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My K9 Immunity Clinical Trial Results

Dr. Mullins listens to lungs during dog cancer checkupRecently, there’s been some discussions here and in the Bone Cancer Dogs Yahoo Group about whether or not mushroom therapy has any real benefit to dogs undergoing cancer treatment.

We wanted to get a current picture on the status of how mushroom therapy treatment is doing out there in the real world, so we wrote to my oncologist, Dr. Marie Mullins, who led the K9 Immunity clinical trial that I participated in, when I was patient in 2008 at the Santa Fe Veterinary Cancer center.

With her permission to quote her, here is what Dr. Mullins said about the study:

“The results of the K9 Immunity trial have not yet been published. They were submitted to JAVMA* but rejected (they rarely publish articles on nutriceuticals). They were going to try to get it published in some international mushroom journal (not sure of the exact name) but I have not heard much since then (October 2008 time frame).

The data that I saw was all very preliminary (some of the dogs were still alive). At that point in time, it did not appear to significantly extend survival times but the case numbers were low and statistics lacking.

However, it seemed to overwhelmingly improve their quality of life and protect most of the dogs from untoward chemotherapy side effects.”

K9 Immunity Dog Cancer SupplementsIn our own limited knowledge about mushroom therapy, we recently learned that mushroom therapy isn’t just something being promoted for dog cancers only. A family friend who is a certified “ND,” a naturopathic doctor, in Washington state, and specializes in holistic cancer treatments, uses mushroom therapy for her own human patients.

It’s so hard to know what is fact and what is fiction when it comes to nutriceuticals, but by posting your stories and experiences with K9 Immunity and other canine cancer therapies here in our Eating Healthy Forums, we can try to help get the official verdict out to the public much sooner.

*Journal of the American Veterinary Medical Association

6 thoughts on “My K9 Immunity Clinical Trial Results”

  1. After reading the report on K-9 Immunity in the Intrenational Journal of Medicinal Mushrooms, it is easy to see why JAMA rejected this paper. The study in question is a short-term, uncontrolled, open label study with many outcomes based upon the open-label subjects owners’ responses to a subjective questionnaire. There is little scientific method and the results are, at best, heavily biased. As a clinician, I often have patients bring me similar “studies” from obscure journals, also sponsored by companies selling expensive OTC nutrients for their systemic disease. Without controls, we do not even know if the nutrients may be harmful. I can only advise for poor suffering dogs what I do for the humans I see – save your money, and do not risk your health on poorly studied supplements.

  2. David, thank you for your opinion on the study and K9 Immunity. Just out of curiosity, can I ask what kind of clinician you are?

    In response to your comment, I would like to take a minute to pass along something I read in a book written by renowned dog cancer veterinarian, Dr. Demian Dressler, on page 121 of his book, The Dog Cancer Survival Guide. In this selection, Dr. Dressler indirectly addresses the historical use of treatments such as medicinal mushrooms:

    “Despite being the Western standard, placebo controlled, double-blind studies are not world renowned. It may surprise Americans, but in other countries with advanced medicine, this kind of study is not used at all.

    In Japan, China and other Asian countries, the use of a placebo is considered unethical and inhumane. Their perspective is that if you give a sick patient a placebo instead of something that might cure them, you are doing nothing to help, while allowing the illness to continue.

    Instead, doctors in such countries use two groups of test subjects, giving one group the best current treatment and the other group the new treatment. They then compare the results to determine which treatment is better. This seems a logical approach to getting information, and a kinder one at that, since both groups are actually being treated.

    Clinical experience or historical use can also be a powerful source of evidence. Many treatments from alternative/complimentary and holistic systems can be shown to be effective through clinical evidence.

    Common sense tells us that if a treatment has been in use for a long time, it is probably doing something helpful. Otherwise, it would have been abandoned. It is also likely that the benefits outweigh the side effects. A tried and true treatment is definitely a valid one.

    Many vets will criticize treatments that are recommended based solely on historical use. They do this because, in some cases, there were never actual studies to prove effectiveness and safety.

