18. marraskuuta 2014

Valkee has sold almost 60 000 pairs its of ear-mounted bright light headsets. They are marketed with lies. How long can this start-up from Oulu keep up its war of information against science?

In the late 90s, twentysomething called Juuso Nissilä pressed a Maglite onto his temple on a dark winter morning. Nissilä, a student of animal physiology, knew that many animals’ brains contain light sensitive opsins. He wanted to test, whether human brains work like the brains of birds.

And yes, he really did seem to feel refreshed by the light.

The observation was akin to Archimedes’ eureka-moment in an overflowing bathtub, or the apple that fell on Newton’s head: a random occurrence that developed into a grand hypothesis. Could it be that if the brain was illuminated through a bone even thinner than the temple – through, for instance, the ear – a person could stay awake and feel lively?

In 2005 Nissilä shared this idea with a friend, Antti Aunio, who was trying to think of a treatment for seasonal affective disorder (SAD), or kaamosmasennus, a depression caused by the long sunless months of the polar winter. Aunio happened to be an engineer at Nokia and he had a good understanding of technology. He was impressed by the idea.

In the year 2007 the pair decided to take a risk and give their concept a go. They founded a startup-company – a company whose product need not be ready and developed, a company with the potential to make Finland a forerunner country.

They named the company Valkee, a colloquial word for white, light and fire. Work was divided so that Aunio would build a prototype and Nissilä, with his understanding of physiology, would formulate a scientific explanation of how brain-illumination might actually work.

Valkee’s prototype was as handy as an iPod. The palm-sized gadget was equipped with earphones that, instead of music, played bright light.

In 2009, two years after the company was founded, a pilot study of the device’s functionality was completed. The study was directed by Markku Timonen, a professor of general medicine and specialist in psychiatry at The University of Oulu.

The research group consisted of 13 clinically depressed individuals. Testees would visit a charity hospital in Oulu every day for four weeks to get their dose of earlight. In addition, psychiatrists would make weekly assessments of their condition.

Results were good. According to patients’ self-assessments, all but one of them felt their symptoms had disappeared. The psychiatrists’ results, too, found that ten out of thirteen testees improved. For the company this was clinical evidence in clinical black and white. The earlight had proof of efficacy.

The next spring Valkee got a CE-marking for Class II (a) medical device. The certificate is mandatory for certain products that are on sale within the European Economic Area. However, Valkee was a medical device and not a medicine, however, the marking did not serve as a guarantee of efficacy. It only guaranteed that it would not be harmful to the user.

This did not hinder the device’s grandiose launch in Finland that autumn. The trendy advertising firm Bob Helsinki designed a campaign that was based on disbelief. In one add Darth Vader beseeched people to listen to the light. Another advertisement asked a simple question: ”Do you believe?”

And many believed.

The media raved in Finland and abroad because the device promised a wondrous cure to a national illness of the north. A reporter for national newspaper Helsingin Sanomat tested the device and felt a “pleasing hum”. The northern newspaper Kaleva called the invention groundbreaking. Internationally, medias such as Techcrunch and Gizmodo wrote about the device.

The allegedly revolutionary earlight was sold for 185 euros apiece by everyone from university apothecaries to the high-end department store Stockmann and the supermarket chain Prisma.

In 2010 Tekes, a government agency for innovation funding, gave Valkee a 320 000 euro grant. Next year, the sum went up by a further 55 000 euros.

Juuso Nissilä, the flashlight innovator, toured events and gave talks on the invention that had revolutionized medicine. Next spring at the Enterprise Forum seminar at Oulu University he boasted that the company’s growth rate was so fast that the owners’ every gesture should be akin to an ice-hockey player`s astounding breakaway goal. Nissilä enthused that by autumn the earlights would be launched in Europe and sales permits would probably be given for migraine as well as SAD.

There was a demand for Valkee’s product. In the 2010s the human brain had become big business. The brain is a complex, mysterious organ, whose functioning is known so sketchily that any solution to any problem can be justified by it.

