How Low Are the FDA’s Standards of Evidence for New Drug Approval?

Last Updated on June 5, 2022 by Shaun Snapp

Executive Summary

  • There is a great misunderstanding as to what standard the FDA uses for new drug approval.
  • We cover the standard they use and the implications.

Introduction

Since its inception, “FDA approved” has carried a great deal of meaning. What is little known are the basic standards the FDA uses to approve a new drug. Pharmaceutical companies leverage this lack of knowledge to trick the public regarding the effectiveness and safety of drugs.

Our References for This Article

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The History of the FDA

The history of the FDA is quite interesting and a great jumping-off point to evaluate the modern standards employed by the FDA in drug testing.

A few quotes from the FDA’s website tell the history of the agency.

The Food and Drug Administration is the oldest comprehensive consumer protection agency in the U. S. federal government. Since 1848 the federal government has used chemical analysis to monitor the safety of agricultural products — a responsibility inherited by the Department of Agriculture in 1862 and later by the FDA.

Although it was not known by its present name until 1930, FDA’s modern regulatory functions began with the passage of the 1906 Pure Food and Drugs Act, a law a quarter-century in the making that prohibited interstate commerce in adulterated and misbranded food and drugs.

And from Wikipedia.

In June 1906, President Theodore Roosevelt signed into law the Food and Drug Act, also known as the “Wiley Act” after its chief advocate.[1] The Act prohibited, under penalty of seizure of goods, the interstate transport of food which had been “adulterated,” with that term referring to the addition of fillers of reduced “quality or strength,” coloring to conceal “damage or inferiority,” formulation with additives “injurious to health,” or the use of “filthy, decomposed, or putrid” substances. The new law significantly increased federal regulatory authority over drugs by mandating a pre-market review of the safety of all new drugs, as well as banning false therapeutic claims in drug labeling without requiring that the FDA prove fraudulent intent.

What comes across very clearly is the enormous amount of lying and unsafe products to the public by private companies.

This historical insight should not be lost on the public. Only the government can be brought to bear on private companies to either provide accurate information or safe products.

As I will show, the objective of private companies since the precursor to the FDA was created under the Department of Agriculture has been to corrupt the agency to sell products that do not work, products that are unsafe and sold based on false claims.

Wikipedia continues.

After passage of the 1938 Act, the FDA began to designate certain drugs as safe for use only under the supervision of a medical professional, and the category of “prescription-only” drugs was securely codified into law by the 1951 Durham-Humphrey Amendment.[1] While pre-market testing of drug efficacy was not authorized under the 1938 FD&C Act, subsequent amendments such as the Insulin Amendment and Penicillin Amendment did mandate potency testing for formulations of specific lifesaving pharmaceuticals.[8]

This did a few important things.

  • First, it brought a large amount of business to physicians. If you wanted to access certain drugs, you were required by law to visit and pay a doctor. It is likely the 1938 act would have been strongly lobbied for by the American Medical Association. Yes, it increased patient safety, but it provided a guaranteed stream of income for physicians.
  • Unfortunately, as time passed, the drug companies could manipulate the doctors into prescribing what the drug company wanted.

Furthermore, the quote explains that “pre-market” testing was still not part of the approval process in 1938. This means that many drugs were put into the market and then later had to be removed by the FDA.

Wikipedia continues.

The FDA began enforcing its new powers against drug manufacturers who could not substantiate the efficacy claims made for their drugs, and the United States Court of Appeals for the Ninth Circuit ruling in Alberty Food Products Co. v. United States (1950) found that drug manufacturers could not evade the “false therapeutic claims” provision of the 1938 act by simply omitting the intended use of a drug from the drug’s label. These developments confirmed extensive powers for the FDA to enforce post-marketing recalls of ineffective drugs.

We see very clearly private drug companies attempting to contest that they should have to provide any substantiation for efficacy claims. Think about that for a moment. They fought in court to keep from having to show their products were effective. This provides insight into the mindset of drug companies, which is that they want to sell defective and ineffective medications. The evidence is that they have repeatedly fought in court to do just that.

