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A glimpse into how the FDA evaluates a pet drug

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Did you ever wonder what the FDA’s approval and review process is for a pet drug?  I did.

Since the time of the Great Melamine Pet Food Recall of 2007, pet owners have been painfully alert to new recalls and warnings issued by the FDA, and there have been many (I just posted another one today on our Daily Paws blog, the second one in a week).

While I was researching a recent article on an FDA issued warning for flea and tick products, I came across this page on their website:

Transcript for the March 24, 2010 Veterinary Medicine Advisory Committee from March 24th, 2010, and this transcript deals with the pet product ProHeart 6, a canine heartworm preventative.

It is a fascinating and revealing look at the process that the FDA takes after it has received complaints about a particular drug or pet food on the market.

The FDA develops a RiskMAP (Risk Minimization Plans, which is a  process of assessing a product’s benefit to risk balance, developing and implementing tools to minimize its risks while preserving its benefits, evaluating tool effectiveness and reassessing the benefit-risk balance, and making adjustments as appropriate to the risk minimization tools to further improve the benefit-risk balance), for a drug and this is one of the terms that you’ll see when you visit the link above so it is good to have a grasp of what they are talking about.

If you google ProHeart 6, you’ll see that it is a product that has been controversial, both with pet owners and with some veterinarians.  I visited www.proheart6.com today and – while the site isn’t working quite right – I saw what I think the is RiskMAP for this product there.

It is well worth your time to peruse these transcripts.  See what a typical product evaluation process is and just how the FDA treats all those reports of adverse results a drug has on our pets.

It’s good to know.

Linda Ferguson

Daily Paws

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7 Responses to “A glimpse into how the FDA evaluates a pet drug”

  1. […] A glimpse into how the FDA evaluates a pet drug « Daily Paws […]

  2. Dr. Jordan says:

    Good post! Read more about how little the FDA really cares about either the veterinary professionals that are responsible for stopping unsafe products by documenting adverse events in our animals from FDA licensed products or the animals adverse events themselves. What the FDA cares about is the collusionary relationship it has with the drug corporations that profit from these products licensing and sale. Also, realize it is the USDA in charge of the veterinary vaccines and that in this dept you will find the worse offesnses of release of unsafe and non efficacious vaccines (biologicals). Only by being proactive and demanding due diligence and post marketing surveillence can we force the government regulators to protect us. Read more in MARK OF THE BEAST HIDDEN IN PLAIN SIGHT avaialble on Amazon.com or on http://www.dr-jordan.com the case against vaccinations.

  3. Jean B says:

    Linda’s post on the RiskMap program is incorrect. While ProHeart
    6 is under this program, not all vet drugs are. This is what the FDA has
    allowed Fort Dodge (now Pfizer) to do with this controversial drug that has
    reportedly killed and/or harmed over 5,000 dogs in the U.S. after its first
    go-round on the market. It is a huge money-maker for the manufacturer, and
    as the FDA is seemingly still in the back pocket of the pharmaceutical
    companies, this is how the drug is able to be on the market in a limited
    fashion. I know, as two of my three dogs were killed by this drug (the
    third remains on medication for his immune system). If you would like
    further information, you can see http://www.thepetguardian.com and
    http://www.dogsadversereactions.com for more information about ProHeart 6, ProHeart
    6 Victims, and Moxidection. I was an attendee and spoke during the public
    portion of the CVM meeting (name misspelled this go-round). Please read the
    transcript. The panel members were “deliberately starved” of the
    information/data they needed to make a complete evaluation of this drug and
    its labeling, that will, I am sure, continue to harm dogs not only in the
    U.S., but the other countries that are, unfortunately, using it.

  4. Linda says:

    Hi Jean,
    >Thank you for your reply which will be posted on the blog as well.
    There is a good reason I posted the transcripts online – because the process
    of gaining a drug’s approval by a drug company is a mystery to most pet
    owners and for those who are interested, it’s good to see how the process
    works – including the chummy drug reps that present there.

    I agree with you that there is much white washing and ‘in-bed’ with the drug companies that
    occurs during this process and that many drugs for pets have their adverse effects squashed by big pharma.

