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This pill used to cost me 10c/pill, now it's $5/pill. I take it 3x day.

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Re: This pill used to cost me 10c/pill, now it's $5/pill. I take it 3x day.

#41

Post by CWuestefeld »

noonespecial wrote: post #2

I think maybe its about time we set up something life the NSF to conduct these trial for the FDA (in the particular case of orphaned and old drugs) and generally does a much better job of dealing with the mess that drug trails have come to be. At some point, this knowledge becomes a public good and the conflict of interest presented by those seeking to win approval also being the ones who stand to win a "get a monopo…

I think maybe its about time we set up something life the NSF to conduct these trial for the FDA

This would be a disaster. It really is expensive to test drugs, and so pharma companies must carefully consider which ones are worth pursuing. If they no longer need to bear the cost, then they'll just throw everything at the agency. Then the agency will either fall behind, so that good new drugs never get approved, or it will tremendously balloon the costs of testing (and we're already complaining about those costs).

Re: This pill used to cost me 10c/pill, now it's $5/pill. I take it 3x day.

#42

Post by roel_v »

mukyu wrote: post #34
roel_v wrote: post #17

Earlier quoted context omitted.

At first I was puzzled by the upvotes because pro-monopoly arguments are usually unpopular here, but then I realized that I didn't really express myself clearly and that probably my argument was misunderstood :) So I'm not against drug monopolies, or patents, (or copyright, for that matter) - in fact I'm staunchly pro those things; the problem in this case is the strictness of the FDA, setting an arbitrarily high bar…

You do not seem to understand orphan drugs or this article. Basically every word of your second paragraph is incorrect. These are drugs that have never been approved by the FDA. No manufacturers were previously approved and no standards have been changed. The FDA wanted clinical trials on the drugs. There are incentives in place to encourage companies to develop drugs for rare conditions where there are not enough pa…

It was my understanding from the article that originally there were several versions of the drug, then something changed (the author seemed to blame the FDA) after which there was only 1 left, and then there was a price hike.

Now it's quite possible that I'm wrong - what was the cheap version that the author was taking before then? Wasn't it a product of a competitor? And if so, why isn't it available any more?

Re: This pill used to cost me 10c/pill, now it's $5/pill. I take it 3x day.

#43

Post by bendmorris »

meric wrote: post #22

Just had an epiphany. If it is these old drugs (since 6th century) that are getting monopolized.... It means they don't really need advanced technology to create! Just grind some herbs, measure carefully, sun dry, etc. If they're over-charging by 5000% you might actually save money producing the drugs yourself for self consumption! Who's up for creating a website to share recipes of these drugs?

...Ever made a bad batch of cookies?

Re: This pill used to cost me 10c/pill, now it's $5/pill. I take it 3x day.

#44

Post by amalcon »

dexen wrote: post #25
meric wrote: post #22

Just had an epiphany. If it is these old drugs (since 6th century) that are getting monopolized.... It means they don't really need advanced technology to create! Just grind some herbs, measure carefully, sun dry, etc. If they're over-charging by 5000% you might actually save money producing the drugs yourself for self consumption! Who's up for creating a website to share recipes of these drugs?

> Who's up for creating a website to share recipes of these drugs? No, seriously, somebody please figure a pharmaceutics delivery business model that does not depend on FDA for legality & operations.

"Don't be based out of the U.S." would seem to be a simple solution. The problem being that most other jurisdictions where you can actually make money have similar problems.

There are ways around that, but (I hope) the "cheap drug spammer" market is saturated.

Re: This pill used to cost me 10c/pill, now it's $5/pill. I take it 3x day.

#45

Post by sp332 »

asmithmd1 wrote: post #31
zaidf wrote: post #5

Earlier quoted context omitted.

I'm still optimistic. For some reason, while the general exclusive is for 3 years, for my condition(Familial Mediterranean Fever) it is 7 years. Yikes.

What does that even mean? The pharmacist is going to ask you why you are taking the drug to decide if they can give you the generic version or not?

Yes. The FDA regulates (among other things) "indications" for drugs. For example, you can't represent that a drug is effective at treating something without FDA approval. So, currently, only one company can make this pill, and even then they can only sell it for a specific list of diseases. After some time, other companies will be able to make the pill and sell it for the same list of diseases, except this one. The FDA has the power to regulate the claims made by various companies, so this was probably a compromise that was part of a larger deal.

Re: This pill used to cost me 10c/pill, now it's $5/pill. I take it 3x day.

