In 2003, an FDA veterinarian named Victoria Hampshire began examining a growing number of adverse reactions to ProHeart 6, a Wyeth med for treating hookworm in dogs. Little did she know that her curiosity and commitment to her work would lead her into a maelstrom that, ultimately, would generate a Congressional investigation and raise questions about industry influence over the agency; the FDA’s ability to properly investigate allegations against employees, and the agency’s own commitment to serving the public.

After the med was removed from the market, you see, Wyeth launched its own secret investigation into Hampshire; raised conflict-of-interest charges against her at the FDA; and implicitly threatened agency officials that further action would be pursued if Hampshire was allowed to remain in place. Among those involved in a failed effort to allow ProHeart 6 back on the market was former Wyeth ceo Bob Essner. Hampshire was, in fact, removed from her post, but negotiated a transfer and now works as director of device review in the cardiac device division for the FDA’s Center for Devices and Radiological Health.

Last week, Chuck Grassley, a member of the US Senate Finance Committee who led the investigation, to recommend the FDA strengthen various procedures and policies, particularly concerning interactions between agency officials and industry execs. “The FDA accepted Wyeth’s allegations at face value and took actions against Dr. Hampshire that may have adversely affected the drug approval and recall processes,” he wrote to FDA commish Andy von Eschenbach. (Here’s his report and the attachments). We subsequently spoke with Hampshire and asked her to reflect on the episode. Here’s an excerpt…

Pharmalot: This is a very detailed report. To what extent were you aware of the goings on described?
Hampshire: Well, of course, I lived this, but there were parts that were new to me. I was unaware of the gossip and speculation that was used to try to discredit me. They hired people - a public relations firm, a veterinarian - who had no access to the (ProHeart 6) data or played a public health role but they suggested I was taking a stance for my own benefit (Hampshire was accused of a conflict of interest because she had a web site that infrequently accepted orders for veterinary meds, although she used it almost exclusively for helping family and friends, and orders were taken by a third party. The Wyeth investigation involved unsuccessful attempts to purchase prescription meds). I was shocked, to be honest. You know, only 2,500 or so people a year graduate from veterinary schools. It’s a small world, but I didn’t know it was vindicative and evil. And the company stooped to the level of hiring a PR firm to investigate me. I would never have dreamed that would happen to me in my public health role.

Pharmalot: And what about your managers at the FDA?
Hampshire: I thought my managers were cowardly…

…But I do understand that the FDA may not have been in control of its own decision. There was a fear of interference from higher levels. I’m not sure if some specific threat came down, but even a low-level manager may have been afraid that somebody in the Bush administration wouldn’t try to take his job away. The whole thing was chilling. And I’m not sure if the rubber hit the road that it would happen again. But it makes you realize your own agency isn’t in control of its decisions.

Pharmalot: In your view, is there any lesson here for the public?
Hamsphire: Looking back, I felt there was tremendous partiality given to industry (by FDA officials). So the public really has to speak its mind to their elected officials. There was no advocate for the public in this story - the people who owned dogs and used ProHeart 6 - but everyone was advocating for the pharmaceutical company. Those dogs (who suffered due to ProHeart 6) were owned by people who, in some cases, undertook financial constraints to care for their pets. But no one in this process advocated for them.

Pharmalot: And what should drugmakers take away from all this?
Hampshire: Well, they should know that not every employee is going to crawl away in fear. I’m sure, from their perspective, I was just a lowly vet. But they shouldn’t underestimate the power of the individual to seek justice.

Special thanks to The Giraffe Heroes Project, which helps those who stick their necks out