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Dog-drug case renews scrutiny on FDA

Agency transferred reviewer after Wyeth unit questioned her

WASHINGTON -- After a Food and Drug Administration reviewer alerted managers to a surge in safety problems with a veterinary drug, supervisors transferred her off the case and the agency began to secretly investigate her.

Victoria Hampshire was the FDA contact for people reporting side effects after dogs received ProHeart 6, a treatment sold by Fort Dodge Animal Health, a division of Wyeth, to prevent heart-worm disease. Soon after the injection, almost 5,500 dogs suffered serious side effects and more than 600 dogs died.

Wyeth told the FDA it had concerns about Hampshire's objectivity, citing an apparent conflict of interest due to her participation in an online pharmacy that sold competing heart-worm drugs. Once Hampshire was ''taken care of," complaints about ProHeart 6 lessened, a Fort Dodge field representative boasted to an Alabama veterinarian.

The case reflects how -- one year after the FDA faced embarrassing testimony that it placed Merck & Co.'s interest ahead of consumers taking the painkiller Vioxx -- that the agency remains ''too cozy" with the industry it regulates, says US Senator Charles Grassley, Republican of Iowa, whose office released documents related to its investigation of ProHeart 6.

Hampshire is the latest in a trio of FDA whistleblowers whose cases reflect agency ties to drug companies that Grassley called troubling. They include Dr. David Graham who voiced concerns about the heart risks from Vioxx and Andrew Mosholder who raised issues about the safety of antidepressants used by children.

The documents provided by Grassley, Senate finance panel chairman, include Wyeth's confidential PowerPoint presentation to the FDA and a letter describing the field representative's allegations.

The FDA's probe exonerated Hampshire, and ProHeart 6 was removed from the market. Grassley has requested more documents from Wyeth, which could form the backbone of a congressional hearing that mirrors one Grassley held last fall, after Vioxx was pulled from the market.

Hampshire, a longtime government scientist who came to the FDA in 2001 from the National Institutes of Health, said in an interview with the Globe that the experience shook her trust in the drug regulatory agency.

''I certainly felt that I was expendable," said Hampshire, 45, a senior regulatory reviewer.

''Given my track record in government, I would have liked for them to have come to me and ask me if the allegations were truthful and what records could I produce to vouch for that fact," she said. ''I don't understand why it was necessary to secretly investigate me and reassign me without a good reason, because it really created fear and paranoia."

''The FDA acted properly with respect to this matter," said FDA spokeswoman Susan Bro. A Wyeth spokesman defended the company's response, saying it acted ''responsibly and appropriately."

When the FDA approved ProHeart 6 in June 2001, veterinarians switched dogs from heart-worm pills to an injection that promised six months of protection. Troublesome signs emerged quickly, with a massive allergic reaction suffered by dogs added to the drug's label. By 2004, ProHeart 6 had $35.2 million in annual sales and more worrisome side effects (liver problems, autoimmune disease, severe seizures, and deaths) Hampshire brought to her supervisor's attention.

Three of Joanne Plummer's dogs were treated with ProHeart 6. A Gordon setter named April and a mixed terrier named Cougie suffered kidney failure and were put down within a week of each other. The third dog, a Jack Russell terrier mix named Angel, survived but went bald.

Dog owners' complaints helped persuade the FDA to ask Fort Dodge to recall the drug on Sept. 4, 2004.

On Nov. 19, Wyeth presented its case against Hampshire to the FDA. Between then and a Jan. 31, 2005, public hearing about the drug, Hampshire was transferred.

''I was given no substantive explanation. I was simply told that Wyeth had pulled some plugs," she said. ''I understand from the person who reassigned me that consumers were one of the things that Wyeth worried about. That I had too much contact with consumers and I should be less visible."

She learned of the FDA's criminal investigation later.

The agency looked into a website for veterinary drugs that Hampshire joined as a prescribing partner. Prescriptions from the site yielded $196 in income over four years, she said. Hampshire said she reported the income to the FDA, as she did moonlighting at the local animal clinic and consulting for the Humane Society.

Doug Petkus, a Wyeth spokesman, said the field representative who derided Hampshire was not speaking on behalf of the company, nor did Wyeth request Hampshire's transfer. ''We made the FDA aware of her affiliation, which we thought really amounted to a potential conflict of interest," Petkus said. ''All we asked is that the agency review the information we provided them."

Diedtra Henderson can be reached at dhenderson@globe.com.

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