Tag: safety

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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The Crucial Connection Between Animal Feed and Human Health

In our modern quest for optimal health, we often focus intensely on what we put on our plates. However, there’s a crucial aspect of nutrition that often goes overlooked: the diet of the animals we consume. (What we eat, eats) This oversight can have significant consequences for our health, particularly when it comes to our intake of polyunsaturated fatty acids (PUFAs).

Consider this startling fact: conventional chicken is now the highest source of linoleic acid, an omega-6 PUFA, in the American diet. This means that a food many consider to be a healthy, lean protein source is actually contributing significantly to our overconsumption of PUFAs.

But it’s not just chicken we need to be concerned about. Pork, another staple in many diets, can be equally problematic. When pigs are fed a high-PUFA diet, their fat can have the same PUFA concentration as canola oil — a fact that might make you think twice about having several pieces of conventional bacon every single day for breakfast.

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Study finds pesticide exposure leads to 41% higher risk of miscarriage

A recent study published in the open-access, peer-reviewed scientific journal Ecotoxicology and Environmental Safety has found that women exposed to pesticides face a 41 percent higher risk of spontaneous abortion compared to those with minimal or no exposure.

It found that exposure to organophosphate pesticides was the most common exposure type, though the study examined various pesticide classes. (Related: 70% of pregnant women in Indiana have herbicide linked to cancer in their urine.)

The comprehensive review, analyzing data from 18 studies across the United States and Italy, included 439,097 pregnant women aged 16 and older.

Though scientists and researchers are not completely certain as to why exposure to pesticides contributes to miscarriage, they believe that contact with pesticide chemicals causes oxidative stress, inflammation and even endocrine function disruption.

Scientists say pesticides are especially threatening to fetuses as their bodies are small, vulnerable and highly sensitive while developing in the womb. The harmful chemicals within pesticides are capable of crossing the placenta that connects the fetus to the mother’s uterine wall. It is during and after this chemical crossover period that the developing fetus is harmed. The harm involves differentiation, cellular division and developmental problems.

Environmental toxins can harm fetal health during pregnancy. Common sources include consumer product chemicals, alcohol, tobacco and heavy metals – all of which increase miscarriage risk.

Pesticides pose one of the most serious risks during pregnancy. Organic food researchers advise that pregnant women choose organic produce when possible, especially for foods known to have high pesticide residues.

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55 Undeclared Chemical Elements — Including Heavy Metals — Found in COVID Vaccines

A group of Argentine scientists identified 55 chemical elements — not listed on package inserts — in the Pfizer, Moderna, AstraZeneca, CanSino, Sinopharm and Sputnik V COVID-19 vaccines, according to a study published last week in the International Journal of Vaccine Theory, Practice, and Research.

The chemical elements include 11 heavy metals — such as chromium, arsenic, nickel, aluminum, cobalt and copper — which scientists consider systemic toxicants known to be carcinogenic and to induce organ damage, even at low exposure levels.

The samples also contained 11 of the 15 lanthanides, or rare earth elements, that are heavier, silvery metals often used in manufacturing. These chemical elements, which include lanthanum, cerium and gadolinium, are lesser known to the general public than heavy metals but have also been shown to be highly toxic.

“The detection of multiple undeclared toxic elements, including heavy metals and lanthanides, in COVID-19 vaccines raises a dual and multiplied concern for human health,” James Lyons-Weiler, Ph.D., a member of the journal’s editorial board who was not involved in the research, told The Defender. “Individually, these chemicals are known to cause neurological, cardiovascular and immunological damage.”

“Together, their synergistic toxicity could exacerbate these risks far beyond what regulators and manufacturers have disclosed or studied,” Lyons-Weiler added.

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5-year-old develops autism after receiving 18 vaccines in one day

In 2016, David Ihben moved his wife and three children from Chicago to Jamestown, in rural Tennessee, with high hopes for a new and calmer life.

But the dream turned into a nightmare for David and his children in December 2019, when divorce proceedings and a subsequent custody battle resulted in the forced vaccination of the children — and changed the family’s fortunes forever.

Ihben said his ex-wife decided “this wasn’t the life she wanted.” So they were attempting to develop a parenting plan in family court — when Tennessee judge Todd Burnett “pulled up the vaccine issue” after discovering the couple’s children were unvaccinated — and forced the parents to vaccinate their children.

