Today is decision time on Pagoclone?

We already know that the Pagoclone trial have been stopped, but not apparently not completely. According to a reader, today is decision time. A reader writes

...I participated in the current Pagaclone study.  I've picked up from sources in the study that Endo Pharmaceutical is having a summit next Tuesday at their headquarters to decide to kill the Pagaclone study or (1) continue the existing study allowing monitoring document to increase the dose in patients they believe would benefit; or (2) extend the study using higher dosages to see if that improves fluency (this additional phase of the test would only take 8 weeks and would potentially save the more than five years devoted to testing this drug); or (3) allow current users that feel they benefit significantly from the drug to continue under a "compassionate use" program; or (4) close the program and give up on the only drug that has helped a substantial number of stutters (like me)...

I am wondering who is attending the summit. How much do these people know about stuttering? And how much do the experts on stuttering know about statistics and random control trials? I would love to be there, and see how good the debate is. But I can already guess the absurdity of the situation: it's about millions of dollars and people from different backgrounds being parachuted into this summit with very different agendas and very few lucid science brains.

Ignorance is bliss.

TheStutteringBrain is on holiday.

Name and shame marketers for KillYourStutter.com scam

Here are the people who are getting paid to channel traffic to the KillYourStutter.com scam site. They are also to be blamed for the deluge of misinformation about stuttering all over the web.

STUTTERINGBRAIN.COM
Roger van Klaveren
corisbergweg 98
Heerlen, NA 6418 CX
Netherlands
+31.0630563056
rogervanklaveren@gmail.com

HOW-TO-STOP-STUTTERING.COM
Registrar: FastDomain Inc.
Registrant Info: (FAST-13883804)
MATTHEW RINGER
1620 SE 39TH AVE
PORTLAND, Oregon 97214
United States
+1.5038041988
matthewringer@yahoo.com

An open letter to the Canadian stuttering association

Dear Lisa from CSA,


Thank you for your email and support.

I have cc:ed all the contacts I have found from Canada to make this a very public issue.

The attached pdf summarizes all the information collected so far. This guy is amazing and has websites on kill your stutter, kill your lisp, grow your penis, cleanse your colon, and brew your own beer! And there is an injunction against him in the UK and a lawsuit.

This guy, Arjun Lal, does his scams from Canada. So he is one of yours!!! ;-) Only you can close him down.

Even if CSA are volunteers, I am sure you will find a lawyer, university professor, or other movers  in your membership that could coordinate efforts to shut his website(s) down.

That's how you scam people.

I have formed a group of people who are willing to get more information about the scam. Please email me if you want to contribute time and expertise. I am looking for web expert, and ruthless lawyers. ;-)

Also, can someone find out which other website Arjun Lal runs? I found already several with the same design and pattern of fraudulent claims. I need to do a reverse whois, but there is not free option right now. I only know that he has 26 websites on godaddy.com, I think.

Hunting down frauds

Much has happened since the last posts. Several readers have helped me to untangle the web of deception surrounding the KillYourStutter.com website and its fraudulent claim to cure stuttering in ten minutes.

First of all, Arjun Lal has confirmed that he is the owner of KillYourStutter in an email with the words "Yes, I am the owner. How can I help you?" ;-) after John called his number numerous times over the last two days, and got his "wife" and "daugher" on the phone who claimed not knowing anything about such a website. Strange, strange.

Second, Deryk has launched a complaint for illegal speech therapy practise, and I am currently getting Canadian contacts together to consider further legal steps.

Third, he is mentioned in another lawsuit for copyright violations, and we are in contact with the lawyers to feed them with extra information for their lawsuit.

Lal's wife didn't know

He must get into trouble now, because his wife didn't know or didn't want to know. Or someone has hijacked his name and address. I contacted a documentary maker who stutters, and he had the ingenious idea to call the number on the registration details! ;-)

Hello Tom

I phoned Arjun Lal's number but he wasn't in. His wife answered. I asked her if Mr. Lal owns KillYourStutter.com. She said that she didn't know. I'll try calling him again in the evening.

