can certain diseases/illnesses be cured

[myntik1]

At lunch a co-worker and I had a lively discussion about certain illnesses.  This was brought on by a debate over Rev Wright.  Without touching that subject, my opinion is that most things can be cured if you have the cash.  My buddy believes the opposite. 

Exhibit A - Magic Johnson.  While he only had HIV and not AIDS, in 91 everyone was under the assumption that HIV=death.  I believe his connections and a bit of wealth enabled him to seek treatment options that aren't available to most helped him beat HIV.  17 years later he still looks healthy.  At the time people felt that he needed to immediately get into the hall of fame because he couldn't wait the necessary 5 years.

Exhibit B - Paul Allen.  In '83 Paul Allen left Microsoft to fight Hodgkins disease.  The fact that he's still with us means the score is Paul Allen 1, Hogkins 0.  In 2008 you beat Hodgkins.  In 1983 my city of 120,000 people didn't even have cable.  My best friend called my house at 9 one night to tell me he had seen the most amazing show ever - the A Team. So when Q Bert was cutting edge technology people were beating cancer.  How come 25 years later people are still dying from it?

Sorry about the long rant, but am I just a conspiracy theorist?  Or does anyone else feel like most medical issues can be corrected with the right amount of cash.

[ahofle]

I think cure is a pretty strong word.  Some of the illnesses you mentioned can be managed, but not cured.  Having a ton of money certainly helps afford the treatments/medication.  MS is another example.  There are drugs out there to help keep it under control, but there is no 'cure'.

[Dartful Dodger]

No one lives forever, no one. But with advances in modern science and my high level income, it's not crazy to think I can live to be 245, maybe 300. Heck, I just read in the newspaper that they put a pig heart in some guy from Russia. Do you know what that means?

[AtomSmasher]

No one lives forever, no one. But with advances in modern science and my high level income, it's not crazy to think I can live to be 245, maybe 300. Heck, I just read in the newspaper that they put a pig heart in some guy from Russia. Do you know what that means?

No, I don't know what that means. I guess longer life.

[boykster]

Heck, I just read in the newspaper that they put a pig heart in some guy from Russia. Do you know what that means?

When he bleeds it smells like bacon? 

[Dartful Dodger]

No, I don't know what that means. I guess longer life.

No, he didn't live. It's just exciting that we're trying things like that.

[CCM]

So when Q Bert was cutting edge technology people were beating cancer.  How come 25 years later people are still dying from it?

You certainly can't lump all forms of cancer together and make a blanket statement like that.   

From wikipedia:
Hodgkin's lymphoma was one of the first cancers to be cured by radiation. Later it was one of the first to be cured by combination chemotherapy. The cure rate is about 93%, making it one of the most curable forms of cancer.


I could almost guarantee that if Paul Allen had pancreatic cancer he would not have survived. 

[ChadTower]

Tommy Morrison claims he tests clean now too.

[Dartful Dodger]

On a related-ish note.  A friend of mine got that "Natural Cures "They" Don't Want You To Know About " book.

The book had an index full of diseases but when you went to the page it said "Disease X has a natural cure, but for legal reasons I can't print it..."

It’s a waste of time.  The book is just a gimmick to get you to sign up on a paid subscription website.

[myntik1]

Maybe I should haven't made a blanket statement like that about cancer.  But I still believe that a lot more things are curable (or treatable) than we are led to believe. I also say that most doctors are still in the dark about certain treatments.  Like everything else money opens doors to new options.

[boykster]

No 2 cancers are alike, and no 2 cancer patients, even with the same "type" of cancer are exactly alike. 

Yes, money can offer treatment courses that insurance companies would be unwilling to pay for, but money by itself cannot cure cancer or any other disease.

[Dartful Dodger]

Yes, money can offer treatment courses that insurance companies would be unwilling to pay for, but money by itself cannot cure cancer or any other disease.

The first part of your statement explains how money can, then the second part says money can't.

