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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.
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.
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.
"State inspection laws, health laws, and laws for regulating the internal commerce of a State, and those which respect turnpike roads, ferries, &c. are not within the power granted to Congress. [emphases added]" - Gibbons v. Ogden, 1824.
"Inspection laws, quarantine laws, health laws of every description [emphasis added], as well as laws for regulating the internal commerce of a state and those which respect turnpike roads, ferries, &c., are component parts of this mass." -Justice Barbour, New York v. Miln., 1837.
"Direct control of medical practice in the states is obviously [emphases added] beyond the power of Congress." - Linder v. United States, 1925.
"From the accepted doctrine that the United States is a government of delegated powers, it follows that those not expressly granted, or reasonably to be implied from such as are conferred, are reserved to the states, or to the people. To forestall any suggestion to the contrary, the Tenth Amendment was adopted. The same proposition, otherwise stated, is that powers not granted are prohibited [emphasis added]. ...” —United States v. Butler, 1936.
So unconstitutional federal government interference in INTRAstate medical practice by constitutionally questionable agencies like the FDA is basically another example of the warnings by James Madison and Thomas Jefferson for patriots to be on guard against the corrupt federal government unconstitutionally expanding its powers in subtle ways.
”I believe there are more instances of the abridgement of freedom of the people by gradual and silent encroachments by those in power than by violent and sudden usurpations.” —James Madison, Speech at the Virginia Convention to ratify the Federal Constitution (1788-06-06)
”To take a single step beyond the boundaries thus specially drawn around the powers of Congress, is to take possession of a boundless field of power, no longer susceptible of any definition.” —Thomas Jefferson, Jefferson's Opinion on the Constitutionality of a National Bank : 1791
”The system of the General Government is to seize all doubtful ground. We must join in the scramble, or get nothing. Where first occupancy is to give right, he who lies still loses all.” —Thomas Jefferson to James Monroe, 1797.
Although the FDA is providing a safety net for citizen concerning medical drugs, it remains that the FDA is arguably another constitutionally undefined agency like the EPA, corrupt Congress wrongly letting the non-elected bureacurats running these agencies get away with stealing and exercising state powers.
Patriots need to work with Trump to not only put a stop to the stealing and exercising of state powers by the feds, but also make the elected members of Congress start taking responsibility for all constitutionally justifiable laws and regulations coming out of DC.
Every cancer is different and drugs for one type of cancer don’t work on cancers of another type. For example the drugs they used on my wife’s breast cancer 10 years back wouldn’t work on leukemia (bone) or melanoma (skin) cancers.
Has to do with the difference cellular structure between tissue types and how they function.
Oddly enough, presidents seem not to die from cancer. Grant is the only one and he would have most likely been cured with ENT surgery.
“Carter reportedly experienced only a few of its effects, which include the usual fatigue, cough, and nausea and, on the more severe end, immune-mediated effects on healthy organs like the lung and colon.”
Yeah, because who couldn’t use a few of the usual side effects?
As a lifestyle nutritionist who actually understands both science and nature, I am not a fan of Big Pharma or the FDA.
(Think what you like. I will, too.)