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An Iron Curtain Has Descended Upon Psychopharmacology

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Re: An Iron Curtain Has Descended Upon Psychopharmacology

#51

Post by davorak »

leonth wrote: post #49

I'm not sure about US law, but there should be a provision like importing a non-licensed drug for a named patient, with declaration from the doctor and pharmacist saying that they bear full responsibility in case anything goes bad. Using this the doctor can import any kind of drug as they wish - but of course they must be responsible for it as there is no more "screening" from FDA. Singapore has this provision becaus…

>Singapore has this provision because the market is too small for lots of drugs to come in.

Interesting how do doctors end up bearing "full responsibility"? It seems like something has to work differently in civil court or current culture most be different enough that the doctor is not run out of business after a few patients die after importing and taking responsibility for a drug.

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#52

Post by a8da6b0c91d »

leonth wrote: post #36
a8da6b0c91d wrote: post #29

Earlier quoted context omitted.

I would be on the same page as you if the FDA and the American medical establishment had a great track record of protecting Americans from harm. As it is there's massive over-prescription of dangerous chemicals doing serious harm. Remember Vioxx? Remember estrogen hormone replacement therapy? There's currently massive, dangerous over-prescription of statins, amphetamines for kids, female hormones, and SSRIs. Conseque…

Over-prescription is the problem of the prescribers' and their incentives, not FDA. FDA opens the tap, prescribers put the water in the cup and give to patients. Patients do not access the water directly. Your concern is better directed to American Medical Association (AMA). If you think you can find helpful chemicals on your own, you are either very confident to use your own body as a guinea pig or suffering from ht…

The FDA specifically on-label approved ritalin for kids, hormone replacement therapy, and statins for people with high cholesterol but no signs of heart disease. Your faith in regulation is misplaced. If you take FDA approval and a doctor's recommendation as proof a prescription is safe you are misguided. (The AMA is a lobbying organization to which about 15% of doctors belong and is irrelevant here.)

There is no reliable government organization out there stopping harmful medical treatments. I just want to acknowledge that as fact rather than pretend otherwise and deny people choices.

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#53

Post by carbocation »

a8da6b0c91d wrote: post #52
leonth wrote: post #36

Earlier quoted context omitted.

Over-prescription is the problem of the prescribers' and their incentives, not FDA. FDA opens the tap, prescribers put the water in the cup and give to patients. Patients do not access the water directly. Your concern is better directed to American Medical Association (AMA). If you think you can find helpful chemicals on your own, you are either very confident to use your own body as a guinea pig or suffering from ht…

The FDA specifically on-label approved ritalin for kids, hormone replacement therapy, and statins for people with high cholesterol but no signs of heart disease. Your faith in regulation is misplaced. If you take FDA approval and a doctor's recommendation as proof a prescription is safe you are misguided. (The AMA is a lobbying organization to which about 15% of doctors belong and is irrelevant here.) There is no rel…

> The FDA specifically on-label approved ... statins for people with high cholesterol but no signs of heart disease.

You say this as if it were bad, but the net effect is to save lives (at a cost of money and increased diagnoses of diabetes). Statins are an example of the FDA and the industry actually doing the job they are supposed to do.

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#54

Post by refurb »

Symmetry wrote: post #42

It's important to look at the FDA's job in terms of diminishing returns, or maybe as a classification problem. You have some number of drugs coming in, some of which are helpful and some of which are harmful. But you don't have any perfect means of figuring out whether a drug is good or bad. If you start from no screening it's very easy to stop a lot of bad drugs without stopping many good drugs, but as you apply tig…

You have to keep in mind the history of the FDA. When kids were being born around the world with flippers instead of arms and legs because of thalidomide, that wasn't happening in the US because of the FDA. Incidents like that breed cautiousness.

The pendulum swings back and forth. A decade ago, the FDA got hammered for being too cautious. Then Vioxx happened and they got hammered for being to lenient. I think the FDA does a dam good job to be honest. Mistakes are made, but I'd give them an A- overall.

The other thing to keep in mind is that the US has pretty lenient "supplement" regulations. As long as you can prove it's safe and don't make efficacy claims you can't backup the FDA will often leave you alone. I'm often amazed at what the FDA allows regular citizens to buy.

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#55

Post by thrownagway »

tormeh wrote: post #38
TeMPOraL wrote: post #18

Earlier quoted context omitted.

> This article is junk science. The author opens by suggesting that Russians have discovered and use a different set of chemical elements than the ones we use in the United States, going so far as to suggest that one of them is a room temperature superconductor in ways that American scientists are uninterested in. Either I completely failed to see sarcasm in your comment, or you completely failed in Reading Comprehen…

I sometimes wonder why people make these egregious reading comprehension mistakes. It sometimes seem to come from reading stuff too literally. Are the people who do this really smart but simply too analytically inclined to comprehend normal prose?

