21 polo ponies died all at once under mysterious circumstances in Florida.Before the last one had even slipped into rigor, I was asked whether I thought it was the work of animal rights lunatics?
No.
I doubted it.
"My bet is that it will be an accidental supplements toxin due to mislabeling by someone who does not speak English too well," I replied.
It looks like I might be right.
This was an Argentine polo team trying to get their hands on a vitamin supplement (Biodyl) made by a U.S.-based veterinary supply company called Merial (they make Heartgard).
Biodyl is not approved for use or sale in the U.S. for animals or humans.
Rather than live with the ban on this not-FDA approved substance, the Argentine polo team apparently got their regular veterinarian, Felix Crespo, to partner with U.S.-licensed veterinarian to do a "work around" on the law by going to a compounding pharmacist.
What's a compounding pharmacist?
Compounding pharmacies are generally small-time operations that cock up mixtures of cold medicines and lotions for doctors. It is not uncommon for compounding pharmacists to pay kickbacks for referrals.
I am not alleging any kickback in this case -- I am simply describing the slippery nature of compounding pharmacies where the "slither quotient" is often pretty high. If a doctor sent me to a compounding pharamacist, I would probably change doctors.
So what's the story with these poisoned horses?
Time will tell, but I will be that it will turn out to be a case of Selenium poisoning.
Selenium is needed in micro amounts by the body, but it is pretty toxic at higher doses.
The problem in Florida was that there were too many cooks in the kitchen, and with each turn of the spoon the chance for the supplments recipe to get screwed up rose exponentially.
Time will tell, but I will bet that the final story is that the Spanish-speaking veterinarian gave a formula to the U.S. vet, who then gave it to the compounding pharmacist. Somewhere along the way -- perhaps due to translation problems -- I suspect a microgram measurement for Selenium was translated as a milligram measurement for Selenium. The result was that 21 horses got 1,000 times more Selenium injected into them than they should have.
Death followed pretty quickly.
This is, of course, entirely speculative. For all I know, the compounding pharmacy hired people straight from a psych ward who then filled every order that day with undiluted rat poison.
But I doubt it.
A weights and measurement mistake in a supplement due to language problem fits the probability curve much better.
A toxins panel will soon reveal what's up. Stay tuned.
.
11 comments:
The humane society is calling for drug testing on Polo Ponies. These horses were not drugged as in steriods, rather they were given too much of natural supplements in their diets. In reality drug testing would not have prevented this tradgedy.
As you may be aware, it now does appear that there was an error in dosage of one ingredient in the supplement that was compounded. It is unclear (I have heard different reports) as to whether the error was made at the pharmacy or if the prescription was incorrectly written by the veterinarian. I am sure time will tell.
I am going to take you to task for one observation... :)
"Compounding pharmacies are generally small-time operations that cock up mixtures of cold medicines and lotions for doctors. It is not uncommon for compounding pharmacists to pay kickbacks for referrals."
I do not have experience with compounding pharmacies in species other than equine, but I do know that in that species, compounding pharmacies provide an essential service in the production of drugs that are not available commercially for one reason or another. There are some very legitimate reasons for compounding. One would be a lack of availability due to a shortage of supply (non-production) from the large drug companies. This has happened many times, and has left the veterinary industry without availability of that product. Another instance may be a drug or drug combination that has been well-researched and demonstrated to be effective, but does not have sufficient income potential for a large drug company to recover costs of FDA testing (which can amount to millions), and therefore never goes into production. A good example of that would be a reproductive drug combination "progesterone and estradiol" which is of tremendous value for synchronizing mares for breeding and has been used for over 20 years for that purpose - but the income potential for a drug company would be minute (there may only be a few thousand doses sold each year). As you can see therefore, there are some very useful attributes to compounding.
While compounding pharmacies are nowhere near as big as the big (and getting bigger with the buy-outs!) drug companies, many are certainly not "hole in the wall" backyard operations! The larger ones will operate with ISO-class "clean rooms", and don't forget that pharmacists are university graduates with significant training, not grocery store check-out clerks (no insult intended to that latter worthy profession!!). There are also very strict legal controls over compounding drugs, and while some compounding pharmacies have got into trouble - and rightly so - as a result of producing compounds of drugs commercially available and in production, there are bad apples is all barrels of life, and I am sure you will agree that it is unfair to lump all compounding pharmacies in one group together, good and bad.
So I can't agree with you on your summation about compounding pharmacies, as I suspect you will gather! :) FWIW though, I do agree with an awful lot about other things you post on here!
