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Wyeth to comply with Senate investigation
Washington — Wyeth Pharmaceuticals plans to aid a Senate investigation after allegations surfaced that the company attempted to discredit a Food and Drug Administration (FDA) officer who challenged the safety of ProHeart 6.
WASHINGTON — Wyeth Pharmaceuticals plans to aid a Senate investigation after allegations surfaced that the company attempted to discredit a Food and Drug Administration (FDA) officer who challenged the safety of ProHeart 6.
The drug manufacturer denies any wrongdoing.
Headed by Sen. Charles Grassley, the investigation focuses on the suspension of FDA safety officer Dr. Victoria Hampshire, 45, from the review of ProHeart 6, which was voluntarily withdrawn from the market in September 2004.
Grassley's office did not return repeated phone calls seeking comment. In a letter to DVM Newsmagazine, officials with Fort Dodge Animal Health, a Wyeth subsidiary, acknowledge the company's involvement with Grassley's investigation and maintain that it has "always acted responsibly and appropriately in all aspects regarding this matter."
Officials with the FDA's Center for Veterinary Medicine (CVM) refused to comment on the case.
While Fort Dodge "continues to believe ProHeart 6 is a safe and effective option to prevent life-threatening canine heartworm disease," Hampshire linked adverse reactions in canines to use of the injectable heartworm preventive.
Conflict accusations arose after Wyeth learned and reported to FDA leadership that Hampshire had a side job with accounts on VetCentric's Web site. While moonlighting isn't unusual among FDA's veterinary officers, Wyeth charged that Hampshire was selling products that compete with ProHeart 6 and perceived the relationship a conflict of interest. The accusations, advanced during private meetings with then-agency Commissioner Dr. Lester M. Crawford, led to an FDA criminal investigation into Hampshire's conduct and her subsequent reassignment to a new CVM position, Grassley contended in a Senate floor speech in November.
Of the VetCentric relationship, Fort Dodge officials say, "If true, this affiliation could impact Dr. Hampshire's independence and objectivity and might prejudicially influence her evaluation of ProHeart 6."
Yet Hampshire describes her relationship with VetCentric as minor, noting she used the online pharmacy because she practiced veterinary medicine in her spare time and didn't want to stock drugs.
"Every year I disclosed my activity to FDA," she says. "I didn't want to be in the business of holding or dispensing pharmaceuticals. When Wyeth lodged their allegation, I was reassigned three weeks before the panel meeting to re-review ProHeart 6. It's true I recommended the recall, but I had no direct role in what happened."
Following Wyeth's voluntary recall of ProHeart 6 in 2004, the company requested an independent advisory council to re-review safety data on the heartworm preventive and determine the cause of related adverse reactions. Yet in a narrow decision, the panel voted for further study to better understand questions surrounding the drug's safety and efficacy.
Although FDA has since exonerated Hampshire following a district attorney's refusal to prosecute, she believes her reputation in the veterinary community has been significantly damaged. She retained counsel with the Government Accountability Project, a non-profit agency that defends whistleblowers. She's now content having moved from CVM to FDA's Center for Devices and Radiological Health.
"Right now we're more interested in assisting the Senate investigation in any way we can and bringing due process into FDA," Hampshire's attorney Mark Cohen tells DVM Newsmagazine.
Fort Dodge says it plans to comply with Grassley's requests within the specified time frame.