It never ends, the neurotypical researchers try to find drug after drug to try to cure us of stimming. It will never happen. There is nothing to cure.
What is Bumetanide?
Bumetanide, branded Bumex, is a strong diuretic (water pill) and can cause dehydration and electrolyte imbalance. It is used to treat edema. This class of drugs works by causing the kidneys to get rid of unneeded fluid and salt from the body into the urine.
Edema is fluid retention, excess fluid held in body tissues. This is a big issue with cardiovascular issues and kidney failure.
Why Using Diuretics with Autistics for Stimming Unnecessary and is a Bad Idea
There is a big issue with using diuretics in the autistic community. There is a high percentage of autistics with Ehlers-Danlos Syndrome. There is a high percentage of people with EDS to have a form of dysautonomia. When you have dysautonomia, you get dehydrated very easily. This type of drug is very dangerous unless you are closely watched by a doctor.
For example:
I naturally have a very high level of testosterone. I take a testosterone blocker called spironolactone. My doctor knows about my orthostatic hypotension. She tells me to take it at night and I am on a low dose. This way I can have normal testosterone levels and not have very low sodium levels to where I would pass out.
This is why I stopped taking it years ago. I had no idea why. This was before I was diagnosed with OH and passed out when working. This was from my blood pressure crashing.
I am told to drink something with electrolytes all day long in order to keep hydrated and to keep my sodium up. Sodium is the electrolyte I have a hard time with. I drink Gatorlyte or NUUN in order to stay functioning.
How Bumetanide Should Be Used
Bumetanide comes in tablet form. It is taken once a day. When used to treat edema, a second or third dose may be given in 4 to 5 hours depending on the amount of edema.
Follow the directions on your prescription from your doctor, exactly how it is written. If you do not understand, ask your doctor or pharmacist for clarification. Do not guess.
Bumetanide controls adema. It does not cure it. Continue to take it even if you do not feel well. Do not stop taking it without talking to your doctor.
Other Uses Of Bumetanide
Bumetanide is also used for high blood pressure. Talk to your doctor about the risks of using this drug for your condition. This medication is sometimes prescribed for other uses. Talk to your doctor or pharmacist.
Special Precautions
Tell your doctor and/or pharmacist if you are allergic to bumetanide, sulfonamide medications, or any other medications, or ingredients in bumetanide tablets. Ask your pharmacist to check the patient information for a list of ingredients.
Tell your doctor and/or pharmacist what prescription and OTC medication, or supplements you are taking or plan to take.
Mention any of the following medications for hypertension (high blood pressure):
- aminoglycoside antibiotics
- amikacin
- gentamicin (also used as an eye ointment or ear drop)
- tobramycin (also used as an eye ointment or ear drop)
- corticosteroids
- prednisone
- prednisolone
- digoxin (Lanoxin)
- indomethacin (Indocin, Tivorbex)
- Lithium
- probenecid (Probalan, Probenemid)
Tell your doctor if you have kidney disease. It is contraindicated in kidney disease.
Tell your doctor if you have any type of diabetes, or heart or liver disease.
Tell the doctor if you are pregnant, or breast/chestfeeding. Formula feed or use donor milk to feed your baby only, when taking this medication. If you become pregnant when on this medication, contact your doctor immediately.
If you are going to have surgery, including dental surgery, tell the doctor or dentist that you are taking this medication.
Before going for bloodwork, let the phlebotomist know you are taking bumetinide. Do not share your medication.
keep a list of all your medication (prescription, over the counter and supplements) in case of an emergency
Side Effects
Common side effects that should be reported to your doctor if they are severe or do not go away:
- frequent urination
- dizziness
- upset stomach
- diarrhea
Serious Side Effects
These side effects need to be reported IMMEDIATELY and go to your local Emergency Room or Accident and Emergency (depending on where you are, it is called differently)
- tinnitus (ringing in the ears)
- hearing loss (no being Deaf or hard of hearing isn’t bad but sudden onset could be a symptom of something serious)
- Unusual bleeding or bruising for you
- severe rash with peeling skin
- difficulty breathing or swallowing
- hives
Studying This Dangerous Medication in Autistic Children
First Study on Children
Design
There was an open-label, three-month trial of bumetanide on six children. This is a clinical trial where both the researchers and the participants know what medication they are getting. They are not counting the psychosomatic aspect of medication efficacy. This is also known as the placebo effect
They at least monitored the children for electrolyte levels. That was the least they could do.
Their excuse for doing this trial was that it was a pilot trial for the two that later flopped.
Method
They measured “improvement” using the Parent Satisfaction Survey (PASS) concentrating on “Communicative and Cognitive Abilities”. This survey was completed by the participant’s parents.
Test Sample
The sample size was too small to make any scientific impact at all. There were five boys and one girl. They were aged 3-14 years old. This means a three-year-old was given this dangerous medication.
What did they care? These are autistic children. Not “normal” children. Autistics get compared to mice and other animals, anyway. To researchers like this, autistics are subhuman.
They tested it on these children because a mechanism of action is reducing intracellular chloride, chloride being an electrolyte. It also inhibits GABAergic inhibition.
The French research company, called Servier, partnered with Neurochlore, another research firm, to conduct these studies. They were looking to control “repetitive behaviors” which is stimming.
Results
Improvements were reported using the CARS checklist.
- Marked and Very Marked for 4 children
- Some improvement for the two children.
- a few negative side effects were reported
- severe hyperactivity (weren’t they trying to treat this?)
