Source: http://www.whistleblower.org/program-areas/public-health/proheart6
Timestamp: 2013-05-24 03:48:05
Document Index: 143853935

Matched Legal Cases: ['art6', 'art6', 'art6', 'art6', 'art6', 'art6', 'art6', 'art6']

ProHeart6 - Government Accountability Project
About Multimedia Press Program Areas Action Center Blog ProHeart6
Dr. Hampshire worked for the FDA’s Center for Veterinary Medicine (CVM), where she reviewed the safety of various animal care drugs, including Wyeth’s ProHeart6. The drug was initially approved by the FDA in 2001 to treat heartworm in canines. By 2004, ProHeart6 claimed sales of over $35 million. The problem, as Dr. Hampshire discovered, was that the drug was related to liver problems, autoimmune disease, severe seizures, and over 500 dog deaths. The FDA pressed Wyeth to recall the drug, which it did in September 2004.
But Wyeth was merely stalling – it set out to gain re-approval for its profitable drug from an FDA Advisory Committee, slated to meet in late January 2005.
Smearing the Whsitleblower
Not trusting the outcome of the process, Wyeth took to the gutter, launching an astonishing and full-on smear campaign. The company hired a private eye to dig up and spread dirt on Dr. Hampshire. At least one company sales representative reportedly told a practicing vet that the only reason ProHeart6 was off the market was because of Dr. Hampshire, who he claimed had a financial stake in a rival product. At that point, then-acting FDA Commissioner Lester Crawford granted Wyeth a private meeting in which the company presented him with “information” about Dr. Hampshire. Just weeks after this secret meeting, Dr. Hampshire was summarily removed by CVM officials from the review of ProHeart6 without explanation or any opportunity to defend herself.
But the tale gets worse: Dr. Hampshire was then subjected to an FDA criminal investigation and sting operation.
That’s when Dr. Hampshire came to GAP for help. With our help, and a mix of legal counseling, personal support and assistance in media outreach, the Wyeth House of Cards collapse. We worked with Dr. Hampshire in communicating her concerns to relevant congressional parties, including Sen. Charles Grassley, and offering her our legal services.
information and documents reviewed by the committee appear to support allegations that Wyeth investigated an employee of the FDA involved in the safety review of ProHeart6. It appears that the express purpose of the investigation was to discredit the employee and have the employee reassigned. Further, following the investigation conducted by Wyeth, the FDA initiated an internal criminal investigation into the same FDA employee. The committee’s review of these allegations raises serious questions regarding, among other things, the appropriateness of the actions taken by both the FDA and Wyeth.
In the end, the amount of praise bestowed on Dr. Hampshire is only matched in scope by the downfall of then-Acting FDA Commissioner Lester Crawford. Crawford was made fulltime FDA Commissioner in July 2005, only to leave two months later amidst scandalous allegations of having financial interests in those companies he was supposed to be regulating. One year later, he received three years’ probation and a hefty fine.
Program AreasCorporate & Financial AccountabilityEnvironmentFood IntegrityGovernment EmployeesNational Security & Human RightsInternationalLegislationLitigationPublic HealthCorexitVioxx/David GrahamKetekActonelProHeart6Sen. Grassley's LetterReports/Publications