Marty Makary seems to be having an effort in the FDA to make some classes of prescription meds OTC, what would be examples that would be beneficial and why? He mentioned anti-nausea, anti-BPH drugs, and naloxone.
Balancing safety, Makary said the drugs that will be approved for over-the-counter status will need to meet certain criteria.
“The FDA is going to create criteria and already has some basic criteria, but we’re gonna formalize that so that companies can understand what we are thinking when we talk about drugs that should be non-prescription, and they are common-sense things,” he said. “Drugs that are safe, no abuse potential, cannot be used in some nefarious way, and don’t require ongoing laboratory testing.”
To me it’s insane, that for example statins are not OTC. As it is, it’s hard to get people to take them, I can’t imagine folks will be rushing to take them for no reason.
Unfortunately, to me it’s a case of “show me”. There’s been talk for decades about getting e.g. statins to OTC status, but it’s all talk. Would be great to see it, but I’m not holding my breath. YMMV.
Some may think this harsh. I don’t believe in protecting people from themselves. They could treat some over-the-counter drugs like cigarettes and alcohol and require that the person be at least 18 years old. I lived in Europe for 7+ years, and I am thankful to be living in the USA. I cannot abide and I abhor “nanny states,” especially London.
“London, United Kingdom: Outside of Asia, London has one of the highest total counts, estimated at roughly 630,000 to 690,000 cameras watching its population.” In the woke United Kingdom, the Orwellian vision has come true: “newspeak” and “doublethink” reign supreme in the British government.
Yeah, OK, Brits beat me up
Agreed on statins. I also feel the jaggedness of the “nanny state”, personally I know the side effects of statins, even the more esoteric ones, and the risks, and what to monitor. It’s my health, I’ve done my research. But the state doesn’t allow me to buy it OTC for a low price. I have to nag a doctor to get on with the latest research, or order it off-shore on the grey market. It’s salient that it feels dumb, and that something’s wrong with the system. There’s plenty of OTC drugs already that can be misused by uninformed people, so there’s an asymmetry with those compared to this. But I haven’t researched the differences.
Most importantly it’s going to open up conversations as well on the public square about what’s good, in a more wider way perhaps. A discussion about early prevention with perhaps SGLT2 inhibitors, controlling BP with meds, or statins for cumulative LDL exposure, inflammation, etc. Now it’s artifically locked in some sense for broader reach between a doctor and patient, and guidelines that even further limits the potential. There are potent therapies out there, applicable in a good way, but no one discusses them, they’re locked.
Some bozo are going to eat 90 mg of Jardiance everyday, and perhaps some will die, but such decision making ability surely generalizes and if not Jardiance it might’ve been something else, at least for some. It maybe comes down to principles, and on net it feels like more lives will be saved than lost or maimed for some of these drugs if used according to the frontier preventative longevity research, like what Attia is doing, but I haven’t ran any calculations.
I’m a Brit living in London and I’m not going to beat you up. In fact I think most Brits would agree with you.
That said, we sound less nannyish than some other places given it is legal for us to import prescription drugs for personal use.
You know, the OTC acetaminophen can very easily be abused to cause irreversible liver failure. You can already do a lot of damage with currently available OTC meds. So that’s not an excuse - Tylenol is one of the most used OTC drugs, but we don’t have an epidemic of liver deaths. And it goes in the other direction too - just because a med is prescription only doesn’t mean it can’t be abused, as sleeping pill suicides prove,
Whatever the original motivation behind keeping meds prescription only, the reality is that tons of drugs are kept prescription only for financial reasons.
Time to clean house and take 90%+ medications to the OTC side. Restrict only those which have a very high odds of abuse, great difficulty in understanding use, and a danger to others when used maliciously.
I guess I am a nanny state fan for certain things.
Statins - yes. OTC. BCPs - yes.
Diabetic drugs - well there is a really big problem here. They often cause weight loss so there is a huge secondary benefit from taking them. I am a physician who works with weight loss. People will do anything including harming themselves to lose weight. And don’t tell me that age restrictions will keep these away from teenagers.
Also. If you have diabetes for real, you are presumably under the care of a doctor who can write you a prescription (neglecting the sad state in the US of health insurance). Does anyone really think the average intelligence patient should be managing diabetes on their own?
Ditto for blood pressure. Sure a few basics could be OTC but I really don’t think we are doing the population a favor by allowing them to “wing it” on managing hypertension.
In the US, the problem isn’t people failing to be diligent about their health because they need a prescription. They mostly could benefit by going to doctors more.