- depressive mood (this is not surprising as they were trying to cure the children of being themselves)
- aggressiveness
- increased urination at night
They concluded that this study was a success but this study had no scientific basis. All they did was experiment with a dangerous drug on children.
Two Phase Three Trials Flop
Two double-blind studies on the effectiveness of bumetanide oral solution for the treatment of stimming were canceled after they saw that this dangerous drug was not effective.
The efficacy and safety of bumetanide oral solution for the treatment of autism in children and adolescents was evaluated in two, international, multicenter, randomized, double-blind, placebo-controlled phase II trials.
One study enrolled children aged 7-17 years old and the other enrolled children from 2-6 years old.
In both studies, children were randomized to be given bumetanide oral solution twice a day or placebo twice a day for a 6-month trial period.
Their goal was a change in the Childhood Autism Rating Scale 2 (CARS2) from baseline to week 26.
Secondary goals were changes in:
- Social Responsiveness Scale
- Clinical Global Impression Scale
- Vineland Adaptive Behavior Scale
Each study had 211 children participating.
- 107 children in each study received bumetanide
- 104 in each study received a placebo.
Both studies were terminated early due to any significant difference between the study drug and the placebo.
In both studies:
- CARS2 total raw score decreased from the baseline to Week 26 in both the test and control group with no statistically significant difference between the groups.
- No differences were observed between treatment groups for any fo the secondary goals
- the test group experienced more frequent side effects than the placebo group
- increased thirst
- increased urination (polyuria)
- hypokalemia (low potassium)
- dry mouth
These large phase III studies flopped. They did not demonstrate any benefit of this drug. They put these children at risk for serious side effects for no reason.
The study sponsor discontinued the development of bumetanide for the treatment of autism.
Why can’t the neurotypicals just leave us alone?
Statement from the Study Firm NeuroChlore
Although the phase III clinical trial was a failure, Neurochlore was able to retrieve data that could be promising. Indeed, we are convinced that Bumetanide works on sub-populations, defined by more specific criteria that were not considered in the selection of the initial trial.
We have entered into a partnership with the company Quinten Health in order to re-analyze these clinical data using artificial intelligence in order to detect and define these sub-populations.
As part of this collaboration, and the GDPR law, we inform you that your health data will be reused.
Please find below the legal information note on this subject.
Information note on the re-use of your health data
“Bumetanide Phase 3 Rescue
Head of the study : Neurochlore
Scientific Director: Pr. Ben-Ari
Dear Sir or Madam,
Neurochlore will reuse the health data collected in the framework of the clinical study entitled SIGN 1&2 between September 24th 2018 and October 26th 2021. The purpose of the re-use of your health data is identical to that of the conduct of the study to which you have consented to evaluate the efficacity and the safety of bumetanide/S95008 in the improvement of Autism Spectrum Disorder core symptoms.
1) What is the purpose of this re-use and what does it involve?
The purpose of the re-use of your data is to perform a detailed analysis of the data collected in the Phase 3 study on Bumetanide. Neurochlore has therefore called upon Quinten Health (SAS, located at 08 rue Vernier in Paris (France) – 75017) in order to identify and characterize the profiles of patients showing the best response rates versus placebo and more generally to identify the causes of failure of the phase 3 study.
This project is based exclusively on the reuse and processing of medical information collected during the SIGN 1&2 study. The reuse of your data does not therefore involve any further examination or intervention on your part.
The data collected will not include your name. Your data will be identified by a confidentiality code and then analysed in an aggregate manner so that it will no longer be possible to identify you, either directly or indirectly.
The results of this study may also be presented at scientific conferences and/or published in a scientific journal.
In all cases, your anonymity will be preserved. You may be informed of the overall results of this study through Neurochlore at the following address: contact@neurochlore.fr.
2) What are your rights?
In accordance with the General Data Protection Regulation (RGPD-2016/679) and the provisions of the amended law on data processing, files and freedoms, you have the right to access, rectify, delete and limit your personal data.
You also have the right to object. You may therefore, at any time and without justification, object to the re-use of your medical data in the context of this project. An objection will have no consequences in the structure you are consulting.
You can exercise all your rights by writing to Neurochlore’s data protection officer at :
- by email to the address : ben-ari@neurochlore.fr ;
- by post to :
Neurochlore – A l’attention de Yehezkel Ben-Ari,
Campus scientifique de Luminy
Bâtiment Beret-Delaage
Zone Luminy Entreprises Biotech
Case 922
163 Route de Luminy
13288 Marseille Cedex 09
FRANCEYou also have the right to lodge a complaint with the Commission Nationale de l’Informatique et des Libertés (CNIL), on the CNIL website or by post.
Do not hesitate to ask any questions you may have by post to the following address: contact@neurochlore.fr.
One of the companies running these studies, NeuroChlore, put a statement out on their website
NeuroChlor Partnered with Quinten Health to Analyze the Data
Yes, NeuroChlor partnered with Quineten Health in order to reanalyze the data and say it could be “promising.” They want to test it on other populations by using the data from autistic children.
They can’t help themselves. If you are approached by a researcher to try this medication, tell them no. The risks are not worth it.
Sources:
https://medlineplus.gov/druginfo/meds/a684051.html
https://onlinelibrary.wiley.com/doi/10.1002/aur.3005
https://www.neurochlore.fr/en/information-note-on-the-re-use-of-your-health-data/
https://clinicaltrials.gov/study/NCT03715153
Aviva Seigler 