I don't think he's talking about liquidating $180,000 and injecting it into the blood stream to cure AIDs.


About 10 years ago I had this same conversation with a friend of mine.  He pointed out that if Reagan can't get a special cure, no one can.  That sort of put things in perspective for me.  I believe there are cures that you can only get access to if you have a lot of money, but not everything has a cure.

[Jdurg]

I work in the pharmaceutical industry, and you would be AMAZED at how much money is spent each year on new compounds in the hopes that they can cure a condition or disease.  The sad thing is, for safety or efficacy reasons, close to 95% of these new compounds never make it to market.  Many people who have conditions such as cancer, or HIV Positive, or Hypercholesterolema, etc. have plenty of access to the thousands of clinical trials going on across the world right now.  When subjects participate in these trials, they are made aware of any possible side effects or problems that can happen because of the compound.  Still, even if a drug gets to market it can have side effects that the manufacturers were not made aware of.  Sadly, that results in lawsuits and retaliation from the public so many companies are less and less willing to release compounds to market.

In case you're interested in how drugs are created and get to market, virtually all of them follow the process seen below;

1):  Chemist develops new compound.
2):  Compound is run through massive computer network which checks to see if it is similar to any known substance out there.  (This helps in the next step).
3):  The compound is simulated through an enormous computer system to see if it has any chance at being effective, and to see if it has any potentially deadly/disabling side effects.
4):  If the compound passes step three, it goes into the animal testing phase to see if the drug will be safe in living beings.
5):  If the drug passes the animal testing phase, it will be sent on to Phase 1 Clinical Trials.  Phase 1 trials are done to see how safe the drug is in human beings and how human beings metabolise the compound.  Minimal doses are used at this stage, and the trials typically last a few weeks.
6):  The drug then goes on to Phase 2 trials where they are tested at various doses to see if they are effective at all, and to see what the optimal dose is.  Most drugs die at this stage due to ineffectiveness, or poor safety characteristics.
7):  If a drug is termed effective, longer term (Phase 3)trials take place to ensure that they are safe and no nasty side effects take place.  (I believe it was durng Phase 3 Trials that Sildenafil Citrate was discovered to have positive benefits for ED Patients).
:  After Phase 3 trials, drugs are typically sent off to the FDA and other approval agencies for mass marketing and distribution.
9):  Once Phase 3 trials are done, Phase 4 trials take place.  These are typically VERY long trials which take place over a course of 5 to 6 years to see if there are any long term effects from this drug.  If any are ever found, the labels with the drugs are updated or if they are severe enough, the drugs are taken off the market.


All of this work requires work by a HUGE number of people (myself included) to ensure that they are safe and effective.  All of these people need to be paid for their insane work hours and amount of work that goes into this.  Hence why drugs aren't cheap.

Now what does all this have to do with the ability to cure a disease or illness?  Well, most insurance companies won't pay for drugs that haven't passed their longer term clinical trials with flying colors.  As a result, it may be more difficult for people to get these successful Phase 4 compounds.  However, when participating in a clinical trial the drug and nearly all other tests and procedures are paid for by the sponsor.  (The pharmaceutical company).  So I really don't think the "money" helps people with diseases/illnesses.  It's just that we hear more about celebrities who fight these diseases/conditions because of the fact that they are celebrities.  There are certainly just as many people who aren't in the public spotlight who are fighting these diseases and winning.

I've been an insulin dependent diabetic for 26+ years now without ANY complications at all.  That is nearly unheard of.  So there are sick people out there who are just able to fight things off without problems.  The human body is an incredible machine and we still don't know 1/100th of what it can do.   

[shmokes]

A cure would never be held back.  If you have a cure for cancer, no matter what the price, you will release it to the public so that more people can afford it.  People will insist that their insurance companies cover it, and then the cost of the ultra-expensive cure will be cost-spread over all the insurance company's customers.  The last thing a pharmaceutical company wants is to hold back a drug, only to have some other company develop a similar compound, patent it, and bring it to market.

