Tag Archives: Betrug

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

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

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

“Doesn’t this need FDA approval?”

valkee-fuck-fda

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

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

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

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

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

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.

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.

Media council favors Valkee, weakens freedom of the press

The Council for Mass Media in Finland has handed out an official notification about misconduct to the Suomen Kuvalehti magazine, part of Otava Media. Valkee Ltd had complained to the council about an article which had analyzed Valkee’s science, much like earlightswindle.com.

The logical conclusion: Valkee’s health claims are bogus. That conclusion was left unchallenged. But the company wanted to present its “dissenting opinion” – i.e. marketing message – along with the criticism.

From the council’s decision:

“the company got very negative publicity from this article […] because the efficacy of the device manufactured and marketed by [Valkee Ltd] was denied completely. […] The company was not heard … There are conflicting expert opinions and understandings of the studies regarding the earlight headplugs, and the final truth is not found yet. For these reasons, [Valkee Ltd] had the right to a representation.” [rough translation]

The council thus decided in favor of the so-called Balance bias, a phenomenon which competent journalists worldwide seek to avoid. The textbook example for catastrophic misinformation resulting from a neutral viewpoint was the row about global warming. The media made it look as if the climate skeptics’ points would be actually discussed in the scientific community. Actually, there was, and is, clear scientific consensus. A representation of scientific facts skewed by “neutral” reporting.

Just the same as in the Valkee case: Nobody except company-affiliated persons ever claimed that the device works. So, how could somewhone claim “the truth is not found yet”? The device does simply not work. Efficacy must be proven, not its non-existence.

With the same logic, a documentary about the Apollo Missions would have to include the dissenting viewpoint, that it’s all a NASA fake. This idea, too, was brought up later by crackpots. Does it mean that “the truth is not found yet”?

The Council for Mass Media in Finland is not alone with its uninformed view. Numerous such cases are documented, some sound funny, others tragic. The BBC was attacked for misrepresenting astrology in an astronomy programme. Public discussion about vaccination risks, started by an now-convicted charlatan, led to a drastic fall in MMR vaccination rates in the UK. (Read the excellent BMJ article in full.)

There have been numerous court cases in Europe, where companies tried to stop negative reports with just the same arguments like Valkee Ltd. It reminds very much of a legendary german trial: 40 years ago, the pharmaceutical firm Nattermann, backed by the industry lobby groups, tried to stop reports about the inefficacy of one of its blockbuster drugs. The final decision by the Köln Apellate Court (OLG Köln) had a remarkable rationale:

[the journal] acted with legitimate interest… [In medicine,] it’s crucially important to inform […] timely about negative findings, to save the patient from possible harm.

If the positive sides [of the product] are brought into prominence by massive advertising, the press has every right to pick negative statements and to cite them, even if the same publication, where the quote is taken from, contains also positive opinions.”

Valkee Ltd has a long tradition of suppressing inconvenient information on the net, and now it takes on the old media. Where’s the actual court decision which gets things right?

update 7.7.2014: there’s a twitter storm going on about this just now. Better late than never. See Longplay.fi and #valkee.

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

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

Die Valkee-Story (1)

Aktenkundig wurde die Valkee-Story erstmals im September 2006, als der Elektroingenieur Antti Aunio und sein Freund, der Tierphysiologe Juuso Nissilä, in Finnland einen Patentantrag stellten.1 Es ging um ein Gerät mit 2 in die Ohren leuchtenden LEDs, die über Kabel an einem Akku mit Zeitschaltuhr und Dimmer hingen. Die Idee zu der Ohrleuchte entstand laut Nissilä ”über einer Tasse Tee” im Winter 2005/06, der Prototyp des Geräts sei dann innerhalb von Wochen fertig gewesen.2,3 Der Widerspruch zur Firmenwerbung, das Gerät beruhe auf wissenschaftlicher Forschung, sollte Valkee später noch zu schaffen machen.

Das finnische Patentamt lehnte den Antrag ab, wie auch weitere Versuche in den Folgejahren.4 Die Idee der Stimmungsbeeinflussung mit Ohrlicht war nicht neu, einige ähnliche Geräte waren bereits zuvor beschrieben.5 Erst 2011, nach mehr als vier Jahren, gelang es Valkee, ein eng begrenztes Patent zu erhalten – für das Ohrlichtgerät in seiner exakten Form (vgl. Geschmacksmuster).6 Die Finnen hatten also nicht die Ohrlichttherapie erfunden, sondern eine bestimmte Ohrleuchte gebaut.

