Monday, July 5, 2010

New developments with Dr. Alson Sears' NDV treatment of Canine Distemper, and more worrying signs of quackery.

I posted about Dr. Alson Sears' treatment for canine distemper last year, and there have been some interesting developments since then that I thought should be addressed.  There is at least one new person involved who I believe genuinely cares about animals and who seems to be convinced that the treatment of canine distemper involving Newcastle disease vaccine is actually effective. Unfortunately, there is not any better evidence that the treatment is effective, despite two different groups collecting donations to support their efforts to have more dogs infected with distemper treated. Ed Bond, the journalism teacher is still promoting the treatment with his own website and a facebook group, and now someone named Jane, who has her own shelter/rescue operation and writes her own blog and a blog on the Houston Chronicle website is now collecting donations for "Project Hope" which is dedicated to producing Dr. Sear's serum using Newcastle's Disease Vaccine administered to dogs and treating distemper cases with it. While I am still convinced that everyone involved in promoting this unproven treatment means well, and that they truly believe that it works, there are some disturbing signs of "mission creep" in the diseases which they claim to be able to treat, and the attempts to prove the treatment effective look inadequate to provide the kind of proof which they would like. At this time, they are selling DVD's and taking donations to provide what is at best an unproven and experimental treatment, while presenting it as something that is a proven treatment. This raises some serious ethical and legal concerns as most of the dogs involved are coming from shelters, and in some jurisdictions it is not legal to experiment on shelter animals, and spending money on an unproven and possibly risky treatment may not be the most effective use of limited funds.

To review my last post, canine distemper is a viral disease that affects domestic and wild canines and some other wild species such as raccoons and mustelids and large cats such as lions and tigers (cats in the genus Felis-domestic cats, and small wild cats also including american mountain lions are not susceptible to canine distemper). The vaccine is very effective, and despite some problems with effectiveness about 20 years ago (1, 2, 3), canine distemper is very rare in vaccinated, well cared for dogs and puppies. It can be a serious problem in large populations of young, unvaccinated dogs, such as shelter populations. There seems to be an ongoing outbreak in shelters in the area in which I live, and there are apparently similar problems in other areas as well, which may be one reason people are looking for treatment options right now. The course of the disease in an infected dog varies depending on a variety of factors depending on the dog's age, immune/vaccine status, and the strain of virus causing the infection. Young puppies are most susceptible, especially during the period when their maternal antibodies are declining but before they have time to develop their own immune response from vaccination. The highest risk period is from 6-16 weeeks, but unvaccinated dogs can be infected at any age. Older dogs tend to have somewhat less severe infections and a higher survival rate. Once dogs do develop immunity, it is long lasting, 3-4 years at least (1, 2, 3). Severely infected dogs are susceptible to secondary, fatal infections such as bacterial pneumonia, and some dogs develop neurological complications that can cause seizures, paralysis and death. Sometimes these problems can occur months or even years after apparent recovery from the infection, and are caused by damage the immune system does in the nervous system while trying to get rid of the virus. It is difficult to predict when or if a dog with a mild or moderate case of distemper will develop neurologic symptoms.

Diagnosing distemper definitively can be more difficult than we would like. Indirect tests such as looking for distinctive inclusion bodies in cells collected from various locations are good, and PCR testing for viral antigen is better, but the standard PCR test does not distinguish between the modified vaccine virus and the wild strains, and it is unknown how often the vaccine virus causes inclusion bodies in cells. This means that vaccination can cause a positive test result for up to three weeks after vaccination. I don't doubt that most of the dogs being treated by these well-meaning people do have distemper, but it is certainly possible that some of the dogs who recover quickly have other types of infections and test positive because of vaccination. Most shelters vaccinate puppies as soon as they enter the shelter in an attempt to avoid problems, so many  of these puppies may have both vaccine and wild virus in their systems at the same time. Other infections like bacterial respiratory infections, canine influenza, and other viruses can all cause similar symptoms. Symptoms consistent with distemper and positive tests make it very likely that these dogs do have distemper, but specialized viral testing would be required to definitively prove that the dogs who recover did in fact have distemper and that the treatment actually killed the virus as Dr. Sears claims. This type of testing is normally only done in some virology research labs and at places like the CDC, where they analyze new strains of influenza and serious, unknown outbreaks of disease. Specialized immunology labs would also be required to confirm that the newcastle disease vaccine is having the effect Dr. Sears claims it has, which is stimulating a strong immune reaction in the donor dogs, such that a few milliliters of serum is enough to kill all the virus in an infected puppy.

