Watchdog risked career over pet-drug warning

In summer 2004, Hampshire was analyzing Proheart 6 side effects for a fast-approaching showdown with drugmaker 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.

Showdown turns nasty
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.

A conflict of interest?
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.

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