Category Archives: valkeeleaks

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!

Valkee Ltd doubles the bribe! (X-mas special 1)

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.

Is there any positive Valkee review written without bribe changing hands? Usually it’s the device itself: Bloggers, journalists etc. get a “medical iPod” (Valkee slogan) for free. Though it’s totally useless compared to the popular music player, and it has no medical effect, it somehow looks nice and that’s what everyone writes after “testing” it.

The review won’t be negative, because it’s 200 Euro a piece. You’re made to think you’re one of the chosen few. Instead, Valkee has given out many hundreds of the “Chargers”. A logical move, as there are thousands unsold devices in stock, and any short blog post is worth more than the few Euros for the 2 LEDs.

With Valkee Ltd going its natural course, this idea metastatizes further:

 

Bribing the same writer twice

Valkee doublecrossed tech writer Robin Wauters back in 2013.

Robin Wauters Tech.eu

Now he has used the trigger words jet lag in a tweet and is provided with the second, identical device.

Robin Wauters bribe 2

Note the word borrow! After Slush 13, the honest one of all the “journalists” really wanted to return the Valkee device. It came out, that Valkee had no wish and no procedure to accept any such return.

 

Doubling the loot

To get rid of the stockpiles, the innovative Valkee Ltd just came up with a new breakthrough idea. Send two instead of one.

Rubbish twice No shit!!

The Christmas special continues tomorrow, with more Valkee buffooning.

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.

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 Ltd vs. Earlightswindle.com: Shutdown Attempt, Legal Action Fails (2. update & document)

The finnish earlight seller Valkee Ltd. sent forth lawyers and tried to misuse police force in a failed attempt to silence this website, which is criticizing the company’s practices. The prosecution was stopped now by the officials, declaring there has been no wrongdoing.

The full document set is not yet available to the public, because it may still be sealed by the authorities. However, according to Finland’s laws on Freedom of Information, after any investigation the material shall be in the public domain. Earlightswindle.com tries to get the scans as soon as they become available. By now it can only describe and cite without revealing the acting persons’ names. It shouldn’t be so hard to guess. See update section below.

 

Behind the scenes

Valkee Ltd demanded to close this website within weeks of its establishment in late 2012. Until then, the critical view on the once-applauded, self-declared startup firm had less than 50 visitors. The first deadlines set by Valkee’s board expired without effect.

valkee-letter-2013

Strangely, all communication was sent to a certain person which Valkee claims to be behind this project. There’s never been any message to the e-mail address given for this purpose from the very first day. They did not demand factual corrections. Instead, the earlight firm made clear that this website had to disappear before it could be noticed by the general public.

The successive additions to earlightswindle.com during 2013 coincided with Valkee’s problems after reports by a now-critical mainstream press, and the widely recognized 2012 FlimFlam award. Social media picked up the Valkee story in August 2013, overshadowing the launch of the Valkee 2 device. The company had a defensive reply attached to its most important campaign in years. A catastrophic event in marketing terms, followed by the even more devastating independent trial countering their 2013 Christmas campaign. Something had to be done.

 

Police is called in

A Valkee representant made a complaint to the finnish police in January 2014. Earlightswindle.com was said to cause massive damage to the company. The person they made responsible should be punished, and convicted to pay compensation.

In May 2014, a renewed complaint came in. Valkee saw this site as a vital threat to its operations and shareholders. It urged the officers to act immediately, because now a twitter account EarLightSwindle existed, making the information available to an even bigger audience.


Warning: Clicking this is hurting Valkee (says Valkee).

lawsuit2-4[1]

(update: p.4 of complaint no.2, Valkee’s CEO said this post to be a pure canard. OMD)

Legal grounds

Finnish libel law only covers insults against persons. It rules out punishment for criticism made about one’s business, or science. But there is a foxhole: If the criticism is too sharp, and may directly harm a specific person, it leads to prosecution. Such cases went through the High Court with considerable sentences. The criticism on this site is extreme, and the things told here are likely to hurt persons involved. Yet, it had to be false and mendacious. The truth cannot be unlawful.