Ihben’s two oldest children — daughter Hannah and son Joseph — were spared significant adverse events following their vaccination.

But his youngest son, Isaac, wasn’t so fortunate. After receiving 18 vaccines in one day, Isaac developed severe regressive autism. Today, he requires around-the-clock care.

The children’s mother soon abandoned the children, leaving Ihben to raise them as a single parent — even though he is still obliged to pay child support.

Ihben shared his story with Children’s Health Defense’s (CHD) Vax-Unvax bus. In a subsequent interview with The Defender, he detailed the challenges he faces in caring for Isaac and the harassment he endured from officials in his community. Ihben shared documentation with The Defender verifying his story.

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We Were Wrong To Panic About Secondhand Smoke

In 2003, UCLA epidemiologist James Enstrom and I published a study of environmental tobacco smoke (ETS)—also called “secondhand smoke” or “passive smoking”—in the British Medical Journal (BMJ). Using data from the American Cancer Society’s prospective study of 1 million adults, we concluded that ETS exposure was not associated with increased mortality.

Since that conclusion flew in the face of the conventional wisdom that had long driven state and local bans on smoking in public places, our study understandably sparked a controversy in the public health community. But the intensity of the attack on us in the pages of a medical journal—by critics who were certain that our study had to be wrong but typically failed to provide specific evidence of fatal errors—vividly illustrates what can happen when policy preferences that have taken on the status of doctrine override rational scientific debate.

A recent study by American Cancer Society (ACS) researchers underscores that point by showing that, contrary to what our critics asserted, the cancer risk posed by ETS is likely negligible. The authors present that striking result without remarking on it, which may reflect their reluctance to revisit a debate that anti-smoking activists and public health officials wrongly view as long settled.

Exposure to ETS is known to cause eye and throat irritation and to exacerbate preexisting respiratory conditions. In addition, it is simply disagreeable to many people (including me). But assessing the claim that ETS is potentially deadly requires dispassionate examination of the available scientific evidence.

That is not what Enstrom and I encountered when we published our BMJ paper. Critics were outraged by the article and demanded its retraction. But they were never able to satisfactorily explain why such an extreme step was justified.

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If Common Chemicals Harm Frogs and Rats, What Are They Doing to Your Children?

The TED Talk below features Penelope Jagessar Chaffer, director of the documentary film “Toxic Baby,” and Tyrone Hayes, Ph.D., a professor of integrative biology at the University of California, who has dedicated most of his career to studying the health effects of the herbicide atrazine.

According to Chaffer, the average American woman today has 30,000 to 50,000 chemicals in her body that her grandparents did not have. Many of these chemicals have been linked to the rapidly rising incidence of chronic childhood diseases.

In her talk, Chaffer cites the following statistics, which are likely higher today, since this talk was given in 2010:

  • In the United Kingdom (U.K.), the incidence of childhood leukemia rose by 20% in one generation.
  • In Canada, the prevalence of asthma increased by 400% in 20 years; 1 in 10 children is now diagnosed with asthma.
  • In the U.S., childhood cancers have seen a similar rise as that of childhood leukemia in the U.K. Autism spectrum disorder has also increased by 600% in the past 20 years; the incidence of autism rose by 57% between 2002 and 2006 alone.
  • In the Netherlands, Rotterdam has seen a 400% increase in genital birth defects.

Obesity and juvenile diabetes have also skyrocketed, and while a high-sugar diet likely bears the brunt of the blame, there’s every reason to suspect that endocrine-disrupting chemicals (EDCs) — many of which enter our system via processed foods — add to the metabolic dysfunction we now see.

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FDA Brushed Off Concerns About DNA Fragments in Gardasil’s HPV Vaccine

Over the last two years, cancer genomic experts have raised concerns about the presence of residual DNA fragments in the mRNA COVID-19 vaccines, saying that it has the potential to increase the risk of developing cancer.

This mirrors the concerns raised several years ago about the safety of the Gardasil human papillomavirus (HPV) vaccine, manufactured by Merck & Co.

In 2011, Sin Hang Lee, a pathologist and 30-year veteran in DNA analysis, made the startling discovery of synthetic DNA fragments in several vials.

“I was shocked to find DNA fragments in the HPV vaccine because DNA is not supposed to be there,” Lee recalls.

