Neoplasene: Benefits Unproven and Risks Severe

Two years ago, I wrote about an herbal product called Neoplasene, an excharotic derived from bloodroot that is marketed for treatment of cancer. I pointed out in that article that apart from a couple of in vitro studies suggesting the active chemical ingredient has some interesting effects on cancer cells, there is little evidence the product is an effective cancer treatment. And there is ample anecdotal and in vitro evidence of harm caused by the product, which kills healthy tissues as well as cancer cells and has been shown in humans to create horrible wounds while leaving hidden cancer that later spreads and kills the patient. No controlled research has been done in dogs and cats, and there is no reliable evidence to support the claims made by the marketers of this product.

Nevertheless, due to the power of anecdotes, and the weakness of government regulation of herbal products, this preparation is still marketed for use, and there are veterinarians who employ it. A recent case report in the Journal of the American Veterinary Medical Association (JAVMA) discusses the lack of evidence supporting the use of bloodroot and illustrates the significant harm these products can do.

Childress, MO. Burgess, RC. Holland, CH. Gelb, HR. Consequences of intratumoral injection of a herbal preparation containing bloodroot (Sanguinaria canadensis) extract in two dogs. Journal of the American Veterinary Medical Association 2011;239(3):374-379.

The report discusses two dogs, belonging to the same owner, who had Neoplasene injected into skin tumors. The first, a 2 year old golden retriever, had a benign tumor about 2cm in diameter. Such masses usually cause no problem for dogs, but if they are disturbing to owners or if they become injured or infected, they can be easily removed surgically, which is curative. Unfortunately, the treating veterinarian elected to inject the mass with Neoplasene. Six days later, the tumor had become bruised and much larger. The veterinarian instructed the client to give an oral homeopathic remedy to reduce the swelling of the tumor (which, given the mountain of evidence that homeopathy is nothing more than water and a bit of placebo effect, cannot reasonably viewed as an acceptable standard of care). After the swelling failed to resolve following drainage and bandaging, the pet was taken to the hospital of the veterinary medical school at Purdue University. By this time the benign 2cm diameter mass had become a 6cm area of severely inflammed and necrotic (dead) tissue.

The dog had surgery to remove the mass and a margin of healthy tissue around it, which involved a very extensive surgical procedure. After many weeks involving several additional surgical procedures and physical therapy to treat the loss of mobility caused by the large wound, the patient eventually made a full recovery.

The second patient discussed in the report, owned by the same client and treated by the same original veterinarian as the first dog, also had bloodroot injected into a benign tumor. A smaller amount of Neoplasene was used, and it appears that some of this leaked out after the injection. As a consequence of this, or perhaps of the variability in unregulated herbal products, the tissue reaction was not as severe as in the first patient. When the mass was surgically removed, an area of inflammation and tissue necrosis was observed near but not in the tumor. Luckily, this dog experienced minimal complications.

Clearly, complications can occur with any medication or treatment that has a measurable physiological effect. Anything that has no possibility of any side effects isn’t doing anything! And it is important to remember that anecdotes cannot be used to prove either the safety or the efficacy of a treatment. Anecdotes of benefit provide only enough evidence to justify more rigorous, systematic testing, not proof that a therapy works. In the majority of cases, such anecdotes turn out not to be accurate when more objective testing is done. Cases in which harm may have resulted from a treatment also cannot prove the treatment is unsafe. They do, however, provide reason to be cautious, and they raise the level of supportive evidence of benefit that should be expected prior to employing the treatment. Medicine is always about balancing the urgency of intervening in a patient’s condition with the available information about the risks and benefits of the intervention.

In the case of bloodroot, there is limited preclinical evidence to suggest it might be a useful treatment. It does kill cancer cells, but so does bleach, which is obviously not a good candidate for use as a medicine. The evidence that bloodroot kills cancer cells and spares healthy tissues is weak and contradicted by numerous cases of obvious tissue damage following application of the chemical. And there simply are no clinical studies to indicate a benefit in actual patients, much less a benefit greater than the potential risks. So we are left with anecdotes about bloodroot curing patients, which are of limited value as such anecdotes are often wrong for many reasons, and anecdotes of patients suffering severe, sometimes disfiguring or disabling injury after using it. Severe injury may not always happen, but it is an extreme risk to take when there is no real reason to expect the treatment has any benefit. Both of these patients would have been effectively cured, with much less suffering, injury, and expense for the owner, if they had been treated with conventional surgery rather than bloodroot.

