U.K. Veterinary Medicines Directorate Promises Crackdown on Unproven Alternative Remedies

In December John Fitzgerald, the Director of Operations for the British Veterinary Medicines Directorate, announced that the regulatory agency will begin more aggressive supervision of medical claims made for alternative medicine products. According to the announcement,  

Some of these products are claiming to be effective and safe when no scientific evidence has been presented to us to show they are

Animal owners have a right to know if a product does what it claims. The products claim to treat diseases which can cause serious welfare problems and in some circumstances kill animals if not properly treated. So in some cases owners are giving remedies to their pets which don’t treat the problem

The agency will begin contacting manufacturers of homeopathic and herbal animal remedies and nutraceuticals to request scientific evidence of safety and efficacy. Unfortunately, if such evidence is not provided, the products will still be legal to sell, however they must remove any label claims suggesting a medical use of the product. Likely, manufacturers will then switch to the vague yet still misleading “structure and function” claims the FDA allows in the U.S. for herbs and supplements without adequate evidence to support true health claims.

Still, it is encouraging to see a government agency somewhere at least making the statement, which is bizarrely controversial in some circles, that before selling pet owners a medicine for their animals the manufacturer ought to prove the medicine actually works and isn’t harmful. Whether or not the VMD will be able to effectively enforce such a regulation given the ease of Internet marketing and distribution of home remedies is uncertain, but it’s nice to see them making the effort.

If nothing else, the publicity surrounding any attempt to sanction a company selling an unproven remedy, and the likely outcry from devoted users, will bring greater attention to the discussion of what is or is not real scientific proof, and will make it more likely that pet owners will at least know that scientists and the government do not accept the manufacturer’s claims. I suspect there are significant limitations to what government regulation can accomplish in terms of protecting the public from ineffective medical therapies, but it can certainly serve as a source of reliable information and a “bully pulpit” for the science-based perspective.

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9 Responses to U.K. Veterinary Medicines Directorate Promises Crackdown on Unproven Alternative Remedies

  1. Janet Camp says:

    I admire your ability to be realistic about this subject. I, on the other hand, become infuriated every time I go to buy dog food and see all the complete crap on display at the box stores for pets. I have moved toward making my own dog food by simply mixing the Science Diet with people food that we eat. Trouble is that we quite a bit of garlic and onions, so I don’t always remember to put some aside without these. It’s a process and I’ll get there, hopefully. I want to stop shopping at places that cater to this stuff just because if “sells” and take no responsibility in the matter. I realize that its everywhere, but I’m trying to eliminate the most egregious offenders one by one. I write and tell them, of course, why I am no longer shopping at their store (for all the good that does–but it makes me feel that I am at least trying to behave ethically).

    I still go to the local co-op for veggies because they are the only decent ones in the winter here in my upper midwest state, but I have to avoid the aisle they call “wellness”, because every time I see that stuff (especially the ossiocillicum (sp?) garbage, I nearly go mad!

  2. skeptvet says:

    Yes, there’s a lot to be crazed about. But of course hostility only begets hostility, and I get enough hate mail as it is! 🙂 I wish more people could turn their frustration with nonsense into concrete action as you do. Keep it up!

  3. art malernee dvm says:

    Trouble is that we quite a bit of garlic and onions>>> whats the problem with that? for a giggle review the history of bogus feline lizard poisoning promoted in vet medicine. Special toxicological problems promoted to occur in pets that at the same dose per pound in children would not be a problem just shows the public that those who now control the veterinary profession can not be trusted not to promote unproven medical care in the market place.
    art malernee dvm
    fla lic 1820

  4. skeptvet says:

    Not entirely sure what you are getting at here, Art. It is clearly demonstrated than onions and garlic can be toxic and cause red cell destruction and anemia in dogs and in cats. The dose needed to cause clinical problems isn’t known for certain, so I don’t think you can say with such certainty that what is ok for human children is ok for dogs and cats. Cats especially have weak systems for detoxification due, probably, to their natural history as obligate carnivores, so it is reasonable to believe they are more sensitive to these compounds than humans, even if we don’t have exact numbers. A statement from the ASPCA poison control center on the subject is copied below.

