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Topic:
The cost of bringing a new drug to market... [Locked] |
Kjarhall  Title: The Pungent One
Posts: 915
Registered: 2002-3-1 15:47:21
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Date Posted:
1/1/00 12:01am
Subject:
The cost of bringing a new drug to market... |
Yep thanks.
In other words, there isn't a solution yet that would satisfy me.
And tell them to put the contraindications on ads and booklets in larger than 3 pt. type, so people can read it! 
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Cawlin  Posts: 1,759
Registered: 2005-2-22 07:58:42
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Date Posted:
1/1/00 12:01am
Subject:
The cost of bringing a new drug to market... |
Kjarhall posted:
Yep thanks.
In other words, there isn't a solution yet that would satisfy me.
And tell them to put the contraindications on ads and booklets in larger than 3 pt. type, so people can read it!
LOL! Yep, that's a pain in the ass for sure. It's all about packaging and labeling and all of that stuff, and one of my stupid little catch phrases for this topic is "Labeling and packaging is serious business, yo!" and it is - if you were to look over FDA warning letters (the step before consent decree) you will see a fair number of labeling and packaging issues as well as the usual manufacturing stuff... anyway...
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If ignorance were painful, half the posters here would be on morphine drips.
Everyone playing WoW knows everything about playing two classes: 1) their own and 2) Hunters
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Date Posted:
1/1/00 12:01am
Subject:
The cost of bringing a new drug to market... |
Cawlin posted:
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Wouldn't you agree that Pharma's principal concern as a business is generating maximum profits?
Wouldn't you agree that Pharma has been found guilty in the past of suppressing unfavorable studies?
For fraudulent marketing practices?
For promoting unapproved uses for drugs?
For providing kickbacks to physicians who proscribe selected drugs?
Wouldn't you agree that companies (like Pfzier) have been protected from prosecution by the Fed because they were also considered too big to fail?
Wouldn't you agree that Pharma has been found using unapproved and experimental drugs outside the US (and the reach of the FDA)?
Isn't it amazing that almost half of the contributing authors of the DSM series that has begun medicalizing human behaviors have prior financial relationships with Pharma?
I don't think Pharma is evil, it is simply amoral, like most mega-corp businesses. But you're kidding yourself if you think Pharma spends more time playing by the rules in spirit as well as letter than it does lobbying to change those rules to its favor, and bending or quietly breaking those rules when there is enough profit for the risk.
You are also kidding yourself if you think the big bad FDA has either the funding or the manpower to oversee things effectively. Surely you're aware that the FDA itself is overseen and regulated and in recent reviews has been found to be underfunded and unable to perform a satisfactory job in regulating drugs, especially new drugs.
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I know what you're trying to do but you're just sailing another failboat over the falls. - imaloon1
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vn_nnanji Title: Outpost Music Expert
Posts: 1,964
Registered: 2001-6-30 17:22:56
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Date Posted:
1/1/00 12:01am
Subject:
The cost of bringing a new drug to market... |
Yukishiro1 posted:
vn_nnanji posted:
They are working on addressing diseases at the level of DNA, creating compounds that will address just the disease and not medicate the whole body when only part is needed. They literally are rewriting the transcription of the disease at the rDNA level, interrupting the diseases ability to replicate and prosper.
The main roadblock is drug delivery but Oligonucleotide drugs are already in use. Naturally the costs are staggering, for many reasons, some natural and some artificial.
I'm sure that's what their PR firm says in their brochures.
It's also what the results and reality say. I have had customers who successfully addressed lupus and saw great results with Oligonucleotide technology.
They couldn't see penicillin coming either. To think we are not going to see a major breakthrough based on the increase of science and technology is very naive.
I'm sure the Doctor who used leeches didn't think they'd ever find aspirin or penicillin. We are one lab accident away from curing many things.
With regards to the OP lets hope stupid is one of them!
Other than that I see no reason to spend 3 pages on whether the process is overburdened. Of course it is. If you've got a better system though lets hear it.
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Cawlin Posts: 1,759
Registered: 2005-2-22 07:58:42
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Date Posted:
1/1/00 12:01am
Subject:
The cost of bringing a new drug to market... |
Eager_Igraine posted:
Cawlin posted:
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Wouldn't you agree that Pharma's principal concern as a business is generating maximum profits? of course, as it is for any business
Wouldn't you agree that Pharma has been found guilty in the past of suppressing unfavorable studies?
For fraudulent marketing practices?
For promoting unapproved uses for drugs?
For providing kickbacks to physicians who proscribe selected drugs?
It's not for me to agree or disagree with, these are facts. Also it's a fact that this is not the case with EVERY product marketed by every pharmaceutical company or every drug, or every physician. This sort of behavior has been committed ad nauseum by insurance companies, investment companies, banks, automobile companies, etc. Pretty much every business sector has malfeasance in it - including the government itself lol. That does not mean that the business sector itself is evil or without merit. If you believe that past malfeasance is a guaranteed indicator of present and ongoing malfeasance, well I'd ask you why you aren't railing against every other business sector and your own government as well beacause all of those have this sort of thing in their past. I also know that companies have gone down hard for doing these sorts of things and that regulations have evolved and are evolving to keep it from happening.
Wouldn't you agree that companies (like Pfzier) have been protected from prosecution by the Fed because they were also considered too big to fail? I have no knowledge of that. Do you have a source?
