The Nobel Disease is a well-known tongue-in-cheek reference to the apparent tendency of Nobel laureates, who have obviously made substantial legitimate contributions to scientific knowledge, to develop strong irrational attachments to questionable theories or outright pseudoscience in their later years. The MD Disease is a variant strain in which ordinary doctors with real medical training and skills become champions of scientifically unsound theories or practices. All of this, of course, is just a way of pointing out why the argument from authority is a fallacy. Smart, educated, well-respected individuals, even with the best of intentions, are not reliably less susceptible to bias, cognitive dissonance, confirmation bias, or any of the mental quirks that lead us to passionately commit to dubious, even ridiculous ideas than the rest of us. The status or personal characteristics of a believer in any given idea is not a useful form of evidence in favor of the truth of that idea.
This phenomenon came to mind earlier this week when I was asked to look into a technique being promoted as a possible veterinary cancer therapy, the Nativis Voyager system, which is apparently the focus of a clinical trial, and some pretty optimistic promotion, by the accomplished and well-respected veterinary oncologist Dr. Greg Ogilvie.
It is difficult to find much information about this product, but it manifests many of the warning signs of pseudoscience. In particular, it is referred to by the company and Dr. Ogilvie as “revolutionary” and “ground breaking,” despite the lack of any substantive evidence to support this claim. And the emphasis of the research seems not so much to find out if the technology works but to find out how well and for which types of cancer: “Voyager is just beginning its voyage as we are beginning the process of identifying the cancers its most effective to treat. It seems to have a broad spectrum of efficacy while being quite safe.”
In a promotional Youtube video for Voyager, anecdotes purportedly showing dramatic improvements are presented, and claims are even made to suggest some patients might have experience complete remissions or a cure. I personally do not feel that contributing to promotional marketing videos for the company while conducting a supposedly objective, scientific clinical trial of that company’s product is appropriate. And the claims made are largely meaningless if they are founded solely on anecdotes, which are an unreliable guide to the safety and effectiveness of medical therapies for many reasons.
The plausibility of this device is not enhanced by the proposed mechanism described in the patent application submitted by Nativis. It is full of pseudoscientific nonsense such as this:
An aqueous anti-tumor composition produced by treating an aqueous medium free of paclitaxel, a paclitaxel analog, or other cancer-cell inhibitory compound with a low-frequency, time-domain signal derived from paclitaxel or an analog thereof, until the aqueous medium acquires a detectable paclitaxel activity, as evidenced by the ability of the composition (i) to inhibit growth of human glioblastoma cells when the composition is added to the cells in culture, over a 24 hour culture period, under standard culture conditions, and/or (si), to inhibit growth of a paclitaxel-responsive tumor when administered to a subject having such a tumor.
This appears to be a claim that one can somehow digitally record the curative properties of chemotherapy drugs in solution and then play them back to water, thus transforming the water into a therapeutic substance with none of the unwanted effects of the cancer drugs. Others have investigated such claims from this company and found more direct statements of this highly speculative and implausible idea:
Nativis has developed and patented a breakthrough technology that captures the unique photon field (signal) of active pharmaceutical ingredients (API), or drugs. . .Every drug molecule in a solution is surrounded by a photon field that contains information unique to the molecule. With Nativis’ technology, the photon field, or “drug signal” can be recorded and then replicated for medical treatment. Nativis has proven in preliminary trials that the drug signal – or photonic signature – mimics the original chemical molecule and can unlock the same biological processes as the original to treat diseases, such as brain tumors. With the technology, the drug signal can be reproduced rapidly and flawlessly, each time containing all relevant biochemical information encoded into the new therapeutic signal to drive a biologic reaction. . .
If this sounds vaguely familiar, that’ because it bears an uncanny resemblance to the theories of some homeopaths that the magical healing energy of homeopathic remedies can be digitally recorded and transmitted by telephone or other electronic media. And by an astounding coincidence (or perhaps not?), at least one of the patent holders and key figures at Nativis has previous professional connections with Luc Montagnier and Jacques Benveniste.
Dr. Montagnier is one of the classic examples of Nobel Disease, a co-discoverer of HIV who later became a proponent of homeopathy in both traditional and digital forms. And of course Dr. Benveniste was the author of a famous study in the journal Nature which appeared to show a real biological effect of a homeopathic solution on cells in culture. This effect, however, was later demonstrated to be an illusion due to improper blinding of study personnel, and decades of attempts to replicate it have proven unsuccessful.
