FDA vet blows whistle, pays price

The first hints of trouble came with vague warnings from the outer reaches of the bureaucracy.

She was “pushing too hard.”

She was “alarmist.”

But it was a clumsy bid to call her off the scent of the dangerous veterinary drug that really galled her:

“When enough dogs die, this product will take care of itself,” a colleague said.

Victoria Hampshire heard herself say: “I don’t know what I’m doing here then.”

What she was doing was her job: counting side effects from animal drugs for the Food and Drug Administration and alerting supervisors when something seemed amiss.

And something seemed amiss that spring of 2004 with Proheart 6, a three-year-old injected drug to prevent heartworm, the common parasite in dogs. Hampshire’s numbers showed that dogs were dying at alarming rates.

What happened next -- and the price she paid for speaking up -- spurred a U.S. Senate inquiry.

Sleeping bags for mice

While dogs were dying, her dad’s heart was failing. Gifford Hampshire was an FDA press officer in the 1960s. His daughter Victoria -- everyone called her Tory -- now worked as a veterinarian at the same agency.

Growing up on a Virginia horse farm, where her mother raised basset hounds, she 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. 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 brown-nosing,” 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 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 different 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.

Showdown

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

She and Tollefson, now FDA’s assistant commissioner for science, remember the confrontation 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. Its veterinary subsidiary, Fort Dodge Animal Health, had sold 18 million doses of Proheart 6, worth tens of millions of dollars. It wouldn’t give up without a fight.

The company said Hampshire was inflating her numbers. 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,” she retorted.

Dr. Stephen F. 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.)

On Sept. 4, 2004, in the face of Hampshire’s damning data, Wyeth recalled Proheart 6 -- without conceding it was dangerous.

A big problem

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

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

His company had uncovered a website that gave Hampshire a cut of its drug sales. Proheart 6 was sold there, but 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,” said 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 website, mainly to prescribe drugs for pets of old clients and friends. 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 acknowledges. An invoice shows she earned just $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. 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 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.

An unexpected call

Two months later, Hampshire was working on Proheart 6 data when she was called to the veterinary director’s office without explanation.

There, 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, then wiped away a tear.

“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 advisors 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’s 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.

Losing sleep

Hampshire was sent to an interim FDA office job within the capability of “anybody with half a brain,” she says. Depressed, she looked for a better job and saw -- or imagined -- warning signs and potential enemies everywhere. She contacted members of Congress, hoping for protection.

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, 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: Hampshire was told she had been cleared. “A valued employee” is how FDA spokeswoman Julie Zawisza now describes her, but she won’t discuss the transfer and investigation.

Tollefson 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 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 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 that she had been “taken care of,” according to the letter, obtained by the Associated Press. He 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. Charles E. 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,

Her husband, Bob Balaban -- a senior scientist at the National Institutes of Health -- says she’s “not the same person.” They hope for more answers from Senate investigators.

Last year, Hampshire was at a veterinary meeting of the U.S. Public Health Service in Denver. As 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.