Category Archives: pseudoscience

Don’t use HumanCharger for Seasonal Affective Disorder: Valkee fools the FDA

As reported earlier on earlightswindle.com, the U.S. Food and Drug Administration has refused the import of Valkee’s HumanCharger earlight headset into the States, when it was misbranded as a therapy device. But now Valkee Ltd actually did a rererere-launch of their hokuspokus in Canada and the US. How is this possible?

Valkee’s resellers explain on amazon.com, how Valkee circumvents FDA requirements.
Hold on to your seats!

“Doesn’t this need FDA approval?”

valkee-fuck-fda

“Only if advertised for use in Seasonal Affective Disorder. The product is advertised for Winter Blues”

It can not make any effectiveness claims, it gets no FDA approval – but it works “for winter blues”? That’s a synonym.

The USA is a known minefield for health fraud businesses like Valkee’s, because of class action suits. Power Balance, the magnetic wrist band sellers, had to return most of their shady businesses’ profits, because they made false health claims.

Valkee really doesn’t know better than to fool around with U.S. legislation. On the other hand, there is nothing to regain from Valkee, as the Company has no assets. They didn’t make even profits.

Congratulations to Merieux Developpement, TEKES and SITRA for making these shameful maneuvres possible. This is what sustainable businesses look like (in Finland)!

Russian TB Quack at the University of Eastern Finland

This blog will now also take on quackery and fraud in Finland’s academic system.

 

Bizarre “innovation” for western healthcare

Photonics Finland and Kuopio Innovation held a “Photonics for Healthcare” event on 14 Sep 2016, at the Spa Hotel Kunnonpaikka near Kuopio. The University of Eastern Finland (UEF) is a member of Photonics Finland, and their Institute of Photonics provided support and speakers for the event.

Here is, what russian researchers from the UEF had to tell about their “innovative treatment for tuberculosis”.

Download PDF: Ultraviolet laser improved for human treatment
by Slava (Viatcheslav) Vanyukov and Vadim Kiyko

The researchers claimed to be affilatiated with the University of Eastern Finland (Kuopio), the company HyperMemo OY (Joensuu, Finland) and the ITMO University (St. Petersburg, Russia). Vanyukov completed his thesis at the UEF in 2015, and Kiyko is also announced as an UEF person.

 uv-laser_improved-treatment

The first tests to treat Tuberculosis with laser beams were done in the Soviet Union, and then Russia, in the early 1990s.

Like the chemist-turned quack guru Linus Pauling, the late russian nobelist A.M. Prokhorov aimed to become an alternative healer. The highly decorated founder of laser theory began to stick lasers into severely ill cancer and tuberculosis patients, with a “see what happens” approach. He was one of the founders of the “lasers for everything” movement.

prokhorov-laser

The method spread to India, and was subsequently used in thousands of “volunteers” in Russia and, mainly, rural India. Although many patients could barely read, even children were exposed to the experimental method.

The idea is to kill the TB bacteria at the spot. The laser light is given by an optic fiber inserted into the TB cavity, puncturing the skin, pleura, and other structures in its way.
Actual photo from India:

tb-laser_2-application

Typically, such a presentation would cite scientific studies which support the treatment.
– This is what the russian UEF researchers present.

exams-report

Untranslated, russian technical papers with “official stamps”. And even this is a fake: the left paper is from the long-void registration of an obsolete device. The other is a letter of recommendation with a stamp from the Blagovestshensk, far-east science center, physiology and pathology, siberian branch of the russian academy of medical sciences.

After 25 years of research, this is all they have to show. “Hey Vasya, we need some nice-looking papers for the presentation in Finland. They can’t read it anyway!”

Actually, the method has been tested in India by doctors who visited the russian centers in the early 1990s. There have been a number of trials, which do not meet basic ethical and quality standards. A 2006 Cochrane review found only one poorly reported study, whose author could not be located anymore. It concluded:

The use of low level laser therapy for treating tuberculosis is still not supported by reliable evidence. Researchers need to focus on conducting well-designed randomized controlled trials to justify the continued participation of volunteers for studies of this experimental intervention.

