Category Archives: pseudoscience

U.S. FDA refused import of Valkee HumanCharger devices

Valkee Ltd now began the third launch of their product – the second relaunch of the LED headset – with its new target North America. But: How could the mighty U.S. Food and Drug Administration (FDA) allow such a scam device onto the market?

It turns out, they didn’t. The FDA had refused the Valkee “HumanCharger” import into the U.S.A. earlier this year. For a number of reasons, mainly misbranding.

fda-refusal

There are several ways to get “approved” by the FDA, depending on the classification. Valkee’s HumanCharger got no 510(k) clearance, and certainly not a Premarket Approval (PMA), for which one must present sufficient clinical trial data.

It is not listed as approved with the FDA (the listings here) in any possible way. [- If any reader has additional information, please let us know. -]

That, however, does not mean it is sold illegally. Many light therapy devices, for example such for cosmetic uses, are exempt from FDA regulation. Then they can’t make relevant medical claims. That’s exactly what Valkee Ltd demonstrates: The device is sold as a lifestyle – weight loss aid – sleep promoter – energy booster. Just typical scam claims. It may work on tech people who are prone to fall for such innovations.

as jet-lag cure ...

Valkee does not need any research staff for this strategy, the marketing trial being published. So the company fired its Research Manager Heidi Jurvelin, the Research and Science Liaison Manager Melanie Rueger PhD, sales people, and replaced the CEO Pekka Somerto with Aki Backman. (Jurvelin and others now appear at Valkee’s sister project JouZen Oy  aka OURA, fulfilling predictions by the social media influencer Vesa Linja-aho: Valkee scales down to a sales bureau, and JouZen takes over.)

The new course is set. Personally, I would miss this absurd tale when it came to an abrupt end, now as they finally seem to stop scamming of sick people and look for the too-healthy jet-set clients. However, it does not look good for Valkee Ltd. There are many wonder treatments for jet lag already.

 

***

p.s. at least left Valkee

  • Heidi Jurvelin (to JouZen/Oura)
  • Melanie Rueger
  • Tuukka Josefsson
  • Tero Vallius (to JouZen/Oura)
  • Jonna Muurinen

 

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.

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

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

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

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

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

Simply incredible.

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.

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

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