Valkee ear light gadget called "scam against sick people"
Valkee portable headsets are worn like light–emitting earbuds(Photo: Valkee website)
A Finnish company selling a device it says will treat Seasonal Affective Disorder is being accused of shady publishing practices, poor research design, and data manipulation – all in a push to get its product on the market.
For €199, Valkee Bright Light Headsets – iPod-like devices that shine LED light into the ear canal – promise to “banish winter depression,” which affects some people living in higher latitudes due to the short winter days. The product purports to treat jet lag and even improve attention and sports performance.
While light (through the eyes) has indeed been shown to be an effective treatment for Seasonal Affective Disorder (SAD), critics say the company is taking advantage of sick people desperate for relief and fudging the results of the scientific studies they conducted in order to bolster the credibility of the product.
“It’s a scam against sick people,” says the editor of a websitedevoted to debunking that company’s claims, who wished to remain anonymous due to legal threats from Valkee stemming from previous criticisms. “I was attacked [by the company] and I am still attacked today.”
The editor has an academic background in investigating the placebo effect in clinical trials, and he says the Valkee studies set off alarm bells.
“It was very big in the media here [in Finland],” he says. “It was in the evening news.”
Valkee filed its first patent in 2008, but didn’t investigate the therapeutic usefulness of light delivered through the ears until 2010. It sold its first unit a month later.
“They got their patent, then they needed a market,” says Dr. Timo Partonen, a medical doctor and research professor at the National Institute for Health and Welfare in Finland. “When the product was already on the market, they started the studies.”
The first of many studies Valkee conducted was a basic pilot study. There were no controls to test what was actually helping the study participants, whether it was the light, the contact with psychiatrists, or the feeling of being treated. The results were fantastic.
The company secured its Class IIa Medical Device statusin 2010, meaning that it is not harmful (although not necessarily effective), and the media campaigns began.
Valkee has a splashy website featuring easy-to-read “science facts” touting the effectiveness of the gadget. It has sold over 60,000 of the headsets to date, and sales are growing around the world as days shorten in northern countries like Canada, the United States, Russia, Norway, Germany and elsewhere.
Sales have reportedly crashed in Finland, however, following media investigations into the product’s claims.
The evidence for the “science facts” listed on the Valkee website range from solid studies showing protein responses to light to questionable or even manipulated data.
Some of the boldest claims are published in journals with less than sterling reputations, for example, Medical Hypotheses, which once published an article (later retracted) asserting that HIV does not cause AIDS.
Another journal bearing a flagship clinical study supporting Valkee is called World Journal of Neuroscience, published by Scientific Research Publishing (SRP). A so-called “open-access” publisher, SRP has been criticizedby Naturefor “reproducing” articles that had appeared in other publications as well as listing academics on its board of directors who have nothing to do with the company.
SRP and its journals have been blacklisted by some academics, and yet Valkee’s website points to the study appearing in the World Journal of Neuroscienceas one of the product’s most significant scientific endorsementsto date.
Valkee CEO Pekka Somerto defends the reputation of these journals.
“I would not necessarily discredit the earlier journals [Medical Hypotheses or World Journal of Neuroscience],” he says. “It’s a platform to discuss and create discussion of new hypotheses.”
However, Somerto looks forward to the day when research about the effects light in the ears will no longer be relegated to the lowest rungs of the science journal ladder.
“It will be great one day when studies about Valkee are published in Nature Magazine or the New England Medical Journal, but it takes time,” says Somerto. “You need to earn the right to be published there.”
The Placebo Effect
The Valkee 2 was announced last year (Photo: Valkee website)
One journal with slightly higher impact has published Valkee science as well – but the circumstances of that publication are in question.
On October 21, 2014, BMC Psychiatry published a peer-reviewed study supporting Valkee’s claim that the device treats SAD. It was a study of how different amounts of light shone into the ears can ease the depression and anxiety symptoms.
Throughout the four-week trial, symptoms decreased significantly across the board for all participants.
But that across-the-board improvement is where the problem lies.
“The authors made a change… [after] they had analyzed the data and knew the results,” explains Partonen. “They deleted the placebo comparator from the study design.”
The issue is the study was originally conducted as a double-blind placebo-controlled study, which helps to demonstrate that the light itself makes a difference rather than the patient’s belief that he or she is being treated and therefore getting healthier.
But after the results had come back and shown that the actual treatment was no different than the placebo, the results were written up as though the study was conducted differently.
“This kind of action is a scientific misconduct,” says Partonen, adding that the study, taken at face value, still only proves that the ear-light treatment has the same effectiveness as a placebo.
Somerto, whose background is in business, denies that there was any scientific misconduct, saying, “When it became apparent in the course of the study that also the one lumen [placebo] dose did not conform with the definition of what a placebo is … the name of the group was changed to a low-dose group.”
He adds that the change has been reflected in every updated version of the manuscript, but Partonen says this isn’t good enough.
“The data should be reported as intended in the beginning,” he says. “So, they should have reported that the high dose bright light and the intermediate dose are equal to placebo.”
Teasing out the placebo effect from the actual therapeutic value of the lights has been neglected in every published study. In the Medical Hypotheses study, the 13 participants were given the treatment at the University of Oulu five times a week for four weeks, and met with a psychiatrist once a week.
“It was sort of a supportive psychotherapy,” says Partonen.
No control group had psychiatrist visits without earlight treatment in order to test if thelight treatment itself made a difference.
Still, the authors insist in the conclusion, “It is hard to believe that our findings could be explained solely by placebo effect.”
All but two of the study’s seven authors listed financial conflicts of interest as employees or shareholders of Valkee.
Money in the mix
The overlap between scientists and shareholders exists in every study.
Each time the product’s effectiveness has been evaluated, the researchers who conducted and wrote the studies supporting Valkee’s claims are shareholders in the company, sit on its board, or both. This is not entirely unheard-of in medical research, but “this is new in Finland, at least,” says Partonen.
One of the scientists on the BMC Psychiatry study, who is a minor Valkee shareholder, was also involved in the assessment of patients’ responses to treatment –the area of the study that is the most open to interpretation.
“This author should have disqualified himself from acting as a rater,” says Partonen.
Somerto disagrees, saying this is common practice in startup companies.
“After a while, after the savings account is depleted, credit card used up, and after the so-called ‘friends, family, and fools’ have supported the first few months… purchases are done in some form of shares in the company,” he says.
Researchers who worked on the early studies were paid in Valkee shares, but, according to Somerto, “both of their ownerships at the time, when the services were rendered, were way below both our university’s and the United States’ limit for what’s considered a conflict of interest.”
As the days are shortening in the northern hemisphere, Seasonal Affective Disorder is starting to take hold for some people. With Christmas around the corner, this is when Valkee makes the most money.
“They are making a big media stunt always before Christmas,” says the editor of earlightswindle.com, the website set up to question Valkee’s claims.
The Finnish government, eager for another Nokia-like success, has poured money into technology entrepreneurship. Valkee has raised €2.2 million in government grants and loans set up to encourage small tech companies.
The company is extremely protective of its reputation, responding to the website with legal threats and to reviews online with earnest rebuttals. The editor says he has been “attacked” by Valkee’s users, upset at his allegations.
“They have followers like a cult,” he says, and although he admits he has never tried Valkee, he says he knows better.
“You do not have to touch the electric fence to know you will have an electric shock.”