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So I saw this article over on @PinkNews about a new monthly PrEP drug and underneath it are people calling for the drug to be fast-tracked. As a Biologist I am going to disagree with that stance and here I explain why.
#NotMedicalAdvice [THREAD] 1/10 https://www.pinknews.co.uk/2021/01/29/islatravir-prep-hiv-pill-trial-2
#NotMedicalAdvice [THREAD] 1/10 https://www.pinknews.co.uk/2021/01/29/islatravir-prep-hiv-pill-trial-2
So to begin with my qualifications: I'm a pretty general biologist. Took some biomedical as part of my undergrad including Pharm-and-Tox, doing a lot more toxicology in my second Masters, but I am not any kind of licensed pharmacist or pharmacologist or medical doctor. 2/10
Now drugs go through a process of trials and evaluations in order to build up a profile of safety and efficacy which is considered by the regulators who then approve the drug or send it back to the lab bench. @bengoldacre has written extensively on this, go read him. 3/10
There wasn't really a way to bypass this process until the AIDS crisis in the '80s. It was decided that AZT should be allowed to go through a shorter period of evaluation in order to get it into patients faster. This was necessary at the time. 4/10
AIDS was a death sentence and there wasn't any viable treatment. This became the basis for the ethical framework for taking shortcuts on the evaluative process: 1) that the disease is highly deadly or crippling, and 2) there is nothing which prevents or cures it. 5/10
Fast-forward a few decades to today and we are in a different situation. Untreated HIV becomes AIDS and is highly deadly, so criterion 1 is met. The second criterion is not met however because we have both AZT and daily PrEP. 6/10
Let us be clear here that a drug exists which can prevent the transmission of HIV and that a drug exists which can prevent HIV from progressing to AIDS. This changes the balance of risk/benefit considerably. 7/10
Let us be clear also that all drugs are dangerous, and that there are no effects without side-effects, and that everything is toxic in some degree (shout out to my dude Paracelsus). The current drugs do unpleasant things and so too will this new one. 8/10
The point of the long-form trial and evaluation process is to ensure that drugs which make it to market are as safe and as efficacious as possible whilst having side-effects which are known and minor and manageable. To avoid intolerable risks when there is an alternative. 9/10
So let this one go the long run, stick with daily PrEP for now, and when monthly PrEP finally hits the market it'll be all the better for spending just a little longer in the pot! Daily PrEP works, and the next generation will thank us for getting monthly PrEP right. 10/10