    The funny thing is this: there are many prescription drugs used here in America that have never been approved by the FDA for use in certain kinds of treatments (cough and cold preparations with antihistamines; single-ingredient narcotics such as Codeine Phosphate and Oxycodone; sedatives such as Phenobarbital and Chloral hydrate).

    I regularly use some of these drugs in my practice, as do most allopathic vets. This is excellent proof that a history of use can be a justification for using a treatment, in any branch of medicine, from allopathic to holistic.”

  3. I am a board-certified allopathic subspecialty surgeon in private practice. I hold an academic appointment at our local college of medicine. I also have a beloved pet suffering from osteosarcoma. He is receiving excellent, compassionate, evidence-based care from an academic institution. The diagnosis is heartbreaking, but I take solace and have confidence in the skill of his attending allopathic veterinarians. We are desperate for help, as our many parent of cancer-stricken dogs.

    Dr. Dressler states that “Western standard, placebo controlled, double-blind studies are not world renowned.” Unfortunately, he is uninformed regarding the state of the art of clinical science. He is partially accurate that the gold standard of the international scientific community has been controlled studies. However, at the beginning of the text, he does not mention that valid controls can be active controls, where an older treatment is compared to a new treatment and superiority is established through careful application of scientific method. Where there is no proven, traditional, or otherwise standard treatment, placebo control may be appropriate, and that type of control is termed passive control. Regardless of whether a study is actively or passively controlled, the absence of any control – as we have in the K-9 Immunity paper – significantly questions the validity of the study.

    My colleagues in Asia agree, and submit controlled studies to our specialty journals every month. Whether a control is active or placebo, the only study results that can be ethically applied to a population are controlled results.

    If you give a patient a placebo instead of an unproven therapy, you may be helping them, since unproven therapy has often been shown to harmful in controlled clinical medical science. There are innumerable paper in which the placebo controls do better or live longer, and the study treatment is abandoned.

    Dr. Dressler does correctly state later in the passage that “doctors in such countries use two groups of test subjects, giving one group the best current treatment and the other group the new treatment. They then compare the results to determine which treatment is better. This seems a logical approach to getting information, and a kinder one at that, since both groups are actually being treated.” He speaks to active control, and, as I stated, he must realize that we do that in America in clinical trials every day. Dr. Dressler’s text clearly emphasizes the importance of scientific controls, which the K-9 Immunity study lacks.

    Dr. Dressler also states “clinical experience or historical use can also be a powerful source of evidence… Common sense tells us that if a treatment has been in use for a long time, it is probably doing something helpful. Otherwise, it would have been abandoned.” Medical history is rife with treatments that were used for “a long time” and then abandoned. For example, bleeding therapy was used for over 2000 years, with its applications dating from Aristotlean ideas which were adopted by Hippocrates in Greece. Medical history teaches us that this flawed theory was supported by the great physicians of antiquity, including Galen. Students of history will recall the George Washington likely died from bleeding treatments, when he likely had a simple bacterial upper respiratory infection that most 1950’s antibiotics would have cured. Bleeding was abandoned after two millenia of use after Louis Pasteur scientifically proved the existence of microorganisms. Given that history, it is foolish for Dr. Dressler to state that, “A tried and true treatment is definitely a valid one.” Many herbal medicines date from the era of bleeding treatment.

    I agree with him that “treatments from alternative/complimentary and holistic systems can be shown to be effective through clinical evidence.” Let’s see the controlled evidence before applying these treatments to our pets or our human patients.

    Dr. Dressler states “there are many prescription drugs used here in America that have never been approved by the FDA for use in certain kinds of treatments… I regularly use some of these drugs in my practice, as do most allopathic vets. This is excellent proof that a history of use can be a justification for using a treatment.” He offers no such proof, and I find his prose deliberately misleading to the lay reader. Dr. Dressler is describing “off label use” as opposed to the “FDA indications” for a therapeutic.

    “FDA indications” are granted after certain trials whose results specify language describing dosage, route and other information to be included on the drug’s label.