Any way we look at it though, and no matter which human erred - veterinarian or pharmacist - this is a tragic situation for the polo ponies and all those who cared for them. Very sad indeed...
Compounding pharmacies can be useful -- for example, the dosage of one medication my cat needs is so small that human pills can't be cut down for him -- but I always make sure my vet writes down exactly what he's ordered and double-check it when I pick things up.
I'm not working through a language barrier, though. If I was, I don't know how I'd feel about the situation.
Whatever happened to these horses, it's just awful.
I work in the arena of pharmaceutical fraud, so I know a bit about how pharmaceutical sales actually work in the real world.
While there is a very small need for compounded drugs for humans, most of those needs are taken care of in nursing homes and in hospitals. So far as I know, there are no compounding pharmacies specifically for veterinary medicines other than through mail order.
Most of the money is in human medicine, and most of the need is created by people who are trying to do a work-around on FDA rules and regulations. As note in the post, a lot of these work-arounds are driven by kickbacks (which come in a 100 different ways) to doctors for sending patients to compounding pharmacies for drugs that will be sold for long-term use. One kickback to a doctor may result in lifetime sales. That's a big part of the compounding pharmacy business model. For an example of this fraud in Florida, where the horses were poisoned, see this DoJ press release >> http://thesop.org/index.php?article=7269
Most of what compounding pharmacies are selling are non-FDA approved drugs, and as a consequence Medicare and Medicaid will not pay for them, and neither will most private insurance companies.
So what do compounding pharmacies do to "work around" that? They lie. A lot. Medicare and Medicaid fraud is legion in the arena of compounding pharmacies.
As for veterinary medicine, here too meds are supposed to be FDA- approved (the FDA has a veterinary division), but sometime they are not. Even when they are, what you have is a medicine being diluted, mixed, or otherwise modified on the fly, in small batches, and without any control samples sent to labs to see if the stuff either works or is safe.
The result at the polo ground was 21 dead horses.
And for what?
Are you telling me there are no FDA-approved vitamin for horses?
Nonsense. The mistake here was predictable, and it's why the FDA and the DoJ have real question about whether compounding pharmacies should be allowed to exist in the manner they do right now, which is largely a vestigial remain harkening back to small-town America and sasparilla sodas.
Patrick
As noted, I can speak only for compounding in the equine species, and only directly relative to the reproductive aspects at that. That is because we are an equine reproductive veterinary practice. And I can assure you that there are no kickbacks in our aspect of compounding pharmacy use! :)
So far as I know, there are no compounding pharmacies specifically for veterinary medicines other than through mail order. So far as I know, there are no compounding pharmacies specifically for veterinary medicines other than through mail order.There are several large veterinary compounding pharmacies that one could describe as "mail order" in that the vet writes the prescription and either the client sends the prescription in to the pharmacy to be filled (pretty much the same way that one does when one goes to the pharmacy with one's own prescription from a doctor); or else the veterinarian orders the drugs from the compounder and dispenses them to the client. Neither the veterinarian nor the compounding pharmacy can "stockpile" orders, so for example, a vet could not call in an order for 20 bottles of P&E and then dispense them to the clients as the need came along. It must be a single animal, single script. So it's not a matter of being made "in small batches - that is a legal requirement!
Several of the larger veterinary practises actually have their own compounding pharmacies - Hagyard, Davidson, McGee (http://www.hagyardpharmacy.com/) for example, or Rood and Riddle (http://www.rrvp.com/) - both in Lexington, KY.
As previously noted, we use compounded drugs specific to reproduction that are not available commercially, but are researched and documented for efficacy. Without them, our (and our horses) lives would be a lot harder.
While I cannot speak specifically to this one unfortunate instance that is under discussion, I will observe, that it appears that these horses had been imported, and it is therefore not unlikely that they had been on the supplement made commercially while out of the country. If one were to suddenly change a supplement, the potential for a drop in both health status and performance of the horse is definitely present. It may well be therefore (conjecture here!) that the reason that the compounding pharmacy was producing this product was because it was not available through a commercial retailer in the USA. There is no doubt that an error was made by the pharmacy - they have admitted as much - but if one is to blame the pharmacy for making the product, one perhaps should also lay some blame at the feet of the big drug company for not submitting the product to the FDA for approval and setting up the scenario that played out!
As I said before, there are good and bad apples in most barrels - be it the compounding pharmacy barrel or the working terrier person barrel - and it is unfortunate that if the apple that happens to be on the top if the barrel and therefore the most visible at the moment happens to have a worm crawling out of it, there is a tendency to think that all other apples in the barrel must be the same! :)
.