Pre Capture FDA

This marks a time when drug companies have not yet captured the FDA, and the evidence is its oppositional attitude towards drug companies. Drug companies should be complaining about the FDA. As soon as drug companies praise the FDA or begin talking about their “public-private” partnership, this is when you know the drug companies have captured the FDA. And consequently, the public interest has been sold out. In fact, the following support for the FDA by industry should raise suspicions.

Over recent months, the biopharmaceutical industry has been increasingly vocal in its support of U.S. health agencies, including the Food and Drug Administration and the Centers for Disease Control and Prevention, and the scientists who work for them. They’ve committed to follow government guidance on how to report safety and efficacy data on vaccinesand therapeutics — something that hasn’t always needed to be verbalized.

Why be so protective of their government counterparts? Because distrust doesn’t operate in a vacuum. If Americans don’t have faith in regulators and other checks and balances, they’ll lose faith in the products at the end of pipeline, too. – Bloomberg

Yes, that is Bloomberg’s explanation, but Bloomberg is the mainstream media and highly corrupt with a multitude of corrupt connections. My explanation is that the pharmaceutical companies run the FDA and CDC, so they will defend them. This is one example. However, if you will note, in the modern era, it is very rare to hear any complaints about the FDA from drug companies. And that is a bad sign for the public interest.

Wikipedia continues.

The 1962 Kefauver-Harris Amendment to the FD&C act represented a “revolution” in FDA regulatory authority.[11] The most important change was the requirement that all new drug applications demonstrate “substantial evidence” of the drug’s efficacy for a marketed indication, in addition to the existing requirement for pre-marketing demonstration of safety. This marked the start of the FDA approval process in its modern form.

This is the process that I will critique later in this article. But note that until 1962 there was no process for submitting a formal clinical trial to the FDA.

Wikipedia continues.

Drugs approved between 1938 and 1962 were also subject to FDA review of their efficacy, and to potential withdrawal from the market. These reforms had the effect of increasing the time required to bring a drug to market.[12] In the mid-1970s, 13 of the 14 drugs the FDA saw as most important to approve were on the market in other countries before the United States.

What this indicates is that the FDA was applying standards. One should not endeavor to approve drugs quickly or to approve them as quickly as do other countries.

Wikipedia continues.

Concerns about the length of the drug approval process were brought to the fore early in the AIDS epidemic. In the mid- and late 1980s, ACT-UP and other HIV activist organizations accused the FDA of unnecessarily delaying the approval of medications to fight HIV and opportunistic infections, and staged large protests, such as a confrontational October 11, 1988 action at the FDA campus which resulted in nearly 180 arrests.[14] In August 1990, Dr. Louis Lasagna, then chairman of a presidential advisory panel on drug approval, estimated that thousands of lives were lost each year due to delays in approval and marketing of drugs for cancer and AIDS.

This is only looking at one side of the equation, that is deaths due to drugs not being approved.

However, this one-sided view was the death knell for standards at the FDA, and the new lower standards were applied not only to AIDS drugs but to all drugs. Recall from what I covered earlier, companies want to sell ineffective products to the market and will use any excuse to reduce standards to do so. What begins as a “tug at the heartstrings” about dying patients, ends with standards being dropped.

Since this time, the FDA’s standards have continually declined as the drug companies have taken more and more control over the agency. The intent of food and drug companies is always the same, to sell ineffective and, in many cases, unsafe products to the public.

They found the stamp of approval provided by the FDA to be quite useful. So they want the best of both world’s to sell ineffective drugs on the basis of false claims while being government-approved.

The company Red Bull makes an unhealthy product that where the active ingredient is high levels of caffeine. However, Red Bull has aggressive marketing that has daredevils performing various stunts. What this has to do with the product is hard to fathom. The false claim of Red Bull and other energy drinks is that they provide “Energy.” In reality, they offer high doses of caffeine. 

The drug ads are enormously deceptive, and the FDA has little oversight of these advertisements. These types of ads are illegal in most developed countries. The drug ads repeatedly refer to FDA studies, which as I will show, is a useless indicator for whether the drug is effective. Direct-to-patient advertising is a way to get the patient to prompt their doctor to prescribe a medication they would ordinarily not prescribe. 

