Thursday, July 19, 2007

Drug Trial for Fluoxetine

I received an interesting email from a friend today. Her career involves clinical pharmaceutical trials, and therefore she keeps a close eye on new trial information.


She forwarded an article from a CNS News magazine. The article announces that Autism Speaks has entered an agreement with Neuropharm to perform clinical trials of Fluoxetine for the treatment of autism.

Some excerpts:
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"The agreement, which gives Neuropharm access to Autism Speaks'
Clinical Trials Network of specialist paediatric centres and key opinion leaders, will expedite the enrolment of patients in this trial, codenamed SOFIA Study of Fluoxetine in Autism."
-
"NPL-2008 is Neuropharm's proprietary preparation of fluoxetine, featuring autism-specific dosages in a melt-in-the-mouth formulation designed specifically for those with autism."
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"...is a randomised, double-blind, placebocontrolled study comprising more than 100 children and adolescents in approximately 12 centres throughout the US,..."

This is not "news", per se, as information on this study can be found simply by visiting Autism Speaks' website. But there are several interesting things to note here.
First of all, fluoxetine is the substance that is marketed under the name Prozac (as my friend refers to it: America's Favorite Food). Keeping in mind that I am not one of the Hub bloggers with a solid foundation in science, it seems to me that this is an appropriate place to spend some research dollars.

While their stated goal: "...to show a reduction in the core symptomatology of autism" is not necessarily in alignment with my views of autism (I would require some clarification from them on that point), it seems to me that any safe, effective way to reduce anxiety and depression issues in autistic individuals would be just great.
In other words, they might not get what they want - to eliminate autistic "symptomatology", or behaviors, but instead they might establish the safety of a drug that could benefit autistic people in the same way it benefits NT people.

It is known that there are neurological differences between autistic and neurotypical people, and therefore drug action - particulary psychoactive drugs such as the SSRI's - may vary significantly between the two populations. Those who know me (unlike, for example, this guy) know that I believe that autism is not curable. They also know that I wish only the best for, well, all people really, but in particular autistic people. If it were to be shown that fluoxetine were to improve the lives of certain autistic individuals, safely, in much the same way that it does for NT's, then some real good could come of this. I expect that the autistic popluation has at least as much anxiety and depression as the NT population, and that therefore a real need may exist. Testing Fluoxetine for safety and efficacy, therefore, seems like the right thing to do.

One must always exercise caution, of course, in relying on a pharmaceutical solution to an emotional or behavioral problem. I am definitely not a proponent of automatically prescribing something like Prozac in response to an autism diagnosis. And certainly pushing Fluoxetine as a cure for autism would be wrong on many levels. Instead, if a given person is experiencing difficulties with anxiety or depression, then it would be nice of this drug was available, among other choices, as a proven-to-be-safe solution.


Contrast this whole idea to the horrible "Lupron Protocol" - another case of attempting to establish a new indication for an existing drug. I actually mentioned this to my friend, and sent her a link to Kathleen Seidel's thorough dismantling of the Geier's work in that area. Her response:
"Lupron is probably the single most dreadful drug ever approved by the FDA.
We used to use it in the infertility clinic to shut down ovaries before starting stimulation protocols for IVF. Icky stuff."
Yes, and the Lupron Protocol is touted by its originators as being a way to "cure" autism.


And regarding the reliability of the Fluoxetine trial, my friend mentions that the "raters", or those who record the behavioral data, are a key component to achieving proper results. In her words: "In clinical trials, those raters have to be certified (often repeatedly) and the protocols will insist that the same rater be used with the same subject throughout the trial. These types of studies depend on the rater completely." I introduced the additional problem of observer bias, which she indicates will level out based on the idea that any inherent bias will be applied across the board, reducing the effect overall. What is far more problematic than observer bias is anything that jeopardizes the "blindness" of a rater. An example here is that Fluoxetine sometimes causes a rash. If the rater knows this, and observes a rash in some subjects, the results of the trial would be severely compromised.


I hope they perform a sound trial, and that the results will provide a viable option to improve the lives of autistic individuals.

10 comments:

Bev said...

The idea of fluoxetine or any medication being promoted as a "cure" for autism is a dangerous one, as it is yet another attempt to define neurological difference as pathology.

