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Nativis Lives the Life

I sort of hate to bring them up again, but a reader sent along this link to a story at Geekwire, all about how there’s a Seattle company has raised $10 million for their new cancer-fighting device “that uses electromagnetic fields to mimic the effects of drugs” and yeah. . .it’s Nativis again. Here’s the last time I wrote about them, a couple of years ago.

I bring them up because I feel sure that the people who ponied up ten million don’t quite realize the extent to which the company’s claims raise the eyebrows of actual scientists. Nor did the writer at Geekwire, apparently, because the article has “explanations” like this:

In other words, the system works by detecting subtle changes in the electromagnetic fields that surround molecules, known as a molecule’s ultra-low radio-frequency energy (ulRFE) profile. These small charges are important as they are how molecules in the body interact with each other.

After collecting information on a cell’s profile, the company’s Nativis Voyager device can then single out specific kinds of molecules and alter their profile to have the same effect a drug would have when interacting with that molecule.

Right. This is more or less authentic frontier gibberish, a homeopathy helmet with a battery pack. I’ll give them credit for persistence, because the company has been pushing this for years now. Back in 2010 they were making noises about suing me because I (and the commenters here) kept saying that we could not see any way this technology could work. Back then we were promised all sorts of groundbreaking publications that would convince the world, and you won’t be surprised to hear that none of those have materialized.

Well, OK, there is a paper at the “Open Journal of Biophysics”, but that’s the thing. What the investors (and the occasional journalist) might not be grasping is that the effects Nativis is claiming are not things that should be scraping into some bottom-tier journal that no one’s ever heard of. If these things are robust and reproducible, the inventors should be out winning Nobel Prizes and astonishing the scientific community. I mean, they claim that a radio frequency signal can do the same thing as drug molecules in solution, and that each drug has a specific RF signal, which can be recorded and played back at will for therapeutic effect. That makes no sense to me at all, but if it were real, it would be revolutionary to say the least.

In case you’re wondering, the glioblastoma patient that was mentioned in that 2015 post as trying the Voyager device died a few months later, which is sadly right on schedule for the condition. Pretty much all GBM patients die very soon when the disease gets to that stage, and I can only note that my own belief is that wearing the Nativis Voyager headband neither accelerated nor slowed this particular patient’s disease in any way whatsoever. I await, with great interest, the actual clinical data that the company is apparently generating. That Geekwire article says that they’re also looking at other cancers, arthritis, and chronic pain, but that these trials are still “testing for safety”, which statement I find grimly amusing.

Well, ten million dollars. And clinical trials at a whole list of reputable – or formerly reputable – hospitals and health centers. And talks with an unnamed Japanese company. And an “evaluation agreement” to study Nativis’ device in agricultural applications, of all things. They’ve come quite a long way for a company whose scientific basis tends to make people roll their eyes or burst out laughing – I’ll give them that.

65 comments on “Nativis Lives the Life”

  1. SedatedFMS says:

    hahahahahahahahahahahaha hahahahahahahahahaha hahahahahahahahahahahaha *cough*

  2. steve says:

    Wait a minute, I thought electomagnetic fields CAUSED cancer. Don’t cellphones cause brain tumors? Don’t electrical power plants induce cancer in everyone living near them? These guys need to be made aware of the dangers!!!!

    1. MTK says:

      Not if at the right frequency that is properly tuned in.

      Get with the program, Steve.

      1. Chuck says:

        Where’s my &^%$ space blanket!

        1. Big Freddie says:

          I think you mean tinfoil Chuck…right reagent, right job…

      2. PharmaPatent says:

        Am I the only one currently singing “What’s the Frequency, Kenneth?”

        1. Daniel Jones says:

          No, sir. You are not.

  3. MTK says:

    This from the one link describing the clinical trial:

    “NAT-101, a first in-human study, will evaluate a total of 64 patients, 32 receiving Nativis’ Voyager treatment as monotherapy and 32 patients receiving Voyager in combination with chemotherapy. The primary outcome is safety assessed by the incidence and evaluation of any serious adverse events through follow-up. Clinical utility will also be assessed by progression free survival at six months as the primary endpoint and by overall survival as a secondary endpoint.”

    A) How is this ethical? So half the patient population (recurrent glioblastoma) is not going to receive chemotherapy, but only the experimental therapy?

    B) Shouldn’t a patient group using chemotherapy as monotherapy be the appropriate control group?