How Many Studies Are Required to Obtain FDA Approval for a New Drug?

Many have claimed that there is a lack of scientific evidence for the use of Ivermectin to treat the coronavirus. The claims of the lack of evidence of the effectiveness of Ivermectin for treating coronavirus are made preposterous when one considers how the FDA approves drugs were far less evidence, and with the studies, or clinical trials, is entirely run by financially biased parties, which are the pharmaceutical companies.

The following quotation explains the number of studies required.

Generally, the agency expects that the drug maker will submit results from two well-designed clinical trials, to be sure that the findings from the first trial are not the result of chance or bias. In certain cases, especially if the disease is rare and multiple trials may not be feasible, convincing evidence from one clinical trial may be enough. – FDA

The FDA leaves out that first, the pharmaceutical company runs the clinical trials without any oversight from the FDA. This false impression is also given again by the following quote from the FDA.

Drug companies seeking to sell a drug in the United States must first test it. The company then sends CDER (Center for Drug Evaluation Research) the evidence from these tests to prove the drug is safe and effective for its intended use.

No, this is misleading.

The drug company does as many tests as it wants and then sends only the positive tests to the CDER.

  • The FDA never audits the pharmaceutical companies and has no visibility into negative tests.
  • There is no auditing or questioning of the submitted tests. This means that pharmaceutical companies can and do fake clinical trials.
  • Not only do they not face repercussions from faked or doctored clinical trials, but the CDER does not look for inconsistencies in the submitted clinical trials.

The FDA leaves all of this out to deceive the reader and provide a false impression of adherence to a scientific approach and a false impression of the integrity of the FDA.

The FDA’s quote continues.

A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company’s data and proposed labeling. If this independent and unbiased review establishes that a drug’s health benefits outweigh its known risks, the drug is approved for sale.

The review is not independent, nor is it unbiased. This lack of independence can be demonstrated.

The FDA receives 45% of its funding from pharmaceutical companies and is well known to have been captured by pharmaceutical companies many years ago. Secondly, there is no measurement for the effectiveness of a drug in terms of some threshold that would be used as a cost-benefit analysis. A drug can improve a condition by 1%, and even if the drug is exorbitantly priced, it will be approved. If the drug improves a condition by any measurable amount, under the fraud of a pharmaceutical clinical trial, it will be deemed “efficacious.”

Drugs are never analyzed in terms of their side effects as part of a cost-benefit analysis.

The FDA continues.

Risk management strategies include an FDA-approved drug label, which clearly describes the drug’s benefits and risks, and how the risks can be detected and managed.

  • The lack of coverage of side effect communication is a massive issue in the pharmaceutical industry.
  • Most drugs are sold with only a portion of the side effects listed.
  • Side effects that the pharmaceutical companies know about are hidden from the FDA but are later reported to the FDA once the drug is in general usage.

The FDA continues.

The center doesn’t actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards.

The main point is that the FDA does not test the drug and has no visibility into the drug testing process of the pharmaceutical company. They only see the final report. There is also a strong organizational resistance to push back on the pharmaceutical company.

The FDA’s Complicity in Approving Opoids

What is further amusing is the FDA’s approval of dangerous opioids, which the pharmaceutical companies have gone on to push doctors to prescribe, causing the “opioid epidemic.” The majority of the opioid epidemic is due to prescribed opioids.

This is expressed in the following quotation.

One of the biggest critiques against the FDA in recent years has been for its continued approval of opioid medicines, despite the increasingly devastating epidemic of opioid abuse nationwide, with overdoses now killing 91 people per day, according to the Centers for Disease Control. – The Smithsonian

Overall the pharmaceutical companies and the FDA has received very little blame for the opioid epidemic.

The FDA continues.

The agency and the drug maker may reach different conclusions after analyzing the same data, or there may be differences of opinion among members of the FDA’s review team. As a science-led organization, FDA uses the best scientific and technological information available to make decisions through a deliberative process.