Complaint launched against Arjun Lal

Deryk is finally outing himself fully as a regular reader and supporter of my blog, and as a Canadian who has sent a complaint about KillYourStutter.com website to CASLPO. I wonder whether Deryk's newly found courage comes from his being awarded a PhD recently. Congratulations on your well-deserved PhD, Dr. Deryk S. Beal! :-)

Dear Brian and Colleagues,

I am writing you today to bring your attention to a possibly fraudulent stuttering program operating in Ontario. Dr. Tom Weidig is a person who stutters and the author of "The Stuttering Brain" http://thestutteringbrain.blogspot.com stuttering news source. Today, Dr. Weidig reported to his readers evidence that a possibly fraudulent stuttering program

Arjun Lal: a swimming pool from stutterers' desperation

Good Girls Go to Heaven (Bad Girls Go Everywhere). It is no different in the stuttering community. I might go to heaven (or hell) for my blogging activities, but Arjun Lal makes the $$$ and has a nice house with a swimming pool in a leafy area of Unionville. According to my humble opinion, he is the crook, fraud, thief, and creator of the website Kill Your Stutter that promises a cure in ten minutes.

A reader emailed me:

Tom, I am incensed by the Kill Your Stutter program, which posts 1-2 ads per DAY on various random sites, and which has zero documentation. The author hides in literally an unlimited number of sites, and presumably hits Google alerts daily by simply posting to the 1-2 new sites per day.

Is there some way to generate a similar posting asking people to be WARY of this scam? I

End of a self-help group

Jim Caroopen wrote to me about the end of Friends 4 Fluency, and thanked me for my support.

The fallacies of the dear reader

My reader comes from all walks of life: university professors, clinicians, person who stutters, person who is affected by stuttering, and scientists. And some dear readers commit fallacies.

I have never in my life read such nonsense in relation to stuttering.

The dear reader is not supporting his statement "your statements about stuttering are non-sense" with arguments. I cannot reply to such comments, because I cannot study his arguments and refute or agree with them. Typically, such comments are more an expression of an emotional reaction, because my statements do not fit with his view of the world. Lesson: Say why I write non-sense.

Sounds like you are simply venting and not proposing any solutions.

The dear reader does not actually address my statement, because s/he claims that I should not be allowed to make the statement or that the statement is wrong, because I am not proposing a solution to issues made in the statement. So I cannot talk about HIV being a major threat to South Africa, because I do not propose a solution? The reader is in the wrong mind setting. In negotiations, business environments, clinical settings, and deadlines, it's often more important to propose solutions than to pinpoint the issue. But we are in a scientific / intellectual debate framework. Lesson: Grow up intellectually and forget about the consequences of your arguments.

You must accept other people's opinions.

The dear reader must be aware that such a statement would make a debate impossible. Of course, everyone should have the opportunity to voice their opinion. But often that opinion is simply wrong, and one needs to be able to express the opinion that someone else's opinion is wrong. The reader confuses this with matters of tastes or person experiences. I cannot disagree with opinions like "Tom's new blog design is awful and I prefer green wall paper" or "I felt anger at Tom's post". These are the reader's experiences and I cannot take them away from them. However, I can argue with their interpretation of their experiences. For example, if someone writes "Stuttering is a learned behaviour, because I unlearned X", I can disagree because the fact that he had the experience "I unlearned X" does not automatically mean that stuttering is a learned behaviour. Lesson: Many opinions can be challenged, because they are not first person experiences or matters of taste but verifiable ideas.

XYZ is a well-respected figure in the stuttering community

The dear reader should put arguments forward to support that figure's statements. Winning the popularity contest or the conference organizers over to give a key note speeches is not relevant to whether the statements made by those people is correct.
Again, statements needs to be supported by arguments and not by authority beliefs. Lesson: KILL ALL AUTHORITY. IF A PROFESSOR OR WELL CANNOT SUPPORT HIS OR HER STATEMENTS THEY ARE NOT WORTH BEING PROFESSORS.

Holding your breath = Holding your stutter?

I have been writing before about my suspicion that mechanisms responsible for holding your breath longer also modulate the occurring and expression of stuttering symptoms: read Diving and Stuttering, and Swimming Crawl and Stuttering. Yesterday, I made a similar observation again. I felt much greater control over my speech and did not feel the need to get the words out immediately, was able to wait a bit to continue speaking, and able to control the expression of my symptoms more. And yesterday I was holding my breath for 2 minutes without much struggle. I just felt that the struggling behaviors while holding my breath were present but less severe and I was more able to ignore them. So what does this mean for stuttering?