    Not a clinical oncologist, so is this how a first in human study of this type is normally conducted?

    1. Steve says:

      No, all clinical trials require that patients receive standard of care in addition to the experimental drug.

    2. Derek Freyberg says:

      If you look at the ClinicalTrials.gov entry for the trial, you’ll see that participation is limited to people who have failed or are intolerant to the usual therapies for GBM (radiotherapy or temozolomide), meaning basically that they are waiting to die of their GBM.
      It is possible to conduct a trial in such patients without a comparison to “standard of care”, because essentially there is no standard of care. So the trial is OK ethically, though I don’t know how they would do Voyager + chemo, when there is no standard chemo at that point: they are comparing one experimental therapy to another, and I’d guess that the people who are receiving chemo are going to be receiving different drugs for lack of a standard treatment.

      1. David Young MD says:

        But still. As a clinical oncologist, I would say that the usual phase III study for patient who have relapsed or failed first line therapy could be done in a few ways. A) the following two arms 1. second line standard therapy (Avastin, in this case), 2. second line therapy with Avastin plus the investigational Nativis therapy. And if the study is directed towards patients who have failed both Radiation/Temodar and Avastin, the treatment arms would be 1. “Best supportive care” vs. 2. Best supportive care plus Nativis. Or, the FDA might allow for third line treatment 1. “Treatment of choice by oncologist (including BCNU / Procarbazine / vincristine) vs Nativis. There is no way that the study would be 1. Nativis vs 2. Nativis plus chemotherapy. Such a study would be done only to find the benefit if chemotherapy.

  4. Dionysius Rex says:

    Surely the trial should be testing Nativis’ Voyager with and without batteries installed? So long all the machine makes all the right flashing lights and noises of course!

  5. Rule (of 5) Breaker says:

    Does this thing have a frequency for ethanol? That would would be pretty sweet.

  6. David Antonini says:

    I thought the Nativis thing was satire, akin to Palin’s candidacy (if you weren’t paying close attention, and lived outside the US, you’d be forgiven, or at least I’ve asked for said forgiveness, for thinking Palin and Tina Fey were the same person…)

  7. anon says:

    I believe that there is an FDA approved treatment for glioblastoma that uses electromagnetic waves. See https://www.optune.com/therapy

    Supposedly, the treatment is supported by clinical trial evidence.

    The theory behind it is remarkably similar to the one that led to the discovery of cisplatin (although in that case theory was wrong, but the result was right)

    1. anon says:

      Yes – made by Novocure. Hasn’t gotten much traction commercially (no one believes the magic hat, for some reason), but the long-term data are pretty convincing. Doesn’t work by mimicking a drug, though… rapid EM fluctuations disrupt mitotic spindle formation, eventually cause apoptosis. Apparently different cell types have characteristic frequencies that’ll target them, so you don’t destroy healthy tissue at the same time.

      1. zero says:

        Now that’s a plausible mechanism. By that I mean it doesn’t sound completely impossible or violate the known laws of physics. One could think of it as being a bit like a microwave tuned to shake up specific cells. Contrast with the Nativis craziness.

      2. David Young MD says:

        It hasn’t gotten much use among oncologist because not just any oncologist can use it. You have to have special credentials to be able to fit and adjust the headband so that it exerts its electromagnetic influence at just the right location in the brain. Few radiotherapist have obtained those credentials, perhaps thinking that the treatment doesn’t do that much. We did get a rep come by a few weeks ago to tells us about the Optune treatment. Yes, in the controlled study the treatment arm did better than the observation arm.

  8. Lane Simonian says:

    All kidding aside, frequency may be the key to whether electromagnetic exposure is beneficial or harmful. That’s probably why there is such widespread variation in cell phone studies: everywhere from it increases the risk for brain tumors to it is perfectly safe. The following is for electromagnetic fields and neurodegenerative diseases but you can see the same seemingly contradictory findings and a possible explanations for them.

    https://www.hindawi.com/journals/ijcb/2012/683897/

    1. steve says:

      No, the reason that there are contradictory data is because even for those claiming there’s an effect it’s at such a low percentage as to be unmeasurable with any degree of accuracy. There is a lot of nonsense published by people who don’t understand statistics.

