Can we trust pharmaceutical trials?

Ora sends me this interesting email:

You might be interested in this article from the New York Review of Books, titled “Drug Companies & Doctors: A Story of Corruption” (http://www.nybooks.com/articles/22237?email)

A main point of this article is that positive results are far more likely to be published than negative results. Although this article concerns the distorting effect of drug companies’ sponsorship of drug trials on the published results of those trials, the same effect is likely in other fields (such as stuttering research) because of the tendency to publish positive results and ignore negative results. And of course, even without the corrupting influence of the Big Pharma money, stuttering research is pervaded by conflicts of interest simply because people have a personal interest in positive results.

Here are a couple of highlights (italics added):

• “In view of this control [the control that drug companies typically have over drug trials] and the conflicts of interest that permeate the enterprise, it is not surprising that industry-sponsored trials published in medical journals consistently favor sponsors' drugs—largely because negative results are not published, positive results are repeatedly published in slightly different forms, and a positive spin is put on even negative results. A review of seventy-four clinical trials of antidepressants, for example, found that thirty-seven of thirty-eight positive studies were published.^[8] But of the thirty-six negative studies, thirty-three were either not published or published in a form that conveyed a positive outcome. It is not unusual for a published paper to shift the focus from the drug's intended effect to a secondary effect that seems more favorable.”
• “Many drugs that are assumed to be effective are probably little better than placebos, but there is no way to know because negative results are hidden. One clue was provided six years ago by four researchers who, using the Freedom of Information Act, obtained FDA reviews of every placebo-controlled clinical trial submitted for initial approval of the six most widely used antidepressant drugs approved between 1987 and 1999—Prozac, Paxil, Zoloft, Celexa, Serzone, and Effexor. They found that on average, placebos were 80 percent as effective as the drugs. The difference between drug and placebo was so small that it was unlikely to be of any clinical significance. The results were much the same for all six drugs: all were equally ineffective. But because favorable results were published and unfavorable results buried (in this case, within the FDA), the public and the medical profession believed these drugs were potent antidepressants.”

Mmmmerry Christmas!

Speakers at IFA 2009

The list of the key note speakers of the International Fluency Association (IFA) congress in Brazil in August 2009 is public: see here.

Claudia de Andrade: The familial profile of stuttering

(Department of Physiotherapy, Communication Sciences & Disorders and Occupational Therapy, University of Sao Paulo, Brazil)

Elizabeth Harrison: Technology in stuttering treatment for children and adults

(Department of Linguistics, Macquarie University, Sydney, Australia)

Luc De Nil: Multiple facets of stuttering: Insights from brain and behavioural research

(Department of Speech-Language Pathology, University of Toronto, Canada)

Suzana Jelcic Jaksic: Comparing the needs of consumers in developing and developed countries

(Children's Hospital, Zagreb, Croatia; ISA)

Registration for talks and seminars is February 28th, so you still have time to get your proposal done. I am not sure whether I will attend or not. It is a lot of money to go to Brazil, and I am self-financed. I probably decide in the last minute, as usual.

Luc de Nil is the only scientist talking. He is a professor in Canada and has done a lot of brain imaging research on stuttering. He will talk on brain and behavioural research. Certainly his brain research is interesting; his students and research staff currently look at dual tasks performance in stutterers. However, I am more sceptical on the recent research on temperament which he supervises; I hope he is not going in that direction in his talk. Then, we have Elizabeth Harrison talking on technology in treatment, which could be interesting. However, I hope she is not diverting to Lidcombe outcome research on which she worked and which she not convincingly defended in an on-line debate I recently had with Susan Block: see here.

Bad Google

According to Leys, google refuses to block adverts with cure promises for stuttering. Though having read his emails to google, he could maybe have been a bit more diplomatic:

Following various email exchanges over the last two weeks, Google have today announced that they will continue to allow advertisers to claim that they can cure or eliminate stammering.  For example, one current Google AdWords ad reads ‘Breakthrough cure takes 9 minutes - 100% guaranteed - eliminates cause’.

As the root cause of stammering is a neurological condition, it is not possible to 'cure' stammering, in the accepted medical sense of the word.  So, whenever they say this, Google advertisers give false hope to those who stammer, and give people who don't stammer the false impression that stammering can be cured very easily.

Respectable healthcare companies carry out independent trials on large numbers of people, over long periods of time before they are allowed to claim any kind of benefit for their products or services.  It should be the same with stammering.

