Stuart Jeanne Bramhall's Blog: The Most Revolutionary Act , page 544
July 4, 2022
Julian Assange files new appeal fighting extradition to US.
Washington Examiner. by Ryan King, Breaking News Reporter, July 01, 2022
WikiLeaks founder Julian Assange is appealing the United Kingdom’s order to extradite him to the United States.
Two appeals were filed in the High Court of Justice in London to challenge the extradition, and the court will decide whether to evaluate the case, Assange’s attorney Gareth Peirce announced, according to the Wall Street Journal……………………………………
Friday was the deadline for Assange to appeal the extradition order, according to the BBC. He is being held at Belmarsh prison in London.
His lawyers claimed that he could face up to 175 years behind bars if he stands trial in the U.S., but the U.S. argued he will likely face between four and six years.
A myriad of groups championing freedom of the press urged the U.K. not to extradite Assange, arguing that doing so could set a bad precedent and hamper press freedoms in the future. For example, the International Federation of Journalists has expressed concerns the move could pose a “chilling effect” on journalists worldwide.
“The US pursuit of Assange against the public’s right to know poses a grave threat to the Fundamental tenets of democracy, which are becoming increasingly fragile worldwide,” the group said. “Irrespective of personal views on Assange, his extradition will have a chilling effect, with all journalists and media workers at risk.”
“The case sets a dangerous precedent that members of the media, in any country, can now be targeted by governments, anywhere in the world, to answer for publishing information in the public interest,” the group added.
Via https://www.washingtonexaminer.com/policy/courts/julian-assange-files-appeal-fighting-extradition
Fake meat grown in labs might make investors rich, but it’s a nightmare for human health
Dr Eddy Betterman
The inputs used to make cell-cultured “meat,” which can hardly be called meat at all, are so unknown in terms of their effects on the human body that it truly is a crime against humanity for the stuff to be gradually making its way into the food supply.
Currently, fake meat is only available to consumers in Singapore. But there are effects to get it into the meat cases in North America and elsewhere in the not-too-distant future, which worries Michael Hansen, a senior staff scientist at Consumer Reports.
Differing from the fake meat offered by companies like Impossible Foods, lab-cultured meat involves the use of bio-engineered proteins to artificially induce undifferentiated animal stem cells into differentiating into muscle tissue.
“This is done in bio-reactor vats similar to those used to make beer,” explained Martha Rosenberg, writing for the Defender.
It is a promising industry for wealthy fat cats like Bill Gates and Sir Richard Branson, who stand to become even more obscenely wealthy than they already are from lucrative investments. But it is a nightmare for human health as nobody knows what lab-cultured meat really does to the body.
In order to make lab-cultured meat, Hansen said, recombinants or manipulated DNA segments must be inserted into the biopsied flesh of animals. And the end product has never actually been tested for nutritional content, as academics have never received a single sample for testing.
“This implies problems behind the scenes,” Hansen said. “I doubt this technology will work.”
There won’t be anything left that’s natural once these demons get finished tampering with the entire food supplyThe only reason to even make fake meat like this is so one smaller group of people can get rich or richer off the backs of the “useless eaters,” whom the “elite” consider to be non-deserving of real meat.
While the rest of us gobble down crickets and mealworms at best – and lab-cultured meat at worst – the upper crust will be fine-dining on real steaks taken from real animals the way nature intended.
The way they are officially branding it, though, is to claim that lab-cultured meat is “great for the environment” and will help to stop “global warming” and “climate change.”
Just like genetically modified organisms (GMOs), lab-cultured meat is also a proprietary thing that is owned and patented by private corporations rather than available to the general public like real plant seeds and real animals.
At least 70 different companies are trying to get into the lab-cultured meat businesses at this very moment. And many more, if they see enough dollar-sign potential, are likely to pile in as well.
The really disturbing part of all this is the ease with which these companies will likely be able to get their products to market, seeing as how the Food and Drug Administration (FDA) is a fully compromised “captured” agency.
Chances are that once lab-cultured meat is ready for the big time, the FDA will quickly usher it to market under its “Generally Recognized As Safe” (GRAS) program. This was according to Tom Neltner, the chemicals policy director at the Environmental Defense Fund (EDF).
