Senator’s Investigation Details Wyeth, FDA Wrongdoing

Grassley Calls Out Pharmaceutical Company and FDA in Letter;
Two-Year Investigation Details Retaliation, Unwarranted Private Investigation, and Smear Campaign Enacted against Drug Whistleblower

(Washington, D.C.) – Earlier today, Senate Finance Committee Ranking Member Charles Grassley (R-Iowa) sent a letter to HHS Secretary Michael Leavitt and FDA Commissioner Andrew von Eschenbach detailing how Wyeth Pharmaceuticals engaged in a smear campaign aimed at discrediting an FDA safety officer assigned to review one of Wyeth’s animal care products. After Wyeth met with FDA officers and presented false and misleading information, the FDA wrongfully removed GAP client Dr. Victoria Hampshire from her position as that drug’s reviewer.

Dr. Hampshire had previously found that Wyeth’s ProHeart 6, a canine heartworm drug, was responsible for contributing to the deaths of hundreds of dogs. Dr. Hampshire followed correct procedures in mid-2005 when bringing forth evidence linking the drug to canine fatalities to FDA colleagues and supervisors, who then decided to remove ProHeart 6 from the marketplace due to obvious safety concerns.

The letter details vast, questionable actions and wrongdoing involving Wyeth and it subsidiary, Fort Dodge Animal Health (FDAH), and FDA management. These actions include:

• The FDAH president apparently threatening to bring down high-level Bush administration pressure on FDA if the FDA Center Director refused to release confidential information to the company.
• FDAH’s hiring of a public relations firm, Germinder & Associates, Inc. (GAI), to conduct a PR campaign aimed at veterinarians after ProHeart 6 was removed from the market. FDAH representatives falsely claimed that Dr. Hampshire forced the recall of the drug because she had a financial stake in a rival hookworm drug.
• GAI’s hiring of private investigators (permitted by FDAH and Wyeth representatives) to dig up any dirt it could on Dr. Hampshire, and included researching her personal property and tax records.
• GAI’s tactics of having consultants lie and mislead Dr. Hampshire into believing they were veterinarians, in a feeble and failed attempt to entrap Hampshire into establishing a direct monetary relationship with a Wyeth competitor.
• A personal call from Wyeth Chairman Robert Essner to then-FDA Commissioner Lester Crawford to arrange a meeting between the two groups’ officials to present the fruits of Wyeth’s bogus “investigation,” attempting to show that Dr. Hampshire had a “conflict of interest.” At this meeting Wyeth officials presented a 29-slide slideshow trumping up charges against Dr. Hampshire, resulting in the FDA removing her as the reviewer of the Wyeth drug. The FDA then opened a criminal investigation into Hampshire’s background, one that saw FDAH ‘s General Counsel repeatedly contacting FDA investigators in an attempt to guide their probe. Dr. Hampshire was not alerted to the fact that she was under any sort of investigation. Lasting nearly a year, Dr. Hampshire was vindicated of all charges.
• Early in the FDA criminal inquiry, the agency, relying on Wyeth’s misleading “evidence,” referred the case to the United States Attorney’s Office of Maryland. The US Attorney, however, declined to prosecute.

Dr. Hampshire, thankful to Sen. Grassley and his staff for their hard work, stated, “If a drug company is willing to go this far to explain away over 5000 pieces of adverse drug information, it should make the FDA think long and hard about whether any of the information presented thus far by this company is credible.”

Hampshire still works for the FDA, but in a different Center. She added she is happy to now be “working for managers with courage who support her. It shows that such places exist within the FDA.”

Overall, Grassley stated in his letter that his findings bring into question “the processes that FDA uses in response to industry allegations of wrongdoing by FDA employees.” The senator noted that the FDA lacks a clear mandate to record industry contacts with the agency, and that the substance of the critical, private meeting in which Wyeth executives presented their slide show to the FDA Commissioner and general counsel was hardly even memorialized by the agency. Wrote Grassley: This “highlights the problem with transparency at the FDA: the transparency is there, you just can’t see it.”

Mark Cohen, Dr. Hampshire’s attorney and GAP Executive Director, echoed Dr. Hampshire’s comment that “the FDA’s leaders who removed her and launched the criminal probe of Dr. Hampshire should be sent to Oz to get some courage – a heart – and some more brains.” Cohen noted that despite Wyeth’s smear campaign and the FDA’s abusive investigation, due to her fearless work on Pro Heart 6, Dr. Hampshire was named the Public Health Service’s Veterinarian of the Year.

GAP’s Food & Drug Safety Program has acted as an FDA watchdog for years. Other prominent clients in this area include FDA Safety Officer David Graham, who revealed the dangers of Merck’s dangerous arthritis drug Vioxx; and several FDA officials who blew the whistle on the unsafe and questionably effective antibiotic Ketek.