Given the current state of the evidence, it is irresponsible of veterinarians to use bloodroot products on their patients. And in my opinion it is absolutely unethical for companies and individuals to profit from marketing these remedies without investing the resources in proper clinical studies to prove that they can be used safely and that they actually benefit patients. As I have discussed many times, herbal remedies are likely the most promising area of alternative medicine in which we will hopefully find effective medicines. But until they have been rigorously tested, and until they are regulated as stringently as pharmaceuticals, they are a dangerous gamble with our pets’ health and cannot reasonably be viewed as an alternative to established conventional treatments. Just as the pharmaceutical industry must be carefully watched to constrain the bad behavior that the profit motive can generate, so the herbal medicine industry cannot be trusted to provide trustworthy information and safe and effective remedies without much more oversight that it currently receives.

 

 

 

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92 Responses to Neoplasene: Benefits Unproven and Risks Severe

  1. Cali_Girl says:

    v.t. – why is marijuana banned in the U.S. and considered to have high addictive potential with no medicinal value when good science, including controlled studies, has concluded otherwise, many times over? The fact that our government has banned bloodroot means nothing to me. Do you think they have our best interests at heart, or are they trying to support Big Pharma, who donates graciously to political campaigns? Hmmmm…

    Also, the moderator deleted the link I posted twice in the comment I made prior to this one. It was a link to a scientific paper written by a veterinarian. Why would you get rid of that relevant link?

  2. v.t. says:

    Comparing MM to neoplasene is apples to oranges. MM is at least at this point, considered helpful in alleviating symptoms such as nausea and pain in human cancer patients, but it certainly has not been proven to be a cure for cancer, as much as woo proponents would like you to believe.

    In real medicine, the risk to benefit ratio is how we attempt to make rational and informed choices. Neoplasene has more risks than purported benefits – it is banned for legitimate reasons, not because of your fear of big brother or big pharma’s influence.

  3. Cali_Girl says:

    v.t. – you’re right about one thing – comparing MM to Neoplasene really is like comparing apples to oranges – but that’s because contrary to what you claim, bloodroot is NOT banned in the U.S. The FDA has banned import of certain products containing bloodroot, primarily black salves. However, the FDA has actually approved bloodroot extract for inclusion in toothpaste! If I’m wrong about that, please provide the source of your information as I could not find anything to confirm that claim of yours. The reason I was comparing the two was because of the supposed illegal status of both. So I guess your argument that MM doesn’t have anti-cancer effects, while horribly contradicted by good science (if you want those sources and can’t find them on your own, I will be happy to provide them – just ask), truly is irrelevant.

    You’re wrong about Neoplasene being banned, and you’re also wrong the lack of influence of Big Pharma in medicine. Dr. Sanjay Gupta recently spoke out about how he was lied to by the medical establishment about the legitimate benefits of medical marijuana. I converse with plenty of doctors and other professionals in the medical field on a regular basis, and I worked in it as well. I can confirm that Dr. Gupta is only one of many who have come to the same realization.

    Please stop providing incorrect information to back up your feeble argument; it is a disservice to anyone seeking good information from this blog.

  4. v.t. says:

    Bloodroot, black salves etc are considered unproven drugs (or, “unapproved new drugs”, “adulterated or misbranded” products and in veterinary medicine, “unapproved new animal drugs”), therefore illegal to market for health claims, distribution in interstate commerce and are subject to fines, injunctions, and federal prosecution. Read the various warning letters on FDA’s site for plenty of examples. Here’s an excerpt from one such warning letter in which the defendants eventually ended up in a boatload of trouble…

    A Warning Letter was issued to Greta Armstrong, Risingsun Health Alternatives and Herbs, Division of McAdam Health Enterprises, Livingston, MT, concerning products marketed on its Internet websites. One of the products, Bla-Cansema Type Black Salve For Pets, is intended for use in cats and dogs; the other products are intended for use in humans. According to the websites, the salves, capsules, and tonics are sold as topical and oral treatments for various forms of cancers, heart disease, high blood pressure, diabetes, and numerous other life threatening diseases. Ordering instructions and a price list for the products are provided on the website. Consumers are directed to select the desired products and are provided with a secure payment processor to facilitate payment by credit card to Risingsun Health Alternatives. Based on the claims cited, the products are “drugs” as defined by 21 U.S.C. § 321(g). Moreover, all the products are either “new drugs” or “new animal drugs” as defined by 21 U.S.C. § 321(p) and 21 U.S.C. § 321(v), respectively, because there is no evidence that they are generally recognized as safe and effective for the intended uses conveyed in their labeling. Furthermore, the salves are topical products and cannot be dietary supplements because they are not intended for ingestion, but rather to bypass the alimentary canal by direct absorption through the skin. The Act defines the term “dietary supplement” to mean a product that is “intended for ingestion….” Consequently, topical products intended to enter the body directly through the skin or mucosal tissues are not “dietary supplements.” For these products, both disease and structure/function claims cause them to be new drugs. Under 21 U.S.C. § 355(a), a “new drug” may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved drug application is in effect for the drug. The distribution of the products intended for humans are in violation of 21 U.S.C. § 355 and prohibited by 21 U.S.C. § 331(d). The Bla-Cansema Type Black Salve For Pets is adulterated under 21 U.S.C. § 351(a)(5), because it is unsafe under 21 CFR U.S.C. § 360b, because it is a new animal drug, and there is no FDA-approved new animal drug application in effect for the drug.