If the FDA were a science-led organization, it would do the following.

  • It would not have all its top administrators on loan from the pharmaceutical industry.
  • It would remove conflicts of interest
  • It would not allow drug companies to hide studies
  • It would have the clinical trials performed by an independent body.

The FDA employs people with degrees in medicine and science, but it is not a science-led organization.

The FDA continues.

In some cases, the approval of a new drug is expedited. Accelerated Approval can be applied to promising therapies that treat a serious or life-threatening condition and provide therapeutic benefit over available therapies.

This means that the FDA’s already ridiculously low standards can be made even lower under Accelerated Approval. You will see how low the standard process is in just a moment.

The FDA continues.

For example, many antiretroviral drugs used to treat HIV/AIDS entered the market via accelerated approval, and subsequently altered the treatment paradigm.

Drug companies opportunistically used the protests and public outcry about the slowness of coming up with AIDS treatment to excuse further to decrease the FDA’s standards for all drugs. At this time, the drug companies began to contribute more funding for the FDA, which led to aggressive capture of the agency.

The FDA continues.

The agency also employs several approaches to encourage the development of certain drugs, especially drugs that may represent the first available treatment for an illness, or ones that have a significant benefit over existing drugs. Each designation helps ensure that therapies for serious conditions are made available to patients as soon as reviewers can conclude that their benefits justify their risks.

Fast Track is a process designed to facilitate the development and advance the review of drugs that treat serious conditions, and fill an unmet medical need, based on promising animal or human data. Fast tracking can get important new drugs to the patient earlier. The drug company must request the Fast Track process.

Breakthrough Therapy designation expedites the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy. A drug with Breakthrough Therapy designation is also eligible for the Fast Track process. The drug company must request a Breakthrough Therapy designation.

Priority Review means that FDA aims to take action on an application within six months, compared to 10 months under standard review. A Priority Review designation directs attention and resources to evaluate drugs that would significantly improve the treatment, diagnosis, or prevention of serious conditions. More information about Priority Review is here.

These programs are designed at the request of the drug companies to further water down the already extraordinarily low standards employed by the FDA.

Every request or “innovation” on the part of drug companies is designed to lower standards and allow more drugs to be approved and approved more quickly.

This is expressed in the following quotation.

Marion Nestle, a food historian and professor of nutrition and food studies at New York University, also worries about the FDA’s rapid approval of many other kinds of drugs. This process, she says, has led to the approval of controversial drugs that she believes should not have been marketed. “The drug industry wants fast approval of the drugs that it’s coming up with, whether they work or not,” she says. – The Smithonian

Testing and Improvement of Ivermectin Versus Already Approved Drugs

The site C19 Early Treatment covers this exact topic when it provides the following table that compares how many studies have proven the effectiveness of Ivermectin for coronavirus.

Yes, Casir/imdevimab was approved with just 799/47,717 = 1.6% of the test subjects than Ivermectin (and a single study), but with a similar improvement level. Budesonide had 3.7% as many test subjects (and another single study) but only a 17% improvement. However, it also had no problem receiving approval in the UK. 

Second, pharmaceutical companies do not, and are under no obligation, to report negative studies to the FDA but rather keep them secret. Pharmaceutical companies can run ten studies and report just the two positive studies to the FDA.

This, of course, entirely contradicts the FDA’s claim that its system controls for…

“the first trial are not the result of chance or bias.”

Therefore the type of analysis you see in the table above is not possible on pharmaceuticals when sent to the FDA.

This is explained in the C19 Early Treatment website as follows.

Pharmaceutical drug trials often have conflicts of interest whereby sponsors or trial staff have a financial interest in the outcome being positive. Ivermectin for COVID-19 lacks this because it is off-patent, has many manufacturers, and is very low cost. In contrast, most COVID-19 ivermectin trials have been run by physicians on the front lines with the primary interest of finding the best methods to save human lives and minimize the collateral damage caused by COVID-19. While pharmaceutical companies are careful to run trials under optimal conditions (for example, restricting patients to those most likely to benefit, only including patients that can be treated soon after onset when necessary, ensuring accurate dosing), many ivermectin trials do not represent the optimal conditions for efficacy.