For the record, I have taken fluoxetine for quite awhile. It has made me less depressed, less anxious and more able to function in a variety of ways. It has not made me any less autistic, and may in fact have allowed me to appear a bit more autistic than before, since I am no longer afraid to be myself and speak my mind.

No anti-depressant works for everyone, this is not an endorsement, just my experience.

I was strongly anti-medication for most of my life and only started taking this when it became clear my life was in danger. I did a lot of research and soul searching first, and approached the possibility with caution. This just happened to be the medication that helped me to get on with living.

Part of the danger in this trial is that indeed some subjects are likely to appear less autistic on fluoxetine. I speak much more than I used to, for example. It would be easy to take this one fact and twist it in such a way to say the person seems less autistic, so this must be working.

That would be horribly wrong and unscientific, of course, but things like this have certainly been done before.

Steve D said...

Thank you for your comment, Bev. You iterated exactly the same concern I have (you just did a better job of it than I).
I, too, perceive a problem with fluoxetine being considered a "cure", and am only saying that if it can benefit an autistic person (as it sounds like it has benefitted you), then it is a good thing.

Anonymous said...

I share bev's thoughts.

Double blind fluoxetine studies in young children with autism is already being done and was started a couple of years ago by the NIMH. I believe there are 7 or 8 universities participating. Someone should tell Autism Speaks before they go out and do what is already being done.

Fluoxetine isn't something to fear and has helped me greatly. I haven't done any great research into it but I think its pretty benign. It does have a black warning label about increased suicide in young people taking it, something like a 2% increase, but I'm not sure that's the fluoxetine or depression. It has helped me be less anxious and not to worry about the little things that can keep me up at night. It has also helped me be able to be a little less concerned with how I might come across to people. I can hardly tell I'm taking it when in small doses but if I take it in larger doses, it does tend to make me a little more forgetful.

CS

kristina said...

Charlie took Prozac for a few days with bad results: He became more aggressive......He has done well with Zoloft and Risperdal, in small amounts and with us constantly monitoring the effects.

Bev's comment is extremely on point-----the medication, as our neurologist emphasized, was just another means to try to help Charlie; he insisted that we focus most of all on Charlie's education. I have wondered if the tendency among parents is to think that a medication might "solve" problems; rather, it is just a first step, and comes with side effects.

Club 166 said...

Wait a minute. Autism Speaks is in bed with "Big Pharma"??? :)

What is the world coming to?

Joe

andrea said...

Although there are plenty of stressed-out autistics, some of whom can benefit from pharmaceutical intervention, this raises some warning flags. Assuming that autism is a condition requiring medication has already been raised.

Something I would point out is that while medication can be helpful, we have to remember that things like fluoxetine treat symptoms.

The conditions that cause the symptoms are not necessarily a given. We should also find ways of making life less stressful and threatening -- for everyone.

LIVSPARENTS said...

I don't have a problem with the drug itself, just the marketing of a 'cure' or even treatment for autism, as if there is something singly to 'treat'. When you look at the business write up, it's somewhat disturbing:
http://www.thebusinessonline.co.uk/home-page/top-stories/43482/neuropharm-enters-final-autism-drug-trials.thtml

It is mearly a drug to treat specific symptoms, but I fear it MIGHT become the knee-jerk reaction of pediatricians to the word autism...
Bill

Steve D said...

To all commenters -
I agree with all points raised, and agree that something like fluoxetine can only be a way to relieve symptoms such as anxiety or depression.
I also see the potential pitfalls and dangers, and would strenuously advise Autism Speaks to remain cognizant of those.

r.b. said...

>>For the record, I have taken fluoxetine for quite awhile. It has made me less depressed, less anxious and more able to function in a variety of ways.<<

Prozac made me aggressive, too, like Charlie. It has done that to many people I know personally. I think the criteria should be that the drug helps the autistic to feel better about themselves, not that they relieve symptoms. Anxiety and Depression are a part and parcel of most autism. In fact, anxiety is the most common reason for psychoactive drug prescriptions, NT or ND.

Lexapro helps me to shrug off NT's constant criticism. Otherwise, I would take it all inside, and finally blow up!

Autism Speaks could hardly care less that it's been done before. They were just looking for an excuse for a study.

Steve D said...

Testing "Recent Comments" function