#46

Post by _delirium »

CWuestefeld wrote: post #41
noonespecial wrote: post #2

I think maybe its about time we set up something life the NSF to conduct these trial for the FDA (in the particular case of orphaned and old drugs) and generally does a much better job of dealing with the mess that drug trails have come to be. At some point, this knowledge becomes a public good and the conflict of interest presented by those seeking to win approval also being the ones who stand to win a "get a monopo…

I think maybe its about time we set up something life the NSF to conduct these trial for the FDA This would be a disaster. It really is expensive to test drugs, and so pharma companies must carefully consider which ones are worth pursuing. If they no longer need to bear the cost, then they'll just throw everything at the agency. Then the agency will either fall behind, so that good new drugs never get approved, or it…

I read the comment as proposing only that the NSF (or someone) run the trials for old drugs that are already widely used, in lieu of the current odd system of re-monopolizing drugs that had previously been widely available as generics.

For new drugs hoping to win approval, which are inventions and are already granted monopolies via patents, things could still work the current way.

Re: This pill used to cost me 10c/pill, now it's $5/pill. I take it 3x day.

#47

Post by ctdonath »

roel_v wrote: post #42
mukyu wrote: post #34

Earlier quoted context omitted.

You do not seem to understand orphan drugs or this article. Basically every word of your second paragraph is incorrect. These are drugs that have never been approved by the FDA. No manufacturers were previously approved and no standards have been changed. The FDA wanted clinical trials on the drugs. There are incentives in place to encourage companies to develop drugs for rare conditions where there are not enough pa…

It was my understanding from the article that originally there were several versions of the drug, then something changed (the author seemed to blame the FDA) after which there was only 1 left, and then there was a price hike. Now it's quite possible that I'm wrong - what was the cheap version that the author was taking before then? Wasn't it a product of a competitor? And if so, why isn't it available any more?

Whatever the prior sources (IIRC, pharmacists could just whip up a batch), making it was cheap, legal, and unrestricted due to grandfathering. FDA wanted to regulate it, and granted someone exclusive rights to achieve it.

It's not available now because the FDA wanted certain tests done which hadn't been. No company did the tests because it wasn't worth their time/money to do so. The FDA _made_ it worth someone's time and money by offering them exclusive rights for 3 years if they did the tests. One company ran the tests, got approved, and was granted exclusivity as a reward. Supply plummeted (manufacturing went from many sources down to one), demand remained high, and prices increased 50x as a natural consequence.

The Law of Supply and Demand rules. It always does. Screw with it and you'll get hurt. The FDA screwed with it, and people got hurt.

Re: This pill used to cost me 10c/pill, now it's $5/pill. I take it 3x day.

#48

Post by jellicle »

dexen wrote: post #25
meric wrote: post #22

Just had an epiphany. If it is these old drugs (since 6th century) that are getting monopolized.... It means they don't really need advanced technology to create! Just grind some herbs, measure carefully, sun dry, etc. If they're over-charging by 5000% you might actually save money producing the drugs yourself for self consumption! Who's up for creating a website to share recipes of these drugs?

> Who's up for creating a website to share recipes of these drugs? No, seriously, somebody please figure a pharmaceutics delivery business model that does not depend on FDA for legality & operations.

Already done. It's called "base your company in India and mail pills to the U.S.".

Re: This pill used to cost me 10c/pill, now it's $5/pill. I take it 3x day.

#49

Post by Symmetry »

zaidf wrote: post #10
roel_v wrote: post #9

Earlier quoted context omitted.

Exactly, and this is the problem, not the drug manufacturers.

The counterpoint to that is if they don't grant the exclusivity, the cos won't be willing to invest money and resources to do the testing because the returns wouldn't be as strong. In these cases though, the counter-argument to that is the price jump is unjustified relative to the $ invested in doing the testing.

In the vaguely similar case of Cylert where there _wasn't_ a monopoly granted the drug just ended up disappearing and the people taking it were SOL.

http://nielsenhayden.com/makinglight/archives/007140.html

EDIT: Which is to say that the problem is the FDA jerking people around in general.

Re: This pill used to cost me 10c/pill, now it's $5/pill. I take it 3x day.

#50

Post by roel_v »

ctdonath wrote: post #47
roel_v wrote: post #42

Earlier quoted context omitted.

It was my understanding from the article that originally there were several versions of the drug, then something changed (the author seemed to blame the FDA) after which there was only 1 left, and then there was a price hike. Now it's quite possible that I'm wrong - what was the cheap version that the author was taking before then? Wasn't it a product of a competitor? And if so, why isn't it available any more?

Whatever the prior sources (IIRC, pharmacists could just whip up a batch), making it was cheap, legal, and unrestricted due to grandfathering. FDA wanted to regulate it, and granted someone exclusive rights to achieve it. It's not available now because the FDA wanted certain tests done which hadn't been. No company did the tests because it wasn't worth their time/money to do so. The FDA _made_ it worth someone's time…

OK thanks, that's indeed a different chains of events than I initially thought, but the derived reasoning still holds - the FDA should've stayed out to begin with.
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