You mention Hagyard Pharmacy.
Go to this web site which is affiliated with Hagyard Pharmacy >> http://www.mwivet.com/SERVICES/tabid/276/Default.aspx
Read the business model offered and suggested.
This is why you, the veterinarian, should be sending your clients to this place.
_ _ _ _ _
** Compete effectively with Over the Counter distribution on both cost and quality of service.
** Maintain control of the prescription medications used by your clients.
** Maintain your consultant role with your clients.
** Keeps veterinarians where they belong—in the center of the treatment cycle.
** Your clients contact you directly for all refills.
** You set the pricing for all your products.
** You control the billing.
** The only things you don’t have to do are: Lose business to online retailers
** Equine ProxyRx® Online
Equine ProxyRx Online allows equine Veterinarians to grow their sales by capturing online product orders otherwise going to other online providers and catalogs.
"
_ _ _ _ _
What's all that mean? Let me translate:
"Send all your clients to us for their veterinary pharmaceutical needs. Never mind if your clients can get the same or better medicines mail order, out of a catalogue, or over the counter. By sending your pharmaceutical clients to us, you ensure that they will have to come back to you for every prescription and refill, and you can charge whatever you want for that prescription. We won't cut you out of the deal -- we know how it works!"
Got it!
You say you and the pharmacy are dispensing medicines that have been "rearched and documented for efficacy." I do not know what that means.
I would not that the words do not seem to include "researched and documented for SAFETY or "FDA approved."
If the drugs you are dispensing are not FDA approved (the drugs, not just the raw ingredients), you are breaking the law. Off-label use of a drug (i.e. using a pig medicine in a dog) is OK, but not off-label marketing.
Nor is there such a thing, in the law, as "bio-equivalency." This is a marketing term, and entirely meaningless. If you have decided that your non-FDA approved recipie is "bio-equivalent" to an FDA-approved product, and are substituting your drug, you are breaking the law.
To read more about the law and regulation here, study these FDA warning letters written to compounding pharmacies for breaking the law >> http://www.fda.gov/cder/pharmcomp/default.htm
Asa general rule, I have less of a problem with compounding pharmacies that are atached to specialized practices (such as a horse veterinarian) or are mail order. These places tend to operate a lot like nursing home compounding pharmacies, which are filling real small niche needs. That said, the economic relationship between the veterinarian and the compounding pharmacy company is not always transparent, is it? Even when their actions are legal (kickbacks for veterinary pharmaceuticals are legal, for example), they may not be operating very ethically. I consider price-gouging and undisclosed kickbacks unethical, and I also consider it bade medicine to send someone to a compounding pharmacy to have made up in single-lots that which can be bought commercially. Call me old-fashioned, but I want my drugs made in large lots and quality-controlled by laboratory inspection if possible. One-offs without lab testing is a recipie for problems.
As for hormone therapy, I cannot speak to horses, but I would note that the quackery in this field as it relates to HUMAN hormones (where the real money is) is legion. See this warning letter from the FDA about compounded human hormones >> http://www.fda.gov/bbs/topics/NEWS/2008/NEW01772.html Also read this piece from the FDA about the marketing term "bio-eqiovalent" >> http://www.fda.gov/consumer/updates/bioidenticals040808.html
I find if very odd that you want to park the blame for these horses on Merial which did not make this drug or have anything to do with thse horses, and were in no part of the decision tree that killed these horses.
How do you figure?
Merial did not own the horses. Merial did not ship these horses around the world at a millionaires whim. Merial did not want to "win at any cost" (which seems to be a notion you are saluting). Merial did not ask for the prescription, did not write the prescription, and did not compound the drugs or inject them into the horses. But from your perspective, it is Merial that is to blame because they did not seek FDA-approval? I would like to see a veterinarian or compounding pharmacy go to court with that argument in hand, as I think it would make for a short day in court.
The screw up here is in the hands of the owner, the vet, and the compounding pharmacy. It is the compounding of their actions (pun intended) that led to the death of these horses.
The word **NO** at any point along the line would have resulted in a different outcome. But, of course, NO is not a very good business model, is it?
Patrick
Never mind if your clients can get the same or better medicines mail order, out of a catalogue, or over the counter.You're missing my point relative to the positions I am putting forward, which are very specialized. The compounded drugs that we - and others like us - are obtaining from a compounding pharmacy are NOT available mail order of OTC, which is why we have to go to a compounding pharmacy in the first place. Heck - if they were available elsewhere, with the cut-throat pricing of the Internet, there's little doubt that they would be cheaper than going to a compounding pharmacy!