There seem to be signs that the proponents of the treatment are using some selection bias when reporting the results of the treatment, and overstating the number of dogs which survive. I will provide some quotes from their sites that seem to illustrate this. Project Hope is named after a puppy that did not survive the treatment, and there seem to be quite a few similar cases when I searched through the discussion pages of the facebook group;
The serum treatment for distemper is nearly 100 percent--I don't know of any cases that failed but in medicine, there is never 100 percent of anything.
(May 5th, 2010 Jane's blog)
This is almost 6 months after "Hope" died despite treatment, and after other failures;
 SaveDogs FromDistemper  Sadly all 5 Croatian puppies died, but the adult with neurologic symptoms has recovered. They are calling it a miracle.
(December 19, 2009 at 7:17am Facebook Group)
There are others as well when you scroll through the discussion pages.

Since distemper is such a serious disease, dogs who recover often have an extended recovery. Despite claims that the Newcastles treatment is so effective, they have many cases where the dogs take a long time to recover. This (and their failures) is blamed on the secondary infections, or the treatment coming "too late", which is unfortunately something which happens all too often in defense of many unproven treatments.

She is a Project Hope serum puppy.  Three weeks ago, after being diagnosed with distemper at her vet, Brindy received Dr. Sears' NDV-induced serum, a treatment for distemper.  She had an advanced case of distemper--green crusty nose, green crusty eyes, pneumonia...and she had a skin condition of some sort. The distemper was dead in 24 hours according to Dr. Sears.  The other issues have yet to be cured.
(Feb. 15, 2010 Jane's blog)
Skin problems can be caused by distemper as well.

 It will take some weeks or even months (4 weeks to 4 months is what Dr. Sears tells me is a good rule of thumb) for the damage that was done to repair itself.                                    (March 19, 2010 Jane's blog)
They are also starting to make claims that the treatment works for a wide variety or other dieseases, with apparently no evidence whatsoever. Occasionally they contradict themselves, as Dr. Sears says at one point in a video clip that the serum does nothing against parvovirus, but claims otherwise elsewhere.
Dr. Sears is now including the NDV-induced serum in protocols to treat not only canine distemper, but parvo and herpes as well as several other diseases.  The first puppy testing positive with parvo had serum and within just several days, her fever went down and her recovery seems to be rapid.  This is making me think some.

First of all, having the serum is like having a life-insurance policy for our dogs/puppies.  As long as we act fast enough, and don't waste weeks with other vets getting ineffective treatments, the serum is very close to miraculous.  If I didn't know that serum was in Houston, I would be very nervous about the outbreaks of distemper and parvo.
(April 3, 2010 Jane's blog)
What is fascinating, is that this same disease model--what Dr. Sears' is using to treat distemper--can be used to eliminate human diseases like MS and maybe even cancer.  Yes, this is huge--and we have to do a little bit each day.  What we are learning and teaching, thanks to Dr. Alson Sears, will make a difference in this world.
(Feb 15, 2010 Jane's blog)
 Those are pretty remarkable claims, and I am sure Jane really hopes and believes they are true, but it does not seem to bode well for the scientific attitude toward the treatment they are promoting.
They seem to want to prove that the treatment is effective, which is a good thing, but they don't seem to have anyone with any scientific training working on it. Their claims of ties to Texas A&M seem to be limited to sending their diagnostic tests to the lab there. At this point there is no indication of involvement of the veterinary school there in researching this treatment.
This will be a publicly-funded project (donation-sponsored) and the serum will then be free to those who need it--and agree to participate in the screenings for distemper which are being sent to, and tested by, Texas A & M. It is our intention to get a peer-review article for vets all over to learn from what we are doing.  How often do we get a chance in our lives to do something that can change the world?