Nativis has previously announced a revolutionary new cancer therapy and supporting research evidence which have, in the three years since, not emerged and which are no longer mentioned on the company web site, now devoted to Voyager. A history of claiming revolutionary breakthroughs without published scientific evidence to support them, followed by closing up shop, moving to a new state, and setting up an entirely new product based on almost the same unproven theories, this time for the veterinary rather than human market, is not the behavior of a company I would trust. Certainly, it is not a sound basis for a respected veterinary oncologist to promote the product and make rather strong, optimistic claims about its benefits, raising the hopes of pet owners and using scare resources in the always struggling domain of veterinary oncology research.
Despite his well-earned status in veterinary medicine, Dr. Ogilvie has shown sympathy towards implausible practices in the past. He has been a regular lecturer, and even the Keynote Speaker, at the annual conference of the American Holistic Veterinary Medical Association (AHVMA). This is the same organization that has encouraged and promoted many ridiculous practices at its annual meetings and which recently mounted a major effort to defend homeopathy as a legitimate and scientific therapy. He is also on the advisory board of a “holistic” supplement company along with many of the most prominent spokespeople for homeopathy, so-called Traditional Chinese Medicine, and other alternative veterinary practices. This might explain why, despite his intelligence and unimpeachable credentials as an oncologist, he seems willing to jump on such a ramshackle bandwagon as the Nativis Voyager system.
Of course, the proof of the pudding is in the eating. If convincing and replicable clinical trial evidence eventually emerges showing a significant therapeutic effect for the Voyager, I will be thrilled to have a new and better cancer therapy to offer. If, as I expect is more likely, such evidence never emerges, and this “revolutionary” product goes the way of Dr. Sanden’s Electric Belt, I will be disappointed; both because of the failed promise of a better treatment for my patients and also because of the damage to the credibility of a brilliant veterinarian whose guidance I have often followed in my career.
Hmmm, thorne-vet’s products, “sold through veterinarians only”, as if their supplements are so effective they can only be sold through vets. Their pricing is all over the place, and as usual, non-affordable to clients even if they believed in the miracles.
I’m truly disappointed to see Dr. Ogilvie associated with any kind of woo, and I’ll admit, surprised. I hope he doesn’t go all woo on VIN, that would be a tragedy.
Greg was the hills n/d cancer diet promoter on vin wasn’t he? The joke among the other oncologist was that the letters stood for the” no data “diet.
Art Malernee Dvm
My concern would be the consults followed by recommendations for this junk, and that the practitioner wouldn’t take the time to evaluate the evidence before “prescribing” to the client. Maybe this is only a private venture for Dr. Ogilvie, but the association and promotion might be telling.
I loathe vets who push unproven alt med to the owners of pets with cancer.
Your Nativis patent reference is not correct. I saw the same reference on Lowe’s site, “In the Pipline”. I suspect that’s where you got it from. Dr. Ogilvie is using a non-invasive medical RFE device in his trials, and not an aqueous solution. The RFE device used by Dr. Ogilvie appears somewhat similar to RFE technologies manufactured by Medtronic, GE, Siemen’s, etc. One example is the Novocure device undergoing trials at UCSD. Dr. Ogilvie (and the Special Care Foundation) has a reputation for competent, well-designed research studies with high compliance. It’s possible you might be mistaken on this one.
Certainly it is possible I am mistaken. I have asked Dr. Ogilvie to comment elsewhere, though I haven’t yet had a response. I have great respect for Dr. Ogilvie, which is why I am concerned about his association with a company and a product that exhibit so many warning signs of pseudoscience.
The previous patent application which I referenced was for a product produced by the same company and initially advertised in much the same way as the Voyager system, as a “revolutionary” cancer therapy, though for human use. While the specific patent filing is for a different application, it appears to reference the same fundamental principles. The following reference to a Nativis trademark filing for the Voyager system suggests as much:
If the RFE signal “played” to the tumor by the Voyager device is derived from “recording” supposed emissions from solutions containing chemotherapeutic drugs, then that is certainly no more scientifically plausible than is using such signals to transform water into a chemotherapeutic agent.
Similarly, another patent the company holds, which may be related to the principles of the Voyager system, suggests one can record signals from drug-containing solutions and play them back to mammalian tissues or live animals to achieve an effect similar to that of the drug:
This same patent application describes an experiment involving playing signals recorded from a chemotherapy solution directly to mice injected with cancer cells to evaluate the effect of these signals on the mice (though I have not yet found a published paper based on this study in a peer-reviewed journal, if it exists):
This sounds an awful lot like the Voyager system, and it is clearly based on the same principles as the previous product, which appear to be pretty implausible, though I admit to being no physicist. So while I am not sure I have found the specific patent application for the Voyager system, the device certainly seems to be based on a dubious proposed mechanism, one which may be associated with the ridiculous notion of “digital homeopathy” given some similarities in the terminology used to describe the theories and possible professional associations between the Nativis leadership and proponents of the digital homeopathy concept.
