Category Archives: pseudoscience

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.

U.S. FDA refused import of Valkee HumanCharger devices

Valkee Ltd now began the third launch of their product – the second relaunch of the LED headset – with its new target North America. But: How could the mighty U.S. Food and Drug Administration (FDA) allow such a scam device onto the market?

It turns out, they didn’t. The FDA had refused the Valkee “HumanCharger” import into the U.S.A. earlier this year. For a number of reasons, mainly misbranding.

fda-refusal

UPDATE 7/2017:
The FDA changed its code, the document can be found clicking the link above and then
Feb > 2015 > Country: Finland. [screenshot]refusal-valkee-fda

 

There are several ways to get “approved” by the FDA, depending on the classification. Valkee’s HumanCharger got no 510(k) clearance, and certainly not a Premarket Approval (PMA), for which one must present sufficient clinical trial data.

It is not listed as approved with the FDA (the listings here) in any possible way. [- If any reader has additional information, please let us know. -]

That, however, does not mean it is sold illegally. Many light therapy devices, for example such for cosmetic uses, are exempt from FDA regulation. Then they can’t make relevant medical claims. That’s exactly what Valkee Ltd demonstrates: The device is sold as a lifestyle – weight loss aid – sleep promoter – energy booster. Just typical scam claims. It may work on tech people who are prone to fall for such innovations.

as jet-lag cure ...

Valkee does not need any research staff for this strategy, the marketing trial being published. So the company fired its Research Manager Heidi Jurvelin, the Research and Science Liaison Manager Melanie Rueger PhD, sales people, and replaced the CEO Pekka Somerto with Aki Backman. (Jurvelin and others now appear at Valkee’s sister project JouZen Oy  aka OURA, fulfilling predictions by the social media influencer Vesa Linja-aho: Valkee scales down to a sales bureau, and JouZen takes over.)

The new course is set. Personally, I would miss this absurd tale when it came to an abrupt end, now as they finally seem to stop scamming of sick people and look for the too-healthy jet-set clients. However, it does not look good for Valkee Ltd. There are many wonder treatments for jet lag already.

 

***

p.s. at least left Valkee

  • Heidi Jurvelin (to JouZen/Oura)
  • Melanie Rueger
  • Tuukka Josefsson
  • Tero Vallius (to JouZen/Oura)
  • Jonna Muurinen

 

Valkee’s jet lag trial, full text: No “HumanCharger” at all (Update)

Valkee Ltd seems to have completely abandoned its SAD claims, now the device is called “HumanCharger” and works – clinically tested! – on jet lag. Marketing bubbles re-used: They only changed some words in their PR stuff, the rest is the same as for SAD. The same unproven claims.

as jet-lag cure ...

as jet-lag cure …

... and for Seasonal Affective Disorder!

… and for Seasonal Affective Disorder!

Needless to say, these things were never tested. Valkee logic: Because it is approved for SAD, and those are SAD symptoms, it works on these. Therefore, it does the same for jet lag users!

The whole jet lag campaign is based on a study, which appeared already on April 1st in the journal Aerospace Medicine and Human Performance. Valkee says that this proves a jet lag effect. Its SAD studies are all on the Valkee website, this one remained behind the paywall. Typical Valkee users and marketing folks don’t need the facts and are better off without it. To pay 30 Dollars for a Valkee paper? Simply believe!

Update 12.6.17:40: The study is now available from Valkee HumanCharger, direct download from the site. It is not linked yet from any of their sites, and not found neither by google nor google scholar. It was added in the meantime to a press release. The leak for this post was several weaks ago.

Now one of Valkee’s little helpers did not get the memo, and leaked the document into the public domain. I can mirror it here without doing something illegal:

The full text of Valkee’s jet lag trial (4,6 Mb)

I do not have the spare time to comment, but the main outcome is, that the device did not work on practically all things measured. No significant difference at the end of the predefined treatment period for 10 of at least eleven tested scores. Only one subscale of the POMS brought a significance, and this can be explained with multiple testing.

The funny point: It was the fatigue subscale. Exactly the same single result, as the homeopathic “remedy” No-Jet-Lag got in its own company trial.

recover "twice as fast" with homeopathy!

recover “twice as fast” with homeopathy!

The difference: The homeopathic treatment is to be taken orally, during the flight. The Valkee device must be used for 6 (six!) days after the flight, 4 (four!) times a day to get to the same result. 24 treatment sessions.

Valkee is nearly as good as the leading homeopathic treatment.

placebo

 

***

Addition: The analysis was done on 52 patients, but the article speaks of 55 (Figure 3). What happened to the rest? Drop-outs happened, but are not reported. The whole statistics are invalidated. Incredible that this got through peer review.

Valkee’s Research: What a Waste!

An extensive article about the Valkee scam was in the Ylioppilaslehti paper. Many new findings, like I promised earlier this year. I don’t have the time to translate it. Always remember the official statement:

The chancellor (rector) of the University of Oulu, Lauri Lajunen, says that Valkee Ltd. did not emerge from research at the university. It had partially sponsored some trials, but there is no scientific cooperation or any other kind of links to the university.

”Valkee’s web pages can easily create the impression, that they have clear scientific evidence, and are based on research done at the University of Oulu. I checked this with our lawyers, and we as an University now have to contact Valkee about this”, Lajunen says.

* * *

A side product was a list of all studies by the Valkee group, or what they claim to have done, and all other earlight-related stuff as per Sep 3, 2014. It is 100% complete with links to papers and should replace the outdated research page at earlightswindle.com.

XLS: All Earlight and Valkee studies, September 2014.

It’s long. I really suggest to have a look. I’m still shocked how far they were allowed to go, and what level of pseudoscience can be done at a finnish university.

Remember that such trials are expensive. Valkee has burned investors’ and tax money for years. And how could any ethics commission still give an OK for more studies?

After all, they could have simply accomplished a straightforward placebo-controlled trial at any point. (BTW they did, but it did not work.) Every unbiased scientist would have stopped this nonsense long ago.

No need for more “research” on an ear lamp scam born over a drink.