Google AdWords have a general policy against what they describe as 'miracle cure' advertisements.  But, although they check the wording of ads submitted for ‘specific diseases such as cancer, AIDS, psoriasis, arthritis, fibromyalgia, cystic fibrosis, multiple sclerosis, leukaemia, bipolar and schizophrenia’, they do not do so for ads claiming to cure other conditions.  Thus ads which claim to cure stammering will still be approved to run.

Google say that their terms and conditions make it clear that all adverts must not violate any applicable law, regulation or code of practice (including the Committee of Advertising Practice Code in the UK, which is enforced by the Advertising Standards Authority).

These kinds of ads, however, clearly DO violate the UK CAP Code, because the ASA have already taken action successfully against one advertiser who was claiming to cure stammering - and is keen to act against others.

Unlike most advertising mediums, Google take no responsibility for the content of the advertising they feature.

Earlier today, I replied to Google, asking to arrange to speak directly to their Policy Team.

I then emailed the Stuttering Foundation of America and the NSA to let them know the situation.

I then reported Google to our Advertising Standards Authority.

I have also contacted various journalists who have been kind enough to support our campaigns in the past.

It started with a whistle

Apparently, Orangutans are able to whistle voluntarily leading to speculations that it is a precursor to speech and language: see here. Maybe early humans first started to whistle, associated a piece of information to a specific whistle, and created their within-group set of whistles. At some point, different whistles were combined to form sentences and language. First, speech was just whistles and all attention was on the whistle: so you have a thought you want to communicate and then you whistle it. Then speech production became more complex and thinking and speaking happened at the same time, leading to automization of speech. You do not have to focus on speaking but just think and it comes out automatically. And stuttering is a problem with this automatism. So first were the whistles, and when humans stopped whistling they started stuttering! ;-)  (Though, I have to admit that I am a bit puzzled why we don't still whistle our speech if the speculation is correct. We could do that, no? Maybe it is not possible to create as many different whistles as we are able in our human voice?)

Vancouver Film School Documentary

Check out this well-done documentary movie on stuttering by Vancouver Film School students through the following VFS production program:

Director Bruce Oothout

Director of Photography Shane Smith

Producer Youssef El-Khoury

Editor Raymund Santos

Political correctness madness

A writes in response to my last post:

This is a horrible idea. It frustrates me to no end that people think that stuttering is something that you can "overcome". To add a competitive edge to it will make those who feel a great shame and pain about their stuttering feel even worse. The movement should be towards a greater acceptance of stuttering in the society. Not changing the stutterers to fit the society's expectations of "normal" speech.

A's statement is a good example of the political correctness madness that distorts current day thinking.

First of all, A asks for greater acceptance of stuttering in our society, when in fact he or she is not even able to give his or her real name but chose to remain anonymous! A puts me down for thinking the politically incorrect, when in fact I do a million times more about greater acceptance and transparency of stuttering by putting my life (including my stupid picture :-) and thoughts on the Internet. Everyone can read my blog including future clients or employers.

Second, I refuse the notion that we are helpless victims of a bad society that puts us down (blame-it-on-society syndrome) and creates the handicap that we experience. What non-sense! The vast majority of people only want to help us, but do not know how. In fact, we do not even know ourselves! Yes, there are some who might laugh or not be accepting of our handicap. So what? Is such behaviour so special? No it is a generic feature of humans. People (including and especially stutterers) laugh or are not accepting of all kinds of things: political attitudes (he is a neo-con republican), beliefs (he believes in the bible), weight (she is really fat), height (he is so small), beauty (she is really ugly), social status (she is white trailer trash), and so on. And yes there are discrimination in the job market. Why? Because stuttering does not help business. So we need to convince our employers that we have compensating strengths or that stuttering is not relevant to the specific job. The same is true for small people, dumb people, over-weight people, and so on.

Third, A seems to imply that somehow society creates stuttering. I say: Complete Delusion. Our genes and other influences have caused our stuttering in the first place with or without society. And we all feel a physical handicap with or without society. We cannot say what is on our mind all the time like a child without legs is restricted. It is not imposed by society, and it is physically experienced. Society reacts to the handicap, and its reaction is to 95% determined by our reaction to society! It reminds me of the talk shows with obese people who say things like "I want people to accept me how I am", "I am happy who I am", and "men find big women sexy", and of course it is society that makes us feel bad. Come on. The vast majority of men and women who are overweight hate it and want to be slim. Not because society wants them to (though it adds pressure), because they want to because you have restricted body movements, you are always out of breath, you have a very restricted sex life or none, diabetes and so on. They are deluding themselves: "I can't loose weight and now I just tell myself I actually feel good about how I am". I am not going to say that I feel good about stuttering, because I do not feel good about stuttering because I experience a physical handicap. What I can say is that I acknowledge that I stutter and that the propensity to stutter will stay with me for the rest of my life. And I also do not accept that I cannot improve my speech. I can if I work on it.