All of this is based on very scant information, of course. The company does not appear to have made more detailed information available through its web site or in the published scientific literature. I may very well be mistaken about the legitimacy of this product, and for the sake of both veterinary cancer patients and Dr. Ogilivie, I hope that proves to be the case. I don’t mind being wrong in a good cause. But I do feel the situation is suspicious enough that it is worth calling attention to, as I have done.
Nativis’ device seems to bear only superficial similarity to the devices you mention.
Tumor treating fields (TTFs) being used in the Novocure product are nearly magical in my opinion, but casually browsing the literature you can see that the mechanism is plausible. Peer reviewed papers on the topic do things like discuss finite element analysis, I can find testimony from reputable scientists and a number of reviews by authors not connected with the Novocure product. Nativis has none of this.
Nativis’ “technology” was “invented” by the four founders, none of whom have scientific credentials or education of any kind. Apparently only one has a college degree and that is in accounting! In the 90s the CEO and his wife the COO (former realtor and retail sales clerk respectively) met the notorious Jacques Benveniste, who appears to be the basis for all of this. They found investors and ran with it. Good for them. Personally, I have no problem with it, people can invest in whatever they like. There are lots of very profitable homeopathic ventures. Where I have a problem is calling this “pharma” and talking about “clinical trials” for desperate human (and canine) patients. That is just wrong. Nativis should promote themselves as what they are, a naturopathic “alternative”, not unlike having a coffee enema. Apparently Dr. Ogilvie believes in a lot of this sort of thing, make of that what you will. Whether it works or not will remain to be seen but if people want to believe in magic water and miracle vitamins, so be it, just call a spade a spade.
Is there really a use for this technology? At the last conference I was at a few weeks ago the therapeutic laser people pretty much have every disease cured for us. 🙁
Good point! 😉
The Ogilvie-Nativis (for lack of a better descriptor) study has been going on since at least July of last year. In 8 months of his first hand observations, Ogilvie hasn’t determined the Nativis technology is crackpot? Perhaps we on the outside don’t have all the facts, let alone understand what they are doing and how they are doing it? An awful lot of reflexive negativity bubbles to the surface whenever these Nativis people are mentioned. I just find it interesting that no person, organization, or lab has decided to out them after having had business and/or scientific dealings. And we’re talking about a fairly large number of people and establishments over the past decade. Do they know something we don’t?
I have communicated with Dr. Ogilvie, and he has indicated that confidentiality prohibits him from discussing the Nativis technology in detail. No pre-clinical or proof-of-concept research appears to have been published on this subject, and there is no information available beyond the press release and the patent applications. This leaves us without much to go on, so obviously no judgment about safety or efficacy can yet be made.
That said, the proposed mechanisms discussed in the patent documents are implausible and would require fundamental re-assessment of the basic physics and pharmacology upon which much of modern medicine is founded. This is possible, but it will take an enormous amount of high quality data and very transparent methods to demonstrate this. And it is not the general practice to proceed to Phase I/II clinical trials in the absence of preclinical research to support the concept, so if this has been done why not publish it? Certainly, the company has an interest in keeping the details of its technology secret in order to make a profit and defend against competition, but there is no obligation for the scientific community to take their word for anything here. Extraordinary claims still require extraordinary evidence even when intellectual property is involved.
And the history of the company does not inspire confidence. Similar claims of imminent breakthrough have not materialized. And some of the folks involved are also associated with some pretty dodgy ideas (e.g. digital homeopathy).
So you are correct there is a lot we don’t know, and we must reserve judgment. However, the fact that we don’t know much is due to apparently deliberate efforts on the part of Nativis, so they bear some responsibility for our ignorance. And there is no “reflexive negativity” involved here. Saying something sounds implausible and unlikely is perfectly consistent with an open-minded, evidence-based approach. If the company and Dr. Ogilvie respond with compelling evidence, as hopefully they eventually will, I will be first in line to start using the product. If not, I will continue to be respectfully skeptical, as all scientists should be.
I agree, respectful skepticism is the professional responsibility of the entire scientific community. My observations were aimed more at the unbelievably hostile reception Nativis has received in general within certain communities, not necessarily your own posts.
