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


#321

I’m responding to someone else actually. If you are actually asking a real question and not making a snide remark, in this context it would be a terrible idea for Congress to whip up some law thinking only of the EpiPen. They need to take time to figure out what they want and what the ramification of the approach would be if their regulations hits a drug that affects 1 in say 100k people instead of the widespread use we have with the EpiPen. Aka, don’t throw out a law to regulate the drug industry just in time for the next round of elections. Playing to the public and the election cycle is how we get badly written laws.


#322

It may lead in the amount of regulations, but the UNECE standards and EU manufactured cars are safer. The entirety of the world except the USA and Canada are signatories to the UNECE standards, with many theorising that the FMVSS are yet another example of non-tariff protectionism.


#323

I admit to not being an expert in the area of car regulation, but my understanding of the topic was that NHTSA testing standards for safety and emissions are stricter than anywhere else in the world. Do you have any good links on the differences?


#324

I definitely think we were having a semantic disagreement then. I won’t disagree that congress can and has passed some very silly laws that benefit narrow interests far more than the general populace or waste a lot of government money to produce very little public good.


#325

There was a study on the differences in safety standards that was commissioned by EU/US automakers on the run up to TTIP (which would have potentially allowed vehicles with US standards to be sold in the EU and vice versa).

The report was quietly buried when it the results found that there were significant differences in risk profiles;

  1. EU cars performed much better in front-side collisions
  2. US cars performed much better in roll overs
  3. US headlamps reduced risk of pedestrian fatalities
  4. EU mirrors reduced risk of driver side lane changes crashes

Overall, it was estimated that the introduction of vehicles with US standards could result in several thousand extra road fatalities a year.

Here [is the study] (https://deepblue.lib.umich.edu/bitstream/handle/2027.42/112977/103199.pdf), and there are several third party articles on it with further analysis which I can’t seem to find. [Here’s] (http://www.independent.co.uk/news/business/news/new-ttip-scandal-car-industry-buried-report-revealing-us-car-safety-flaws-10514716.html) a not great Independent.co.uk one.

As for emissions, NHTSA has always put a much stronger emphasis on NOx and particulate matter than the EU, with the EU emphasising GHG emissions. EU emissions are better for the environment, US emissions are better for people.

When you look at the market make up (e.g. prevalence of trucks in US vs prevalence of small hatchbacks in EU), the waters become even more muddied.


#326

Interesting paper on the effects of FDA delays. It includes this fine anecdote:

Also on the imbalance of political risks that the FDA faces:

[quote]
If FDA approves a
drug that turns out to be disastrous, people will suffer; if it
delays or denies a needed drug, people will also suffer. Both
mistakes are medically harmful.
But from a political standpoint, there is a huge difference
between them. Those injured by an incorrectly approved drug
will often know that they are victims of FDA mistakes. Their
stories make riveting news, and their testimony, or that of their
surviving families, is powerful. But for victims of incorrect
FDA delays or denials, who are prevented from using drugs
that could have helped them, the situation is far different. All
they know is that their doctors told them that nothing more
could be done to help them. Only a fraction of these people will
understand the reason for this—namely, that a useful drug was
bottled up at FDA.
Unlike in the first scenario, these people do not realize that
they too are victims of FDA mistakes. Their suffering or death
is simply viewed, by them and others, as reflecting the state of
medicine rather than the status of an FDA drug application. In
short, victims of incorrect FDA approvals are highly visible,
while victims of incorrect FDA delays or denials are
practically invisible.[/quote]

One possible alternative:

[quote]
One simple but apparently radical approach would be to
leave the agency’s safety and effectiveness standards in place,
while simply removing its veto power. In effect, FDA would
become a certifying agency. Rather than being banned
outright, as they are now, uncertified therapies would be
available under medical supervision, with informed consent
documentation of their uncertified status.[/quote]


#327

Yes, I suppose not regulating drugs would be a solution to the “problem” of the government regulating drugs.


#328

Well they’d still be regulating drugs, they just wouldn’t be able to prevent you from taking drugs they didn’t certify.

And frankly, this seems totally reasonable to me. If I want to take some new experimental treatment, I should be able to, without having to go to Mexico or some other place with lower overall standards.


#329

We’ve already established that pharma companies spend vastly more on marketing (to medical professionals and the public) than they do on research.

If you think that having no regulations on what drugs can be prescribed is reasonable, there is something wildly wrong with your thought processes. It would unequivocally have negative results for everyone except the pharma companies.

You most certainly are not equipped to make an informed choice on prescriptions, nor are 99.9925% of the general public


#330

No… but your doctor is.

The reality is, I don’t need the government dictating that kind of thing to me. I’m able to make an informed decision, and if I want to take a risk, that’s my right.


#331

Just to note, but I dunno if any of the general physicians I’ve seen over my life’s all that qualified, but maybe I’ve just had bad luck with my choice in doctors. . .

