Posted by Rhiannonpa on May 29, 2003, at 10:19:10
In reply to Re: Abilify (aripiprazole) cost is PROHIBITIVE!, posted by ItsHowdyDudyTime on November 28, 2002, at 23:19:09
Ok, let me see if I can explain this. I worked for Bristol-Myers Squibb (BMS) prior to this drug being approved. I watched the information going around the company to find out when it would be available. You see amoung other things I am a manic depressive already taking one of BMS's drugs, Serzone, along with Depakote. So I was very interested in this. I left the company before it was approved and went to a differnet Rx company.
Let me see if I can explain some of the cost issues you will not hear Peter Jennings discuss on World News Tonight as to why Rx cost what they do.
In some cases, yes, the NIH "discovers" the compound. HOwever they have little ability to fully develop or research the compound to meet the government standards before approving the drug for human use. Nor does the government have a sales and marketing staff to educate the M.D.'s who will write the Rx.
That is where private industry comes in. Currently I am working in Clinical Oncology for a major Rx company. I am learning a great deal about how the process works.
Did you know that the government regulates what the Rx companys do? Did you know that the gov't has to approve every study on a drug that is done? That the government requires the Rx company to pay all expenses to the Dr.'s and patients including drug during studies? That the gov't REQUIRES Rx companys to hold in person meeting with all dr's and their study teams prior to the study starting? Which means the Rx co. has to pay for transportation, along with hotels, meals etc. for all study investigators involved.
Did you also know that even if the NIH develops the compound it is up to the Rx compnay to do the work...read: shell out the bucks, to prove the drug actually WORKS and is safe for humans? The Rx company is also the ones that have to write the study platform (a.k.a. Protocol), track and analize the data from the studies, and submit to the FDA (food and drug administration) for approval. Which the FDA and approve, reject for more data, or simply reject.It is also the Rx companys responsiblity to have highly qualified Drs, and other scientists on staff to monitor the drug through every step from writing the protocol to writing the Final Study Report for the FDA. who as I said, can do anything they want with the data.
Now after spending anywhere between 100 million and 300 million dollars of manpower hours, travel expenses, expert meetings to bring top people in the field from all over the world together to discuss the merits of the drug and how to proceed with studies, etc. And in many cases, taking YEARS to do all of this, the Rx company is LIMITED to how many years they have the right to sell the drug before it goes generic. That's it! If they do not make their money back and make enough to continue to fund other drugs research as well....too bad, the drug is going generic and the gov't gets to decide who will make and market the generic version.
If it patent ends after 7 years the Rx compnay only has 7 years to get its money back. Meanwhile it continues to study the drug to see if it can be used for other disorders, if the current compound can be improved for current disorders, etc.
All of this is federally mandated. MOnitored by the FDA, etc. So while everyone thinks the government is doing so much actually they are the ones, in the name of patient safety, that slows the process down, increases the cost with the safeguards it requires and the mass amount of people that must be involved in each set of the process to get approval.
The world wants the cure for the common cold, cancer and every other thing that plagues mankind, however they seem to think it should be free. Well at least cheap. Not to mention they are looking for someone to blame for what things cost. "oh look at the profits the drug companies make!"
Do you think that EVERY thing you use, wear, drive, or live in someone does not make money on it? Did you know that Rx companies GIVE away large amounts of both money and drug in times of need and to charities? ARe you aware that many of the studies you read about taking place in private colleges and universities are funded by Rx companies.
Why is it in this country it is so very easy to find someone to blame instead of looking at what is really going on? I am sure many of the people on this board see or have seen a therapist. Mine was very determined to break me out of playing the "blame game". You know if something is wrong find someone to blame, they you can feel better cause you can point a finger at someone else. Much easier to do that then to step back and look at what is really going on.
The Government that everyone is waiting for to fix the situation is basicly the one who put all the expensive safeguards in place. They are the ones that require tons of research and study prior to approval and continue to require it for every new indication. Requires more research to keep the patent on the drug.
So the next time you want to rag on the Rx companies for how much something costs or someone close to you is very sick and you want to know why there is no cure, remember ... you don't what to help pay for the research.
Rhiannon
Wiccan High Priestess, Manic Depressive, & Rx Company Sr. Administrative Assistant, Cancer Drug Studies.> Hmmmmmm I wonder why Abilify costs so darn much? Its not because the drug companies "invented" Abilify...they didnt invent it. See, all the core medical and pharmaceutical research in the USA usually starts out at a taxpayer funded place called NIH. National Institute of Health does the majority of basic research on new potential drugs and treatments. The pharmaceutical companies then come in, take the good stuff and capitalize on it. They then run clinical trials, perfect it, etc. and then market and sell it. But it shouldnt cost $13 a pill, because the company that makes Abilify didnt actually invent it. Taxpayer funded government research labs invented it.
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> Gee, that makes a lot of sense. You pay all these taxes to our government for basic, core level science research. Then elitist greedy pharmaceutical companies come along and say "hey, that compound looks like it has promise lets pick it up and develop it further." So they do and end up charging YOU, the American taxpayer an arm and a leg for a drug that YOU helped pay for the basic core level research on. How unAmerican.
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> Damn, maybe we need to get rid of our present government and replace it with one that has balls and a backbone for a change.
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> Howdy Dudy.
poster:Rhiannonpa
thread:129761
URL: http://www.dr-bob.org/babble/20030525/msgs/229924.html