Valkee is a great example on how medical devices will be like in the future. A small post on the topic at http://timoahopelto.wordpress.com/2010/12/15/all-medical-devices-will-be-like-valkee/

I still don't get this one. We have light receptors in our eyes, not our brains. The vast majority of light processing takes place there. People with e.g. cataracts can develop winter depression (without it being winter). As far as I can tell there have been no published, independent double-blind tests, but I'd be happy to be proved wrong.

Kristoffer - Do you "know" or "think" that we do not have light receptors in our brains? ;-) New things can be found... ;-)

Well, that's why I said I'd be happy to be proved wrong :-) I have never read of any actual light receptors in our brains, but I am no medical doctor. Light has an affect on many things, but our eyes are massive light receptors. If you think of it, there's not much sense in having them anywhere else.

Kristoffer, did you know that inflammation is cured by light? FOr example, if you have psoriasis on skin, the first line treatment is light... ;-)

Beating existing methods to treat depression may not be that difficult, after all:

http://www.timesonline.co.uk/tol/life_and_style/health/article3434486.ece

Valkee product has not been doubleblind tested and it is probably just a PLACEBO.

Also there is no physiological theory behind it.

http://grohn.puheenvuoro.uusisuomi.fi/55143-onko-kirkasvalokuulokkeelle-tehty-kontrolloidut-sokkokokeet

Valkee is medical device approved, so there are studies. The question is then when will they be published. ;) If Valkee would be placebo, it would be a miracle to have in practice 100 percent placebo effecxt. ;)

That's not true. No double blind tests have been done and published. If done, what was the control?

Only comparison with the normal bright light system.

What do you mean by "100 percent placebo effect" ?

I find it hard to believe that a product for the effectiveness of which there is no hard fact evidence would have engaged the interest of the likes of Esther Dyson and Anssi Vanjoki. After all, by investing, these angels are putting their name on the business being solid.

From that point of view it should go without question that studies on the effectiveness of Valkee have been conducted and that there is more to the effectiveness than just a mere placebo effect.

Granted, for the general public and physicians on a general level, the publication of study results is the only way of to clear any existing doubts.

Sampo,

no matter how effective this device is (and money can be made on placebo effect), experienced people have been taken into a ride before.

Here are pointers to another case:
http://www.finder.fi/Insinööritoimistoja,%20suunnittelutoimistoja:%20kone/Utele%20Energy%20Oy/OULUNSALO/paattajat/497403

http://fi.wikipedia.org/wiki/Utele-teoria

Timo,

could you please share with us the details behind your statement that "Valkee is medical device approved, so there are studies".

Are you talking about FDA or EMEA approval of a therapeutical device based on clinical research or, on the other extreme, something like CE Mark based on manufacturers assurance that the device is safe, i.e. the LEDs in the ears don't cause any harm to the user?

Professor Timo Takala characterises the method "at least revolutionary".
"All symptoms disappeared in a short perod of time", Takala confirms the results from the test group.
"Light has direct biological effect and we now have clear proof of this."
---
An article has been sent by Takala to a "high valued refereed scientific paper".

BUT:
professor Takala is the member of the Valkee board ...

AND:
it takes time before that article is rejected (?) ...

SO:
a lot of money is collected before that...

Thanks for all the comments.

It is good to see that there is passion in the air! That's what we want. Everyone has a right to be a sceptic - constructive argue typically takes the world forward, and it is a basis of the modern science.

I am sure that Valkee would have loved to share all the science already for so many people who are asking for it and want to learn more. Unfortunately the leading science journals have their publication schedules that cannot be dictated - and for a very good reason. At Valkee we respect this and operate up to high scientific standards - the scientists shall have their role and right to tell to the world first what they have found and how. Prior to the launch there has been three years of lab work dedicated to science.

So - please be patient and expect to get answers to many of your burning questions during the early part of 2011.

Paying about 200 euros for two leds without any real proof...

Ok, granted, its not impossible for experienced and talented angels to be wrong about a concept. But I for one do believe that some level of proof-of-concept has been needed in order to get the investors on board in the first place.

Although as always with new concepts, a critical discussion is in order, I do not believe in judging Valkee based on the current lack of published independent research. If the lack of such independent research is prolonged and simoultaneously research indicating that the Valkee product could not physically do what it claims to do, that would be a different story.

