Should our family join a clinical trial?

[Chris_uwd]

I'm not a regular poster so I'll introduce myself first. I am NT with a 6 year old daughter who has autism. She's currently in mainstream school with one on one support (fairly unusual for France, where we live). She's happy at school, has friends who love her with her differences, fab teacher. She's still mostly non verbal and has trouble with organising, structuring work, concentrating for a long time, abstraction.
We've just (today) been invited to join a clinical trial which aims to reduce the concentration of chlorine around certain neurons to improve executive function.
We have so far rejected offers of neuroleptics etc on the basis that we don't want to change our daughter, we love her as she is and if she needs/wants to stim or behave in a particular way, then that's ok. But this feels different, less like trying to change who she is and how she behaves and more like helping her achieve her potential.
But I don't know.
The trial is very clear : this is not and isn't intended as a 'cure'. If anyone wants to read about it, the last paper is here Effects of bumetanide on neurobehavioral function in children and adolescents with autism spectrum disorders
Sorry this is such a long message but if really appreciate your thoughts, if you have time?
Thank you in advance.
Hannah

 

[the_tortoise]

I would be loathe to medicate any child unless the situation was desperate, (particularly if that child had serious communication difficulties so they couldn’t necessarily tell me if the medication made them feel bad) and you have painted a picture of a happy child who is doing well.

Also there did not appear to be anything specifically about executive functioning mentioned in that paper (unless I missed it?), only about reduction in core autism symptoms.

(I am not anti-medication, by the way, and I know how disabling executive functioning problems can be - I have taken medication for them myself.)

 

[Autistamatic]

What provisions have been offered should the trial be unsuccessful? What plans have they in place to look after your daughter if she should suffer side effects or worse from the drug (as in real help, not financial compensation)? How would you cope with the knowledge that your decision to participate had harmed your child's health or future prospects if the trials had an unfavourable outcome?

I think you need to have answers for all those questions and more before even considering any possible benefits. As it stands, it sounds like she's doing quite well and is happy for the moment. Are her differences actually in need of trying medication - experimental or not?

 

[Dadwith2Autisticsons]

I'm not a regular poster so I'll introduce myself first. I am NT with a 6 year old daughter who has autism. She's currently in mainstream school with one on one support (fairly unusual for France, where we live). She's happy at school, has friends who love her with her differences, fab teacher. She's still mostly non verbal and has trouble with organising, structuring work, concentrating for a long time, abstraction.
We've just (today) been invited to join a clinical trial which aims to reduce the concentration of chlorine around certain neurons to improve executive function.
We have so far rejected offers of neuroleptics etc on the basis that we don't want to change our daughter, we love her as she is and if she needs/wants to stim or behave in a particular way, then that's ok. But this feels different, less like trying to change who she is and how she behaves and more like helping her achieve her potential.
But I don't know.
The trial is very clear : this is not and isn't intended as a 'cure'. If anyone wants to read about it, the last paper is here Effects of bumetanide on neurobehavioral function in children and adolescents with autism spectrum disorders
Sorry this is such a long message but if really appreciate your thoughts, if you have time?
Thank you in advance.
Hannah

We have a 7 year old that has Autism that is mostly nonverbal too, and has difficulties with organizing, structure, and concentration. You may want your daughter to be medically evaluated for either ADD or ADHD as well, as one of those diagnoses combined with Autism are not uncommon comorbid diagnoses, and as those signs and symptoms you mention are common signs for such.

Our child has both conditions, but admittedly, at times his severe adhd behavior, hyperactivity, concentration and attention problems is overwhelming us as parents that we had at least considered an off use medication that our doctor suggested we try for him, that could help control his severe adhd signs and symptoms. The medication is prescribed for high blood pressure issues mainly, but an off use for adhd.

We have not used such yet, as we personally are extremely hesitant using medications for children, and as we strongly prefer more natural ways to better health. I understand some conditions may require such, but one has to balance any not guaranteed benefits of taking such, with any side effects, short term and long term, and the fact any medication could change one’s natural way of being, and their differences often should not be seen as bad.

