Drug Goes From $13.50 a Tablet to $750, Overnight

Again, we aren’t even talking about people being able to go and buy drugs without any prescription. You could still require a prescription from a doctor for treatment, even if you remove the requirement that the FDA approve that treatment.

A doctor could determine, with their patient, that a specific treatment which was not yet certified, perhaps due to it still going through the process, or perhaps due to known high chances of side effects, is in fact the best option. And this could very well be the case, for that individual.

I think that the drug company would likely require some waiver to be signed, but such an agreement is one that responsible adults should be able to enter into.

Well, walk it back a bit then. Do you believe that you have the right to control your own body?

I suspect pretty much no doctor would do it though, due to malpractice concerns. We could in theory pass laws giving doctors and drug companies legal immunity from the consequences of people making these decisions, but it seems like a poor idea.

If delays in certification are a concern, then directing more resources to speed certification seems like the simple solution.

I think that, again, it would require the patient to sign waivers.

Indeed, this kind of thing actually already happens. It happens in clinical trials. The only thing we’d be talking about here, would be essentially opening up that access to other patients who wanted to participate in trying those drugs.

Well not that I based all or even most my information on a movie, The Dallas Buyer’s club movie covers this very thing, someone smuggling in and selling an FDA unapproved drug that was approved elsewhere, if I remember right. At the time though, in the 1980s, it seemed like the physicians were just telling people to sit back and die. On one hand, it’s a scary idea to think the pharmaceuticals can just skip a lengthy process, sell drugs to those who can basically pay cash for it and then be completely insulated from any lawsuits or anything of that nature for doing it. On the other hand, if you’re sentenced to death… shouldn’t you have a chance to try something else? I don’t know.

The example of Clinical Trials is a poor example, very poor actually.

As for this dogma mantra coming from Timex, it’s the response I expected. This right to do anything to my body and my property is not in fact a right so much as a belief a certain group has that they sell as a right.

Could you expand on why it’s a poor example?

So you seriously do not believe that you in fact have a right to control your own body?

You’re not really listening to any other explanation. In fact you’ve decided because I don’t subscribe to your belief that somehow I am deficit in my thought process based on a response like this:

So why would I tell you why a controlled process like Clinical Trials is quite different from what you’re proposing if you are not wiling to listen to other points of view?

Ok then, don’t explain yourself then.

That doesn’t sound like a commitment to actually listening to me.

Ok, then DO explain yourself. I’m not going to beg you for the honor of your participation. If you want, do it, if you don’t, that’s fine too.

You do realize that this hard stance where the other “side” can’t possibly contribute or have anything worth stating came from you right?

As for clinical trials, let’s start with the fact that only a fraction of clinical trials ever move out of clinical trials. This means the majority of drugs that go through clinical trials are not next step on the market. There are also different kinds of clinical trials… not all clinical trials are 800 numbers where you feel like you have some sort of disease so you show up. There are different kinds of trials. Some clinical trials even have a placebo piece where a person in the trial didn’t actually get the drug which you obviously can’t do with people paying for the drug.

What about people who have other complications… in a clinical trial you might remove someone who has kidney disease, or heart disease or some other disease on top of the one you’re trying to treat, prevent or just study. And then we add children, children are constantly a problem for the industry. These drug companies, in our existing controlled environment, have been in trouble repeatedly for instructing physicians or implying that people under the age 18 should be treated with a drug without actually doing the study on the affects on children. They had trouble with Paxil on this and allowed physicians to prescribe it for children, as they often do with drugs that were tested on adults, on a case by case basis before they uncovered suicidal and depressive side affects specific to young people.

The latest issue, the EpiPen, has had a lot of conversations around the access to this device for children, on schools, on school trips and just handy where they’re at. Where do you put children on our proposal? Do we let any parent do whatever they want because it’s their child. If that’s the case the power of prayer must also be on your list right? The groups that refuse modern medicine entirely.

Clinical trials are a controlled process often designed with specific testing and goals. You’re proposal turns the entire process into a Wild West scenario where any drug with even the slightest unproven promise of a solution into the patient’s hand with the hope they could get better. It’s not a coincidence I chose the Wild West as a reference either. Snake oil sells.

