Tag Archives: Timo Ahopelto

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.

Finnish Government gives Science & Ethics a GFY, promotes Valkee’s Chairman

The Finnish Government (valtioneuvosto) has promoted Valkee’s chairman, Ex-CEO and investor Timo Ahopelto to the board of the tax-funded TEKES agency. The man who has wasted millions in this scam. The person who was in charge when a fake publication by Valkee lured TEKES into throwing more millions on the company.

This is the most bizarre and absurd political move possible – at a time when Valkee’s fast demise became apparent. Ahopelto is now responsible for TEKES spending policy, he decides about projects greater than 3 M Euros.

Now a few words in private. No, I don’t expect Valkee to get another 3 M€ from TEKES. But I expect that they went finally too far with this.

The policy makers could hardly say it more directly: Fuck the public opinion. Fuck science. Fuck ethics. Here is money to be spent.

Simply incredible.

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

Study: Valkee’s earlight does not improve athletes’ performance

Even in Finland, the SAD season is too short for Valkee Ltd to survive the summer months. Thus, the company seeks to ensure revenue by promoting the scam device for jet-lag, sports performance, and many other things .

In winter 2013/14 they started a campaign with Jarkko Nieminen, a finnish tennis pro. Sponsored by Valkee, he tells in childish, poorly ghost-written words to perform better with the earlight (although he actually only loses ATP ranks since he’s “using” it).

 

Background

The company shows around a 2011 study with Oulu’s Kärpät hockey team. In May 2014 Valkee fanfared that it’d been published in a peer-reviewed journal. Since such claims were always false so far, it would be an enormous achievement if true.

The following information is from Valkee’s article, and from the TV testimony of the study’s main author, Mikko Tulppo, if not stated otherwise.

Valkee bought the study from the rehab and research firm Verve in Oulu for 10.000 Euros. A remarkably low price for the tremendous marketing effect coming with Finland’s serial champions (they just took also the 2014 championship). Tulppo and Valkee’s CSO Nissilä worked together before, which may explain the discount.

 

How was the study done?

The study took place in October 2011 (Tulppo said November). There were 10 matches in 24 days. Twenty-two players did participate. Eleven got an earlight device. The other 11 got a defective earlamp which produced no light at all – the so-called placebo group. All were instructed to keep the earplugs, lighted or not, in the ears at home every morning for 12 minutes. They should keep a diary for observations possibly related to the study.

Mikko Tulppo on YLE TV

Mikko Tulppo on YLE TV (MOT)

Before and after the 3 weeks treatment, at least these 8 outcomes were recorded:

  • reaction time to a visual signal (a yellow light)
  • motor time (hand movement to press a button)
  • total time from signal to effect, i.e. light … button pressed
  • reaction time to an audio signal (a beep)
  • motor time (hand movement to press the button)
  • total time from signal to effect
  • a memory test
  • sleep quality (VAS, visual analog scale).

 

What were the results?

Initially, all outcomes were negative – No significant changes (sleep data not shown):

valkee-results-karpat-oulu

The authors then used a data torturing technique to make at least one outcome positive: Adjusting for age brought a difference for the motor time to visual signal measure in the earlight group, marked in the table. The reaction time was unchanged, also the most important stimulus → action outcome.

Dredging with the Bonferroni test brought post-hoc (!) a success within the earlight group for the motor time component. Despite the variety of statistical tools available, the other 7 of the 8 outcomes stayed negative.

Side effects are not mentioned, but at least one player from the sham group had to stop after three days. He got no earlight – but severe sleep problems from the strong nocebo. Although not all 22 players completed the trial, handling of such dropouts was not described. However, it dictates the results.

 

Where are the bugs?

Even the authors state that the study was probably not double-blind – it cannot be, if one gets a lightless lamp home in a light treatment trial. The correct conclusion: Even with open treatment, the device’s placebo effect did not produce significant changes.

The paper, full of orthographic mistakes, holds another nonsense claim:

  • “light treatment was administered during the darkest time of the year”

The trial was conducted in October, shortly after the autumn equinox, which is the same even in Oulu. Day length in mid-October is nearly 10 hours there, just one hour less than in London. The darkest time of the year has only 3,5 hrs day light in Oulu (Dec 22). Whoever reviewed this paper was apparently not familiar with the european calendar.

