I have some potentially quite good news to share. This will be of specific interest to PAS sufferers, but it’s also no doubt relevant to the wider cause.
The MHRA, the drug regulating body in the UK, have announced that they are going to convene an Expert Working Group (EWG) on Isotretinoin, with submissions from the public regarding this matter open until 2nd Feb 2021.
EWGs are convened to consider specific safety concerns relating to a drug. This particular EWG will be evaluating three main areas of concern in relation to Isotretinoin:
- Psychiatric adverse effects (particularly depression and sucidiality)
- Sexual dysfunction in both men and women
- Long-term impact on fertility
The purpose of the EWG is to conduct a comprehensive scientific evaluation of all the available evidence relating to these three areas, before advising on any further research that might be deemed necessary.
The group will be made up of independent experts selected because their expertise specifically covers the relevant areas, as well as members of a group called the Commission on Human Medicines (CHM), which is a subcommittee of the MHRA.
It is also stated that “views of stakeholders are considered”, which, de-jargonised, I think means there will be pharmaceutical industry representatives present.
But crucially, the group will also include lay people i.e. non-experts. This opens up a space for PAS sufferers themselves to attend and give testimony.
So this is a call to all PAS sufferers/Accutane victims living in the UK. This is an opportunity for your story to be heard by people who might actually have the power to make a difference.
This is the first time an EWG has focused on the association of Isotretinoin with sexual dysfunction. There was one convened in 2014, but back then it was only to look at the psychiatric effects.
While the MHRA doesn’t conduct or directly commission clinical research itself, based on the findings of the EWG it is capable of imposing a requirement for further research on the drug companies which they must fulfil or risk losing their licence to market the drug.
We must do all we can to ensure this is precisely what happens.
It should go without saying that further research into the association of Isotretinoin with sexual dysfunction has the potential to benefit all of us on this forum.
And if the drug companies failed to fulfil the requirement for further research in a satisfactory way, and the MHRA revoked their licence to market the drug in the UK, not only would many young people be saved from the Hell we have had to endure, but it would also send out a huge statement about the safety of this drug to the international medical and scientific communities, raising the profile of PAS significantly. This, in turn, would be likely to spark off further research by independent researchers.
It’s not yet clear what the selection criteria will be, if any, for who will be allowed to participate in the EWG as a lay person, nor has a date yet been set for when the group will take place - though it seems likely we will hear more within the next few weeks.
But if you are are a PAS sufferer based in the UK and you’re brave enough to consider speaking about your condition before a committee and contributing to what could potentially be a big win for all PAS sufferers, please let me know, and I can keep you informed of further developments.
It’s easy to be cynical about the limits to the power regulators actually have, and much of that cynicim is for good reason, in my opinion. However, this is an opportunity to exert some pressure and really test those limits. We musn’t let this one pass us by.