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Offline Tripster

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« Reply #30 on: April 27, 2009, 09:30:58 AM »
V, I respect you!
« Last Edit: December 31, 1969, 07:00:00 PM by Tripster »

Offline Viratas

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« Reply #31 on: April 27, 2009, 09:32:02 AM »
Quote from: "Tripster"
V, I respect you!
I will sleep much better tonight Trip.
« Last Edit: December 31, 1969, 07:00:00 PM by Viratas »
Aequitas - Veritas (is Latin)
Cóir - Fírinne
Justice - Truth

"College has become a cruel, expensive joke on the poor and the middle class, that benefits only the perpetrator of it." - Peter Gregory

Offline AKHvywght

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« Reply #32 on: April 27, 2009, 09:57:25 AM »
Quote from: "Viratas"
Quote from: "Tubalard"
Quote from: "Viratas"
I look forward to hearing the answer to this.

Why would you say Drug costs in the US are so high?
They cost so much because the pharmaceuticals exes make TONS of money.  In addition, since we have a bought government, thanks to the republicans, the pharms have to pay the lobyists TONS of money to pay off the republican politicians with TONS of money.

So it all go back to rich undeserving republicans taking away our hard earned money.  And you see, that's why the redistribution of wealth plan under Obama is so important.  

It will put back $ in the hands of working people.
Wow you could not be any further off but this is all proving my point, also your envy is showing tubby.

1. The cost to produce a new drug or medical device is artonomical just to get it through the FDA. Patents are for 7 years, meaning the company only have 7 years to recover the costs it took just to develop it and get it approved.

2. This is why when a generic comes out (after the patent) Wal mart can sell the drug for pennies.

3. Coutries where drugs are much cheaper do not have the same process as our FDA, which brings development costs way down.

Again I knew you lefties would march out and say its all business fault our Govt, can save us banter.

Well done fellas.
1. The cost to produce a new drug or medical device is astronomical just to get it through the FDA. Patents are for 7 years, meaning the company only have 7 years to recover the costs it took just to develop it and get it approved.

Again, this is an example of companies overextending themselves.  That companies spend so much money on R&D for penis enlarging drugs is a little bit irresponsible.  Also, from what I've heard, the drug companies often have more than 7 years to recover their costs.  They go to court and get patent extensions until they actually have recovered their costs, which can be as much as 15-20 years sometimes.  It is a lot like the government bailouts.  The company spends too much to develop a new drug, then expects the government to change the rules for them.  

2. This is why when a generic comes out (after the patent) Wal mart can sell the drug for pennies.

No offense V, but the subject of this sentence is not very clear.  What is "This" at the beginning of the sentence?  The economic ramifications of a patent system are intentional.  Essentially, when the patent is up, the market goes from being a monopoly to being a competitive market and the price comes down.  

3. Coutries where drugs are much cheaper do not have the same process as our FDA, which brings development costs way down.

Very true, the costs are much lower.  Countries without drug regulations also have more incidents with side effects and drug related deaths.  Consider that without the FDA to ensure the safety of the drugs on the market in our country, many people would not trust the drug industry, and the market for their products would be smaller.  All of the drugs that eventually come to the market in the US have been available in other countries for at least a couple years.  These countries get the drugs cheaper, but the price they pay is that they are treated like human lab rats and considered disposable.  


I'm not real sure what your point is with all this V...this is a complex issue.  The drug companies are one of the biggest lobby's getting the most favors from our government officials.  I don't know if a politician can get elected without the drug companies on their side.  It's not a partisan issue, it goes both ways.  It doesn't matter, republican or democrat.  It is ridiculous that big money industries like pharmaceuticals, defense contractors, and multinational engineering and consulting firms have bought our government.  There is a lot of evidence out there to support the notion that we live in a "corporatocracy" rather than a democracy.
« Last Edit: December 31, 1969, 07:00:00 PM by AKHvywght »

Offline AKHvywght

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« Reply #33 on: April 27, 2009, 10:01:28 AM »
Quote from: "Cougar1"
But, I agree that people who want to take risky drugs should be able to with the proper waivers, and I think that drug companies should have the abilty to opt out of the FDA approval process, but if they do that then they be open to unlimited liability.