    2. Dr. Manhattan says:

      You do know that the article is in a journal by Hindawi Publishers, which is on several lists of predatory journals? It costs authors $750 for “processing” and they just had 100 of their “journals” delisted by ISI. We’ve had the predatory publisher’s discussion here before…

  9. anonymous says:

    I am an organic chemist/Medicinal chemist by training and am appalled at science practiced at Nativis. But, not long back I watched American Experience @ local PBS station on Nikola Tesla. His work in the area of alternating current hypothesis in the face of legendary opposition from Edison (DC fame) was the talk of his day. When an electrical engineer Marconi known for his pioneering work on long-distance radio transmission across Atlantic came into being Tesla challenged him that those ideas were his and later on Marconi’s patent discovery for his discovery was invalidated. Tesla went to New York trying to find investors for what he thought would be a viable system of wireless transmission! We know now how the microtower work these days for cellular communication! But then Tesla went crazy and Nativis people are almost there!

    1. Sean Fearsalach says:

      They laughed at Tesla, they laughed at the Wright brothers . . . . And they laughed at Koko the Clown

  10. cynical1 says:

    So, if you invert the phase of the Rf signal 180 degrees, do you get the activity of the opposite enantiomer if the drug is chiral? Inquiring minds want to know.

    The other thing that comes to mind is that there seems like there would be an awfully easy way to prove this works rather than in terminal cancer. Instead, just use THC as their drug versus taxol. No need to resort to glioblastoma patients. Find some stoners for a phase I trial, turn the device on, and if they get stoned, get the munchies and immediately start downloading Grateful Dead bootlegs, then the device works. If they start streaming Adele, chances are it’s a sham. Wouldn’t that be easier and cheaper than what they are doing? And I don’t see any ethical violations with this sort of trial. But maybe I’m missing something. After all, I thought Voyager was a Star Trek series.

    1. Me says:

      Gold star award for fairly decent science proposal that is also funny as **%#

    2. flblbl says:

      The first ever chemistry paper where the results will be expressed in vk.me download history stoner music percentages. Love it ! But of course, any individual with a particular taste in stoner music while sober should be considered an outlier and accounted for.

  11. DCRogers says:

    I wonder if they charge for participation in the clinical trials? That seems to be the latest scam drug discovery business model…

  12. Barry says:

    Of course every drug has an rf signal (several actually); we call them NMR spectra. They have nothing to do with Nativis’ therapeutic claims.

    1. Anon says:

      So if we eat the NMR spectrum of the drug we get the same effects?! Or do we have to translate it into a song like that unicorn thing?

  13. Chrispy says:

    As someone who struggles to make actual drugs, I do not find the kind of breathless coverage provided by the likes of Geekwire to be amusing. This is a damn difficult business, even if you are rational. The venture capitalists seem to have dispensed with even trying to understand the science, and the pool of funded research is diluted by irrational plays like this one. The opportunity cost is real.

    1. fajensen says:

      That’s our career problem right there. Business would be so much more rewarding if one could all skip that tedious work which is bounded by Physics and Stuff and just straight-up lie and bullshit instead:

      Behold the ADE-651 – http://www.bbc.com/news/uk-29459896

      Just need to keep repeating the mantra: “Sure some people got killed … but they were suckers anyway” and eventually Epiphany will come together with millions in sucker money. .

  14. Jeff says:

    “…each drug has a specific RF signal, which can be recorded and played back at will for therapeutic effect.”

    Reminds me of an anecdote from John Clark’s “Ignition”, in which a team of rocket scientists tried to make a motor burn properly by aiming loudspeakers at the thing, blaring the noise of a running rocket engine (trying to shame it into working, as he surmised).

    1. aairfccha says:

      That’s not entirely crazy if your rockets malfunction due to acoustic issues like combustion chamber resonance – but the sound recording probably wouldn’t work anyway as it is the combined vibrations of everything rather than of key parts.

  15. Jim Teason Cromey says:

    What’s the frequency, Kenneth

  16. Anon says:

    Honestly, blame (and change) the laws, not the companies that exploit them. Because for every company you manage to embarrass into submission, 10 more companies will pop up, and none of those will care.

    1. Pennpenn says:

      Nah, I’m totally down with blaming the company, though I will agree that the laws should be changed. Groups like Natavis know exactly what they’re getting in to with scams like this. Exploitation of a system or trust is almost always a deliberate act, and that kind of behaviour should at least be shamed even in cases where we can’t punish it.

      1. Anon says:

        My point is: As long as it is legal, why should they care about ethics?

        Unfortunately, many people judge what’s ethical only by what’s legal, and nothing’s going to change that, so we have to change the laws (instead of just moaning).