In glorious socialized medicine utopia, I’d prefer if you didn’t take the drug that had a 90% chance of making your leg fall off to get rid of your common cold 20% faster.


#332

A thing to consider here too, is that there may be treatments with a potential for serious side effects, in some patients. Perhaps even death. But some people may be willing to take that chance, if there is also the potential for curing an ailment which is ALSO going to kill them anyway.

I don’t think we’re talking about taking experimental drugs to treat a headache or a cold. Rather, we’re talking about experimental treatments for terminal illnesses, where the alternative is death anyway.


#333

I dunno. I’m firmly in the camp of believing that people are far too stupid to be allowed that kind of say in the matter. People still buy healing crystals and prayer beads from shady sources at it is; if GloboPharmoCo gets to start hocking those wares at Walgreens, it only increases people’s likelihood of getting suckered in.

But that’s why I believe in Big Strong Government to protect us from ourselves, I guess.


#334

Yeah, I’m on the other side of things. I’d rather let people be stupid, rather than remove freedom to make their own decisions.

Just because some people are stupid and do dumb things, isn’t a reason for us to assume everyone is a child and needs to have their lives dictated to them. Because, honestly, the government isn’t some kind of omnipotent super being. I’m better able to make decisions about my life than the government is.

Maybe you aren’t. That’s fine, you can do what the government says about everything. But don’t force me to leave everything in the hands of some bureaucrat thousands of miles away from me, just because you don’t feel up to making decisions.


#335

It’s not so much that I don’t want to make decisions as that I really don’t trust Ted next door to do so, but people take an even dimmer view of political systems that begin with “IQ test the lot and dump the bottom third on an island somewhere with one spear and a goat” than they do of my usual Pinko-Commie-ism ;)


#336

But Tim’s an adult. Making dumb choices is part of life.

Ceding freedom in order to oppress others and prevent them from making what we believe to be poor decisions, generally does not end well.

It’s better to let people make their own mistakes, than take away the freedom to choose our own paths.


#337

I don’t think the only issue would be people being “stupid”. Most people don’t have the time or resources to educate themselves on a myriad of drugs and their potential side effects vs what benefits it could provide for their ailment. As you say, their doctors do, but I’ve seen… well, not firsthand, but I’ve seen secondhand how that’s already abused due to pharma kickbacks. Use our widget in your next surgery and get a 10-20% kickback on what is charged! Don’t use the competitor’s widget, even though it’s better suited for this particular procedure…

I don’t want doctors prescribing people dangerous/uncertified medications or recommending procedures due to financial incentives. I don’t have the background or available time to do the necessary medical research to determine if it’s relatively safe and I would like there to be a check in place to make sure that kind of thing doesn’t happen.

EDIT: I kind of waded into this discussion while it was already mid-stride, so apologies in advance if I’ve misinterpreted your position at all. :)


#338

I’m just frustrated at the usual right-wing tactic being peddled here.

“Look here, I’ve found a deficiency in a government body. Clearly, the solution is to BURN IT DOWN AND PISS ON THE ASHES.”

Could the FDA handle approvals better? Probably. Is the whole system set up to erect enormous barriers to entry and favor the giant multinationals? Certainly. Does this imperfect regulatory regime result in better aggregate outcomes than a system in which Joe Fuckstick can give the FDA the finger and prescribe whatever he likes? I am confident that yes, yes it does.


#339

I think you are underestimating the value of the FDA as a certification process, especially in a world where FDA certification has traditionally been required. I certainly wouldn’t be leaping out to try uncertified medicines except in extreme circumstances and I think doctors would be reluctant to take that risk unless they were quite confident of the outcome or the circumstances were extreme. I’m sure most who have something to lose would prefer the shield of FDA approval in most cases.

On the other side is those who have died because of long delays in approval, and many others who have died from rare conditions where pushing possible cures through the approval process is not economically viable. Then there is the long-term effect of the FDA barrier on the rate of treatment development in general. Add that all up it’s not at all clear to me that the current regime is better than a certification-only role.

That said, maybe there is a sort of middle ground. Maybe you are only allowed to use a drug at the point where currently human-stage trials are allowed. Maybe the FDA reserves the right to ban use until full approval for certain drugs or certain classes, but it’s not automatic. There are a lot of possibilities, but I don’t think the author is being disingenuous or employing a tactic just because they propose something a bit more extreme. The proposition apparently does have a lot of support among physicians.


#340

But we’re talking about situations where something isn’t certified by the FDA. I mean, that fact would not be some trivial thing.

Even if the FDA couldn’t legally prohibit you from pursuing uncertified treatment, that doesn’t mean that their certification would cease to carry any weight. Even if I could legally try some experimental drug that the FDA had yet to certify, that doesn’t mean I actually WOULD except in the most dire of circumstances.

No one’s talking about the FDA certification process going away, just allowing people to make their own decisions to voluntarily undergo treatments which are not certified as safe.