  • First, [X] declared to be Valkee in person (“Valkee henkilöityneenä”). Everything said about the company would mean him, because he was speaking for it on countless occasions, and is presumed to be its face.
  • Second, criticism of his work would ruin his career as a researcher.
  • Third, authorities had never investigated Valkee for fraud or anything else, and therefore it cannot be called a scam.

Would that have gone through, it would have enormous impact on free speech in Finland: It would be a punishable offence to use the word swindle, scam, hoax (“huijaus”) without a court decision.

480px-Free-speech-flag

Unthinkable? Not for Valkee, the innovative young firm from Oulu Helsinki.

Fortunately, earlightswindle.com is in English and made for an English-speaking audience. The U.S. Food and Drug Administration defines a health fraud scam as:

products that claim to prevent, treat, or cure diseases or other health conditions, but are not proven safe and effective for those uses.

Valkee Ltd has sold, or is selling, the earlight devices for

  • Migraine
  • Shift work disorder
  • circadian rythm shifting
  • optimizing cognitive performance
  • Bipolar Disorder (!!), and
  • Seasonal Affective Disorder.

It has no accepted evidence for any of those claims. It has only an approval for SAD. So Valkee is per definitionem a scam, or health fraud, or however one may call this. Practically, and in legal terms. The FDA exculpates that fully, without any need to explain, or to understand scientific details.

 

Closing the case

After one year, the officers working on the case and the prosecutor made the decision to end the investigation, because it is highly unlikely to lead to a conviction under these circumstances. There has been no wrongdoing. Valkee has left only the possibility to call on a civil court. The chances to win the facts are near zero, after it was made clear that nothing unlawful happened. But the company has money left. It would not surprise if they make a last stand.

The important message is, that here is no slander, no lies, no defamation. Don’t expect Valkee to accept that. Be sure, Valkee will not be prosecuted for … at least not for their false claims about earlightswindle.com.

 

Some words in private

This thing has caused me sleepless nights, as you may understand. Not so much because of the criminal case in itself – the website was considered court-proof from the beginning simple because of its factual correctness. It shocked me, after all I’ve seen from Valkee, that they are willing to misuse authorities and to mislead them with such bogus claims.

Oskari Onninen seems to be correct when he notices:

This is Valkee, a company of two truths. One the company’s own, the other the outside world’s. Comparing them is like reading Russia Today and the New York Times at the same time and trying to assess whether Vladimir Putin is a good guy or a crook.

And if a Valkee-truth is collided with another truth, the company is instantly at your throat.

The original, 50+ pages lawsuit material contains absolutely incredible misconceptions, false translations and awesome claims by Valkee. This post may be updated with that if readers wish so.

I never told about these Valkee activities before, though I know that “the Internet” hates such commercial censorship. I was just so fed up with the evil. On the other hand, the finnish scam company knew what they were taking on. They knew it would become public one way or the other.

Now I need some time out.

CU./-ed.


UPDATE 2.4.2015:

Mr [X], who filed the complaint for Valkee Ltd, did not want the documents online – for personal reasons, he said. Fine with me, although disappointing for some readers: Saves time and money. His decision demands no comment.

I have the complaint scans here, and if someone wants them, you’re free to check it, if you don’t put them online. I gave my word.

Then I discovered, that Valkee’s PR-mistress kittikatti alias Christina Forsgard was retweeting foul and despicable claims about me to over 6.600 persons. These may not be aware of the role she played in the scandal.

forsgard-crackpot

– The prosecutor would’ve had stopped the investigation because only a fine (= and no jail term) was to be expected. As if our “too liberal justice system” prevented a conviction. Absolutely awful. Just think a moment: If that would be a reason for stopping, how could anybody be fined at all in Finland? Forsgard must have known that this is rubbish.

– The prosecutor’s decision would not tell, if there had been a crime or not.

– The prosecutor would have looked, if I did harm to [X]’s family. This is an extremely abject claim, and there was not a single word about this even in the complaints. Of course the prosecutor didn’t check this. Unbearable.