Even the most ostensible proof can make products seem credible: they are, after all, based on biology and not on feelings like all those self-help methods that bring to mind women`s magazines at best. The brain is a way to sell self-help to rational people. In the USA the value of such brain self-help has been estimated at 11-12 billion dollars (about nine billion euros) and growing.

Valkee found an eminent backer in the Finnish startup-sponsor Timo Ahopelto. Ahopelto is the second founder and partner of Lifetime Ventures, a major Finnish business accelerator that has helped such companies as Supercell and ZenRobotics find their footing in the startup world.

Ahopelto began coaching the earlight company as part of the Vigo programme, an initiative founded by the Ministry of Employment and the Economy, in which investors cooperate and aid startups that meet two criteria. Firstly, the business-idea must be good enough for the world’s preeminent risk investors. Secondly, the company must have the potential to become a global market-leader in its field.

Ahopelto saw so much potential in Valkee that he took the company under his wing and became its CEO in the spring of 2011.
Not everyone was deked out by the tricks Valkee pulled off. But then again one of the aims of the company’s launch campaign had been to raise doubts, which could subsequently be laid to rest. The social media and discussion boards had long harboured doubts about the company’s scientific argumentation. Then in March 2012, MOT, an investigative programme produced by Finland`s national broadcaster YLE, took up the subject.

The programme went through Valkee’s research, declared it insufficient and showed the company’s marketing to be dishonest.
Valkee vehemently denied everything. It claimed that the programme contained mistakes, which YLE had not corrected despite numerous requests.

YLE insisted that everything was true even though the programme did in fact contain one mistake. Although one for which Valkee would probably not demand correction.

MOT claimed that in the pilot study of 2009 patients’ symptoms had disappeared at a rate of 100% whereas in reality the treatment’s efficacy had been between 77% and 92% depending on the method of assessment.

The pilot study was unusual in other ways too. It used no control group which would have enabled researchers to determine whether alleviations of the testees’ symptoms were caused by the earlight, placebo or, for example, regular human contact.

The director of the research, Markku Timonen, had been paid in Valkee stock and one researcher, then chief physician of the Oulu Deaconesses’ hospital foundation, Timo Takala, was later to hold a seat on Valkee’s board.

And furthermore, the study was published in a scientific journal, whose credibility is at best doubtful. True to its name, the journal Medical Hypotheses deals mainly with interesting, novel hypotheses. In some cases an article in the magazine has led to a scientific breakthrough but at the same time the journal is a haven for antivaccinationists, HIV-denialists and other conspiracy theorists.

A professor of physiology at Helsinki University, Antti Pertovaara, comments that the journal doesn’t even try to claim that hypotheses it publishes are true.

This kind of presentation of evidence is common practice for brain self-help. A study done at The University of Indiana on the popularization of cognitive neuroscience found that companies add credibility to their marketing through academic titles, scientific jargon and fMRI images – pictures in which grey brains are smattered with splashes of colour.

Ordinary language is reserved only for user experiences, reports of high customer satisfaction and simplified test results – which claim that the device illuminates brains and make them work better.

Timo Ahopelto, investor and chairman of Valkee's board.

Timo Ahopelto, investor and chairman of Valkee’s board.

Valkee did not let MOT and discordant voices in the web disturb them. As former CEO Ahopelto says in an early infomercial, Valkee makes a ”positive product”.

In the video Ahopelto stands on a snowy street in central Helsinki and explains how Valkee brings joy to its users in the darkest time of the year:”We’re very excited and our customers are very excited.”

In January 2012 Ahopelto resigned as CEO of Valkee but stayed on as chairman of the board. His successor, former marketing director for Nokia and Coca-Cola, Pekka Somerto is a herald of positive thinking as well. In an interview, smiling, he tells how cheering for innovation is an ideological endeavour. Innovations create jobs in Finland: currently Valkee employs twelve permanently and ten more during production.