And next, the website explains the pharmaceutical company’s incentive to produce studies that undermine Ivermectin.

Two ivermectin trials to date involve very large financial conflicts of interest [López-Medina, Together Trial] — companies closely involved with the trial or organizers stand to lose billions of dollars if ivermectin efficacy becomes more widely known. The design of these trials favors producing a null outcome as detailed in [López-Medina, Together Trial]. Note that biasing an RCT to produce a false positive result is difficult (suppressing adverse events is relatively easy [Evans]), but biasing a trial to produce a false negative result is very easy — for example, in a trial of an antiviral that works within the first 24 hours of symptom onset, trial organizers only need to avoid treating people within the first 24 hours; or with a disease like COVID-19, organizers only need to select a low-risk population where most people recover quickly without treatment.

We note that, even under the very suboptimal designs, these trials produced positive results, although without statistical significance.

It is also humorous that the FDA would state that they make sure there is “no chance for bias” when they allow the pharmaceutical company itself, which has an enormous bias, to run 100% of the studies.

A way to eliminate bias is to have a completely independent entity kept secret from the pharmaceutical companies (so they can’t corrupt them) perform the clinical trials. However, pharmaceutical companies control the FDA, so the FDA will never admit the bias of the submitted studies and will never do anything to reduce the corruption of their drug approval process.

When reviewing the FDA’s standards, combined with the 100% control over the process by the pharmaceutical companies and their ability to control precisely which studies the FDAs see, it is made clear that the FDA holds no standards and is nearly a rubber stamp for pharmaceutical companies.

Yet with applying no standards for drug approval that the pharmaceutical companies want to be approved that control the FDA, the FDA has the following to say on using Ivermectin for coronavirus.

The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals. Ivermectin is approved for human use to treat infections caused by some parasitic worms and head lice and skin conditions like rosacea.

The first question I would have is why not? This is the FDA’s explanation.

Currently available data do not show ivermectin is effective against COVID-19. Clinical trials assessing ivermectin tablets for the prevention or treatment of COVID-19 in people are ongoing.

The many studies chronicled on the C19 Early Treatment website contradict this claim.

Never use medications intended for animals on yourself or other people. Animal ivermectin products are very different from those approved for humans. Use of animal ivermectin for the prevention or treatment of COVID-19 in humans is dangerous. For one thing, animal drugs are often highly concentrated because they are used for large animals like horses and cows, which weigh a lot more than we do—a ton or more. Such high doses can be highly toxic in humans.

Who is proposing using animal ivermectin or animal doses on humans? What has occurred is people have been using animal ivermectin, but only because there have been insufficient quantities of human Ivermectin. These comments could have been written by the pharmaceutical industry. If one can’t figure out if the FDA issued a statement, or that statement was issued by Pfizer, that is a good indicator that the agency has been captured by the industry it is meant to regulate.

The Compared Benefit of Ivermectin Versus Already Approved Drugs

The C19 Early Treatment site then compares the net benefit of Ivermectin for covid-19.

*RCT stands for Randomized Control Trials.

So the question is, why is Ivermectin not approved for coronavirus treatment. And secondly, what does the term “FDA approved” or “scientific evidence” or “scientifically proven” actually mean? Because it does not mean that the drug is proven to be effective. At least, that is not the FDA’s definition or standard. 

Evidence from the Approval of the Covid Vaccines

The FDA approved the Pfizer, Moderna, J&J, and AstraZeneca vaccines, on the basis of relative risk reduction, which is irrelevant to actual risk reduction, something I cover in the following article.

This means that the FDA has entirely departed from any realistic measurement of efficacy, or cost-benefit analysis and now will approve anything that is submitted to them. This issue is addressed in the following quotation.

As for the other shot brands, the same study that looked at J&J’s injections found that Pfizer’s similarly declined in effectiveness from around 91 percent, supposedly, earlier in the year, to 50 percent in August. – News Target

Remember all of these percentages are relative risk, they have nothing to do with actual or absolute risk.