“Under the program,” explained Rosenberg, “a company simply tells the FDA its product is safe, based on the company’s own documentation, and bypasses the public comment process.”
Neltner would prefer to see such products have to be approved using a “food additive petition,” which includes a “right to challenge.” But time will tell how the FDA handles this emerging industry.
[…]
Via https://dreddymd.com/2022/07/04/fake-meat-grown-in-labs-nightmare-for-human-health/
The Role of Rumi and other Sufi Mystics in Converting Byzantium to Islam
Episode 23: The Sultans of Rum
Barbarian Empires of the Steppes (2014)
Dr Kenneth Harl
Film Review
This lecture explores how Seljuk Turk victories on the Anatolian peninsula (which Harl refers to as Asia Minor) ultimately led to an independent Turkish Muslim civilization with Kanya as its capital
In the early 13th century, the Anatolian peninsula was ruled by numerous competing Turkish tribes. In 1237, Sultan Kaykhusraw II unified the entire peninsula under a single Seljuk regime. Unlike many Turkish rulers, he refused to submit to Mongol rule until the Mongols invaded Anatolia and crushed the Sejuk army. According to Harl, Genghis Khan allowed him to continue his rule as a Mongol vassal.
Although Anatolia had reverted to rival Turkish states by the early 14th century, Kanya would remain the religious and cultural enter of Turkish civilization. Having thrown off their nomad identity, Kanya sultans employed Persian administrators and used Persian as their official language. Their embrace of Islam linked them closely to the caravan trade, as more an more Muslims flocked to the Anatolian cities, bringing their skills as architects, engineers, mystics, scholars and poets. Muslim migration to Anatolia increase substantially as Mongol warriors pushed westward and drove the Turkish families out of Transoxiana* and Persia.
An independent Turkish architectural style developed during this period with the building of mosques, madrassas,** mausoleums and camel rest stops. The latter were unique complexes providing secure storage for caravans – as well as heavily taxing them. The revenue they produced enabled the Seljuk sultans to issue silver coins replacing Byzantine currency.
The most interesting part of this lecture concerns the wholesale conversion of Byzantine Christians to Islam, largely thanks to the charismatic influence of Sufi mystics who also migrated to Anatolia to escape the Mongols.
The family of the famous Persian poet and Islamic scholar Rumi fled Central Asia for Kanya some time between 1215 and 1220. In 1244, he became an ascetic. He and his followers (known as dervishes) incorporated poetry, dancing, whirling and miracles into their practice.
By 1350 AD, the vast majority of Anatolia had converted to Islam.
*Transoxiana is the Roman name for the central steppes region roughly corresponding to Uzbekistan, Tajikistan and southern Kazakhstan and Kyrgyzstan.
**Madrasa is the Arabic word for any type of educational institution, secular or religious, whether for elementary instruction or higher learningFilm can be viewed free on Kanopy with library card.July 3, 2022
Bill Gates Granted Authority To Buy 2100 More Acres Of North Dakota Farmland
Gates is circumventing a 1932 anti-corporate farm ownership law
Blogging Hounds
Bill Gates, who already owns close to 270,000 acres of land in the U.S., has been granted the legal authority to buy another 2100 acres in North Dakota despite protests by local residents.Gates, already the largest farmland owner in the country, has secured the go ahead to buy the land for $13.5 million under his ‘Red River Trust’ company.()
Gates is circumventing a 1932 anti-corporate farm ownership law by pledging to lease the land back to farmers after the purchase is complete.
The Daily Mail reports:
North Dakota’s Agriculture Commissioner, Republican Doug Goehring, previously said that many people feel they are being exploited by the ultra-rich who buy land but do not necessarily share the state’s values.
‘I’ve gotten a big earful on this from clear across the state, it’s not even from that neighborhood,’ Goehring told KFYR-TV. ‘Those people are upset, but there are others that are just livid about this.’
()
Gates now owns 268,984 of multi-use land in 19 states:
As we have previously noted, Bill Gates and other billionaires have been buying up huge amounts of farmland while Americans are being told by neo-feudalist ‘Great Reset’ technocrats that the future is one without private property.