    “Off-label use” is applied every day in the practice of allopathic human medicine. Once a drug is FDA-approved, it is available for prescription by individual providers based upon their best judgment. There is very often copious controlled evidence for the off-label use of available therapeutics, and, every off-label drug Dr. Dressler cites has controlled data available at PubMed (a free digital archive of study data supported by the National Institutes of Health). Only those controlled studies provide proof and justification for off-label treatment. History has nothing to do with it.

    I am behind everything and anything we can do for our dog. We have gone to great lengths to provide him with the most effective, humane treatment option. We are desperate and vulnerable, but we must remember to first cause no harm. And we must reach that conclusion through appropriate controlled clinical science – not the study cited in the Intrenational Journal of Medicinal Mushrooms supporting K-9 Immunity’s use. There is no scientific evidence that it is not hurting our pets.

    I appreciate your reply, Jerry, but now it’s my turn for a question: Do you have any direct or indirect financial interest in K-9 Immunity or Aloha Medicinals? Do you receive any form of royalty from the promotion or sale of K-9 Immunity?

    When I speak and mention any drug as a licensed physician, regardless of my opinion on its use, my full financial disclosure regarding pharmaceutical royalties is required by law. Please reciprocate.

  4. Hi David. I am so sorry about your beloved dog, if there is anything we can do to help, please let us know.

    Thank you for the lengthy reply which helps to provide another point of view here. In all fairness to the portion of Dr. Dressler’s book that I spotlighted in my reply, I urge you to read it for yourself, as he takes both an alopathic and holisitic approach to canine cancer care.

    To answer your question; yes, we have made it very clear to our audience in the past that we are affiliates for manufacturers of some products we have tried, and believe may help others who have been in the same situation we have. We strongly believe K9 Immunity helped with my quality of life and longevity when battling osteosarcoma, and, like our oncologist Dr. Mullins, we stand behind it 100 percent.

    Thanks for asking.

  5. Hi Jerry. Thank you so much for your sympathy and your support of our baby. He is certainly in need of love and compassion.

    Also, thank you for your response and honesty regarding your financial benefit from the sales of K-9 Immunity. “Believing” is wonderful for religious holidays and football fans, but, selling one’s unproven beliefs to desperate victims of disease is something I do not condone. I have seen patients spend their life savings, lose their insurance (which had provided funding for proven, appropriately studied treatments), and driven to poverty while paying cash for someone else’s “medical beliefs.”

    Profit from drug development is appropriate, and successful pharmaceutical companies like Merck, Pfizer, and Genentech do it every day. The difference is their drugs are profitable for them and widely used only after controlled clinical trials. Profit from unproven, underdeveloped treatments has likewise been around for centuries – in human medicine, we call it selling snake oil.

    I appreciate the support and community on this site, and there are many valuable insights and stories of encouragement I have read. However, until K-9 Immunity is shown to help and not hurt my sick puppy in a controlled, scientific fashion, I am sending my $59.95 payments to animal charities to help those who do not have the funds to help themselves.

    Healthcare for humans and pets does not have a bottomless pit of money, and there are thousands of patients of all species who suffer each year from inadequate funding. The fortunate pets whose owners who can afford K-9 Immunity are not probably among them. I encourage everyone to consider a charitable option before contributing to the profits of this site’s owners.

    If this site needs funding to run, Jerry, I am certain that an honest plea for donations would receive support. I, for one, would contribute. Excess profit to you out of the pockets of cancer victims from selling false results as “science” is not right.

  6. Thanks again for your comments David. If you really do appreciate our efforts, and want to help keep this community of support online, please do consider a small contribution.

    And for the record, we make no true “profit” from any sales on this site whatsoever. What little commissions we do make, do not nearly cover our hosting expenses, let alone our endless hours of programming and management. That is why we did have our first fundraising campaign last March, and will most likely need to do so annually.

    We are not pushing anything as science here, only documenting our experiences and what we believed help our beloved Jerry live two years when he was given only a few months after his amputation.

    The fact that very little data exists for any proven canine cancer treatment plan is the reason we started this site in the first place – so others can share their chosen methods, and results. And just as science cannot prove K9 Immunity works, it cannot prove it does not.

    Every dog is different of course, and we always stress the “consumer beware” factor when determining treatment protocols. Your comments will clearly help readers decide for themselves.

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