In order to reasonably suggest that cures are being withheld, you have to point how that can possibly benefit the company who made the cure.  If they're in it to help people, they release it to the public.  If they're in it for the money.  They release it to the public.  If they're in it to be diabolical . . . well, I guess you have me there.

[shmokes]

Oh yeah . . . my brother's boyfriend has tested negative for HIV for at least a decade and he used to test positive.  But he has to pop a bunch of pills every day.  I'm pretty sure that he will start testing positive again if he goes of his suppression drugs.

[Jdurg]

The drug companies have no control over whether or not they can release a new compound.  The FDA, or whatever regulatory agency exists in the country being discussed, determines if a drug can be released to the public.  Filing an NDA (New Drug Application) is NOT cheap and can not be done the moment a chemical is made in a lab.  The FDA and other regulatory agencies require a TON of research be done before the compound can be released to the market, and even after the compound has been released the regulatory agencies can revoke their ability to distribute it if anything is deemed to be "unsafe".

It could cost BILLIONS of dollars if a drug company releases a compound to market that is subsequently deemed "unsafe".  It will ruin all current sales, lead to lawsuits, and result in loss of "trust" with the public.  Look at Merck.  They got ---fouled up beyond all recognition--- by releasing their compounds to market without full testing.  Also, when an NDA is filed th company gets a limited amount of time for exclusivity.  The exclusivity means that nobody can produce the same compound, no generics can be made, etc.  The company that filed the NDA has exclusive rights to tha drug.  If a safety finding is discovered and the drug is taken off the market, the company doesn't get an extension on their exclusivity.  So in the meantime, other companies can model their research to "correct" any safety issue and take a huge chunk of money from the company that had to withdraw their compound.  (As the other company didn't have to spend nearly as much time or money researching the compound.  They could basically just steal it).

So yes, a pharmaceutical company will withold the release of a compound to the public for purely financial and legal reasons.  If during the Phase 1 and Phase 2 trials they see that the drug is doing miracles, they may file the NDA early and just pray that their are no safety issues.  They'll do this with the hopes that any lawsuits or fines they may have will be overwhelmed by the profits they'll make.  It's just that with the % of compounds that actually make it to market, it is incredibly stupid to release something without A, being sure it works, and B, being sure it's safe.

By the way, you really can't patent a drug.  You can only apply for exclusivity and that runs out after a while.  If you could patent a drug, I'm sure that Pfizer would have patented Viagra and we'd never see Cialis, or any of the other "-enafils" that you see out there.

[ark_ader]

So when Q Bert was cutting edge technology people were beating cancer.  How come 25 years later people are still dying from it?

You certainly can't lump all forms of cancer together and make a blanket statement like that.   

From wikipedia:
Hodgkin's lymphoma was one of the first cancers to be cured by radiation. Later it was one of the first to be cured by combination chemotherapy. The cure rate is about 93%, making it one of the most curable forms of cancer.


I could almost guarantee that if Paul Allen had pancreatic cancer he would not have survived. 

Steve Jobs has it and he is still kicking M$ around.  So there might be some truth in it.

My stepfather died of cancer, he didn't go quietly and fought it until the very end. 

There was no miracle cure.  Except the hospice - they were the miracle workers.

If I had a date with Mr. C I would have a 1st class round the world trip and book a room at the tallest hotel with large open windows, the best view and the best champagne.    

That would be my cure.   

[boykster]

Yes, money can offer treatment courses that insurance companies would be unwilling to pay for, but money by itself cannot cure cancer or any other disease.

The first part of your statement explains how money can, then the second part says money can't.

I don't think he's talking about liquidating $180,000 and injecting it into the blood stream to cure AIDs.

You missed my point;  Money can possibly buy you a chance above and beyond what insurance companies may pay for, but if there isn't a cure, no amount of money will buy you a cure.  There is not a magic pill/treatment/surgery for ever disease out there with "just a matter of money" to make it happen.