[…]
The New Watergate: Post-Jab Disease Spike Coverup
Dr Mercola
Story at-a-glanceIn the wake of the COVID jab rollout and additional boosters, a number of health conditions are on the rise, including cancer, most notably cancers of the uterus, endometrial cancers, and very aggressive blood and brain cancersCancer has been on the rise for decades, thanks to dietary factors, but the COVID jabs appear to dramatically accelerate the disease process. Many doctors report cancer patients with stable disease, and those who have been in remission for years, will suddenly and rapidly develop Stage 4 diseaseA military whistleblower has come forward with data from the Defense Medical Epidemiology Database (DMED) database showing dramatic increases in medical visits for cancers and other conditions, post-jabFor neurological side effects of the shot, four remedies that can be very helpful are fluvoxamine (an antidepressant that blocks cytokine production in neural tissues), pharmaceutical grade methylene blue (improves mitochondrial respiration and repair), near-infrared light (triggers production of melatonin in your mitochondria) and hyperbaric oxygen therapy (boosts mitochondrial function, decreases inflammation and much more)The COVID jabs also downregulate toll-like receptors 7 and 8, which allows latent viruses such as herpes EBV4 — Epstein-Barr, aka, mononucleosis — to flourish that would otherwise have been kept in checkDr. Ryan Cole, an anatomic clinical pathologist with a subspecialty in skin pathology and postgraduate Ph.D. training in immunology, has been on the frontlines exposing the fraudulent COVID narrative.
Since 2004, he’s been operating his own business, a pathology laboratory, which gives him rare freedom and flexibility to comment on what he’s seeing. Most others would lose their jobs for speaking out the way Cole has.
Truth Telling Is a Risky BusinessThat doesn’t mean he hasn’t paid a price for speaking out about and defending real science though. He’s triple board certified and has 12 state licenses, and because of his stance against COVID recommendations, some of the credentialing organizations have taken action against him.
“I’ve seen 500,000 patients diagnostically in my career through the microscope. So, I have a long track record of diagnostics. I have not had a patient care complaint against me in 26 years of being a physician,” he says. “I still don’t, and this is what’s fascinating.
Of those 12 licenses, four were under attack, three are still under attack — in Washington, Arizona and Minnesota — [yet there’s] not a single patient care complaint. All the attacks against me have been political complaints to boards of medicine, which is not legal for them to do. Not a single one of those complaints is from a patient.
And then — really the most egregious thing — was ex parte, without me being present, without even sending a certified letter, the College of American Pathologists removed my fellowship status, which is defamatory.
I went back and found their complaint and looked at what they did, and I actually have a wonderful defamation lawsuit against them, because everything they did was anti-scientific. So, they can either restore [my fellowship] now, or just pay me a big check down the road. One or the other.”
He’s also lost about half of his business, as two insurance companies canceled him for “unprofessional behavior,” i.e., for sharing and discussing the science of COVID, and one of his best friends, whom he’s worked with for 12 years, canceled their business relationship as he didn’t want Cole’s outspokenness to affect his business. “All because of the defamation by the media, so to tell the truth in this day and age is a dangerous thing,” he says.
Suspicions Arose Early OnFrom his Ph.D. work in immunology, Cole was very aware of SARS-CoV-1 and MERS, having studied both, so when the warp speed program to develop a pandemic SARS-CoV-2 vaccine was announced, he became immediately suspicious.
“I thought, wait a minute, you can’t vaccinate against corona viruses!” he says. “This family of viruses is not amenable to vaccination, based on mutation rates. So, my concern was very high, early on.”
[…]
Post-Jab Cancer ExplosionOne of the apparent side effects of the COVID jab that Cole has been warning and talking about is cancer. He explains:
“Obviously, during COVID, we saw some parameters change in blood tests. There was a concern about clotting. We saw elevated clotting factors. We know that the early variants were pretty severe in terms of inducing clotting, which was a shame because the whole world should have been simply using anti-inflammatories, steroids and anti-clotting agents, and so many more people would’ve lived.