Fourth, the movement should not be about greater acceptance, but about greater knowledge about stuttering. I am not sure it is healthy for society to accept us like we are; should be accept overweight people to be overweight? I do not think so. We should help everyone with a handicap to improve as much as possible and educate others about the handicap, but how can I say something is OK when it is not OK. My speech is not OK, I cannot say what I really want to say. (If I only stutter slightly but say exactly what I want to say, then it is OK for me personally.) I am just deluding myself if I say it is OK. Not a single person in their right mind will listen to stuttered speech and say: Well that's OK even though they might publicly say so. I want them to think: "That's not OK, but it is not his fault. He is a person with strengths and weaknesses of which stuttering is one. I admire his courage to live life despite his handicap and if I can help him to improve, I will."

We need more competition!

Becoming more fluent is hard work over a longer period. You can also say that becoming fluent is like achieving mastery in a sport; the skill of controlling our propensity to stutter. How do you become a top tennis player at your local club? You need to be focused, live in the right environment, have spare time, be motivated, have a competitive spirit, some talent, receptive to coaching and ability to practise regularly and hard. For example, I am a strong tournament chess player and spent hours and hours playing chess. Much more than I ever spent on treatment. Is it no surprise that I am not a master in more fluent speech? Why did I not spend more time on stuttering? I would happily be the worst chess player ever for stable fluency.

I guess one reason is that the rules of chess are laid down. You know what you have to do to win, and you know what you have to study to become better. And most importantly, you have constant competition. Other people are challenging you, and I do not take it well when I loose after a hard fought hour-long game! It motivates me to get better and beat my opponent next time! And I know just how bad I am, and no therapist putting on a positive spin. In stuttering treatment, there is no competition. There is no declaration of a win or a loss; you have to make the judgment call.You have only yourself to fight against, or if you wish against the unknown enemy that makes you stutter.

Maybe we should establish a stuttering league where stutterers can compete against each other. In speech, reading and debate contests. We could also have a first-block-out competition. Two people are talking and the first who stutters looses. Another competition could be the-best-secondary-symptoms contest, but I guess that's a bit counter-productive. Well, we can just change it to the-best-simulated-secondary-symptoms contest, and that it is about voluntary stuttering. How about establishing a rating system? So if you win, you get extra points, and the more so the higher rated your opponent was. We could even have national teams that compete against each other. How about club names like Stuttering Sox, Stuttering United, Real Stuttering?

I tell you already you now. If you ever compete again me, you will loose! I am the best! ;-)

Connectionist modeling for stuttering?

I am currently doing a postgraduate Open University course on Exploring cognition: damaged brains and neural networks. The course explores two methodologies to study the brain: case studies on damaged brains, and connectionist modeling. We learn much more about the brain when it does not work properly as opposed to when it works well!

Think of your car. After any breakdown be it the battery or gears, you know much better how the damn thing really works! Or go back to the pain and handicap from your last toothache or back problems. Now you really know what and how teeth or backs do every single day. Stuttering is no different. A speech scientist should see the disorder as a blessing. Any scientist who claims to know how the brain speaks must be able to explain why the brain does not speak fluenty for some people. In fact, stuttering is key to understanding normal speech production. If we know why we stutter, we also know much more about the normal brain processes underlying speech and related activities.

The second methodology is connectionist modeling which models brain processes by constructing mathematical models that mimic features of networks of neurons and "injures" them to see the effects. I do not know of any group working on this topic in stuttering. I vaguely remember Pete Howell, professor at University College London, trying to get a group in connectional modelling to work on stuttering. The Boston group around Prof Guenther does mathematical modeling, especially his PhD student Oren Civier: see here. However, they use the differential equations approach which is a very different modeling technique. Ludo Max has worked on models together with them, but I think they agreed to disagree on the right approach. Within the research community their work is completely ignored, simply because no-one understand what they have done or are doing! It took me some time to understand what they have done, but I would need to play around with the equations myself to give good feedback on the usefulness of their models. My intuition tells me that the models are too simple to capture the essentials, and that even if a model reproduces the essentials of stuttering, it does not necessarily imply that it is implemented in the brain in this way.

Easier said than done: what makes someone implement change?