    Just because fraudsters sell it on the internet (health claims, interstate commerce etc, making it illegal) and back alleys doesn’t mean it’s legal or appropriate, the FDA, FTC and other entities work hard to prevent fraud and dangerous products from reaching unsuspecting consumers. But go ahead and call it a conspiracy to suppress “natural” treatments, since nothing here nor there is going to change your mind.

    More:

    http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116913.htm

    http://www.fda.gov/forconsumers/consumerupdates/ucm048383.htm

    Big Pharma “influence” has nothing to do with neoplasene, bloodroot or black salve, if they were the least bit interested in it, they would be doing clinical trials. Neither does the FDA, since it is currently has not been given the power to regulate beyond importation, illegal marketing etc, much like most of CAM and CAVM (supplements, herbs etc, you can thank the DSHEA Act for that). My biggest beef is the marketing, selling and promotion of these harmful products for the use in pets and misinformed owners with no critical thinking skills to evaluate the safety of the products and non-evidence for efficacy. If you can’t grasp the real harm done to pets without a voice to consent or complain, then you have a problem.

  5. Cali_Girl says:

    v.t. – nothing in all the FDA-related info you provided specifically mentions Neoplasene nor the company that manufactures it. Yes, it mentions black salve and related items, but that’s like equating aspirin with willow tree bark. But I guess posting all that information was more of an attempt to save face after I pointed out that your claim that bloodroot was banned was incorrect, and that bloodroot extract actually was approved by the FDA for use in humans (in toothpaste).

    Neoplasene for pets is the topic of this article; the FDA has zero role in veterinary medicine (they only evaluate products for human use), so you can’t claim that they have approved or banned ANYTHING for use in pets. And Neoplasene is NOT ILLEGAL, nor is it directly marketed to “disinformed pet owners”; it is only distributed to veterinarians, who are likely more informed than you are regarding Neoplasene – especially considering the incorrect information you’ve included in your comments above.

    We can keep this back-and-forth going if you want, but I’m just going to continue to point out incorrect information you share as well as any erroneous applications of correct information to the topic of concern. I feel it is my duty as a scientist, researcher, informed pet-owner, and decent human being.

  6. skeptvet says:

    You are factually incorrect on one of your points, though doubtless you will not see the irony in that despite your snarky final paragraph.

    The FDA does, in fact, have regulatory authority over veterinary drugs and medical devices. Any drug marketed for veterinary use must either have a drug label, obtained through the same new drug application process used to evaluate drugs for human use, or it must be used off-label by licensed veterinarians. Wide lattitude is given, via the Animal Medicinal Drug Use Clarification Act due to the cost and difficulty of getting an FDA label for using a drug in the relatively small veterinary market, but the FDA does have complete regulatory authority over veterinary medicine use.

    In the case of Neoplasene, since specific therapeutic claims are made for it it falls under the category of a veterinary drug, and as such it is illegal to market without an FDA label since there is no human approval, which would allow an off-label use by veterinarians. Some refer to it as an herbal medicine, which would be covered under the Dietary Supplement Health Education Act (DSHEA), however for products regulated under this law, specific claims to treat or cure disease are not allowed, only much more vague so-called “structure and function” claims. The claims the manufacturer makes for it are almost certainly illegal, however the sad reality is that until there is a public health or food safety problem affecting humans, the FDA Center for Veterinary Medicine simply does not have the resources to pursue such claims even if they violate the law.

    As for the use in toothpaste, that is still the only approved use in humans (there are no approved uses in pets). There is considerable controversy about the safety and efficacy of the practice, however, as illustrated by the most recent review:

    Vlachojannis C1, Magora F, Chrubasik S.Rise and fall of oral health products with Canadian bloodroot extract. Phytother Res. 2012 Oct;26(10):1423-6. doi: 10.1002/ptr.4606. Epub 2012 Feb 8.

    Abstract

    The rhizome of Sanguinaria canadensis (SC, bloodroot) contains an active principle with antimicrobial, antiinflammatory, antioxidative and immunomodulatory effects. For this reason SC extract has been added to toothpastes and mouthwashes in various concentrations. When tested separately, neither the toothpastes nor the mouthwashes with SC extract had any demonstrable clinical effectiveness against dental plaque and gingivitis. Although using them together twice a day seemed more effective than using placebo, more recent studies have shown conflicting results. Preclinical safety studies up to 2000, which did not include studies longer than 6 months, were thought not to indicate any appreciable potential for harm – to the oral mucosa in particular. In 2003, the FDA Subcommittee on Oral Health Care Drug Products for Over-the-Counter Human Use concluded from a review that using SC-containing products is safe. However, for reasons unknown, the review failed to consider publications between 1999 and 2001 that suggested a possible link between the use of SC-containing products and the pre-neoplastic lesion, leukoplakia. As it happened, bloodroot had already been removed (in 2001) from the formula of one of the most widely used products in question and the brand has since then disappeared altogether from the worldwide market.

