Some of you may have personal experience with the once-popular canine heartworm preventative, ProHeart 6. It was marketed from June 2001 to September 2004, until the FDA recalled it after thousands of adverse reaction reports crossed its desks. And now, almost four years later, it's making a comeback (that's the plan, anyway).
According to the FDA, 5,552 ProHeart 6 reactions were reported after dogs received this every-six-month injection. 500 dogs died, though definitive causality in these deaths was not established.
Fort Dodge, the manufacturer, claims a total of 18 million doses were sold during this period, implying that the risk of reaction is one per every 3,242 injections.
I saw two of them. One was not terrible, just some mild muscle pain and a low-grade fever for two days. The other was comparably horrendous, LOTS of pain and a high fever for three to four days. Fluids and pain relievers treated both cases successfully. I’m not so sure we reported the first reaction (it was so mild and he wasn’t my patient) but I’m sure we reported the second one.
The generic name for ProHeart 6 is moxidectin. Fort Dodge stands by it. It’s been used in Europe and Australia for over a decade with relatively few complaints. The Aussies even use it in its ProHeart 12 form as a once-a-year heartworm preventative. Beats heartworms, they say.
Here in the US, about 250,000 of our dogs are infected with heartworms every year. That’s in spite of the widespread use of heartworm preventatives.
Why? Because some of us refuse to seek preventative medical attention for our pets. And the rest of us who manage a heartworm-positive status for our pooches? We simply forget to give the meds as prescribed.
Fort Dodge says it seeks to cut into the latter group’s prevalence with an every-six-month approach. And it’s true, client noncompliance is probably the biggest source of heartworm disease in this country these days.
Some vets like it, too, since it requires that owners come in and see the vet twice yearly (though most of us don’t charge for an exam at the same time).
But I’m largely unmoved. My position with respect to ProHeart 6 stands: The drug has its place. But it’s a very limited one in my practice.
Why?
1-Noncompliance is a major source of heartworm disease but by far the largest subset of this group includes those who refuse any preventatives at all.
2-Noncompliance in my area (where year-round heartworm meds are a must) means owners don’t come back in a timely fashion for their ProHeart 6 shot. (That’s what happened when we carried it, despite our reminders.)
3-The risk/reward axis is mighty high with ProHeart 6 relative to alternative means of heartworm prevention.
Then why would any vet use ProHeart 6?
Plenty won't. Yet despite my reservations, I likely will. That’s because some of my clients will swear there’s no other way they’ll consider using heartworm preventatives (yes, I swear I have clients like this). And, remember, I live in Florida.
Fort Dodge is making sure any of us who plan to use this product at least understand their basic rules. Veterinarians can only access ProHeart 6 through a limited distribution approach. An online seminar must be completed before a veterinarian can place an order.
And that makes sense to me. Though I seriously doubt that any reactions were caused by veterinarians administering an injection incorrectly, as the company infers may have been the case in the past, setting a bar (even a low one like this) helps ensure we vets know what we’re in for when we use it.
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In other words, they don't buy the severity and/or number of the reactions. They believe their significance was overblown by the FDA.
Fort Dodge seems to think that by limiting its first-run to only "the best and the brightest" of dogs, consumers will be fooled into believing the product is safe if/when minimal reactions are reported. Savvy consumers know that for a drug to be "safe", it needs to work for MOST dogs in MOST conditions - not just the healthiest select few.
Fort Dodge is offering a temporary discount, something along the lines of 10%- that will not cover the separate office call required to give PH6 (seeing as it can't be given with vaccines), nor will it cover the blood work.
This is a trial phase as part of the FDA testing, of sorts- If I were the person in charge of ordering (still have a few years left of school) I can't see this as being a great product. FD is placing a lot of the cost of drug testing on the client (or at least it seems that way). They made minor alterations to the adjuvent of the formulation but the drug is essentially the same.
It is used in Australia with significantly less bad press than it had in the states. I'd be inclined to sit back and wait a few years and see what happens. But after reading a bit about what happened to the FDA vet who first revealed there may be a problem with PH6, I'm also inclined to read a bit more and become a more informed consumer before picking suppliers once I get into practice. My boss is going to love it!
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Frankly, there is a much better solution for preventing HW disease - which would be to make monthly hw pills available over the counter. The precaution of testing dogs for hw before using monthly preventive has pretty much been proven unnecessary, I believe. In fact, some vets now treat hw positive dogs with HeartGard or a generic formula. And the dosage in these monthly pills is so minor that most collies can even tolerate it - and a label warning about sensitive breeds would solve that problem.
I've been told that monthly hw pills are available over the counter in other countries.
I think a lot more people would use the monthly preventive if they could get it OTC without having to pay for a vet visit.
10kg dog (22lbs)
Heartgard at 6 monthly doses of 68mcg ivermectin would be 408mcg total ivermectin
Proheart injection at rec dose of 0.5ml would be 1700mcg moxidectin
Moxidectin is reportedly more active due to it's pharmcokinetics:
http://www.ncbi.nlm.nih.gov/pubmed/17847063?ordina...
Then again, the injection vehicle has some interesting compounds. Perhaps
this is responsible for a lot of the allergic type reactions, where none of the
typical avermectin overdosage symptoms are experienced.
It would be interesting to know, because moxidectin has potential for the treatment
and prevention of mites.
small dog, yet the production expense for the pharmaceutical company is only
increased by a few cents.
Why? Pharmaceutical companies have done their market research. They know
that large dog owners are usually willing to pay more, and vets expect to make a
little more off a large dog client. It's kind of ridiculous, but it works.
As a matter of fact, the preventatives could be priced at three or four dollars
for a years supply and still be profitable, but they aren't. Covering less animals
maximizes profit. That is not necessarily a bad thing.
Honestly, I see nothing nefarious about this. If I ran a drug company I'd do the same. It's not dishonest or unfair. Neither is it dishonest or unfair for me to buy the big dog sizes of the flea drugs and split the doses to keep my outdoor strays flea-free.
As far as profitability goes, i'm not sure that the Heartgard brand would be profitable if the product was priced as you suggest. Too much has gone into their marketing over the years. Sure, they've got a cash cow on ther hands and it's true they might save more dogs if they priced the product more affordably, but IMHO, they've earned their right to do so by leading the market so far in advance of their competitors.
You are right. The profitability of the market seems to keep the companies
on their feet with newer and better products. In the long run, this means
we get more safety and efficacy per dollar spent. Had the profitability not
been there, we might be stuck with narrower spectrum products. In which
case you just end up buying more products and/or tests to cover the bases.
Thanks!