 

[Streetwise]

I'm not a regular poster so I'll introduce myself first. I am NT with a 6 year old daughter who has autism. She's currently in mainstream school with one on one support (fairly unusual for France, where we live). She's happy at school, has friends who love her with her differences, fab teacher. She's still mostly non verbal and has trouble with organising, structuring work, concentrating for a long time, abstraction.
We've just (today) been invited to join a clinical trial which aims to reduce the concentration of chlorine around certain neurons to improve executive function.
We have so far rejected offers of neuroleptics etc on the basis that we don't want to change our daughter, we love her as she is and if she needs/wants to stim or behave in a particular way, then that's ok. But this feels different, less like trying to change who she is and how she behaves and more like helping her achieve her potential.
But I don't know.
The trial is very clear : this is not and isn't intended as a 'cure'. If anyone wants to read about it, the last paper is here Effects of bumetanide on neurobehavioral function in children and adolescents with autism spectrum disorders
Sorry this is such a long message but if really appreciate your thoughts, if you have time?
Thank you in advance.
Hannah

Id definitely avoid it ,the research was in the form of vivisection and that is always inaccurate !

 

[GadAbout]

I have a bias about clinical trials. If the trial seems benign, it's still a certain amount of effort to participate, but it might be worth doing to further science and help others. But giving an unknown drug to a child seems very questionable. I'd be very reluctant to participate in this study.

The governing principle, as far as I'm concerned, is "Let somebody else be the guinea pig." I know that's selfish. But where a person already has many struggles and challenges, they SHOULD be selfish.

 

[Tom]

In general I don't agree on using young children, non volunteers, or those that cannot provide significant feedback in experiments. I could possibly see exceptions such in extreme cases such as otherwise terminal illness, when it had at least already been tested to the extent that it was reliably not going to make negative symptoms worse,etc.

Also the results are based on subjective outside observation. What appears to be be going on with a subject that cannot provide feedback and what is going on may be very different things.

Last, The supposed improvement (ie. less repetitive movements, lessened narrow interest) could simply be the effect of being in some way sedated. No improvement was noted in social interactions, awareness of others, thought clarity, etc)

 

[Chris_uwd]

Thank you for all the thoughtful responses. Currently at work but will return later!

 

[Aspychata]

Okay let's just talk gut here. First are u offered contacts such as actual human beings with phone numbers?

Most importantly--- Why would u drug your daughter? Why? Why? What would u think of your parents who drugged u? Aren't u saying to her somehow she isn't up to some imaginary standard u have?

My beautiful daughter- thanks for asking. l let her pursue her interests, celebrated every interest, every unconventional relationship she had, and guess what- she is a functional adult. Through horrible gas lighting, she took herself in for meds when she got depressed all by herself a year after l left extremely abusive relationship with her father.

And yes, she is very spectrum, and l celebrated her *differences* every day.

Who would ever drug their child in any interest, do u know how powerful the pharmacy industry is? Do u have any idea how much money they spend influencing our lobbyists?

Your beautiful daughter is already navigating life with her *filter* why would you subject her to something experimental at this age? My daughter- l had to warn her at a early age about predatory behavior which l did very carefully without causing any trauma.

 

[Chris_uwd]

I would be loathe to medicate any child unless the situation was desperate, (particularly if that child had serious communication difficulties so they couldn’t necessarily tell me if the medication made them feel bad) and you have painted a picture of a happy child who is doing well.

Also there did not appear to be anything specifically about executive functioning mentioned in that paper (unless I missed it?), only about reduction in core autism symptoms.

(I am not anti-medication, by the way, and I know how disabling executive functioning problems can be - I have taken medication for them myself.)