My colleague, Dr. [Shankara] Chetty in South Africa, was having phenomenal success with antihistamine steroids and anti-clotting agents. So anyway, that first year, we saw drops in white blood cell counts, we saw decreases in certain subsets of T-cells. But when the shots rolled out, things changed.
At first I noticed kind of an innocuous little bump that we see usually in children. It’s a little virus called molluscum contagiosum [that causes] a little white bump.
Usually, by the time you’re a tween or early teen, you’ve built immunity to that and you never get them again, or rarely get them again. But after the shots rolled out, all of a sudden, in 80-year-olds, 70-year-olds, 60-year-olds, 50-year-olds, I started seeing literally a 20-fold increase in this little innocuous viral bump. And I thought, ‘Uh oh, this means they’ve lost immune memory’ …
Those subsets of T-cells that keep viruses in check are very important for keeping cancer in check. And this is where immunology jumps into the picture. All of us have some atypical cells, and we have the ‘Marines’ of our immune system, our natural killer (NK) cells. They’re on the frontline circulating. We have about 30 billion T-cells circulating in our blood, many of which are killer cells and NK cells.
Our other innate cells are our macrophages, monocytes and dendritic cells. They’re on that frontline. They’re shaking hands with every cell in your body all day long saying, ‘Friend or foe? Friend or foe? Oh gosh, this one has some mutations, it’s now a foe.’ They’ll poke a little hole in it, throw in a little enzyme called a grandzyme — a ‘hand grenade’ — blow up that cell, and we’re good.
But what happened after these shots rolled out is that many of those cell subsets started decreasing in number. The first cancer I saw uptick was cancers of the uterus, endometrial cancers. Usually, I would see maybe two endometrial cancers a month. All of a sudden, a few months after the rollout of the shots, I was seeing two or three a week.
[…]
Eradicating cardiovascular disease with vitamin C
Paul Anthony
Dr Rath Foundation
Among the general public, arguably the best known of the above-listed vitamins is vitamin C. Discovered by Hungarian scientist Albert Szent-Györgyi, who was rewarded with a Nobel prize in 1937, its use as a therapy for fighting the common cold became popularized by two-time Nobel prizewinner Linus Pauling in the 1970s. Pauling went on to become an early proponent for the use of high-dose vitamin C in the treatment of cancer. As important as his pioneering efforts were, however, it was Pauling’s later collaboration with Dr. Matthias Rath on the role of vitamin C in preventing cardiovascular disease that was ultimately to prove transformational.
A series of key scientific papers coauthored with Pauling in the early 1990s outlined Dr. Rath’s revolutionary scientific discovery that the primary cause of cardiovascular disease in humans is a deficiency of vitamin C. As these papers described, ensuring optimum daily intakes of vitamin C can ultimately pave the way towards abolishing human cardiovascular disease as a cause for human mortality.
Building on this groundbreaking work, in a study published in 2015 scientists at the Dr. Rath Research Institute definitively proved that cardiovascular disease is essentially an early form of the vitamin C deficiency disease scurvy. Notably, therefore, in parallel with a growing worldwide awareness of Dr. Rath’s scientific discovery, recent decades have seen a significant decline in cardiovascular mortality. This development opens up the tantalizing possibility that in the years ahead, the eradication of cardiovascular disease – or, at least, its near-eradication – can be achieved.
Reaching this monumental goal for global health is as much a political challenge as it is a scientific one. Reducing the influence of the trillion dollar a year pharmaceutical ‘business with disease’ will be vital. So too will the need to educate open-minded politicians regarding the facts about vitamins and health.
[…]
July 2, 2022
Post-Vaccine Wipeout of Children’s Immune Systems?
Dr Eddy Betterman
The United Kingdom-based news outlet Daily Mail reports that these babies are getting sick and dying because they have “no immunity.” This points to the children’s parents, and mainly their “fully vaccinated” mothers, not conferring to them proper immunity.
Reports indicate that these little ones are developing a mysterious respiratory illness that requires critical medical intervention. The media is calling the disease respiratory syncytial virus, or RSV.
Every year, some 120,000 young children are said to die from RSV. And in NSW, rates of it exploded from just 355 cases per week just three weeks ago to 3,775 cases per week currently.
