Tag: big pharma

The Era of Informed Consent is Over

In a significant blow to patient autonomy, informed consent has been quietly revoked just 77 years after it was codified in the Nuremberg Code.

On the 21st of December 2023, as we were frantically preparing for the festive season, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) issued a final ruling to amend a provision of the 21st Century Cures Act. This allowed 

…an exception from the requirement to obtain informed consent when a clinical investigation poses no more than a minimal risk to the human subject…

This ruling went into effect on January 22nd, 2024, which means it’s already standard practice across America. 

So, what is the 21st Century Cures Act? It is a controversial Law enacted by the 114th United States Congress in January 2016 with strong support from the pharmaceutical industry. The Act was designed to

…accelerate the discovery, development, and delivery of 21st-century cures, and for other purposes [?]…[emphasis added]

Some of the provisions within this Act make for uncomfortable reading. For example, the Act supported: 

High-risk, high-reward research [Sec. 2036].

Novel clinical trial designs [Sec. 3021]

Encouraging vaccine innovation [Sec. 3093].

This Act granted the National Institutes of Health (NIH) legal protection to pursue high-risk, novel vaccine research. A strong case could be made that these provisions capture all the necessary architecture required for much of the evil that transpired over the past four years.

Overturning patient-informed consent was another stated goal of the original Act. Buried under Section 3024 was the provision to develop an

Informed consent waiver or alteration for clinical investigation.

Scholars of medical history understand that the concept of informed consent, something we all take for granted today, is a relatively new phenomenon codified in its modern understanding as one of the critical principles of the Nuremberg Code in 1947. It is inconceivable that just 77 years after Nuremberg, the door has once again opened for state-sanctioned medical experimentation on potentially uninformed and unwilling citizens.  

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A lifesaving therapy for children with a rare disease is now the world’s most expensive drug, raising questions about access

A new gene therapy for the fatal genetic disorder metachromatic leukodystrophy, or MLD, will carry a wholesale price of $4.25 million, its manufacturer announced Wednesday, making it the world’s most expensive medicine.

Lenmeldy was approved by the US Food and Drug Administration on Monday and is the first therapy for the rare and devastating disease, which typically kills affected children before they turn 7.  About 40 children are born with MLD in the US each year.

The wholesale cost isn’t usually what patients pay, but it’s a cost that’s considered and shouldered by public and private health insurance plans, including state Medicaid plans, which cover roughly 4 out of every 10 children in the United States.

Manufacturers of gene therapies say the big prices reflect big benefits — the chance to be free of a disabling or even fatal disease — and they point out that they need to be able to recoup the steep costs of development, testing and manufacturing their products.

Health policy experts say that as the list of gene and cell therapies with eye-popping prices grows, it may strain the ability of states and other insurers to cover their costs, and ultimately limit patient access if plans begin to exclude these therapies as a class from coverage.

Dr. Bobby Gaspar, the co-founder and CEO of Orchard Therapeutics, the company that makes Lenmeldy, said the treatment is “paradigm-shifting medicine and has the potential to stop or slow the progression of this devastating childhood disease with a single treatment.”

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How the National Institutes of Health became a den of cronyism

For too long, the bureaucrats at the National Institutes of Health (NIH) have been lining their pockets through clandestine agreements with big corporations, getting cozy with the very entities they are tasked with overseeing.  

In an era where trust in our public institutions is alarmingly low, this isn’t just a minor oversight; it’s an outright epidemic of corruption. Shockingly, over 55,000 royalty payments have been overlooked in the past decade alone. Each undisclosed royalty payment is a potential conflict of interest, undermining the credibility of our institutions and eroding the trust of the American people.  

The explosive revelations by Open the Books in 2022 shed light on this den of cronyism. It was uncovered that more than 2,400 NIH scientists pocketed a whopping $325 million in royalty payments in the last decade, with an average of $135,000 per person. Yet, the details of these sweetheart deals remain hidden in the shadows with vital information redacted from public view.  

Despite attempts to bring these details to light, the NIH refuses to disclose essential information, including the amounts of individual payments and the identities of the payers. 

In June 2022, my Republican colleagues on the Homeland Security and Governmental Affairs Committee and I sent a letter to NIH, demanding information about these royalty payments. But NIH is stonewalling, claiming they are above disclosing such details. It’s this kind of arrogance that fuels distrust and raises legitimate concerns about whose interests our government agencies are truly serving. 

