PolyPill for Autism - Part 2

In an earlier post I referred to polypills for autism. 

Polypill for Autism

These are one-size-fits-all pills that contain multiple drugs.  In theory they should be cheap and make it more likely that patients takes their medications.  It has been shown that the more pills you are on, the less likely it is you are to take them all.

The most popular application is heart disease, where the combination of a handful of drugs would extend many people's lives by several years.

In the UK such a pill has been launched and is, remarkably, available on-line.  It contains drugs that each have existing licences; but this polypill, as a combination, has not yet been licensed. 

Here is an except from PharmaTimes:-

The pill's four component medicines - the cholesterol buster simvastatin and blood pressure lowerers bendroflumethiazide, losartan and amlodipine - have each been licensed for individual use in the UK for many years, but the combination has not been cleared by any regulatory processes. 

This is because to obtain official approval through normal channels for the polypill as a preventative medicine is extremely complicated and "would take years and years", a spokesman for the programme told PharmaTimes UK News.

"You need randomised trials that demonstrate efficacy and safety for each component and in combination. It’s so difficult that for practical purposes it’s impossible,” Polypill patent owner Professor Sir Nicholas Wald, from the Wolfson Institute of Preventive Medicine at Queen Mary University of London, told the Financial Times.

However, the spokesperson confirmed to PharmaTimes that regulatory approval for the single pill is still being sought, "but we wanted to provide people with access to it in the meantime", he said. 

It is perfectly legal to sell the polypill because doctors are allowed to prescribe unlicensed drugs "off-label" where appropriate.

The unusual thing is that you get your consultation with a doctor on-line and for free.  Given how parents with kids with ASD struggle to access prescription medications for "off label" use, I found this interesting.
 
Here is the site:-

https://www.polypill.com/   

So when I finish my investigation into autism, in a few months time, maybe I will after all create the Peter Autism PollyPill, which will be a combination  of licensed drugs for "off label" application.