Wyeth, the Veterinarian and FDA
Things are not going well these days for Wyeth or the US Food and Drug Administration. In the latest of a series of complaints over FDA's safety review of drugs and industry influence on the agency, a Senate panel found flaws in its scientific objectivity when it reassigned an agency veterinarian over unfounded conflict –of- interest accusations by Wyeth.
The congressional inquiry looked into how the FDA dealt with Wyeth’s accusations against Dr. Victoria Hampshire, an FDA regulator who was helping to review the safety of one of Wyeth’s lucrative veterinary drugs. The case centers on Proheart 6, an injected dog heartworm medication that Wyeth pulled from the market in September 2004 after Hampshire linked the drug to dog deaths. Wyeth later complained about alleged bias by Hampshire. The company claimed that she intend to sell competing drugs through her own Web site. After Wyeth made the allegations, Hampshire was abruptly reassigned to another job within FDA and her case was referred to the U.S. attorney's office for possible criminal prosecution. Federal prosecutors quickly dropped the case, and much to FDA’s chagrin, in 2006, the U.S. Public Health Service named Hampshire veterinarian of the year.
Congressional investigators discovered that FDA referred Hampshire's case to prosecutors on the basis of mistaken allegations about her Web site that could easily have been checked but were not. As it turned out, Hampshire’s did little business at her website and did not sell any products that competed with Proheart 6. In fact, she actually sold Wyeth’s Proheart 6 until the company pulled it from the market. Go figure….
In a letter to HHS Secretary Michael Leavitt and FDA Commissioner Dr. Andrew von Eschenbach, panel Chairman Senator Charles Grassley (R-Iowa) wrote that the panel’s findings suggest “that the scientific process is being compromised internally" at the FDA. Also, he wrote that the case brings into question "the processes that FDA uses in response to industry allegations of wrongdoing by FDA employees."
FYI, a FDA advisory panel narrowly voted to keep Proheart 6 off the market shortly after Hampshire was reassigned in 2004.
Until next time….
Good Luck and Good Job Hunting!!!!!!!!!