    Of course, what this all has to do with “those who control the veterinary profession” (whatever that means) isn’t clear.

    Garlic does have toxic potential to pets, and is generally more potent than onion, also a member of the Allium species, in causing changes in red blood cells in dogs and cats. This is true in raw, cooked or powdered forms. In theory, “deodorized” garlic is allegedly less toxic, since the disulfides, responsible for both the odor and the toxicity, are usually largely removed.

    Even at low levels of exposure to garlic, some change in red blood cells is likely; it is typically only when a significant number of red blood cells are altered that their oxygen-carrying capacity is noticeably compromised and clinical signs develop. Generally, it takes either a fairly large single ingestion or chronic exposure. These effects are also somewhat more likely to be seen in cats, as their red blood cells have shorter life spans and they’re more likely to have bone marrow issues. However, the possibility exists that some dogs may also be genetically more susceptible to problems from garlic ingestions.

    The lowest observed effect level in dogs in the scientific literature that we are aware of is 2.5 mg/kg of encapsulated garlic powder; slow heart rates and increased urination were seen. For comparison, a 20-pound dog consuming 1000 mg of garlic powder is exposed to a dose of 110 mg/kg.

    The bottom line….is that we do not definitively know at what dose any given dog may experience problems. An occasional low dose, such as those found in most commercial pet foods or treats, would not likely cause problems. A conservative approach might be to avoid exposure to more concentrated garlic-based products.

  5. art malernee dvm says:

    Not entirely sure what you are getting at here, Art.>>>> when i was a young vet I was taught in our toxicological books to treat for lizard poisoning in the SE USA. When some students at vet school in Auburn went out and caught lizards and fed them to the lab cats and could not produce the disease it was then promoted in nationwide vet columns in the newpapers the lizards had to have blue tails to produce symptoms. It turned out the cats who get feline vestibular disease in the SE USA like to eat lizards just before they get the disease. The dose makes the poisoning so even water can be toxic at high doses. The claim that these things can be toxic while true is not the information clients want or need. Im sure if you fed enough lizards to a cat you could kill him but that information is not what a emergency caller at midnight who saw her cat eat a lizard needs. Cats do get liver flukes from eating lizards. The claim that many in vet medicine seem to want people to believe is that for rat poison, onions, garlic, artificial sweetener, grapes, raisins and chocolate dogs would be expected to become toxic or have a special sensitivity at doses where a child getting the same dose per pound would not be a concern. Vet medicine has a history of seeing things that are not there if enough money can be made. For example revaccinating pets every 1-3 years with the same non toxioid vaccine is promoted by “experts” to protect pets against viral and bacterial disease. No one is getting polio or whooping cough vaccines every 1-3 years and we have no proof these pets are better protected with annual or triannual boosters. I am skeptical that rat poison, onions, garlic, artifical sweetener, grapes, raisins and chocolate are anymore toxic or sensitive for dogs than they would be a child given the same dosages per pound. I got a email yesterday from someone who post on quackwatch who made the claim that she has personally seen three dogs die from eating only one stick of sugarless gum telling me that if you give them hydrogen peroxide and get them to vomit soon enough you can save their life. That is not the kind of non prospective information i consider evidence. And what i can find in the vet literature is not much better. Estimate Claims of LD50 vary all over the place and when I look I can usually find a claim the LD50 is about the same for dogs and humans. Claims of special dog sensitivity are retrospective not prospective like the girl who was sure she saw three dogs die from eating only one stick of sugarless chewing gum. Retrospective studys are not reliable. Take a look at all the drugs we use on both a fifty pound child and a fifty pound Labrador and name one that would be a problem for the dog but not the child given the same dose.

    art malernee dvm
    fla lic 1820

  6. skeptvet says:

    So what does constitute adequate evidence to warn pet owners of a potential danger? I have seen dogs die of acute renal failure after eating raisins, and I have seen severe refractory hypoglycemis following ingestion of tiny amounts of xylitol-sweetened gum. These are not prospective, controlled trials, but they suggest a risk. How is ti irresponsibe to say to clients, “Vets are seeing these correlations and until a clear pathophysiology and dose-response relationship is worked out, it would be safest to avoid these possible toxins?” Do you really think anyone is ever going to perfom a prospective study involving feeding dogs escalating doses of these compounds to determine the LD50? And given that this is not going to happen for logistical and ethical reaons, do you suggest simply telling people there’s nothing to worry about?

