The FDA Is Corrupt – Why You Shouldn’t Trust It

The FDA is corrupt and can't be trusted. The organization's approved drugs have caused severe side effects years after approval.

In this blog post, you will learn about FDA's financial ties to drug companies and the corruption in this agency. And finally, you will discover drugs approved by the FDA that caused severe side effects.

What Is The FDA?

The Food and Drug Administration is the oldest consumer protection agency in the U.S. The organization was not known by its present name until 1930. In 1905 the American Medical Association created a system for controlling drugs.

President Theodore Roosevelt signed the Pure Food and Drugs Act in 1906. The FDA's modern regulatory functions began the same year.

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. The FDA also regulates the manufacturing, marketing, and distribution of tobacco products.

Drugs need to pass through FDA's three-step process before they can go on the market.

FDA's 3 Step Drug Evaluation Process

One part of the FDA is the Center for Drug Evaluation and Research(CDER). It reviews new drugs. The CDER breaks down the process into three phases:

Let's learn what these steps are:

1. Preclinical 

After a drug company discovers a new compound, it starts the FDA approval process. The preclinical phase is the drugmaker'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. After gathering initial data, the drug company submits an Investigational New Drug (IND) application to the FDA. 

The IND includes basic facts about the drug and a plan for human testing. After the FDA verifies the planned clinical trials will not harm humans, it moves the drug to the next phase.

2. Clinical Study Phase

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

The final stage of the drug approval process is the New Drug Application phase.

3. New Drug Application (NDA) Review

Once clinical trials finish, the drug company submits a New Drug Application. It contains data about animal and human testing. There is also information on the drug manufacturing process.

The FDA has 60 days to review the NDA before filing it. After the FDA files the NDA, it reviews all the research submitted by the drug company. Next, it reviews the drug's proposed label. 

The FDA needs to ensure health care professionals and consumers get the correct information. Finally, the FDA inspects the drug manufacturing facility.

What's most shocking about the approval process is that the FDA doesn't make drug trials.

Drug Companies Make Studies Not The FDA

The FDA is supposed to regulate drugs on the market. You would think that the organization makes clinical trials of drugs on the market. But you're mistaken. 

It's pharmaceutical companies that do clinical trials of various drugs. The FDA only reads these studies and then decides whether to approve the drug or not. 

Drug producers only need to prove that a drug is somewhat better in two placebo trials. There are many ways a drug company can manipulate clinical trials. If the sample size is large enough, any effect will become statistically significant. 

And if the company didn't succeed in its first two tries, it can perform more trials until two stick. Drug companies may cherry-pick the data they want the FDA to see. One example is Eli Lilly.

Eli Lilly Got Prozac Approved Despite 17 Previous Failures

Eli Lilly Pharmaceuticals conducted 20 studies to prove the safety of the antidepressant Prozac. Only three studies were ever submitted to the FDA for approval despite 17 prior failures. The FDA denied Lilly approval for Prozac.

After Lilly sent in the third data submission, the FDA finally approved the drug. But, there were no new trials. The company only used statistical manipulation and repackaging of existing data. Manipulating study data is more common than the public knows. 

Pharmaceutical companies use legal ways to manipulate FDA rules. They hire a team of writers, statisticians, and editors to "repackage" trial results. Whether the FDA acknowledges this practice or allows it is anybody's guess.

Drug companies hide serious harms in mountains of documentation that drug agencies will never find. Why did we create a system where the industry is the judge when it doesn't make sense? Only an unbiased third-party entity should do the testing.

Companies have to submit all trials they have carried out when they ask for drug approval. But the problem is that we cannot trust drug companies.

Trials may be missing or conducted in countries with little public oversight. It might be impossible to know they existed. 

What's worse is that only drug companies have actual trial data.

Only Company Employees Have Seen The Actual Data Of Trials

Drug companies only focus on profit. It is naive to expect the industry will perform honest research on its products. 

If the industry had this aim, it would compare its drugs with active placebos. It would also let independent researchers perform its trials.

Bias is often introduced already in the design of the trial. Academic investigators have little or no input into the trial design. They have no access to the raw data and limited participation in data interpretation. The drug industry hijacked clinical trials for marketing purposes.

Only company employees have seen the actual data. Most trials are industry-sponsored, both in the E.U. and in the United States. They decreased from 63% in 1994 to 26% in 2004. 