Thank you for your reply.
I agree with you about not medicating a child who can't communicate if the meds are making her feel bad. However there is no suggestion that this medication, which has been used for other purposes (treating high blood pressure) since the 70s, has any side effects (other than a risk of low potassium, which can be countered), particularly at such low doses.
B is a happy child generally but I am concerned that she won't be able to continue in school, where she is happy and has friends, if there isn't significant improvement in her ability to do school work.
I will get in touch with the professor re the effects expected, because he was very clear that he expected results in executive function and speech, whereas I can't find anything about this in the papers.

 

[Chris_uwd]

What provisions have been offered should the trial be unsuccessful? What plans have they in place to look after your daughter if she should suffer side effects or worse from the drug (as in real help, not financial compensation)? How would you cope with the knowledge that your decision to participate had harmed your child's health or future prospects if the trials had an unfavourable outcome?

I think you need to have answers for all those questions and more before even considering any possible benefits. As it stands, it sounds like she's doing quite well and is happy for the moment. Are her differences actually in need of trying medication - experimental or not?

Thank you for your thoughtful reply.
It's not an experiment drug, it's been used since the 70s, and all results appear to be entirely reversible within a short period of stopping treatment. Obviously this poses other questions: is the neurodivergent brain wired differently, if so does thus have a protective mechanism? If the results are wholly reversible, do you want a lifelong medication?
As it stands, we feel that there is little risk and possibly a high benefit, allowing b to focus on her school work more easily, and communicate better with those around her, which will allow get to stay in the environment where she is currently happy.
But there are no guarantees.
And I need to ask the question the other way : as a parent, how would I feel if I don't take up a treatment which could improve b's quality of life and help her realise her potential, and in 10 years she's in a worse place?
Just to add, I'm not being defensive, I'm conflicted and trying to work though the process!

 

[Chris_uwd]

We have a 7 year old that has Autism that is mostly nonverbal too, and has difficulties with organizing, structure, and concentration. You may want your daughter to be medically evaluated for either ADD or ADHD as well, as one of those diagnoses combined with Autism are not uncommon comorbid diagnoses, and as those signs and symptoms you mention are common signs for such.

Our child has both conditions, but admittedly, at times his severe adhd behavior, hyperactivity, concentration and attention problems is overwhelming us as parents that we had at least considered an off use medication that our doctor suggested we try for him, that could help control his severe adhd signs and symptoms. The medication is prescribed for high blood pressure issues mainly, but an off use for adhd.

We have not used such yet, as we personally are extremely hesitant using medications for children, and as we strongly prefer more natural ways to better health. I understand some conditions may require such, but one has to balance any not guaranteed benefits of taking such, with any side effects, short term and long term, and the fact any medication could change one’s natural way of being, and their differences often should not be seen as bad.

Thank you for sharing your experience. Being a parent is hard.

 

[Chris_uwd]

Id definitely avoid it ,the research was in the form of vivisection and that is always inaccurate !

Vivisection? I think we read different papers!

 

[Chris_uwd]

I have a bias about clinical trials. If the trial seems benign, it's still a certain amount of effort to participate, but it might be worth doing to further science and help others. But giving an unknown drug to a child seems very questionable. I'd be very reluctant to participate in this study.

The governing principle, as far as I'm concerned, is "Let somebody else be the guinea pig." I know that's selfish. But where a person already has many struggles and challenges, they SHOULD be selfish.

Thank you for your reply.
I have a different perspective on clinical trials, but I understand and respect your position.
It's hard to determine the benefits/risk in a particular situation. We have stopped some assessments because we've decided it is asking too much of b for little or no benefit to her, just the scientific advancement. I feel this may make life easier for her, which given things are a struggle, is a good thing, right?

 

[Streetwise]

Vivisection? I think we read different papers!

If you look up the research on the drug before it’s going to be possibly adapted for autism it says animal that means that vivisection,Look up rxlist.com I put the name of the drug then tested on animals and that’s what came up

 

[Chris_uwd]

In general I don't agree on using young children, non volunteers, or those that cannot provide significant feedback in experiments. I could possibly see exceptions such in extreme cases such as otherwise terminal illness, when it had at least already been tested to the extent that it was reliably not going to make negative symptoms worse,etc.