(February 28, 2010 Jane's blog)
 In conclusion, the evidence of their own websites, and the fact that they seem to be using the donations they receive honestly, indicates that Ed Bond, Jane, and others involved in this are honestly trying to help sick animals. Unfortunately, after 40 years of using this treatment, Dr. Sears still has nothing more than anecdote and testimonial to prove that the treatment works. While he has managed to convince some well meaning laypeople, the evidence is still inadequate to non-existent, and of all the people involved in this, he is the one who should understand this. Apparently he does not. If this treatment is ineffective, the effort and money they are spending could be much better used elsewhere. I would be happy to be wrong about this, but so far they have not presented anything to convince me that I am. If they really want to show that the treatment is effective, they need to establish that the treated dogs all actually had wild strains of distemper, and their tests are not being interfered with by vaccine strains of virus. Ideally, they could run a blinded, controlled trial to be sure that treated dogs survive distemper at a higher rate than dogs given standard, supportive care. They also need to keep meticulous and honest records of both positive and negative outcomes. It might be difficult to convince everyone involved to do this, since the primary promoters of the treatment already seem convinced that it works, and may be reluctant to not treat some dogs in a trial. However, if they really want to know if this treatment is effective, and produce evidence that other veterinarians would accept, that is what they need to do, even if the results are disappointing in the end. It is possible that the treatment is a false hope, which would be worse than the small hope available now to owners of severely infected puppies. If the treatment is ineffective, as I suspect it may be, then they can concentrate on helping dogs in more effective ways.

Addendum; 7/28/10;
For those who might be interested in another, science-based resource on shelter medicine and issues such as distemper problems in shelter animals, the UC Davis Koret shelter medicine program has an excellent website with a page on canine distemper. Related to the outbreak local shelters are experiencing, the use of the relatively new recombinant distemper vaccine produced by Merial can be useful as it does not cause false positive PCR tests. The use of this vaccine by those trying to demonstrate efficacy of Dr. Sears' treatment would be one thing that would help to increase the validity or their results.

15 comments:

  1. (note; this comment has been moved to this post by the blog author)

    Anonymous said...

    Dear Bartimaeus,

    Thank you for posting your misgivings about the potential for Newcastle Virus vaccine induced serum to effectively treat Canine Distemper.

    On the Wikipedia site, there are references to other possible treatments for Canine Distemper and also for Canine Parvovirus, please see:
    http://en.wikipedia.org/wiki/Canine_distemper
    http://en.wikipedia.org/wiki/Canine_parvovirus

    Other treatments Wikipedia mentions for Canine Distemper include:
    1- the antiviral Ribavirin
    2- Vitamin A
    3- Interferon Alpha

    Regarding Ribavirin, please see:
    www.vetinfo.com/treating-canine-distemper-ribavirin.html and
    http://en.citizendium.org/wiki/Canine_Distemper_Virus

    Regarding Vitamin A please see:
    http://jn.nutrition.org/cgi/content/abstract/137/8/1916

    I did not find any sites discussing treatment with Interferon Alpha.

    What is your opinion of the potential efficacy of any of these treatments for Distemper?

    Other treatments Wikipedia mentions for Canine Parvovirus include:
    1- the antiviral Tamiflu
    2- colloidal silver
    3- IMULAN Bio Therapeutics LLC is researching a new biologic?
    4- Recombinant Feline Interferon Omega which is produced in silkworm larvae using a baculovirus vector. Wikipedia lists 4 references for this treatment:

    ^ Ishiwata K, Minagawa T, and Kajimoto T. (1998). "Clinical
    effects of the recombinant feline interferon-ω on
    experimental parvovirus infection in beagle dogs.". J. Vet.
    Med. Sci. 60 (8): 911–7. doi:10.1292/jvms.60.911. PMID
    9764403.
    ^ Martin V, Najbar W, Gueguen S, Grousson D, Eun HM,
    Lebreux B, Aubert A. (2002). "Treatment of canine parvoviral
    enteritis with interferon-omega in a placebo-controlled
    challenge trial". Vet. Microbiol. 89 (2-3): 115–127.
    doi:10.1016/S0378-1135(02)00173-6. PMID 12243889.
    ^ De Mari K, Maynard L, Eun HM, Lebreux, B. (2003).
    "Treatment of canine parvoviral enteritis with
    interferon-omega in a placebo-controlled field trial". Vet.
    Rec. 152 (4): 105–8. PMID 12572939.
    ^ Kuwabara M, Nariai, Horiuchi, Nakajima Y, Yamaguchi Y,
    Horioka I, Kawanabe M, Kubo Y, Yukawa M, Sakai T. (2006).
    "Immunological effects of recombinant feline interferon-ω
    (KT80) administration in the dog.". Microbiol. Immunol. 50
    (8): 637–641. PMID 16924149.

    Please also see:
    http://www.ncbi.nlm.nih.gov/pubmed.9764403 and
    http://www.felipedia.org/~felipedi/wiki/index.php/Feline_Panleucopenia
    which states that:
    "Feline recombinant interferon-omega is effective in the treatment of parvoviral enteritis in dogs and also inhibits replication of FPV in cell culture(9). So far, no data are available on the efficacy of this cytokine in FPV-infected cats, but it is expected to perform well - if not better - in the homologous host (Evidence based medicine grade IV)"

    Regarding Tamiflu please see:
    http://www.jackbroadhurstdvm.com
    A Dr. Broadhurst in NC seems to be having success treating Parvovirus (Canine Parvovirus in dogs, and Feline Panleukopenia in cats and Feline Panleukopenia or maybe Raccoon Parvoviral Enteritis in raccoons) with the antiviral Tamiflu.

    As for colloidal silver I did not find anything to support it as a treatment for parvovirus, and I did not find anything about IMULAN Bio Therapeutics new treatment either.

    What is your opinion of the potential efficacy of any of these treatments? Not asking much eh? :)

    Thank you in advance for any insights you can offer.

    Sincerely,
    Edythe Butler
    Ottawa, Ontario, Canada
    July 25, 2010 1:16 PM

    ReplyDelete
  2. Thanks for your comment Edythe; I will try to address your questions.

    There have been some interesting in-vitro studies showing that Ribavirin is active against Distemper virus, but so far evidence of in-vivo effectiveness is lacking. There may be some research going on right now, but so far nothing has been published. Antiviral medications are generally more useful if given during the early stages of the disease, which can be problematic with the difficulty of definitively diagnosing Distemper and the confusion caused by vaccine virus. The same applies to Tamiflu for Parvovirus-it seems to be more effective when given early, and the effect seems modest, especially in severe cases. The only recent controlled trial (http://www.ncbi.nlm.nih.gov/pubmed) looked promising-the treated dogs did better than those that were untreated, and side effects appeared minimal, but again the sample size was small and the results should still be considered preliminary.
    Vitamin A may be helpful, especially if the patient is not eating well and is deficient in vitamin A. This could fall under the category of supportive care for any sick animal, where supplementing vitamins and nutritional support can be valuable. The study involved ferrets, so again the evidence for effectiveness in dogs is
    somewhat lacking, but judicious use of a safe dose of vitamin A is inexpensive and might be helpful.
    Interferons have generally been disappointing, but some of the newer recombinant interferons look promising, for parvovirus at least, but so far are not available commercially in the U.S. The studies you cite look promising, but at best can be considered preliminary-the sample sizes are small, and it seems little work has been done in the last 8-10 years, which is disappointing, and may indicate that it was not considered commercially viable.
    Colloidal silver seems to be a popular item with many alt. med. folks these days, but there is no evidence that it is effective against serious systemic infections, viral or otherwise. The only proven use of silver products is as a topical ointment such as silvadene for burns and other surface wounds.
    At this point I don't know anything about an Imulan product either.