Agreed on the taking risky drugs with waivers. "Unlimited liability". That's one of the other problems we have that contributes to the high cost of doing business. Is there another country on the planet that allows for the types of settlements we do? Totally disagree with that. I know people that have just shut down their businesses and retired prematurely to avoid the risks of outrageous lawsuits. Noone is benefitted by that.
I totally agree with this.  

This is a burden for every industry in our country though, not just the pharmaceuticals.
« Last Edit: December 31, 1969, 07:00:00 PM by AKHvywght »

Offline Jointdoc55

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« Reply #34 on: April 27, 2009, 10:36:49 AM »
V has it right.

We live in a capitalistic country. Every company is free to make a fair product within the confines of the law. The process for bringing medications to market in this country is indeed laborious.  Our FDA is extremely cautious, and that is mostly appropriate. The creation of the appropriate chemical compounds is only a small fraction of the cost of the medications.  Research and Development costs are enormous. It starts with an idea in the head of a scientist/physician. Testing is first done by creating the right compound.  Then it is formulated to make sure that it has the right physical characteristics (pH, etc.) to withstand stomach acidity (in the case of oral meds), and to be sure it is likely to be absorbed effectively. Then there are animal studies to study pharmacokinetics (drug metabolism and clearance, etc.). Because animals are not the same as humans the same parameters must be studied in humans.  In human studies many questions must be answered:  Is it absorbed adequately?  Any significant side-effects?  How long do the desired benefits last?  How is it metabolized and excreted?  Is it broken down in the human body by an enzymatic or chemical process to something toxic?  These are all of critical importance.  Then come Phase 2 and 3 trials.  A typical study might have 500 or more patients in it and cost multiple millions of dollars. The FDA requires at least 2 such studies for effectiveness and safety for each drug, if not more.  If the molecule being tested is a new one, then the FDA may be even more cautious and require further testing and studies. Some people claim the FDA is too cautious while other claim it is not cautious enough. The other dirty little secret is that out of 10-20 drugs that are formulated and studied in animals and in phase 1 trials in humans, only 1 ultimately comes to market. To remain viable pharmaceutical companies recoup those losses.

One last thing. I agree with the poster who suggested that trial lawyers are part of the problem here. Pharmaceutical companies must retain large contingents of lawyers in the process of bring a drug to market. Lawyers must be involved in all sales and marketing decision and to be available to defend the company against law suits. Sometimes pharmaceutical companies should be sued. However, most law suits against pharmaceutical companies are submitted for outcomes for which no cause and effect can be determined. I can provide many examples in which pharmaceutical companies were sued because of some outcome that was almost certainly unrelated. Trial lawyers love those kinds of law suits. Watch daytime tv for 30 minutes and you’ll see several commercials saying that “if you’ve suffered x, y or z from drug A, then call this 1-800 number…â€
« Last Edit: December 31, 1969, 07:00:00 PM by Jointdoc55 »

Offline ac1998

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« Reply #35 on: April 27, 2009, 10:53:24 AM »
Jointdoc,

Your post was really interesting.  One thing I didn't get is what is your personal opinion on the FDAs's stringent requirements?  As a physician would you be less willing to perscrbe a drug to a patient that hasn't been tested as thouroughly as the FDA requires?  Should we allow more experimental drugs to be uesed at the discretion of pateints and doctors even if they haven't been approved?