So here is the prosecutor’s decision in full. See for yourselves.

 prosec000  prosec001  prosec003

 “… THE CASE:

[X] is suspecting [Ed.] to have committed defamation by making untrue claims and hints about Valkee Ltd. and [X] on the website earlightswindle.com. [Ed.] is also suspected to have maintained the website korvavalohuijaus.com, where also Valkee Ltd’s earlight device was criticised. [Ed.] had also given an interview in the YLE TV program MOT: The Earlight Tale. (…)

GROUNDS:

(…) the investigation shall be stopped on grounds of the crimes’ negligibility, because the prosecutor would not be able to bring a charge. Also, there is no important public or private interest in bringing a charge.

(…processual law tells, that) the official prosecutor may abstain from bringing a charge, if the expected sentence is no more than a fine… or if the crime can be seen as negligible.”

It tells, that the prosecutor is allowed to drop charges, if no more than a fine is expected. Only then. This is not the reason, this is the condition for stopping.

The next paragraph cites the defamation chapter of finnish penal law, and that criticism of one’s business, science, politics, etc. is not libel, if it can be seen as acceptable. As I told in the post above.

“In the present case, [Ed.] has criticised the company founded by [X] and the device which is developed and manufactured by them. Therefore his criticism is about business and science. It is a new product, about which absolutely no independent study results are available. [not true, /-Ed.]

Taking into account the newness of the device and the method, and the lack of evidence, it is understandable that it is met also with fierce criticism.

The vast majority of [Ed.s] claims are about the efficacy of the device produced by the company and its possible benefits for users. That is criticism related to business and science. For that, the criteria of defamation according to penal law are not fulfilled. Even if some of the claims would be false, these would be negligible. [Ed.s] claims and his criticism of Valkee Ltd. and [X] do not exceed the acceptable.”

Then the points of the 2 leading GROUNDS paragraphs are affirmed.

For those who are familiar with finnish lawsuits, the prosecutor is going very, very far, as he can, in making clear that there is nothing punishable. The statement even rules out that charges could be brought for other claims.

The text even tells, that it is OK to criticise Valkee Ltd, because there is no accepted evidence. Thanks for that nice feature, Mr Pyykönen!

It is absolutely disgusting to see, how Valkee’s PR people work. Making statements for those, who do not check the facts anyway. Or for those, who aren’t aware that Valkee’s words always have to be checked. They are seldom true.

FYI: Valkee Ltd told it has nothing to do with that lawsuit. Ok. Readers know by now, that everything written here is provable and correct. Just because lawsuits are expected. QED. I see this as a nice joke, and there is no need to answer that nonsense defense.

Follow the money: How Valkee’s leaders are cashing in

Personal tax data is public in Finland. Tax offices have terminals where the data can be viewed easily. The screens look like this:

somerto-screen-2012

Screenshots are on file for all of the following. Numbers rounded to x1000€. The mean wage in Finland is 3.200, and at the median 2.900 Euro monthly.

 

Pekka Somerto, CEO

2013: 226.000 Euro (18.800€/month)

2012: 355.000 Euro (29.500€/month)

Joined Valkee in January 2012. The extraordinary 2012 sum may partially stem from a “golden handshake” from Nokia, his former employer. The typical way to get rid off such high cost managers. Somerto made 242.000 in 2011.

Somerto is paid like CEOs of companies listed at the Helsinki stock exchange. With that kind of firm. The finnish prime minister Alexander Stubb gets about 11.000€/month.

 

Juuso Nissilä, CSO

2013: 94.000 Euro (7.800€/month)

2012: 76.000 Euro (6.300€/month)

2011: 79.000 Euro (6.600€/month)

Nissilä was asked on Radio Helsinki, how much he’s cashing in. He refused to answer. He’d just posed with a new car on facebook. No further questions.

 

Aki Backman, CTO

2013: 107.000 Euro (8.900€/month)

A Chief Technology Officer for this product. With such a pay check.

 

Antti Aunio, CTO (-2012)

2012: 83.000 Euro (6.900€/month)

2011: 84.000 Euro (7.000€/month)

Valkee’s co-founder has left, which clearly downed his income: To 58.000 in 2013.

