Category Archives: science

No false information on this website, Valkee reassures

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

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

Valkee’s CEO Pekka Somerto does not challenge the crucial facts, i.e. that so many unpublished negative results exists, and that claimed findings were forged.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

 

Conflict of interest

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

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

source: PRH.fi

source: PRH.fi

source: Valkee.com

source: Valkee.com

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

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

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

 

Approval as a Medical Device

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

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

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

 

A study from Switzerland

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

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

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

 

Medicines or Medical Device

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

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

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

 

Fake peer-review

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

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

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

that's definitely not "peer-review"

that’s definitely not “peer-review”

 

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

Thousands of users

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

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

 

Final conclusion

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

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

/-ed.

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.

#valkeeleaks 5

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.

#valkeeleaks 4

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.

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.

First placebo-controlled study and peer-reviewed publication: Valkee is useless

[exclusive] The first-ever peer reviewed article about Valkee’s earlight was published last week. It was a placebo- and active-controlled study. It was negative.

Bromundt V, Frey S, Odermatt J, Cajochen C.
Extraocular light via the ear canal does not acutely affect human circadian physiology, alertness and psychomotor vigilance performance.

It was accomplished by scientists from the Centre for Chronobiology, Psychiatric Hospital of the University of Basel, Switzerland.

Valkee knew about this piece for several months. They were asked in public in the summer but declined comment. The company remained silent to its customers.

More about the results later on. For the moment, I am waiting for Valkee to react. They have always brought some marketing fakes before Christmas. There is not much time left, so the IFMAD tomorrow and other congresses have to be watched. Valkee is not on the scientific program, but their CEO Pekka Somerto has announced that they will put poster commercials on some walls shortly.

Now they have to compete with a real publication in a really peer-reviewed journal.

/-ed.

UPDATE 21.11.13: Like predicted, Valkee reacted with a weak poster presentation at the IFMAD in Monaco. Nothing in the scientific programme. It looks faulty at the first glance, but more when my time it allows.

Valkee dismissed this swiss study, of course. The points in the company’s rebuttal were not very valid. Their CEO promised a real journal article, but so they did before. Which journal will ever publish such a foul thing?

Nobody should waste $50 on the article full-text, it is available from the lead author’s page.

/-ed.

Update 25.11.2013: THAT’S ALL? A trash claim – that Valkee “does not work via Melatonin”? and that this study did not add anything new?

Two possible scenarios.
1.) Valkee does not want to talk about the negative results at all. From a marketing viewpoint understandable. Hope that all will forget, and nobody else notices.

2.) Valkee has nothing else to tell. They simply are done. Or maybe, it’s both.

For the endless discussions on several blogs: Don’t let them troll you.
It is absolutely justified to say “Valkee is useless” based on the current information.
Scientifically spoken: A fact.

Read the analysis of this study, and Valkee’s bogus comments here.
/-ed.