It is now mainly private companies, contract research organizations (CROs) that run trials. Some of them also work with marketing and advertising. 

In the 1980s, marketers became louder and more aggressive. Salespersons with no sense of science or medicine took control over clinical research. The science turned into marketing, and professors ended up as promoters. 

Drug companies also highjacked scientific journals.

We Can No Longer Trust Medical Journals

It's no longer possible to believe much of the clinical research published today. 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. Medical journals are nothing more than an extension of the marketing arm of Big Pharma.

Sometimes drug companies order reprints if the journal publishes a positive study. They may threaten to pull a paper if the peer review is too critical. 

If journals don't do as told, they may lose $100 000 of profit and not meet the end-of-year budget. Journals partake in information laundering operations for the pharmaceutical industry. 

We don't have safe drugs. The drug industry more or less controls itself. Politicians have weakened the regulatory demands over the years. They think more about money than patient safety. 

There are also conflicts of interest at drug agencies. 

FDA Regulators Have Financial Conflicts Of Interest With The Drugs They Test

Pharmaceutical companies have people on the FDA's board of directors. They can affect what happens during these meetings.

Many FDA regulators have financial conflicts of interest with the drugs they test. Lester Crawford approved Vioxx, a Merck drug. After resigning, he became senior counsel for Merck's P.R. firm, Policy Directions Inc. 

Crawford later received a fine of $90 000. He got charged for falsely reporting he had sold stock in companies regulated by the FDA. 

Another FDA employer with severe conflicts of interest was Henry Welch.

Henry Welch A FDA Chief Received Private Fees From Drug Companies

Members of advisory committees at drug agencies also contribute to the scam. Some of them work for both sides. They extort drug companies by demanding high consulting fees. In the late 1950s, Henry Welch was chief of FDA's antibiotics division. 

He collected more than a quarter of a million dollars in private fees from pharmaceutical companies. Henry certified the efficacy and safety of their antibiotics. He also edited a journal and shared papers in print with drug companies.

There have been other cases of bribed FDA officials that approved drugs. People who get money from the industry cannot advocate for their patients. 

The title "independent expert" is thus an oxymoron. When problems arise, agencies use fake fixes they know won't work. When FDA scientists find serious harm, they often get intimidated by their superiors.

The FDA has accepted safety data it knew were fraudulent. On many occasions, the data showed the drug was not safe. If the FDA can't be 95% certain a drug will kill you, the agency assumes it's harmless and allows it.

If you thought everything up to this point was crazy, you won't believe what you will uncover next.

Big Pharma Is The FDA's Biggest Source Of Income

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. This act ensured that the FDA could hire more medical scientists to deal with the drug application load.

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.

Taxpayers provide the agency with one-third of its funding. Two-thirds of its review budget comes from the pharmaceutical industry. As a result, speed of review and approval is more important than public health.

These influences have caused a decline in drug regulation. In 1988, the FDA only approved 4% of new drugs introduced into the world market. 

Ten years later, it was 66%. By the end of the 1990s, the FDA approved more than 80% of the industry's applications for new products. The FDA has also been the last to withdraw several new drugs in the late 1990s banned in Europe.

Even if the FDA wanted to stop dangerous drugs, finding all side effects is almost impossible.

Limitations Of FDA Regulations

Clinical trials have short timeframes and can't determine safety. Only several hundred to a few thousand patients are part of drug tests that the FDA approves. These clinical trials last several weeks or months.

As a result, the FDA can only detect the most common types of severe adverse effects. Most trials use healthy participants to show that the drug works. But this doesn't reflect its use in sick patients.

Even if a team of experts analyzes a drug before approval, it's impossible to find all bad reactions. Some dangerous adverse events occur after several years. 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. Doctors may prescribe the drug for off-label uses. It means they use it for conditions not approved by the FDA. Not everyone reports adverse events because they're voluntary.

There have been several drugs approved by the FDA that later were dangerous.

Drugs Approved By The FDA Later Got Recalled After Causing Severe Side Effects

A 2012 study found the FDA's recall system isn't enough to warn health care providers or patients. The study said that the FDA only issued notices for about half of Class I recalls from 2004 to 2011. 

Class I recalls are the most serious and typically cause death or severe injury. While the FDA may suggest or request a recall, it has no legal authority to enforce a drug recall. Manufacturers are responsible for pulling dangerous products off the market. 