Die Firma Valkee Oy wurde im Frühjahr 2007 gegründet, um das Gerät zum Markt zu ”entwickeln” (zum Verkauf zu führen).7 Die Idee: Valkee hebt sich von anderen Verfahren der Alternativmedizin durch die Existenz wissenschaftlicher Forschung ab. Wann und wie die Universität Oulu ins Spiel kam, darüber machen alle Beteiligten abweichende Angaben. Valkees offizielle Version ist jedenfalls, dass das Ohrlicht Begeisterung hervorrief, als die Erfinder mit der Uni Kontakt aufnahmen. Ein ganzes Forschungsprojekt sei daraufhin gestartet worden, mit Wissenschaftlern verschiedenster Disziplinen und hunderten Patienten.8

Die Realität dürfte profaner sein: Auf der Suche nach Drittmitteln akzeptierte die Universität Oulu die Firma Valkee als Sponsor, woraufhin die Ohrleuchtenbauer Räume und Ressourcen der Uni nutzen durften. Am wichtigsten war jedoch der Name der Universität, der dem Gerät den Anschein von seriöser Forschung gab. Das Resultat des Programms blieb bis 2014 dann auch mager, mit einer Handvoll Artikel, die bis auf einen umstrittenen nichts mit der Ohrleuchte zu tun haben.9-14

Die behördliche Zulassung als medizinisches Gerät war eine Formsache. In Europa zeigten die Skandale um mangelhafte Brustimplantate und defekte Hüftprothesen, wie einfach so ein Zertifikat zu bekommen war.17,18 Valkee erhielt es mit nachgewiesener Produktsicherheit und Produktionsqualität, aber ohne Prüfung auf Wirksamkeit. Das geht aus den Zuständigkeiten der Prüfer und dem Zertifikat hervor, das bis zur Martkeinführung der Valkee-2 Version auf der Firmenwebsite zu finden war.19,20 Die Ohrleuchte war ausreichend ”getestet” – weniger als manche Zahnpasta.

Ohne eine einzige wissenschaftliche Publikation zum Thema, ohne dass irgendjemand sonst außer den Firmenmitarbeitern je daran ”geforscht” hätte, wurde Valkees Ohrleuchte im Spätherbst 2010 am Markt eingeführt.

 

WEITER: Das Millionengeschenk der Medienbranche

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.”

Einführung: Valkees Ohrleuchtenschwindel

Der Valkee-Schwindel ist ein Betrug aus Finnland. Die Firma Valkee Oy verkauft ein Set aus zwei dimmbaren LED in Ohrhörer-Form und einem kleinen Steuergerät für rund 200 Euro. Diese “Ohrenscheinwerfer” sollen angeblich eine Reihe von Krankheiten und Beschwerden zuverlässig beseitigen, darunter Migräne, Jet-lag und Winterdepression. Neuerdings  wird selbst eine Wirkung gegen Krebs und andere schwere Krankheiten angedeutet.

Andere Quacksalbereien dieser Art, wie z.B. Magnettherapie, “Zapper”, Ohrkerzen,  usw. behaupten ganz einfach, Wunder zu vollbringen. Valkee dagegen hat eine Reihe von pseudowissenschaftlichen Präsentationen und gefälschten Studien erzeugt. Damit gelang es der Firma eine Zeitlang, die Medien in Finnland und anderen Ländern zu täuschen. Die vorgeblichen wissenschaftlichen Erkenntnisse wurden in vielen Werbeartikeln der Laienpresse verbreitet. Mit falschen Angaben hat Valkee sogar einen Ehrenpreis der finnischen Präsidentin Tarja Halonen erhalten.

Der Valkee-Schwindel ist eine der wenigen Scharlatanerien, deren Unwirksamkeit wissenschaftlich belegt ist. Eine von der Firma selbst angestrengte placebo-kontrollierte Studie zeigte die Unwirksamkeit für Winterdepression – Scheinbehandlung war sogar numerisch besser als echtes Ohrlicht. Die einzige bekannte unabhängige Studie bezog sich auf den behaupteten Effekt bei Jet-lag – dieser konnte ausgeschlossen werden. Das Gehirn reagiert in keiner Weise auf die Ohrleuchten.

Es dauerte in Finnland anderthalb Jahre, bis dieser Schwindel aufflog. Der Autor dieses Blogs hatte entscheidenden Anteil an der Aufdeckung. In Deutschland findet sich derweil keinerlei firmenunabhängige Information. An dieser Stelle werden zentrale Punkte des Betrugs kurz abgehandelt, sofern es zeitlich möglich ist.

Fortsetzung: Die Valkee-Story, Teil 1

/-ed.