Also if you watch daytime TV you do get lots of commercial describing what you said about lawyers.  But you also get lots that sound like the drug companies are inventing medical conditions and implore you to ask your doctor about such-and-such drug.  Is there really a "restless leg syndrome" ? How much of the comsumer marketing that drug comapanies do, as oppoesed to presenting results in medical journals, add to the cost of drugs.
« Last Edit: December 31, 1969, 07:00:00 PM by ac1998 »

Offline Jointdoc55

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« Reply #36 on: April 27, 2009, 12:44:48 PM »
Quote from: "ac1998"
Jointdoc,

Your post was really interesting.  One thing I didn't get is what is your personal opinion on the FDAs's stringent requirements?  As a physician would you be less willing to perscrbe a drug to a patient that hasn't been tested as thouroughly as the FDA requires?  Should we allow more experimental drugs to be uesed at the discretion of pateints and doctors even if they haven't been approved?

Also if you watch daytime TV you do get lots of commercial describing what you said about lawyers.  But you also get lots that sound like the drug companies are inventing medical conditions and implore you to ask your doctor about such-and-such drug.  Is there really a "restless leg syndrome" ? How much of the comsumer marketing that drug comapanies do, as oppoesed to presenting results in medical journals, add to the cost of drugs.
Very good points.  As I said early in my post, I "mostly agree" with the stringent requirements imposed by the FDA.  If I had to say, I'd say that the FDA is a bit too restrictive. however.  I will acknowledge that it is easy for me to say that. To be fair, the FDA is in a tough spot also. It's kind of like fighting terror. If there are no attacks on our soil, then not much credit is given to the government, but if an attack occurs there are no shortage of people lining up to criticize. Our FDA, with all it's limitations, is the best such group in the world (more on this by request). I do believe that sometimes it is a bit too conservative. Some diseases are so catastrophic that it may be reasonable to try to bring potentially life-saving drugs to the market more rapidly. Although we can proffer such an opinion, who should ultimate be responsible to make that decision? I recall vividly when AIDS was first recognized as an infectious disease caused by a retrovirus. As recently at the mid 90's it was considered uniformly fatal. Now, with medications, most people with HIV don't develop AIDS, and most people with AIDS live more than 5 years. From the mid 80s through the mid 90s many people were clamoring to get the FDA to relax it's process to allow some of these drugs to come to market sooner than would ordinarily happen. I had a friend at the FDA at that time who described the medical-legal milieu to me in detail. Some AIDS activists were calling the FDA anti-gay, even going as far as to accuse the FDA of wanting to kill gay men.  In the end, the FDA held fast. I am aware of at least one drug that was never made available to the public because it was associated with a huge number of liver failure deaths. Had it been released, many AIDS patients would have died much sooner as a result.  However, during that 10 year period, many AIDS patients died of the disease also. It is very hard to know where the correct balance is in this regard.

Ialso agree with the comment about direct-to-consumer marketing by drug companies. The problem is that risk-benefit issues cannot be adequately presented in 1 minute sound bites, especially when the sound bites are created by sales and marketing teams. It is a real paradox that one case of heart failure in 1 million prescriptions will result in the FDA mandating a "dear doctor" letter to physicians detailing this risk, and possibly a "black box warning" in the package insert, where as an over the counter drug, like Enzyte can beat around the bush – suggesting a that users will experience an increase in penile size – with no legitimate scientific evidence to support this claim – only anecdotal evidence.  It is a large loop hole in our system that distinguishes “herbal remediesâ€
« Last Edit: December 31, 1969, 07:00:00 PM by Jointdoc55 »

Offline Intensity guru

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« Reply #37 on: April 27, 2009, 12:56:52 PM »
Quote from: "Tripster"
V, Cuba's government runs their healthcare and their costs are very low and their life expectancy is the same as in US.
Sitting around all day playing checkers and not working is not very taxing on the body.
« Last Edit: December 31, 1969, 07:00:00 PM by Intensity guru »
I always bring my hips to the party.

Offline Intensity guru

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« Reply #38 on: April 27, 2009, 01:32:43 PM »
Quote from: "Viratas"
Quote from: "Tripster"
The cost to produce a new drug or medical device is artonomical just to get it through the FDA.

