4 ms·
What evidence do you have that they didn't properly consider this for this one specific drug when we trust them to do it for hundreds of other?
by TheCoelacanth 3y ago
What evidence do you have that they didn't properly consider this for this one specific drug when we trust them to do it for hundreds of other?
- giantg2 3y agoIn my opinion, they are not taking a systems thinking view when considering the alternatives. They mention risks associated with cancer recurrence, but then say it is unknown how high the risk is. There doesn't seem to be any mention of the probable increase in risk of developing certain cancers, like gliomas. They mention that STD rates will go up if condom usage decreases, yet didn't measure if there was an increase or decrease in condom usage associated with the product. They also seem to ignore that making the pill OTC may influence some people to rule out higher efficacy prescription options like IUDs. They talk about almost half of pregnancies being unplanned, yet there was no real analysis on how many of those would be prevented by this OTC pill. It feels to me like there wasn't much investigation or thought involved in the overall process. They're just going to use the safety study from 1973 and a small nonprescription study to bring back a pill that was uneconomical for the company to sell as Rx. Seems a lot like the notorious 510k process they use for medical devices. So I'm not saying it's the wrong thing to do, but I'm skeptical of the benefits. They don't have any compelling reasoning to make me believe there will be a bet benefit when they fail to quantify several of the risks and only provide a comparative analysis with OTC only products of the potential failure rates without any impact analysis on the desired metric of unintended pregnancies.