Neoplasene: A Danger to Our Pets

The first article here was written about two years ago. Since that time, a case report illustrating some of the dangers of this product has appeared in JAVMA, and the second article discusses that.

A reader recently drew my attention to a form of CAM that is particularly dangerous and irresponsible but that like the mythological Hydra manages to raise its ugly head again and again despite efforts to kill it. Its latest incarnation in the veterinary field is as Neoplasene, yet another example of how CAM can achieve success through marketing unsupported by any evidence of real benefit.

According to the marketing materials, the ingredient in Neoplasene is “one of the prominent candidates deserving of the wonder drug designation.”(1) Pretty exciting, no? The promoters go on to follow the well-traveled road of CAM marketing, explaining why scientific medicine has missed the obvious truth, and only the iconoclastic promoters of the “wonder drug” can see it. “[Pathologists] clearly have not made reliable sense out of biopsy analysis…they just aren’t up to the task of reliable diagnostics.”(1) Of course, that doesn’t really matter since “this author…believes that inordinate attention is paid to diagnostics because, until now, little could be done to eliminate neoplastic disease so instead of treatment mainstream protocol has been to study the symptoms a lot and treat the disease a little.”

Oh, instead of studying the disease, we should be treating it!!! Gosh, how could we have been so blind? Oh, maybe because of “the barriers to the development and use of really effective cure oriented chemical treatment of neoplasm which are intertwined with political, economic and regulatory realities.”(1) See where this is going? “Cancer treatment and research are big business. Tremendous resources of facilities, personnel and funding are allocated to address education, equipment, real estate, personnel and patented designer drugs. Big organizations have momentum; they do not change direction easily or quickly…It has been viewed by drug developers that patentability may not be attained on some pharmaceuticals.”(1) So we in mainstream haven’t seen that “these alkaloids clearly attack neoplasm preferentially” and “this fact has been known and largely ignored by pharmaceutical researchers for nearly two hundred years” because of institutional inertia and the fear that we won’t make back the cost of developing such a miraculous cancer cure.

Such clichés seem as obviously ridiculous and unbelievable as the fake moon landing sort, yet they are just as persistent, and even more dangerous in that they drive people away from real medicine and into the arms of CAM.

The Neoplasene marketing materials go on in some detail, using testimonials and sloppy semi-scientific verbiage to clearly claim that the product treats, and even cures cancer, despite a few lame disclaimers to the contrary. And what is this miracle elixir the bloated bureaucracy of scientific medicine has overlooked?

Neoplasene is a derivative of bloodroot, which is one of several caustic herbal products known as escharotics(2). When applied topically in sufficient concentrations, these derivatives burn the flesh and cause tissue necrosis, often leaving thick scabs called eschars, and tremendous local devastation of healthy tissue. The danger of these products is well-illustrated by case reports in the scientific literature(3,4). Though the promoters claim the chemicals somehow recognize cancerous tissue and spare healthy tissue, there is no clinical evidence of this. Some preliminary in vitro research certainly shows the chemicals can kill cells. And there is some limited evidence that they may even be better at killing diseased cells than healthy cells in culture.(5) But when you smear the stuff on your skin to “draw out” the neoplastic cells and leave untouched the healthy tissue, you’re likely to wind up with a gaping hole and a lot of plastic surgery to look forward to. If you’re especially lucky, though, some deeper neoplastic cells will be left behind, and the provider of the salve can then explain why the recurrence or metastasis of your cancer despite its apparent removal by the product is not their fault. Probably chemicals in the water or something.

The promoters of Neoplasene acknowledge, while downplaying, the risk of tissue damage from topical use of their product. They say you should “expect a wound to manage. It size will be in proportion to the extent of the tumor and the amount of Neoplasene compound applied…expect some scarring.”(1) The relevance of their earlier claim that “bloodroot chemicals and Neoplasene are simply not escharotics. They do not burn flesh” isn’t entirely clear, since they seem to be arguing that causing tissue to die and slough off leaving a bloody great hole is fine, so long as it’s through some mechanism other than chemical burn. Hmm.