”I for one think this is valuable work and that we’re really doing something that could benefit Finland as a nation. Finland can’t screw up with the opportunities offered by this breakthrough in health technology.”

According to Somerto, the opportunity must be seized even though the innovation-critical atmosphere in the country is against it.

”Lots of people are anxious about change. In other countries the culture is more open to innovations, research into new subjects and upgrades in human knowledge”, he says.

Valkee’s leadership speaks in words that many are eager to hear in this time of structural change in Finland. And the words are heard very high up.

In 2010 Valkee received the InnoSuomi innovation award from president Tarja Halonen. Three years later current Prime Minister Alexander Stubb, then Minister of Foreign Affairs and European Trade, and his Team Finland -delegation left for China to promote earlights along with other Finnish startup innovations.

Valkee’s list of financiers is very impressive. In addition to Ahopelto’s Lifeline Ventures, the company has received investments from former Nokia-boss Anssi Vanjoki and technology-focused business angel Esther Dyson. The private innovation fund, Keksintösäätiö, and the state-owned venture capital company Veraventures, which finds business angels for growth enterprises, have also staked money in the company.

Valkee got its greatest haul for the time being in the summer of 2013 when a venture round brought in 7.4 million euros. The main investor was Mérieux Développement, a French giant in healthcare finance.

These achievements are so big that they can be bragged about at Slush, an event which marks the year’s high point for the Finnish startup-scene every November.

A mélange of festival and fair, the gathering gives centre stage to speeches that mix innovation and inspiration, allowing successful people to praise their stevejobses and waltdisneys while imparting how they have the courage to fail and how everybody has something to learn from their stone-age forebears.

At last winter’s event Valkee presented accredited visitors with a special Slush-edition of its 199 euro Valkee 2 device. The instructional leaflet in the packaging recommended a 12-minute dose of light during commuting and before important events.

It is very probable that Juuso Nissilä, the company’s chief science officer, had taken just such a dose before he lectured on circadian rhythm and claimed that tinkering with body clocks is true biohacking.

A single hormone, melatonin, has decisive effects on circadian rhythm. Its secretion is a direct sign of how the body clock is working. For instance, a traditional light box works by affecting melatonin production.

The hype sounds great, but it’s difficult to find real scientific evidence of Valkee’s effectiveness.

As with other cerebral self-help, the consumer is king at Valkee. That’s why he’s allowed to be smarter than the doctors and the scientists. To give the right impression, it suffices to claim that there are studies, which give proof of efficacy. Very few people can be bothered to click open a PDF-file, let alone look into what the studies are like and where they have been released.

On their website Valkee presents research in A4-sized summaries with diagrams, squiggles and coloured fMRI-images. The pages’ tops have been stamped with the logos of Valkee, Tekes and The University of Oulu.

Among other things, the summaries describe Valkee’s findings on light-sensitive proteins in the human brain, encephalopsins and melanopsins. The latter are receptors, which react to bright light. Prior to the publication of Valkee’s research-poster, contemporary science had only found them in the eye.

Valkee has presented these research summaries at science conferences around Europe, but they can’t be found in any scientific journals. Apart from one, the posters haven’t even found their way into The University of Oulu’s databases, even though each of them carries the University’s logo.

The University’s rector, Lauri Lajunen, says that Valkee as a company wasn’t born out academic research conducted at the university. The company has invested in some research projects, but they have had no direct scientific cooperation or any other connections with the university.

”From Valkee’s website, you can easily get the idea that they are backed by clear scientific evidence, which is based on studies done at The University of Oulu. I went through this with our lawyers and they will contact Valkee,” says Lajunen.

In addition to summaries, Valkee has released four peer-reviewed studies to prove their earlight’s efficacy. The peer reviewing was a bit subpar.

Medical Hypotheses, the journal that released the pilot study, clearly states that its peer reviewing process does not conform to scientific standards. The next peer-reviewed study advertised by Valkee claimed that neural tissue reacts to light.

