Over the past several weeks promotion of the newly licensed Cuban anti-cancer medication Vidatox has been evident. The venom from the Cuban scorpion Rhopalurus junceus is the base for this supposed cancer treatment, and the manufacturer has received permission from the Chinese and Albanian governments to distribute the remedy in those countries. The treatment was previously only available in Cuba but they are now seeking licensure and distribution opportunities abroad, including, we must assume, Canada and Mexico (due to the US embargo, Vidatox could not be imported into the US). It remains, however, a dubious and dangerous treatment that is worth our skeptical attention and we must remind our governments and regulatory agencies that its sale should not be allowed.
There is research into the venom of R. junceus and its components, and it may indeed have anti-tumoral properties that deserve further research. This paper available on the Cuban digital library system Infomed, as well as PubMed, describes the effects of the venom on molecular and cellular systems, including mouse models. There are other papers to be found on Pubmed also describing the qualities of the scorpion venom, but this interesting research becomes immediately irrelevant when we look closer at the Vidatox product.
Vidatox is a homeopathic preparation at the 30CH potency. As such, it defies the basic principles of chemistry and physics that we all know well. We do not need to reiterate the poor reasoning of homeopaths here as homeopathy has been covered enough on this site for readers to understand its fantastical nature. The chance of the presence of a single molecule of any of the 5 proteins said to be the active ingredients in the product is extremely low. Even more, as this is an oral medication, the chance of the proteins making it though the gut would be zero, if they were even present.
A closer look, however, at the evidence put forward by the state-run Laboratorios Biológicos Farmacéuticos, or Labiofam, reveals information that is infuriatingly deceptive. The “evidence” page on the marketing website for Vidatox lists study after study about the undiluted testing of the venom of the R. junceus species as well as related scorpions, but makes no reference to direct testing of the Vidatox product. Even more, the only information resembling a study that I could find published is a phase IV trial protocol listed on the site of the international distributor of the product Pharmamatrix. This phase IV trial describes an open-label (meaning un-blinded) and uncontrolled post-approval test of the product; a standard procedure for any regular drug approved by the FDA or Health Canada. The catch is, of course, that there is no record of a published phase I, II, or III trial of the drug and in fact no record of any testing of the product on Pubmed, Google Scholar, or even on the Cuban Infomed server.
This is, sadly, not surprising from the manufacturer of a natural health product. Little Mountain Homeopathy, the bane of Canadian skeptics, is promoting Vidatox, despite it is lack of approval from Health Canada, for the treatment of cancer. The study listed on that site (without a reference) was presented at a recent conference put on by the manufacturer to support the launch of the international registration of the product, which had previously only been available in Cuba and was the source for medical tourism to that country for treatment of cancer. In this press release available on Infomed, several papers were presented to the Chinese government when seeking approval, but they appear to remain unpublished and in house information, unavailable for scrutiny.
What is most disturbing is the claim that Vidatox had already been tested on 10000 patients in Cuba, including 3500 foreign patients who had traveled to Cuba. This is very troublesome language in the context of drug testing. Prior to any drug being approved for use therapeutically, it must be shown to be efficacious. In the case of Vidatox, as is the case for most alt-med therapeutics, it was decided that it should work and it was given experimentally to anyone who would pay for it as a standard treatment. It is unethical for a physician to give an experimental treatment outside of an approved trial and it is doubtful that any institutional review board approved such treatment. The trial of 174 patients listed on LMH website is unavailable online and appears to be completely unconnected to any peer-reviewed journal. It is far too credulous to accept this study as proof of efficacy directly from the company in the context of what is essentially a product launch, and homeopaths espousing their scientific acumen should be vilified if they use this data to justify Vidatox’s use to treat cancer or its symptoms.
What is even more incomprehensible is the use of such a preparation at all, in the context of homeopathy, which purports to individualize treatment for a patient, and adhere to the “law of similars”. Labiofam used to produce the full concentration product as Escozul, which may have been shown in vitro studies to have cytotoxic effects (see above). With the “law of similars”, this means that the homeopathic prep should be used to protect against cytotoxic effects, not produce these anti-tumor effects like the mother tincture. As well, where are the homeopathic “provings” or “triturations” for Vidatox, and why is it appropriate to prescribe its use for everyone’s cancer given the supposed variability of a patient’s complete and holistic symptoms? It is nothing short of hypocrisy to promote homeopathy as treating the patient not the disease and then turn to medicines that are marketed to treat a specific disease. It belies the ideological back flips that homeopaths will go through to justify their system of medicine, and shows their treatment decisions to be not only externally inconsistent, but internally inconsistent as well.
Vidatox, Labiofam and Pharmamatrix have all ignored my email requests for the studies they purport to have to support the use of Vidatox for cancer treatment. Labiofam is a large pharmaceutical company in Cuba and produces mainstream medical products as well as non-medical lifestyle, cleaning and plastic-based products. They must have scientists trained in biochemistry, molecular biology, medicine and other disciplines required to produce such products. To promote what is, at the 30CH or 10^60 dilution, a very cheap drug to manufacture, and with in-house experts who would be terrible scientists not to realize the unsupportable claims of this drug it is nothing short of fraud and should be treated as such.
Labiofam and its distributors have been taking advantage of those suffering from cancer and the side-effects of its conventional treatment for years; the travel costs alone would strain the budgets of most people, and combined with individuals who do not have good insurance and who had already laid out tens of thousands of dollars for mainstream diagnosis and treatment of cancer, we have fraud at its worst: selling false hope to the disadvantaged. We must keep the product from being licensed in Canada and Mexico in order to prevent injury to those North Americans suffering from this already intractable disease.
*According to this investigation of the history of scientific publication in Cuba, the Infomed system, which is the primary system by which medical investigators share knowledge in post-soviet Cuba, exists without peer-review; it is only an information sharing system, so the competition of ideas which exists in mainstream publishing, even in open-access publications, does not exist to winnow out the bad ideas from the good.
Michael is a paramedic from Toronto Ontario and blogs regularly for skepticnorth.com. He is also a former co-chair of the Committee for the Advancement of Scientific Skepticism (CASS) at the Centre for Inquiry Canada and is endeavoring to create a new Canadian national skeptical activist group focused only on the promotion of science in society.