Tag: big pharma

FDA Knows That China and India Drug Quality Is Poor, But Independently Collects and Tests Only about 0.001%

Quality control errors during pharmaceutical manufacturing are unfortunately common occurrences. The majority (around 50%) of employees that work in pharmaceutical manufacturing tend to have duties which are safety/quality-control related, but apparently even that isn’t enough. 

Even with a major focus on quality, there is still an estimated 2-3σ (sigma) level of imprecision when it comes to pharmaceutical manufacturing. That corresponds to 66,807 to 308,537 defects per 1,000,000 opportunities. But with pharmaceutical development being so complicated, there could be more than 1,000,000 “opportunities” for error. 

The above listed error calculation – while alarming enough – was referenced in small-molecule pharmacology. However, increasingly complex pharmaceuticals (such as today’s widely used biotechnological products, including GLP-1 diabetes/weight loss or mRNA products for Covid-19) have molecular weights that can be thousands times larger than small molecule compounds. That could mean an even greater opportunity for error. 

The FDA is abundantly aware of pharmaceutical fragility and potential quality shortcomings, including at the highest levels of its leadership. 

In fact, Dr. Michael Kopcha, the current Director of the FDA’s Office of Pharmaceutical Quality (OPQ), wrote and published the above published Six Sigma calculation, lamenting the imprecise nature of pharmaceutical manufacturing – back in 2017. 

Any alteration in structure that occurs during manufacturing has the potential to vastly change a compound’s clinical activity, including a change from therapeutic drug into a poison.

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HPV vaccine harms were evident before covid vaccines were introduced

Two decades ago, Merck introduced Vioxx, a profitable NSAID, despite knowing it could cause numerous heart attacks. After facing overwhelming lawsuits and ultimately withdrawing Vioxx, Merck quickly pushed Gardasil, an HPV vaccine, to market to recover losses.

Gardasil proved to be extremely dangerous, yet both Merck and the FDA ignored the alarming data and continued promoting it, even as it resulted in unprecedented injuries, including autoimmunity, POTS, infertility, and death. Notably, many of these issues mirror those associated with the covid-19 vaccines.

This article examines the dangers of the HPV vaccine, the reasons behind its risks – including its tendency to cause rather than prevent cervical cancer – and the extensive negligence of the FDA and CDC. These lessons are crucial for understanding the events surrounding covid.

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Top 12 NEW “SYNDROMES” created by insidious government forces, Big Pharma and their propaganda-purporting media complex

Got new physical, mental or emotional health problems that no medical doctor can seem to solve? You must have one of those brand new “syndromes” that suddenly appeared on the “market” since Trump, Covid, and the clot shots hit the scene.

Are you absolutely mind-locked into voting for more communism in America? You must be suffering from TDS. Are you feeling sick in the head because millions of Republicans and Conservatives won’t give all their money to rich, white elitists who are trying to save the world from crazy storms and the sun’s ever-increasing heat? You’ve been indoctrinated by the Climate Change Cult and you are suffering from a syndrome called CCS.

Ever since you got “vaccinated” for Covid-19 Wuhan virus, have you noticed that your heart feels like it’s about to explode every time you exercise? You are suffering from Spike Protein Syndrome, where billions of tiny nanoparticle “proteins” join together to form fibrous white clots in your vascular system, putting a severe strain on your heart. Your medical quack is not allowed to tell you this.

Did you catch Covid and somehow, months or years later, you’re still suffering from the “after-effects” of it, like ringing in your ears, sciatica, chronic inflammation, irregular heartbeats, myocarditis, pericarditis, brain fog and lethargy? You’ve got “Long Covid,” which means you got the Covid vaccine, and it has royally screwed up your body systems, but Big Pharma told all the medical doctors to call it “Long Covid.”

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Medical Marijuana Improves Chronic Pain And Mental Health Symptoms While Reducing Prescription Drug Use, Study Shows

Results of a new yearlong study of prescribed medical marijuana for patients with chronic pain and mental health issues observed an association between cannabis use and symptom improvement, with most side effects limited to dry mouth and sleepiness. At least some of the benefits appeared to fade as the 12-month study period went on, however.

The report, published in the Journal of Pain and Palliative Care Pharmacotherapy, evaluated the effects of medical marijuana on 96 patients over the course of the yearlong observational study, with measurements of pain, depression, anxiety and sleep problems taken at three, six and 12 months.

“We found that the use of medical cannabis was associated with reduced pain during the first 6 months and improved mental well-being over 12 months,” wrote authors, from the University of Melbourne in Australia. “Patients reported not only less pain but also experienced reduced interference from pain in their daily functions. Furthermore, they reported decreased use of pain medications and a large proportion felt that their pain symptoms had significantly improved, as reflected in their reported changes in the severity of pain.”

