Say what? We all know, don’t we, that drugs and medicines, even foodstuffs, have to be approved by the FDA as right and proper. Well, that’s not really true!
The FDA is busy meddling in the affairs of holistic health practitioners, trying to stop as much as possible of the grass roots indulgence in natural and traditional recipes that we all love. They cite “lack of scientific proof” as their objection. But you just wait till you see what I am going to reveal…
At the same time as attacking natural cures, they are not doing their real job; we all know that too. They toady up to Big Pharma and give them what they want, re-interpreting the rules and going easy on the proper demands and requirements.
But surely, in the end, a drug has to prove it has some value before being “approved”? Even if they covered up the side-effects and negative, there must be something concrete required?
Well, let me tell you that in the 9 years from 2013 to 2022 the FDA approved 429 drugs, most of which were authorized on the basis of wholly inadequate evidence that they worked as claimed. This is according to a database of government records set up to analyze this criminal defect in our protection!
In fact, according to Jeanne Lenzer and Shannon Brownlee, writing for The Lever, over those years:
• Seventy-three percent of drugs approved by the FDA did not meet the agency’s four foundational standards required to show they work as expected.
• More than half of drug approvals were based on preliminary data rather than sound evidence that patients had fewer symptoms, improved function, or lived longer.
• Fifty-five of the 429 drugs approved met only one of the four standards needed to show that a drug is safe and effective; 39 drugs met none of them.
Drug companies have been allowed to market hundreds of prescription drugs to doctors and sell them to unsuspecting patients despite glaringly inadequate evidence that they offer any benefit and in many cases amid clear signs that they pose a risk of serious, often irreparable harm.
These are just some of the findings of a two-year investigation by The Lever and the McGraw Center for Business Journalism into all 429 new drugs approved from 2013 through 2022. A team of four experts, three of whom are physicians and one a postdoctoral fellow at Harvard, evaluated the scientific studies cited by the agency in its approval decisions.¹
So what are these four basic standards of proof that the FDA supposedly demands? They are simple enough:
• Control group: Patients taking the drug were compared to a control group that was given a placebo or a comparator drug.
• Replication: At least two “well-controlled” trials showed the drug was effective.
• Blinding: Subjects in the studies and the doctors who cared for them don’t know which patients are on the drug and which are in the control group.
• Clinical endpoint: The studies measured the drug’s effect on patients’ survival or function rather than a surrogate measure.
Seems reasonable, just basic science. Yet these were not being upheld. Only 2.4% of the 123 cancer drugs approved from 2013 through 2022 met all four of the FDA’s basic scientific criteria. 2.4%! A shocking 29 drugs (23%) met none of these criteria!
Eighty-one percent of cancer drugs were approved based on preliminary evidence rather than data showing patients would live longer. Studies of cancer drugs approved on preliminary evidence have failed to show they improve survival in the vast majority of cases.
Surrogate Evidence
So what is surrogate evidence, referred to in the requirement for a clinical endpoint? It means showing you did something that is arguably useful but not actually proving the drug has any value to the patient ie. of no proven clinical value.
A good example is a vaccine, where manufacturers simply show that they produced a rise in antibodies against the pathogen. That’s a “surrogate” result. We really want to show that it stops people coming down with the disease!
But that’s not what happened with Gardasil. IT HAS NEVER BEEN SHOWN TO PREVENT YOUNG GIRLS GETTING CERVICAL CANCER. But among all the lies, cheating, corruption and meddling with statistics of which Merck was guilty, they did (just) manage to show it increased antibodies against the human papilloma virus (HPV).²
Another example of a surrogate result is with cancer drugs. Shrinkage of the tumor has become the gold standard of a drug deemed effective. But that really has no benefit in terms of quality of life, comfort and the most prized result of all: longer survival!
[Indeed, as I teach, half the tumor is your own immune cells in there fighting the cancer. Reducing the tumor by knocking off the T-cells would be a disaster, yet looks attractive as a surrogate result]
Negative Outcomes (Side-Effects)
If you are crafty like Big Pharma you can often try to blind the reviewers with surrogate outcomes and distract attention away from a lot of negative or even fatal side-effects being caused.