 

Timo Ahopelto, Chairman

2013: 82.000 Euro (6.800€/month)

2012: 68.000 Euro (5.700€/month)

The LifeLine Ventures investor gets the smallest pay check – from his Finland activities.

 

Overview for direct links (pure numbers, avoiding my comments):

valkee-cxo-income

 Note that Valkee is steadily losing ground, making losses for years, and exists on tax and investors’ money.

***

In the meantime, the company tells about a journal publication which was portrayed already here. Of course it’s foul. I will not explain it again. The journal has a problem now, as have the authors.

For those who aren’t familiar with clinical studies: Professor Timo Partonen, head of the mood disorder department at the finnish Institute for Health and Welfare (THL) and a world-leading expert for Seasonal Affective Disorder, commented on that study

[this is] scientific misconduct.

Partonen is, amongst many other tasks, editor-in-chief of the Annals of Medicine.

Valkee’s sales crash, loss explodes, tax funding stops: The results

Valkee Ltd has filed its 2/2014 balance with the tax office just hours before the last deadline on 27th June 2014. It seems they had every reason to keep it private as long as possible. However, yesterday Valkee’s results became available.

Interestingly, the press remains silent so far. The disaster is worth reporting.

balance2014-1

Revenue

Valkee’s sales are down 44,3% from 1,941 million in 2/2013 to 1,080 million Euros. The scandinavian campaign last winter has not paid off, it seems. The Valkee 2 must be a total flop.

Loss

Loss grew by more than factor 10 to 2,919 million. Loss is therefore nearly x3 the revenue.

Debt

Debt grew by a million to 2,55 million.

Investments

Last year, Valkee told on all media channels they had acquired a giant 7,4 M investment from old investors and abroad. The balance tells only of 3,456 M and 1,75 M in new shares. Where is the rest they promised? Capital left was 843.000 843 T€.

Tax funding

Public funding by TEKES was all the years booked as “Other income”. Last year Valkee got over 878.000€ tax money. This is down to 70.000 71.000 which would mean that state funding has practically stopped.

***UPDATE 11.7.2014***

The press has finally reacted to the ass-kick: Helsingin Sanomat, Kaleva, Kansan Uutiset, …
Some of the journalists have been in contact with earlightswindle.com. Radio Helsinki gave Valkee’s “CSO” Juuso Nissilä massive air time in a 2-hr program. The trashy interview included strange remarks about this site and this blog, may be commented later. Nissilä admitted, that this website has had a central part in Valkee’s downturn.

Pekka Somerto, CEO of Valkee Ltd, told that it’s nothing special for a company to have ups and downs (!), and that the result was within the acceptable range – because Valkee had not gone for new markets in the last fiscal year. Somerto lies to the press, at least that is then business as usual.

Valkee expanded to Norway and Sweden - An epic fail.

Valkee expanded to Norway and Sweden last winter: An epic fail.

The Paholaisen Asianajaja-blog was able to confirm that TEKES funding for Valkee has stopped. The agency told that already. Thx Juha for the cross-check!

Valkee’s balance sheets seem to be of public interest, and were requested by many. So here the documents are in full:

valkee-balance-2-2014
Valkee_balance-2013
Valkee_balance-2012
Valkee_balance-2011

University of Oulu: Valkee’s “revolutionary research” is a sub-standard bluff

Valkee’s central marketing story: Ground-breaking research by the University of Oulu shows that the brain senses light, enabling earlight to affect the mind. Valkee’s sales and investment acquisitions rely completely on the tale of world-class research from the far North. The university never confirmed that.

Seven years after Valkee Ltd. was founded, and with the scam device being sold for 3½ years, the first independent evaluation of their alleged research appeared. Finally, it is possible to check what really happens in Oulu.

Punchline:
Independent peer-reviewed evaluation finds that Valkee’s research is of the lowest possible quality. The University of Oulu tells publicly that there are no breakthrough findings, and such may never come. – Valkee’s claims are completely unproven. Thousands were conned into buying crap, and critics have been right for years.