Wouldn't you agree that Pharma has been found using unapproved and experimental drugs outside the US (and the reach of the FDA)? I'm sure it's happened. I don't know why you have an issue with it. If pharmaceutical companies are going to compete in a global market where the USFDA does not have oversight, against companies that also don't have to comply with FDA, why should the businesses handcuff themselves? I don't really know what you're getting at here. If a US pharma company wants to sell drugs in Croatia or who the hell knows where else, if that country allows drugs to be sold without FDA approval (and most countries outside the US do not require FDA approval since you know, the FDA is a UNITED STATES government agency), why should a US pharmaceutical company not attempt to compete in that market? Further, companies from abroad that want to sell in the US must comply with FDA and get FDA approval to do so...
It's also true that pharmaceutical companies give their drugs away to 3rd world nations or sell them for pennies on the dollar because those nations will not adhere to copyright and patent law and will simply buy the drug made "illegally" by another company if they don't give the drugs away or sell at a pittance.
Isn't it amazing that almost half of the contributing authors of the DSM series that has begun medicalizing human behaviors have prior financial relationships with Pharma? No, it's not amazing at all. I'm sure there's some shadiness there. There is also some good coming from it. I'm not a physician, are you? Are you so certain that all of this stuff is inappropriate? Physicians are prescribing this stuff... maybe there's some validity to it? Maybe there isn't as much validity as there ought to be. I don't know though. Supposedly this whole field is virtually brand new...
I don't think Pharma is evil, it is simply amoral, like most mega-corp businesses. But you're kidding yourself if you think Pharma spends more time playing by the rules in spirit as well as letter than it does lobbying to change those rules to its favor, and bending or quietly breaking those rules when there is enough profit for the risk. So pharma is like every other business (which is true), but you have a bone to pick with pharma and not every other business? I am puzzled by your selectivity here. You do realize that the virtually equally enormous lobby from the insurance industry is pretty much the sworn enemy of pharma and that it works just as hard to vilify pharma and against pharma in their lobbying efforts and against pharma in their media and advertising efforts, don't you?
You are also kidding yourself if you think the big bad FDA has either the funding or the manpower to oversee things effectively. Surely you're aware that the FDA itself is overseen and regulated and in recent reviews has been found to be underfunded and unable to perform a satisfactory job in regulating drugs, especially new drugs.
It's an arguable point whether or not FDA is effective or underfunded. Who is overseeing the insurance companies? Who is overseeing the oil companies? Who is overseeing the automobile companies, the banks, the investment companies? We're not in a GLOBAL recession right now because of pharma. It's because of banks and the financiers, and yet your ire is all focused on pharma... 
See my replies above in red text.
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If ignorance were painful, half the posters here would be on morphine drips.
Everyone playing WoW knows everything about playing two classes: 1) their own and 2) Hunters
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Cawlin Posts: 1,759
Registered: 2005-2-22 07:58:42
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Date Posted:
1/1/00 12:01am
Subject:
The cost of bringing a new drug to market... |
vn_nnanji posted:
Other than that I see no reason to spend 3 pages on whether the process is overburdened. Of course it is. If you've got a better system though lets hear it.
For the record, I don't think the process is particularly overburdened. Of course I work in QA though so I may be biased. I think that there are some issues with the way regulation happens and there are some catch-22 situations and things of that nature, but in general I think it's working fairly decently, all things considered.
My point with this thread was not to say "look how burdensome it is!" but to just set the record straight or at least provide some clarity to the issue of how much it really does cost to get drugs approved and on the market.
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If ignorance were painful, half the posters here would be on morphine drips.
Everyone playing WoW knows everything about playing two classes: 1) their own and 2) Hunters
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Sin_of_Onin Posts: 1,307
Registered: 2005-6-29 08:21:12
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Date Posted:
1/1/00 12:01am
Subject:
The cost of bringing a new drug to market... |
Actually big pharm has stolen billions from people and the states which has dragged down recovery for a long time.
Growth in health care costs are clearly one of the top 3 things that are impacting out economy right now and pharm is part of that.
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Date Posted:
1/1/00 12:01am
Subject:
The cost of bringing a new drug to market... |
My eyes!!
The red, it burns!
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I radiate more heat than light.
I know what you're trying to do but you're just sailing another failboat over the falls. - imaloon1
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Cawlin Posts: 1,759
Registered: 2005-2-22 07:58:42
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Date Posted:
1/1/00 12:01am
Subject:
The cost of bringing a new drug to market... |
Sin_of_Onin posted:
Actually big pharm has stolen billions from people and the states which has dragged down recovery for a long time.
Source?
Sin_of_Onin posted:
Growth in health care costs are clearly one of the top 3 things that are impacting out economy right now and pharm is part of that.
Yes, therapies are getting more expensive, people are living longer, quality of life is improving.
Here's a big hint too by the way about healthcare costs: Despite their continued whines about having to pay for more expensive drugs and therapies and how they have to increase premiums all the time or drop coverage of this or that, yet insurance companies continue to make money hand over fist as fast or faster than ever.
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If ignorance were painful, half the posters here would be on morphine drips.
Everyone playing WoW knows everything about playing two classes: 1) their own and 2) Hunters
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Yukishiro1 Posts: 3,243
Registered: 2002-9-20 23:52:57
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Date Posted:
1/1/00 12:01am
Subject:
The cost of bringing a new drug to market... |
Big pharma gets the vast majority of its profits these days from drugs that let people be fat and not die and drugs that let people ignore their problems by medicating away their stress.
This is a fact. 
edit: Not that the drugs in question don't have benefits for some people. They do. But they should be niche products, not the everyday products they are. You can't blame pharma for people being fat losers but we spend way too much money on letting people be fat losers. Pharma is just responsing to societal demand to be able to be fat losers but where the money is going does show our priorities.
Also insurance companies tend to have margins in the 1-2% range. They make lots of money because they have lots of customers. Compare that to pharma profit margins, which tend to be above 10%. |
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