The recruitment into these low-standard studies alone was deemed to be unethical already 10 years ago. Nevertheless, the questionable trials went on, without any demonstration of benefit or harm. The newest was published in 2015. One earlier trial, published in 2010, used such a simplified treatment device (actual photo):

tb-laser_1appliance

The russian devices are more sophisticated, but use the same technique.

milestones-development

The advantages of the russian device (from the presentation):

Description

  • Portable semiconductor laser with diode pumping-that makes the usage convenient for the user. Since it is compact, light in weight, absolutely safe considering the electronics
  • Friendly device as a normal household devices[sic!]
  • Passed 3 official clinical examinations in hospitals in Moscow and Moscow region”

 

system-advantages

The russian device has no CE mark or other registration in the EU for medical use. We’re told, that the procedure is survivable:

1200 patients were treated, all recovered!

It is absolutely incredible, that such a “treatment” is advertised at a public, and pubicly funded event. Hopefully, the UEF did not use own ressources for this quack. Maybe it’s “only” misuse of the UEF brand – like in the case of Valkee Ltd, which misused the Oulu University brand.

welcome-cooperation

The poor people in India may not understand what happens to them, but doctors and university officials in Finland should recognize a quack as such.

Surprise: Elisa Oyj sells Valkee-succeeding Oura crap

Some twists in the Valkee saga still may surprise me. That one is hard to comment:

Oura-Valkee-Somerto-Elisa

Oura-Valkee-Somerto-Elisa

[ background 1 ] [ background 2 ] [ background 3 ]

The Oura ring is another gadget linked to unfounded claims, misleading advertising, and Valkee. Elisa Oyj‘s new Business Development Director is the former CEO of Valkee, and multiple Valkee employees now appear at Oura, which original name is JouZen Oy. Valkee’s co-founder is listed among the inventors of Oura’s founding patents. Among JouZen/Oura leaders is Petteri Lahtela, from Valkee’s Japan operations.

A so-called butt-on-bucket constellation, with helping hands by good old boys.

Valkee’s chairman joining antivax conspiracists?

Valkee Ltd’s chairman Timo Ahopelto has often been reluctant to give interviews to critical, or un-bribed reporters. The finnish SEURA magazine tried to get an interview last year, but he refused for many weeks. Finally Ahopelto agreed to answer questions, which he approved beforehand. Here is what he said about the faulty scientific base for Valkee’s claims:

“In Finland, there are also doctors who want everybody to be vaccinated against influenza. Others think nobody should be vaccinated, and then there’s everything in between. In science, it takes time to find the final truth and get it accepted. Things get either rejected or accepted at a certain time. For Valkee, the talk in Finland is not very important. Here’s 5 million people, but the world has 8 billions.”

In Finnish:

”Onhan Suomessa lääkäreitäkin, joiden mielestä kaikkien pitäisi ottaa influenssarokote, toisten mielestä kenenkään ei pitäisi ottaa, ja kaikkea siltä väliltä. Tieteessä lopullisen totuuden löytäminen ja hyväksytyksi saattaminen vie aikaa; asiat joko hylätään tai hyväksytään tietyssä vaiheessa. Valkeen kannalta suomalainen keskustelu ei ole kovin merkityksellinen. Täällä on 5 miljoonaa ihmistä, ja maailmassa on 8 miljardia.”

 

Ahopelto has defended Valkee’s actions with conspiracy theories before. For finnish readers, the SEURA article is worth a read. An important piece about probably corruptive practices in TEKES. — However, stay tuned for Monday, April 4th.

New (not so) independent study: Valkee’s HumanCharger is a placebo (Update)

The finnish earlight maker Valkee Ltd is putting all-in on the american market after plunging sales in Europe. Its product, the premium-priced placebo HumanCharger, is sold with wonder claims online by Walmart and others:

Walmart as a co-scammer!

  • Keep in sync, all the time: regular exposure to light helps maintain the rhythm of our natural body clock, so with HumanCharger you always feel “in sync”
  • Better sleep, better health: HumanCharger reduces the need for excess sleep and reduces food cravings associated with jetlag, tiredness and low energy levels

At the same time, the second independent study about the device’s effects (or the lack thereof) is published. The result … is the same as in all other placebo-controlled tests.

Independent trial: Valkee is a sleep and mood placebo

It is concluded that transcranial bright light, at times where conventional light therapy has phase-advancing properties, did not influence any sleep parameters differently than placebo.

This is by no means surprising, as the first independent trial, published in November 2013, came to similar conclusions with a somewhat different methodology. Valkee’s HumanCharger has no effects on circadian rhythms. The new independent study is from the University of Bergen, Norway. With 50 participants, it was adequately powered to detect any effects consistent with Valkee claims.

The company has admitted, that their earlight doesn’t have any physiological effect comparable to standard light therapy. Their own data also show, that it does not influence Melatonin or Cortisol like real light therapy. Now we know, it doesn’t improve or at least change sleep in any way.