Be certain, drug manufacturers know all about side-effects, even deaths, produced by their products. Merck was well aware of the huge number of deaths being caused by their NSAID Vioxx. They hid the problem (oh yes, they did, and all has now been exposed), in order to protect their sales.
The penalty for killing in excess of 50,000 people? None. Nobody was indicted for a crime. The company was fined $321 million. That’s just chump change. A fine of $10 billion would barely hurt them or their profits.
Deferred Science
The biggest subterfuge of all was that the FDA adopted the position of “we’ll approve your drug for the time being but you need to come up with some science to prove it works, PDQ.” (PDQ British slang from the Raj days: pretty damned quick!)
The resulting seismic shift from proving drugs work before they are approved to showing they work only after approval — if ever — has been quietly accomplished with virtually no awareness by doctors or the public.
On occasion, a pharmaceutical company did come up with retrospective science that showed their product had value. But most of the time, as you would expect, they simply failed to do so. And, also as you would expect, the FDA was pretty sluggish at withdrawing its approval even when the drug was shown to be worthless.
According to a 2022 analysis by the U.S. Department of Health and Human Services Office of Inspector General, more than one-third of drugs approved on an accelerated pathway have never seen a confirmatory trial. When they did conduct the studies, regulators found companies took anywhere from a few months to 12 years to do so. This investigation found that confirmatory trials can take even longer — up to 30 years — and may not be performed at all. Even if they were, it was often not a clinical trial but more surrogate preliminaries!
This also, incidentally, makes a joke out of the defense by drug companies that they need to charge inordinate prices, to cover the costs of research. B*S*! They just slide a product past the all-too-compliant FDA and they can pay for “research”, such as it was, out of the profit from the bogus approved product!
Avastin was approved in 2008 for use against metastatic breast cancer. By 2010 sales had risen to $6.8 billion. But it was useless. One of the conditions imposed by the FDA was that the manufacturer, Genetech, conducted a study to prove the drug worked. A full two years later, Genetech finally came up with two studies which actually suggested the opposite: the drug did not help patients live longer.
In total, the company had conducted five clinical trials, none of which demonstrated that Avastin helped breast cancer patients live longer or with less disability. The new studies also documented the drug’s more serious side effects, which included blood clots, perforated intestines, stroke, heart problems, and kidney malfunction.
Eventually the FDA did withdraw its approval but against massive opposition from Genetech and various cancer advocacy groups (all funded by Big Pharma, of course).
One more example and I’m done: Copiktra, a cancer drug manufactured by Secura Bio Inc. was approved in 2018 for use in cases of leukemia and lymphoma. But it took 11 months off the average survival of patients. That’s bad.
But it was 6 years later before the FDA spoke out against it and announced that Copitra should not be used as first- or second-line treatment for certain types of leukemia and lymphoma “due to an increased risk of treatment-related mortality.” I think that means it was killing people.
How many patients had their lives shortened in those 6 years, because of an “FDA approved” drug?
What Is Success?
Even when cancer drugs do improve survival, the gains can be meager. A 2022 study by researchers at the National Cancer Institute found that the median [increased] survival time for 124 cancer medicines approved from 2003 through 2021 to treat solid tumors was just 2.8 months. The average cost of such drugs is more than $24,000 per month.
In other words, after patients and their families spend financially crippling sums and go through side effects ranging from nausea to death, their outcomes are hardly better — and could be worse — than no treatment at all.
We’ve all known that Big Pharma and the FDA are engaged in an elaborate dance of deception, which doesn’t just put people at risk: IT KILLS. But just remember what I’ve written when you hear screams and cries that RFK jr. is destroying medicine and “people will die” as a result of what he’s doing!
We’ve got a minimum of 4 years to clean up the evil and he’s off to a good start in my view!
To your health,
Prof. Keith Scott-Mumby
The Alternative Doctor
References:
- Main Source: https://www.levernews.com/fda-approved-and-ineffective/?utm_source=substack&utm_medium=email
- HPV vaccines and cancer prevention, science versus activism, Infectious Agents and Cancer, Lucija Tomljenovic, Judy Wilyman, Eva Vanamee, Toni Bark, Christopher A. Shaw; doi:10.1186/1750-9378-8-6