You want to know what this will look like, just look at the supplemental market which is largely unregulated and promised the world right up until someone slaps them on the hand for it or some people start dying. Right now for the supplemental market it’s largely a reactive response we have to that.

Despite what you think you know about me and my position, I absolutely understand the problem and complication of telling someone there is nothing approved on the market for you right now but across the sea this xyz drug seems pretty promising… hopefully you’ll be around long enough to try it when the FDA finally approves it. I do.

The problem is… I don’t believe in reducing the surplus population because a physician tells them their child has a 5% change of making it past the age of 2 but for 100k they can try some unproven drug to see what happens. They’re going to choose hope even if there really isn’t any, and if we’re looking at some drugs that never make it to market… sometimes for good reason, do we really want to give that access to the public?

For the record, I have a hard time opening up the organ market too, basically giving likely the poor and desperate a chance to sell parts of their body to the rich which I think would probably fall into your field of view too.

And just to be clear, I am not saying your position doesn’t have merits. I think it does. I just think the risk outweighs the benefit in the scenarios presented.

Let’s also remember that doctors get their much of their information on side effects, complications and dosage from those trials. Bypassing that step would require your doctor to know as much as the drug’s researcher in order to prescribe it. That doesn’t seem realistic to me.

Are you an anti-vaccine supporter?

I posted a study far up above on where doctors (in the UK) actually get their information. They are more likely to get their information from colleagues & pharma marketing than they are from peer reviewed studies.

Yet another reason for how out of touch Timex’s ideological Libertarian suggestions are.

I’ll just put it out there that I partook of several clinical trials to help pay my way through college. It was major money, as these were what are now known as “phase 1” trials with completely untested medicines. We’re talking an inflation-adjusted equivalent of anywhere from $3,000-$5,000 for a few days of my time, during which I’d be fed, get to watch all the cable TV I wanted (this was back when that was a major luxury), access to a game room, free time to study or do homework as much as I wanted, and in exchange I took only one dose and then gave blood roughly every 4 hours or so (yeah, it was annoying to not get solid sleep, but not THAT annoying). And yes, half the people would get placebos.

I was one of their “usuals” - I got to know all the staff, many of whom were experienced Russian doctors who had to go through med school in the US to get certified over here. We shared crazy stories, joked about any- and everything. It was normally a fun time (especially when they were testing what wound up being a very effective anti-depressant, given in rather large doses to determine safe levels; people were breaking into song periodically).

Once - only once - did I have a negative response, causing a burning sensation in my throat. I didn’t think much of it, but they acted very quickly and gave me some antidote which INSTANTLY made the sensation vanish. I realized they knew that response might have been a possibility, and I was a little scared for the first time. The reality of the danger set it. I still went back from time to time, but far less often.

About 10 years later, after having moved all over the place, I got a call.
“Hello, is this Dan_Theman?”
“… Yes, how may I help you?”
“This is so-and-so from the Whatever-Pharmacology Lab. We have you as one of our test subjects from such-and-such a date. Is that correct?”
“… um … yes.”
“Have you had any unusual medical issues since your time here?”
“I don’t think so … but, like what?”

At that point, I was provided a list of possible things which made my heart pound a thousand beats a minute. Apparently, one of the drugs I tested had some BAD long-term side effects on some of us. The majority wound up fine, but 3 of the 20 who actually took the medicine suffered from devastating medical issues which manifested over time, 1 of which died from them. Another 5 had somewhat lesser but still persistent related issues. The drug never made it out of testing, but the pharmaceutical company (likely in an effort to dodge additional liability, regardless of our waivers) was paying for everyone’s medical bills and untold compensation for anyone who suffered from negative side-effects.

I was very fortunate, and that was in a tightly controlled, heavily monitored situation. The benefit to me was simply money, not saving my life or curing some seemingly incurable malady. I was healthy, and I put myself through that risk.

To dangle such uncertain hope in front of someone who is desperate without those controls in place is abhorrent to me. A typical doctor does not have the time to thoroughly research all medicines in testing. They’re very busy people. I’m all for opening up testing as long as significant controls are in place, but I would never in a million years support the equivalent of a layperson knocking on a pharmaceutical company’s doors and asking how much it would cost to get a dose of unproven medicine X, and that seems to me the logical extension of “I should be able to put whatever I want into my body.”

