's swift return
to market.<BR><BR>That Wyeth manager, Glen Kimmorley, did not answer
AP<BR>messages left at a home phone in his name. The Wyeth<BR>spokesman said
Kimmorley ''was expressing his<BR>own opinion and was not authorized to speak on
behalf<BR>of the company.''<BR><BR>However, Sen.<BR>Chuck Grassley,<BR>R-Iowa,
who has been investigating Hampshire's case,<BR>says Wyeth ''tried to destroy a
reputation.'<WBR>'<BR><BR>He added: ''Her own agency sold her down the
river.''<BR><BR>------<BR><BR>Hampshire still feels edgy, less trusting,
shamefully<BR>naive about corporate influence on government. Her<BR>husband, Bob
Balaban -- himself a senior scientist<BR>at the National Institutes of Health --
says she's<BR>''not the same person.'' They hope for more answers<BR>from Senate
investigators.<BR><BR>Others have reached their own conclusions. Last
year,<BR>Hampshire was sitting in a big conference room in<BR>Denver at a
veterinary meeting of the U.S. Public<BR>Health Service. The agency was
announcing its<BR>veterinarian of the year. She grabbed her camera
to<BR>photograph the winner.<BR><BR>And then, as if scripted by Hollywood, her
own name<BR>was announced.<BR><BR>She heard a health officer say she had
''raised the<BR>bar in every category of professional and personal<BR>integrity,
passion, and commitment.'<WBR>'<BR><BR>People rushed over to hug her. For the
first time in<BR>years, she let down her guard.<BR><BR>Copyright 2007 The
Associated
Press<BR><BR>____________<WBR>_________<WBR>_________<WBR>_________<WBR>_________<WBR>__<BR>Do
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