Tag Archives: buried results

New (not so) independent study: Valkee’s HumanCharger is a placebo (Update)

The finnish earlight maker Valkee Ltd is putting all-in on the american market after plunging sales in Europe. Its product, the premium-priced placebo HumanCharger, is sold with wonder claims online by Walmart and others:

Walmart as a co-scammer!

  • Keep in sync, all the time: regular exposure to light helps maintain the rhythm of our natural body clock, so with HumanCharger you always feel “in sync”
  • Better sleep, better health: HumanCharger reduces the need for excess sleep and reduces food cravings associated with jetlag, tiredness and low energy levels

At the same time, the second independent study about the device’s effects (or the lack thereof) is published. The result … is the same as in all other placebo-controlled tests.

Independent trial: Valkee is a sleep and mood placebo

It is concluded that transcranial bright light, at times where conventional light therapy has phase-advancing properties, did not influence any sleep parameters differently than placebo.

This is by no means surprising, as the first independent trial, published in November 2013, came to similar conclusions with a somewhat different methodology. Valkee’s HumanCharger has no effects on circadian rhythms. The new independent study is from the University of Bergen, Norway. With 50 participants, it was adequately powered to detect any effects consistent with Valkee claims.

The company has admitted, that their earlight doesn’t have any physiological effect comparable to standard light therapy. Their own data also show, that it does not influence Melatonin or Cortisol like real light therapy. Now we know, it doesn’t improve or at least change sleep in any way.

The HumanCharger does not influence the biological clock.
No “better sleep. better health – sync with the sun”. It’s all made up.

Ironically, Valkee Ltd is just touring the US with exactly these false claims. The company has been presenting on the Consumer Electronics Show CES2016 from Jan 6-9 in Las Vegas. It would be interesting to see the reactions of any resellers, when they realize that the HumanCharger again is scientifically demonstrated to be humbug.

 

Update 1: I got the study pdf. Cool, that was fast! Big thanks to J. – and to all the other nice readers whose support I am experiencing regularly.

Update 2: According to the small print in the full text, Valkee Ltd paid 12.000 Euros for this trial. That’s more than for the ice hockey trial a few years ago. But they did not get full control over the results and the publishing. Literally a bad investment. (16.1.2016)

Two Valkee trials declared published junk (X-mas special 5)

Dozens of hilarious details about Valkee Ltd’s HumanCharger scam go untold because they don’t warrant a full blog post. As a present for Christmas Day, here’s the best of all.

The Valkee “research” group has published a number of trial results in unfavorable ways:

The only positive trial with evidence value for Valkee in a scientific journal was the one with the 22 ice hockey players supposedly pimped by earlight to better reaction, published in Frontiers in Physiology.

I say it was, because it had been until now.

It is a real pleasure for me to tell you, that this very special journal series was officially elevated to junk status, by Scholarly Open Access. That’s the No.#1 authority. The list is used by, for example, finnish universities to determine the standing of a publication.

christmas for gloom, frontiers and valkee!

With it, a second Valkee study goes down the tube, which is no longer on their website. It was in Frontiers in Systems Neuroscience.

The decision was overdue: The fake peer-review was obvious in the ice hockey article, where one of the authors was among the editors, and a dance instructor with no idea was assigned to review it by her lab boss. That’s not a fluke. It’s systematic pseudoscience done by Frontiers.

Is there anything left of Valkee’s evidence, among the ruins?

According to usually well-informed sources, there is one final blow still coming.
A nice Christmas to all and a Happy New Year!

HumanCharger study done to counter critics, disappears again (X-mas special 4)

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.

When Finland’s Valkee Ltd re-launched their earlight device in 2015 under its new name HumanCharger, there was an exceptional piece among all the PR articles which simply reuttered their press release.

Fierce Biotech criticism

This is the first placebo-controlled trial ever conducted for a bright-light device, the company said.[SIC!] The data may be designed, at least in part, to address allegations widely publicized online that the company’s product is a scam.

Stacey Lawrence of Fierce Biotech had a bright moment.

You may wonder how the company can be forced into a study because of this blog and a few articles elsewhere. And how could they possibly even succeed?

Simple as it is: Valkee bought the “evidence”. The study has disappeared from the net and Valkee’s websites again, but is still available in full from earlightswindle.com/gloom (PDF). The small-print in the last paragraph reads:

We would like to thank Clinius Ltd., an independent company, which conducted the study on behalf of Valkee Ltd.

The study is not done for any scientific purpose and as such unethical from the start. And it’s unclear who the real investigators were. Clinius is a company from Helsinki, Finland.

 

Stay tuned for the next part tomorrow, and the best of all on December 24th!

New placebo-controlled, buried Valkee trial identified (X-mas special 3)

Dozens of hilarious details about Valkee Ltd’s HumanCharger scam go untold because they don’t warrant a full blog post. As a Christmas present, here are some of such pearls.

My deepest apologies. We misrepresented a clinical study in our YLE MOT TV program, and so did all those people after us, who reviewed Valkee’s stuff systematically. We were mislead by the company, but that’s no excuse.

The critical point with Valkee’s earlight is the obvious lack of placebo-controlled studies for the claims in Seasonal Affective Disorder. Valkee Ltd told it’s easy, and they will come up with great results. They never did.

We do know, however, that they attempted such a study 3 times: One was halted, one is completely buried, and the third showed the device to be non-inferior to placebo by a small margin. This result was falsified then, because it would have obviously stopped the whole scam at once.