However as it stands currently, there is no real reason for undermining Valkee's product and its ability to produce results. So far they have created a product, built a great network and team, received considerable funding for an essentially pre-revenue stage venture, gained large public interest and have been recognized on a national level. Not bad I'd say.

And with the risk of sounding far fetched, there might be more compelling reasons for holding on to any potential independent research proving Valkee's functionality than releasing it to the public at this stage.

Distributing this kind of information is leadind astray:

"Valkee delivers bright light direct into the brain via ear canal, where the skull is at its thinnest. In clinical studies, 9 out of 10 seasonal affective disorder patients had symptoms relief in four weeks, using Valkee daily for 8-12 minutes - a revolutionary result.
http://www.valkee.com/tiede.html

That test is NOT VALID because no doubleblind test can't be done that way by comparing the product with standard bright light lamps.

The test was ordered by Valkee Oy and "research" was directed by member of the Valkee Oy board.

Sampo, angels are, as you know, in it for business. So the core is that the product sells, and that the company has plans for good expansion. The device is well designed and appealing, so I'm pretty sure there is a market for that.

I think it's very fair that the more engineer-minded of us remain skeptical until the independent research and double blind tests get released. It's in our nature. As stated, light receptors are primarily in our eyes. To claim otherwise needs serious scientific backing. While light does have many properties, and affects things in many ways, there are previous studies which specifically link winter depression with light reception in the eyes. So for us with some scientific training, we need that proof before splashing out with €200 :-)

Kristoffer,

For science, human brain photosensitiveness has not been extensively researched. However, in animals it is well understood and accepted. Few pointers:

- Eye vs brain has been extensively studied. For example, in pigeons, if you cover their eyes and give light, circadian rhythm stays. If you cut their eyes off, it stays. If you cut their visionary nerves out, it stays. Only when you cover their whole head completely, it gets messed up.

- Regards to eyes vs brain in humans, listen to the experts. Fr example our own SAD guru Markku Partonen has several times said that 'traditionally it is thought that bright light GETS TO THE BRAIN via eyes but it is possible it gets there also via ears'. We treat brain in depression, not eyes.

- Regards to clinical results, check YouTube for MIT and 'controlling brain with light'. More importantly, check Juuso Nissilä in TEDx: there is a chart on clinical trial results. Amazing? Compare that to any depression drug trial, where typical starting HAMD is 13-15 and placebo group remits to 9-11 and treatment arm to 7-10. Compare these numbers and think -- can 9/10 remitted be placebo or worse than existing anti-depressants?

Finally on price - 1/10 in Finland eat depression drugs and they cost eur 500-1500 a monh for us, tax payers... EUR 185 for a device that you can use for 5 years is a bargain.

You mean TIMO Partonen. Many thing are "possible" but not true before there is some proof.

Where Partonen has written this:
'traditionally it is thought that bright light GETS TO THE BRAIN via eyes but it is possible it gets there also via ears'

Also:
Ylilääkäri Timo Partonen Terveyden ja hyvinvoinnin laitokselta kertoo, että masennusoireet eivät kuulu kaamosoireisiin, mutta nukkumisen ja syömisen muutoksia esiintyy aina syksyn ja talven tullen.
http://www.kaleva.fi/uutiset/kirkasvalo-auttaa-kaamosoireissa/877688

But what is said in a research ordered by Valkee and realised by Takala, member of Valkee board:

"TMK-tutkimuksissamme keskitymme masennuksen ja ahdistuksen kannalta olennaisten toiminnallisten verkostojen muutoksien seurantaan sellaisissa osissa aivoja, joissa tiedetään olevan masennuksen kannalta olennaisia toimintoja.!

Kristoffer, for sure, it perfectly acceptable to remain critical and cynical before independent research doubleblind tests are released, I for one would not buy Valkee until clear undisputed proof of effectiveness is published either.

However what I did not understand was that the conversation about Valkee and its product began with the assumption that the product does not work. In my view making such a claim at this stage is on a similar level as claiming that there is published, independent clinical research evidence on the effectiveness of Valkee.

My only point was to highlight that currently there is no indepedent research data published one way or another, so there is no point in condemning the product.

