Official takes risks warning on pet drug

What happened next - and the price she paid for speaking up - have spurred a U.S. Senate inquiry and shined a spotlight on the complex topography of drug safety, where interests collide like tectonic plates and squeeze decisions from all sides.

On this landscape, the government's watchdogs come in disparate breeds too. Some whimper at approaching trouble; others bark gamely. And some, like Hampshire, won't give an inch.

While dogs were dying, her dad's heart was failing.

Gifford Hampshire was an FDA press officer in the 1960s, when the agency firmly held the public trust. There was no Vioxx scare, little fuss about taking money from industry.

His daughter Victoria - everyone called her Tory - now worked as a veterinarian at the same agency. She grew up on a Virginia horse farm, where her mother raised basset hounds, and learned to treat animals with compassion. She once crafted little sleeping bags from cloth to help mice recover from surgery.

Her dad was so proud of her. She'd worked hard on her government career. Then age 44, she was smart and upstanding in everyday life too, someone who points out undercharges and never speeds. But she wasn't timid. When she'd stare over reading glasses, it wasn't always fun to be her focal point.

"I could feel like I'd get an honest opinion from her, without brownnosing," says Dr. Judith Davis, her former supervisor at the National Institutes of Health. That meant Hampshire was not always "a real subtle person," says Dr. Linda Tollefson, who was deputy head of the FDA's Center for Veterinary Medicine.

In summer 2004, Hampshire was analyzing Proheart 6 side effects for a fast-approaching showdown with drug maker Wyeth. Evenings, she'd visit her dad at the hospital. Then she'd work into the night.

She asked her dad if he wished she'd done anything differently in her life. Be less intense and have more fun, he suggested. That evening, she noticed an old Jaguar for sale on the roadside. She wrote a $1,000 check on the spot and drove it back to the hospital. She made a martini for her dad and pointed to the car parked outside.

It would be her last moment of comfort for a long, long time.

Two days after his death, setting aside her grief, Hampshire went toe-to-toe with Wyeth.

She and Tollefson clearly remember the confrontation in a conference room at FDA headquarters. As adverse events coordinator, Hampshire was anxious about thousands of reported autoimmune, allergic, liver and other reactions. Almost 500 dogs had died after taking Proheart 6_surpassing all competitors combined.

But Wyeth was known for strongly defending its drugs from claims of harm. It had rallied for its estrogen replacement and for its half of the fen-phen diet combo. Its veterinary subsidiary, Fort Dodge Animal Health, had sold 18 million doses of Proheart 6, worth tens of millions of dollars. It surely wouldn't give up without a fight.

Many vets also liked replacing pills with the twice-a-year shot, which put heartworm prevention back into their hands. One vet with ties to Wyeth lectured colleagues about seizing on Proheart 6 as a "hook" to pull in healthy pets for profitable regular exams.

As the FDA meeting unfolded, the company said Hampshire was inflating her side-effect numbers. Things turned nastier when Hampshire said Fort Dodge had previously expressed its own concerns over tumors. Fort Dodge said it hadn't.

"Either you're lying, or I'm imagining it," Hampshire erupted.

Dr. Stephen Sundlof, FDA's veterinary chief, grabbed her hand under the table, silencing her, Hampshire says. (He didn't answer messages seeking comment for this story.)

"Tory did not have experience dealing with animal pharmaceutical community people, who are not different than the human pharmaceutical people. They make a lot of money on this stuff. They will never ever admit there's something wrong," says Tollefson, who is now FDA's assistant commissioner for science.

On Sept. 4, 2004, in the face of Hampshire's damning data, Wyeth ordered all Proheart 6 back from vets - without conceding it was dangerous.

It was perhaps the largest recall ever of a pet drug.

Two months later, Wyeth's chief executive officer went to FDA offices for a personal meeting with then-FDA Commissioner Lester Crawford.

The CEO, Robert Essner, wanted to work out a big problem: Victoria Hampshire.

His company had uncovered a Web site that gave Hampshire a cut of its drug sales. Though Proheart 6 was sold there, Wyeth focused on competing drugs.

"We felt Dr. Hampshire had a conflict of interest in regard to her evaluation of this product, and we wanted the agency to be aware of it," says Wyeth spokesman Doug Petkus.

FDA policy banned agency vets who moonlight from taking payments by pharmacies independent of their own practices. But so many staffers unknowingly violated the rule that it was rewritten the next year.

Hampshire acknowledges using the Web site, mainly to prescribe drugs for pets of old clients and friends, without needing to warehouse medicines at her Bethesda home. She says she meant to drop the site and hadn't bothered to disclose it as an outside activity that year - a bad decision, she now acknowledges. But an invoice shows her earnings were a mere $160 over 2 1/2 years.

Wyeth also accused her of inciting complaints from dog owners like Jean Brudd, of Thornton, Colo., who had contacted the FDA about the deaths of her two dogs.

In one e-mail to Brudd, Hampshire had written that "autoimmune disease is being reported in growing numbers" and laid out how Brudd's friends could submit side-effect reports.

Hampshire says it was her duty to check complaints and help people navigate the FDA.