  7. v.t. says:

    Cali_Girl, who do you think regulates animal feeds, including pet foods? Pet food recalls? Drugs? They are generally voluntary action by the manufacturer, however if labs test positive for harmful substances and/or if such substance can also be harmful to human health, the FDA has the power to enforce a recall – same goes for, as skeptvet mentions, drugs and devices.

    Both the DSHEA and CVM division of the FDA have little resources to battle with alt medders, but that doesn’t mean they can’t do something about it, on the contrary.

    I feel it is my duty as a scientist, researcher, informed pet-owner, and decent human being.

    But you’re not a veterinary scientist, obviously, and your research “skills” need to be defined more, since you had no clue the FDA’s role in veterinary medicine, products, etc. “Informed” pet owner, maybe, but don’t be so open-minded that your brains fall out.

  8. Cali_Girl says:

    SkeptVet –

    My “snarky final paragraph” is this: “We can keep this back-and-forth going if you want, but I’m just going to continue to point out incorrect information you share as well as any erroneous applications of correct information to the topic of concern. I feel it is my duty as a scientist, researcher, informed pet-owner, and decent human being.” If you’re finding that “snarky,” it’s probably more of a reflection of your attitude than of mine. All I said was that I would continue to correct information that was incorrect, and that I felt it was my duty and explained why. There was no name-calling, sarcasm, insults, or disrespectful language.

    And you’re right – I was wrong about “one thing” – the FDA’s role in veterinary medicine. I apologize for that error. I guess what I read was incorrect or I misunderstood it. I have no problem admitting when I’m wrong about something. Unlike you and v.t., my ultimate goal is to provide the audience reading this the most correct information I can–not to use whatever I can to support my argument. Oh look, there’s the snarkiness you were looking for! 🙂 (If you’re going to read it into sentences in which it’s absent, I may as well have fun and include in my future comments).

    Here’s what the FDA did about Neoplasene, from http://holvet.blogspot.com/2011/09/notes-on-neoplasene-for-treatment-of.html :
    “The formulator, Dr. Terry Fox, wanted to get the drug out on the market quickly, into the hands of those who could immediately create great benefit with it – veterinarians. To present it as a drug for humans would have initiated a plethora of legal hoops to jump through and would have cost millions of dollars. The drug would not have reached patients for years, and it’s price would have been much, much greater. The FDA has visited Dr Fox and examined his facilities and manufacturing practices. They were satisfied with allowing him to go forward with Neoplasene on the market for animal use only, through sale exclusively to licensed veterinarians.”

    So you’re right that the FDA has a role in regulating veterinary medicine. Thank you for enlightening me. In fact, by doing so, you weakened your argument as well because you clearly think the FDA is a proper authority on this, and then I found that the FDA is aware of its distribution to veterinarians and use in animals and approves. That might be even more ironic than my “final snarky paragraph”! However, I’m not sold on the authority of an agency that has approved dangerous medicines like Vioxx while not approving medicines that have been shown to have minimal harm and great benefit (back to medical marijuana). As I don’t give much credit to the FDA, their stance on Neoplasene means nothing to me–their approval of it neither convinces me of its safety nor makes me suspicious of it. So that anyone reading this can get both sides of the debate, here is Wikipedia’s page on criticisms of the FDA: http://en.wikipedia.org/wiki/Criticism_of_the_Food_and_Drug_Administration

    Lastly, SkeptVet, I would like to ask you – and this is not intended to be snarky or a challenge; it is a true question of curiosity: could you outline a study design for assessing the safety and efficacy of Neoplasene that would contribute more than the hundreds of case studies and the in vitro study while still meeting ethical standards? Who would be your cases and controls? How would you control for variables not controlled for in case studies while ensuring the external validity of the study is as good, if not better, than the external validity for hundreds of case studies? Would you allow your own pet to be a case? If not, are you OK with asking other people to use their pets as cases?

    And now we come to v.t. – thank you for your advice about my open-mindedness; I assure you my “brains” are still safely inside my head. You should give open-mindedness a try instead of worrying about your brains falling out. Hey, SkeptVet – I think that v.t.’s comment about my brains is a better example of what “snarky” is than my final paragraph from my previous comment was! 🙂

    My “research skills” are that I do research as my job, my career. I have a Master’s degree in Epidemiology. I am very familiar with study design and research methods. You are correct – I am not a veterinary scientist. But the main issue I have with SkeptVet’s opinion on Neoplasene is the rejection of evidence that shouldn’t be rejected. One, two, ten cases studies – OK, maybe I’m not convinced. But I know of one veterinarian who has 300+ case studies of Neoplasene working in cats alone. When the volume of “anecdotal evidence” gets to be that high, you can’t just brush it off.

