The makers of Harmonized Water (a.k.a. drinkable sunscreen) do a “clinical trial.” Hilarity ensues.

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About a week ago, my good bud Steve Novella noted a tasty bit of silly pseudoscience finding its way around the usual places, such as Facebook, Twitter, and the like. It was one of those times where I smacked myself on the forehead (metaphorically speaking, of course) and asked, “How on earth did I miss this bit of pseudoscience?” It is, after all, more than Your Friday Dose of Woo-worthy, even though I haven’t done a YFDoW segment for over a year. (Remember, I found that my creation had become too constraining; so I retired it. I might bring it back someday, but today is not the day, obviously, because it’s Wednesday, not Friday.) In any case, Steve had fun with something called Harmonized Water by Osmosis Skin Care.

The website claimed these sorts of miraculous properties for its “drinkable sunscreen”:

  • A new technology that imprints frequencies as “standing waves” onto water molecules.
  • The ability to “stack” thousands of frequencies onto one molecule, for better “healing” effect
  • Revolutionary formula that allows Osmosis Skin Care to reverse engineer the frequencies of substances found in nature and/or the human body.
  • Recently identified frequencies that have beneficial effects on the body.


As Steve noted, if all these claims were true, and “Harmonized Water” could do all the things claimed for it, in particular to “vibrate above the skin to neutralize UVA and UVB, creating protection comparable to an SPF 30,” the creators of this magical water would be in serious consideration for a Nobel Prize. When you look at the ingredients listed, they’re listed as “Distilled Water and Multiple Vibrational Frequency Blends,” whatever that means, and the company claims that “similar to how noise reduction headphones work, these waters cancel out UV rays by delivering targeted wave patterns to the skin in the form of water.” So what’s more likely, that this company has made a Nobel Prize-worthy discovery and is marketing it as a “drinkable sunscreen” or that Harmonized Water is complete and total pseudoscience? I mean, come on!

I think you know the answer to that one.

Apparently, all the criticism of Harmonized Water as quackery and a scame that’s appeared in the skeptical blogosphere and in various other publications has concerned Osmosis Skin Care. I found this out because people have been forwarding to me an e-mail from the company touting the results of a “clinical trial” that, if the press release is to be believed, proves that this magic water can do what the company claims it can do. The press release begins by touting the glories of the product:

Osmosis Harmonized Water UV Neutralizer, also known as the world’s first drinkable sunscreen, went viral this summer, attracting record media coverage. To solidify the brand’s clinical and holistic approach to treating the source of skin conditions using non-harmful ingredients with guaranteed results, Osmosis Pür Medical Skincare executed the line’s first clinical trial on June 28, 2014.

This randomized clinical trial was designed to evaluate a new technology, scalar waves, to provide sun protection. Osmosis Harmonized Water UV Neutralizer in Tan Enhancement and No Tan both contain this form of radio-frequencies called scalar waves. When ingested, they vibrate above the skin to neutralize UVA and UVB, creating protection comparable to an SPF 30.

24 patients ranging from 18 to 60 with various ethnic backgrounds and skin types were exposed to one hour of sun to one side of the body between noon and 1pm after ingesting 3ml Osmosis Harmonized Water UV Neutralizer. Paul Ver Hoeve, MD, FACS of Facial Beauty by MD conducted the study and documented the results which showed 16 out of the 24 patients did not experience any burning. This testing provides evidence that this new form of sun protection is a viable alternative.

No just hold on thar, pardner! Let’s take a look at how this clinical trial was done. Right off the bat, it sounds—shall we say?—fishy even from just the press release. I see no description of an adequate control group. But, Orac, you say, the company provides pictures of the participants; so it must be science, right? Hilariously, the eyes are boxed out, as though this would prevent anyone who knew any of these people from identifying who the participants were. Be that as it may, the color balance of these photos is such that I can’t tell which of them have sunburn and which don’t, with the exception of a couple of particularly pasty-skinned Caucasians who are still pasty-skinned. Given that the pictures tell us virtually nothing, I guess we have to go to the methodology—after, that is, noting that this study was not published in even a bottom-feeding peer-reviewed scientific or medical journal. It was published on the company website, and it was clearly intentionally formatted so that it looks like a real journal article.

The authors also seem to have difficulty understanding what a randomized clinical trial is, as you can see from this excerpt from the abstract:

24 patients were randomly selected to participate in this trial. Each of them ingested 3ml of UV Neutralizer and was then exposed to one hour of sun to one side of the body between noon and 1pm on June 28, 2014 in San Diego.

And in the Methods section:

In this study, 24 patients were randomly selected as test subjects with no consideration for their natural skin tone.

[…]

The decision was made to not do a double-blind test for this application because of the ethical implications of knowingly causing a sunburn in many people.

I laughed out loud when I read this. First of all, if these investigators were so concerned about the ethics of their clinical trial, maybe they should have submitted their protocol to an Institutional Review Board (IRB) and had it approved before undertaking this research. I realize that they’re not really required to, given that their research is not funded by the government and—clearly!—not intended to be used as part of an application to the FDA for approval of their “drinkable sunscreen.” but their protestation of not wanting to intentionally inflict a sunburn on patients would carry more weight if they did that.