By far the most significant problem, however, is that the players’ true strain was ignored. The paper tells

  • potential confusing factors like training load, competitions, and travel are virtually identical within the team

Why wasn’t corrected for time on ice? It’s readily available, and stands probably also for other confounders. An injured player would not play. He trains differently. A player who is perfectly fit at the beginning may be tired after 10 matches. Databases indicate sharp differences during the trial (jatkoaika.com):

  • Of the twenty Kärpät players from the first match, 15 played also the last.
  • 27 athletes were on ice during the trial period.
  • 15 of them appeared in 9 or 10 out of 10 matches.
  • Six persons played only on 1 – 4 of all 10 occasions.

karpat-stats-oct-2011

Thus, the results are completely meaningless. With such a low quality, the study would not be accepted for a peer-reviewed journal.

 

How was the paper published?

Announced by Valkee’s frontend Timo Ahopelto for April 2012, the article appeared 2 years later. Ahopelto told repeatedly that it is under review somewhere. Received for his final resting place in February 2014, it must have been submitted to at least 4 other journals before. Possibly there were more fruitless submissions.

Frontiers in Physiology is one of dozens similar journals by the swiss company Frontiers Media SA, known for dubious practices – just what to expect from any predatory publisher. Started recently, it’s available electronically only. The Nature Publishing Group owns the company, and thus participates in the boom of more or less suspicious open access publications. The business model “pay-for-publication” without editorial interference reached the big players.

The journal is not indexed for MedLine, which accepts only quality journals. The surprising twist: It slipped into the PubMedCentral repository of free articles, and because PubMedCentral is raked regularly by PubMed with the eCollection stamp, it got a PubMed citation. “MedLine and “PubMed” are nowadays synonyms, blurring the borders between the worlds, and between real and fake peer-review.

see the difference?

see the difference?

Frontiers in scamming: Valkee article

Frontiers in scamming: Valkee article

Frontiers in Physiology has no real peer-review. The journal’s website says, that it is very unlikely to get an article rejected, and so the Valkee paper got accepted: The associate editor for the Exercise Physiology part assigned it to one of his subordinates at his workplace, the “Department of Applied Physiology and Kinesiology” of the University of Florida.

Their homepage promotion: Daniel Wolpert Ph.D. explains, ‘Why we need a brain?

This assignee is an experienced dance instructor from Korea, which explains her unawareness of the European calendar (see above). Seemingly not confronted before with clinical trials and (other than descriptive) statistics, she could do nothing else and returned the paper to her boss. He okayed it.

Peer-review usually means that two or more independent reviewers from the same field look at the paper. They shall certainly not be dependent from the editor.

While Frontiers is praising their “efficient” process, it would not surprise if more suspect publishers sprang on board. Valkee has shown again, that they are able to cheat beyond the last frontier of academic credibility. As the company is armed with time and money, we have hardly seen the last junk study from the earlight scam.

Buried Study: Earlight does not influence heartbeat and blood pressure

we will continue to present … at conferences [and] share information with anybody interested in their own well-being” – Pekka Somerto, Valkee CEO

The mainstay of Valkee’s marketing has been the production of pseudoscientific congress presentations in lieu of scientific journal articles. Their website has more than half a dozen such commercial posters, meant to deceive the lay reader about the efficacy and background of Valkee’s device.

However, a number of studies does not make it into Valkee’s ad circus, despite their leaders’ promise to “inform our customers” whenever “new results become available”. One of three buried studies known to earlightswindle.com was done to show an effect on the cardiovascular system. If earlight mysteriously “activates” the brain, what does it do with the heart and the blood pressure? You may guess it: Nothing.

The following abstract is from a poster drowned among hundreds of its kind on the EuroPRevent 2013 congress. Like all other earlight studies, this one is not published in a peer-reviewed journal.

