What Steps Do You Need to Take for the FDA to Aprove a New Drug?
Question by scarlett: what steps do you need to take for the FDA to aprove a new drug?
hi is there anybody who knows what steps you need to take for the FDA to approve a new drug? this would be really helpful to me thanks a bunch!
Best answer:
Answer by Laura J
I do.
First they patent a steroid molecule by shifting the molecules around from a natural substance to a synthetic substance, because he who owns the patent, controls the money. They will even use patents just to claim ownership if a use hasn’t been established at all. So, many patented synthetic molecules never make it to drug treatment.
Next are three scenarios that are faced by drug companies to determine the next step.
A. If the first study is promising for a cure and it costs too much to fund for further research it is abandoned. (How convenient with all of those fund raisers for a cure).
B. If the first study is promising for a cure and it does not cost too much for further research a committee abandons it because there is no money in a one time cure. (Supply and demand reveals this fact).
C. If the first study is promising as a “treatment” then they must establish a toxicity level, first.
Once the C. answer is picked, it then goes to lab animals to determine toxicity levels. You must establish an LD50, which is an abbreviation for Toxic Half Life.
This method is the next step, you must kill half of your lab animals. After you do that, you can write down an exact measurement of how much can possibly kill a human being.
The next step is to test it on real human beings. They attract college students who need tuition to pay for their books, have them sign a waver so that they are not liable if they come down with a life threatening side affect and or die.
They also test it on terminal patients sent home to die for what they like to call “trial studies.”
They give half the subjects (real people to those families) a placebo and half the drug. They then report on what side affects and what measurable affects to the body by drawing blood to check blood serum levels of HDL, LDL, sugar, enzyme readings etc.
The ones that report good effects from the placebo are taking Glucose. Glucose has been identified recently as one of the 8 sugars for cellular communication, so here is why there is a positive affect because of glucose:
Glucose – A potent fast-energy source that can be released directly into the bloodstream, glucose also enhances memory, stimulates calcium absorption, and enhances cellular communication. Too much of it can raise insulin levels, leading to obesity and diabetes. Too little glucose can be problematic as well. Elderly Alzheimer’s patients, for instance, register much lower glucose levels than those with organic brain disease from stroke or other vascular disease. In addition, glucose metabolism is disturbed in depression, manic-depression, anorexia, and bulimia.
Is it any wonder why people who take glucose feel better? By the way, you are learning what your doctor does not know.
Anyway, once they establish the affects of the drug and how much it tweaks a reaction to someones blood serum level, the next step should be a longitudinal study, like following the subjects of this “trial” study for several years to track if the benefit out way the side affects. However, they are not doing that any longer.
A good example is the HPV Vaccine, which only had 3 months of testing before they are trying to make it a mandatory vaccine for 6 year old girls.
Anyway, they are supposed to go through FDA approval with stricter guidelines, but somehow that all fell apart, so the FDA isn’t this protective infrastructure we were all lead to believe.
There are three scenarios in which the FDA passes a drug.
A. People inside the FDA are corrupt and accept payment from pharmaceuticals to expedite the approval.
B. The FDA makes sure it has been properly tested for measurable toxicity levels in order to market that product as a drug.
Well, its is more of answer A. then B. these days.
ONLY drugs can be marketed with the word cure, ameliorate or treat. If a product is non toxic at any level and cannot kill a rat, then it cannot be marketed as a drug.
Therefore, supplements have to be tested differently and what people don’t understand is that if a supplement is non toxic, they should not be required same kind of criteria as drug testing. That’s why double and triple blind placebos shouldn’t apply to supplementation, because there are measurable results with the bio markers of aging not tweaking the body to react like a drug does.
Non toxic supplements that are based on research and development have to go through very strict peer reviewed panels to warrant supplements to be accepted in main stream disease treatment centers.
The confusion is that people don’t get that the studies for supplements are just as legitamate but should not follow the same rules as drug research.
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