Valkee Ltd knew what will come when this post was announced a month ago. They “took action” in advance, an incredibly desperate move.

 

The 2014 RAE Report: Evaluating Research at the University of Oulu

The methods of the peer-reviewed evaluation are described in its final report (pp.10). 49 Research Communities were evaluated by a panel of 32 international experts.

[ Download the Report from the University of Oulu (PDF, 8 MB) ]

The research project Valkee is always referring to is named here “Phototransduction in mammals”, in short RC Phototransduction. It started in the veni category for very early-stage research and hypotheses, the other categories being vidi for groups still lacking international recognition, and vici for world-class projects.

The personnel is known from Valkee’s presentations.

rc-photo-staff

Of all evaluated RCs at the University of Oulu, this one scored worst. On a scale 1-6 it was deemed unsatisfactory (2), all other research was at least 1 point better (p.140).

Health & Biosciences RCs

Health & Biosciences RCs final ranking

The only exception was an incomplete and fully inappropriate application that could not be evaluated (RC GSC, 1.5 pts).

only slightly better as this

Valkee’s stuff slightly better than this (p.30)

Valkee’s “cutting-edge research” is just better, by a small margin, than no science, a bunch of paper grabbed by an incompetent secretary.

Thirteen RCs were recognised as outstanding and nine as excellent, demonstrating a generally high standard of research in Oulu.

 

The findings in detail

a nice opportunity for researchers

a nice opportunity for researchers (p.34)

A research field worth to be explored. But the scientists seem to have submitted something very close to Valkee’s outline.

[ Download: Evaluation results for RC Phototransduction (PDF) ]

  • “It appears that the research project challenges a generally accepted paradigm, and, thus, is both intrinsically innovative but also risky. Present results are promising although often very preliminary. … the preliminary findings […] are mentioned but not presented.”

This paragraph is nearly identical with the company’s mantra. Valkee’s wording is slightly different – findings were “preliminary but very promising” – but apparently the promised results were not available.

 

Outdated and unconfirmed claims about light and the brain
  • The findings that outside light can reach the brain seem to be quite old and should have been confirmed in the meanwhile supported by a reference. At least, some of the data from clinical examinations are supporting this effect.

That quits one of Valkee’s central claims. It’s bitter that after 6 years into what the company calls “ground-breaking research”, nothing more positive can be said than please try to see at least some hints in this stuff.

  • “Since the project has not yet been funded, based on expert peer-review, and the RC director does not report any currently active external funding relevant to the project, its quality cannot be considered favourably at this time.
    The chances of success can only be properly judged after the project has been evaluated by expert peer-review for an appropriate funding agency.”

If correct, then Valkee does not pay for this (more below). No expert from the same field has yet checked the details of the phototransduction project, what can be considered a basic task before money is thrown into it.

 

Stagnation, not innovation
  • “The project addresses a novel paradigm but besides a preliminary test of the hypothesis, it seems to be largely descriptive and to lack development. Its outcome with regard to wide clinical application is uncertain with respect to the present still early stage of research. This is, however, not an argument against performing this type of research at a place like Oulu with its Northern location.”

There is nothing going on here, although it could be OK to move on. Note that this is a description of possible research into a project that never brought significant results – after generating the hypothesis, which stems from the earlight company. Could this stuff have any clinical significance someday, even lead to a treatment? Impossible to tell.

  • “The formation of an RC will strengthen this unique field but this research while being needed, might also be performed in a smaller research environment. The project as set out clearly requires expertise from different scientific disciplines.”

No reason for a big research project, a few people could do it.

  •  “No timetable is given and the methods are sketched out in insufficient detail to be able to judge how far they are appropriate. The above point regarding peer-review is reiterated. Ethical permission for a study on human subjects is mentioned, but how this study addresses the main hypothesis of opsin involvement is not clear.”

To test the earlight in humans has nothing to do with the research tasks. Valkee has defended publicly (here in the comments), that their negative placebo-controlled trial would somehow inform on opsin involvement.