Well, as I wrote many times before, I believe in a neurological deficit that increases frequency and length of internal jams in speech initiation. And I believe that most stuttering events are learned behaviors arising from conditioning processes due to neurological stuttering events, and easily triggered by different stimuli to which they have been associated with. The expression and occurrence of the symptoms and occurrence is directly related to the ability to control those jams in order to avoid a triggering of learned behaviors.

In holding your breath, your brain needs to override the strong reflex to take a breath, and this is only possible if the reflex is weak or the control of the inhibition of the reflex is strong, or both. On such days, the brain is probably also more able to resist the urge to react to a small neurological jamming and wait, or to resist triggers by stimuli conditioned on stuttering events.

Some mothers are the worst for stuttering kids

I have listened to StutterTalk's chat with well-adjusted mothers. But when I think of mothers, I think of many as being the biggest hurdle for stuttering kids. In my private one-to-one conversations with speech and language therapists, I hear them bitterly complaining about mothers. Of course, publicly they would never say such things. Not even or especially not at a conference. Has any therapist ever talked about the issues of mothers? No, everyone says "We need to embrace mothers as co-therapists. They know best what's good for their kids". Bullshit! Here are the most common complains:

1. Mother knows exactly what is best for their child, because she is the mother.

2. Mother complains bitterly about therapist to the director but does not even follow the daily practice.

3. Mother has a strong world view on how to treat kids like alternative medicine.

4. Mother over-rides the more rational approach of father because she as the mother knows intuitively what's right for her child.

5. Mother spends the whole session crying and talking about her bad husband, how she is left alone, and basically blaming her troubles on everyone else except herself.

6. Mother is totally hysterical and out of herself with anxiety and runs around to millions of different places for help.

7. Mother keeps on saying that she feels guilty even though everyone including the rational father tells her a million times that that's obviously not the case.

Any more?

As I always say, you need a qualification for everything in life except for having children. Luckily or else humanity would have gone extinct for a long time...

De-constructing Emily Blunt's stuttering and recovery

Here is an article on Hollywood actress Emily Blunt: How I Beat My Stutter. As I always say: You cannot take away people's experience, but you can take away their interpretation of their experiences. Here is my interpretation of Emily Blunt's experience on why she started stuttering and recovered:

It set in around age 10. “I remember that when it first started to kick in, I thought it was a habit,” she says, “but when it really starts to ingrain itself upon you, it becomes an anguished situation to live your life in, especially when you’re a kid, when you’re only trying to appear very cool. I was definitely not cool.”

Hormonal or physical changes due to the onset of puberty are the most likely cause leading to

Why stuttering at low stress/load levels

A reader ig88sir asks the following question:

Can anyone explain how a late onset completely destroys a previous stable system even when going back to low stress-demand situations? I can almost fathom that when the stress/load is large enough the system jams and breaks down AT THAT LEVEL but why does the system break permanently in the previous lower stress/load levels? Is there a physical rewiring that sets due to the low plasticity? Is it like a breaking dam that once broken is never fixed? Any thoughts?

That is a good question leading to a good debate. I wish more people would ask such questions. Here is my answer:

1. a person who has a late onset might already have an on-the-edge stable system. Such systems are very common in all kinds of situations. Think of a transport system, where you have not jam and just five minutes later there is a jam.
2. a late onset is not destroying the stable system, but a relatively small change in neurotransmitter levels or neurological incident can push a stable system over the edge. And this is not destruction but modulation of the capacity of the system.
3. the over-the-edge is not dramatic but just noticeably increases frequency and length of a jam in the brain under high stress/demand.
4. this low capacity system leads to learned behaviours (secondaries or associations of letters with jams) and cognitive beliefs (I have trouble of those situation, I am scared that I will stutter.)
5. those learned behaviours and cognitive beliefs lead to stuttering behaviours without a neurological jamming.
6. I would not talk about a breaking dam but more like a dripping (a bit like Chinese torture: let water drip on a prisoner for a few hours) that will lead to maladaptive reactions.

Conferences are the best therapy.

(by Mike Bauer)

BREAKING NEWS: PAGOCLONE NOT SUCCESSFUL.