Abstract: P534
Effects of transcranial bright light treatment on cardiovascular autonomic regulation

Authors: MP Tulppo1, AM Kiviniemi1, AJ Hautala1, J Karjalainen1, JJ Jaakkola2, TM Ikaheimo2, J Nissila3, H Jurvelin3, T Takala4, HV Huikuri5
1Verve Research, Department of Exercise and Medical Physiologic – Oulu – Finland
2Centre for Environmental and Respiratory Health Research, University of Oulu – Oulu – Finland
3Department of Biology, University of Oulu – Oulu – Finland
4Oulu Deaconess Institute – Oulu – Finland
5Institute of Clinical Medicine, University of Oulu – Oulu – Finland

Topic(s): Hypertension (Rehabilitation & Implementation)
Citation: European Journal of Preventive Cardiology ( April 2013 ) 20 ( Supplement 1 ), 96

Purpose: A recent study suggests that transcranial brain targeted light treatment via ear canals may have physiological effects on brain function studied by functional magnetic resonance imaging techniques in humans. We tested the hypothesis that an acute transcranial bright light treatment via ear canals may have effects on autonomic regulation in mild hypertensive subjects.
Methods: Hypertensive men without any medication participated in the study (n=19, age 61±3 years, systolic blood pressure 140-160 and/or diastolic blood pressure 90-100 mmHg during one week follow up at home). In a blinded study design, a twelve min dose of bright light treatment or sham treatment were administered in a random order on separate days by a transcranial bright light device via the ear canals (blue based LEDs). Blood pressure and ECG were measured during the treatments. Heart rate variability was analyzed in 5 min periods at baseline, at the end of treatment, immediately following and from 7 to 12 min after treatment. Standard deviation of R-R intervals (SDNN) and high (HF), low (LF) and very low (VLF) frequency powers of R-R intervals were calculated by standard spectral techniques. Analysis of variance for repeated measures with time x group interaction was performed for the measured variables.
Results: There was no time x group interaction in heart rate or blood pressure. SDNN and VLF power increased during the bright light treatment but not during the sham treatment (time x group interaction p=0.019 and p=0.040 for SDNN and VLF, respectively). VLF power was 6.7±0.7 vs. 6.6±0.6 ln ms2 (p=ns) at baseline for bright light treatment and sham, respectively. The corresponding VLF values for bright light and sham were 7.0±0.7 vs. 6.6±0.7 (p=0.034) at the end of treatment, 7.3±0.7 vs. 6.8±0.7 (p=0.013) immediately after treatment and 6.9±0.5 vs. 6.9±0.6 ln ms2 (p=ns) at the end of the recordings. LF or HF power did not differ between treatments (interaction p=0.33 for both).
Conclusion: The results of this blinded and sham controlled trial provide evidence that acute transcranial bright light treatment via ear canals have effects on cardiovascular autonomic regulation in hypertensive males documented by increasing long-term heart rate variability indices.

The only transient difference between placebo and Valkee treatment was found for a tertiary calculated value:  Very low frequency (VLF) oscillations are for instance dependent on the ambient temperature. The difference vanished quickly and was not seen at the end of the recordings, after approx. 10 minutes. The VLF measure is very questionable.

dubious-heart-study

SDNN is not valid for short-time recordings (same source). The authors have a background in physiology, they surely know that they are faking.

The important LF and HF values were unchanged, and heart rate and blood pressure did not change with earlight.

“In clinical trials … Valkee light exposure has been evidenced to have effects that also regular sunlight has: reduced stress and blood pressure, elevated mood … “– Timo Ahopelto

A dubious study for a dubious device – and Valkee spreads dubious information.

How many buried negative Valkee trials may be out there? One more will be featured on this blog soon.
On twitter: @earlightswindle #valkeeleaks – or simply #Valkee.

#valkeeleaks 3

Update 14.3.2014: This trial was announced by Valkee’s Timo Ahopelto shortly before their bust in 2012.  A good example of how Valkee’s trials and publications are announced by their marketing team and later vanish without any word. At the same source a second broken promise – also the Kärpät Ice Hockey trial remains still unpublished.

Die Valkee-Story (2)

Das Millionengeschenk der Medienbranche

Die Markteinführung von Valkees Ohrleuchte ging mit einer für mitteleuropäische Verhältnisse schwer vorstellbaren Medienkampagne einher. Die rührende Geschichte der kleinen Firma aus dem von Nokias Absturz gebeutelten Oulu, die mit einem schrägen Produkt die Behandlung der Volkskrankheit Depression revolutionieren wollte, kam gut an. Der damalige Geschäftsführer, Juuso Nissilä, zählte im Mai 2011 bereits an die 700 Beiträge in Zeitungen, Radio und Fernsehen – eine praktisch komplette Abdeckung der Nation. Diese kostenlose PR sei bis zu diesem Zeitpunkt schon 4 Millionen Euro wert gewesen.21

Selbst die Präsidentin Tarja Halonen blieb nicht verschont. Mit der falschen Angabe, das Valkee-Gerät hätte in Studien 9 von 10 schwer depressiven Patienten geheilt, erhielt die Firma den INNOSUOMI-Ehrenpreis 2010.22 Valkee konnte zwar keinerlei Belege dafür vorlegen. Die Geschichte wurde aber dringend gebraucht in einem Land, das mit Nokia gerade die wichtigste Steuerquelle, zehntausende Jobs, und ein nationales Symbol verlor.