What makes someone change? Here, I might align myself with the soft thinking side of many therapists. Science says relatively little about what creates change in a person. I have seen this documentary on this slimmed-down woman who lost 30 kilos and has kept her new weight ever, for several years. The journalist asked her: So what has made you change? She said that she was on a hike and just couldn't make it up the hill without constant stops. And at that moment she swore to loose weight by keeping on walking up this hill every weekend until she can do it without stops. And she never stopped pushing herself, and her weight dropped slowly. She also said that it was not about the diet because any sensible diet will work: eating a bit less, a bit more healthy, and exercise more and keeping it at this pace for ever will do the job.

What creates such a moment that sets in motion such a change? I am not sure. But it is not about that moment. That moment is only the start, the first spark. If you do not have the dried-out land with a hill next door, hiking- friendly social setting, competitive attitudes, friends with similar aims, no life-changing events like death of partner, the right genes, the ability to change quickly, right personality traits, and tools like sensible diet, the spark cannot live on and create a fire. You cannot model such behaviour in a sensible way in the same way as it is difficult to predict revolutions, wars or economies. 

So how can you as a therapist induce change? I have no clue. I fear that the answer is that they cannot. Maybe induce the spark, for who is not excited about starting a potentially life-changing treatment. But will it light the fire? Only the patient can. But actually not even the patient can. The time and place must be the right one. And then the right spark at the right time will light it up. However, therapists can help in that they create treatment that requires as little change as possible to be successful. Like a pharmaceutical treatment. Or improved behavioural therapies.

Therapy is an implementation issue

How do you win the 100 meters? Run faster. How do you become slim? Eat less. How do you pass an exam next time? Study more. How do you stutter less? Speak slower, avoid secondary symptoms and make more pauses. The issue is not in that we do not know what to do, but in us not being able to implement what we should do.

Live from ASHA

StutterTalk.com has broadcast from ASHA: see here. Listen to the first 15 minutes. It reminds me of giggling teenage girls. A brilliant snapshot of the atmosphere in which therapists interact. Laden with the following commandments:

• do no criticise your colleagues
  
• always praise your colleagues
  
• always accept everyone's ideas (even if wrong)
  
• never publicly admit that you have made a mistake
  
• we are all a big family of friends
• smile, smile, smile, smile, smile, smile, smile, smile, smile, smile, smile, smile.
  
• displeasure is shown by a shorter-than-usual smile

These taboos cause discussion rounds with most therapists to be completely and utterly useless unless you talk to them one on one! And filters through to research and debate on research. There is this immense strong emotional desire for harmony and peace (though if you know them personally, you realize that many don't like each other and bitch all the time! :-). Listen to the first 15 minutes again. Not a SINGLE CRITICAL THOUGHT on their own work. Their sentences contain virtually no information. Their workshops are brilliant, wonderful, I have learned so much, exceptional experience, I was so lucky to have X, amazing exhibition, so valuable, though i am confident of my skills I learned so much more. Let's do the reality check. Let's now compare what people who stutter write to me in tens and tens of emails: I am still stuttering (that's like 95% of emails), I am desperate, speech therapy was pretty useless for me, she saw me fluent but then my stuttering came back, and the only thing she did was smile all the time.
As I have said many times before, this atmosphere of forced harmony and peace is counter-productive to real constructive debates, because therapists are scared to speak out and from the beginning as students their brains are forced into into intellectual schizophrenia as it has to spend 99% of the resources in adhering to the prevailing social atmosphere (what should or can I say in this situation, how do others expect me to react) instead of speaking out (what do I think and what do I feel)
And regarding StutterTalk, from now on I call them the Larry Kings of stuttering. Whoever you are, from saint to dictator, you feel comfortable in their interviews, and leave with your world view intact!

Learn more about our brain

Looks like an interesting website on the human brain: see here. Sorry for the few posts, I am preparing an exam with 3000 pages to learn and understand...

Two types of genes?

I have spoken about my view before, that stuttering might well be a two-phase disorder, see here . Adult stuttering is the result of causes that lead to onset of stuttering and causes that lead to non-recovery from onset of stuttering. Maybe this structure extends to genes. There are stuttering genes and there are recovery genes. Put yourself in nature's shoes, you have all these early humans stuttering and it affects survival rates. Nature can either select out the bad stuttering genes, OR it can select in good recovery genes. If we assume stuttering is only genetics, then from 100 babies 5 have the stuttering genes, and 4 have recovery genes, which leaves us with 1%,  the adults who stutter. The picture is of course more complicated, because it is not 100% genetics but you get the twist. If this dynamics is dominant, the search for genes will be more complicated, because currently the trait is adult stuttering whereas the trait should really be ever-stuttered-as-a-child.