 

Can they find anything at all?
  • “No alternative approaches are considered, and the possibility of the main hypothesis being false has not been taken into account.” – Valkee Ltd puts it:
they knew it already!

they knew it already! (valkee.com)

No open-minded research, let’s see what we find. This is let’s find stuff that fits. Described from the start on earlightswindle.com.

A “sauna idea” like the Nissilä&Aunio 2005 earlight cannot be confirmed later by basic research. The vast majority of such basic results is false, especially if there’s a financial interest, or findings are chased. The rest will only exceptionally lead to a final product. It’s a ludicrous idea, that someone foresaw everything the other way. Indeed, Valkee has claimed just that publicly:

A 2010 “discovered” protein would have lead to an existing product dating from 2005. The study is not even published. – Back to the text.

research-plan_rest

Even if successful, there wouldn’t be much to publish on the international stage. The researchers are well qualified. Or are they?

timonen-qualification

Markku Timonen has a reputation, but nothing to do with experimental neuroscience.

investigators-qualification
The other researchers, too, are working on different things, unrelated to the project’s questions. No-one is somehow specialized. It is not a group working really on the project. Significant findings are unlikely to come.

missing-expertise

 

Excursion: Publications.
The RC leader Timonen has only two related articles, he “published only one significant, original paper relevant to the application (in a specialised physiology journal, plus a hypothesis paper)”. These are all identifiable publications. The bibliometric analysis in the annex was done on papers from 2007-2011, it could not include these articles and says nothing at all about earlight research. However, for the RC Phototransduction evaluation, the publications from 2012 were sighted.

Valkee claims there would be an additional, crucially important 2012 article: A “placebo-controlled” fMRI study showing that earlight activates the brain, allegedly showing “final proof”. It also lists Timonen as an author. It is not included, although Timonen et al. had the chance to add it. Understandable: With a weak methodology not able to show an effect, and its unsupported conclusions, it was published in a blacklisted pseudojournal not indexed in the relevant scientfic databases.

When the finnish funding agency TEKES was asked, why they supported Valkee Ltd for years with millions of tax money, the local representative answered:

Kaleva newspaper, no. 36/2014, page 3

Kaleva newspaper, no. 36/2014, page 3

He believed that the NASA cooperated with Valkee, and said that … decisions were based on documents the applicant produces. Valkee would have shown in a study that brain cells are reacting directly to light. [thanks to OULUN1]

Valkee had produced a garbage paper, which was not even considered for the peer-reviewed evaluation. It was used to get substantial public funding. The company succeeded because the responsible officials are of stunning incompetence, like from another planet.

All the other alleged results of Valkee’s research played no role in the evaluation, because they are practically completely unpublished and have only marketing relevance. – Back to the analysis.

 

The commercially steered project will probably not find anything

success-not-probable

“… they might reach an internationally leading position if their research resulted in major findings which based on the present proposal does not seem very probable.”

A bleak, but obviously justified prediction.

Does it hold promise for teaching and careers, or the society, if there really should be anything?

would be nice, should it not fail

would be nice, should it not fail

 

  • “The research team is already involved with the manufacturer of a device for bright light therapy of seasonal depression.”

Valkee speaks of “joint cooperation” and partnership. Officially, the company does not pay for this. The earlight company is an external activity by the researchers, they are “cooperating” with themselves in double roles. Evidently, there is no cooperation by the University of Oulu with Valkee. Valkee’s CSO Nissilä and the research coordinator Jurvelin registered as PhD students. They got involved with the university that way.

Valkee is also not a university spin-off, just in case somebody should think so.

The evaluation described the situation until early 2013. In June 2013, Valkee reported a giant investment, and made an important statement:

nothing to do with the university
nothing to do with the university

“The University of Oulu had previously been an important research partner, but exceptionally, Valkee itself is now responsible for these [jet lag, anxiety] trials.”

The anxiety trial Valkee used for the 2013 pre-christmas marketing was not an university study, and other current research is no longer done there.