In my mind, this is not the open and shut case that the more hard-line (perhaps rabid would be a better term) commenters would suggest. Certainly the issues you’ve brought up are very real, and disconcerting. I have no idea why this company has behaved in the secretive/obscurity-seeking manner it has. However, this is clearly not some fly by night magic water factory. We’ve all seen the names (corporate and individual) Nativis has been associated with – and continues to be associated with – over the years. These associations suggest something very different is going on than the rabble rousers would like to believe.
Personally I think something is going on behind the scenes there in Seattle (and San Diego previously) that we have little conception of. Perhaps it is something revolutionary, perhaps it isn’t. But the names associated with Nativis don’t seem likely to put up with magic water hoaxers for any longer than is necessary to see the trick that first time. Many people have apparently seen something behind the curtain, and have decided to stick around.
That’s what’s frustrating, to me at least. This is in the internet, after all, I’m aware that even the scientific community has its share of internet tough guys/knuckle draggers. But I take a look at the big picture surrounding this strange little company and think, this is the sort of strange that borders on interesting.
I guess I still enjoy the mystery. *shrug*
A number of respected names supposedly advise the company but the reality is none of them are named as inventors for any of the “technology”. The entire “team” has absolutely no scientific credentials or education whatsoever. The idea that such people will “revolutionize medicine” is beyond far fetched. Universities and hospitals undertake all sorts of studies that are paid for by all sorts of companies, including homeopathic ventures. Most accomplish nothing (sadly). Legitimate pharma companies announce the successful published results of a study not the start of one, because most lead nowhere. This is why the majority of pharma startups burn through mountains of cash and fail. For example, Apollo Hospitals (India) did a “clinical trial” for Herbalife recently. Herbalife, the “I’ve lost weight, ask me how” people. Nativis claimed they were about to start “Human Trials” in 2010, release papers and submit to the FDA, etc. What happened with that? Their product at the time was a “magic water” and their work is based on that of Jacques Benveniste, who has already been discredited. He is apparently referenced in some of their patents. They also have a history of creating slick marketing videos. They apparently paid for an infomercial in 2010, talking about their water drug “Digitax”. Good luck finding that anywhere online now! 3 years later and they have this video of Dr. Oglivie talking about “beaming healing energy” into dogs. They are secretive about specifics but happy to market generalities to investors. What happened to the human trials and accompanying papers from 2010? A distant memory. Lets wait for some clinical data to be published and see what the FDA has to say. Prepare to be very patient! In the greater scheme of things this is a tiny little company which a handful of people (mostly its investors) are aware of. I bet it stays that way and will remain in business for exactly as long as it can continue to find new investors who know nothing of pharma. It would be interesting to see if any pharma VC firms have invested in this, or how much money these advisors have put in. Has Dr. Ogilvie been paid or if he likes this so much, has he invested? All good questions for potential investors. Again, I have no problem with Nativis or Herbalife (which is good enough for Carl Icahn). My issue is calling this pharma when it is (at best) homeopathy. I wish the company, its investors and most of all any patients in its “clinical trials” (should they ever occur) the very best of luck.
Yes, there’s certainly far more we don’t know than we do know. I hope eventually the real nature of what’s going on becomes apparent, and that the process and the data concerning it are presented publically in the usual way of scientific discoveries so the entire community can evaluate them.
The association of individuals with the company is a bit of a mixed bag. Dr. Ogilvie is great oncologist and an important figure in veterinary medicine, and he deserves to be taken seriously. However, his association with groups like the American Holistic Veterinary Medical Association does not give them greater credibility, and sadly it threatens to tarnish the reputation he has earned. The tenuous connection to Luc Montagnier, if it proves real, would be a mark against the theories being advanced since, despite his own significant contributions, he has advocated for some thoroughly discredited, and somewhat similar, propositions before (Montangier may or may not be involved with Nativis. I can find no acknowledged connection, but I have also been told repeated that a Nobel Laureate is associated with this work, and many of the figures at Nativis have professional connections to Montagnier or institutions he’s worked at. And there is a striking similarity between the digital homeopathy notion and the purported mechanism of the Voyager system). So it’s not clear to me if the individuals involved necessarily support or undermine the credibility of the project.
As you say, mystery makes for good narrative, so I’ll keep watching to see what develops. Thanks for your comments.
Skeptvet, curious if you have heard anything more about Ogilvie’s trials (or the company in general) lately?
