Sounding the alarm over animal drug's risk, regulator jeopardized her career

BETHESDA, Md. -- The first hints of trouble came with vague warnings from the outer reaches of the bureaucracy.

But it was something else -- a clumsy bid to call her off the scent of the dangerous veterinary drug she was tracking -- that really galled her. Maybe that was her last possible moment to keep soundless and safe.

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

Her reply tumbled out like a boulder that, once rolling, will no longer stop. Victoria Hampshire heard herself say: "I don't know what I'm doing here then."

What she was doing -- trying to do, at least -- was her job: She kept count of side effects from animal drugs for the Food and Drug Administration. She made tallies, analyzed numbers and alerted supervisors when something seemed amiss.

And something seemed amiss that spring of 2004.

A drug maker had crafted what seemed a star performer in Proheart 6, a three-year-old injected drug to prevent heartworm, the common parasite in dogs. Hampshire's numbers showed, though, that dogs were dying at alarming rates.

What happened next has spurred a U.S. Senate inquiry and shined a light on the complex topography of drug safety, where interests collide and squeeze decisions from all sides.

On this landscape, the government's watchdogs come in disparate breeds, too.

"I could feel like I'd get an honest opinion from her, without brownnosing," says Dr. Judith Davis, Hampshire's 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 father, who was suffering heart problems, at the hospital. Then she'd work into the night.

Two days after his death, Hampshire went toe-to-toe with Wyeth.

Battling 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. 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.

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

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 drug for pets.

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.

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.

Doing her duty

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.

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.

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.

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, 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.

"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.

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 or investigation.

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.

Last year, Hampshire was sitting in a 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.