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.
Doctors and patients should make their own decisions based on what is known and unknown about the potential treatment.
“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.
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.
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.
You are 100% correct. The FDA prohibited the sale of Thalidomide in the USA though approved in Europe. This was a good call and prevented many thousands of deformities in the USA. At the same time the USA did not have access to beta blockers being used in Europe until years later.
The FDA did stop the tragedy of thalidomide deformities for thousands. However, at the same time they condemned many tens of thousands to death because doctors in the USA could not use beta blockers for hypertension.
All drug carry risks but the FDA puts to much emphasis on total safety as opposed to probably benefit.
Drugs can be dangerous, death is death and it is a terminal one way ticket with no return voucher.
I am a pharmacist.
It depends on the drug and the disease.
Any “one size fits all” solution is asinine.
Government has made health care and medicine so expensive that people have no choice in many cases but to turn to other options. Those options should continue to be available to people who need and want them to be.
Constitutionally the government has no business regulating drugs at all beyone the COnstitutionally mandated requirement to guarantee weights and measures, the wording of which originally meant that the government should fix a uniform standard of weights and guarantee that when something is claimed to weigh a pound it weighs the same as anything else that weighs a “pound.” It can be stretched to mean thatif it is claimed that there is a gram of substance in a package, that there is a uniform gram of substance in the bottle. Perhaps under the rubric of guaranteeing W&M it can be required that what is claimed to be the ingredients are in fact the ingredients. I don’t think the language can be twisted any farther than that. All the rest is government Mommy saying to hell with the rules, Everyone has to be nice andonly do what I think are nice things!
This $billion must be recovered by the drug maker before the patent runs out in order for the company to remain in business and to develop the next drug so they can remain profitable in the future. This is what dominates the price of drugs in the US.
One of the big problems is their rigid scientific methodology.
Granted, some parts of it are essential, to insure safety and effectiveness. But other parts need new methodologies to keep from getting new drugs expensively bogged down.
Several examples:
Avon Skin So Soft was originally designed to be a mosquito barrier, but the FDA testing required to sell it as such was anticipated to cost more than the entire profits to ever be gained from the inexpensive product. So instead it was sold as a skin softener, an OTC item that required no FDA approval, because it exclusively used already approved ingredients.
DMSO (Dimethyl sulfoxide), is a very simple molecule that is very effective as a topically applied anesthetic for muscle pain. Football teams buy huge amounts and swab it on the skin over the muscle. It easily penetrates the skin and relieves the pain. But it has two very serious problems.
The first is that it creates a unique and unpleasant taste in the mouth, so it cannot be double blind tested. The other, and worse problem is that when absorbing through the skin, it can act as a carrier to other substances that are not good for you. This is overcome by carefully cleaning the area with water first, but is still a real danger.
So, for these reasons, DMSO is “sold as a solvent only”. However, it is not the only product that cannot be double blind tested, an absolute requirement for FDA approval.
Specialized case and orphan drugs. There are many rare conditions that are denied effective drugs because those drugs will *only* have an effect on the people with those conditions. But the FDA requires some control groups to be of healthy people, so when the drug does nothing for them, it is deemed ineffective.
Conversely, orphan drug approval has a litany of problems, from inadequate numbers of experimental subjects, to manufacturer only research.
A “drug” that has more adverse side effects, including DEATH, than the original malady is despicable. How come we can not SUE the FDA..
I forgot to add something about fast tracking drugs. Drugs that treat AIDs are on the fast track for approval as they should be. Unfortunately they are on fast track due to political pressure. The same consideration should be given to all drugs that may cure a terrible illness of any kind.
I have absolutely no problem with the FDA slow walking a new drug in a class of drugs that can already treat an illness. They must do due diligence. To slow walk a new drug that has no comparable drugs that can treat terminal illness is immoral. People die because of this. It is also true that people may die because of a hasty approval. More people will live with fast track approval of a new and novel drug to treat terminal illness if no other drug can treat it effectively.
Drug therapy is science but not perfect. All drugs must be evaluated by risk benefit ratio. When people are dying for lack of a new drug the risk benefit ratio changes on the side of more risk.
The FDA is not the friend of the terminally ill.
I am a pharmacist and know of which I speak.