Category Archives: valkeeleaks

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)!

Valkee Ltd to go belly-up: The 2016 balance

Traditionally, earlightswindle.com makes Valkee’s balance sheets publicly available. Here is it for the fiscal year 3/2015 – 2/2016:

Valkee balance 2016

Revenue is down to 426.000 Euro from 645.000, again -35%. That’s directly continuing the long-time downward trend (2014: -44%, 2015: -40%).

Loss is also down, to “only” 1,646 million. Now the equity ratio (omavaraisuusaste) fell sharply, own capital is now negative (-1,049 million). In other words, there’s nothing left than debt. Banks and investors will not recover what they gave.

Last year, there was still some money left from the 7,3M investment. That’s completely burned now, and an additional million evaporated. As last year, Valkee got an audit warning. Now plus a clear prognosis, that the company will run out of capital during the next 12 months – cease to exist – if no new cash is found from some easy-to-fool investor. Or the americans buy millions of HumanChargers.

Update:
The snail media has reacted to this post: Kauppalehti 1 | Kauppalehti 2 | Talouselämä

Valkee’s CEO Aki Backman made absurd comments. Interestingly, he admitted that the earlight does “practically” not sell anymore in Finland. An open secret, now confirmed.

How to handle an unwanted blogger – the Valkee solution

Imagine the following: You have a company selling some unproven wonder treatment to naïve customers. You get maximum-level political support – even from the President of the Republic and the PM. You’re getting multi-million public and private funding enabling you to produce “research” to bolster your marketing.

But the target population still doesn’t believe you. An ugly makeshift website with an unfriendly blog draws as much attention as your glossy campaign. Although it is maintained anonymously, it has higher credibility. The facts presented there are a threat to your business, you want to get rid of that. What shall you do?

Here is, what Valkee Ltd did.

 

1. Send a threatening letter

in which you demand to shut down the website.

cease-and-desist letter by Valkee's CEO Somerto

 

If unsuccessful,

2. Let your lawyers send a threatening letter.

cease-and-desist by Borenius law firm

Luckily, you have Borenius, a leading law firm, at hand – at the expense of others.

 

If unsuccessful, start some

3. Text message stalking

somerto-sms1

Send the messages preferably in the morning (before 7:30 a.m.) or at night (after 8:00 p.m.). You may achieve a good shock-and-awe effect when the target is with the family, not expecting anything bad.

somerto-sms2

 

If unsuccessful, make a

4. Denunciation to the police.

The outcome may be disappointing (detailed description of the case here), because the website/blog does nothing illegal. The presented facts are correct, as you know.

 

Anyway, if unsuccessful, try a

5. Second complaint to the police

in which you decry the activities of that blog as a vital threat to your business. Urge the police to do anything soon. At least, it will keep the blogger busy and under pressure.

lawsuit2-4[1]

 

If all those methods are unsuccessful,

6. Hire a private investigator.

This may be outsourced to some of your pals. Their growing concerns about the failing investment could make them try a whole bunch of unconventional measures. You must convince them, that all negative publicity is caused by that blogger and his friends, not by your foul claims.

valkee-amateur-spies

Security expert Dave may find out interesting things about one’s personal life (cut out from the JPG above). Keep it for later use. But next time avoid leaking the memos, because of your sheer incompetence with web techniques.

  • Guessing game: Who hired David as a private eye?
    • Hint 1 (symbolic picture):
      (symbolic picture only)
    • Hint 2: it begins with M.

 

If still unsuccessful,

7. Contact the blogger’s employer.

This is, of course, a do-not for a civilized person. Use only if despair strikes. You may try to find out more details about your target. Or simply ask random things, to make clear you’re despicable enough to actually play that card.

Be aware, that the HR department may be used already to 3C-requests (criminals, crooks, and crackpots) due to the nature of that institution. Your questions may be redirected instead and cause further damage.

update: Pekka Somerto contacted my employer via phone and from a DNA welho.com e-mail (probably he changed it now to Elisa.fi). I received a HR call at home on my day off, and had to explain. An uncomfortable situation, as you may understand./-Ed.

 

If all is unsuccessful,

8. Leave the company

after all you’ve done.

thelastoneswitchesoffthelight

Your pals/investors could help with parachuting you into a leading position elsewhere – even with comparable pay checks.

valkeelisa

Then resume where you stopped: Selling flimflam devices. Enjoy life!

***

The 3rd Relaunch of the Valkee Scam: “SummerLight”!

With worldwide sales nearing zero, the finnish earlight maker Valkee Ltd undertakes the next (and probably last) “relaunch” of its 10 year-old scam. The product is now called SummerLight. The accompanying website summerlight.com is a shady copy of the previous humancharger.com fraud.

valkee-summerlight-therapy-deviceNo further comment needed.

Update: Valkee’s scam sites won’t open w/ earlightswindle.com referrers. They also block me on Twitter. OMG. OMG!!1!

Valkee Ltd, Elisa Oyj and TEKES: Good Old Boys at Work

Valkee Ltd’s previous CEO Pekka Somerto has a new job, he tells at LinkedIn: Business Development Director at Elisa Oyj, a major finnish operator traded at the Helsinki stock exchange.

I won’t again talk about what I call his competitive relation with the truth, which he has publicly demonstrated at several occasions. I am just wondering how they took into account his performance as CEO of Valkee Ltd. Here the figure for his tenure, quite exactly that specific interval.

Valkee results in Pekka's tenure

Nothing against the new job. He is qualified. But at Elisa’s board of directors is Petteri Koponen. In the specific sub-commitee he is responsible for recruitment to the leading posts in the Corporation.

Koponen is founding partner of LifeLine Ventures, together with Timo Ahopelto, Valkee’s chairman. LifeLine is the lead investor in Valkee.

Ahopelto again is at the board of the tax-funded TEKES agency. And the biggest single Investment of TEKES goes into … LifeLine Ventures. As well as most of it investments. TEKES again has poured millions into Valkee.

Corporate governance, Finland style.

***

Personal note: To my knowledge, Valkee’s leaders have told investors and others, that I am a malicious person with an agenda to bring down Valkee. I may advise Elisa Oyj to look rather at the company turned down by a blogger, not at the blogger who turned the company down.

I have no specific hatred towards Somerto.

 

 

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!