The FDA has actually gone so far as to ban importation and marketing of bloodroot and other escharotics for cancer treatment, an all-too-rare example of government challenging “Big CAM” which further illustrates how frightening these products are(2). And yet these products are easily found on the Internet and used by a depressingly large number of CAM-oriented veterinarians, likely with a genuine belief that they are curing cancer through a miraculous means ignored by the corrupt and blind medical-industrial complex. I can’t say whether the active use and promotion of such products in the veterinary field, free from government sanction, is due to a loophole in the law or just the fact that the Hydra has many more heads than the FDA has paid investigators.

The only FDA-approved use of a bloodroot derivative, sanguinarine in dentifrice, is no longer popular as it proved to be a significant risk factor for leukoplakia, a potentially pre-cancerous disease(6). And while removal of low-risk, superficial skin tumors can be accomplished with escharotics, there are safer and more effective methods. Far from being a “wonder drug,” these products are an inappropriate and dangerous substitute for real scientific diagnosis and therapy of cancer. And contrary to the nonsense about the venality and blindness of the “cancer industry” and their own great insight, the promoters of Neoplasene are simply the latest head of the corrosive hydra that is bloodroot derivative cancer salves.

1. Fox, T.S. Discussion of and clinical guide for: the treatment of neoplasm, proud flesh and warts with sanguinarine and related isoquinoline alkaloids. Buck Mountain Botanicals, Inc., www.neoplasene.net, 2008.

2. Barrett, S. Don’t use corrosive cancer salves (escharotics); Quackwatch. www.quackwatch.org, 2009.

3. McDaniel, S., Goldman, G.D, Consequences of using escharotic agents as primary treatment for nonmelanoma skin cancer. Arch of Dermatol 2002; 138:1593-1596.

4. Moran, AM., Helm, K.F. Histopathologic findings and diagnostic difficulties posed with use of escharotic agents for treatment of skin lesions: a case report and review of the literature. J Cutan Pathol 2008; 35:404-406.

5. Ahmad, N., et al. Differential antiproliferative and apoptotic response of sanguinarine for cancer cells versus normal cells. Clin Cancer Res 2000; 6:1524-1528.

6. Mascarenhas, A.K., Allen, C.M., Moeschberger, M.L., The association between Viadent use and oral leukoplakia-results of a matched case-control study. J Public Health Dent 2002; 62:158-162.

 

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.

Comments




  • Just wanted to say that we're using Neoplasene and it's been WONDERFUL! It's prolonging our dog's life. We understand that he will be on it for the rest of his life. It's not a cure, it's a treatment. He was diagnosed with Histiocytic Sarcoma, a very aggressive and always fatal cancer. He was treated at UPENN and we were told to expect no more than 4 months. It's now been 7 months and Indy is happy and cancer free as of this week! He had an x-ray and ultrasound done and they can't find any signs of cancer! No side-effects and we have a very happy and playful puppy.


    UPENN is an excellent Vet Hospital/School and of two Indy's doctors there are now paying attention and following his progress on this drug and so far they are VERY impressed.


    When we considered using Neo, we did our research and printed off more than 100 pages of case studies and articles about the drug. We love our pet and we are more concerned about the QUALITY of his life than the quantity. We agreed that if we started seeing negative side effects, we would stop using it. None ever developed. He's a happy, playful and energetic dog.


    I'm not a doctor and I don't have a degree in biochemistry, but I have found and read many amazing success stories that involve this drug. I think it's worth serious consideration. It's been a better alternative for us than chemo, which we were told wouldn't work well for this type of cancer anyway.


    At some point, people need to realize that we don't know, what we don't know. Something is missing from the research above, because this is working for us and doctors can't give us another explanation. I'm sure God loves my dog, but it's more logical to believe that the drug is responsible for his remission.


    It's been a blessing for us and I hope it continues to be a blessing a for others in our situation and I hope someday you experts figure out the real what and why. Best Wishes.

    JenniferM, 2 years ago | Flag

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