    Unfortunately money speaks loudly and buys approvals that it should not. Your story is a perfect example of when it should not have.

    I am including your side of the story for pet owners to see and be informed on. It’s powerful and I am SO SORRY to hear of your loss.


  5. Jean B. says:

    Dr. Jordan, thank you so much for your post! You are so right when you say “how little the FDA really cares about either the veterinary professionals that are responsible for stopping unsafe products by documenting adverse events in our animals from FDA licensed products or the animals adverse events themselves. What the FDA cares about is the collusionary relationship it has with the drug corporations that profit from these products licensing and sale.”

    It is absolutely shameful what the FDA has done to the whistle blowers of these unsafe drugs, true, caring professionals who do their j-o-b as public servants. Dr. Victoria Hampshire, the drug reviewer for ProHeart 6, was removed from her post and thereby not permitted to present the data she compiled before the FDA asked Fort Dodge to remove their product from the market back in 2004. Without the public — especially former victims — knowing about this re-release, the FDA permitted Fort Dodge to back-door ProHeart 6 back onto the market, without the benefit of a public hearing. Then in March 2010 a public hearing was held, this time with Dr. Hampshire and other experts in the room present and available to testify. Were they asked to? No! I feel they can’t handle the truth.

    I still want to know what happened to the 5,000-plus adverse events reports and data compiled of the dogs that were affected and/or killed by ProHeart 6. I think the FDA must have “lost” it all or shredded it. The FDA admits there is “underreporting” of adverse events. Personally, I don’t think they care one iota what happens to the animals with these drugs they’re approving. As long as Big Pharma provides most of their funding, the FDA is not going to bite the hand that feeds them.

  6. Liam Price says:

    Thank you for posting this article. I wondered how it worked.


  7. Jean B says:

    Thanks for your note, Linda, and for your kind words.

    I’ve not known of any other vet drug that has gone through this Risk Map program. Maybe it will be a new thing, I don’t know. I do know that ProHeart 6 was the first veterinary drug ever taken off the market (U.S.), and it’s because there were so many reports of adverse reactions and deaths reported to the FDA, and the FDA doing their own investigation, and us getting media attention on what was happening to the dogs that the FDA asked Fort Dodge to take it off the market. But the FDA also allowed Fort Dodge to “back door” the drug onto the market almost four years later without the public knowing about it.

    Why it was let back onto the market is beyond me, except obviously it’s all about the money. I’m sure you remember Fen-Phen, also a Wyeth drug. Once that was finally removed from the market — after the FDA files had been “lost” — you’ve not seen that drug come back under a Risk Map program.

    Why the FDA is choosing to look past all the 5,000+ reports of adverse reactions/deaths from the first go-round is appalling and shameful. No one even addressed where all those dogs’ prior reports/records are now. There’s so many lies and such deceit surrounding this drug, it’s not even funny.

    It’s a joke that vets are supposed to undergo “Internet” training to be able to administer the drug now to dogs under the Risk Map program. There’s no way to police that these vets are actually sitting in front of a computer learning what they’re supposed to as opposed to a secretary or someone else. And apparently some of these vets didn’t learn anything from the training as they were supposed to stay away from giving ProHeart 6 in conjunction with vaccines, and at least eight dogs got vaccines and reacted. There were dogs that had the shot in the first go-round that died under the Risk Map program when they received ProHeart 6 again.

    You can see for yourself on the FDA’s Web site — if you need the links, I can try to locate them again and provide them — the actual adverse events reports of these dogs and Fort Dodge’s comments. As usual, they blamed everything on the dog guardians and the dogs when these dogs reacted and died.

    If you don’t know what Wyeth and the FDA did to the FDA drug reviewer for ProHeart 6, Dr. Victoria Hampshire, you can Google around for that information as well as see what I have on my Web site. Even the Government Accountability Project under Senator Grassley didn’t get very far in taking care of Dr. Hampshire after the hell she went through for trying to do her j-o-b.

    Anyway, that’s enough information for you. Thank you for your time and your note!

    Warm regards,

    – Jean

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