“They use DNA to make the vaccine, but then it is supposed to be chopped up and removed in the manufacturing process,” he said.

Lee, an internationally recognized expert in molecular gene detection, carefully documented his findings in a report that was sent to the U.S. Food and Drug Administration (FDA) for review.

The FDA investigated.

On Sept. 23, 2011, the FDA’s Center for Biological Evaluation and Research (CEBR) responded by saying it had evaluated the concerns in Lee’s report, and determined that the Gardasil vaccine was “safe and effective.”

The FDA did acknowledge that Lee found residual DNA in the vaccine, but said it was “expected” and “inevitable” in products that are manufactured using recombinant technology.

The agency also said it remained confident that the residual DNA was “not a risk to vaccine recipients.”

“The presence of residual DNA is not a safety factor as defined by US regulations, and is not required to be included in Gardasil’s labeling,” wrote the FDA.

The following month (Oct. 21, 2011) the FDA quietly updated its website to reflect the presence of DNA fragments in the vaccine, assuring the public there was “no safety risk.”

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‘Reckless Disregard for the Truth’: Shareholders Sue Moderna for Misleading Investors on RSV Shot Efficacy

A group of shareholders is suing Moderna alleging the company knowingly inflated claims about the efficacy of its RSV vaccine for older adults. When the drugmaker later lowered expectations for the vaccine’s efficacy the stock price dropped precipitously.

A class-action lawsuit accuses Moderna of making “materially false and misleading statements” about the efficacy of its respiratory syncytial virus (RSV) shot, leading to significant damages for investors.

The lawsuit, filed Aug. 9 in the U.S. District Court for the District of Massachusetts, covers investors who owned or purchased Moderna stock between Jan. 18, 2023 — the day that Moderna announced that mRNA-1345, its candidate RSV vaccine, met primary efficacy endpoints in Phase 3 clinical trials — and June 25, 2024.

According to the lawsuit, Moderna misled investors by failing to disclose that “mRNA-1345 was less effective than Defendants had led investors to believe” and that “mRNA-1345’s clinical and/or commercial prospects were overstated.”

“As a result, the Company’s public statements were materially false and misleading at all relevant times,” the lawsuit states.

The lawsuit names Moderna and its key executives, including its CEO Stéphane Bancel, Chief Financial Officer James M. Mock and President Stephen Hoge, as defendants.

“Defendants acted with reckless disregard for the truth in that they failed or refused to ascertain and disclose such facts as would reveal the materially false and misleading nature of the statements made, although such facts were readily available to Defendants,” the lawsuit states.

Brian Hooker, Ph.D., chief scientific officer for Children’s Health Defense (CHD), told The Defender he is not surprised by allegations of fraud concerning Moderna.

“It is unfortunate that Moderna lied about the efficacy of the vaccine and misled investors,” Hooker said. But Hooker said the “bigger tragedy here is the lack of safety testing for modified mRNA products such as their RSV shot.”

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The emasculation of the American male: Testosterone-crushing chemical herbicide banned in Europe gets sprayed freely on U.S. crops and ends up in our food

We’ve all heard about the historic drop in male testosterone levels over the past 50 to 60 years but rarely does anyone delve into the causes of this disturbing trend.

A recent guest on the Joe Rogan podcast blew the whistle on a chemical herbicide widely used on large swaths American croplands that has wrought catastrophic effects on the reproductive hormones and organs of the American male.

Atrazine, a herbicide sold under various brand names such as Bullet, Lariat, Guardsman Max, Bicep II Magnum, Dual II Magnum, Medal II, and others, is proven to have harmful effects on boys and men of all ages.

Dr. Casey Means explained that atrazine is widely present in American foods. It has even found its way into some public water systems. This testosterone-crushing chemical is banned across Europe but not the United States.

What is atrazine, and how does it do this?

The Vigilant News Network reports that Atrazine is a widely-used herbicide sprayed on crops like corn and sugarcane to control weeds. It disrupts hormone function by increasing the activity of an enzyme called aromatase, which converts testosterone into estrogen.

In men, this can contribute to conditions like decreased muscle mass, low libido, and even feminization.

U.S. farmers spray 70 million pounds of this tasteless, odorless, chemical on our food, while it’s illegal to do so in Europe.

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