    Is my prior lack of knowledge about the FDA’s role in veterinary medicine the best thing you two can use against me, after everything I’ve contributed to this discussion? OK, I can live with that. I just brushed up on it, so I won’t make that mistake in the future. Again, thank you for pointing that out. I do want to know when I am wrong about something.

  9. skeptvet says:

    Do you have any evidence for your claim that the FDA approved of Dr. Fox going forward with marketing Neoplasene without a label and espite it’s being prohibited for human use other than a holistic vet blog? There is no mention of Neoplasene anywhere on the FDA web site, and this would be an unusual step, so I am skeptical of the truth of that claim.

    As for the value of FDA approval, that’s an entirely different subject. Personally, I think the system is flawed and much greater oversight and premarket evidence should be required. However, you seem to feel that the absence of formal, controlled evidence is not a problem and that since the FDA system is imperfect it is useless and irrelevant. That is not, in my opinon, a rational or useful attitude. The fact is that the food and drug regulations we have have dramatically reduced the harm done to the public by medical products, and it is only an ignorance of history that allows people to imagine that remedies validated only by uncontrolled anecdote are safe or that we would be as well off or better off without the FDA system. I’m afraid our understanding of the situation is so dramatically different it is hard to imagine how we could have a productive discussion about it. It is much like a debate between a creationist and someone who accepts evolution: the differences are not really about the facts or the details but about entire world views.

    And yes, I believe blinded, randomized, placebo-controlled studies would be far more reliable than the uncontrolled anecdotes. I believe it is unethical to sell a remedy based only on such anecdtoes. What you seem unable to accept is that no matter how many anecdotes you have, because each one is unreliable the collection is unreliable. Anecdotal evidence has supported every failed medical therapy in history. There is no difference between the millions of people over thousands of years who believed they had been helped by bloodletting and the people who believe their pets have been helped by Neoplasene. Controlled research showed bloodletting to be harmful, not helpful, despite all those anecdotes, and only controlled research can tell us if Neoplasene is safe and effective. I realize you will never see this, but it is an axiom of the scientific method, and if you reject it you have essentially given up on a scientific approach to medicine regardless of your claims to be a scientist in some domain.

    And I will remind you one more time, it is not up to the rest of us to prove Neoplasene works or doesn’t work. It is the responsibility of those making a claim to prove it is true, particularly when they are profiting from selling what they claim is an effective therapy. You are willing to give Dr. Fox and Buck Mountain a pass on the basis of anecdotes, but that is a mistake.

  10. Art Malernee Dvm says:

    They were satisfied with allowing him to go forward with Neoplasene on the market for animal use only, through sale exclusively to licensed veterinarians.>>>>

    I wonder what “go forward” means? Maybe he is making homeopathic Neoplasene with no measurable active ingredient.

  11. v.t. says:

    Exactly, skeptvet and Art, the FDA expects manufacturers to follow the standard guidelines and regulations on a variety of issues, and as we see every single day, there are many manufacturers and more snake oil salesman who don’t abide by the rules. But those who are biased against any regulatory body will of course see it as something entirely different with all of the FDA’s sinister intentions.

  12. Vikki C. says:

    I would like to report my personal experience using bloodroot to treat my dogs. Of course this information is totally anecdotal and I am not advocating the use of bloodroot by any individual. I am simply sharing my experience with it.
    I first learned about blood root when my veterinarian applied it to a sarcoma on my donkey’s supraorbital area. We applied it everyday for about 2 weeks and the lesion finally fell off and never returned. This was after months of using surgery and other methods. The lesion had always returned prior to treating it with bloodroot.
    My dog had a tumor in his bottom jaw which was large enough to displace 2 teeth. I applied bloodroot extract to the area 2 times a day for a month. The tumor finally fell out without leaving any evidence in his mouth that it had ever existed. This was a year ago and it has not grown back.
    Another of my dogs had a large growth in her ear that grew on a stalk and totally blocked her outer ear canal. It appeared to be painful with a good blood supply to it.
    I applied the blood root extract for about 3 weeks and it grew smaller and smaller each day until it disappeared leaving no scarring and a clean disinfected ear canal. It has not returned.
    Say what you will, but I have learned to regard this root as something of a miracle. I am quite sure a vet would have wanted to resect my dog’s jaw and the other dog’s ear. I’m not saying people should take the risks I did. I just wish this root and it’s properties could be sufficiently studied for any and all possible applications as a viable treatment alternative.

