Monthly Archives: April 2014

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.