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Valkee’s CEO Pekka Somerto does not challenge the crucial facts, i.e. that so many unpublished negative results exists, and that claimed findings were forged.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.
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:
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.
I just don’t understand how you can say that light doesn’t influence us, or is it just the way it works(in the ears) I’ m a flight attendant and I’ be been using Valkee for one and a half year, I really feel incredibly better and have no problems anymore with jet lag or night flights, several colleagues use it as well, my mother and friends too , all of them have noticed an improvement ( less tireness and better sleep) for some people it may have no influence because they don’t’ need it, my husband for example has never used it because he’s not tired but for me who was easily tired it’s magical. I had the same effect with a normal light therapie lamp but Valkee is so much easier to use, if I write you this it is because I’ m so convinced of it that it makes me angry to read such things about it. Best regards. Ines de San
I want to say that I thought that the device was too expensive, so i went ahead and made my own replica using leds in a cheap pair of ear buds. I used red leds plus a simple circuit to power the leds. It might have been 100% placebo effect, but i did notice an effect – similar to what i had when looking at bright lights for SAD treatment.
I am still not convinced by the research done by valkee but i seriously hope they invest some money into doing some independent reaseach. SAD is a serious disorder and it should be taken seriously.
It seems they still sell it… :-((
https://humancharger.com/humancharger-wireless-headset/
Is it really history?? :-/
All belongings, furniture, leftover devices and spare parts have been auctioned and the company is stricken off registers. They cannot sell and if you send money it will be lost to scammers.