You say you and the pharmacy are dispensing medicines that have been "rearched and documented for efficacy." I do not know what that means.Example: Progesterone and estradiol. Used to induce synchronized estrus in the mare for breeding purposes where synchronization is needed (e.g. embryo transfer donor/recipient mares).
Research and documentation: (1): Loy, R.G., Pemstein, R., O'Canna, D., and Douglas, R.H.: Control of ovulation in cycling mares with ovarian steroids and prostaglandin. Theriogenology 15:191-200, 1981.
(2): Varner, D.D., Blanchard, T.L., and Brinsko, S.P.: Estrogens, oxytocin and ergot alkaloids - Uses in reproductive management of mares. Proc. Am. Assoc. Equine. Pract., 219-241, 1988.Loy, R.G., Pemstein, R., O'Canna, D., and Douglas, R.H.: Control of ovulation in cycling mares with ovarian steroids and prostaglandin. Theriogenology 15:191-200, 1981.
2: Varner, D.D., Blanchard, T.L., and Brinsko, S.P.: Estrogens, oxytocin and ergot alkaloids - Uses in reproductive management of mares. Proc. Am. Assoc. Equine. Pract., 219-241, 1988. (there are others too).
Commercial availability: None.
There are other examples as well that I could list, but hopefully you get my point. Again - I am not dealing with compounding formulations for a species outside the equine, and specifically equine reproduction at that. It's the only field I know, and I'm not going to attempt to comment about a field that I have no knowledge of.
If the drugs you are dispensing are not FDA approved (the drugs, not just the raw ingredients), you are breaking the law.I'm not 100% clear on what you are saying here, but I can assure you that our prescribing or dispensing something like P&E is absolutely legal in the veterinary world. It's being done many times a day by many veterinarians US-wide.
study these FDA warning lettersIt is important to note that these are only warning letters, and that some of them have been successfully contested by the compounding pharmacies involved. And again - as noted above - there are bad apples in every barrel, so one cannot judge a whole profession by looking at FDA letters to a handful of pharmacies!
I have less of a problem with compounding pharmacies that are atached to specialized practices (such as a horse veterinarian) or are mail order. These places tend to operate a lot like nursing home compounding pharmacies, which are filling real small niche needs.I think we may be making headway! :) You see my point! Not all compounding pharmacies are bad apples, and some serve a useful purpose! As I have said all the way through this thread, I am responding only to that which I know, and what I know is not parallel to your observations above about compounding pharmacies, so I am saying that it is not fair to tar all of them with the same brush.
I consider price-gouging and undisclosed kickbacks unethicalI also call it damned annoying! :) While it is not unreasonable to place a standard mark-up on compounded drugs - just as a commercially available drug is marked up for retail - it annoys me to see huge mark-ups on compounded drugs and commercially available drugs (which is why we don't). But once again, that is the "bad apple syndrome", and one cannot specifically blame the compounding pharmacy for the veterinarian that marks up product excessively!
I also consider it bade medicine to send someone to a compounding pharmacy to have made up in single-lots that which can be bought commercially.I don't consider it bad medicine, I consider it illegal! :) That's not permitted in veterinary compounding. If the drug is commercially available in the same form then it is illegal to compound it.
As for hormone therapy, I cannot speak to horses, but I would note that the quackery in this field as it relates to HUMAN hormones (where the real money is) is legion.Different worlds and not comparable. Hormone use (in our field) is primarily to induce estrus and promote timely ovulation. We don't have mares needing HRT because of menopause! :)
I find if very odd that you want to park the blame for these horses on Merial which did not make this drug or have anything to do with thse horses, and were in no part of the decision tree that killed these horses. How do you figure? My point was somewhat tongue-in-cheek in response to your observations which - at least at the start of this thread - suggested that all compounding pharmacies were worthy of obliteration. :) I chained logic to put "spin" on the blame in that if the big drug company (Merial) hadn't been so money-conscious, but wanted to do the best it could for horses, it would have submitted the product (Biodyl) to the FDA for approval for use in the USA, but because it was going to cost so much for approvals, they had not done it, ergo one could (and I did) argue that they could be held partially to blame for non-provision of the previously used supplement, and that required the horse's owners/managers to seek a source of a Biodyl-like product elsewhere, which was what led to the disaster. :)
Incidentally, here's another thought to throw in the mix (and I don't have an answer for it!) ... equine supplements are HUGE business, so one has to wonder WHY Merial haven't applied to FDA for approval (because there probably should be enough potential income to cover testing costs). Is it because Merial is marketing something out of the country that hasn't got proven efficiency? If so, that means that we need to include big drug companies in the same barrel of apples as the "bad" compounding pharmacies! :)
The screw up here is in the hands of the owner, the vet, and the compounding pharmacy. It is the compounding of their actions (pun intended) that led to the death of these horses.Agreed - which is what I observed in my first post on the subject "Any way we look at it though, and no matter which human erred - veterinarian or pharmacist - this is a tragic situation for the polo ponies and all those who cared for them. Very sad indeed..."