The United Kingdom-based news outlet Daily Mail reported that these babies are getting sick and dying because they have “no immunity.” This points to the children’s parents, and mainly their “fully vaccinated” mothers, not conferring to them proper immunity.
Recognizing that Wuhan coronavirus (Covid-19) “vaccines” destroy the reproductive process, it only makes sense that those babies who somehow make it through alive will more than likely be defenseless immune-wise, as we are now seeing.
Babies with RSV are also testing “positive” for covidDoctors familiar with the disease say that children born with it develop serious illnesses “from encountering viruses they haven’t come across before,” such as influenza and covid, which are said to be in the same family as RSV.
Dr. Philip Britton from the Children’s Hospital at Westmead says that an analysis of intensive care unit (ICU) admissions across Australia show that babies with RSV are testing positive for both influenza and covid, all at the same time.
“Over the last month or so, we have seen four times the admissions to hospital for flu in children as for covid,” he told The Daily Telegraph.
Right now, about five percent of all children presenting with these co-infections are having to be admitted to the ICU. Britton says this is “very concerning” and out of the ordinary.
“About half of the children had no pre-existing health conditions, with the elevated number of admissions putting pressure on the hospital system,” the Daily Mail adds.
“Some of the ‘pandemic babies’ are presenting with inflammation of the chest, brain and heart caused by influenza, Covid, and RSV.”
RSV, which has technically been around for a while, has not seen a surge like this since, you guessed it: right around the time when Operation Warp Speed was launched.
“Among that group who are previously well … It’s not just a chest infection, some of these children can be impacted with the flu affecting the heart and the brain,” Britton further warned about the severity of the disease as it is now being seen in tiny babies.
Reports indicate that around 20 percent of the babies developing RSV in Australia also develop potentially lethal bronchiolitis. Some 40 percent of these end up having to be admitted to the hospital.
[…]
Via https://dreddymd.com/2022/07/02/post-vaccine-wipeout-of-childrens-immune-systems-has-arrived/
Pfizer’s Puppet President Biden Gives $9 Billion Taxpayer Funds for Millions More COVID Vaccines Nobody Wants
by Brian Shilhavy
Editor, Health Impact News
Is there any more doubt that the COVID-19 plandemic, which was used to transfer America’s wealth to Big Pharma with literally TRILLIONS of taxpayer funds transferred into their accounts, has now allowed Pfizer to have complete control of the country by buying the White House and President of the United States?
It began with fellow billionaire Donald Trump, of course, in 2020 who strong-armed the FDA into giving fast-track emergency use authorization to Pfizer’s COVID-19 vaccine. (This is from our Bitchute channel.)
Then Biden was installed as President and kept the coffers full, and now that 80% of Americans have already received a COVID-19 vaccine and demand is waning, with 98 million doses of Pfizer’s vaccine currently sitting unused due to lack of demand, the call was put in to Joe this week to keep the faucet running, and the White House obliged and pledged another $9 BILLION for 300 million more doses of the deadly COVID-19 shots.
Trump and Biden might disagree on a lot of things, but Pfizer COVID-19 vaccines ain’t one of them. (This is also on our Bitchute channel.)
The top three firms who hold the most stock in Pfizer are Vanguard, Blackrock, and State Street (source), and there probably are very few investment firms who do NOT own some Pfizer stock, so when you see officials with the FDA, CDC, and others promoting Pfizer COVID-19 vaccines, they are probably all shareholders and cashing in, as are most members of Congress (unfortunately, these records at opensecrets.org only go through 2018; it would be interesting to see from 2020 and later.)
Of course we’ve known for a long time that Pfizer owns most of the corporate media:
And they are the largest criminal organization in the world, based on settled criminal cases with the Department of Justice.
[…]
The Role of the Seljuk Turks in Triggering the First Crusade
Episode 22: The Turks in Anatolia and India
Barbarian Empires of the Steppes (2014)
Dr Kenneth Harl
Film Review
This lecture covers the conquest of the Anatolia peninsula by Seljuk Turks and the conquest of northern India by the Ghaznavid Turks.