    At this point, prevention of disease with vaccination, isolation, etc. is still by far the most effective way to control these diseases. It would be nice to have an effective treatment for those dogs who fall through the cracks and suffer from distemper, but at this point we are still working with antivirals and other treatments of limited effectiveness.

    Thanks for you comment, I hope this helps.
    Bartimaeus

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  3. Hi I am the "Jane" who writes the Houston Chronicle blog and founder of "Project Hope" in Houston. I wanted to test Dr. Sears' protocols present day after seeing so many puppies especially dying of distemper in the shelters, in foster homes, etc.

    I am happy to open a dialogue between you and Dr. Sears and/or Project Hope's vet. I think if you have a distemper case, try the serum yourself. There are vets in different parts of the country who have it now and I can work to make it available to you if the intent is genuine to help the animal. There is nothing like seeing a very sick animal recover.

    Sometimes, I feel, there is a time to be skeptical; other times is is appropriate to jump in the ring and not call the game from the sidelines--and so I did. I am amazed at what I have seen.

    I do indeed appreciate how you articulated your concerns/thoughts. It gives us lots to consider. My email is animalrescuevolunteer@yahoo.com Thank you for being an advocate for the animals.

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  4. Hi Jane, I have seen several puppies with Distemper in this area in the last year, but none in the last 3 months or so-the local shelters may be getting a handle on their prevention/quarantine procedures. I agree that caring for puppies with distemper is an emotionally draining experience, and I can understand wanting an effective treatment.

    I would be interested in hearing about your experiences-specifically data concerning how many puppies survive with treatment and without treatment. I have seen very sick puppies survive without the NDV treatment as well, so I just wonder how significant the difference is, and how we can be sure that the NDV treatment is having the dramatic effect that is claimed for it. It is very easy for us (clients, vets, humans in general) to think we are doing helpful, when perhaps we are not. Collecting the data in a careful, unbiased way and evaluating it is the only way to know the difference.

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  5. I have pulled SO many pups/ dogs from shelters with distemper. Many vets (at least 15 over the years) I have been to have no answers - so, why not try this? The only other option is DEAD! I have tried so many things but the survival rate is VERY slim with pups (less than 10% in my experience of fostering/ in charge of fosters in over 100 pups in 8 yrs). My personal dog survived distemper as a baby 7 yrs ago (and he had hard pads, all the classic symptoms from a shelter with a history of over 90% puppies having distemper) using transfer factor plus. I am not sure if this helped but it didn't hurt.

    My former vet prescribed marbofloxin for pythiosis. It was worthless and stupid but he didn't know what it was so wasted valuable time that led to my girls death. In my experiences, vets try things all the time that they "think" may help but don't do anything. I understand that dogs can't explain what is going on so it is very hard to diagnosis.

    I agree trials and scientific data is needed but I know this costs money and takes time. I am willing to give anything a shot - as the only other option is blue juice so why not?? What worse outcome can you have? It cost us MUCH less than the over $400 bill we paid for the vet to keep a distemper pup giving it just antibiotics only to have to euthanize him in the end.

    Personally, I am tired of vets trying to make a buck without thinking outside the box - most won't even check VIN to get some alternatives. I have saved many dogs/ pups that my vets said were hopeless using alternative treatments. So, I have seen MANY other unproven, unscientific remedies save many dogs/ pups. At this time, there are still vets out there that don't know to use tamiflu for parvo. Well, I haven't lost a parvo pup in YEARS b/c I get tamiflu in immediately.

    I have tried the Merial vaccine - and so did the shelter with distemper problem and we saw NO significant improvement with the number of pups dying. When you have held as many puppies in your arms while being euthanized that you have put your heart and soul into saving, you may change your mind about trying something - even if there is no scientific data, research studies or adequate sample sizes. I don't know if this will help but I will try just about anything that MAY help b/c it is better than dead!

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  6. The problem with trying "alternatives" without evidence is that you really don't know if you are helping or doing nothing, or even making things worse without collecting evidence in a careful, systematic way. The NDV treatment for canine distemper has been around for 40 years or so now, and there is still only anecdotal evidence for it's use. Other uses of NDV vaccine for treating cancer, etc have been shown to be unreliable and or ineffective after careful study.

