The website Whistleblower.org provides some interesting history to the pet heartworm medication ProHeart6.   This history gives insight into what some companies are capable of should anyone interfere with profits.

ProHeart6 is a canine heartworm medication initially approved by FDA in 2001, withdrawn from market in 2004, and returned to market in 2008.  The market approval, removal, and re-approval of this heartworm preventative is a very interesting tale.  The following excerpts are from Whistleblower.org – Government Accountability Project on ProHeart6…

“Victoria Hampshire was a model employee of the FDA. Working as a veterinarian, she was dedicated to monitoring drug interactions in animals, and received numerous accolades for her work.

In 2004, Dr. Hampshire discovered that a popular heartworm medication for dogs was killing hundreds of animals. Her analysis and reports pulled the drug off the market. That should have been the end of it. But the drugmaker, Wyeth Pharmaceuticals, conducted a iniature smear campaign against her, and used its connections with the FDA to have her criminally investigated on trumped-up charged. Although vindicated completely in the end, the horror story that Hampshire experienced illustrates how FDA brass can be manipulated to inflict wrongful action, simply based on the will and connections of drug behemoths.

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.”

According to the Whistleblower.org website, Wyeth Pharmaceuticals hired a private investigator to “spread dirt” on Dr. Hampshire, including (reportedly) convincing FDA administration Dr. Hampshire “had a financial stake in a rival product.”  Wyeth was granted a “private meeting” with then-acting FDA Commissioner Lester Crawford (who has an interesting history all his own); the result of this ‘private meeting’ removed Dr. Hampshire from review of ProHeart6 (without explanation by FDA) and a FDA criminal investigation of Dr. Hampshire.

“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.

Fighting Back
Even though CVM did not permit Dr. Hampshire to present the case about the drug’s dangers to the Veterinary Medicine Advisory Committee, the Committee still voted to keep ProHeart6 off the market. The internal FDA investigation of Dr. Hampshire ended in complete failure – a full and explicit exoneration of her actions. In fact, the agency ended up honoring her with an award for her work on the drug. Several major news outlets chronicled her story.

Soon thereafter, Dr. Hampshire transferred from CVM to the FDA’s Center for Devices and Radiological Health where, in happy contrast to CVM, her current superiors completely support her.

Grassley’s Crusade
Dr. Hampshire was safe, but Sen. Grassley, long known as a champion of whistleblowers, wasn’t finished. Grassley wrote the CEO of Wyeth that:

“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.”

Sen. Grassley sought all FDA communications related to the infamous closed-door meeting that then-Acting Commissioner Lester Crawford held with Wyeth executives immediately before Hampshire was removed from her post.

In 2008, at the end of a long and thorough investigation of this awful affair, Grassley to HHS Secretary Michael Leavitt, and FDA Commissioner Andrew von Eschenbach, detailing how Wyeth Pharmaceuticals engaged in this horrific smear campaign against Hampshire. 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.

The Hero and the Crook
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.”

This ordeal regarding ProHeart6 ended in 2008…the very same year Fort Dodge Animal Health entered into a four year partnership program with the American Veterinary Medical Association (AVMA); a partnership that gave the national veterinary organization $1.5 million dollars over four years.  Fort Dodge Animal Health is now a division of Pfizer Animal Health.

Interesting dates and more information…

June 5, 2008 FDA re-approved ProHeart6 (Fort Dodge Animal Health) to return to market.

July 15, 2008 AVMA announces “multimillion-dollar partnership” with Fort Dodge Animal Health

ProHeart6 was a product of Wyeth Pharmaceuticals Fort Dodge Animal Health division, Pfizer agreed to purchase Wyeth in January 2009 in a reported $68 billion deal, completed in October, 2009.

Senator Grassley letter to FDA questioning re-approval of ProHeart6.

More on Former FDA Commissioner Lester Crawford.