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Acetaminophen is unsafe for kids at any dose because it can cause AUTISM, review finds

A groundbreaking literature review by William Parker, Ph.D., has raised significant concerns about the safety of acetaminophen — commonly known as Tylenol — when administered to children. Published in Clinical and Experimental Pediatrics, the study reveals troubling associations between basic pediatric doses of the drug and severe, potentially permanent impairments in cognition and socialization in children. These cognitive impairments may lead to various levels of autism.

Acetaminophen, the gateway to autism

Acetaminophen, widely used for fever reduction, mild to moderate pain relief, and adverse events from vaccination, has long been associated with liver toxicity. Additionally, the scientific literature also provides evidence that the drug disrupts the nervous system of children in a way that can forever change how they communicate and process the world around them.

Dr. Parker, the CEO of the nonprofit research firm WPLab, highlighted a critical oversight in previous studies on this issue. These studies focused primarily on acetaminophen use during pregnancy, while neglecting postnatal exposure — an area where he suspects the greatest risk lies.

“Less than 20% of autism spectrum disorder (ASD) cases can be attributed to maternal acetaminophen use during pregnancy. The majority of risks occur after birth,” Parker explained in an interview with the Defender.

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15.5 Million Adult Americans Think They Have ADHD

Like most alleged psychiatric disorders, attention deficit hyperactivity disorder (ADHD) is a fraud diagnosis. Put simply, and honestly, there is no abnormality in the brain that is ADHD.

The mental health and pharmaceutical industries can say it exists…that it’s a real brain disorder, but it just isn’t true. This doesn’t stop such august institutions like the Center for Disease Control and Prevention (CDC) from reporting that fifteen and a half million American adults suffer from ADHD. Of course, this is the same federal agency that said the covid vaccine was effective, would stop people from getting covid and stop them from spreading covid. Oops!

Nevertheless, the recent report from the CDC’s National Center for Health Statistics (NCHS) claims that 15.5 million US adults are living with the condition and explain that “many are being let down by poor access to treatment.”

First let’s review what the American Psychiatric Association says about ADHD in its billing bible, the Diagnostic and Statistical Manual 5. According to the nation’s top psychiatric doctors, ADHD in adults consists of the following:

An ADHD presentation that’s predominantly hyperactive/impulsive can be diagnosed if five or more symptoms of hyperactivity/impulsivity have persisted for at least six months. The person should also have less than five symptoms of inattention.[3]

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Addicted To Drug — Statistics

I have long told you that when drug companies produce statistics, for the consumption of regulatory agencies or the public, their products look better than the same statistics produced by others, or on trials when the drugs are in the wild.

Partly this is because of the greater care pharmaceuticals take in running their clinical trials. It’s true. They are forced into this vigilance by regulatory agencies. I do not mean the results are therefore more likely to be correct. I mean trials proceed in a more orderly manner, including the writing of the statistics at the end, that the process is better controlled for them than in teams of researchers laboring away in the hope of papers.

Drug companies know how to get wee Ps better than anybody, since it is their business. Regulatory agencies require wee Ps, you see. Alas, wee Ps are proof of nothing. Nothing having to do with whether a drug works, or it causes harm, or is useless, or anything like that. I know I am almost alone in saying this. For now. Maybe after reading this, you will join me.

In the speech I gave to the at Hillsdale (blog/Substack), which included many nervous scientists who met beforehand to plan a strategy of reaction, I remarked, “The British Medical Journal 2017 review of New & Improved cancer drugs found that for only about 35% of new drugs was there an important effect, and that ‘The magnitude of the benefit on overall survival ranged from 1.0 to 5.8 months.’ That’s it. An average of three months.”

In other words, two-thirds of new drugs that waved their wee Ps in the faces of regulators failed when released into the wild. And the ones that succeeded provided a barely there effect.

This is only one of many similar stories of what happens when drugs are out of the hands of manufacturers and put into the hands of the people who you ask if the drugs are right for you. The well known John Ioannidis examined forty nine top medical papers and found: “…7 (16%) were contradicted by subsequent studies, 7 others (16%) had found effects that were stronger than those of subsequent studies, 20 (44%) were replicated, and 11 (24%) remained largely unchallenged.”

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The Remarkable History and Safety of DMSO

My time in the medical field has led me to accept many medical practices are adopted because of politics or economics rather than because existing evidence shows they work. Nonetheless, certain instances of this happening still astound me to this day, particularly the blacklisting of DMSO (dimethyl sulfoxide) as:

•This simple chemical is incredibly safe and effective and treats a wide range of challenging medical conditions that impact millions that still lack an effective therapy (outside of DMSO).

•Because of its efficacy, once discovered, it took the country by storm, resulting in millions using it, the scientific community getting behind it and publishing thousands of studies on DMSO, numerous pharmaceutical companies making large investments to bring it market, professional athletes promoting it, numerous governors, congressional representatives and senators (on behalf of both themselves and their constituents) pressuring the FDA to give it a fair chance for decades and state legislatures independently legalizing it because the federal government would not.

•Many approved pharmaceutical products take advantage of DMSO’s properties to work (e.g., in those products, DMSO is often classified as an inert “vehicle”). Similarly, DMSO is FDA approved for one condition (interstitial cystitis) and is approved for a wide variety of veterinary uses (e.g., the same conditions it treats in humans).