Jdurg's portrayal of the drug development process is a bit off, but does illustrate the complexity of the process.  The average cost of bringing a new "drug" to market is 1 billion dollars.  Doesn't matter if it's to cure a type of cancer, or a rare type of defect found in a small population.  The cost from discovery to market is a billion dollars.

Drug companies can and do patent drugs all the time; however patents have a finite lifespan of exclusivity, then other companies have the right to produce generics.  The rub is that typically companies will file for a patent at the time of DISCOVERY and not approval.  If you're upset at the high cost of pharmaceuticals, lobby for longer patent protection for non-generic drugs.  Extend their exclusivity and you reduce the cost of the drug.  How it works now is that companies price drugs high to recoup discovery and development costs before their exclusive patent runs out and generics take over.  Allowing for patent protection to kick in at time of approval would seriously decrease the cost of many pharmaceuticals.

[boykster]

Also, it's a catch 22;

people want timely inexpensive drugs to cure what ails them, but they want them to be safe.  To be safe, they need to be extensively tested -> expensive and time consuming.  The FDA has to balance these factors and both protect the public while allowing for drugs that serve the greater good to be available.

Easy? No......

[shmokes]

If I had a date with Mr. C I would have a 1st class round the world trip and book a room at the tallest hotel with large open windows, the best view and the best champagne.    

LOL

I didn't know you had feelings like that for him.  I'm surprised you don't spend more time in PnR . . .   

[Jdurg]

Also, it's a catch 22;

people want timely inexpensive drugs to cure what ails them, but they want them to be safe.  To be safe, they need to be extensively tested -> expensive and time consuming.  The FDA has to balance these factors and both protect the public while allowing for drugs that serve the greater good to be available.

Easy? No......

Spot on.     Just out of curiosity, do you work in the pharma industry?  You've spouted out pretty much everything I've been telling people ever since I started in the industry oh so many years ago.     My attempt to summarize the process of drug discovery was simplified quite a bit as the actual process is very detailed and would take years to learn it.

[CCM]

Steve Jobs has it and he is still kicking M$ around.  So there might be some truth in it.

This just furthers the point that you can't lay a blanket statement on cancer.  You can't say  'Well person X had cancer and died, so everyone with cancer should die'.  Or, 'Person Y survived cancer, so everyone with cancer should be cured'.

There are so many different types of cancer and so many levels of severity that makes it impossible to lump all forms of cancer together.


From wikipedia:

In mid-2004, Jobs announced to his employees that he had been diagnosed with a malignant tumor in his pancreas.[48] The prognosis for pancreatic cancer is usually very grim. Jobs, however, stated that he had a rare, far less aggressive type known as islet cell neuroendocrine tumor.[48] After initially resisting the idea of conventional medical intervention and embarking on a special diet to thwart the disease, July 31, 2004 Jobs underwent surgery that successfully removed the tumor; he did not apparently require nor receive chemotherapy or radiation therapy.[48]

[ark_ader]

Thanks for that.   

[boykster]

Spot on.     Just out of curiosity, do you work in the pharma industry?  You've spouted out pretty much everything I've been telling people ever since I started in the industry oh so many years ago.     My attempt to summarize the process of drug discovery was simplified quite a bit as the actual process is very detailed and would take years to learn it.

Yep, but in biotech rather than big pharma for the most part.  I've been a bio/cheminformatics developer for drug discovery for most of my career, but currently I'm working in clinical informatics @ a non-profit cancer center (FHCRC).

Its definately a different perspective seeing the dtug discovery/development process from the inside.

 

[Jdurg]

Spot on.     Just out of curiosity, do you work in the pharma industry?  You've spouted out pretty much everything I've been telling people ever since I started in the industry oh so many years ago.     My attempt to summarize the process of drug discovery was simplified quite a bit as the actual process is very detailed and would take years to learn it.