It was released in The World Journal of Neuroscience, a publication with even less credibility than Medical Hypotheses. Anybody can release a ”peer reviewed” study through them as long as they pay 800 dollars. The journal’s publisher, Scientific Research Publishing, can be found on the blacklist of predatory journals, which means that for example The University of Helsinki won’t accept papers released in it as part of doctoral dissertations. (At The University of Oulu Valkee’s study was used as part of a doctoral thesis inspected in August.)

Valkee’s third study claims that earlight improves psychomotor speed in athletes.

It was released in a journal called Frontiers in Physiology. The research article’s first author, Mikko Tulppo, who is chief science officer at the Oulu-based rehabilitation centre Verve, belongs to the journal’s board of editors. Moreover, two of the article’s peer reviewers work in the same laboratory. This goes against good peer reviewing procedure, says Timo Partonen, research professor at the National Institute for Health and Welfare (THL) and renowned expert for seasonal affective disorder.

Frontiers in Physiology also lacks an impact factor, a measure of a scientific journal’s importance, and it hasn’t been listed in either of two closely monitored bibliographic databases, Web of Science and Medline.

Valkee’s second and third studies haven’t been registered in a clinical trials registry (CTR) and they are therefore not health studies. For this reason alone neither is suitable scientific proof of the efficacy of earlight treatment.


Pekka Somerto, CEO of Valkee

Pekka Somerto, CEO of Valkee

Five days after Nissilä’s speech at Slush, a scientific study done independently of Valkee was finally released.

Vivien Bromundt with a group of researchers at The University of Basel released a study of the earlight in the respected journal Chronobiology International. Via email, Bromundt says he did it out of sheer curiosity.

The study found that earlight doesn’t have a similar effect on biological clock as bright light received through the eyes. When light was administered through the eyes, melatonin secretion dipped and test subjects felt momentarily refreshed.

A 12-minute dose of light through the ear, however, did not have any effect on melatonin secretion, drowsiness or levels of activeness any more than a placebo did.

”I’m very sceptical as to whether Valkee’s device work as anything other than placebo,” Bromundt says.

Valkee’s website does not say so, but the results were not new for the company. It had already presented them a year ago at a science conference.

In the spring of 2014 Valkee published its own melatonin study in the same journal, Chronobiology International that had published Bromundt’s findings. Its result was also the same: earlight has no effect on the production of melatonin or cortisol, the two hormones most often used in the study of biological clocks. From then on, Valkee’s working mechanism has been new and unknown, even though it isn’t stated anywhere. Nobody at Valkee wants to talk about the effective compound of earlight.

”We have a strong hypothesis, but it’s pointless to talk about it in advance,” says CEO Somerto.

Another study carried out by Valkee shows that earlight doesn’t have an effect on blood pressure either. A summary of the research can be found on the website of a science conference held in Rome in the spring of 2013, but Valkee’s own website omits the results.

Even the results of Valkee’s most important study results are kept quiet. The results were gotten at Oulu University as early as 2011. The study, large as artificial daylight research goes, was originally added to ClinicalTrials.gov registry as placebo research. It compared the effects of earlight to placebo.

A placebo-group was given one lumen of earlight while other groups were given four or nine units. The results showed that that earlight isn’t any better than placebo.

Later in the spring, a couple of months after the study was completed, its research design was altered. The placebo group was completely removed from the study and its title. What had been a ”Placebo-controlled double-blind trial” became a plain ”double-blind trial”.

No official article has been published based on the study, but Valkee presents the results in the familiar form of a conference talk summary. It contains no mention of placebo.

Professor of psychology at Oulu University, Pirkko Räsänen, who was initially named as director of the study says via telephone that she has no knowledge of subsequent tinkering with its structure and that she has had no contact with Valkee after the study was made.

She recommends contacting her doctoral student Heidi Jurvelin, who is employed at Valkee and who, according to the company’s website, was the study’s director. Jurvelin doesn’t want to answer and directs inquiries to CEO Somerto, who says via email that the study was done with due regard to ”the principles of good clinical research procedure”.