  13. skeptvet says:

    You are welcome to share your experience, but I would suggest you consider some of the reasons why this might not mean what it appears to mean.

    Medical Miracles: Should We Believe?

    Why Bogus Therapies Often Seem to Work

  14. Christie Rahul says:

    http://www.buckmountainbotanicals.net/pdf/clinical_guide.pdf

    I can see my previous comment was deleted. This is to educate people.

  15. skeptvet says:

    First of all, don’t be paranoid. I actually approved your comment and provided a response.

    Secondly, this is not new evidence, simply the marketing materials of the company selling the product, which I discussed in the original article. Still nothing to your case other than personal faith.

  16. Pingback: The Harm Complementary and Alternative Medicine Can Do | The SkeptVet

  17. stephanie says:

    just came across this article and read through all the comments. thought i’d add my own anecdote. 9 year old, neutered, male rottweiler. surgical resection of what turned out to be an hemangiopericytoma. it instantly regrew in an aggressive manner as they always do. the dog had bilateral severe hip arthritis so amputation wasn’t an option and radiation therapy was financially out of the owner’s reach. i resected the mass again and covered the surgical site with neoplacene gel which remained in the wound for 12 hours then was rinsed away. the owner was aware of the huge wound that always ensues following neoplacene treatment and managed the case exceptionally well. over an 8 day period the wound deepened and widened, including tentacle-like fissures radiating outward. time to total recovery=90 days and the tumor never recurred. the dog died years later of organ failure. i have complete medical notes and daily photographs of the progression of the treatment.

    so, yes this is an anecdotal account. but it is also a well documented account by a veterinarian who supervised the case from start to finish. this case cannot be poopoo’d away as misdiagnosis, placebo, regression to the mean, or self-limiting disease.

    i am very selective of the patients on whom i choose to use this compound. i have had amazing success with non-resectable tumors and no success with systemic cancers such as lymphoma. it’s my belief that this compound DOES have an invaluable place in veterinary medicine and warrants the research that is necessary to bring it into mainstream medicine. in the meantime i am grateful to have it available to my terminal patients for whom mainstream therapies are not an option. my clients are always well educated regarding the product and it’s potential side effects prior to implementing treatment.

  18. stephanie says:

    i meant to add that the tumor was on the distal medial carpus so adequate surgical margins for this tumor type were not possible.

  19. skeptvet says:

    Anecdotes are anecdotes, and collecting them doesn’t correct for their limitations or improve their reliability. Any therapy that has such dramatic success and minimal risk as you suggest should be easy to validate with true controlled research, so the question remains why the company feels no responsibility to conduct this while profiting from selling the therapy.

  20. v.t. says:

    Skeptvet said: Any therapy that has such dramatic success and minimal risk as you suggest should be easy to validate with true controlled research, so the question remains why the company feels no responsibility to conduct this while profiting from selling the therapy.

    Likewise, why some vets feel no responsibility to their patients and patients’ owners to continue using this dangerous crap while profiting from selling it. No studies proven effective, yet obviously well-known dangers, and a half-baked excuse to use it under the DSHEA (if promoted to clients as herbal).

    Pray tell, stephanie, what “education”, disclosures do your clients receive regarding “potential side effects”?

  21. gmact says:

    As long as there is big money to be made from people who have cancer and receive ‘ conventional’ treatment, there will be no cure forthcoming.

  22. skeptvet says:

    Depressing, cynical, and frankly inconsistent with the history of modern medicine, which has alleviated a tremendous amount of suffering with “conventional” medicine.

  23. horswmn97 says:

    yes, there are case studies.

  24. skeptvet says:

    Yes, there are anecdotes both for and against the product. There are anecdotes for and against every medical therapy ever invented, from bloodletting and ritual sacrifice to homeopathy and pharmaceuticals. What is lacking for bloodroot is real scientific evidence of safety and efficacy. Much of the case report data shows injury from the product, and there is good reason to believe that suing it to treat malignant cancers will injure the patient without effectively removing all of the cancer.

  25. QuackersNCheez says:

    Oh I wanted to suggest people watch One Answer to Cancer the full length documentary is on youtube. This has some information about phama companies and bloodroot.

  26. Ben blankenship says:

    I had a golden retriever who developed a small squamous cell tumor on his gum line. My vet removed it with clean margins. She recommended I see an oncologist. The oncologist said there would be a 95 percent chance that with 11 sessions of radiation , this would take care of it. After radiation therapy,and about 10k everything seemed fine for about 2 months, then my boy developed full blown nasal cancer. Side effect from the radiation,as it was close to the nose. Oncologist gave me no hope! Found a vet at our humane society who uses neoplasene, his nose was closing up from the cancer, not being able to breath, we used neoplasene with a q tip in his nose. Not only could he breath now, but he was comftorable. We also gave oral neoplasene orally with no ill effects. He lived 2 years like this. If only I had known about neoplasene when this tumor was tiny, and would never have to go through this deadly radiation!

