Posted on 12/10/2016 8:27:47 PM PST by MtnClimber
There is persistent tension over the issue of drug regulations. On one side are those who think that before we sell drugs to the public with health claims, we should ensure there is a reasonable amount of objective quality scientific evidence to demonstrate that the drugs are safe and effective. I admit this is the side of the discussion on which I fall...
The other perspective is that requiring too much research and regulation slows the passage of potentially new and lifesaving drugs to the public. Potentially useful drugs should be fast tracked as much as possible. In the extreme version, held by some Libertarians, there should be no regulation (or perhaps minimal regulation for safety) and the free market should sort out what works and what doesn’t. The Food and Drug Administration (FDA) is the regulatory agency in the US responsible for ensuring the safety of drugs and that efficacy claims are backed by adequate evidence. The FDA, however, is a creature of congress, from which it derives its authority. It can only do what the law says it can do. Within that law the FDA also has a certain amount of discretion. How much evidence is enough is a judgment call. Therefore who heads the FDA can have a significant impact on how tightly or loosely regulated the pharmaceutical industry is at any given time. The FDA’s mandate is now being threatened from both ends, congressional law and possible picks by Trump to head the FDA.
Congress has just passed the 21st Century Cures act, which is a terrible law that weakens FDA regulations and shifts the power tremendously in the direction of the pharmaceutical industry. The core of the bill, however, is based upon a false premise and provide a counterproductive fix.
(Excerpt) Read more at theness.com ...
Control over who lives and who dies. Adolph Hitler stated that who held healthcare controlled the people.
I hope the TRUMP Administration will include supplements and preventive holistic treatment in drug plans.
American medicine is the best in the world. Most of that progress came from traditional American ethical edisonian empiricism by physicians trying different modalities and techniques on their desperately ill patients. Today the FDA controls all. Id a physician gets off the FDA reservation, they won’t be practicing too long.
I hope I get input to 0bama’s and democRAT health plans It will mave massive amounts of arsenic and will help the nation recover from the communist disease.
Doctors and patients should make their own decisions based on what is known and unknown about the potential treatment.
When the government controls health care they control the people “Adolph Hitler”. I just hope the republicans can pass late term abortions for democRATs.
If the drugs are ok in Europe/Canada that’s good enough for me. If you’re dying what Hillary does it make.
guess what else? the FDA review panels are made of of experts... who work for the major drug companies....
My father worked on a study for a treatment for type 2 diabetes 20 years ago. Study was completed, worked good. FDA panel made of competitors to the startup sent it back for more trials that they knew the startup couldn’t afford.
the kicker? The treatment used a drug that had been on the market for decades at a fraction of the dosage it is used to treat other things.
And snake oil and colloidal silver and smurf farts... Because all have equal evidence of effectiveness
“In the extreme version, held by some Libertarians, there should be no regulation (or perhaps minimal regulation for safety) and the free market should sort out what works and what doesn’t.”
I would add to this: strict punishment for fraud and for willful concealment of negative information. But, if the risks are known and disclosed, and patients choose to take those risks, it is not within the FDA’s (or, even, the federal government’s) charter to take those choices off the table.
It is ironic that many in the “pro-choice” crowd are so eager to deny so many choices to the people, except one particular one. You can’t choose any medication (or, apparently, your doctor), you can’t choose certain kinds of guns or their accessories, you can’t choose which school gets your funds (e.g. through vouchers), you can’t choose certain lightbulbs, toilets, etc. The list goes on.
It is not the purpose of the government to provide healthcare, therefor any options one would want in a health plan should be based on consumer demand in a free market. The only thing the Trump admin should do is repeal. The free market will replace.
I beg to differ with you on nano silver. It was instrumental in healing the MRSA my elderly mother contracted when she was in the hospital.
FDA reform is desperately needed. The epi-pen corruption made this evident to the least informed.
It would preferable if it was a smaller peer reviewed group that could evaluate evidence of efficacy.
No. It wasn’t. Her body fought off the infection despite the poison you were giving her.
Health supplements should be an option for Medicare. They are a better prevention than all the vaccinations the government is trying to push on the elderly.
Your opinion.
No. The fact of many studies. No actual scientific study has shown any positive therapeutic effect of colloidal silver but huge health risks.
Zero. Zip. Nada.
“And snake oil and colloidal silver and smurf farts... Because all have equal evidence of effectiveness”
Well, maybe snake oil, at least if you go to a Chinese herbalist. Then there is bear bile, deer antler, dried scorpions, sea horses and star fish not to mention pig penises. /s
Currently my husband is suffering from peripheral neuropathy probably caused by a drug that he took years ago.
There is no other reason for the neuropathy that they can find.
So I am in favor of long term testing. However there comes a time when you are going to die and a not yet fully tested medicine may keep you alive a bit longer. You should have the option of volunteering to be give that drug if you are willing to take that chance.
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