Endo has released a statement on its website

Endo Pharmaceuticals has completed the initial analyses of the data from an ongoing pagoclone study (IP456-041). Although the study did not meet its pre-specified criteria for success, there were some trends of interest that Endo will look at more closely by conducting additional analyses of the data. The last part of this study will continue until completion late this year. A second active pagoclone study (IP456-039) will be closed in an orderly manner over the next several months. Patients participating in that study will be encouraged to discuss other treatment options with their physicians.

For further questions, please call Endo Medical Information at 1-800-462-ENDO (3636).

Endo's statement is in line with my predictions. Pagoclone did not meet the pre-specified criteria for success. Re-phrased for common people: Pagoclone was not successful. ;-) Each trial needs to set a hurdle for success before the trial to avoid shifting the definition of success after data analysis. And the open-label trial of Phase IIa is closing, but the other one is running until the end of the year. They write that "trends of interest that Endo will look at more closely by conducting additional analyses of the data". There are two interpretations, both not mutually exclusive. First, every good PR will add some positive spin or anchor of hope to soften the blow of negative news. We humans need hope when our dreams are hit. They also want to smooth out any hit on their stock price, which has not yet seen a hit by the news. Interestingly, the stock price has been very stable: see graph. Given that the revenues for Pagoclone are now much more likely to be zero, reducing the company's future cashflows and thereby reducing the company value and its equity part. If you have stocks, sell. Or short the stock, sell a future, go long a put or short a call. Second, I would not be surprised if there were pockets of real hopes, i.e. deviations in the data. Some might have responded well while others didn't.The question remains then whether there is a sub-type reacting to Pagoclone. My gut feeling is probably. Maybe for those that are borderline anxiety/panic disorder, which in combination with a low capacity speech system develop significant symptoms. But that's pure and total speculation on my part. A rigorous statistical analysis combined with deep understanding of the nature of stuttering and its traps is needed.

To be crystal clear: Pagoclone is not the wonder drug for everyone many hoped for. At the very best, Pagoclone might be able to modulate the fluency of a sub-type of stutterers. I am sorry to tell you. You will all hate me for spreading the bad news, right? ;-) Tom is just so skeptical and negative. But listen it is not my fault. I am just telling you about reality. I am not creating or causing it!

What did Maguire say in his NSA speech?

Check out StutterTalk's interview with Jerry Maguire: here. Peter and Eric manage to go through half an hour without asking the question everyone wants them to ask. So go to 30:00 to spare yourself the non-essentials which on any other day would have been interesting to listen to! Like Jerry's new book: here. And Peter and Eric interviewing the author without having read the book!

Jerry said that the trial are finished. He is bound to confidentiality agreements, and is not allowed to publicly discuss the results. However, he expects the company to release a written press release or to answer individual questions at some point. Interestingly, as he announced, he did reveal the summary results at his NSA speech, but cannot publicly repeat it. So what did he say? They must be someone of you who attended. But to be honest, I sometimes have the impression that the majority just get lost with all those numbers...

In any case, the case for a negative/null outcome of Pagoclone study is becoming stronger. Had Pagoclone been a success, Indevus/Teva would have gone big on a press release. And if it was a success, they would need to fire their public relationship manager for not having a big press release!

In defense of pharmaceutical companies

In the comments sections, some of you criticize the pharmaceutical companies of being greedy and doing the trials for the money. Let me ask you a simple question: Would you be willing to risk your savings in trials that take years and millions of dollars to complete with the risk getting no return whatsoever? Let's take Pagoclone. Let's assume the trials were not successful. Indevus and Teva have lost millions of dollars and years of their company's life. Not only did they loose millions, but they also had an opportunity cost in that they could not invest the money otherwise.
Sure, they can make millions or even billions with successful drugs, but they need to risk a lot. The restrictions are getting greater, and more costly. Only the desire of making money, i.e. greed, makes progress possible. No money, no progress. Without greed, no medication. Society needs to reward them. Of course, you can imagine that the companies are sometimes pushing the limits. Imagine you are stuck in a situation where you have invested millions and years, how would you react if the drug is on the edge from being licensed or not? You would do anything possibly to twist the drug into the market. So it's important that government but also bloggers keep watching them, so they do not stray from the right path.
You should also consider that human beings are working in the pharmaceutical industry, and they are not worse than any of us. They spent a lot of time and efforts to get the trials arranged. They spent time in labs or behind computers to get the compounds isolated. They might have spend years and get no return...