Die breite Öffentlichkeit war dem Märchen gegenüber kritisch geblieben, und die Verkäufe im Weihnachtsgeschäft 2010/2011 blieben mager. Die Firma stand wirtschaftlich am Abgrund, der Verlust überstieg den Umsatz deutlich.23 Auch wissenschaftlich war Valkee am Ende: Das Resultat der einzigen placebokontrollierte Studie mit Valkees Gerät war vernichtend. Placebo war sogar numerisch besser als die Ohrleuchte.24

Der LifeLine Ventures-Fonds, der auch Anteile an Pharmafirmen hält, rettete Valkee, setzte Nissilä ab und den neuen Geschäftsführer Timo Ahopelto ein. Ahopelto kam ebenfalls aus dem Bereich der Pharmaindustrie.25

Die Medienkampagne bekam eine beispiellose Intensität. Plötzlich machten die Valkee-Forscher bahnbrechende Entdeckungen – von denen in der Fachwelt niemand Notiz nahm. Die Universität Oulu fand nun 2011 heraus, dass Nissilä und Aunio 5 Jahre zuvor eine völlig neue Wissenschaft vorausgesehen hatten. Die Ohrleuchte bekam den theoretischen Hintergrund, der immer gefehlt hatte. Das Gehirn wurde über Nacht lichtempfindlich, was Valkee immer hellseherisch behauptet hatte, und reagierte auf Ohrlicht mit “Aktivierung”.26,27 Das war zwar neurophysiologisch Unsinn, aber eine konsequente Umsetzung von Ahopeltos Geschäftsmethoden.

Das komplette Desinteresse der seriösen Wissenschaft sei, so erklärte Nissilä, eine Verschwörung der Herausgeber der wissenschaftlichen Fachzeitschriften mit der Industrie.28 Die revolutionäre Ohrleuchte wäre zu neu und zu gefährlich für die Pharmafirmen (!), als dass auch nur eine Zeile irgendwo veröffentlicht werden konnte.

Das entscheidende Weihnachtsgeschäft 2011 wurde eingeleitet mit Auftritten von Valkees “Forschern” und Führern im Frühstücksfernsehen, in den Hauptnachrichten, und ungezählten Presseberichten.29,30 Es lägen nun endlich die lange erwarteten Studien vor, die eine herausragende Wirksamkeit des Valkee-Gerätes zeigen sollten. Zwar nur als kommerzielle Poster auf einem Kongress, aber die wissenschaftlichen Artikel würden sicher bald erscheinen. Es handelte sich um eine Pilotstudie mit 13 Patienten, die dank intensiver klinischer Betreuung eine typische Placebo-Heilungsrate von 77% zeigten, und die gescheiterte placebokontrollierte Untersuchung. Nur war Placebo als echte Behandlung deklariert worden – eine massive Fälschung.31,32

Der Winter brachte eine Verdreifachung des Umsatzes auf 1,4 Millionen bei nur moderat wachsendem Verlust. Die staatliche Wirtschaftsförderung war eingesprungen mit 350.000 Euro geschenktem Steuergeld. Zum Ende des Geschäftsjahres hatte Valkee dennoch 1,7 Millionen Schulden und lediglich 76.000 Euro Bargeld.33 Das reichte nicht für die monatlichen Grundausgaben, ohne neue Geldquellen hätte der Geschäftsbetrieb eingestellt werden müssen.

 

NÄCHSTER TEIL: Valkee fliegt auf, und stürzt ab

Fanatics, evil journalists and scientists unduly attacking Valkee, Chairman says

Valkee’s chairman Timo Ahopelto has written an incredible statement in Finnish, which was not translated into English. In a few seconds you will understand, why Valkee keeps this from foreigners. Actually, it tells all about Valkee’s public image in Finland.