    I guess this touches on the pragmatic issue of what to do in the absence of high quality controlled research evidence. Opponents of science-based medicine like to make the charge that we are so fixated on randomized clinical trials that we are paralyzed without them and can make no decisions at all. I tend to agree with the folks at Science-Based Medicine that we can, in fact, make reasonable provisional judgements based on lower level evidence when that is the best we have, especially when the issue is one of avoiding a potential risk rather than actively implementing an unproven intervention.

  7. art malernee dvm says:

    If I was writing a poison guideline and all I had was expert opinion the guide would state there is insufficient evidence to actively implement an unproven intervention. I do not have a problem using unproven medical care but until its proven I think it should be presented to the public as investigatory medical until the benefits and risk are known. I do not consider level three evidence (see table below)as real evidence just one place to look for evidence. I am aware of the BMJ parachute study that concluded there was not enough evidence to issue a guide to wear a parachute when jumping out of a plane. The problem I have with unproven medical care is that studies show its more likely to harm than help. Alot like paying the lottery. Some people win big like the people who treated themselves with antibiotics for stomach ulcers thirty years ago. Most loose using unproven medical care just like in the lottery. Even the FDA only approves about 20% of the drugs submitted for approval. Thats after millions of dollars of pre approval testing before FDA submission.

    Level I: Evidence obtained from at least one properly designed randomized controlled trial.
    Level II-1: Evidence obtained from well-designed controlled trials without randomization.
    Level II-2: Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group.
    Level II-3: Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled trials might also be regarded as this type of evidence.
    Level III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.
    art malernee dvm
    fla lic 1820

  8. Bartimaeus says:

    I think we all understand the levels of evidence you cite Art, and level III evidence is certainly not good evidence that a treatment may be useful or not, but the previous comments were more about the precautionary principle in regard to potential toxins. There is some strong, basic scientific evidence that onions and garlic and related species can cause toxicity in dogs and cats, even though exact lethal doses are not well established. I have seen a couple of dogs on homemade diets that included onion or garlic (It is not always easy to determine exactly how much the animal is getting, due to natural variation in the plants, owner uncertainty or misrepresentation of what the dog is getting, and other factors) who had anemia and blirubinuria which resolved after discontinuing the onion/garlic. Similarly, some animals react quickly with hypersalivation and vomiting after biting certain kinds of lizards, so the idea that certain lizards may be toxic is not completely unjustified, even if specific treatment in the absence of more than transient symptoms is probably not justified. Following the precautionary principle and avoiding a few potentially toxic items is more justified even on poorer quality evidence than selling an unproven, expensive treatment is. Avoidance is cheap and is not really an “unproven intervention”, it is just that the toxicology of every possible thing has not been established for every species and breed. The other problem with that type of evidence scheme is that it ignores prior probability, and has led to many weakly positive trials of completely implausible treatments such as homeopathy for any indication, which results in Cochrane reviews saying “more research is needed” and proponents using publication bias and cherry picking to try to make it look like there is positive evidence for their treatments. Sticking rigidly to that evidential classification while ignoring basic science and prior probability has been the great weakness of EBM over the last 20 years. While it probably was not an intended consequence, it has given the alt-med proponents a large loophole to exploit.

  9. art malernee dvm says:

    Sticking rigidly to that evidential classification while ignoring basic science and prior probability has been the great weakness of EBM over the last 20 years. >>>>

    still waiting to see what EBM says about SBM, The spoke person that SBM quotes for the EBM side is making money running chiropractic studies. I cannot see David Sackett or anyone wanting EBM to be successful taking money to run a chiropractic study. Sort of like taking money from the Indians to run a rain dance study by saying it will somehow help everyone.
    art malernee dvm
    fla lic 1820

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