Yes, OTC saves money. But it is a sad state that we would consider letting people self manage their serious chronic diseases in a population where 40% are functionally illiterate. All because we can’t organize our health care better and cover everyone for a reasonable cost.
Most people here want OTC not just for cost savings but because the providers are inflexible. That is its own problem. But India is cheaper than OTC ever would be (I think)
The fact is with telehealth opportunists and India, we have never had so much freedom regarding getting medications.
Even though I don’t want to personally be on camera, and I do feel they are an invasion of my privacy, I think the tradeoff to catch more bad guys is very worth it to me, so I think we should have more cameras.
@DavidCary I agree with you on what people will be willing to do for weight loss… I remember reading about models eating spoiled seafood before shows.
Having said that, in this day and age, all people with means can lose all the weight they want. Those who are less financially fortunate are the only ones who can’t. Even taking off work to see a doctor is a meaningful burden due to lost wages and transportation, so I do see a great case to make weight loss drugs OTC, especially because obesity is so common and is at the root of so many diseases.
But GLP-1s can be had at various price points by telehealth. And now with oral options. And I am sure they are open after work hours.
Nothing cheap for sure but cheap allows overdosing. Also easy enough now to take to get to BMI of 16 or supporting eating disorders but at least telehealth offers some barrier to that. And prescriptions control overdosing chronically pretty well.
Tylenol overdose is 500 deaths per year in the US and 50,000+ ER visits.
NSAIDs are far more but numbers hard to get a grasp of - 15,000 has been thrown out. Many of these had prescriptions but I would guess the majority are OTC.
The better answer is better provider access. We have probably cut by 50% the cost for a visit just for a script with the Amazon like telehealth model.
People misusing drugs bypassing age restrictions to lose weight beyond what’s healthy have a serious medical issue that most likely generalizes to other things as well. I.e treat that medical issue. The weight loss with anti-diabetics drugs that aren’t GLP-1 agonists is pretty low, AFAIK.
It’s not more of the bad guys, it’s more of the same bad guys. There’s probably a Pareto distribution where 20% of the criminals commit 80% of the crimes, even after repeated incarceration. But now we’re going off-topic.
I can be pretty argumentative so cut me some slack.
When you look at weight loss for diabetics taking a medication for diabetes, it isn’t the same as weight loss on non diabetics trying to lose weight.
Rybelsus at 14 mg compared to oral wegovy at 25 mg is instructive regarding the studies and demonstrated weight loss.
I think Jardiance and even Metformin beats any other OTC weight loss medication on the market. So, while not GLP-1 level, it is decent. And I wonder what metformin at 2g a day in a non diabetic or 50mg of Jardiance would do if someone was really trying to lose weight. Heck take both along with some caffeine pills.
Of course, a lot of this is philosophy on nanny states. Anyone in medical field is biased because we have seen what people do and dying based on ignorance is not something we approve of. Hence helmet laws and such. And I suppose mandatory vaccines too… I mean otherwise, a lot of what doctors do is irrelevant - just let them die. The ultimate rugged individualism.
Even if you don’t think certain meds should be OTC, many should be very easily available through healthcare providers who provide guidance on their use.
The problem with the current healthcare system is a doctor can arbitrarily deny access to certain medications causing a patient to go to underground sources which risks contamination, uncertain dosing and no professional guidance and testing.
Perhaps even not requiring booking an appointment but before purchase you need to read and sign a document that outlines proper usage.
Or an online provider system with no barrier to entry for proven longevity medications other than mandatory initial education on safe use and contraindications that just allows you to refill prescriptions easily once they are initiated and have them delivered or pick up from any pharmacy.
Many people are afraid of being honest with their doctor about what medications they are using off label. If they could be honest without fear of being denied treatment in the future there could be better healthcare provided.
I wish everyone had access to BP meds, GLP1s, cholesterol meds, SGLT2i, rapamycin and more. There are so many ways we can improve our healthspan and lifespan now while we wait for better options to become available to the public.
I asked my mother as a child, why do so many people want to tell other people what to do.
Still no answer
Why do people think that they are entitled to tell other people what to do when they were not asked?
We give elected officials the power to do this, but they frequently overstep boundaries.
I prefer borderline anarchy.
I am of the mind that if I am not harming others, it is none of their business.
Perhaps we could have periodic tests like a driver’s license test and be issued a card that would let us buy certain drugs based on how well we did on the test.
This topic relates to rapamycin news because it illustrates the problems that many people have in obtaining health and life extension drugs. I feel privileged not to have this problem.