FDA To Review Safety Of Controversial Dog Drug
5 CommentsBy Ed Silverman // February 3rd, 2010 // 8:36 am
Nearly two years after after a controversial drug used to prevent heartworm in dogs was returned to the market, the FDA will hold a meeting to review a Risk Minimization Action Plan that was put in place to track the safety of the med, known as ProHeart 6. The meeting will be held on March 24 by the FDA’s Veterinary Medicine Advisory Committee (see here) and review 18 months’ worth of data. The question at hand: is the drug truly safe to use?
For those who don’t recall, ProHeart 6 was yanked in 2004 after being linked to a high rate of deaths and serious side effects following a review by an FDA vet. However, Wyeth then launched a secret probe into the vet, Victoria Hampshire; raised conflict-of-interest charges against her at the FDA; and implicitly threatened FDA officials that further action would be pursued if the vet was allowed to remain in place. Among those involved in the attempt to have the drug returned to the market was former Wyeth ceo Bob Essner.
Meanwhile, a 2005 FDA advisory committee evaluated safety and risks, and recommended more data, including targeted animal safety studies, was needed. However, a Wyeth application indicated the panel “did not require target animal safety studies for this supplemental approval.” The episode prompted a Congressional probe amid outrage over the FDA and Wyeth’s conduct, and the FDA was asked to explain its decision in 2008 to allow ProHeart 6 back on the market, particularly since the drug contains moxidectin, which an FDA panel concluded earlier wasn’t safe for dogs (background).
The decision to return ProHeart 6 to the market was made without the sort of transparency the FDA appears to be seeking this time around. Whether Essner or Hampshire will be on hand for some closure is unclear. Essner, of course, retired from Wyeth before it was purchased last year by Pfizer. And Hampshire, who refused a reassignment within the FDA’s Center for Veterinary Medicine, later took a different position at the agency’s Center for Radiolocial Devices and Health.
ellen
Wouldn’t the attempts to smear reviewer Hampshire suggest that the argument to return this drug to market was not relying on scientific data? Rather Wyeth pursued a strategy of intimidation with the goal of closing down, freezing the debate.
Robert Essner is now a mentor at Columbia University Grad School of Business, lecturing on success stories derived from his years of service in the industry. Clozaril, fen-phen, PremPro. Just a few of many troublesome examples that come to mind. One wonders how much responsibility Mr. Essner assumes in his case studies of dubious marketing strategies. Not to mention the responsibility for authorizing regulatory strategies such as the one presented here. At the very least this breach occurred under his watch.
Here’s hoping the MBA students and their benefactors know where their tuition dollars are going. Not to mention recognizing the false impressions upon which their management lessons might be based.
John
Wyeth “implicitly threatened FDA officials”???? Anyone who claims to follow this industry should know that NOBODY threatens the FDA.
Wyeth “secretly” launched a conflict of interest investigation??? Give me a break, once again the language here is intended to imply some sort of conspiracy. Clearly Wyeth has every right to pursue a conflict of interest investigation if they believe a conflct exists.
Ed Silverman
Hi John,
Thanks for the note. And I understand your point. Yes, Wyeth had every right to pursue concerns over a potential conflict of interest situation. No question about that.
As to the choice of wording, the reference was to the possibility of legal action being taken. Companies do sue the FDA. I wasn’t referring to anything of a different sort and didn’t intend to suggest otherwise. Apologies for any confusion.
As to the use of the word ’secretly,’ the company hired a private eye to investigate the FDA reviewer, which you can read more about
in a report prepared by Sen. Grassley, whose staff investigated. Although it’s available in earlier posts about this topic, here is a direct link…
http://finance.senate.gov/press/Gpress/2008/prg020608.pdf
I hope this helps,
ed
ex-FDA
John,
That is absolutely false. It has been documented several times with several different drugs that FDA management collaborated with companies to threaten or retaliate against FDA employees. The best known example is David Graham and Vioxx.
I have personally been subjected to several instances where companies tried to retaliate against me for raising safety concerns. If a company doesn’t like something all they have to do is make something up and make complaints to FDA management. Your only hope is if your superior will defend you, which I am thankful for. I am declining to discuss the cases even without providing identifying information, which I could do legally, as I am still fearful of retaliation.
I’ve also had companies apparently try to bribe me with ‘consulting work’ while employed with the FDA and that I could “name my own price”.
patrons99
Ex-FDA:
Retaliation and attempted bribery. That is simply astounding! Don’t federal criminal statutes cover that? Can you prove that? That sounds like one for DOJ, criminal division, to look into. This kind of misconduct will continue indefinitely unless someone puts a stop to it, e.g. by whistleblowing.