The FDA may request post-marketing studies to follow up on safety concerns. But drug makers don't always do them. On average, the U.S. pulls about 4500 drugs and devices from shelves each year. Recalled products have FDA approval. 

FDA-regulated products subject to recall include:

Reasons for a recall can range from packaging issues to life-threatening injuries. The FDA has made some pretty huge blunders that have ended in irreparable damage and even death. 

Here are just a few disastrous FDA mistakes that unleashed harmful drugs into the market.

The FDA's Biggest Blunders

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. Or, they ended up addicted. 

Quaaludes are now considered a Schedule 1 drug like heroin and LSD. By the 1970s, Quaaludes had become a popular street drug. In 1982 alone, there were 2764 reported emergency room visits as a result of Quaalude use. 

Cylert went on the market in 1975. It treated ADHD/ADD by stimulating the central nervous system. But the drug caused liver toxicity. There were 13 cases of acute liver failure reported to the FDA. Eleven of these cases resulted in death or liver transplants. 

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. 

When it came time to get it off the market, the FDA did nothing. The FDA refused to take it off the market until 2010, when a clinical trial showed that the drug altered the heart's electrical activity. 

Another fatal drug approved by the FDA was DES.

DES A Drug Meant To Produce Healthy Babies Caused Cancer

DES was a synthetic form of estrogen marketed to expecting mothers who wanted to have healthy babies. The drug company claimed it prevented spontaneous abortion, miscarriage, and premature labor. Instead, it created a slew of other problems that affected many generations. 

Some side effects included: 

About 5-10 million mothers and female fetuses got exposed to DES. It was one of many destructive, ineffective FDA mistakes. The FDA finally banned it in 1971.

Posicor was a drug intended to treat high blood pressure and chest pain. The drug company recalled it within a year of its release. Early clinical research indicated that the drug caused potentially dangerous irregular heartbeats. 

Vioxx was an anti-inflammatory medication intended to treat arthritis. It was the subject of one of the most extensive recalls in history. 

After approval in 1999, over 20 million people took the drug. Merck recalled it the following year. The drug was one of the most widely prescribed medications of 2003. 

Original clinical trials showed no increased risk of heart attack or stroke. Later studies revealed a large number of heart attacks associated with the drug. 

The FDA also approved chemo drugs that caused more cancer.

Breast Cancer Drug Tamoxifen Causes More Cancer

FDA-approved chemotherapy drugs kill numerous cancer patients each year. An Australian study showed that chemo drugs were only 2% effective in healing cancer. 

The FDA approved Tamoxifen, a drug that blocks estrogen, a female hormone. Certain types of breast cancer use estrogen to grow. 

The World Health Organization classified Tamoxifen as a human carcinogen. It caused over two dozen health-destroying side effects. Yet, hospitals still use it as a first-line treatment for certain types of breast cancer. 

The most scandalous approved drug by the FDA is the COVID-19 vaccine.

Dangerous Gene-Altering COVID-19 Vaccines Approved In Record Time

Lately, the FDA approved COVID-19 vaccines under Emergency Use Authorization (EUA). These vaccines use brand new gene-altering technology never used before. Usually, stage 3 vaccine trials take several years until approved. 

But the FDA allowed everyone to become guinea pigs. Everyone that takes the jab is part of stage 3 trials. We don't know the long-term effect of the jabs. On August 23, 2021, the FDA approved the first COVID-19 vaccine. That is the fastest approval of any vaccine.

The Pfizer-BioNTech COVID-19 vaccine will now be Comirnaty. Comirnaty and the Pfizer-BioNTech COVID-19 vaccine have the same formulation. But somehow, Comirnaty is fully approved for 16 years and older, while BioNTech is still under full EUA. 

What's more infuriating is that the FDA knew about potential side effects before the vaccine hit the market. Steve Anderson is a director for the Center for Biologics Evaluation and Research. 

He had an online presentation on October 22, 2020. On slide 16, he included a list of possible adverse COVID-19 vaccine side effects. One negative outcome was death.

Knowing that the FDA has approved dangerous drugs, can we trust that these vaccines are safe? The FDA only seems to regulate natural remedies. It suppressed alternative treatments such as:

Yet when drug companies make dangerous drugs, the agency often does nothing. If you look at the evidence, it's evident that the FDA is corrupt. It works for Big Pharma, not the people.