The HumanCharger does not influence the biological clock.
No “better sleep. better health – sync with the sun”. It’s all made up.

Ironically, Valkee Ltd is just touring the US with exactly these false claims. The company has been presenting on the Consumer Electronics Show CES2016 from Jan 6-9 in Las Vegas. It would be interesting to see the reactions of any resellers, when they realize that the HumanCharger again is scientifically demonstrated to be humbug.

 

Update 1: I got the study pdf. Cool, that was fast! Big thanks to J. – and to all the other nice readers whose support I am experiencing regularly.

Update 2: According to the small print in the full text, Valkee Ltd paid 12.000 Euros for this trial. That’s more than for the ice hockey trial a few years ago. But they did not get full control over the results and the publishing. Literally a bad investment. (16.1.2016)

Two Valkee trials declared published junk (X-mas special 5)

Dozens of hilarious details about Valkee Ltd’s HumanCharger scam go untold because they don’t warrant a full blog post. As a present for Christmas Day, here’s the best of all.

The Valkee “research” group has published a number of trial results in unfavorable ways:

The only positive trial with evidence value for Valkee in a scientific journal was the one with the 22 ice hockey players supposedly pimped by earlight to better reaction, published in Frontiers in Physiology.

I say it was, because it had been until now.

It is a real pleasure for me to tell you, that this very special journal series was officially elevated to junk status, by Scholarly Open Access. That’s the No.#1 authority. The list is used by, for example, finnish universities to determine the standing of a publication.

christmas for gloom, frontiers and valkee!

With it, a second Valkee study goes down the tube, which is no longer on their website. It was in Frontiers in Systems Neuroscience.

The decision was overdue: The fake peer-review was obvious in the ice hockey article, where one of the authors was among the editors, and a dance instructor with no idea was assigned to review it by her lab boss. That’s not a fluke. It’s systematic pseudoscience done by Frontiers.

Is there anything left of Valkee’s evidence, among the ruins?

According to usually well-informed sources, there is one final blow still coming.
A nice Christmas to all and a Happy New Year!

HumanCharger study done to counter critics, disappears again (X-mas special 4)

Dozens of hilarious details about Valkee Ltd’s HumanCharger scam go untold because they don’t warrant a full blog post. As a Christmas present, here are some of such pearls.

When Finland’s Valkee Ltd re-launched their earlight device in 2015 under its new name HumanCharger, there was an exceptional piece among all the PR articles which simply reuttered their press release.

Fierce Biotech criticism

This is the first placebo-controlled trial ever conducted for a bright-light device, the company said.[SIC!] The data may be designed, at least in part, to address allegations widely publicized online that the company’s product is a scam.

Stacey Lawrence of Fierce Biotech had a bright moment.

You may wonder how the company can be forced into a study because of this blog and a few articles elsewhere. And how could they possibly even succeed?

Simple as it is: Valkee bought the “evidence”. The study has disappeared from the net and Valkee’s websites again, but is still available in full from earlightswindle.com/gloom (PDF). The small-print in the last paragraph reads:

We would like to thank Clinius Ltd., an independent company, which conducted the study on behalf of Valkee Ltd.

The study is not done for any scientific purpose and as such unethical from the start. And it’s unclear who the real investigators were. Clinius is a company from Helsinki, Finland.

 

Stay tuned for the next part tomorrow, and the best of all on December 24th!

New placebo-controlled, buried Valkee trial identified (X-mas special 3)

Dozens of hilarious details about Valkee Ltd’s HumanCharger scam go untold because they don’t warrant a full blog post. As a Christmas present, here are some of such pearls.

My deepest apologies. We misrepresented a clinical study in our YLE MOT TV program, and so did all those people after us, who reviewed Valkee’s stuff systematically. We were mislead by the company, but that’s no excuse.

The critical point with Valkee’s earlight is the obvious lack of placebo-controlled studies for the claims in Seasonal Affective Disorder. Valkee Ltd told it’s easy, and they will come up with great results. They never did.

We do know, however, that they attempted such a study 3 times: One was halted, one is completely buried, and the third showed the device to be non-inferior to placebo by a small margin. This result was falsified then, because it would have obviously stopped the whole scam at once.

Juuso Nissilä of Valkee gave an interview back in 2012.

placebo controlled data surfaced

Unlike other bright light therapies, the Valkee unit has been tested in a placebo-controlled trial. ‘You can’t tell, when it’s in your ears, […], it’s possible to have a placebo,’ Nissilä explained.