Juuso Nissilä of Valkee gave an interview back in 2012.

placebo controlled data surfaced

Unlike other bright light therapies, the Valkee unit has been tested in a placebo-controlled trial. ‘You can’t tell, when it’s in your ears, […], it’s possible to have a placebo,’ Nissilä explained.

The trial, with 26 patients receiving treatment and a control group of 23, showed that depression – […] – decreased when the device was used for 12 minutes per day.

That is, to my knowledge, the halted one with 60 persons to participate. It actually had results which never officially surfaced. Valkee’s then-board member Timo Takala, at the same time “researching” his product, told the reporter it was because of low enrollment. That’s what I remember, this part was not broadcasted.

It fits: They had at least 26+23=49 patients of planned 60 when the data was unblinded to the investigators. That’s to say, the trial was dumped then. When the investigators know such interim results, it cannot be continued anymore.

Valkee initiated the notorious 3-group trial in November 2010 with 90 participants, later to be faked. But the “halted” trial was projected to run through that very same winter. Registered completion was March 2011. That means it was not halted for low enrollment. They could have continued. But they recruited patients for the other and declared the first to be failed. Entry criteria and study design were the same.

I won’t comment any longer, it would be too speculative. The real reasons for disrupting the placebo-controlled trial are unknown. Nissilä’s comment reads to me like “symptoms decreased in both groups”, i.e. placebo performed as well as earlight. The similar result as in all other placebo-controlled tests.

Once again, crucial placebo-controlled results remain buried by Valkee Ltd. WHY?
(Ok, that’s pathetic to ask.)

The Christmas Special continues tomorrow. Stay tuned!

Valkee’s jet lag trial, full text: No “HumanCharger” at all (Update)

Valkee Ltd seems to have completely abandoned its SAD claims, now the device is called “HumanCharger” and works – clinically tested! – on jet lag. Marketing bubbles re-used: They only changed some words in their PR stuff, the rest is the same as for SAD. The same unproven claims.

as jet-lag cure ...

as jet-lag cure …

... and for Seasonal Affective Disorder!

… and for Seasonal Affective Disorder!

Needless to say, these things were never tested. Valkee logic: Because it is approved for SAD, and those are SAD symptoms, it works on these. Therefore, it does the same for jet lag users!

The whole jet lag campaign is based on a study, which appeared already on April 1st in the journal Aerospace Medicine and Human Performance. Valkee says that this proves a jet lag effect. Its SAD studies are all on the Valkee website, this one remained behind the paywall. Typical Valkee users and marketing folks don’t need the facts and are better off without it. To pay 30 Dollars for a Valkee paper? Simply believe!

Update 12.6.17:40: The study is now available from Valkee HumanCharger, direct download from the site. It is not linked yet from any of their sites, and not found neither by google nor google scholar. It was added in the meantime to a press release. The leak for this post was several weaks ago.

Now one of Valkee’s little helpers did not get the memo, and leaked the document into the public domain. I can mirror it here without doing something illegal:

The full text of Valkee’s jet lag trial (4,6 Mb)

I do not have the spare time to comment, but the main outcome is, that the device did not work on practically all things measured. No significant difference at the end of the predefined treatment period for 10 of at least eleven tested scores. Only one subscale of the POMS brought a significance, and this can be explained with multiple testing.

The funny point: It was the fatigue subscale. Exactly the same single result, as the homeopathic “remedy” No-Jet-Lag got in its own company trial.

recover "twice as fast" with homeopathy!

recover “twice as fast” with homeopathy!

The difference: The homeopathic treatment is to be taken orally, during the flight. The Valkee device must be used for 6 (six!) days after the flight, 4 (four!) times a day to get to the same result. 24 treatment sessions.

Valkee is nearly as good as the leading homeopathic treatment.

placebo

 

***

Addition: The analysis was done on 52 patients, but the article speaks of 55 (Figure 3). What happened to the rest? Drop-outs happened, but are not reported. The whole statistics are invalidated. Incredible that this got through peer review.

Valkee’s Research: What a Waste!

An extensive article about the Valkee scam was in the Ylioppilaslehti paper. Many new findings, like I promised earlier this year. I don’t have the time to translate it. Always remember the official statement:

The chancellor (rector) of the University of Oulu, Lauri Lajunen, says that Valkee Ltd. did not emerge from research at the university. It had partially sponsored some trials, but there is no scientific cooperation or any other kind of links to the university.

”Valkee’s web pages can easily create the impression, that they have clear scientific evidence, and are based on research done at the University of Oulu. I checked this with our lawyers, and we as an University now have to contact Valkee about this”, Lajunen says.

* * *

A side product was a list of all studies by the Valkee group, or what they claim to have done, and all other earlight-related stuff as per Sep 3, 2014. It is 100% complete with links to papers and should replace the outdated research page at earlightswindle.com.

XLS: All Earlight and Valkee studies, September 2014.

It’s long. I really suggest to have a look. I’m still shocked how far they were allowed to go, and what level of pseudoscience can be done at a finnish university.

Remember that such trials are expensive. Valkee has burned investors’ and tax money for years. And how could any ethics commission still give an OK for more studies?

After all, they could have simply accomplished a straightforward placebo-controlled trial at any point. (BTW they did, but it did not work.) Every unbiased scientist would have stopped this nonsense long ago.

No need for more “research” on an ear lamp scam born over a drink.

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.

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

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.

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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.

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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.