Yep, but in biotech rather than big pharma for the most part.  I've been a bio/cheminformatics developer for drug discovery for most of my career, but currently I'm working in clinical informatics @ a non-profit cancer center (FHCRC).

Its definately a different perspective seeing the dtug discovery/development process from the inside.

 

Very cool.  I've been in the pharma industry for a bit over 5 years now, and while that doesn't really sound like much, in this industry five years is a lifetime.  It's incredible how much work goes into the discovery and development of new drugs or application devices.  Most people just don't understand how much work goes into this.  I work on the Data Management side of the process which basically means that I look through the data collected from these clinical trials and ensure that it is accurate, sensible, and reported correctly.  The amount of stress and work that you go through around the closeout of a clinical trial is insane.  Typically you work 60 hour weeks at a minimum around that time frame.  However, when you lock that database and give it the final approval, it feels pretty good.  Though not as good as when you're at the pharmacy picking up a script and a complete stranger happens to see your badge hanging off of your belt and tells you about how a product you worked on has made their life so much better.  That feels awesome.   

[boykster]

Yep, it's good stuff, and hard work.  I've been in the industry for about 13 years now, working on projects as diverse and genomic sequencing of parasites and bacterium, developing tools to assist in rapid target discovery using DNA microarrays, building data mining tools to do in silico drug candidate discovery/filtering, etc.

I worked at the company that developed TOBI - Tobramycin Inhalation Solution - a front line treatment for patients who have CF.  Our company had sequenced the genome of P. aeruginosa - the primary bacteria that patients with CF suffer infections from - and the department I managed had built the genome annotation tools, done much of the gene discovery and mapping.  It was a huge accomplishment for our company and department, and we had a large circular map of the genome hanging in the hall by our department offices:



Being a research company, we regularly had delivery and service people in the halls, and one day I hear one of them asking someone in the hallway what that circular thing was.  I explained to them it was a circular map of the genome of PAO1, the bacteria that afflicts patients with CF, and that our company had developed the leading treatment for this infection and that we had sequenced the genome with the end goal of discovering new drug targets to develop better treatments, etc.  The usual 30 second spiel about what we do, etc.

Turns out this guy's daughter - 18mos old - was just diagnosed with CF and that their pediatrician had been discussing treatment with them, and was re-assuring him and his wife that with the current treatments their child could lead a very healthy and productive life - much more so than just 15 years ago.  The treatment that the pediatrician was outlining was TOBI.

I can't even begin to tell you how emotional he got when he found out that this goofy circular picture in the hallway of a business he delivered CO₂ canisters to was essentially the roadmap to his daughter's near to mid-term quality of life.  He and I have kept in touch over the years (this was about 4 years ago) and his daughter is doing very well, has only suffered from some mild respiratory attacks but overall has been leading a very normal early childhood.

 

[boykster]

Oh, and is there a cure for CF?  No.

Does TOBI treat CF? No; it treats the secondary infection that leads to discomfort and death in most CF patients though

Was our company treating the disease but not looking for a "cure" for CF? No, much work by the CF Foundation, of which we were a part, is with the idea of understanding the diseas of CF and ultimately finding a cure.  Being a genetic disorder, its much more complicated than say curing the flu however.

Is it true that drug companies purposely treat diseases but don't try to cure them?  Absolutely not.  But understanding root cause of diseases and finding true "cures" or preventative measures is very difficult.  Identifying and developing treatments that improve the quality of life for people suffering from disease is still VERY difficult, but more easily attained.

[Jdurg]

Awesome.     The way this industry knows, someday we may end up working for the same CEO.     If we do, there better damn well be an arcade cabinet in the lounge.   

[shmokes]

The conspiracy-theory concept of avoiding cures so you can keep making money off the treatment is crazy.  It makes no sense.  Let's say, for the sake of argument, that boykster's company makes a lot of money on their CF treatment, and they're not very good people, so they don't want CF to be cured cos that would mean no more ongoing revenue stream from the treatment medication.