Moderna’s shot also fell from 92 percent effectiveness to 64 percent effectiveness during the same timeframe.

“That suggests natural immunity is now more than a hundred times more effective than J&J’s vaccine, yet the federal government and most companies do not even recognize natural immunity as a justification not to get vaxxed,” reported Information Liberation.

“They insist you take some experimental jab – any jab at all now that the FDA has endorsed mixing and matching vaccines for “boosters” – or get fired from your job … Meanwhile, the FDA is approving the rollout of boosters despite little to no data showing their effectiveness based off ‘gut feeling’ rather than data.”

This “gut feeling” comment refers to statements recently made by Patrick Moore, a member of the U.S. Food and Drug Administration’s (FDA) vaccine advisory committee who says that the recent unanimous vote to approve a Moderna “booster” shot was based on wishful thinking, not science.

“The data itself is not strong, but it is certainly going in the direction that is supportive of this vote,” he added, using strange language to explain why a third round of the mystery drug was approved.

What this all goes to show is that we are witnessing a clown show circus of pseudoscience being paraded around as if it was sound science. The plandemic clearly continues to hoodwink only the dumbest among us as those in charge openly admit, pretty much, that the whole thing is a scam. – News Target

Conclusion: What Does the Term “FDA Approved” Mean in Reality?

The most accurate translation of the term FDA-approved means it will deliver high profitability to pharmaceutical companies. Ivermectin is one example of this. Ivermectin is no longer on a patent and therefore has low profitability. This undermines the ability of pharmaceutical companies to charge high margins on vaccines. So Ivermectin is not “FDA approved,” but not because it has not that it does not have overwhelmingly more studies that support its effectiveness (and more reliable and less financially biased studies to boot), but because Ivermectin is not protective of the profits of pharmaceutical companies.

This is how the term FDA-approved should be interpreted. The drug companies have their pet agency approve drugs and put the government stamp of approval on a test and process that the pharmaceutical companies control.

Be Notified When Our Upcoming Subscription Website on Ivermectin and Other Medical Treatments is Ready

Ivermectin has many treatment applications outside of its approved use (as an antiparasitical. These treatments include cancer, covid, immunity, and more. And due to perverse financial incentives, many of these applications are hidden from the public.

Due to the many questions we receive on Ivermectin, we are now working on a subscription website that covers everything related to Ivermectin ranging from its many health improvement applications to dosages, and contrasting this with the false information presented on Ivermectin by medical authorities. The site will be ready soon as we are making good progress. We will also be adding questions from subscribers answered as customized articles. 

If you are potentially interested in subscribing, contact us using the text chat widget in the lower right-hand corner of this page and just tell us you are interested in being informed when the website is live.

Interesting Story on the History of the FDA

One of the most powerful advocates of food and drug regulation was Harvey Wiley, who served as head of the USDA’s Bureau of Chemistry. Wiley’s official role was to support scientific developments to help farmers, but his passion was to make America’s foods and medicines safe.

Wiley tapped into a network of powerful support: millions of American women who feared for the safety of themselves and their families. Led by activist Alice Lakey, these women formed an unstoppable crusade of lobbyists. “Historians and Dr. Wiley himself credit the club women of the country for turning the tide of public opinion in favor of the ‘pure food’ bill,” FDA historian Wallace Janssen wrote in 1981.

The crusade for the Pure Food and Drug Act received a final push from the 1906 publication of Upton Sinclair’s The Jungle. This powerful exposé, which set out to document the inhumane labor conditions in America’s factories, also ended up drawing attention to the horrifically unsanitary production of many processed foods.

One of the biggest critiques against the FDA in recent years has been for its continued approval of opioid medicines, despite the increasingly devastating epidemic of opioid abuse nationwide, with overdoses now killing 91 people per day, according to the Centers for Disease Control.

“They’re listening to these patients, and the people who stand to gain a lot financially from opiates, instead of taking notice of the evidence,” University of Washington physician Jane Ballantyne told Roll Call in 2015. – Smithsonian Magazine