After the Seljuk Turks took control of Baghdad (see 9th Century AD: Mass Migration of Uighur Turks to China Lead to Rise of Seljuk Turks on the Steppes), their biggest political/military challenge was the Shi’a caliphs operating out Cairo. Following the withdrawal of the Seljuk army from Baghdad in 1057, opponents to Seljuk rule sought support from the Fatimid (Shi’ar)my in Cairo. The latter occupied Baghdad for 40 days before being expelled by the Seljuk army. To suppress the Fatimid regime, the Seljuks subsequently invaded Cairo, the Byzantine Empire (allied with the Fatimid regime), Syria, Medina and Mecca.
This ongoing conflict caused major disruption in the Christian pilgrimage routes to Jerusalem (agreed between the Byzantines and the Abassid Caliphate), inspiring Pope Urban II to launch the first Crusade in 1095, nominally to restore Christian access to Jerusalem.
This is the time line Harl presents:
1071 Seljuks open up the eastern Anatolia peninsula to Turkish settlers, cutting the area controlled by the Byzantine Empire in half.
1081 Byzantine Emperor calls on western Europe to send mercenaries to help liberate eastern Anatolia. Pope Urban II “mistakenly” interprets this as a call to “liberate” Jerusalem and mobilizes 50,000 European mercenaries to join the first Crusade. Totally unprepared to confront European cavalry, the Turks suffer initially suffer stunning defeat. Nevertheless the Crusaders are ultimately unsuccessful in driving the Turks, who created a Turkish homeland in eastern Anatolia, from the Anatolian plateau. Christian farmers Initially pay tribute to Seljuk Turk rulers, but ultimately most of eastern Anatolia reverts to grasslands and nomadic pastoralism.
1204 Europeans Crusaders respond by sacking Constantinople. This backfires, shifting the balance of power in Anatolia to the Seljuk Turks.
On the southeaster steppes, Ghaznavad Turks repeatedly invade India during the 12th century. Beginning in 1101, they gradually brring first Lahore, Peshawar and other Indian cities under Turkish (Muslim) control. By 1192, the Turks have conquered Dehli.
Unlike the Seljuk conquest of eastern Anatolia, the Turkish occupation of India is purely military. With no grasslands to support pastoral nomadic tribes, northern India never attracted Turkish settlers.
The film can be viewed free with a library card on Kanopy.
July 1, 2022
BMJ: Big Pharma Money ‘Permeates’ World’s Drug Regulatory Agencies
Over the past decades, regulatory agencies have seen large proportions of their budgets funded by the industry they are sworn to regulate, according to an investigative report published Thursday by The British Journal of Medicine.
Over the past decades, regulatory agencies have seen large proportions of their budgets funded by the industry they are sworn to regulate, according to an investigative report published Thursday by The BMJ.
The report examines whether drug regulators in six countries, including the U.S., “have sufficient independence from the companies they are meant to regulate.”
Investigative journalist Maryanne Demasi found significant conflicts of interest have developed between drugmakers and the agencies charged with drug regulation, resulting in a negative impact on the quality of pharmaceutical products that reach the public.
In all 6 countries, ‘Big Pharma’ provided bulk of drug regulator funding
The issue of conflicts of interest between pharmaceutical regulators and “Big Pharma” is not new. Demasi referred to a 2005 example from the U.K., where the House of Commons health committee investigated the drug industry’s influence on health policy, including the Medicines and Healthcare Products Regulatory Agency (MHRA), the U.K. equivalent of the U.S. Food and Drug Administration.
The committee expressed concern that pharma’s funding of the MHRA and similar agencies could lead them to “lose sight of the need to protect and promote public health above all else as it seeks to win fee income from the companies.”
“Nearly two decades on, little has changed,” Demasi reported. “Industry funding of drug regulators has become the international norm.”
Demasi based her conclusion on interviews with regulators in Australia, Canada, Europe, Japan, the U.K. and the U.S.
She asked them about their funding, the level of transparency in their decision-making and data and their drug approval processes.
According to Demasi, her findings broadly indicate, “industry money permeates the globe’s leading regulators, raising questions about their independence, especially in the wake of a string of drug and device scandals.”