Also the results are based on subjective outside observation. What appears to be be going on with a subject that cannot provide feedback and what is going on may be very different things.

Last, The supposed improvement (ie. less repetitive movements, lessened narrow interest) could simply be the effect of being in some way sedated. No improvement was noted in social interactions, awareness of others, thought clarity, etc)

Thank you for taking the time to reply.
I'm going to get back to the Dr about results expected, I agree there seems to be a gap between what he said and what is in the papers.

 

[Chris_uwd]

Okay let's just talk gut here. First are u offered contacts such as actual human beings with phone numbers?

Most importantly--- Why would u drug your daughter? Why? Why? What would u think of your parents who drugged u? Aren't u saying to her somehow she isn't up to some imaginary standard u have?

My beautiful daughter- thanks for asking. l let her pursue her interests, celebrated every interest, every unconventional relationship she had, and guess what- she is a functional adult. Through horrible gas lighting, she took herself in for meds when she got depressed all by herself a year after l left extremely abusive relationship with her father.

And yes, she is very spectrum, and l celebrated her *differences* every day.

Who would ever drug their child in any interest, do u know how powerful the pharmacy industry is? Do u have any idea how much money they spend influencing our lobbyists?

Your beautiful daughter is already navigating life with her *filter* why would you subject her to something experimental at this age? My daughter- l had to warn her at a early age about predatory behavior which l did very carefully without causing any trauma.

Thank you for taking the time to respond. I'm sorry your daughter has had to deal with gas lighting, it sounds like she is very fortunate to have a parent like you to support and love her.
The doctor who has assessed b (we've seen him 4 times now and his team a few more) has given us his email and phone number and has said if we want to see him he will see us whenever. I've been impressed at how patient, responsive and available he has been so far.
I'm aware of the strength of the pharmaceutical industry, and the potential conflict of interest between caring for patients and wanted to advance your research career. I believe the Dr genuinely wants to help b, and he believes the treatment will do that. It's the conflict between, do you just accept that neurodivergent is 'the way you are, cope by yourself' or do you try to find tools, including medication, to help with the challenges of being neurodivergent in a NT centric world?
I love my daughter but I'm sad for her seeing her struggles and want to make it easier.

 

[Chris_uwd]

If you look up the research on the drug before it’s going to be possibly adapted for autism it says animal that means that vivisection,Look up rxlist.com I put the name of the drug then tested on animals and that’s what came up

I understand. Thank you for sharing. I don't really want to get into a discussion about the ethics of animal testing in medical research. Sorry.

 

[Streetwise]

I understand. Thank you for sharing. I don't really want to get into a discussion about the ethics of animal testing in medical research. Sorry.

Im not talking about ethics It’s proven that vivisection does not give accurate results ,humans are not herbivores ,carnivores or ruminants ,we do not have the same chemical make up ,all of those animals can make their own! vitamin c We !cannot ,I cannot live on a diet of animal flesh alone !Or grass ,wheat or flowers like a ruminant! Female humans do not have the ability to produce a child within 60 days or 40 days ,like some herbivores ,it changes the results of a medical trial if your body is that different.

 

[Chris_uwd]

Im not talking about ethics It’s proven that vivisection does not give accurate results ,humans are not herbivores ,carnivores or ruminants ,we do not have the same chemical make up ,all of those animals can make their own! vitamin c We !cannot ,I cannot live on a diet of animal flesh alone !Or grass ,wheat or flowers like a ruminant! Female humans do not have the ability to produce a child within 60 days or 40 days ,like some herbivores ,it changes the results of a medical trial if your body is that different.

Yes, I agree. In the current situation, there is no way I would let my daughter take part in a early stages trial, there are simply too many unknowns.
However this is a drug which has been used since the 70s for high blood pressure, and already been through 3 trials on children and teens with ASD. So it's not the same as having only ever been tested on animals. The arguments for and against are different.
Is it ever ok to give a neurodivergent child a medication to help with the symptoms of autism? Regardless of whether it's been proven effective?
What is the benefit/risk?