 

“The RC claims to represent a unique constellation of researchers. In the neurosciences community more widely, it is less obvious that these scientists have a high standing. With positive results, they would reach an important position, internationally. Yet, the opposite will happen, should their underlying hypothesis remain unconfirmed.”

As the report pointed out before, that’s the probable outcome. The researchers are not *neuroscientists*, and they presented a weak project with no future.

assessment-conclusions

At the moment, it is not a viable activity.

 

Are there alternative explanations?

Did the researchers submit an incomplete “not-so-serious” application? This is unlikely, because research funding depends on the evaluation results. No-one will deliberately waste funding. Participation in the evaluation was voluntary. Thus, it is theoretically possible that Valkee’s trustees are misjudging the quality of their work.

The text reads sometimes like criticizing a proposal, but it is clearly the existing work to be reorganized as an RC. Consequentially the investigation found all stuff known to exist, the research results are completely covered. The known scientists with their qualifications and publications are on board. Even the headcount is what Valkee told, 15 (to 20) persons. – The message is always the same, the earlight device is neither based on research nor backed by science.

An expert peer-review of the scientific details was beyond the scope of the evaluation, as it was the case for all evaluated RCs. Valkee’s phototransduction research hardly is exempt from general scientific quality standards (e.g. output, impact, etc.) used here. – However, “alternative medicine” proponents often aver that their treatments cannot be examined with usually accepted procedures. It would not surprise if the earlight company claims that a “proper review” would have had totally different conclusions.

Valkee Ltd will probably deny the findings regardless of the facts.


Verdict

A group of non-specialists, not working on a one-way hypothesis dictated by their commercial side project. This lowest-performing of all research groups at the University of Oulu lacks results, and is deemed to have no perspective.

For the company selling the earlight device, this means:

  • Valkee Ltd has made false claims that there are significant research findings backing up the earlight treatment.
  • Valkee Ltd has made false claims that there has been high-quality earlight research.
  • Valkee Ltd has made false claims about its cooperation with the University of Oulu.

This is the official stance by the University of Oulu. Finally,

  • Early expert warnings were correct, but Valkee Ltd did maliciously defame critics.
  • Valkee Ltd fraudulently made thousands of people buy the scam device.

 

#valkeeleaks 6  |  go to earlightswindle.com

No false information on this website, Valkee reassures

Valkee Ltd is having a hard time. They are producing a stream of apologetic “corrections” – to the press, critics and scientists, and now they take on earlightswindle.com. I got the doubtful honor of being addressed in Valkee’s longest blog post so far. The company’s rant comes at the time of disastrous #valkeeleaks publications on this site, after I announced the most important leak to come.

Valkee was asked for many months, to name bugs on this site. Where am I lying? What are false accusations? What is made up? – Until now, the company did not answer. Not surprising, since the files and statements documented here are made by Valkee and/or independent organisations. Here are no accusations.

Valkee’s CEO Pekka Somerto does not challenge the crucial facts, i.e. that so many unpublished negative results exists, and that claimed findings were forged. But he says here are wrong points. I comment on what I could identify, though Somerto was not able to cite properly.

 

Conflict of interest

  • “…contrary to allegations made by earlightswindle.com, none of the researchers – other than the two founders Juuso Nissilä and Antti Aunio – have ever served on Valkee Board of Directors or in Management or staff of the company.”

The finnish trade register tells clearly, that from 2009-2011, Timo Takala was on Valkee’s board. He is listed in publications from that time up to these days, and still serving as a principal investigator for the company.

source: PRH.fi

source: PRH.fi

source: Valkee.com

source: Valkee.com

A blatant lie by Valkee’s CEO. But why? Is Valkee so desperate that nothing matters anymore? Did they want me to waste €6,20 for trade register database access? – I think, Valkee’s financiers and followers are reading this blog, too. Somerto tries to keep them confident. Facts are not important.

But earlightswindle.com is reporting facts, not “allegations”.

NOTE: When people asked Somerto publicly, why he is lying, their questions got deleted, and the text on Valkee’s blog changed mysteriously. See here.