  17. Emjeff says:

    The recent upheaval at Theranos and now this story confirms my view that most investors are idiots.

    1. PorkPieHat says:

      And lemmings (who cant or wont do their own due diligence, so they simply follow others whom they trust).

      1. I suspect it’s more of a Pascal’s Wager, and arguably a rational one for investors who don’t know a lot about the science.

        It would not be rational for you and me, because we have rational reasons for knowing more about the science.

        But, these things have a way of adjusting itself, based on a very important fundamental principle of economics: “A fool and his money are soon parted.”

  18. anon says:

    jeebus, they get 10M for this crap and my grant app with great in vivo data for a small molecule with efficacy in a neurodegenerative disease model, with high oral bioavailability, high brain penetration, an no structure alerts gets 13th percentile…

    I need a better junk science angle I guess.

    1. Emjeff says:

      How quaint, your thinking that science, data and a reasonable hypothesis will get you somewhere…

  19. Peter Kenny says:

    The guys who are going to disrupt drug discovery with mobile apps will love this. Perhaps Artificial Bayesian Intelligence driven by Fifth Generation Quantum Computing will deliver NCEs with tumor-killing hyperpolarizability tensors. Vorsprung durch elektromagnetik!

  20. Pennpenn says:

    Isn’t this clinical trial just a load of grandstanding for cash? I mean, as far as I understand the technology (such as it is) and the (many many many many) objections raised against it, I’m pretty sure being able to reliably have a desired effect on cell cultures in a petri dish would be grounds for amazement and heralding a revolution in science.

    But no, they’re just going to use people as props in their scam, because “trying to cure cancer” tugs more heart strings (and more importantly, investors purse strings) than actual honesty.

  21. MA-MKII says:

    OK, so I haven’t read the paper or any blurb from Nativis, but to me the concept isn’t entirely crazy. That being said I would guess that in order for this to work for say, tumour cells, that the device would have to be tiny and located inside the patient right next to the tumour or even interacting directly with the tumour cells in order to be close enough to target the specific proteins involved. Secondly, I would think that such a system would still need to be pretty powerful to cause electrochemical changes to the local cell environment (which is mainly water so will absorb a lot of the energy) sufficient to produce an effect in proteins in such an environment. That would probably cause local heating, pain and be potentially damaging to surrounding cells. Finally, I believe there are already examples of this in the literature for cancer where electromagnetic pulse devices and even nanoplasma devices are implanted within tumours to oxidatively/reductively damage cell components in order to initiate cell death.

    1. Pennpenn says:

      Nativis’ original decive claimed to be able to “record” the “photon field” of a drug and be able to play it back on a sample of water, somehow imbuing that water with the active properties of the drug. Everything out of this company is complete and unmitigated styrofoam chewing nonsense from start to finish, and any resemblance to real science is coincidental at best.

  22. Grey says:

    You may already be aware of the Mann vs. Steyn (and Steyn vs. Mann) legal battle, but it applies directly to any threats Nativis makes to sue you.

  23. Anonymous says:

    On Feb 15, Derek posted “Guess How This Latest Alzheimer’s Trial Came Out.” If I can get investors to back my plan, I’d like to start a company to license the Nativis technology for AD. As Pres, CEO, and CSO, I’ll accept $1M per year, annual bonus, and stock options. I will get an extra big bonus when we announce “Clinical trials prove Nativis as effective as all secretase inhibitors combined!”

    1. Lane Simonian says:

      Too late it is already being done:

      https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4040449/

      I am not really optimistic about any of this. From very tentative mechanisms to successful results is a very long jump.

      1. Me says:

        Lane: that looks like deep brain stimulation: a similar approach that is used in PD. That type of DBS is very invasive indeed, and some patients seem to benefit. it is reimbursed in some places as were. I know very little about it.

  24. Me says:

    Now here’s another question for those with a more physics leaning:

    Radio waves have a wavelength of around 1 metre. Considering the device is meant to match the ‘ultra-low radio frequency energy’ emitted by a molecule……can a molecule measuring a few angstroms emit a signal with a wavelength of metres?

    1. anon says:

      Yes. Molecules can and do interact with light having wavelengths much longer than molecular dimensions. Even visible light already has longer wavelengths than molecular sizes. Long wavelengths merely limit (due to diffraction) your ability to spatially resolve molecules in an imaging experiment.

