Tuesday, August 24, 2010

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.

10 comments:

Anonymous said...

Welcome back, Tom!

Will you give us a report on your vacation? Apparently you escaped being swallowed by the giant squid.

Scott said...

I am aware of this summit. The physician in charge of my study has the most participants of any location and is very involved in the creation of the summit. What was discussed in the post is exactly what he described to me.
We'll see what happens.

Anonymous said...

Hi !! Something news? I hope that it is positive.

Anonymous said...

Have Stuttertalk start a petition to send to the AMA demanding Pagoclone remain available to PWS that find it beneficial.

Goncalo said...

welcome back Tom!

Anonymous said...

I sent an email to my trial center but haven't gotten any response back yet. Anybody else got any news?

Anonymous said...

Thank you Pagoclone for causing my DIABETES. & I can't be the only one.

Anonymous said...

After getting my checkup phone call from the research company this week, I was told that it was highly unlikely that the study would continue since it is reaching the end and they have no instructions on what to tell those still in the study. Being a former pharmaceutical sales rep who also stuttered his way through the job, I didn't go into the trial with high expectations. This is because I had seen and sold meds that were at their best, 50 to 60% effective for a sample group. Fortunately, though, I had also seen hundreds of psych beds emptied when Prozac was released in 1989. Interesting factoid, in the mid-80's, Lilly was going to abandon Prozac (fluoxetine) studies because after economic review, the antidepressant market was too small. Their studies though, showed 50% efficacy and somehow it came to market. In hind sight, it was clear that there was no $$ market because amitryptiline, which was the primary drug for depression, had so many side effects that very few people with depression stayed on it to get the clinical benefit.
A few years ago, in anticipation of my upcoming wedding and accompanied concern over being able to say my wedding vows, I was surfing the net for stuttering med info to see if there was any "news" and came across pagaclone and found a link on the company's site to sign up for more info if there was a trial. I had COMPLETELY forgot about it. Then, around December, 2008, I received a call from a research office in Georgia wanting to sign me up for the pagaclone trial. I explained that I lived in the West and by some kind of grace, they took some interest in connecting me to the closest office for me which was 225 miles away. After driving to the site a couple of times and going through the process, I got into the study. Being 42 at the time, having worked on my fluency through self and clinical therapy with moderate success, I thought of putting myself in this situation as more for the scientific advancement and study of SOME medication for alleviation of stuttering. What I experienced after being in the study for a month was completely unexpected. I "forgot" I was a stutterer and was finding myself in speaking situations that I realized had, over the years, become subconscious avoidance patterns. I had been speaking for about a week and I realized I wasn't even thinking about easy onsets, full breaths, etc. All of my "techniques" I had acquired through the years of speech therapy, weren't even a thought in my mind as I began to speak or thought about piping up. I was once told by my speech therapist in Colorado during college to listen to "normal" people talk and take note of their disfluencies. I did this with her in several environments and was amazed at how many normal people have a significant amount of disfluencies but wouldn't in their wildest dreams consider themselves stutterers or be seen by others as stutterers. Come back to the study, by the second office visit, I was actually attending business networking opportunities and really advancing in some business areas. When it was my turn to read a bible verse in bible study group, it was absolutely second nature to just read it in front of the group like I was reading it to myself. Then, third office visit in Sept 2009, new bottles of pills, two weeks later, I found myself anticipating speaking situations like it was a year before. This time, though, I saw the speaking anxiety more clearly. I called the research office and they informed me that in study protocols, a 1/3 of the group that started on active med was going to be put on placebo, and that on my next visit, if I wanted to continue in the trial, it would be open label active ingredient for 10 or so months. A couple of weeks after that visit, I was back in a world of blissful, anxiety free fluency.

Anonymous said...

After getting my checkup phone call from the research company this week, I was told that it was highly unlikely that the study would continue since it is reaching the end and they have no instructions on what to tell those still in the study. Being a former pharmaceutical sales rep who also stuttered his way through the job, I didn't go into the trial with high expectations. This is because I had seen and sold meds that were at their best, 50 to 60% effective for a sample group. Fortunately, though, I had also seen hundreds of psych beds emptied when Prozac was released in 1989. Interesting factoid, in the mid-80's, Lilly was going to abandon Prozac (fluoxetine) studies because after economic review, the antidepressant market was too small. Their studies though, showed 50% efficacy and somehow it came to market. In hind sight, it was clear that there was no $$ market because amitryptiline, which was the primary drug for depression, had so many side effects that very few people with depression stayed on it to get the clinical benefit.
A few years ago, in anticipation of my upcoming wedding and accompanied concern over being able to say my wedding vows, I was surfing the net for stuttering med info to see if there was any "news" and came across pagaclone and found a link on the company's site to sign up for more info if there was a trial. I had COMPLETELY forgot about it. Then, around December, 2008, I received a call from a research office in Georgia wanting to sign me up for the pagaclone trial. I explained that I lived in the West and by some kind of grace, they took some interest in connecting me to the closest office for me which was 225 miles away. After driving to the site a couple of times and going through the process, I got into the study. Being 42 at the time, having worked on my fluency through self and clinical therapy with moderate success, I thought of putting myself in this situation as more for the scientific advancement and study of SOME medication for alleviation of stuttering. What I experienced after being in the study for a month was completely unexpected. I "forgot" I was a stutterer and was finding myself in speaking situations that I realized had, over the years, become subconscious avoidance patterns. I had been speaking for about a week and I realized I wasn't even thinking about easy onsets, full breaths, etc. All of my "techniques" I had acquired through the years of speech therapy, weren't even a thought in my mind as I began to speak or thought about piping up. I was once told by my speech therapist in Colorado during college to listen to "normal" people talk and take note of their disfluencies. I did this with her in several environments and was amazed at how many normal people have a significant amount of disfluencies but wouldn't in their wildest dreams consider themselves stutterers or be seen by others as stutterers. Come back to the study, by the second office visit, I was actually attending business networking opportunities and really advancing in some business areas. When it was my turn to read a bible verse in bible study group, it was absolutely second nature to just read it in front of the group like I was reading it to myself. Then, third office visit in Sept 2009, new bottles of pills, two weeks later, I found myself anticipating speaking situations like it was a year before. This time, though, I saw the speaking anxiety more clearly. I called the research office and they informed me that in study protocols, a 1/3 of the group that started on active med was going to be put on placebo, and that on my next visit, if I wanted to continue in the trial, it would be open label active ingredient for 10 or so months. A couple of weeks after that visit, I was back in a world of blissful, anxiety free fluency.

Anonymous said...

Wow, that 10 months is up in early November. My quality of life without major stress from speaking situations this past year and a half is NIGHT and DAY. I should say though that not all stress is gone from speaking situations. It is just more normal now. Like when I need to confront someone, speak in front of a group I don't know very well, or just having a crappy day. But that stress feels "normal". To summarize, my experience in the trial has been life changing. Stuttering and disfluency is a complicated condition. I don't think this medication is a magic fluency creator. I think it worked on the areas of my brain that somehow produce consistent small, medium and large panic attacks while speaking and when I am anticipating even the most speaking situations. I know that not everyone in the study had the same experience. I feel extremely blessed to have been included in the study and to have experienced the everyday benefit of pagaclone. In the words of one of my marketing professors, it had the basic marketing benefit of "It works for me."