ASHA2008

The American Speech and Hearing Association (ASHA) holds its annual meeting End of November: see here . It is a very big conference, and a small part of it is on stuttering. I never went. Too expensive for a non-member. I was unable to get the program from the web. If you can find it, let me know!

Myth Creation

This cartoon illustrates well myth generation and it is no different in stuttering research. Through subtle changes of findings, summarizing of findings, and discussing based on these derivates, the story changes. Whenever you hear any statement, try to follow it back to the roots and you will be shocked to see that in 99.99% of all cases it is far more complicated. The absolute climax in my life was when I asked a therapist on the source of a claim and she referred me to the British Stammering Association (BSA). And I suddenly realized that as a member and chair of the BSA research committee I/we were actually her source of something I never heard anyone in the committee claiming let alone believe in!

Obama a stutterer?

Obama is at best a marginal stutterer. He just has a tendency to use fillers when he is under stress or tired. Maybe his brain is slower to give him the words he needs and so he uses fillers. He just has to train himself to slow down a bit, and I think this is what he has done recently. What is your opinion?

(Thanks for Dave for the tip).

Blog from research team

The research team at the Brain Imaging Lab of Columbia University, New York State Psychiatric Institute, had an interesting new idea, namely to create an Internet blog which aims to inform and recruit stuttering adults and children for brain imaging studies and reporting on its findings. I have already written this post on them. It is always great to have new independent team working on the neurosciences of stuttering, and please if you live in the area get in contact with them and get them in touch with self-help groups.

Did Dracula stutter?

I will be in Romania from Thursday to Sunday visiting Timisoara, Sibiu, and Brasov, and checking out whether Vlad Dracula stuttered and whether being impaled does really make you more fluent. If you are living in the region, let me know and we can meet up.

Good initiative

I 100% support Leys Geddes' initiative to fight claims of cure without any substantial evidence. (Though I still disagree with his early intervention "cure" claims! :-) If you know of any such cure claims, please send Leys or myself an email. Please also check out my Crackpot Posts highlightening similar issues.

Hello, Tom

...

We’ve all seen ads claiming to cure or eliminate stuttering. But as my company does a lot of consultancy work in the UK, in healthcare marketing, with big companies like GlaxoSmithKline, I know that the words used in advertising, and particularly in healthcare advertising, are normally very carefully written and policed.

So my feeling for some time has been that any organisation which claims it can cure or eliminate stammering gives false hope to people who stammer and gives people who don’t stammer the false impression that stammering can be dealt with quite easily.

Not only is the word ‘cure’ not used by speech therapists, but also it is not used in any other form of healthcare advertising, for any other condition, of which I am aware. No company, for example, is allowed to claim it can ‘cure’ even something as simple as a cold.

We had a Trustees Meeting of the BSA in the summer and discussed this issue. It was agreed unanimously that I should contact all the UK advertisers who are making doubtful claims and ask them to reconsider. If there was any disagreement, I would then refer them to our Advertising Standards Authority who, I know, are keen to stop advertisers making doubtful claims.

This simple plan is working out very well: all except one of the UK advertisers I have contacted so far have agreed to stop using the words ‘cure’ or ‘eliminate’ in their ads. The one which disagreed was passed to the ASA - and they agreed with us, and told them to stop it.

But a lot of ‘cure’ claims are being made in other countries and, with the increasing use of the web as an advertising medium, this can spill over into all other countries.

If you stutter, and the frustrations are immense, you might reasonably go to Google and enter ‘stutter cure’. You will then be greeted by a massive list of doubtful claims. Here are some examples:

- Loggita, who claim a 100% cure for stuttering in 25 days
- StammeringFree, who offer a stammer no more’ treatment, effective in 97% of cases
- JustBeWell, who will cure your stutter
- Stop Stuttering Secrets can cure you in three easy steps
- Stutter Cure, who, as you might imagine, will cure your stutter

This kind of slack and easy-going culture also affects the media, so that when they get served up a good story by the PR department of a stuttering ‘help’ organisation, they think they can talk about ‘miracles’ and ‘cures’ for stuttering, as everyone seems to do the same. And nobody stops them, because everyone is keen to sell their stuff, hype the outcome and give us a good happy story - and, hey, nobody does anything to say they shouldn’t. If you now put ‘stuttering cure’ or ‘stuttering miracle’ into YouTube, you’ll see what I mean.