The original article, and the discussion on VIN with Dr. Ogilvie, was posted just last month, so I wouldn’t expect any news for quite some time. If there is a formal, organized clinical trial underway, I would imagine that could take a year or two to result in published data, if that happens at all. In the past, the company has promised imminent publication and not delivered, so I’m not optimistic. If you run across any additional infomrtaion, please share it with us here!
The first clinical trial involving Voyager:
“A Feasibility Study of the Nativis Voyager System in Patients With Recurrent Glioblastoma Multiforme (GBM)”
ClinicalTrials.gov identifier: NCT02296580
Have a nice day
Yes, I’ve seen this. It will be interesting to see what is done with the results. It only involves up to 11 patients and, as far as I can tell, is an unblinded and uncontrolled safety study, so it will almost certainly appear positive. It seems likely that will be reported as proof the therapy works and should be used for pets, even though additional trials that are larger, blinded, placebo-controlled, and conducted in the species in which it is intended to be used are required to show this.
I doubt the intent of this -human trial- is to facilitate the device’s use on pets. My speculation is that animal trials and human trials were/are dual track, and that the animal treatment aspect has been sidelined or abandoned for unknown reasons. The human trial has seen regular updates, and slow but steady expansion, while the animal side of things has been dormant for over three years.
The safety study has been expanded to 64 patients in the United States, with 11 more in a trial expansion in Australia. Not particularly small for a safety study. Also just to note, it would be highly unusual for a trial of this type to involve placebo controls. As far as I am aware, in the presence of cancer, placebos are really only used in treatments that attempt to control or relieve symptoms. I wouldn’t expect much in the way of placebo-controls during this or future trial phases, and that wouldn’t be in any way unusual.
I’m not sure what human trial you are referring to. Dr. Ogilvie is conducting a trial in dogs, which I mentioned in the post. Extrapolation from human trials is common in veterinary medicine when we don’t have direct evidence in the species we treat, but in this case it appears Dr. Ogilvie and the company are working with veterinary patients.
As for controls, the usual basis for comparison in an oncology trial is standard care vs standard care plus the novel therapy, and often there will also be a standard care plus placebo group, depending on the number of patients that can be recruited. Such a design presents no ethical problem and provides better quality evidence, and for common cancers it should be possible to use a placebo. Without doing so, the risk of bias and confounding are higher and the results less reliable.
Also remember: this is a device and not a drug… So requirements are not the same even with the stated “fact” the device enables a “drug like response / interactions” –as it would be, this would require a whole new category –a device that mimics a drug :-)…
On the website for Dr. Ogilvie, it lists the “pet” trial and attempts to describe the mechanism of action: the one described looks very much like the one for Novocure or Optune device.
“Study Title: Voyager, a non-invasive anti-cancer medical device. Voyager emits specific low level radio frequency energy [vs. electrical currents] that blocks cancer cells from dividing by blocking the dis-assembly [sic] of microtubule, leading to aberration, multi-nucleation and interruption of mitotic spindle activity during cell division, at metaphase”
This is nothing compared to the Nativis “listed” mechanism of action:
“Every molecule contains a unique electromagnetic radio frequency energy (RFE) potential. Using superconducting quantum interference device (SQUID) technology, we have developed a technique to specifically record the RFE of a given molecule, and then expose living tissues to the specific and precise oscillating magnetic RFE field of that molecule. We discovered that exposure of a molecule’s unique RFE through a transmitting electromagnetic coil device can specifically impact biological systems as if the authentic molecule were present. We have recently acquired the RFE signals of siRNA oligonucleotide molecules. Here, we demonstrate for the first time that disruption of signaling pathway using ultra-low radio frequency energy (ulRFE™) can significantly inhibit target mRNA and protein expression. EGFR and PLK1 blockade by ulRFE caused a 30-70% reduction of mRNA expression and ~40% protein expression vs. control treated cells. Moreover, using RNA microarray and protein array we validated specificity of cellular EGFR knockdown. Finally, we demonstrated that RFE-mediated knockdown of EGFR and PLK1 was associated with decreased U87 GBM cell proliferation. These are the first results to demonstrate that specific ulRFE signals can be used to knock down specific gene products, impacting key pathways associated with cancer signaling.”
And the Novocure:
“…works by creating low-intensity, alternating electric fields that disrupt cell division — confusing the way chromosomes line up — which makes the cells die. Because cancer cells divide often, and normal cells in the adult brain do not, this in theory mostly harms the disease and not the patient.”
The lease on the Novocure device is about $700/day, or about 252,00 annually…