When I directly challenged Dr. Anthony Fauci, former director of the National Institute of Allergy and Infectious Diseases, on royalties paid by vaccine manufacturers to members of the vaccine approval committees, Fauci argued the law protected scientists from revealing their royalties. The implications of these undisclosed payments extend far beyond simple bureaucratic secrecy. They cast a long shadow over the impartiality of our regulatory processes.  

Moderna’s royalty payments to the NIH, Dartmouth and Scripps Universities in the amount of $400 million will make it challenging for NIH scientists to treat Moderna objectively.  

The NIH’s potential profit from future royalties on Moderna’s COVID-19 vaccine is the icing on this conflict-of-interest cake, raising grave concerns about the integrity of our regulatory processes. This is not merely about financial transparency; it is about ensuring public health decisions are made in the American people’s best interest, untainted by the prospect of financial gain. 

The lack of transparency surrounding these payments is downright alarming. Americans deserve to know who is paying whom, how much and for what. The current ordeal of accessing public inspection reports — jumping through bureaucratic hoops, facing delays and obfuscation — is an insult to the American people and a hotbed for corruption. 

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Measles, Oh My!

History is repeating itself. We’re back in 2014, folks.

Remember the absolutely horrifying and sure-to-be-lethal “outbreak” of the measles at Disneyland? The one that killed caused a rash in so many children?

That same measles scare prompted mainstream media to call for parents who did not vaccinate to be put in jail (this brilliant idea came to us courtesy of Useless USA Today).

It was also used to justify the idea that vaccine choice needed to be abolished to keep us all safe. (Thank you, Washington Post)

So here we are again, hearing about measles outbreaks

In the last two days there has been a new onslaught from the media—from television news to internet sites—seeking to terrify parents about a small number of recent cases of … yeppers … measles.

The Atlantic is reporting a “Return of Measles” (because of three cases in Chicago).

STAT is regaling readers with tales about “What it’s like to watch children die of measles.” (Spoiler: it’s devastating to watch a child die of any cause. The chief of medical research who wrote this absolute must-read article lives in one of the poorest provinces in one of the poorest countries in the world where half the people are under 18 and almost no one has access to paved roads, clean drinking water, or enough to eat.)

And Live Science wants us all to know that 300 people have “possibly” been exposed to measles at the UC Davis Medical Center where a child was treated for measles on March 5th.

To say nothing of the Big Bad Measles that have devastated hurt no children in Broward County, Florida.

Oh my god. I am so so scared.

I will rush out and get as many MMR vaccines as I can. For myself. And for my children. Shoot ‘em up. In the back arm.

Because if one measles vaccine works, like the CDC says, more will work even better!

And you can’t have too many of such a good, effective, and wonderful thing!

Besides, the ONLY way to not get the measles or not die from the measles is by supporting Big Pharma’s Big Profits.

Big Fear: 1 million
Commonsense: 0

But who’s keeping score?

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The 1918 ‘Pandemic’ & the Viral Theory – ‘The Unproven Notion of Airborne Viral Illness That has Enslaved Humanity to the Corrupt Medical Cartel.’

There are multiple lines of evidence to dispute the classic viral disease paradigm, including historical records,  biological evidence (or lack thereof) and clinical “experiments” according to Dr Lee Merritt. Yet, while this is true, there are many self professed “awake” individuals who although are willing to accept that we have been continually lied to on a grand scale to enable our enslavement, will not open their minds even to the possibility that one of those lies has been the unproven viral disease paradigm.

Orthopaedic surgeon and past president of the Association of American Physicians and Surgeons, Dr Merritt writes “I hear it all the time.  From Physicians, “How can you say viruses don’t exist? I treat people with viral illness all the time.”  Or from patients, “My whole family got really sick—so there must be viruses!” Dr Merritt adds “Let’s be clear.  There is disease, as in “Dis-Ease”.  People get sick and some die of the sickness.  And I can admit to the ability of harvesting tissue from one animal and injecting it into another species and causing disease– as Judy Mikovits describes it—“infection by injection”.  But that does not prove the existence of invisible, sub-microscopic unicorns that fly from one person’s nose to another as the CAUSE of that disease. 