  27. skeptvet says:

    Glad things worked out, but unfortunately this doesn’t prove anything about the safety or effectiveness of Neoplasene. Such stories exist for every treatment ever invented, included many we know for certain do more harm then good. Science is needed because anecdotes are misleading. Here’s more discussion of why:

    Why Anecdotes and Testimonials Can’t Be Trusted

  28. Rickarus says:

    Ben Blankenship,

    I am very sorry to hear that you had to say goodbye to your golden retriever. It is evident that you cared for and loved your dog greatly.

    I would point out the incorrect assumption that your dog formed a radiation-induced nasal cancer. Radiation-induced cancers are sarcomas, not the typical carcinomas found in dogs with nasal tumors, and take a median of YEARS to develop secondary to radiation, so it is not likely that this was a radiation-induced cancer in your dog. Just an unfortunate case of genetic bad luck for your pup that developed two cancers.

    Again, I am sorry for your golden retrievers passing. It sounds like you sought out possibilities to preserve his quality of life, which came from the heart. As for Neoplasene, what works in ONE dog, maybe not work in MOST dogs, and I am hard pressed to recommend this treatment to my clients for their dogs based on the information we have at this time.

    Sincerely,
    A Veterinary Radiation Oncologist

  29. Mary says:

    Yes it works. My cat had a cancer on her nose and we tried topical chemo, this made it worse. We went to a holistic vet and after 4 treatments the cancer was gone as was a little bit of the nose tissue. We have had the cat for 6 more years and the cancer is on the other side of her nose. Are we going to use blood root again? YES!
    Does anyone know how to apply at home?

    Thanks,
    Mary

  30. Mary Dixon says:

    If it saved my pet then it works for my pet. I will use it again because it works for her.

  31. v.t. says:

    Mary, chances are, it was the chemo (and a delayed effect), that targeted the nasal lymphoma – “holistic” most likely did nothing for her, and the blood-root, as you clearly claim, is responsible for DAMAGING her nasal tissues!

    How to apply at home? Answer: DO NOT APPLY BLOOD-ROOT, it’s caustic, damages vital tissue, and does NOT cure cancer!

  32. Deonet says:

    Not sure of the verity of this guy’s comments. I have personally used bloodroot products on myself and on one of my dogs. There is a long, proven history of bloodroot in use for abnormal cells successfully. I have very sensitive keloid skin that scars from paper cuts and cat scratches. The bloodroot paste I used did not react to normal skin on the inside of my arm but killed and caused my body to eject several mottled moles and an area of skin that was cancerous. It killed my dogs basal cell sarcoma without harming any healthy cells on his elbow. Bloodroot products used properly from a good company work as advertised. Buck Mountain Botanicals shows and explains what happens with abnormal cells, that the whole thing is to be done under veterinary supervision, and has case studies with pictures. If the cases this guy brings up were non-cancerous, then the stupid dog owner should have just left the growths alone or had them surgically removed. Considering how case one reacted, not sure it was non-cancerous at all – thus a false negative on the lab’s part.

  33. skeptvet says:

    The problem here is that many of the claims you make aren’t actually true, and the support for them of personal experience isn’t really reliable. There is not, in fact, research showing bloodroot kills abnormal cells and spares healthy ones in living patients, and plenty of evidence that it damages healthy and unhealthy tissue alike. The evidence suggesting this selectivity comes from in vitro experiments which turn out not to accurately reflect what happens in real patients.

    Otherwise the idea that you accept vague, unpublished”case reports” from the seller of this snake oil as proof but look for reasons to ignore the detailed and published case report showing harm in these dogs just shows that you are determined to believe in this product regardless of the actual evidence.

  34. v.t. says:

    Deonet,

    2016 Warning Letters – Health Fraud
    Examples of FDA Warning Letters that cite unapproved or unsubstantiated claims, tainted products or other health fraud* – related violations.

    Buck Mountain Herbs Botanicals, Inc. Warning Letter:
    https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm526534.htm

    *The FDA defines health fraud as the deceptive promotion, advertising, distribution, or sale of a product represented as being effective to prevent, diagnose, treat, cure or lessen an illness or condition, or provide another beneficial effect on health, but that has not been scientifically proven safe and effective for such purposes.