Yes, it's associated with Asperger's syndrome. Some people do not automatically recognize non-literal communication forms like metaphor, hyperbole, analogy, satire, irony, and so on. Those who are clever and aware of their deficit can often compensate by recognizing the patterns analytically. Those who are clever but prideful assume everyone else is wrong, and become indistinguishable from trolls or cranks.

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#56

Post by leonth »

davorak wrote: post #51
leonth wrote: post #49

I'm not sure about US law, but there should be a provision like importing a non-licensed drug for a named patient, with declaration from the doctor and pharmacist saying that they bear full responsibility in case anything goes bad. Using this the doctor can import any kind of drug as they wish - but of course they must be responsible for it as there is no more "screening" from FDA. Singapore has this provision becaus…

>Singapore has this provision because the market is too small for lots of drugs to come in. Interesting how do doctors end up bearing "full responsibility"? It seems like something has to work differently in civil court or current culture most be different enough that the doctor is not run out of business after a few patients die after importing and taking responsibility for a drug.

Singapore is not really as litigious a society as US, I don't think there is ever a case where the patient sues the doctor because s/he uses an exemption (non-registered) drug. In some cases the patient probably doesn't even know that the drug is not registered.

Importing a drug under exemption is "serious business" and is usually only done by the most senior doctors (or by approval from a committee of senior doctors). They must exhaust all registered options first before moving to exemption drugs, and the pharmacists play a role in ensuring that (another incentive to do that is the paperwork can be rather significant).

Because you need a pharmacist to do this, it usually happens only in larger establishments like hospitals, where pharmacists are readily available and cooperative.

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#57

Post by Symmetry »

refurb wrote: post #54
Symmetry wrote: post #42

It's important to look at the FDA's job in terms of diminishing returns, or maybe as a classification problem. You have some number of drugs coming in, some of which are helpful and some of which are harmful. But you don't have any perfect means of figuring out whether a drug is good or bad. If you start from no screening it's very easy to stop a lot of bad drugs without stopping many good drugs, but as you apply tig…

You have to keep in mind the history of the FDA. When kids were being born around the world with flippers instead of arms and legs because of thalidomide, that wasn't happening in the US because of the FDA. Incidents like that breed cautiousness. The pendulum swings back and forth. A decade ago, the FDA got hammered for being too cautious. Then Vioxx happened and they got hammered for being to lenient. I think the FD…

I'll admit that on average the FDA has gotten better over the last few decades. They are genuinely better than when they caused 10,000 excess deaths a year for a decade due to their refusal to permit beta blockers during the period they were in use in other countries. But you can't say "Both Type 1 and Type 2 errors are occuring, so they must be balanced."

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#58

Post by refurb »

leonth wrote: post #49

I'm not sure about US law, but there should be a provision like importing a non-licensed drug for a named patient, with declaration from the doctor and pharmacist saying that they bear full responsibility in case anything goes bad. Using this the doctor can import any kind of drug as they wish - but of course they must be responsible for it as there is no more "screening" from FDA. Singapore has this provision becaus…

That kind of already exists. US resident are allowed to import up to 90 days worth of a prescription drug. For drugs that aren't prescription-only, the FDA doesn't really care unless they feel the drugs are unsafe.

Most of the drugs mentioned in the article can be purchased by people in the US through the internet.

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#59

Post by refurb »

Symmetry wrote: post #57
refurb wrote: post #54

Earlier quoted context omitted.

You have to keep in mind the history of the FDA. When kids were being born around the world with flippers instead of arms and legs because of thalidomide, that wasn't happening in the US because of the FDA. Incidents like that breed cautiousness. The pendulum swings back and forth. A decade ago, the FDA got hammered for being too cautious. Then Vioxx happened and they got hammered for being to lenient. I think the FD…

I'll admit that on average the FDA has gotten better over the last few decades. They are genuinely better than when they caused 10,000 excess deaths a year for a decade due to their refusal to permit beta blockers during the period they were in use in other countries. But you can't say "Both Type 1 and Type 2 errors are occuring, so they must be balanced."

I think the point stands that the FDA get almost no credit when it rejects drugs that could have harmed Americans and get fully blamed when any drug causes excess deaths in the US.

That's the big problem.

In addition, the public has little appetite for conversations that start with "We balance risk so only a handful of Americans die..." The public has zero tolerance for any mistakes the FDA makes, which I think is unfair, but that's the world the FDA lives in.

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#60

Post by tim333 »

drcode wrote: post #31
tim333 wrote: post #24

Maybe the FDAs mandate could be changed to regulate drugs to maximise the benefit to society. That way things like Melatoin should be allowed and the shenanigans detailed in Bad Pharma (book by Ben Goldacre) should be dealt with. There seems a lot of stuff that is not entirely in the public interest at the moment.

Yes, regulation is always improved by additional regulation.

I was thinking more changing the priorities rather than more.
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