“It is the unproven notion of airborne viral illness that has enslaved humanity to the corrupt  medical cartel.“

“What better psychological wedge can be implemented against humanity than making people afraid of invisible emanations from other people?” she asks.

In this article Dr. Merritt discusses the largest clinical case study of all time—the 1918 worldwide influenza outbreak.

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How Doctors Have Betrayed Patients

Those who argue that doctors are responsible for any improvement in life expectancy which we may enjoy overlook the fact that from the Dark Ages, through the Renaissance and up to the first few decades of the 20th century, infant mortality rates were absolutely terrible and it was these massive death rates among the young which brought down the average life expectation.

The Foundling Hospital in Dublin admitted 10,272 infants in the years from 1775 to 1796 and of these, only 45 survived. In Britain, deaths among babies under one-year-old have fallen by more than 85% in the last century. Even among older children, the improvement has been dramatic. In 1890 one in four children in Britain died before their tenth birthday. Today 84 out of every 85 children survive to celebrate their tenth birthday. These improvements have virtually nothing to do with doctors or drug companies but are almost entirely a result of better living conditions.

In 1904 one-third of all British schoolchildren were undernourished. Poor diets meant that babies and small children were weak and succumbed easily to diseases. Older children from poor families were expected to survive on a diet of bread and dripping and many women who had to spend long hours working in terrible conditions were unable to breastfeed their babies, many of whom then died from drinking infected milk or water.

When the improvements in child mortality figures are taken out of the equation it is clear that for adults living in developed countries life expectation has certainly not risen in the way that both doctors and drug companies usually suggest.

It isn’t even possible to credit vaccination programmes with the improvement in life expectation since the figures show quite clearly that mortality rates for diseases as varied as tuberculosis, whooping cough and cholera had, as a result of better living conditions, all fallen to a fraction of their former levels long before any of the relevant vaccines were introduced.

There are real doubts, too, about the value of the drugs which doctors prescribe.

If drugs were only ever prescribed sensibly and when they were likely to interfere with a potentially life threatening disease then the risks associated with their use would be acceptable. But all the evidence shows that doctors do not understand the hazards associated with the drugs they use and frequently prescribe inappropriately and excessively. Many of the deaths associated with drug use are caused by drugs which did not need to be taken.

The best example of the modern tendency to over-prescribe probably lies in the way that antibiotics are used. One in six prescriptions is for an antibiotic and there are at least 100 preparations available for doctors to choose from. When antibiotics – drugs such as penicillin – were first introduced in the 1930s they gave doctors a chance to kill the bacteria causing infections.

The impact made by antibiotics has been exaggerated because most of the diseases which are caused by organisms which are susceptible to antibiotics were on the decline before the antibiotics were introduced.

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9 New ‘Independent’ Advisers to CDC Publicly Promoted Vaccines or Took Money From Pharma — or Both

Nine new members named to the committee that advises the Centers for Disease Control and Prevention (CDC) on vaccine recommendations have financial ties to pharmaceutical companies or have worked with public health agencies to promote the COVID-19, RSV or HPV vaccines.

The U.S. Department of Health and Human Services (HHS) in mid-February appointed the new members to the Advisory Committee on Immunization Practices (ACIP), which shapes U.S. vaccine policy.

Commenting on the new appointments, Children’s Health Defense (CHD) President Mary Holland said:

“ACIP has long been a rubber stamp for any and all vaccines Big Pharma wants to push. But the brazenness of the HHS-Big Pharma fusion has never been so much on display.

“The only silver lining in this grotesque display is that more and more people are waking up to the reality that ACIP has nothing to do with health and everything to do with profit.”

The ACIP is described as an independent, nonfederal expert body made up of professionals with clinical, scientific and public health expertise. The committee decides which vaccines should be recommended to the public, who should take them and how often — recommendations the CDC typically rubber stamps.

This external advisory committee includes a chair, an executive secretary, and 15 voting members — 14 medical experts and a lay member representing consumers.

It also includes a non-voting body that offers input composed of eight ex officio members from other federal health departments and liaison representatives from health-related professional organizations like the American Association of Pediatrics.

