Posted on 11/16/2016 9:15:11 AM PST by SeekAndFind
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Here's what I'm trying to understand --- why can't it be approved for ALL cancers regardless of stage? Why does one have to go through chemotherapy first, fail and then as a last resort try this cure? What is the FDA's rationale?
Can Anybody who understand the FDA process explain this?
Trump can hopefully knock some heads around, and get things fixed at the FDA
[Here’s what I’m trying to understand -— why can’t it be approved for ALL cancers regardless of stage? Why does one have to go through chemotherapy first, fail and then as a last resort try this cure? What is the FDA’s rationale?]
The answer is very simple....
It’s more profitable for Rx companies to TREAT the disease, than it is to cure it.
I firmly believe the cure for all cancers, HIV, and other treatment-heavy conditions already exists. But once everyone is cured, there will be no more Rx money to be made.
Does that mean his brain is made of skin?
It would certainly explain a lot...
Lawyers
“Its limited applications didn’t stop it from making roughly $566 million for Merck last year worldwide.”
Under the ACA the $566M was probably made by selling just 37 pills. Upside - someone just made their deductible! Woo Hoo!
Nope, it’s just the good die young. That bastard will be crawling around the planet for another hundred year.
He must’ve had this same “brain infection” back when he was president. That would explain a few things.
...What is the FDA’s rationale?...
Bureaucratic red tape justifies their existence. The more there is, the bigger the staff needed, and the bigger the budget,and so forth. Self perpetuating Government bloat.
Reagan said that a government agency is the closest thing to human created eternal life.
I am guessing because of cost. The blockbuster drugs are new to market and pharmaceutical companies have to recoup the cost, so they are very expensive compared to traditional chemo. Insurance companies will only pay for those as a last resort, for example to people who are chemo refractory (no longer responding to chemo). But this is going to change. I have heard CEOs of smaller biotech firms who are doing cutting edge work on cancer Immunotherapy say that chemo is going to become obsolete within a decade. Immunotherapy will become first line treatment.
My wife’s weekly chemo was running over $30,000 every week. She only has to go once every three weeks now at a cost of $17,000 per visit.
They mix it at the office once insurance approves her visit.
I am glad that this drug has proven effective. Good for Carter - because, while I despise him as a politician and as a VERY flawed individual, he is still a human being. The best part about this is that many, many other lives will also be saved by this drug (and perhaps others in the same family, or operating under similar principles).
I do have a question, though - how is it, exactly, that the doctors could tell that the cancer had spread to his brain? Really, did he suddenly become pro-Israel, or did he start praising the Presidency of Ronald Reagan?
What is the cost of the drug?
It ain’t cheap:
Merck said Keytruda (pembrolizumab) would cost $12,500 per patient per month, or $150,000 per year.
R&D ain’t cheap.
I guess its your on Obamacare then you don’t get it and die. Think about the savings for the Federal Gov. But if your on Medicaid its probably approved as your a democrat.
If it’s not approved for all cancers of all stages, it’s because clinical trials haven’t been done for other cancers or they were done and it did not demonstrate value.
FYI Phases of trials: Phase I is give the drug and verify it’s not going to outright kill the patient. Phase II give the drug and look for positive effects against the disease. Phase III give the drug and look for positive effects that are superior to the currently standard treatment. If the positive effects are inferior to standard treatment, then don’t change the definition of standard treatment. If the results are superior, then the drug becomes the new standard treatment.
Unless a drug jumps through all those hoops, it’s not approved as the new standard.
Pharma companies need a lot of data for approval. Melanoma is a common cancer for which much data can be rapidly generated. With a 25% success rate, which is low relative to proven therapies, some as high as 99% cure, it would be unethical to use this drug for all cancers and without proven methods being used first.
Docs have the option to use a drug “off-label” for other cancers, but most would not want to risk the lawsuits that are likely in such scenarios. Medicine is about stats and ethics; rolling the dice is not looked favorably upon by the profession, the FDA, or the people who like to file lawsuits.
The FDA is one of the stupidest agencies around.
There are probably 10 times as many useful drugs that never make it to the market because of the incredible expense.
So you develop something, the FDA kills it with bureaucracy, then a friend of the administration buys it (cheap) and makes a fortune.
It is the same way government kills other businesses.
Let’s say you work hard and invent something and set up manufacturing. The government comes along an lets a competitor build a new site, (a crony freind of whoever’s is in office), and gives him tax incentives.
The government holds a news conference and announces how IT CREATED JOBS, in the meantime he is able to outbid you because you dont have the same tax icentives and you go out of business.
The government then ‘saves’ your company and the jobs by giving your competitor more ax advantages to buy it.
The government’s crony friend now has a new successful business without all that bothersome and messy research and development and life’s work and sweat put into it.
And the bureauscrat gets to anounce how many MORE jobs he saved’, and gets re-elected with the help of donations to his campaign from the crony.
That’s the government money cycle of life.
Kill the FDA and implement a simple rule- if yu create something, you must have well documented research of your own. The FDA just certifies that you have done that, without repeating the process and forcing you to pay for it again, at government prices, where they can leak your research to competitors.
Merck and Co. The one that gave us the Gardasil fiasco. Seems there’s money to push one drug but not others.
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