The trial, with 26 patients receiving treatment and a control group of 23, showed that depression – […] – decreased when the device was used for 12 minutes per day.

That is, to my knowledge, the halted one with 60 persons to participate. It actually had results which never officially surfaced. Valkee’s then-board member Timo Takala, at the same time “researching” his product, told the reporter it was because of low enrollment. That’s what I remember, this part was not broadcasted.

It fits: They had at least 26+23=49 patients of planned 60 when the data was unblinded to the investigators. That’s to say, the trial was dumped then. When the investigators know such interim results, it cannot be continued anymore.

Valkee initiated the notorious 3-group trial in November 2010 with 90 participants, later to be faked. But the “halted” trial was projected to run through that very same winter. Registered completion was March 2011. That means it was not halted for low enrollment. They could have continued. But they recruited patients for the other and declared the first to be failed. Entry criteria and study design were the same.

I won’t comment any longer, it would be too speculative. The real reasons for disrupting the placebo-controlled trial are unknown. Nissilä’s comment reads to me like “symptoms decreased in both groups”, i.e. placebo performed as well as earlight. The similar result as in all other placebo-controlled tests.

Once again, crucial placebo-controlled results remain buried by Valkee Ltd. WHY?
(Ok, that’s pathetic to ask.)

The Christmas Special continues tomorrow. Stay tuned!

HumanCharger endorses Zapper scam (X-mas special 2)

Dozens of hilarious details about Valkee Ltd’s HumanCharger scam go untold because they don’t warrant a full blog post. As a Christmas present, here are some of such pearls.

Valkee recently retweeted a nice, very telling picture.

HeartMath, Zapper, Valkee!

The HumanCharger among other travel essentials. HeartMath and Zapper. – Wait, WHAT?

HeartMath

The HeartMath Institute claims to have technologies to reduce stress, give energy, etc.pp. It says to be built on science. It is detailed here on a professional website:
HeartMath BS

“extensive research and findings on stress, heart intelligence, coherence and the energetic connection between all things are featured”

No further questions. They tell that people’s hearts are magnetically interconnected and communicating. Read it in full on their site, which is quite impressive.

 

The Zapper

The Zapper actually doesn’t differ much in principal structure from the HumanCharger (see picture). As a notorious bullshit, it’s a textbook example for quack. It’s quite famous. People are buying these boxes from different manufacturers. If you have time, look at the site of Dr. Clark, mother of all zappers.

Excerpts taken from Dr. Clark’s : “The Cure for all Diseases” Book

It cures all diseases, right. Not making this up! All diseases are caused by the same single pathogen, an intestinal parasite. A worm, which then can be killed by such a device.

zapper variant

Evolution of scams

So there we have them in a perfect arrangement. Ingenious. I couldn’t have done it better – though I cited the Zapper scam from the very first day on earlightswindle.com.

HeartMath, Zapper, Valkee!

 

The Christmas Special continues tomorrow with a more serious revelation. Stay tuned!

Earlight revenue implodes further, Valkee receives audit warning: The 2014/2015 Balance

Valkee Ltd, the maker of the earlight headset called HumanCharger or Valkee 2, has published its 2014-2015 balance as required by finnish law. The good news for the company: Loss per fiscal year is down from 2,9 M€ to 2,3 million.

The bad news: That’s because the turnover fell again by 40% from 3/2014 to 2/2015 . The earlight made only 654.000€ last year. 2013 revenue was still 1.080.000€, 2012 nearly 2 million. Valkee shrunk by 2/3 in 2 years.

Traditionally, earlightswindle.com makes the balance freely available. Here it is:

Valkee Ltd balance Mar 2014 – Feb 2015

 It is an absolutely catastrophic result. Debt to institutional creditors alone is 1,650 million, 500.000€ was a convertible bond for (quote) “a very serious economic reason”. Cash flow is less than 600.000€: From 7,3 million invested 6,7 million are burned.

I don’t comment any further, see for yourselves. One thing is worth noting: The auditor of Ernst&Young remarked that the balance is problematic, because the development costs are partially booked on the +side. Actually, this is burned money, which will not be recovered with future sales. Recalculate with this in mind, the balance would be a crazy  3 million less than it shows now.

The auditor did not want to sign this without an explicit warning. Interestingly, this is what one commentor predicted last year on this blog, when earlightswindle.com broke the news about Valkee’s nose-dive.