However, when the committee convened last week to make its spring recommendations, it was missing so many voting members that it lacked a quorum. Vacant committee spaces on the “independent” committee had to be temporarily filled by government employees — ex officio members can be sworn in as temporary voting members.

Over the last year, HHS struggled to fill eight vacancies. An additional four members will be needed when existing members’ four-year terms are up at the end of June.

As seats on the committee sat unfilled, industry news sites like StatNews suggested the committee “appears to be atrophying” and Medriva said there is an “unprecedented lack of expertise in the committee.”

When HHS finally announced the new members to fill the vacancies, it was also reported the new members would be filling spots at last week’s meeting. However, they had not yet taken their positions at the time the meeting occurred on Feb. 28-29.

A CDC spokesperson confirmed to The Defender that nine members have been appointed to the committee, including Dr. Helen Keipp Talbot, an infectious diseases researcher at Vanderbilt University who previously served on the committee from 2018 through 2022 and will rejoin the committee to serve as chair.

Members typically are not eligible for reappointment, but in Talbot’s case, the HHS provided a waiver to that existing policy.

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Rand Paul’s Bill Would Require NIH Scientists To Disclose Royalties They Receive From Drug Companies

Over the past decade, scientists working at the National Institutes of Health (NIH) have earned an estimated $400 million in royalties from third-party companies for medical treatments and innovations they’ve helped produce. The NIH often provides grants to these same companies and produces research on their products. Despite that, the agency has resisted disclosing how much its scientists are getting paid and by whom.

A bill moving its way through Congress would change that.

On Wednesday, the Senate Homeland Security and Governmental Affairs Committee passed the Royalty Transparency Act of 2024 by a 12–0 vote.

The legislation would require that royalties received by federal government employees be included in their financial disclosures and that those disclosures be made available online for the general public to view.

“This is just basic 101 of conflict of interest. We’re letting the billions of dollars that change hands over at NIH and between NIH and Big Pharma to be completely unscrutinized,” says Sen. Rand Paul (R–Ky.), the author of the legislation. “This is probably the first reform bill that actually has a chance to correct some of the things that are rotten in the system.”

The NIH’s lack of transparency about the royalties paid to its scientists has been a source of controversy for decades.

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90% of U.S. Cheese Contains GMO Made by Pfizer

Who doesn’t love cheese?! And for good reason — it is not only delicious but also incredibly nutritious. And despite what the mainstream tells us, humans have been making and consuming this superfood for over 7,000 years. In fact, cheese serves an important role in human history.

Historians document that milk, dairy and fermented dairy products, like cheese, served as a nutrient-dense calorie source that was storable, allowing some of the first explorers to safely travel and expand communities, creating more demographic shifts and diverse farming communities.

“Dairy provided food security, as it is a nutrient-rich superfood.

“Consumption of milk and dairy products would have had many advantages for early farming populations. Milk, yogurt, and cheese are good sources of calories, protein, and fat. They provide a reliable food between harvests or during droughts, epidemics, or famines.

“Milk is a relatively pathogen-free source of fluids that could be critical during times of water scarcity. Cheese provides a means of storing these nutrients to be used when milk production is low, and can be easily transported.

“Furthermore, fermentation of milk into yogurt or cheese lowers lactose content and allows lactose intolerant individuals to reap the benefits, while maintain, or in some cases enhancing, other essential nutrients such as fat and calcium.”

But cheese was traditionally made with just these four ingredients:

  1. Milk.
  2. Salt.
  3. Starter culture, what’s used to make the desired cheese strain (for ex. Muenster versus Swiss).
  4. Animal rennet is used as a clotting agent to curdle the milk into cheese, separating the liquid parts of milk from the solids — a very vital part of the cheese-making process!

You add culture to milk and let it ferment. Then, you add rennet, which separates the milk into curds and whey. Then you press the curds and age them. And voila — cheese!

Rennet is a complex set of enzymes that are naturally produced in the stomachs of ruminant animals, like cows.

The main enzyme present is chymosin, which is a protease enzyme, meaning it breaks down protein. Rennet from animals also contains other enzymes like pepsin and lipase.

So these enzymes in rennet target casein, the main protein in milk. They cause the casein molecules to divide and re-coagulate into even larger clumps, forming cheese curds.

So, rennet serves as a vital part of cheesemaking since it helps curdle the milk into cheese, separating the liquid part from the solid part.

