Thursday, June 24, 2010

Waiting for the Pagoclone study....

The Pagoclone Phase IIb study has still not been published. Several sources tell me that the company TEVA has all the data for several weeks now. There is no doubt in my mind that they know the outcome of the study. Sometimes they wait with an announcement to coincide with another corporate event. But the longer we have to wait, the more pessimistic I get. Do they actually have to publish the study? What if the study turns out to be a null-result, do they have to publish the details? I believe that they have to register their study, but I am sure how much of the data they have to release. It's very important that all studies are made public. If only the positive ones are published but the null ones not, we have a publication bias. And that can be a big big issue.

12 comments:

Anonymous said...

We are desperately waiting for the result, hope it gets published soon !

Scott said...

At my appointment last month, the doctor said that he's confused by why the results are not being made public either. So we are all collectively waiting.

Anonymous said...

Pagoclone is not the magic bullet for stuttering, but it does reduce the stress respond and can make you more fluent at the max dosage. It has been studied for years and they know its safe, but they are playing games with it. They could care less about helping people that stutter and only want to maximize the bottom line.

Anonymous said...

"They could care less about helping people that stutter and only want to maximize the bottom line."

And what's wrong with that? Should we expect companies to want to help people independent of the bottom line? Companies produce products and services that people will want to buy, so that they can make money doing it. It's silly to criticize a company because it wants to make money.

Anonymous said...

"They could care less about helping people that stutter and only want to maximize the bottom line."

I guess one can implied that its wrong for "They" to want to make money but that was not the primary intent of my statement. I was referring to the length of time that this drug has been in testing and the long delay in bring it to market. The burdensome requirements of the FDA and the companies need to maximize utilization of drug have prevented a known safe drug that can help some stutters from entering the market in a timely manner.
And that is wrong considering how fast some other drugs go through this process.

Gerald Maguire, M.D. said...

Hi, Tom. I will be presenting the results of the Pagoclone Phase IIb study at this week's NSA convention in Cleveland. I'll be available to you and your readers for any questions. Jerry

Anonymous said...

Jerry,

Is the news positive?,
Is the drug effective?
When will it be available?

UrbanMermaid said...

"They could care less about helping people that stutter and only want to maximize the bottom line."

I have to say I agree with this to some extent.. I remember watching a news story on CNN about Pagaclone about a guy who had the most severe stutter and after taking Pagaclone was pretty much fluent, so that makes me believe that Pagaclone does work but maybe to different degrees for different people.

Tom Weidig said...

But maybe the guy was just more fluent due to placebo or because he just went through a more fluent patch!

Anonymous said...

@Tom it is possible but I've already read a lot of stories about people for whom it has worked very well. It can't just be a coincidence ;)

Anonymous said...

StutterTalk needs to start a petition to demand all the information be released immediately.

Anonymous said...

Been on the study for 4 years...first 2 years it was a miracle drug...stuttering disappeared. Then it came back and I became immune to my dosage and they wouldn't increase my dosage. Got a call yesterday that said that the company running the study Indevus has been bought out and the new company is closing the study.

From my understanding...they weren't have great success with the drug.