I totally get the rationale behind it, but it doesn’t jive with the reality I’ve seen.

This is a fair question, and helps clarify the position.

I think that most folks do indeed accept that a fundamental basis of all of our rights is a basic belief that we have the right to liberty of person. That is, you have the right to control your own body. I think this is generally a fundamental basis for all of our other rights, but in terms of the constitution, it’s most directly codified in the 14th amendment, under the umbrella of “liberty”.

Now, like most rights, it is not absolute. In terms of the 14th amendment, this limitation is laid out by the due process clause. That is the government is able to restrict your liberty, as long as you have due process. But this does not only mean procedural due process, but also substantive due process. That is, the government is not allowed to make arbitrary restrictions on your liberty, and instead there must be a substantive benefit to society that is provided by that restriction of liberty.

So, for something like vaccines, a mandatory vaccine can be justified because, while it constitutes a limitation on your liberty, that limitation is bound by due process. By forcing you to be vaccinated, it benefits society as a whole, in a very direct way.

For things like drug criminalization, I would offer that there is little substantive reason for drug criminalization laws, as after being in effect for decades, there is little if any empirical evidence of them being beneficial to society. Indeed, there’s a great deal of evidence to the contrary. Thus, I would argue that such laws violate the due process clause by restricting your right to liberty, without substantive due process.

Likewise, another aspect of liberty is liberty of contract. Again, not absolute, but a right none the less. The government cannot arbitrarily limit your ability to enter into a voluntary contract with another person, unless there is some substantive benefit to society. For a while, this notion was even stronger than it is now in Constitutional law, preventing most wage laws, but then in the early 1900’s some case with a hotel worker established that there was a legitimate benefit to society from limiting that right through minimum wage laws.

Now, the right to liberty of person and contract is a limited right, but it is still a fundamental basis for our entire notion of rights, which was my original point. That’s why it’s codified in the 14 amendment as it is. We have a right, albeit a limited one, to liberty. And that includes being able to do what you want to your body, and buy things that you want to.

In cases where the government wants to infringe on that right, it needs to provide a substantive reason for why that restriction will benefit society.

In the case of a mandatory vaccination, I think that reason is fairly clear, and given that there is no real liberty being yielded (since the supposed dangers of vaccinations are generally all fictional), it makes a fairly clear choice to me.

But in the case of legally preventing a person from undergoing a treatment which may hurt themselves, but no one else? And voluntarily entering into a contract waiving their ability to sue people for the outcome of this voluntary action? I do not believe there is a legitimate argument for there being a benefit to society for that restriction on their liberty.

Now, that last part can be discussed and argued, as whether there is a substantial benefit to society involves perhaps some amount of opinon. But my initial rejection was of the notion that you do not have a right to liberty of person or contract, and this is factually incorrect. You do indeed have those rights, not only a fairly fundamental basis for our entire system of rights (such rights generally exist in most modern legal frameworks in some form), but actually as codified in the US constitution. Again, those rights are not absolute. But they certainly do exist.

Thank you for sharing this.

I have my own health…challenges…and I absolutely lean on my doctors to tell me what is what. I really don’t need some possibly-but-untested maybe-cure dangled in front of me. I have no way to evaluate that.

Maybe I’m wrong to do so, but I do trust the establishment. It’s gotten me this far.

Not really. Should we? Probably, but that isn’t the case.

I tend to agree with your ideals on this, but the reality is that the law tends to say otherwise quite often and has plenty of cases affirming it.

I’m not really understanding the rights-based argument for allowing the purchase/sale of unapproved drugs as long as there’s a doctor prescribing them, but not if there isn’t. Either you have the right to put the drugs in your body or you don’t, under that view.

And this:

…is spectacularly weak sauce. We have copious evidence of people taking tremendous risks and using unapproved substances to address medical issues. Desperate people do desperate things.

My body is hardly in my control, or least my conscious control. Keep in mind, in the end of the day, libertarians works in the principle of perfect knowledge, because then everyone make make perfect rationale decisions. Except that we don’t have perfect knowledge, and rationale decisions are skewed to the short term or whatever our peers thinks, and all that is double true when we are in danger or sick.