FDA approves first nonprescription daily oral contraceptive • Hacker News Board

Re: FDA approves first nonprescription daily oral contraceptive

#291

Post by 0cf8612b2e1e » Thu, Jul 13, 2023, 5:27 PM UTC

giantg2 wrote: post #267

travisjungroth wrote: post #209

Earlier quoted context omitted.

Having a doctor rubber stamp a prescription does more harm than good. If the argument is that getting a prescription is such a simple task it should cost almost nothing and be done instantly, then it likely doesn’t need to exist as a barrier at all.

"Having a doctor rubber stamp a prescription does more harm than good." The question was how/why, not to simply restate it as fact wilit supporting data. "If the argument is that getting a prescription is such a simple task it should cost almost nothing and be done instantly, then it likely doesn’t need to exist as a barrier at all." That's not the argument. The argument is that the current system already meets the n…

Net benefit is the enormous hassle a woman has to go through to get an approved treatment.

Annual checkup, prescriptions only good for three months, and then typically only allowed to pickup one month dose at a time. That is a huge logistical burden being put on people. Maybe if a prescription was annual and included a year of pills, that would make the OTC case marginally less compelling. Given the status quo, OTC would be an improved quality of life for many.

Re: FDA approves first nonprescription daily oral contraceptive

#292

Post by travisjungroth » Thu, Jul 13, 2023, 5:28 PM UTC

hadlock wrote: post #279

travisjungroth wrote: post #194

Earlier quoted context omitted.

Tylenol/paracetamol/acetaminophen also barely works. It increases the effectiveness of an aspirin and caffeine combo to relieve headaches (but not migraines). It’s generally ineffective against chronic pain, back pain, and severe pain. It’s a weak fever reducer. It’s one of the most popular medications in the world and its use isn’t especially supported by science. To the point of this thread, don’t mistake official…

I also do not like how toxic tylenol is, but I'll echo the other (probably parents) posters pointing out that dropping a fever from 104.2 down to 100.9 is... pretty awesome when you have a screaming 6 month old and panicking mother. Arguably it's best feature is mild fever reducer. I love that feature. My child will peacefully go back to sleep within an hour of taking it and we can go get prescribed antibiotics for h…

My first paragraph lumped together a bunch of pros/cons. Tylenol definitely reduces fever and eases mild headaches. It doesn’t do some other things that it’s prescribed for.

The thing about the weak fever reducing is it’s useful for reducing the suffering from the fever itself, like letting your baby sleep. It’s surprisingly ineffective at reducing febrile seizures. I think it’s that it doesn’t have much against a fever that bad.

Re: FDA approves first nonprescription daily oral contraceptive

#293

Post by helipod12 » Thu, Jul 13, 2023, 5:29 PM UTC

jeffbee wrote: post #250

noodlenotes wrote: post #182

Earlier quoted context omitted.

You can add to that list - Have to get pap smears before being granted a prescription Doctors will withhold birth control to coerce women to get regular pap smears, just because it's a lever they have available, not because it's related to the prescription. I have to take both ADHD meds and birth control, and while it is much easier to get prescribed birth control, it's a similar level of stress of making sure my med…

Do they still do that? HPV vaccine is on its way to eradicating cervical cancer.

Yeah they do that, way too often. My wife went in to a 32 week OB appointment and the hospital staff were trying to force her to get one, she just left and got a new OB clinic.

Re: FDA approves first nonprescription daily oral contraceptive

#294

Post by Eisenstein » Thu, Jul 13, 2023, 5:30 PM UTC

giantg2 wrote: post #224

Eisenstein wrote: post #156

Earlier quoted context omitted.

Let's make people go to a clinic to get any medicine then. If it isn't such a hassle, you won't mind? I have a feeling you might be the type of person to think government should get out of the way of most things. Why is it not such a big deal in this case?

I generally am in favor of government getting out of the way. I'm not necessarily against this being OTC either. I think a lot of the arguments being made here are not applicable and this won't be as big of a deal as people are making it out to be. I'm skeptical that this will bring any real net benefit over the current state. That said, I do believe there is a massive overuse of hormonal contraception which is parti…

You are letting one ideological belief conflict with another and yet you don't realize it. When you feel strongly about something, don't excuse it like "I think a lot of the arguments being made here are not applicable and this won't be as big of a deal as people are making it out to be."

First of all: are you the person affected by this change? If you aren't, try and imagine being a person that was. If you cannot empathize at all with the other side, perhaps it isn't something you should be arguing for or against.

Second: does this vibe with how you would treat someone you normally would disagree with politically, if the position were flipped? Say there is something you think government shouldn't have a say in (apparently not family planning, but you can think of something... guns? business?) then have them argue 'it isn't such a big deal to have to jump through this bureaucratic hoop and the reasons we make you do this is are obviously not as overt as we pretend'. How would you feel about that argument?

Re: FDA approves first nonprescription daily oral contraceptive

#295

Post by helipod12 » Thu, Jul 13, 2023, 5:30 PM UTC

cogman10 wrote: post #260

tyre wrote: post #58

Earlier quoted context omitted.

The FDA regulates both risks and efficacy. The efficacy of hormonal birth control plummets if not taken consistently, which for progestin-only pills (like this) includes the same time of day[0]. Talking to a doctor ensures that people really understand this. The downside of forgetting to take more advil in time is short-term pain. The downside of not understanding that your birth control isn't working is a child. As…

I'm not sure the point you're making here. The potential danger of forgetting to use a condom or misusing one (like a condom that's too old) is also a child. Condoms are currently sold in truck stop bathrooms. I really see no distinction between a condom and a birth control pill. Even with misuse, making the pill more widely available will almost certainly be a social good. It will prevent more unwanted children.