It is, however, amusing how it was pointed out that the examiner who looked at the skin of all the participants was “skeptical” of this Harmonized Water, which was described in the paper as water that’s somehow infused with something called “scalar waves” by a—of course!—proprietary process. In woo-speak, scalar waves are electromagnetic waves (radio waves, to be precise) that appear not to work according to the laws of physics as currently understood. According to a zero point energy advocate, Thomas E. Bearden, claims that scalar waves differ from real electromagnetic waves by having two oscillations antiparallel with each other originating from opposite charge sources, which means (if you believe this woo) that they lack any net directionality. In alternative medicine, all sorts of beneficial effects are attributed to scalar waves, if—of course!—the frequency is correct. (Remember, it’s always about the vibrations.) Harmonized water is no different, and these tricky scalar waves that physics doesn’t appear to be able to detect or characterize, at least not in the way that woo peddlers claim.

I’ve frequently written about the fascination alternative medicine has with “vibrations” and the frequencies of these vibrations, but I hadn’t heard of scalar waves before. If the RationalWiki entry is correct, apparently this particular bit of woo, which existed in free energy pseudoscience, found its way into alternative medicine somewhere around 2005 or 2006 and have since been invoked to waves explain homeopathy and cure diabetes, short sight, kidney stones, Parkinson’s, strokes, arthritis and cancer, not to mention reverse the aging process. Indeed, I came across something called the Metamatrix Healing Chamber, which is scalar wave pseudoscience cranked up to 11 and beyond.

So, if we are to believe this “clinical trial,” see if you can make heads or tails out of these results:

16 out of 24 patients exposed one side of their body to summer sun after ingesting 3ml of UV Neutralizer 90 minutes before the study was initiated. All 24 patients were evaluated before, and immediately after the exposure as well as the following morning. There was no evidence of a sunburn on 16 patients, 5 had minor or partial sunburns and 3 had significant sunburns in the study. All of the patients who burned said they would not normally lay out in the sun for one hour. Many of them said they burn with the use of other sunscreens as well. This proves UV Neutralizer effectively limited the sun damage for a majority of the users that consumed it.

People, this tells us nothing. Further up, the paper tells us that all 24 patients were exposed to the sun 90 minutes after drinking the Harmonized Water, but here it sounds as though only 16 were exposed to the sun. Which was it? And if it was the latter (only 16 patients exposed), how were these patients selected? By random? What was the randomization procedure? In particular, if it was only 16 who were exposed to the sun, then the results described were meaningless, given that it doesn’t describe which groups these patients fell into. Strike that. It just doesn’t make much sense anyway. Without a control group, even if all 24 subjects were exposed to the sun, you can’t say much of anything. This is particularly true given that there was only one observer (there should have been more than one, so that interobserver reliability could be assessed).

Oddly enough, even the authors seem to realize this, as later they write:

Clearly more discussion needs to be performed on what percent of the population can tolerate sun exposure regardless of the sunscreen used.

Ya think?

None of this stops them from proclaiming:

While the results were not 100%, the authors believe this was due solely to the excessive amount of sun they received to their relatively virgin skin and their overall health. Those who sunburned said they have never stayed out in the sun for one hour on one side before. Several of the sunburned patients did not burn on the parts of the body which had been exposed to the sun recently. There is the basic premise that there are a select group of people who cannot undergo any long term (in this study, 1hr on one side) sun exposure. It is the author’s opinion that a similar study using SPF 30 topical creams would produce a similar success rate.

And these guys are doctors? Really? Clearly they are doctors without any experience in clinical research and a poor grasp of basic science. For instance, get a load of Dr. Ben Johnson, one of the authors of this study. Specifically, take a look at his response to criticism when the British Association of Dermatologists challenged him:

I understand the skepticism. This is a new science. We did not learn about frequency medicine or scalar waves in medical school so I don’t expect most physicians to be open to it. That being said, the technology is real and incredibly effective. We have been selling waters imprinted with scalar waves for 7 years with roughly 90% success in each treatment category. We offer a money-back guarantee. Placebo only works when you actually think it will work, as you can imagine, most first time users are quite skeptical.

We can offer you evidence that we can make water anti-bacterial and anti-fungal by adding scalar waves since that can be tested in the lab. I will also have my PR person, Jessica, send you some information on scalar waves. Trust me when I say I would never sell or promote a Harmonized Water formula that wasn’t universally successful.

So not only does Dr. Johnson not understand physics or clinical trial design, but he doesn’t understand placebo effects, either. Indeed, he and Paul Ver Hoeve, MD, FACS fail Clinical Trial Design 101. I’m also puzzled by Dr. Ver Hoeve’s credentials. In his biography he is described as an internal medicine doctor. Yet, he appends “FACS” after his name. As a surgeon who is entitled to use that credential myself, I found that very strange, because “FACS” means “Fellow, American College of Surgeons.” To be able to use the “FACS” after one’s name, one must be an actual fellow of the ACS, which one can’t be if one hasn’t finished a surgery residency, applied to the ACS to be a fellow, and gone through an interview process with the local ACS chapter. How could Dr. Ver Hoeve use this title? Doing some searching on the web failed to find anything other than that he received his medical degree from Sapienza University of Rome and did an internal medicine residency at St Joseph’s Hospital & Medical Center from 1985-88. That’s the standard three year residency, and no mention of a fellowship is made, nor is any mention of a surgery residency. I did a search of the American College of Surgeons website for Dr. Ver Hoeve, and found zero records corresponding to him as a fellow.

So why is he using “FACS” after his name? As a surgeon, I am offended. That designation is not easily earned, and I earned it. I call foul and fake.

Actually, foul and fake describe drinkable sunscreen very well.