The Shocking Deceit Going On In The Food And Drug Administration

2 years ago
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In this video, you will learn about FDA's fraudulent drug approval process and its financial ties to drug companies. Also, discover drugs approved by the FDA that caused severe side effects.

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The Food and Drug Administration is the oldest consumer protection agency in the U.S. The agency aims to protect public health by ensuring that drugs are safe. 

It also has to make sure that the food supply, cosmetics, and products that emit radiation are harmless. FDA also regulates the manufacturing, marketing, and distribution of tobacco products. 

FDA Approval Process

The FDA's Center for Drug Evaluation and Research (CDER) reviews new drugs. The CDER breaks down the process into phases: 

• Preclinical
• Clinical
• New Drug Application (NDA) review

The preclinical phase is the drug maker's discovery and screening phase. First, it must test the drug on animals to determine its toxicity level. Researchers then find out how safe and effective the new drug is.

The clinical study phase is when the drug maker conducts tests on human subjects. Clinical trials go through three phases.

Once clinical trials finish, the drug company submits a New Drug Application. Then, the drug company submits an official NDA that includes animal and human data.

It's pharmaceutical companies that do clinical trials of various drugs. Drug producers only need to prove that a drug is somewhat better in two placebo trials. If the company didn't succeed in its first two tries, it can perform more trials until two of them sticks.

FDA Conflict Of Interest

Most prestigious journals have a severe conflict of interest. The income from reprints is a significant part of top journals' income. They might lose large incomes from sales of reprints if they are too critical of industry trials. 

Many FDA regulators have financial conflicts of interest with the drugs they test. Members of advisory committees at drug agencies also contribute to the scam. Some of them work for both sides. They extort the drug companies by demanding high consulting fees from them.

FDA Fraud

The demise of the FDA started in 1992 with the Prescription Drug User Fee Act. It allowed drug companies to pay the FDA for its services. The FDA receives the majority of its drug-review funding from Big Pharma. It is the same industry it should be regulating.

Big Pharma pays a substantial amount of FDA's operating costs. This payout is a significant conflict of interest.These influences have caused a marked deterioration in drug regulation. 

FDA Recalls

Each year, more than 2 million Americans suffer severe adverse reactions to FDA-approved drugs.
These side effects lead to about 100 000 deaths per year.

Manufacturers are responsible for pulling dangerous products off the market. On average, the US pulls about 4500 drugs and devices from shelves each year. Recalled products have FDA approval. 

The FDA has made some pretty huge blunders that have ended in irreparable damage and even death. 

Quaaludes were sedatives used as sleeping aid between 1962 and 1985. Many people who took the drug became manic, had convulsions, vomited, and some even died.

Cylert went on the market in 1975. It treated ADHD/ADD by stimulating the central nervous system. But the drug caused liver toxicity. 

Darvon/Darvocet was on the market for 55 years as an opioid pain reliever. But it was awful for your heart. The drug killed 2110 patients between 1981 and 1999 alone. 

DES was a synthetic form of estrogen marketed to expecting mothers who wanted to have healthy babies. But the drug caused cancer in women and fertility problems.

Vioxx was an anti-inflammatory medication intended to treat arthritis. Later studies revealed a large number of heart attacks associated with the drug. 

FDA-approved chemotherapy drugs kill numerous cancer patients each year. The FDA approved Tamoxifen, a drug that blocks estrogen, a female hormone. The World Health Organization classified Tamoxifen as a human carcinogen.

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