 

Approval as a Medical Device

  • “The publisher of earlightswindle.com accuses that Valkee does not meet the acceptance criteria set for medical devices in Europe, and that Valkee has fraudulently falsified research results to gain medical device approval.”

I never said or implicated anything like this, because this would be a stupid thing to do. It is very easy for manufacturers to gain approval, they do not have to falsify studies for this. Somerto made this openly dishonest accusation already in September 2013. He had, and has, no proof for this. That’s the advantage for someone refusing to cite.

On the other hand, the fact that Valkee falsified results is properly documented and proven beyond any doubt. Not just by me, others came to the same conclusion.

 

A study from Switzerland

  • “When referencing a recently published study by the University of Basel, earlightswindle.com draws a conclusion that the study would prove that transcranial bright light therapy does not work.”

Not true. I had reiterated the basic statement, that the device is useless, as I do on many occasions. The post explains clearly, that the evidence as a whole is telling so – and that there is not a single piece pointing to an effect. The earlightswindle.com main page holds the same distinguished statement. It is a logical conclusion, that because the swiss study showed that Valkee’s device does not influence the internal clock, it is probably ineffective for the claimed indications. However, the independent study did not, and could not, demonstrate this directly.

I am definitely not descending to Valkee’s level: The company claims that a protein in the brain means that the organ is photosensitive. It’s always dangerous to use only own standards when judging other people’s work.

 

Medicines or Medical Device

  • “When referring to “regulatory guidelines” earlightswindle.com points to certain specific guidance for evaluation of pharmaceutical medicinal products and not medical devices at all. The publisher of earlightswindle.com has either misunderstood or intentionally misrepresented the scope of regulation of pharmaceutical products, or is not aware of the Medical Devices Directive that applies to medical devices.”

The text cites guidelines to show that there are officially recognized standards for efficacy in depression. The source is unmistakably labeled, it contains the word “medicine” twice in one line.

It’s worth acknowledging that Somerto points to the harsh difference between devices and medicines regulation: The latter is strict, demanding placebo-controlled trials. The fluffy rules for medical devices do not include such a mandatory efficacy test.

 

Fake peer-review

  • “Peer-reviews are valuable for quality control of scientific work and really cannot be faked – contrary to the allegations made by earlightswindle.com – as the submitting authors do not know which reviewers will check the article, nor do the reviewers know whose article they are reviewing.”

There are journals that claim to be peer-reviewed while they are not, or the review is fully incompatible to what a reader expects when the term is used. Valkee’s earlight studies are published in such journals. To claim that an article has passed peer-review, without pointing to the exceptional circumstances, is what I call a fake peer-review. Valkee’s CEO seriously claims that the label peer-review cannot be misused because peer-review stands for good quality. Is a cigarette healthy, if the manufacturer claims so on the pack?

Every researcher aims to publish in the most prestigious journals and is perfectly aware to what kind of journal he submits his work. This is not a misunderstanding. Pekka Somerto tries to defend improper actions by obstructing the view. Valkee’s only earlight article in a, somehow, medical journal was submitted through an online system which states on its entry screen:

that's definitely not "peer-review"

that’s definitely not “peer-review”

 

I’ll leave it at that. A waste of time and effort. One thing is still worth noting:

Thousands of users

Homeopathy has millions of users though it’s a placebo phenomenon. Valkee is selling through the same channels for “alternative treatments”.

Every humbug will sell when it is marketed to an audience big enough to include susceptible individuals. Valkee’s scam was presented carelessly by the media to tens of millions of potential consumers. It is nice to see that the often denounced masses are not so dumb as Valkee wants us to believe.

 

Final conclusion

It is very reassuring to see, that Valkee Ltd. cannot find false information on this site. The company’s CEO has to lie, to make things up, or he is deliberately misinterpreting simple statements. The crucial points go unchallenged, i.e. that many negative studies remain unpublished, and claimed findings were forged.

Somerto has succeeded in delaying the next of #valkeeleaks by some days. Probably this rant is meant to answer upcoming painful questions: “We’ve already commented on earlightswindle.com and there is nothing more to say.” However, Valkee will have to comment on the facts.

/-ed.