  35. Louise Thurman says:

    time for me to weigh on in this as I begin the journey of finding potential life-extending treatments that don’t drastically reduce quality of life for my 10 year old ornery girl. She’s also my running partner, so this is a particularly hard time for me. After consultation with our usual vet who referred us to a specialist who laid out a grim course based on typical experience with nasal tumors I once again explored non-traditional techniques.
    Now let me say a couple things about myself here- I’m an MD. I specialize in pharmacology, though not experienced in oncology. As a relatively normal human being I don’t translate what works for one person works for everyone. That certainly applied to a devastating back injury I had 10 years ago. The one and only thing that helped my recovery from that was- get ready for it- Chinese medicine, a combination of acupuncture and herbals.
    So yes, I researched use of these in canines, and indeed there are some few “scientific” articles out there. I found a book on acupressure for canines. Oddly, the meridian (the energy stream) where my buddy’s cancer is located is right along the same meridian she had a torn ligament about 10 months ago. So I’ve started acupressure with her.
    Additionally, after doing some crazy research, artemisinin and its co-compounds have demonstrated anti-cancer effects in bench science trials. Additionally, I researched non-scientific articles, and found promotion of Essiac- a combination of herbs allegedly from an Ojibwa Indian medicine practitioner, with substantial body of anecdotal or case report level of evidence. Given the low risk of these two compounds I started my dear companion on these two 10 days ago.
    Her nasal tumor is about half the size it was. About once a day she has a small amount of bleeding from her nose, usually when I first get home from work and she has her usual crazy sneezing fit from being excited. This is in contrast to nearly 2-3 sneezing and bleeding episodes every hour.

    I came across your website while researching Neoplacene after consulting further with a naturopathic veterinarian in my area. I appreciate your skepticism as a scientist and physician, as well as a “co-patient”. And it sounds form my research that Neoplasene has more toxicity associated with it than her current herbals.

    All that being said, it is possible for some animals (and humans) to have a positive response to these types of products. I have several colleagues and many friends that have had remarkable symptom improvement, and sometimes cures or at least extended life beyond expectations by incorporating non-traditional methods in their care. I have turned my practice into one that welcomes combinations of approach, while heeding potential from drug:drug interactions, as of course herbal products are well known to interfere with metabolism of other medications through cytochrome P450 systems, for example.

    I am providing these comments not to criticize any particular opinion or stance, but to open discussion (again) around sensical and reasonable use of treatments outside of therapies that have undergone rigorous testing via double blind, placebo controlled trials. As you likely are aware, it takes a BILLION dollars or more to get a drug FDA approved. It’s very difficult to get products approved for humans, who spend far more on medictations and other treatments than pet owners do. It’s unlikely that Buck Mountain or other herbal product producers can raise that kind of capital to do these kinds of trials. I support your point that this level of evidence is necessary to make claims that it has broad efficacy for a particular indication. But the human side of me says when you have access to a product that has case report evidence of some effectiveness that is better than no hope at all. Physicians are responsible for providing hope, and to do that sometimes we may encourage hope and thought-provoking ideas to help people. Should it be different for veterinarians? I think we both have a responsibility to our patients and their loved ones to serve up a big piece of hope with every consultation.

  36. skeptvet says:

    All of the arguments you make are reasonable, but of course they don’t overcome, in my view, the problems with anecdote and trial-and-error treatment. We know this product ahs causes severe injury in some individuals. We know that there is only anecdotal evidence for the claimed successes, and that anecdotes are routinely dramatically mistaken. If that’s all we have, I think we are more likely to do harm than good with such a product, and I believe it is unethical to sell it and then claim that it is fair to profit by doing so without making the investment to prove safety and efficacy. The fact that such proof is difficult and expensive doesn’t make doing without it any safer.

  37. alex says:

    Will you update this article if you find that Sanguinarine (bloodroot) extracts are being shown to work by credible sources?
    https://www.ncbi.nlm.nih.gov/pubmed/28636454

  38. Alex Destefanis says:

    Will you update this article if you find that Sanguinarine (bloodroot) extracts are being shown to work by credible sources?
    https://www.ncbi.nlm.nih.gov/pubmed/29783958
    https://www.ncbi.nlm.nih.gov/pubmed/30187808
    https://www.ncbi.nlm.nih.gov/pubmed/273639
    (separating my comments due to spam filters on your site)

  39. skeptvet says:

    Sure. If there are well-designed and well-conducted clinical trials showing a specific bloodroot derivative improves the outcome for patients with a particular disease, I will be thrilled and happy to recommend it. However, there is a huge gulf between showing one chemical from the plant has some effects on cells in a test tube and claiming Neoplasene is a safe or effective therapy for anything! The vast majority of medicines which look promising at the lab stage fail to make it to real-world use because of risks or less benefit than suggested by the early testing. Heck, even bleach kills bacteria and cancer cells in a test tube, but that doesn’t make it an antibiotic or cancer treatment.

  40. skeptvet says:

    Same issue as with your previous links (and the third link is probably not what you intended since it is about a very different subject).

  41. Pr says:

    Agree. I.have used neoplasene for systemic mast cell tumors with the results of my fur baby living another 6 years with good quality of life. After the first 2 vet visits,i removed the tumors anout 10 with the neoplasene salve myself.

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