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Trump's new drug approval process

Posted on 03/24/2020 8:27:01 AM PDT by nagant

Something like 20 years ago the FDA overhauled its drug approval process for cancer patients. Hospitals had new experimental drugs, but were forced to withhold them from study control group patients while watching them die. The revised rules said oncologists can test drugs on terminally ill patients without feeding placebos to control group participants. Trump further changed the rules to allow experimental cancer treatments which have only been tested safe, not effective, to terminally ill patients. Trump overruled the previous FDA reasoning which said that we can't feed experimental drugs to terminally ill patients because it could kill them.

Today Trump is shipping hundreds of doses of hydrochloroquine to New York hospitals in order to test its efficacy on COVID-19 patients. The process eliminates the FDA's normal double-blind placebo control group requirement in smaller studies. The FDA has already approved HCQ for use against malaria, so we already know it's safe.

It's high time we spread these pragmatic drug approval principles to other types of drugs. Hydrochloroquine is a start.

The next drug treatment this principle should be applied to is naltrexone, the time-release form of naloxone. People know naloxone as Narcan. The FDA approves use of naltrexone for treating opioid overdose. However, hundreds of people across America are using low doses of naltrexone for treating various autoimmune diseases. Ongoing high doses of naltrexone present health risks, but long-term use of low doses have been shown to be safe. The treatment is known as low-dose naltrexone (LDN).

Prescribing off-label use of LDN subjects doctors to career-ending criminal prosecution. The obstacle standing in the way of the FDA testing and approving LDN comes from the chemical pathways which LDN exposes. The fact that LDN works against opioids and against autoimmune disease says that people must be ingesting harmful opioids regularly.

Besides drugs the FDA is responsible for approving foods, and LDN approval says that some of the FDA’s approved foods are harming some people. Besides this, medical operators and doctors have erected a huge multi-billion dollar industry around the approved medical treatment of autoimmune disease. FDA approval of LDN for autoimmune disease threatens this industry as well as the careers of the practicing physicians.

Trump needs to ignore the professional interests of the medical industry, and concentrate on curing patients.


TOPICS:
KEYWORDS: drugapproval; hydrochloroquine

1 posted on 03/24/2020 8:27:01 AM PDT by nagant
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To: nagant

HCQ has also been used by arthritis doctors for years Have a friend who’s first prescription for it was over 25 years ago. She takes it daily.

No need for all this testing to see if it’s safe. Just need to get correct combinations and dosages in place.


2 posted on 03/24/2020 8:32:35 AM PDT by hoosiermama (When you open your heart to patriotism, there is no room for prejudice.DJT)
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To: nagant
Trump overruled the previous FDA reasoning which said that we can't feed experimental drugs to terminally ill patients because it could kill them.


3 posted on 03/24/2020 8:36:48 AM PDT by SanchoP (Living your life in fear is merely existing. You might as well be dead already.)
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To: nagant

FWIW. Quick recovery response to the drug combo will significantly reduce Medical Costs. You don’t hear Leftists praising that.
Nobel Prize for Trump on the way.
Prog heads exploding at 6.


4 posted on 03/24/2020 8:43:20 AM PDT by griswold3 (Democratic Socialism is Slavery by Mob Rule)
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To: nagant

MSNBC told me the approval process is now “Trump mentions it on TV so we drive to the pet store buy it and ingest it” Right?


5 posted on 03/24/2020 8:47:07 AM PDT by Ndorfin (Kitties,titties, and fiddies)
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To: nagant

Not approving for treatment of Covid-19 is witholding the drug and inhibits widespread use and distribution, despite successful double blind peer reviewed studies abroad.


6 posted on 03/24/2020 8:50:14 AM PDT by Chauncey Gardiner
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To: nagant

It has been clear for decades that the FDA regulation, while fundamentally necessary, is completely over the top in practice.


7 posted on 03/24/2020 9:00:39 AM PDT by lepton ("It is useless to attempt to reason a man out of a thing he was never reasoned into"--Jonathan Swift)
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To: Ndorfin

MSNBC told me the approval process is now “Trump mentions it on TV so we drive to the pet store buy [something with a similar name] and ingest it” Right?


It’s not as far off as conflating sodium chloride and hydrogen chloride, but it’s still stupid.


8 posted on 03/24/2020 9:02:26 AM PDT by lepton ("It is useless to attempt to reason a man out of a thing he was never reasoned into"--Jonathan Swift)
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To: griswold3

9 posted on 03/24/2020 9:08:42 AM PDT by knarf
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To: nagant

“Trump overruled the previous FDA reasoning which said that we can’t feed experimental drugs to terminally ill patients because it could kill them.”

Wasn’t “right to try” supposed to fix this?


10 posted on 03/24/2020 9:16:17 AM PDT by aquila48 (Do not let them make you care!)
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To: nagant

Bureaucracy Kills.


11 posted on 03/24/2020 9:20:28 AM PDT by Seruzawa (TANSTAAFL!)
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To: aquila48

Yeah, I believe Trump called his cancer rule change “right to try.”

Trump’s drug policy changes are a breath of fresh air, especially when compared to the competing strategies of murdering babies and euthanasia.


12 posted on 03/24/2020 9:27:27 AM PDT by nagant
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To: nagant

Milton Friedman, economist, was of the opinion that regulation is the tool for more for control. In this current instant he is SO right. Thankfully President Trump agrees with Friedman.


13 posted on 03/24/2020 9:49:04 AM PDT by pacpam (action=consequence and applies in all cases - friend of victory)
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To: SanchoP

But do you understand how many bureaucrats can be hired to execute dumbass? Legions.


14 posted on 03/24/2020 10:10:16 AM PDT by AndyJackson
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To: AndyJackson

Oh yeah. An endless supply according to Einstein.


15 posted on 03/24/2020 10:15:35 AM PDT by SanchoP (Living your life in fear is merely existing. You might as well be dead already.)
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