Posted on 07/09/2018 10:37:07 AM PDT by Jeff Chandler
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>> “Holy Sh*t, why in the world would I take that?” <<
Precisely!
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I know a woman who was on two kinds of insulin. The cost was $4000 a month!
BTW, she went on a low-carb diet and was able to get off insulin completely.
As it’s required long before launching the drug, pharmaceutical companies are required to publish the structure of the molecule (the underlying active ingredient in their new drug.) Without a patent, anyone would be able to copy the drug and sell it. How does that create incentive for anyone to discover and development new medicines?
Natural substances are not patentable, but they’re still sold (e.g., Vitamin A, vitamin K, etc.). The best brands sell expensively. So without patents there would still be incentive to sell drugs. Ton of the research is government-funded anyway, to the benefit of a private company.
Proving the safety of a substance is expensive in part due to excessive government regulations.
That’s painting with a really, really, really broad brush, generalizing a statement like that.
How about you use the brain the Lord gave and say something like ...
And yet THERE ARE SOME that totally trust these cheating companies blah blah blah.
But, I guess that was too hard.
Most food is "natural," yet a lot of it is processed in ways that make it convenient for people. Not the same thing as medicines...
Without patents, there's incentive for every one BESIDES the company that discovered and developed the drug to make and sell it. The (relatively) easy part is making and selling molecules that are already proven to work on a given disease.
Ton of the research is government-funded anyway, to the benefit of a private company.
A "ton?" False. This is fake news. Agencies like the NIH that offer "seed" money for companies to research certain diseases is just that...seeds. If they're lucky, they may offer enough to conduct PK studies in rats or mice. The real costs mount in later-phase II and phase III trials. Hundreds of millions, even upwards to 2 billion dollars can be spent in these stages, and there's still a chance the drug will not be approved.
For as smart as many people on FR are, I'm amazed at how lacking in knowledge some of them are on the subject of pharmaceuticals.
Proving the safety of a substance is expensive in part due to excessive government regulations.
Except in those instances where taking a life-saving drug actually SAVES your life.
“The real costs mount in later-phase II and phase III trials. Hundreds of millions, even upwards to 2 billion dollars can be spent in these stages”
Those are unnecessary government regulations.
“and there’s still a chance the drug will not be approved”
The government shouldn’t be deciding what medicine can be taken for what disease or allowing or disallowing people to get the treatment they choose.
The Libertarian side of me says, "perhaps not," but the industry professional says that there is some validity with the structure of clinical trials: starting first with a basic test for safety, gradually moving to efficacy, and then moving to compare against established standards of care.
Not only from a pharmaceutical approach is this a reasonable structure, but from a business approach as well. Various phases allow you to gauge clinical results compared to the investment made, along with future commitments.
For some drugs, especially oncology drugs, clinical trial testing takes time and money; there's simply no shortcuts around it. I'm involved with a trial where patient visits can take a full day--12 hours. We're measuring blood pressure, taking blood samples, and taking scans. The patient is provided an iPad for their personal use, and we even pay for a cellular connection if wifi isn't available.
Is it necessary for clinical purposes? No, it's not. But if we want to engage patients and keep them in the trial, we have to do what we have to do.
As for the government deciding on drug approvals, what would you have in its place? An independent body? Who would that be, and who would it comprise? Medical professionals, experienced doctors? How would those doctors become "experienced?" By prescribing medicines, interacting with pharma sales' reps? No concerns there, are there?
You have all the concerns--where are your suggested improvements?
where are your suggested improvements?
Eliminate patents, the FDA and all other federal agencies that regulate health, and all government intervention in a patient’s and doctor’s decision of what medicine to take.
What kills me about what you said is, with all the documentation and approvals and copies, in triplicate, and bids and RFPs, etc etc, and the taxpayer still gets bent over the barrel every single time.
You’re absolutely right!
What used to kill me with the Air Force, was that every form you filled out had an additional page attached, called the “Paperwork Reduction Effort” form, or something similar.
The intent was that airman could fill out this form if they thought of a way to reduce the amount of paperwork, and paper, being used for whatever process they were initiating.
Problem was, this form was attached to everything, even single-page forms! Insanity. haha
In other words, what incentive does a company have to invest billions of dollars to develop new medicines, if they can't be reasonably certain they can make a profit from them?
Also, please clarify--are you arguing that there should be NO approving authority over pharmaceuticals? Companies should be able to sell any medicine, any "cure" that the allege will benefit sick people? I'm pretty sure that if you ask the public, they won't sign off on such a thing. The FDA may be inefficient, but they serve a function in the protection of common welfare...something that's actually Constitutionally prescribed.
Also, please clarify—are you arguing that there should be NO approving authority over pharmaceuticals?
Yes, no government role in that. Someone in the private sector could provide a similar service. It will be faster, less expensive, and much more accurate and useful.
The Constitution doesn’t allow the Federal Government to regulate medicine. It only allows governments at the state level to do so.
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