  25. a says:

    Once Trump gets rid of the pesky fda regulations, we’ll be free to enjoy the fruits of this wonderful work with our vouchers for health ‘Insurance’, unencumbered by big government. USA USA USA USA

  26. Isidore says:

    Remember (if you are of a *certain* age) the game “Operation”? Nativis is offering the 21st century equivalent apparently.

    1. Hap says:

      I bet you could find it a lot cheaper on Ebay or Amazon than from Nativis, though.

      Maybe investing in Nativis is another sign (besides using cocaine) that you have too much money for your own good.

  27. Ronke says:

    More like “Nativis Lives the Lie”.

  28. Dr. Manhattan says:

    Well, if they ever need a new CEO, there’s always Shkreli…

  29. idiotraptor says:

    Maybe Nativis and Theranos could merge. The RF technology platform of the former could used to quantify analytes in the insufficiently small blood volume specimens collected by the latter. The new company could named “Gata cacca” Therapeutics :))

  30. Jeff Posakony says:

    I don’t think this directly applies to Nativis’ system or rationale, which seems pretty hokey, but there is a mechanism by which electromagnetic fields could affect chemical reactions.
    http://pubs.acs.org/doi/abs/10.1021/acs.accounts.6b00608

  31. Ignaz Pollack says:

    Does this count as real?

    https://link.springer.com/article/10.1007/s11060-017-2440-x

    It looks like the Nativis technology may be doing something?

    1. CanadaGoose says:

      @Ignaz Pollack
      Thanks for the link. I was hoping Derek Lowe would weigh in on this…..
      JNO is a respected journal, yes?
      What are we to make of this publication?

      1. Derek Lowe says:

        I’m having a look at it – posting to come. . .

        1. Razorbacks says:

          @ Derek
          You said “Right. This is more or less authentic frontier gibberish, a homeopathy helmet with a battery pack.”
          Come on man, this is where you insult their scientific team, insist any positive observations are due to placebo effect, and imply that JNO is not a “real” scientific journal.
          What’s to look into?

        2. snapshot says:

          @ Derek
          http://www.businesswire.com/news/home/20170517005071/en/Nativis-Publishes-Abstract-Voyager-System-Patients-rGBM
          Maybe you could get @HAP to help you sort through the “gibberish”? Plus, it looks like a entirely new group of doctors the two of you can insult LOL .

          Voyager System for Patients with rGBM at 2017 ASCO Annual Meeting
          Nativis, Inc., a clinical stage life science bio-electronic company developing non-invasive, safe and highly effective treatments for cancers and other serious diseases, today announced the release of an abstract on its Nativis Voyager® system for use in patients with recurrent glioblastoma multiforme (rGBM). The abstract will be published online during the American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held June 2-6, 2017, in Chicago, IL. Abstracts are available to the public at http://www.abstract.asco.org.

          The Nativis Voyager system is a non-invasive investigational device that delivers ultra-low radio frequency energy (ulRFE™) profiles to the brain. The ulRFE profiles are derived from changes in molecular electrostatic surface potential. The Voyager system is being studied in a first-in-human study to assess the safety and feasibility of treatment for recurrent glioblastoma multiforme.
          In the publication entitled “A Feasibility Study of the Nativis Voyager™ System in Patients with Recurrent Glioblastoma Multiforme (GBM): Interim results of first-in-human study,” the authors, Garni Barkhoudarian, Charles Cobbs, Edward McClay, Brian Vaillant, J. Paul Duic, L. Burt Nabors,Benjamin M. Ellingson, Deborah Sheffield, Santosh Kesari, highlighted the interim results of the first part of a 2-stage study. This first study enrolled 14 patients at four clinical trial sites across the United States, in which 11 subjects were followed per protocol, with 3 subjects dropping out for reasons not associated with the study. In the first two months of treatment, 2 of the 11 subjects were Avastin-naïve and exhibited a partial response. After 6 cycles (24 weeks) of treatment, the local sites reported 2 patients were progression free. No serious adverse events associated with the investigational therapy were reported.
          “We are honored to have our first-in-human study recognized by ASCO as we continue to pioneer our novel ulRFE technology,” commented Chris Rivera, Nativis President and Chief Executive Officer. “The interim data from this feasibility study provide an encouraging outlook for the Voyager system, which appears to be feasible and safe for the treatment of recurrent GBM. With these data in hand, we look forward to moving forward into the second and final stage of the study.”

  32. Bueller says:

    Bueller? Bueller?

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