Domboski

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It is, and rightfully so ( see my above comment on the AMA's guidelines and my dean ). If anyone is interested, PM me and I will send you some articles that we used for this topic discussion in school. Most of it was directed at doctors accepting gifts. A more contentious, and bigger, problem than your average MD accepting the lunch and pens is when researchers ( many of whom are pHD's and not MD's ) dont disclose their connections and/or funding sources from pharmaceutical companies in their papers. A study showed that this greatly influenced ( whether openly funded or not ) the outcome of the research. Dom, I think you'd be interested in that one.

Yeah the whole "Medical Education" part of a drugs clinical development life is real shady. I think it is that way because it costs so much to run these drug candidates through the clinical trials that only pharma companies can afford to pay for them. Generic houses get off real easy. To me the generic companies are the biggest thieves. They take someone else's life work, reverse engineer it and make billions off of it without putting anything remotely close in terms of finances into development that the pharma company did. On average a pharma company has a drug on market 5-7 years (I think) before they are in danger of losing patent. That is a small window to try and make all of your money back and some.
 

Domboski

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This is very true. They are out to rip off the insurance companies, HMO's, Medicaid and Medicare. Thats where the big bucks are.:biglaugh:

But in all seriousness, like Dom said, they play the same business practices as every industry, but when it comes to things that deal more directly with life and limb, people will be more emotional and we do need higher standards - cases in point are tobacco, alcohol and firearms industries.

This is a very good point :scratch:
 

jejton

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Dom - The generic makers arent really that bad. Its kind of the way to even the playing field. It gives the original manuafacterer enough time to make a very nice profit and then makes the drug more affordable. Otherwise we would all still be paying $50 a pop for a Tylenol. Don't forget that even the big pharmaceutical companies work is done on top of the work of many many small advances made by academic researchers who publish their work and don't receive big monetary rewards. I'd direct that anger more at the illegal reverse engineers in places like India who do what the generic companies do but without waiting for the patent to expire, and often without any of the oversight and regulations that exist in mainstream places. India happens to be a hotspot due to a very open hole in their patent ( un )protection laws there. They were enacted to help India break from its colonial economy and build homegrown industries. Unfortunately now they are just as often, if not more so, used for legal theivery.
 

Domboski

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Dom - The generic makers arent really that bad. Its kind of the way to even the playing field. It gives the original manuafacterer enough time to make a very nice profit and then makes the drug more affordable. Otherwise we would all still be paying $50 a pop for a Tylenol. Don't forget that even the big pharmaceutical companies work is done on top of the work of many many small advances made by academic researchers who publish their work and don't receive big monetary rewards. I'd direct that anger more at the illegal reverse engineers in places like India who do what the generic companies do but without waiting for the patent to expire, and often without any of the oversight and regulations that exist in mainstream places. India happens to be a hotspot due to a very open hole in their patent ( un )protection laws there. They were enacted to help India break from its colonial economy and build homegrown industries. Unfortunately now they are just as often, if not more so, used for legal theivery.

From a competitive standpoint they definitely serve a purpose. My main problem with them is they go under the radar by using someone else's life work. You have heard of places like Merck and Pfizer being sued. You don't hear too much about Teva or Ranbaxy (Ranbaxy is actually based in India). I guess it evens out because pharma companies constantly sue generic houses and win quite often.

Don't the scientists who discover these drugs get paid out either by buying the drug from them out right or a licensing agreement is developed usually containing \payments based on reaching certain milestones?
 

jejton

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Don't the scientists who discover these drugs get paid out either by buying the drug from them out right or a licensing agreement is developed usually containing \payments based on reaching certain milestones?

Sometimes yes, sometimes no. It depends on the university and their arrangements with the researchers and the companies they license the patents to. The problem is that in science, most advances are incremental. Very rarely can you point to one lab's work and say that is the pivotal research. If you want to make big bucks, academic research is not really the place for you. It happens, but so does winning the lotto ( just make sure to give a good tip ! )
 

Domboski

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That makes sense. Patent life is no different for pharma then. On average clinical trials take about 10-12 years so that would leave about 5-7 years of in market life (if there were no delays). I know pharma companies re-formulate compounds and file for patent protection again. There is also unique cases when the same compound has two different brand names because the difference of therapeutic indication. This is extremely rare but has happened a handful of times. One example is fluoxetine. You can get Generic fluoxetine for Prozac but you can not for Sarafem even though they are both fluoxetine. This is not easy to get done though. Two things have to be shown to get this done and it is quite costly:

1- You have to have trial information that should this drug be double or triple dosed by accident there is no major harm (See bupropion which is branded Wellbutrin and Zyban).

2- You have to show compliance issues because of the stigma associated with the original brand name and it has to be blantant. Prozac has a strong association with depression. If a women was suffereing from symptoms of PMDD they would not want to be seen with a depression drug to treat the condition for many reasons. That makes it a compliance issue. Therefore after a lot of money is spent showing fluoxetine is safe, effective and there is strong stigma associated with the brand name, they might get a new name for the second indication. They would also file patent protection for the new indication. I can only think of 4 or 5 cases that this has ever been allowed but I am sure there will be more in the future.

It used to be illegal to have multiple brand names for a single chemical entity but the FDA was sued for not allowing it and lost. The only legal grounds for rejection the FDA has now is Safety issues which is very common. In the case of fluoxetine, you may see two different doctors (one specialist for depression & one for symptoms associated with PMDD) and both may prescribe fluoxetine under two different brand names. If the patient doesn't tell the doctor what drugs they are currently taking they may get a double dose of the same drug without knowing. This is where hopefully the pharmacist catch it should it pass the physician evaluation stage. This is also another reason for DTC advertising. Educating the patients to be aware of these circumstances is probably part of a risk management program that has to be developed by the pharma company as part of the conditions of having the second brand name. TV Commercials would be one of the best channels of communication :)
 
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BZOFIQ

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. Let me tell you, there are few easy answers.


I'd have to agree with you on that. This industry with FDA heading it is as corrupted as it gets. FDA is as corrupted as every other branch of our government. I don't foresee any changes in any near future. It irks me thou that money is found for all the crap going on and by the time we retire they probably won't be perks left for us.
 

BZOFIQ

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This is very true. They are out to rip off the insurance companies, HMO's, Medicaid and Medicare. Thats where the big bucks are.:biglaugh:

.

YES but that is short-sighted. In turn the patients are ripped off with high insurance premiums.


So, YES, pharma companies are ripping off their clients (patients).
 

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