V, can you elaborate on this?
Sure, example: My friend is a engineer at Medtronic. He said just to get through the FDA it takes about 3-5 years. With that are not only your R and D costs but Millions and Millions in legal costs to go through the FDA. This all ads up.

Like he say, do people expect the company to set a price that they know will lose them money? How would the stay in business to make more advancements? They could not. So they have to find a point when they can make a profit (to do more research on new and better devices) and to well pay the workers. etc.. when the patent runs out their window is closed.

I am not saying the execs take to much etc... But Medtronic here in MN employ thousands of people who make a good living. The same companies you hate also employ many people trip.
I work for a large (top 10) pharmaceutical company and have for years. The costs of discovery are unbelievably enormous. For a pharma company, the pipeline is everything. If you don't have and maintain a healthy pipeline of potential molecules to move forward with you're done. When this happens you're forced to look in the marketplace to buy smaller companies and research labs with promising molecules or treatments already discovered (Like Pfizer). Right now my company has over 30 potential drugs discovered and is constantly moving forward with that research. Roughly half of them will make it into phase one FDA trials. Of those roughly half will make it into Phase 2. And if just one of those drugs makes it to market, the company will be lucky. So when you figure the costs of R&D you're not just figuring the costs of what it took to discover one particular drug. You can't ignore the costs of maintaining the pipeline and the money lost pursuing the other 29 potential drugs that were never approved.

<span style='font-size:14pt;line-height:100%'>IF</span> that drug makes it to market, you have the expense of building a huge manufacturing facility and distribution center based on marketability estimates which may or may not be accurate. A facility which has to be ready and fully staffed with competent and trained people BEFORE you have the green light to sell the drug so you can have inventory to sell.  The process that you use to produce the drug has to be reviewed and approved by the FDA also. The facility and equipment itself has to be inspected and approved for production too. Your automation systems, valves, piping, tanks, instrumentation, cleaning systems, data historian systems, quality systems, procedures and documentation has to be validated and approved too. Don't forget you have to hire and train a global sales force too. many drug companies do all this nearly blind. That is the nature of the business. It's a total gamble. If the drug flops in the market or is scratched in phase 3 by the FDA you're out hundreds of millions of dollars. I've experienced this first hand. (Xigris)

The amount of money spent getting a drug most people take for granted on the shelf is astounding. Like V stated earlier, you have a very limited amount of time to recoup your money depending on how long it takes you to get the drug to market. The patent time-line starts when you discover the molecule or chain not when you start selling it. Executive salaries are over the top. But they are NOTHING compared to the cost maintaining a pipeline. Not even a drop in the bucket.

Now having said all that, these companies generate a lot of money. Everybody in my company makes darn good money. 99% of us work "core hours" where we only have to be there between the hours of 9 and 3. We get paid sick leave, personal business time and exorbitant vacation time. We get 10 paid holidays a year and three "year end" days every year. The entry level employee get's 120 hours of paid vacation time. That's 28 paid days off at entry level not counting "personal business" which could be anything, and sick leave. We also have a fully endowed pension program that pays you your average salary over the best 5 of your last ten years for life. I know control room operators that make 100k per year and will get 70k per year in pension money plus full medical until they're dead. Yeah our wormy CEO retired last year and took a $30 million parachute with him. So what? The company has 45000 employees. Divide his $30 million by 45000 and that equals $666 dollars each. It's not like the guy is robbing us of our retirement.

In closing, the cost of drugs has everything to do with FDA review and government regulation in general. Regulatory costs are huge and those losses need to be recouped too.
« Last Edit: December 31, 1969, 07:00:00 PM by Intensity guru »
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Offline Jointdoc55

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« Reply #39 on: April 27, 2009, 03:13:20 PM »
Quote from: "Intensity guru"
Quote from: "Viratas"
Quote from: "Tripster"
The cost to produce a new drug or medical device is artonomical just to get it through the FDA.

V, can you elaborate on this?
Sure, example: My friend is a engineer at Medtronic. He said just to get through the FDA it takes about 3-5 years. With that are not only your R and D costs but Millions and Millions in legal costs to go through the FDA. This all ads up.