It takes a lot to refrain from commenting, as the author of this site is adressed agressively by Ahopelto (who even waggles the nazi card in the end). Read for yourselves, which conspiracies Valkee unravels. Images and links added.

Valkee covered in the Media: Rumours have become facts

“Valkee seems to be the world’s only scientific innovation, about which everybody has an opinion. It tears down fences by bringing science straight to the customer, and that is apparently just what annoys. Valkee annoys so much, the row has got inconceivable dimensions. Rumours and hearsay have turned into facts even in intelligent people.

“I don’t know any other small business, that was attacked by such masses of fulltime critics. Those people call in their free time journalists writing about Valkee, and tell anonymously that Valkee is a scam. Among the world brands, not even Apple has met such fanatism.

“This journalism, which messes up fact and fiction, started with YLE’s MOT TV program. The crew contacted us – and, without our knowledge, also our collaborators – on Christmas 2011 in an ambush. The reporter told, that according to reliable sources Valkee is hiding state subsidies in offshore accounts, and that there were incoherences in our accounting. This hefty claim vanished when I told the reporter how to read finnish balance sheets. The program was finally produced, despite of this. It’s a pity that we didn’t correct all the errors then. MOT is fuel that is still burning.

The opinion of a small, but noisy group of skeptics has risen and turned into a fact, which is cited by others. It’s neither the people’s nor the media’s fault, but if you look into Valkee, you get a textbook example of a chinese whisper, and how skillfully presented rumours turn into facts in the people’s minds. It would pay off for every PR company to hire Valkee’s critics, because their media work is really skilled and efficient. However, I know that the people will understand the truth in the end.

“In the following, three things which are systematically presented as true, while they are not. I could go on with the list up to 20.

“1. Valkee claims, that the bright light earbuds work against nearly anything.
If you really get familiar with Valkee’s stuff, you will note soon that the only health claim is about easing the symptoms of winter depression. Timo Partonen, MD from the National Institute of Health and Welfare has researched winter depression mainly with regular Philips bright light lamps. According to him, symptoms of winter depression are for instance increased appetite, sleep problems and craving for sweets. Valkee claims nothing else than to relieve winter depression and its symptoms.

“We have presented our studies on scientific conferences and reported results in the treatment of anxiety, cognitive performance and jet lag [where?/-ed.]. There is a really big difference between telling results on conferences and marketing claims. They cannot be mixed up. The whole pharmaceutical and medical devices industry works this way. All companies work this way: They are allowed to tell, and have to tell, what they are doing.

Valkee's "science" - marketing

Valkee’s “science” – marketing

“I’d think that the reason for this misconception is the critics’ sloppy reading of Valkee’s material, social media users that comment freely on Valkee with different intentions, and the reckless marketing by some of our resellers. All this has given ground to the idea, that Valkee claims. But that’s not true, and we are very strict about this. Valkee is only speaking of winter blues, and you can check this from the company website.

OK, I checked Valkee's website! Feb 2014

OK, I checked Valkee’s website! Feb 2014

 

“2. Valkee’s marketing is illegal and officials cracked down on this.
I’ve had three roles at Valkee since 2009: investor, CEO and member of the board. During this time, the overseeing authorities never notified Valkee about any violation, and we were not forced to modify our marketing. I personally felt that the cooperation with the authorities – Valvira, VTT, and the equivalent bodies abroad – was really constructive and professional.

“The rumour about an official crackdown on Valkee’s marketing began with an YLE radio reporter, had swolen in YLE’s web service and was translated into english in the end. The reporter had obviously read the blog of a certain noisy skeptic and mistook it for a reliable source. YLE modified the story upon our request, but the damage was already done: Noisy skeptics repeated the thing, which was then taken up by the mass media as a truth, they did not bother to check it. Fortunately, the world’s supervising authorities for medical devices consider research instead of hearsay.

“3. Valkee’s efficacy was not demonstrated, and light does not reach the brain.
It takes a lot to say, that two trials in winter depression, which showed a 74-92% treatment response, a double-blind anxiety study, and a controlled trial on cognitive performance would not demonstrate, that a person’s mood elevates while using Valkee. It is also a bold claim, that light does not reach the brain via the ear canal, when a double-blind MRI study showed an activation of the brain without any light passing to the eye. These results cannot simply be coincidential, or a placebo effect. Sometimes it feels like also objective persons are losing their capability to understand things, painting all just black and white from their dugouts.