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Botched execution of serial killer in Idaho puts focus on capital punishment secrecy laws

In 2012, two Idaho prison officials chartered a private plane and flew to Washington state with thousands of dollars in cash.

They met with a pharmacist behind closed doors and bought the drug for a convicted murderer’s lethal injection.

Only a years-long public records lawsuit revealed the pharmacist’s name, the pharmacy and other details of the exchange. After prison officials said the pharmacist’s exposure had scared away other lethal drug suppliers, Idaho lawmakers barred such information from getting out again.

Idaho tried and failed Wednesday to execute Thomas Eugene Creech, a 73-year-old serial killer who had been in prison for 50 years. Neither his attorneys nor the public knew where the state obtained the drug or the exact qualifications of his executioners.

Opponents say secrecy laws are are a significant hurdle to accountability and make it hard to ensure that the procedures aren’t unconstitutionally painful, whether the deaths are carried out successfully — as Texas did Wednesday in the case of Ivan Cantu — or botched like Creech’s.

Idaho long kept the identities of execution team members and drug suppliers secret but judges were still able to force disclosure of the information if it was relevant to lawsuits or appeals. The new law prohibits state officials from disclosing the information, even if under court order.

The law also prevents professional licensing boards from taking disciplinary action against people for participating in executions.

Such secrecy is typical among states that impose capital punishment, including Texas, where lawmakers passed a similar measure in 2015 to ensure drug suppliers did not face retaliation or harassment for cooperating with executions.

“States are saying, ‘We don’t need to show you the information about … how we find or drugs or the training of the prison staff,’” said Robin Maher, the executive director of the Death Penalty Information Center, a nonprofit that tracks executions. “And then, when things go wrong, they can’t be held accountable.”

Creech was convicted of five murders in three states and suspected of several more. He has been in custody since 1974 and was already serving a life term when he beat a fellow inmate, 22-year-old David Dale Jensen, to death in 1981 — the crime for which he was to be executed.

When his appointed hour came at 10 a.m. Wednesday, Creech was wheeled into the execution chamber and strapped to a table. Medical personnel poked and prodded at his arms, legs, hands and feet for nearly an hour, making eight attempts, but they couldn’t find a vein they thought would hold up long enough to deliver the fatal dose. He was returned to his cell.

It is unclear whether or when the state might try again, or how. Like other states concerned about the availability of lethal injection, Idaho recently passed a law allowing for firing squads as a backup, but the state has yet to write protocols for using that method or build a facility where it could shoot people to death. It has not approved the use of nitrogen gas, a method used for the first time early this year in Alabama.

Creech’s execution team comprised volunteers who, according to Idaho execution protocols, were required to have at least three years of medical experience, such as having been a paramedic, and to have “current venous access proficiency.” They were not necessarily doctors, who famously take an oath to “do no harm” — though Idaho Department of Correction Director Josh Tewalt later told lawmakers that the executioners regularly use their IV skills to save lives in their day jobs. They wore white balaclava-style coverings to conceal their faces.

Tewalt defended the state’s approach, saying the department ensures execution drugs are acquired lawfully, provides test results showing their authenticity, and ensures medical members of the execution team meet or exceed required qualifications.

“I would argue we are very transparent about any information that speaks to the integrity of the process,” said Tewalt. “What we won’t do is tell you their names.”

Tewalt also disagreed with characterizing the attempt as “botched” — stopping the execution after the failed IVs prevented the process from truly going awry, he said.

Creech, according to his attorneys, suffers from several conditions that could have made vein accessibility challenging: Type 2 diabetes, hypertension and edema. It can also be more difficult for older people to have IVs inserted, as their veins can be less stable.

“This is precisely the kind of mishap we warned the State and the Courts could happen when attempting to execute one of the country’s oldest death-row inmates in circumstances completely shielded in secrecy,” Creech’s attorneys, with the nonprofit Federal Defender Services of Idaho, said in a written statement.

Among the arguments they made in their unsuccessful last-minute petitions to the U.S. Supreme Court was that the secrecy violated Creech’s due-process rights and could constitute cruel and unusual punishment if the lethal drug, the sedative pentobarbital, was of poor quality and caused unnecessary pain or complications.

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