Well you should, hormonal pills and latex are entirely different.

Re: FDA approves first nonprescription daily oral contraceptive

#296

Post by kaitai » Thu, Jul 13, 2023, 5:30 PM UTC

tyre wrote: post #58

runako wrote: post #16

Earlier quoted context omitted.

> but there may be risks, especially if folks don't take the medicine correctly. This describes every over-the-counter drug that has ever been sold. Keeping contraception prescription-only has always been about politics.

The FDA regulates both risks and efficacy. The efficacy of hormonal birth control plummets if not taken consistently, which for progestin-only pills (like this) includes the same time of day[0]. Talking to a doctor ensures that people really understand this. The downside of forgetting to take more advil in time is short-term pain. The downside of not understanding that your birth control isn't working is a child. As…

In the United States, there are two quite distinct aspects.

1) Health. Agree that talking to a doctor -- or a nurse, or a midwife, or a well-trained community health advocate -- is quite useful when understanding the practicalities of taking hormonal birth control. Talking to someone helps people understand this; I think you may overestimate the efficacy of an MD per se here.

2) Insurance as gatekeeper. The narrow windows to get a limited supply, whether you can get it locally or must mail order it or can't mail order it or can or can't get a refill -- none of this is medical. It's all insurance bureaucracy. I find no benefit to this bureaucracy.

Good education about the full range of options would be great (from pill to ring to IUD to condom). Universal health care availability would be a good mechanism by which to deliver that, it's hard to accomplish when it's all gatekept by insurance.

I got laid off recently & had a routine physical that took place 2 days after my health insurance thru Company ended, went anyway, got a bill for $552. This is for conversation only, haha, but the type of conversation one would need to get an annual renewal for birth control controlled by prescription.

Re: FDA approves first nonprescription daily oral contraceptive

#297

Post by giantg2 » Thu, Jul 13, 2023, 5:32 PM UTC

TheCoelacanth wrote: post #248

giantg2 wrote: post #171

Earlier quoted context omitted.

This is false equivancy. We would need to view that on an individual basis. Just because we have done it for one type of drug, doesn't mean the concerns are the same for another type. This is especially true when considering alternatives during evaluation.

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?

In 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.

Re: FDA approves first nonprescription daily oral contraceptive

#298

Post by PraetorianGourd » Thu, Jul 13, 2023, 5:33 PM UTC

xyzzy_plugh wrote: post #238

maerF0x0 wrote: post #198

Earlier quoted context omitted.

It's often funny to me how there will be such a massive gnashing of teeth about whether or not something is prescription or OTC available to women, when Men essentially have no contraceptive choice and have 100% liability the moment it leaves our body, potentially including in cases of paternity fraud. It'd be like if we told women they had to have the baby the moment their egg accepts a sperm, regardless of the reas…

> It'd be like if we told women they had to have the baby the moment their egg accepts a sperm, regardless of the reasons it ended up there. I'm not sure if you're being sarcastic or not here, but that is pretty much what exactly is happening in much of the USA. It's sad, disappointing and, frankly, irrational, at least from the perspective you present.

A majority of Americans still have access to abortion that is _less_ restrictive than most EU countries. The Supreme Court did not outlaw abortion. In my state, abortions can be legally performed right up until birth.

Re: FDA approves first nonprescription daily oral contraceptive

#299

Post by Zak » Thu, Jul 13, 2023, 5:35 PM UTC

giantg2 wrote: post #62

0cf8612b2e1e wrote: post #43

Earlier quoted context omitted.

That’s still a needless barrier. If you are poor every dollar counts and being required to pay for a medical professional to rubber stamp a prescription does more harm than good.

I'd like see the data that supports that. If true, we would do away with the prescription process altogether for most drugs.

> If true, we would do away with the prescription process altogether for most drugs.

That might not be a bad idea. In theory, a prescription means that a doctor who has an intimate knowledge of the patient's health works with the patient to make a carefully-considered mutual decision about medication.

In practice, much of the time the process is just a formality which imposes a huge time and financial cost on some patients as well as reducing the time the doctor has for patients who really need more attention. In the past, when access to information was more difficult, this might have been necessary.

In the modern world, a simple automated flowchart on a pharmacy website or in-store terminal can do as good a job selecting appropriate medications, avoiding drug interactions, screening for side effects, and informing patients how to take the drug correctly than a doctor. Of course, not every condition can be treated by merely dispensing pills, nor is this appropriate for medications that require more in-depth monitoring or have severe public health consequences.

Advertising drugs should probably be more restricted than it is now to put such a system in place.

Re: FDA approves first nonprescription daily oral contraceptive

#300

Post by giantg2 » Thu, Jul 13, 2023, 5:37 PM UTC

0cf8612b2e1e wrote: post #291

giantg2 wrote: post #267

Earlier quoted context omitted.

"Having a doctor rubber stamp a prescription does more harm than good." The question was how/why, not to simply restate it as fact wilit supporting data. "If the argument is that getting a prescription is such a simple task it should cost almost nothing and be done instantly, then it likely doesn’t need to exist as a barrier at all." That's not the argument. The argument is that the current system already meets the n…

Net benefit is the enormous hassle a woman has to go through to get an approved treatment. Annual checkup, prescriptions only good for three months, and then typically only allowed to pickup one month dose at a time. That is a huge logistical burden being put on people. Maybe if a prescription was annual and included a year of pills, that would make the OTC case marginally less compelling. Given the status quo, OTC w…

Those are not restrictions under the Rx process. One can easily access hormonal Rx birthconrtol online - virtual appointment and mailorder pharmacy with auto renew. If people are unhappy with their service, there are other providers able to provide a convenient experience.

You can't get a year of pills at one time. These pills expire 1 year from the manufacture date.