Category Archives: pseudoscience

HumanCharger study done to counter critics, disappears again (X-mas special 4)

Dozens of hilarious details about Valkee Ltd’s HumanCharger scam go untold because they don’t warrant a full blog post. As a Christmas present, here are some of such pearls.

When Finland’s Valkee Ltd re-launched their earlight device in 2015 under its new name HumanCharger, there was an exceptional piece among all the PR articles which simply reuttered their press release.

Fierce Biotech criticism

This is the first placebo-controlled trial ever conducted for a bright-light device, the company said.[SIC!] The data may be designed, at least in part, to address allegations widely publicized online that the company’s product is a scam.

Stacey Lawrence of Fierce Biotech had a bright moment.

You may wonder how the company can be forced into a study because of this blog and a few articles elsewhere. And how could they possibly even succeed?

Simple as it is: Valkee bought the “evidence”. The study has disappeared from the net and Valkee’s websites again, but is still available in full from earlightswindle.com/gloom (PDF). The small-print in the last paragraph reads:

We would like to thank Clinius Ltd., an independent company, which conducted the study on behalf of Valkee Ltd.

The study is not done for any scientific purpose and as such unethical from the start. And it’s unclear who the real investigators were. Clinius is a company from Helsinki, Finland.

 

Stay tuned for the next part tomorrow, and the best of all on December 24th!

New placebo-controlled, buried Valkee trial identified (X-mas special 3)

Dozens of hilarious details about Valkee Ltd’s HumanCharger scam go untold because they don’t warrant a full blog post. As a Christmas present, here are some of such pearls.

My deepest apologies. We misrepresented a clinical study in our YLE MOT TV program, and so did all those people after us, who reviewed Valkee’s stuff systematically. We were mislead by the company, but that’s no excuse.

The critical point with Valkee’s earlight is the obvious lack of placebo-controlled studies for the claims in Seasonal Affective Disorder. Valkee Ltd told it’s easy, and they will come up with great results. They never did.

We do know, however, that they attempted such a study 3 times: One was halted, one is completely buried, and the third showed the device to be non-inferior to placebo by a small margin. This result was falsified then, because it would have obviously stopped the whole scam at once.

Juuso Nissilä of Valkee gave an interview back in 2012.

placebo controlled data surfaced

Unlike other bright light therapies, the Valkee unit has been tested in a placebo-controlled trial. ‘You can’t tell, when it’s in your ears, […], it’s possible to have a placebo,’ Nissilä explained.

The trial, with 26 patients receiving treatment and a control group of 23, showed that depression – […] – decreased when the device was used for 12 minutes per day.

That is, to my knowledge, the halted one with 60 persons to participate. It actually had results which never officially surfaced. Valkee’s then-board member Timo Takala, at the same time “researching” his product, told the reporter it was because of low enrollment. That’s what I remember, this part was not broadcasted.

It fits: They had at least 26+23=49 patients of planned 60 when the data was unblinded to the investigators. That’s to say, the trial was dumped then. When the investigators know such interim results, it cannot be continued anymore.

Valkee initiated the notorious 3-group trial in November 2010 with 90 participants, later to be faked. But the “halted” trial was projected to run through that very same winter. Registered completion was March 2011. That means it was not halted for low enrollment. They could have continued. But they recruited patients for the other and declared the first to be failed. Entry criteria and study design were the same.

I won’t comment any longer, it would be too speculative. The real reasons for disrupting the placebo-controlled trial are unknown. Nissilä’s comment reads to me like “symptoms decreased in both groups”, i.e. placebo performed as well as earlight. The similar result as in all other placebo-controlled tests.

Once again, crucial placebo-controlled results remain buried by Valkee Ltd. WHY?
(Ok, that’s pathetic to ask.)

The Christmas Special continues tomorrow. Stay tuned!

HumanCharger endorses Zapper scam (X-mas special 2)

Dozens of hilarious details about Valkee Ltd’s HumanCharger scam go untold because they don’t warrant a full blog post. As a Christmas present, here are some of such pearls.

Valkee recently retweeted a nice, very telling picture.

HeartMath, Zapper, Valkee!

The HumanCharger among other travel essentials. HeartMath and Zapper. – Wait, WHAT?

HeartMath

The HeartMath Institute claims to have technologies to reduce stress, give energy, etc.pp. It says to be built on science. It is detailed here on a professional website:
HeartMath BS

“extensive research and findings on stress, heart intelligence, coherence and the energetic connection between all things are featured”

No further questions. They tell that people’s hearts are magnetically interconnected and communicating. Read it in full on their site, which is quite impressive.

 

The Zapper

The Zapper actually doesn’t differ much in principal structure from the HumanCharger (see picture). As a notorious bullshit, it’s a textbook example for quack. It’s quite famous. People are buying these boxes from different manufacturers. If you have time, look at the site of Dr. Clark, mother of all zappers.

Excerpts taken from Dr. Clark’s : “The Cure for all Diseases” Book

It cures all diseases, right. Not making this up! All diseases are caused by the same single pathogen, an intestinal parasite. A worm, which then can be killed by such a device.

zapper variant

Evolution of scams

So there we have them in a perfect arrangement. Ingenious. I couldn’t have done it better – though I cited the Zapper scam from the very first day on earlightswindle.com.

HeartMath, Zapper, Valkee!

 

The Christmas Special continues tomorrow with a more serious revelation. Stay tuned!

Earlight revenue implodes further, Valkee receives audit warning: The 2014/2015 Balance

Valkee Ltd, the maker of the earlight headset called HumanCharger or Valkee 2, has published its 2014-2015 balance as required by finnish law. The good news for the company: Loss per fiscal year is down from 2,9 M€ to 2,3 million.

The bad news: That’s because the turnover fell again by 40% from 3/2014 to 2/2015 . The earlight made only 654.000€ last year. 2013 revenue was still 1.080.000€, 2012 nearly 2 million. Valkee shrunk by 2/3 in 2 years.

Traditionally, earlightswindle.com makes the balance freely available. Here it is:

Valkee Ltd balance Mar 2014 – Feb 2015

 It is an absolutely catastrophic result. Debt to institutional creditors alone is 1,650 million, 500.000€ was a convertible bond for (quote) “a very serious economic reason”. Cash flow is less than 600.000€: From 7,3 million invested 6,7 million are burned.

I don’t comment any further, see for yourselves. One thing is worth noting: The auditor of Ernst&Young remarked that the balance is problematic, because the development costs are partially booked on the +side. Actually, this is burned money, which will not be recovered with future sales. Recalculate with this in mind, the balance would be a crazy  3 million less than it shows now.

The auditor did not want to sign this without an explicit warning. Interestingly, this is what one commentor predicted last year on this blog, when earlightswindle.com broke the news about Valkee’s nose-dive.

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

UPDATE 7/2017:
The FDA changed its code, the document can be found clicking the link above and then
Feb > 2015 > Country: Finland. [screenshot]refusal-valkee-fda

 

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.