Wyeth isn't have great luck getting the FDA to approve its drugs for humans, but dogs are another matter. The agency is allowing a limited return of a reformulated version of ProHeart 6, a heartworm med for Fido that was yanked four years ago after being linked to an unusually high rate of deaths and serious side effects - lethargy, vomiting, seizures, difficulty walking, jaundice, bleeding disorders, allergies, and convulsions. With drugs like that, who needs disease?
The new version is an injectable and will be available on a restricted basis under a so-called 'risk minimization' program, in which vets must register and participate in an Internet training program. This is a first for a veterinary drug, says Bernadette Dunham, who heads the FDA’s Center for Veterinary Medicine, in a statement. “While we concur with the limited return of ProHeart 6 to the US market, we strongly encourage veterinarians and pet owners to report any possible adverse reactions.”
Wyeth has worked hard for this moment, but not without enduring a series of embarassments that also spoke poorly of the FDA. In 2003, an FDA vet named Victoria Hampshire began examining a growing number of adverse reactions to ProHeart 6, which was ultimately withdrawn based on her reports.
But then, Wyeth launched a secret investigation into Hampshire; raised conflict-of-interest charges against her at the FDA; and implicitly threatened agency officials that further action would be pursued if Hampshire was allowed to remain in place. Among those involved in a failed effort to allow ProHeart 6 back on the market was former Wyeth ceo Bob Essner. Hampshire transferred to a different FDA job, but the episode was investigated and publicized by US Senator Chuck Grassley.
The FDA says the return of the infamous med is based on results of additional toxicological and pharmacologic studies by Wyeth's Fort Dodge Animal Health units, along with the "low adverse reaction frequency" in international markets.
After the 2004 withdrawal, the FDA says, Wyeth conducted additional tests showing residues of solvents used to make ProHeart 6 may cause allergic reactions. So Wyeth has improved manufacturing specs to decrease the residues, the FDA says, and has marketed the product in international markets, where few adverse events have been reported with the reformulated version.
UPDATE: Grassley, who is the ranking Republican on the Senate Finance Committee, today wrote a letter to the FDA seeking info about how the agency went about approving the new version of ProHeart 6. Among his concerns - whether Wyeth submitted studies that used guinea pigs. Here is his letter.
ANOTHER UPDATE: Victoria Hampshire calls us to say she has concerns. "I'd like to know how the FDA will enforce the process...If (Wyeth) is willing to go that extent to discredit a safety officer it raises questions about how the FDA can enforce restrictions on veterinarians...And given the way the whole matter was handled by the CVM, there should have been a public meeting before the approval."
5 Comments
This is blatantly irresponsible. There is no need for this product and it puts pets at risk for no reason!
Unbelievable! And to launch a secret investigation into someone doing their job at the FDA, this company is sorely lacking in ethics.
It's amazing to me that after all the scandals, corruption, and adverse side effects that the drug companies have been responsible for, that people will still trust the lives of their pets and themselves to selfish drug companies whose only concern is to make a profit. People are stupid.
Guess Wyeth is taking a pro-active stance . . . now they can't have the label "species discrimination" hung around their neck.
Matt, I was one of those "stupid" people six years ago when two of my dogs died ("in my opinion," legally speaking) and my third dog's immune system was compromised (and is still on medication to this day) due to ONE shot of ProHeart 6.
At that time I was totally ignorant on how Big Pharma works, and I was so trusting of vets because, after all, they are supposed to be the "experts," as Fort Dodge would refer to them.
It seems to me that we have all learned more about Big Pharma since all the controversy surrounding ProHeart 6.
Back when my dogs got this shot, I was a "dutiful" pet guardian taking my dogs in for their yearly checkups and vaccines (another subject I was ignorant about!), practically every time one of those computer-generated postcards from the vet arrived in the mail.
Losing my dogs the way I did; suffering financially for MANY years afterwards because of trying to save my dogs; continued treatment for my third dog; warning other unsuspecting consumers who have dogs what could possibly happen to them; taking written complaints from other victims from over 39 states; pursuing legal action against Fort Dodge, hoping to recover not only legal expenses, reimbursement for vet bills, and compensatory damages, etc. -all the many thousands of dollars of which I asked Fort Dodge to donate to three different nonprofit animal-based charities of my choosing in my dogs' names -- I did NOT accept any money from them, as I decided to "keep my voice" and still warn unsuspecting consumers - well, needless to say, I am STUPID NO MORE! It is my mission to do my best to educate other pet guardians so they don't make the same fatal mistake I did.
It's bad enough that Fort Dodge/Wyeth gives a crap about the animals and the public, but it's totally disgusting that the FDA has allowed this drug to slip back onto the market without allowing a public hearing.