And incidentally, regarding your suggested affiliation of myself with a named company that appeared in the e-mail version of your post - no. I am not affiliated in any way. As noted, we operate a reproductive veterinary practice, not a compounding pharmacy! :)
(BTW - quotes in my post for some reason were being duplicated, in come cases at the time of posting even after being removed)
To get back to the original post, which was about a componding pharmacy dispensing a non-FDA approved drug which killled 21 horses .... So far, I have to say that you have not had too much to say on that topic, Eqrepro.
No one has said there is no reason to have a compounding pharmacy, only that the industry has a very high slither quotient, which I think has been proven, even with one of the pharmacy companies you seem to salute. The FDA agrees that compounding pharmacies are often operating in a very shady arena, and so does the U.S. Dept. of Justice.
Why is the slither quotient so high? Simple: the underlying business model is very weak if the business is run honestly. As a consequence, a lot of compounding pharmacies simply bend the rules until they break, all in the name of strengthening the business model and turning a larger profit.
You might want to strengthen your knowledge of the econonics of pharmaceutical sales and compounding. I am serious about this. There is a lot of profit to be made by compounding cocked up drugs and generic versions of commercial drugs, and the idea that there is any lab control or uniformity in production is simply not true. See >> http://www.quackwatch.org/01QuackeryRelatedTopics/compounding.h*tml for a brief summary and some illuminating numbers about the quality control (or lack thereof) in product manufacture by compounding pharmacists.
You know what the original post was NOT about? It was not about equine reproduction. It was not about you or your business. It was about 21 dead horses that were poisoned by a compounding pharmacy and couple of veterinarians, all intent on producing a non-FDA approved drug for no medically-necessary purpose at all. Pardon me I do not salute that outcome, and pardon me if do not salute the decision tree that got to that outcome. And how sad that anyone would.
Patrick
Patrick, it looks like your selenium-poisoning theory is correct. I'm interested in knowing what in your experience lead to that so quickly. Perhaps because I've lost animals due to malicious poisoning using warfarin, when I heard of the excessive internal bleeding, my mind went to that possibility. In any case, the cheaters killed 21 of their own expensive ponies. Disgusting doesn't begin to describe these assholes.
Seahorse
Both warfarin poisoning and selenium poisoning can occur in nature.
Warfarin (i.e. coumidin), is named after the Wisconsin Agricultural Research Foundation (WARF) which dicovered that red clover contained an anti-clotting agent when a bunch of cattle got very sick from eating Canadian forage with a lot of red clover in it. On the upside with warfarin, when administered to humans (as coumidin), it is a marvelous blood thinner for patients with heart stents and the like.
To kill a horse with Warfarin would take a pretty big dose -- probably more than you could shoot into a horse with a regular hype. Ditto for some of the other stuff suggested.
The speed of the decline suggested a shot, however, and the fact that all of the horses got it suggested a vitamin or other performance additive. When it came out that the horses had been administered the Merial product, selenium jumped out of the recipie. Horses are very sensitive to selenium, and though it is a necessary micro nutrient, there are pastures in the world where you cannot let horse or cattle graze unrestricted without some fear of selenium poisoning.
The dosage error guess was made on the fact that the symbols for miligram (mg) and microgram (µg) look about the same when you write them up in long hand. It turns out that this was not the exact problem (it was a decimel point issue), but that the core problem -- dosing -- was.
Patrick
Thanks. I found that all very interesting. I feel a bit naive, but frankly, it didn't occur to me that the horses' own owners/trainers or whomevers might have given them something that killed them. I'm incredibly careful with my own guys, and not being a cheater sure as hell would never risk their health to simply win something. I didn't want to believe they were intentionally poisoned by someone from the outside, but I wondered. The staggering around was consistent with poisoning, the bleeding consistent with warfarin. I also wondered about ethylyne-glycol which would be easy to get them to drink, but death comes after a certain time interval (with crystals forming in the kidneys, etc.), and it seemed the ponies were collapsing quickly. Then, I considered CO2 or something else in transit, but that was dismissed early on. In any case, the innocent suffered again. Tragic and criminal.
Seahorse
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