“With the current media attitude, it is very simple to find always a new researcher to criticize Valkee’s studies. After all this rumble, when an academic is asked, he has no other choice than to comment, that more research is warranted. Nobody else than Valkee’s tenacious entrepreneurs and the brave researchers from the University of Oulu is ready to testify with their name. Against a common belief, besides the company’s founder Juuso Nissilä, they have no substantial commercial interests in the company.

“Valkee also made a number of traditional bright light researchers to declare war. That’s always happening in science: The discoverer of the New faces the resistance of the Old.

“Vivien Bromundt, of a swiss university, has made very aggressive remarks against Valkee on scientific conferences. She published a study in which a Valkee dose did not influence salivary melatonin or alertness. This melatonin response was already made public by the University of Oulu in 2012. It takes regular use, over 1-2 weeks, to get a treatment effect. We think that the Bromundt study is interesting, confirms what we knew before, and strengthens our idea of Valkee’s mechanism. But the media took up the skeptics’ interpretation and told, that now the first independent study showed that Valkee does not work. Nobody spent any effort to note that melatonin response is a different thing than effects on the mood, and that according to the trials you must use the device for a longer time. […]

“It is correct, that Valkee’s science and research is just in its beginning, but the evidence is already very strong. Of course, everything can be criticized. If somebody tells hat usual bright light is proven effective, and that it works through the eyes, then I can respond: show me a study, which demonstrates that bright light works only through the eyes. I tell you, such a study does not exist. In all bright light trials the whole head is illuminated by high power lamps. In science, you can’t take anything for granted, it goes ahead with new discoveries.

non-existent in hamsters - but in humans?

non-existent in hamsters – but in humans?

“Let’s cut the wings off those rumours. I invite all to discuss the very core of it. Without fury, without 1940’s propaganda attitude, and through objective lenses.”

An epic press fail: How Valkee made your brain photosensitive

When Valkee was on the verge of bancruptcy in spring 2011, left with a negative placebo-controlled trial and no money, they needed positive results fast. They came up with an extremely simple and fast-to-breed histochemic thing, some protein found in all brain regions they chose.

The low-impact test was for Valkee’s PR machine an international scientific breakthrough. The poor encephalopsin was named “OPN3″ and mutated to be “known as the photoreceptor protein”.

opn3-prweb

Oulu’s local paper Kaleva was one of the first targets. A patriotic article about the “breakthrough” appeared soon.

kaleva-fail-earlight

From there, it spread widely and reached even the respected YLE TV news. Now, it was no longer a protein with unknown function, it was the human brain being photoreceptive.

yle-fail-earlight

 And, miraculously the earlight was overnight working as claimed – in the press.

Valkee’s then-new CEO Timo Ahopelto said straight, that Valkee had just made the human brain photosensitive. They really did.

Now it’s the third year since this very finnish scientific breakthrough, and still no journal has showed mercy and found some pages for the poor study. The only echo has been in the Journal of the Finnish Medical Association, mocking about the idea that a protein could mean something for the treatment’s efficacy.

Timo Ahopelto fixes the world:

ahopelto-opn3-fake

Still waiting. It must be the conspiracy of journal editors and industry, which Valkee’s Juuso Nissilä was speaking of, that hinders publication of these grandiotic findings.

You have to remember, that those colleagues who accept new research articles into the journals, they have their own paradigms and also connections to the industry.

What would this society be without this kind of journalism?

Valkee resorts to lies, gives up on science upon Swiss study

The first-ever peer-reviewed scientific article about Valkee was published some 3 weeks ago. It was the first placebo-controlled study on Valkee reaching the public, and it was done by independent, well-known researchers. Therefore, it’s not surprising that the result was negative. Valkee’s scam device is useless.

Valkee had time enough to answer to this piece threatening their scheme. Here is what their chairman Timo Ahopelto had to say:

ahopelto-twitterAs usual for Valkee’s leaders, Ahopelto does not give any proof for those claims. Just tell some random lies, who cares? On Facebook a more common-sense statement:

valkee-facebook-re-1

At this point, the swiss study was not “about to be published”, it was already published 6 days ago. But why not try to mislead those who cannot use PubMed? Valkee’s own earlight research never even came close to a scientific publication – i.e. it never passed independent peer-review.