Demasi said “industry money saturates the globe’s leading regulators,” with the majority of their budgets — “particularly the portion focused on drugs” — coming from the pharmaceutical industry.
For instance, the FDA, despite being the most highly funded of the six regulatory authorities studied, receives 65% of its funding for drug evaluation from industry user fees.
In 1995, the European Medicines Agency (EMA) received just 20% of its funding from industry fees. Today, that figure is 89%.
At the high end, 96% of Australia’s regulatory budget comes from industry monies, while even the regulatory authority with the smallest percentage of the six — Canada (50.5%) — still receives the majority of its funding from pharma companies.
Australia’s regulatory authority, during the 2020-2021 time period, approved more than 90% of drug applications.
Pharma funding contributes to lower-quality drugs and healthcare
Demasi references several academic studies which, over a span of several decades, “have raised questions about the influence funding has on regulatory decisions,” especially in the context of a series of “drug and device scandals,” involving “opioids, Alzheimer’s drugs, influenza antivirals, pelvic mesh, joint prostheses, breast and contraceptive implants, cardiac stents, and pacemakers.”
Focusing on the U.S., Demasi cited the example of a 1992 law, the Prescription Drug User Fee Act (PDUFA), passed in the aftermath of the AIDS crisis.
The legislation permitted the pharmaceutical industry to directly fund the FDA through “user fees,” which were “intended to support the cost of swiftly reviewing drug applications” via the funding of “additional staff to help speed the approval of new treatments.”
What in fact happened, according to Demasi, is that “the FDA moved from a fully taxpayer-funded entity to one supplemented by industry money.”
Over time, PDUFA user-fee funding has increased thirty-fold — from around $29 million in 1993 to $884 million in 2016, Demasi said.
This has contributed to “a decline in evidentiary standards, ultimately harming patients,” due to practices such as the creation of “PDUFA dates” — referring to deadlines for the review of applications by the FDA, as well as “a host of ‘expedited pathways’ for speeding drugs to market” —- a practice Demasi describes as having become “a global norm.”
The BMJ article quotes Donald Light, a sociologist based at Rowan University in New Jersey, who has extensively studied drug regulation. He told BMJ:
“Like the FDA, the [Therapeutic Goods Administration (TGA) was founded to be an independent institute.
“However, being largely funded by fees from the companies whose products it is charged to evaluate is a fundamental conflict of interest and a prime example of institutional corruption.
“It’s the opposite of having a trustworthy organisation independently and rigorously assessing medicines. They’re not rigorous, they’re not independent, they are selective, and they withhold data.”
Light said doctors and patients “must appreciate how deeply and extensively drug regulators can’t be trusted so long as they are captured by industry funding.”
Industry funding helps ‘green light’ new medications
Demasi presents figures showing the high percentage of drug approvals across the six regulatory agencies studied.
For instance, 68% of new drugs in the U.S. are approved by the FDA via an “expedited pathway,” as are 50% in Europe.
In the U.K., 98.5% of new medicines are approved by the MHRA.
All six regulators offered an expedited process for the approval of new medicines. Accelerated approval processes have, according to Demasi, “resulted in new drugs which were more likely to be withdrawn for safety reasons, more likely to carry a subsequent black box warning, and more likely to have one or more dosage forms voluntarily discontinued by the manufacturer.”
This is partly due to the lower burden of proof required for accelerated approvals.
The BMJ article quotes Aaron Kesselheim, professor of medicine at Brigham and Women’s Hospital and Harvard Medical School, who, along with two others, resigned from an FDA advisory committee in 2021, in protest over the FDA’s approval of Aduhelm, a controversial Alzheimer’s drug.
Kesselheim told The BMJ:
“The accelerated approval pathway explicitly changes the underlying efficacy ‘standard’ in that it allows approval based on changes to a surrogate measure that is not well-validated, and is only reasonably likely to predict clinical benefit.”
In June 2021, NPR reported that Aduhelm was approved by the FDA “against the wishes of nearly every member on the [advisory] panel,” leading Kesselheim to tweet “Accelerated Approval is not supposed to be the backup that you use when your clinical trial data are not good enough for regular approval.”
Via https://childrenshealthdefense.org/defender/big-pharma-drug-regulators/
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