Like he say, do people expect the company to set a price that they know will lose them money? How would the stay in business to make more advancements? They could not. So they have to find a point when they can make a profit (to do more research on new and better devices) and to well pay the workers. etc.. when the patent runs out their window is closed.

I am not saying the execs take to much etc... But Medtronic here in MN employ thousands of people who make a good living. The same companies you hate also employ many people trip.
I work for a large (top 10) pharmaceutical company and have for years. The costs of discovery are unbelievably enormous. For a pharma company, the pipeline is everything. If you don't have and maintain a healthy pipeline of potential molecules to move forward with you're done. When this happens you're forced to look in the marketplace to buy smaller companies and research labs with promising molecules or treatments already discovered (Like Pfizer). Right now my company has over 30 potential drugs discovered and is constantly moving forward with that research. Roughly half of them will make it into phase one FDA trials. Of those roughly half will make it into Phase 2. And if just one of those drugs makes it to market, the company will be lucky. So when you figure the costs of R&D you're not just figuring the costs of what it took to discover one particular drug. You can't ignore the costs of maintaining the pipeline and the money lost pursuing the other 29 potential drugs that were never approved.

<span style='font-size:14pt;line-height:100%'>IF</span> that drug makes it to market, you have the expense of building a huge manufacturing facility and distribution center based on marketability estimates which may or may not be accurate. A facility which has to be ready and fully staffed with competent and trained people BEFORE you have the green light to sell the drug so you can have inventory to sell.  The process that you use to produce the drug has to be reviewed and approved by the FDA also. The facility and equipment itself has to be inspected and approved for production too. Your automation systems, valves, piping, tanks, instrumentation, cleaning systems, data historian systems, quality systems, procedures and documentation has to be validated and approved too. Don't forget you have to hire and train a global sales force too. many drug companies do all this nearly blind. That is the nature of the business. It's a total gamble. If the drug flops in the market or is scratched in phase 3 by the FDA you're out hundreds of millions of dollars. I've experienced this first hand. (Xigris)

The amount of money spent getting a drug most people take for granted on the shelf is astounding. Like V stated earlier, you have a very limited amount of time to recoup your money depending on how long it takes you to get the drug to market. The patent time-line starts when you discover the molecule or chain not when you start selling it. Executive salaries are over the top. But they are NOTHING compared to the cost maintaining a pipeline. Not even a drop in the bucket.

Now having said all that, these companies generate a lot of money. Everybody in my company makes darn good money. 99% of us work "core hours" where we only have to be there between the hours of 9 and 3. We get paid sick leave, personal business time and exorbitant vacation time. We get 10 paid holidays a year and three "year end" days every year. The entry level employee get's 120 hours of paid vacation time. That's 28 paid days off at entry level not counting "personal business" which could be anything, and sick leave. We also have a fully endowed pension program that pays you your average salary over the best 5 of your last ten years for life. I know control room operators that make 100k per year and will get 70k per year in pension money plus full medical until they're dead. Yeah our wormy CEO retired last year and took a $30 million parachute with him. So what? The company has 45000 employees. Divide his $30 million by 45000 and that equals $666 dollars each. It's not like the guy is robbing us of our retirement.

In closing, the cost of drugs has everything to do with FDA review and government regulation in general. Regulatory costs are huge and those losses need to be recouped too.
Pretty similar to what I said.
« Last Edit: December 31, 1969, 07:00:00 PM by Jointdoc55 »

Offline bigokieguy

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« Reply #40 on: April 28, 2009, 01:14:25 AM »
Quote from: "Tripster"
Drugs cost too much because we pay for them too much because many of us are sick and drug companies know we desperately need drugs, kind of like oil prices last summer.

Or perhaps because there are too many costly lawsuits and the government taxes and regulations are too high.
You're now a self admitted Left wing Economic Guru  :blink:
« Last Edit: December 31, 1969, 07:00:00 PM by bigokieguy »