All those snippets link to a blog entry by Melanie Rüger, PhD, in Valkee’s pop-science blog Shine. It’s reproduced here, because their statements are often volatile.

valkee-blogshine-reWhat Valkee is trying to sell tell on all channels: The Swiss had investigated something which is not related to the earlight’s function. The device does not influence Melatonin, because it’s not needed. All are looking on the Melatonin, but they’re all wrong. If they’d be experts, they’d know that Valkee had already told this – so nothing new here.

The reality, however, is somewhat different from Valkee’s tales.

Salivary melatonin is measured in such studies, because it is the direct marker of the internal clock’s state. That’s a basic thing with references ad libitum. Here, here, here, …

If something works on the internal clock, then it can be checked through salivary melatonin levels. Such studies are usually conducted at the evening or at night, to allow for best signal detection. The melatonin secretion rises in the evening, peaks around 03.00 – 04.00, then falls. It is very low during the day, making it difficult to find changes then. Light suppresses this melatonin level rise, and bright light applied in the evening makes alert. This was shown in the study for the active control condition, standard ocular bright light over 12 minutes. It clearly reduced sleepiness, although normal therapeutic exposition would be 30min or longer.

Valkee’s earlight performed on melatonin secretion like the sham condition, an ear lamp with no light output, it had zero effect. In other words: Valkee’s device does nothing on the internal clock. That’s why the swiss researchers’ conclusion is fully correct:

bromundt-2013-conclusion

Politely they add that longer-term effects were not studied. But how could chronic use have any effect, if there’s not even a short-term reaction to the light?

This has grave consequences for Valkee. All known treatments for jet-lag are interfering with the body’s internal clock. Phase-shifting, clock-setting effects are needed to work against such symptoms and circadian sleep disorders in general. If something is supposed to work on the internal clock, then it has to work on the internal clock. And Valkee’s device doesn’t.

Even if the company would be right with some of their marketing-driven speculations about alternative pathways – the output of the internal clock still says it is not affected by earlight. All embellished talk about feel-good monoamines is pointless, it misses the central question. A smoke screen.

But also the alternative path for promoting alertness is not for Valkee:

brainstem

This result smashes in any case Valkee’s marketing speech of a “portable substitute for sunlight”. Light through the ears definitely has not the beneficial effects of real sunlight on the brain. Their earlight device has nothing to do with true bright light therapy, which works on the internal clock. Valkee’s use of bright light studies for marketing is absolutely inappropriate, at the very least.

Valkee has every reason to silence the public discussion about these facts.

placebo

The company tells further it had foreseen these results already in a 2012 IFMAD congress presentation. They link to a PDF (page 18) with poster titles and author names, but no information on what the research (?) allegedly showed and how it was done. Not only that there’s no scientific publication. Not even the abstract can be found through database searches, and the content is inaccessible. It is virtually non-existing, in terms of science. To compare such a fictive thing to a real journal article is bad misinformation.

catintelligent

Furthermore, the effect of bright light therapy on Seasonal Affective Disorder (SAD) is thought to be related to the internal clock. The swiss results are excellently in line with the findings from clinical trials demonstrating that earlight works, at best, like a placebo in SAD.

Earlight lacks an alerting effect which was demonstrated for bright light, and the study showed that it also has no effect on motoric reaction and attention. The short ocular exposure in the control group did have neither. It is not marketed as improving sport performance in healthy people.

To make it short: Valkee is useless. And that is proven by clinical trials.

There is no reason, whatever, to suspect that it could work.
Are there any doubts, what Ms Rüger is being paid for by Valkee?

/-ed.

Update 28.12.2013: Valkee is reading this blog carefully. They’ve put now online the poster which allegedly told that Valkee’s earlight is working through some alternative pathway, not melatonin.

Here it is.

Instead, the poster says only, that earlight does not suppress melatonin (=does not influence the internal clock). Valkee had known for at least a year, that their marketing claims about effects on circadian rhythms are baseless.

Valkee is telling us, that “Light elicits its effects through different mechanisms than melatonin alone” without knowing a single bit what these mechanisms are. Because it does not work, it works! Because it has to work! We are telling you that it does!!

It is absolutely clear to me, why they hid this poster from the public. Incredible./-ed.

Note 7.2.2014:
On the IFMAD website, the 2012 and 2013 poster abstracts are available now.

UPDATE 18.7.2014:
Noted that the article PDF is better linked here than in the previous post.

Full-text PDF of the Bromundt study.