Sunday, 24 August 2014

The Cost of Approving an Old Generic Drug as a New Autism Drug

Some readers of this blog are commenting how hard it is to obtain prescription only drugs for “off-label” use in autism.

None of the drugs mentioned in this blog are actually approved for use in autism.  There is some science showing that they might be effective, but there is no mention of autism on the “label” approved by the regulator.

This means that your doctor will not know how to prescribe it and your insurer will not want to pay for it.

So how do I access these drugs?

This is a frequent question.  In theory you do not need to wait for the drug to be approved, you can apply to the national drug agency in your home country for permission to use a drug based on the experimental use that showed it might be effective.

Better still, in many countries like the USA, doctors are not banned from prescribing “off-label” drugs.  If the doctor follows the new research, he is permitted to apply it on his own patients.  If he does it recklessly, he might eventually lose his license.

In cancer therapy, many drugs are used off-label.

Why not just approve a new use for an old drug?

This would seem an obvious question and this is what is being done with bumetanide, one of drugs described in this blog.

The problem is the cost and the time taken: EUR 4 million  (USD 5 million) and four years.

As you can see below, in the case of Bumetanide, the French Government will contribute EUR 1 million and it appears the Simons Foundation another EUR 1.5 million.

Since Bumetanide is available today as a cheap generic drug, they cannot really ever get their money back.  Only if they modified the molecule slightly, patented it, and got that new drug approved could they recoup their USD 5 million, which would then be even more, since they would have even higher costs.

The last I heard, Bumetanide will only be approved for autism in Europe, not the USA, due to cost issues.

So with this kind of financial logic, you can see why off-label uses of old generic drugs are likely to stay off-label.  

Best find yourself an off-label doctor.


  1. There is no such thing as "asperger's". Psychiatry itself is a bogus science. The following articles and essays explain this:

    12 Part essay that exposes psychiatry as a bogus science

    Inventor of ADHD: “ADHD is a fictitious disease”

    Co-Founder of DSM admits there is no way to scientifically prove that mentall illness is real

    One year old babies and younger being put on psychiatric drugs

    Psychiatric Drugs Shorten Life Span by 15 years on average

    Psychiatry is based on lies and falsehoods

    Psychiatry is a fake science

    Every human emotion is now a "mental illness"

    Ten Myths about Psychiatric Drugs

    Studies show psychiatric drugs have no benefits and are dangerous

    Psychiatry is now giving 3 year old children drugs

    Psychiatric drugs make you sicker

    A few free eBooks talking about how psychiatry is a massive hoax

    A list of THOUSANDS of psychiatrists who have committed crimes against their patients

    1. I tend to agree that that Psychiatry is anything but a science. I think brain disorders should be diagnosed and treated by neurologists, in a hundred years this may just happen.


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