    I think you misunderstood my discussion of the Merial vaccine-I did not suggest that it could cure a dog already infected with distemper, but that using it could help to avoid confusion in diagnosing distemper in these puppies. Many of the normal vaccine strains of distemper can cause inclusion bodies, or otherwise confuse the diagnosis. Quite a few of the treated dogs still die of distemper, and some of those that survive may not have had distemper at all. Vaccine virus interfering with diagnostic tests is a possible confounding factor that the promoters of the NDV treatment need to consider if they have any hope of proving that what they are doing is useful.

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  7. Have any of you had a pet die of this virus? Do you know how devastating it is? They likely have less than a 50/50 chance of surviving the disease, so isn't trying something better than sitting and waiting for the dog to die slowly, or euthanizing. I for one think it is. They don't claim to work miracles, and they say so up front. The dogs' chances are better with having tried the treatment than not.

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  8. Michelle, I do indeed know how devastating distemper can be. The problem with the NDV treatment is that it has been around for 40+ years, and we still don't have good data to show if it really does anything. Just "trying something" can be a satisfying thing for the people involved, but if it is not really helping, it can be a waste of money and time and may in fact be harmful. That is why the proponents of any new treatment need to collect data in a careful, systematic way to show a possible benefit, and possibly get eneough interest and funding to test the treatment in a controlled manner. At this point no one really knows if the dog's chances are really better, they just like to think they are. Just trying something in an uncontrolled manner opens all of us up to the cognitive errors that we are all susceptible to, and misleads us more often than not.

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  9. Jane promised all her donors that her findings would be published in June, 2010. Didn't happen. She caused terrible agony to the little pup named Hope by having a needle stuck into its brain, which was an illegal experiment by the way since the pup came from Houston's dog pound, BARC. She recruited donor dogs from rescue groups that had pulled the dogs from BARC, again illegal and unethical. Some of them got sick which she explained away by saying they were already sick. She does not have tax-exempt status although she constantly says that she is getting it. She has donation buttons everywhere she can put and constantly solicits donations for project Hope and her special needs dogs many of which are highly adoptable.

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  10. Skeptivet there's a announcement. SUCCESS has been claimed by Jane Ward and Ed Bond, published in fact her Chronicle blog as of this week. States: "SUCCESS!: Dr. Sears' Canine Distemper Treatment Results": http://www.chron.com/channel/petshouston/commons/persona.html?newspaperUserId=rescuevolunteer&plckController=PersonaBlog&plckScript=personaScript&plckElementId=personaDest&plckPersonaPage=BlogViewPost&plckPostId=Blog%3arescuevolunteerPost%3a0929b53a-f8e3-46fa-ad66-8d5f5a7fa5b3

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  11. Jane has a booth at the Houston Pet Expo on April 16. She won't be there but she will have volunteers passing out literature touting this "treatment" as a cure for distemper. How can she do this? Is it even legal? What a scam? Shouldn't Pet Expo protect pet owners from snake oil salesmen?

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  12. The links in the addendum from 7/28/10 no longer work.

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  13. The Merial vaccine was indeed marketed as a "subunit" vaccine that, in theory, could overcome maternal antibodies. In our use of the vaccine, we saw poor immunization resulting in post-vaccine infection and returned to the traditional modified live vaccine. The issue of the subunit vaccine being useful to avoid interference with a PCR test was never an issue, since IDEXX has a quantitative PCR for distemper. The emergence of quantitative PCR tests for other viruses will be a significant improvement in diagnosis, and hopefully will lead to an admission that SNAP tests do run the risk of failing in specificity for a recently vaccinated dog.

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  14. Hi there fellow skeptic! I just wanted to say "thank you" for your post on NDV and distemper. It supplied some great ammo for a little controversy here in Alabama where some well meaning folks are claiming a "cure" for distemper in an animal shelter that had to put down 8 dogs.

    I'm very happy to see the veterinary equivalent of "sciencebasedmedicine.org."

    In Reason!

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