”The study groups weren’t changed at any stage during the research”, the message says.

The assertion is odd because the change is indicated in a clinical trials registry and Timo Ahopelto has admitted to the change in the research design in a public Facebook comment.

In his next message Somerto explains that placebo was just a name for the study group because it wasn’t ”an actual zero-dose”.
”The change on the internet does not indicate the removal of a group from the study, but merely the removal of a word from the name of one group. The change was unnecessary and meaningless from the point of view of the study and its results,” Somerto writes.

This is untrue. If the change hadn’t been made, the study would have been a placebo-controlled double-blind trial. In that case its result would have been that Valkee’s product is only as effective as placebo.

”The research was conducted from beginning to end with three groups and three different doses and we measured the differences between those. It produced valuable information on the light-sensitivity of opsins and in this regard the names of the groups are completely irrelevant,” Somerto explains, even though the study was in no way connected with opsins.

”When the article is published we’ll see what the peer reviewers think about this matter.”

Publication probably won’t be happening any time soon. Research professor Timo Partonen at THL says that no journal with any credibility in the scientific community will publish a study, whose research design has been altered afterwards. (Despite the misconduct, the study was published in BMC Psychiatry in October, after this article was written.)

This is Valkee, a company of two truths. One the company’s own, the other the outside world’s. Comparing them is like reading Russia Today and the New York Times at the same time and trying to assess whether Vladimir Putin is a good guy or a crook.

Valkee drums its message first and foremost in the media, not in the scientific field. It sends its press releases through the world’s biggest communications distributor, PR Newswire, lets reporters do their copy pasting and spreads the result on social media.
It’s easy to recognise an accepted Valkee-truth: it is liked and retweeted by Valkee’s leadership and representatives of their PR agency.

And if a Valkee-truth is collided with another truth, the company is instantly at your throat. Whether it’s a blog or a zero-star review in the Guardian’s technology pages, a representative of Valkee can probably be found in the comments section correcting alleged factual errors. The company even threatened to silence one blogger with a police investigation.

When the company itself is allowed to speak, it speaks random things. Valkee’s employees and researchers write newspapers’ opinion pages and call themselves professors, but never mention having been involved in earlight research.

Valkee also claims it has never marketed its earlights for anything other than SAD. It was for misleading advertising that Finnish sceptics’ association Skepsis ry gave the company its Huuhaa prize in 2012. The annual prize is awarded to a person or an organization who has diligently promoted pseudo- or fringe science.

There’s still a Valkee advertisement on the internet that claims the earlight treats migraine among other things. According to Timo Ahopelto the company advises its distributors on what they can say and intervenes if necessary. A distributor made the Norwegian video and Valkee has instructed for it to be taken down.

Yet apparently the company’s Polish distributor has made exactly the same video, only dubbed in a different language, because the same advertisement can be found on the company’s Polish website.

Valkee’s own communication channel is a blog called #shine on its website. In it the company misleads without remorse. Other people’s words are twisted and commentators who speak against the marketed truth, such as Vivien Bromundt who made a neutral study of the ear-light, are blamed for ”very aggressive remarks against Valkee”. YLE’s MOT programme is claimed to have studied whether the company has tax haven connections.

Through his Twitter-account Ahopelto has written that ear-light treats migraine and post-traumatic stress syndrome. On the other hand he calls Swiss researcher Bromundt a ”well-known critic of Valkee”, whose study is, according to Ahopelto’s tweets, poorly conducted and based on the wrong conclusions – even though it produced the same results as Valkee`s own melatonin study.

In spite of all this Ahopelto claims via telephone that his communication about Valkee has been completely truthful all of the time.

Jukka Häyrynen, Tekes

Jukka Häyrynen, Tekes Executive Director for Startup Companies

Standing behind Valkee there’s one silent force above all others: the government’s funding agency for innovation, Tekes.
Already in 2011 Timo Ahopelto wrote in his blog that without Tekes there would be no Valkee. By 2013 Tekes had granted Valkee a total sum of over 2.2 million euros. In July Timo Ahopelto was given a seat on Tekes` board of directors.

