Monthly Archives: March 2014

Depublished media files confirm: Valkee was an intentional scam

Many sources here are Finnish only. A shame, because Valkee’s own statements are often more telling than my texts. In the following video, their “CSO” Juuso Nissilä explains his breath-taking plans for Valkee, how to make a fortune out of pseudoscience. It was a presentation on the so-called Enterprise Forum 2.0 at the University of Oulu on May 17, 2011. The video was available at the University’s website for a time in late 2011/2012.

[ Download ad-free MP4 (100Mb) ]

Snippets from this 22 min. piece were used to make central points in our  YLE TV1 prime time program, MOT’s The Earlight Tale. After the broadcast in March 2012, the University of Oulu blocked access and later deleted the file. It was too obvious what happened here.

This was the only link to Valkee’s fraud from the University. All other claims about a partnership between Valkee and the University of Oulu come exclusively from the scam sellers.


Valkee scam Howto: Ideasta kasvuun. J… by earlightswindle

Valkeen “tiedejohtaja” Juuso Nissilä Oulun Yliopiston Enterprise Forum 2.0:lla, 17.5.2011. Valehtelun, salaliittoteorioiden, typerän ja manipulaation ilotulitus. Huom miten Nissilä heti alussa selittää, miksi hän ei ole enää toimitusjohtaja: Firmalla on kova vauhti päällä, ettei edes itse huomannut pestinvaihtonsa. – Hän sai juuri potkut koska ajoi firman konkurssikypsäksi.

Oulun Yliopisto poisti tämän tiedoston nettisivultaan MOT: Taru korvavalosta ohjelman jälkeen. Tämä oli ollut yliopiston ainoa vihje mahdollisesta yhteydestään Valkeeseen.


On March 13, 2012, the day after MOT, Nissilä was interviewed live on the phone by the local Radio Mega station (now sold). Asked if MOT was right or not, he confirmed all of the program’s facts: By declining to comment, avoiding direct answers, telling other things than asked, etc.

  • Is it proven that the device works? – It takes decades to build such an evidence base.
  • Is it correct that the researchers own shares in Valkee? – That’s normal in the (pharmaceutical & device) industry.
  • Is it bullshit or not? – No, we’ve clearly made a scientific revolution.

At 2:05 min, when asked if it’s true that Valkee’s biggest trial was negative, Nissilä claims we have several such big trials in publication, or undergoing statistical tests; Valkee has more big completed positive studies. – A bold lie. In contrast to other false claims by Valkee, for which one needs basic knowledge of scientific standards, this one is easily disproved by a mouseclick.

TV-ohjelmamme jälkeen Radio Megan haastattelussa Nissilä sanoo aluksi että Taru korvavalosta ei tosiasioista kertonut, ja sitten joutuu myöntämään että MOT:n esittelemät faktat ovat totta.

Kuitenkin Valkee olisi tehnyt tieteellisen vallankumouksen.

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Yet another buried Valkee study: Placebo-controlled, completed, and silenced.

After Valkee’s public bust in 2012, humiliated with the flim-flam award just before christmas, the company was under immense pressure to come forward with placebo-controlled research. That winter saw a negative sham-controlled study, testing effects on blood pressure and heart rate. It failed and was buried. According to Valkee, a placebo-controlled anxiety study was ongoing, but unknown to the public.

In Seasonal Affective Disorder, there had been an inconclusive pilot trial, a halted one, and a negative placebo-controlled study. I.e. in the main indication, there was only proof that the device does not work. Valkee kept on selling the earlight, while it had been scientifically demonstrated to be ineffective. So another trial was set up, the third placebo-controlled study in SAD. As with its predecessors, the results would never see the light of the day.

sad3
The power was as low as in the previous two SAD placebo trials: 30 persons per treatment group. 60 participants were recruited to receive earlight or “placebo treatment” at home.

It is fully unclear how the placebo could have been given unidentified. If there was dim “placebo light” – then the setting would have been a copy of their previous failure, where placebo light scored better than earlight. Or, if there was no light, then it would be an obvious fraud as it was in the Oulun kärpät ice hockey study.

Therefore, the study quality seems not better than in the failed trials. No additional statistical power, no advanced methods. Why would someone waste time and money to conduct such a trial? Just to show “we are doing research”? Or to fake results planfully?

The results of the blood pressure trial were at best neutral and shown to maybe a few congress visitors. The results of this SAD trial were buried completely. There is no way to guess what the outcome was, as long as the data is hidden from the public. It’s not a good sign when the very existence of a study is silenced.

Until proven otherwise, there are now 3 unsuccessful placebo-controlled earlight studies in Seasonal Affective Disorder: The first, with 60 participants – halted. The second – failed. The third, again with 60 persons – buried. And sales go on.

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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