Okay . . . so far it's a bit diabolical, but there's certainly an intuitive appeal.

But it's totally simple-minded.  In order to come to that conclusion, you have to look at his company as though it exists in a vacuum.  It doesn't.  His company exists in the same world that Jdurg's company exists in.  And Jdurg's company doesn't have the leading treatment for the CF infection business.  boykster's does.  so Jdurg's company would like nothing more than to come up with a cure for CF, cos they'd like to get a piece of the CF pie that boykster's company has been hogging to themselves.

But see, boykster's company knows that Jdurg's company, and a thousand others, are all out there jonesing for some pie.  Boykster's company knows that, even though it will cannibalize their own product-line, if they don't develop the cure for CF, another company will.  It's not a matter of if the treatment drug will become obsolete, but when.  And the only important question for the company is, when it does become obsolete, will they get to keep eating the pie, or will some other company have come along and taken the pie away from them? 

As a pharmaceutical company, you don't have to be altruistic to create cures vs. treatments.  You just have to have taken a basic economic class in college.

[myntik1]

I don't subscribe to the theory that pharm companies intentionally keep drugs off the US market.  I do have a renewing subscription to the theory if we can clone sheep why can't we mass produce a economically priced mid-sized vehicle that can get more than 30 mpg.  I'm sure every intelligent person would agree that the oil companies don't want that to happen.

Now back to the topic at hand.  I think we can all agree that some countries are not as strict in their drug guidelines as America.  Often people with wealth travel abroad to seek remedies that are not available in the US. My thought and my intention of this thread was to say that I believe there are a variety and cures for many ailments (I'll use that instead of illness/diseases this time) that are not available to the average joe.  If you have Magic Johnson type money (big $, but not Paul Allen type lot) and not working Joe money (living check to check) it's insane to think you wouldn't have access to better care, better facilities, and cutting edge techniques and drugs. 

[ChadTower]

But it's totally simple-minded.  In order to come to that conclusion, you have to look at his company as though it exists in a vacuum.  It doesn't.  His company exists in the same world that Jdurg's company exists in.  And Jdurg's company doesn't have the leading treatment for the CF infection business.  boykster's does.  so Jdurg's company would like nothing more than to come up with a cure for CF, cos they'd like to get a piece of the CF pie that boykster's company has been hogging to themselves.

So Boykster's company develops the cure, determines that it is far less profitable than the treatment... patents the cure... and then sits on it.  The patent prevents anyone else from using that method of cure yet the cure does exist.  If one is connected enough, and connections equal cash in this world, one manages to get a hold of the cure via black market means.

This is just as plausible, though not likely, because of the public nature of patents.  Someone would eventually notice and the media would have a field day.

[RayB]

Welp, I just saw a certain episode of South Park and now know where myntik1 got his idea/question from. (Should have just cited your source from the start myntik1 !  )

[myntik1]

The funny thing is the old lady loves South Park, but I never watch the show.  I lost interest after the April fool's fiasco a decade ago.  So I may think along the same lines are the writing staff from time to time, but it didn't come from them. 

[ChadTower]

I loved it when it first came out - felt fully betrayed (and on way too many substances that night) when the identity of Cartman's father was revealed.  They promised to show that episode for like three weeks in a row and then didn't.  Then whey they finally did, and the answer was so ridiculously lame, and (I was at UMass) were so effed up, we all pretty much swore off the show.  Never really did get back into it.

[boykster]

So Boykster's company develops the cure, determines that it is far less profitable than the treatment... patents the cure... and then sits on it.  The patent prevents anyone else from using that method of cure yet the cure does exist.  If one is connected enough, and connections equal cash in this world, one manages to get a hold of the cure via black market means.

This is just as plausible, though not likely, because of the public nature of patents.  Someone would eventually notice and the media would have a field day.