At least Valkee has a concept, idea and product that is in a sense unique, not simply a model copied from the US only to have a slight twist inserted (which can be said for numerous start-ups in the Nordic region). Whether or not it can deliver, remains to be seen.

Kristoffer -

Thanks for the highly analytical and good comment again.

In science, to say that something does not work you need to prove it, similar to saying that something works, you need to prove it.

In other way, by saying that human brain is not photosensitive, one is saying that there are studies that are credible and demonstrate that they are not.

Has anyone seen such studies ih humans?

I have not.

At least I have not seen such studies. On contrary, there are studies that show in humans that even people whpo are born-blind (and therefore lack light receptors in their eyes) have SAD. How would that be possible if only eyes would play a role here? Also, multiple animal studies show photosensitiveness of e.g. pigeon brain.

Therefore I value your openness to say aloud that there is a theory and a chance that something new can be found - and believe me, something new has been found, these smart guys have niot spend three years in doing nothing.

Again, I accept the benefit of doubt, but please be patient. The scientists need to be given the credit they deserve in publishing something groundbreaking as this will be.

Over and out from this discussion on my part - let's stay in touch!

Sampo, oh my point was not to condemn anything, but I do remain skeptical and do not understand how this is supposed to work. For instance it's not that eyes just let in light, they convert it to signal, which is what the brain is generally thought to deal with.

For the record, I absolutely agree that we do have a bit of a problem in the Nordics with too many copycat ideas. Something I'll still be writing about when doing an overview of the Travelling Salesman project. Luckily there are exceptions too :-)

Timo, just a final point on the research in blind people with SAD — I believe the result was that even the blind have some form of reception in their eyes (actually a new discovery), as they did test by shining light and covering the eyes, and that did not help. Only providing brightness for the eyes did the trick.

I'd have to dig around to find the research, though, but I remember seeing something like that.

"People with this disorder fall asleep at a different time each day. For example, you may fall asleep at 10 p.m. one day, Midnight the next day, 2 a.m. the next, etc. This most often occurs in people who are blind. Light therapy may help blind people, even if they can't perceive visible light. Studies show that light treatment may be useful in the early morning hours."
http://www.sleepeducation.com/Treatment.aspx?id=4

How Valkee product is connected with daily hours?

Ahopelto:
"Therefore I value your openness to say aloud that there is a theory and a chance that something new can be found "

There is no "theory" but only unproven hypothesis.

And how magnetic photography can show symptoms, concerning your "proof"?

Valkee claims that clinical tests have been done. Which parts of this have been done:
http://en.wikipedia.org/wiki/Clinical_trial

Is that "9/10" based really based on clinical tests?

9 out of 10 people having their symptoms go away is based on properly and very carefully conducted clinical trials.

With double blind tests?

I have made a complaint about Valkee's Clinical trials to VALVIRA. http://www.valvira.fi/en/

http://grohn.puheenvuoro.uusisuomi.fi/55374-kirkasvalokuulokkeen-kliiniset-testit

Subject: Vast:Kliinisten testien etiikka ja yrityksen markkinointi
Date: December 17, 2010 11:54:00 AM GMT+02:00
To: Lauri Gröhn

Viestinne on siirretty terveydenhuollon laitteet ja tarvikkeet -yksikköön Valvirassa.

>Lauri Grohn (17.12.2010 11:42):
>Tervehdys
>
>Valkee Oy:n kirkasvalokuulokkeen markkinoinnissa vedotaan kliinisiin testeihin,
>joiden suorittamiseen on osallistunut yrityksen hallituksen jäsen ylilääkäri
>Takala. Voidaanko katsoa, että tuo on kliinisten testien etiikan mukaista?
>
>Linkki:
>http://www.valkee.com/tiede.html
>
>Terveisin
>Lauri Gröhn
>yrittäjä, Nauvo
.

Thanks Lauri. I guess we then just wait and see what Valvira does. I am confident that Valkee will pass any scrutiny that has real scientific grounds.

My complaint was about CONLICT OF INTEREST, not about science.

But concerning science the effectiveness of the device can't be proven without double-blind trials. Not done. Agreed?

Valkee's marketing claims that the device will cure BOTH seasonal affective disorder AND mild depression patients. Those to are different states of health.

PS.
Valkee has deteted my messages in Valkee/Facebook forum where I have written the same texts as in here.