Wyeth wanted Hampshire reassigned and threatened to sue her, says agency manager Tollefson, though Wyeth denies it.

In the end, Crawford "thought it best ... to protect Tory to get her out of it completely," explains Tollefson, who was briefed after the top-level meeting. She says she and Sundlof, the center head, agreed to transfer Hampshire.

Tollefson says they also wanted to keep her from being a "distraction" when the recall was reviewed, because they too were troubled by the drug's safety record.

Crawford didn't respond to interview requests for this story. In 2005, he abruptly quit the FDA and later admitted hiding stocks he owned in medical and food companies it regulated. He was fined about $90,000.

But former FDA lawyer Daniel Troy, also at the Essner-Crawford meeting, defends how it was handled. "At the same time the FDA is actually getting smashed and bashed by the news media on conflicts of interest, here there was an allegation of conflict of interest, and the FDA took it seriously," he says.

One morning two months later, Hampshire was working on Proheart 6 data when she was called in to the veterinary director's office without explanation.

There, in a bright office decorated with a folksy painting of dairy cows, Tollefson waited with an FDA manager of market reviews. Hampshire figured they needed help as the FDA prepared to reconsider the Proheart 6 recall.

But Tollefson inhaled sharply, as if steeling herself. Then she wiped a tear from her eye. Hampshire had known Tollefson since working at the health institutes; they were friendly, but she'd never seen anything like this.

"Wyeth has pulled all the plugs at the level of commissioner," Tollefson told a stunned Hampshire. They were transferring her to the vaccines building to care for the rats and monkeys.

She pleaded for her job. They refused to give details but reassured her that this would all blow over. She was likened to a cop who'd shot somebody in the line of duty.

"I haven't shot anybody," she protested. "I've done my job."

She left the office in tears.

Her shame deepened when a committee of FDA advisers took up the Proheart 6 recall three weeks later in January 2005. She wasn't allowed to talk to them, and they voted just barely, 8-7, to keep the drug off the market for the time being.

The next month, an agency inspector from Internal Affairs asked to see Hampshire. He told her she was under investigation over Wyeth objections to her outside activities. He referred obscurely to a "sinister plot."

A prosecutor had already ruled out most criminal charges. But the inspector made her sign a statement saying she could be fired and, if she lied, charged with perjury. He reminded her about the jailing of domestic guru Martha Stewart over a financial conflict.

Hampshire dragged herself through the next several months, feeling she'd been cast, weak and worthless, into a hole. A colleague worried she was headed for a breakdown.

She was sent to an interim FDA office job within the capability of "anybody with half a brain," she says. She didn't know where the investigation would lead. She didn't know who might be bent on ruining her career, but she looked for a better job somewhere. She saw - or imagined - warning signs and potential enemies everywhere. She hoped for protection from members of Congress she contacted.

She fretted at home. "To take this much stress home and not to sleep for weeks is not worth it," she says. Even her two children noticed changes in her.

Then, out of the blue, there was a flicker of light. In April 2005, she landed a better job in the FDA itself, at a separate office that evaluates devices for the human heart. "It sounded to me like she really hadn't done anything wrong," explains her new supervisor, Dave Buckles.

That July, more relief came: Hampshire was told she was cleared by agency investigators. "A valued employee" is how FDA spokeswoman Julie Zawisza now describes her, but she won't discuss the transfer and investigation.

Tollefson now believes the affair was mishandled. "Everybody saw that we reassigned Tory, no explanation was ever given - not a good one - so the message to me was very clear: If you do your job right and you're questioned, you lose your job."

Although Wyeth has been sued on behalf of dozens of people whose pets took Proheart 6, the company hopes to be vindicated too. It has kept selling the drug in Canada, Europe and elsewhere, and it has approached the FDA with more data for a possible U.S. comeback.

In June 2005, a Wyeth manager made a sales call at an Alabama veterinary practice, where he openly blamed Hampshire for the Proheart 6 recall, according to a confidential letter written by a vet there to the FDA. The Wyeth employee boasted that the company had her investigated by private detectives, and she had been "taken care of," according to the letter obtained by The Associated Press. He then predicted the drug's swift return to market.

That Wyeth manager, Glen Kimmorley, did not answer AP messages left at a home phone in his name. The Wyeth spokesman said Kimmorley "was expressing his own opinion and was not authorized to speak on behalf of the company.

" However, Sen. Chuck Grassley, R-Iowa, who has been investigating Hampshire's case, says Wyeth "tried to destroy a reputation."

He added: "Her own agency sold her down the river."

Hampshire still feels edgy, less trusting, shamefully naive about corporate influence on government. Her husband, Bob Balaban - himself a senior scientist at the National Institutes of Health - says she's "not the same person." They hope for more answers from Senate investigators.

Others have reached their own conclusions. Last year, Hampshire was sitting in a big conference room in Denver at a veterinary meeting of the U.S. Public Health Service. The agency was announcing its veterinarian of the year. She grabbed her camera to photograph the winner.

And then, as if scripted by Hollywood, her own name was announced.

She heard a health officer say she had "raised the bar in every category of professional and personal integrity, passion, and commitment."

People rushed over to hug her. For the first time in years, she let down her guard.