And the patent protection would expire, so that 'protection' would be fleeting and would be developed by another competing company.  Thats exactly how the generics market works; they keep tabs on what pharmaecuticals are due to go off patent, start their own development on those compounds and are ready to get to market when the patent expires. 

If my company patented the "cure", our monopoly on treatment vs cure would be fleeting and only last a couple of years.  It is possible for companies to get patent exclusivity extensions on pharmaceuticals they are actively selling, but no way on something their sitting on.

[ChadTower]

If my company patented the "cure", our monopoly on treatment vs cure would be fleeting and only last a couple of years.  It is possible for companies to get patent exclusivity extensions on pharmaceuticals they are actively selling, but no way on something their sitting on.

I bet there are ways to fudge the testing status to extend that.  There is probably a reason some stuff takes many years to get FDA approval.

[boykster]

I bet there are ways to fudge the testing status to extend that.  There is probably a reason some stuff takes many years to get FDA approval.

Actually no; the reason that many pharmaceuticals are SOO expensive when they are "on label" is directly due to the fact that there is such a short window to recoup discovery and development costs.  The patent is generally filed at the time of 'discovery', and doesn't offer any sort of buffer for approval time.

Its not uncommon for a drug to reach market and only have a single year or two of exclusivity before generics hit the market.  The bulk of the patent is eaten up by development and approval time.  I've never heard of a case where a patent was extended for a non-marketed pharmaceutical - and generally the 'extension' is for a new indication or delivery method, rather than just a blanket extension.

No company would purposely extend their clinical trial testing phases - that's the single most expensive phase in bringing a drug to market.  

[Jdurg]

Its not uncommon for a drug to reach market and only have a single year or two of exclusivity before generics hit the market.

 

No.

Patents can be extended to make up for time lost in the FDA approval process.

Not unless the FDA says so.  Typically, the FDA will say "We'll extend your exclusivity if you do x-and-x."  NEVER have they said "Well, it took us a while to approve this so we'll extend your right to exclusivity for a while." 

Boykster pretty much hit the nail on the head with his last post.

In addition, "fudging" the testing status would result in criminal prosecution of a pretty significant level, and some SEVERE backlash from not only the FDA and other controlling organization across the world, but from your employer as well.  You do NOT make up anything when dealing with drugs or clinical data unless you want to blacklist yourself and wind up in prison.

[boykster]

I'm not going to argue the legal ins and outs of patents and exclusivity; I'm not a lawyer, I'm a software guy.  I have seen first-hand products reach approval and have short time on market prior to generics being available. 

Drug patents are valid for 20 years, and are generally filed for at the time of discovery.  The lifecycle of drug development is: Pre-clinical testing R&D (1-3 years), Clinical Research Trials (2-10 years), NDA Review for approval by FDA (2mos - 7years).  It is not inconceivable for a drug to be discovered and run through this timeframe at the cost of nearly a billion dollars, and receive approval by the FDA with only a few years of patent protection left.

The FDA can't impact the duration of the patent, but it can grant 'exclusivity' for a certain drug (5-7 years of exclusive marketing approval) but only if certain requirements are met.  Patent protection and exclusivity run concurrently thus exclusivity doesn't extend the patent, but rather it only ensure approval exclusivity for that drug for a particular indication.  If a drug has approval for more than 1 indication, and only one of those indications has exclusive status, a generic manufacturer can still produce and market the drug for the other indications. 

Its not a perfect system, but it does work.

[shmokes]

I'm not concerned.  Drug companies are enormously profitable.  You have to be to get a "Big" moniker.  We've got Big Tobacco, Big Oil, Big Pharma, etc. 

Anyway, patents and the prospect of making billions of dollars encourage research and innovation.  But generics make badly needed treatments available to the masses.  We have to strike the right balance, keeping both vitally important goals in mind.  I can't say I've studied the issue well enough to say that I think the patent period should be longer or shorter, but my gut tells me that that I'd lean toward shorter, if anything.