In spite of Tekes and other investors, Valkee has operated at a loss throughout its existence. Its financial statement of 2013 shows the company’s sales to have fallen from 1.9 million euros to one million. Its income deficit is 2.9 million euros and the company is hounded by 2.5 million euros of debt.

For Tekes this is not a problem because it is primarily a risk investor, and startups with spectacular revenues in their early years are extremely rare.

Tekes has been the strongest single financial lever in the startup-fever of post-Nokia Finland. In 2013 the agency gave 135 million euros worth of funding to startup-companies. In that year they received six hundred applications.

This year Tekes has already received over seven hundred applications by august. They are processed by Tekes’ own experts in teams of 2-4.

Documents related to funding are not public and the agency won’t show them on request. It tells the total amounts of funding given to companies and nothing else. This is why we must listen to Jukka Häyrynen, a Tekes Executive Director who specialises in start-up companies.

Häyrynen speaks of Tekes’ start-up-programme according to a well-known liturgy: products must be introduced to international markets fast in order to turn around the national economy. Puttering around in Finland won’t help.

Luckily there are already signs that things are taking a turn for the better. Finns have finally learned to brand their ideas. In the past they were sat upon for so long that somebody else made the same innovation in the meantime.

”This change in know-how in Finland is just stupendous. It’s great that we’re coming up with stuff to pay our bills, the story of Supercell is just epic,” Häyrynen exclaims.

Häyrynen says that a company’s product is of foremost importance to Tekes and that the most important assessment of a product is its demand.

Additionally, a project gets credibility through its investors, its advisors and its team.

”When we’re doing one thousand project assessments a year with this team of 40 people, were not going to look very deep if the team is experienced. Getting private investments is partial evidence that a company is acting rationally and correctly,” he says.
According to Häyrynen a common problem with medical technology and cleantech-companies is that even though nature obeys a certain phenomenon, an idea doesn’t necessarily obey product design.

In Valkee’s case, however, the opposite applies: it is the product that tries to make nature obey.

”There we had a product idea with a CE-marking and strong financial backing. It’s a strong basis. We believe the team has made a good analysis.”

How strong an indication is a CE-marking?

”Well, it’s a certification that the product can be sold.”

Häyrynen explains that in projects where the scientific background is an important part of the product, Tekes strives to inspect it. And according to him, low quality scientific publications aren’t good enough.

”If proof is required, it’s got to be solid.”

But in Valkee’s case the proof is shaky, isn’t it?

”I don’t want to comment on this separate case.”

Isn’t there an ethical problem with funding a product that claims to treat illnesses but doesn’t have scientific proof of it?
”We haven’t really considered this when making funding decisions.”

Could Tekes fund an innovation in alternative medicine if the product sold well and had good financing?

”If there seems to be some level of proof, it should be checked out.”

What if there’s no scientific evidence to back the company you are about to fund?

”If the product doesn’t work and doesn’t sell, its funding can’t be continued.”

When Tekes initially granted funding to Valkee in 2010, the company couldn’t present a single ear-light study in any scientific publication.

And there is still no research into the device’s efficacy in a credible journal with proper scientific peer reviewing procedures.

What is Valkee’s true innovation, then? The company hasn’t been able to patent its treatment method, the stimulation of neural tissue with light, in Finland. It only has a patent for a portable electronic device with lights in the earphones.

In the United States, the treatment’s patent application has passed but FDA, the Federal Agency for Food and Drug Administration, does not regulate bright light therapy devices and there’s virtually no oversight of them.

There the company has left patent applications for the earlight’s use in treating delirium, cancer and Alzheimer’s disease, among other things.

Text: Oskari Onninen
Translation from Finnish: Pauli Tapio
Photography: Jussi Särkilahti
Illustration: Jaakko Suomalainen

The article was originally published in September.