•Over the past 40 years, more than 10,000 articles on the biological implications and 30,000 articles on the chemistry of DMSO have appeared in the scientific literature—much of which, as I’ve shown here is remarkably compelling and paradigm shifting in healthcare.

•Yet, despite all of that, DMSO was effectively erased from history. It is now widely seen as an unproven and dangerous therapy, and even within the natural health field, most people do not know it exists.

Because of all that, I’ve felt a responsibility to use this platform to get the knowledge on DMSO out, which I began by presenting the strong case that DMSO is an incredible therapy for:

•Circulatory disorders like Reynaud’s and varicose veins.
•A wide range of neurological disorders, including ischemic and hemorrhagic strokes, and spinal cord injuries leading to paralysis or dementia.
•Allowing patients who’ve had decades of chronic pain (from a variety of different causes) to get their lives back.
•Healing a wide range of injuries (e.g., sports injuries, traumatic impacts) and chronic musculoskeletal problems (e.g., spine and shoulder issues) and wounds (e.g., burns or surgical incisions).
•Chronic rheumatic conditions (e.g., arthritis).
•Complex protein disorders (e.g., amyloidosis).
•Down Syndrome.

In turn, I’ve received numerous reports from readers (I’ve been gradually sharing here) from readers who’ve experienced rapid life-changing benefits from DMSO, very similar to the data I provided, which showed DMSO had an 80-90% success rate in treating.

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Court Confirms Merck Lied on Mumps Vaccine Label — But Lets Drugmaker Off the Hook in Antitrust Lawsuit

An appeals court this week ruled that even though Merck misrepresented critical data to the U.S. Food and Drug Administration (FDA) to gain approval for its updated mumps vaccine — and even though the FDA knew about the false claims — because the agency approved the vaccine anyway, Merck can’t be held responsible for unfairly hurting competitors.

The ruling stems from a class action lawsuit brought by a group of physicians and physicians groups who alleged Merck violated the Sherman Antitrust Act by making false claims about the efficacy of its mump vaccine on the product’s label in order to stifle competition and maintain a monopoly in the marketplace.

The Sherman Antitrust Act prohibits companies from conspiring to create a monopoly.

The U.S. 3rd Circuit Court of Appeals didn’t dispute the plaintiffs’ allegations that Merck lied to the FDA about the vaccine’s efficacy.

However, citing the Noerr-Pennington doctrine, the court ruled that because the FDA took no action against Merck after discovering the false claims, it was the FDA’s decision — not Merck’s fraud — that injured competitor GSK and the physicians and physicians groups who bought the ineffective vaccine at inflated prices.

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‘Should Not Be Used in Any Infants’: Higher Death Risk in Beyfortus RSV Shot Clinical Trials

Infants treated for RSV with the monoclonal antibody nirsevimab have significantly higher mortality rates than those treated with a different monoclonal antibody or with a placebo, according to an analysis by the Japanese journal Med Check of three major randomized control trials.

The report reanalyzed clinical trial data showing that nirsevimab — marketed by Sanofi and AstraZeneca as Beyfortus — reduced RSV-associated lower respiratory tract infection and hospitalizations in both high-risk and healthy infants.

However, babies treated with the drug had a higher mortality rate likely linked to adverse effects — including thrombosis (blood clotting) — from the drug itself, the study found.

“Due to the increased mortality, nirsevimab should not be used in any infants,” the study concluded. “Do not use nirsevimab for universal immunization.”

Shortly after its approval by the European Medicines Association in October 2022, and fast-track approval by the U.S. Food and Drug Administration in July 2023, the U.S., France, Spain and Luxembourg launched universal Beyfortus infant immunization campaigns for the 2023-24 RSV season.

Med Check published its appraisal of the clinical trials shortly after France’s National Agency for the Safety of Medicines and Health Products (ANSM) published its first pharmacovigilance data on the drug, compiled during the 2023-24 season.

The ANSM report tracked adverse events related to Beyfortus in France between Sept. 11, 2023, and April 30, 2024. Of 244,495 doses delivered, 198 adverse events were reported to the pharmacovigilance system, of which 153 were considered serious.

The report identified safety signals for stroke, respiratory conditions and hypotonic-hyporesponsive episodes — when an infant suddenly loses muscle strength and becomes “floppy.” Hypotonic-hyporesponsive episodes also are associated with the diphtheria-tetanus-pertussis, or Tdap, vaccine and other vaccines.

There were also three reports of sudden infant death syndrome (SIDS), although researchers said at least one of them was likely not linked to the drug.

The ANSM said each of the signals would be closely monitored in the future, but that a causal link between Beyfortus and those adverse events had not yet been established. The agency concluded the results confirm that the benefits of using the drug to treat bronchiolitis, an RSV infection, outweigh the risks.

The ANSM continues to recommend all newborn babies receive the Beyfortus shot this RSV season.

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