Tag: big pharma

AstraZeneca withdraws Covid vaccine worldwide

AstraZeneca pharmaceutical company has announced the withdrawal of its Covid-19 vaccine from global markets, claiming the drug has been sidelined by alternatives.

The development comes after the drug manufacturer recently admitted that the vaccine can cause potentially fatal blood clots in rare cases.

In a statement on Wednesday, cited by multiple media outlets, a spokesperson for AstraZeneca said multiple variants of the vaccine had been developed since the start of the pandemic, leading to a decline in demand for Vaxzevria, which is no longer being manufactured or developed. A spokesman also cited independent estimates claiming that “over 6.5 million lives were saved in the first year of use alone and over 3 billion doses were supplied globally.”

The AstraZeneca vaccine was rolled out in early 2021, shortly after the Covid-19 outbreak was declared a pandemic by the World Health Organization. AstraZeneca voluntarily withdrew its market authorization for the vaccine in the EU last March, with the European Medicines Agency confirm.

Shortly after the rollout, AstraZeneca found itself at the center of controversy after numerous Western countries suspended the use of its vaccine over fears that it may have caused some patients to develop blood clots. However, EU health officials at the time insisted that the benefits of the inoculation still outweighed the risks.

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Historic Drug Shortage Exacerbated by EPA Overreach

Concerning new reports reveal that the drug shortage in the U.S. has reached its highest level since the American Society of Health-System Pharmacists began tracking data. In total, 323 medicines are now in short supply.

However, the problem is about to get worse because of government regulations on an entirely different issue. Counterintuitive measures from the Environmental Protection Agency (EPA) are set to effectively ban the domestic production of chemicals that are used in the process of manufacturing vital prescription drugs and vaccines.

Shortly after Congress amended the Toxic Substances Control Act (TSCA) in 2016, the EPA began the rulemaking process on 10 chemicals currently in use in the United States using a broad and overreaching definition of “unreasonable risk.” Now, the EPA is expected to release a final rule on methylene chloride under TSCA.

Methylene chloride has several applications, including in the process of manufacturing hundreds of medicines and vaccines like those that treat Hepatitis B and HIV infections, mental illnesses and epilepsy, heart failure and high blood pressure, and high cholesterol.

If this rule goes into effect, it will exacerbate the drug shortage by bringing domestic manufacturing to a halt while making our supply chains more reliant on foreign nations like China for pharmaceuticals. This runs in direct contradiction to the Biden administration’s “Investing in America” agenda, which aims to onshore supply chains critical to our economy and security.

For example, methylene chloride is used to make hollow fiber cartridges which are used in the manufacture of monoclonal antibodies and vaccines, including the COVID-19, HPV, Hepatitis B, and flu vaccines, as well as therapies for arthritis, migraines, osteoporosis, and autoimmune diseases. In a letter to the EPA, the company that produces these cartridges wrote their product is used in at least 190 human therapeutics and vaccines. Their supply is so essential that the U.S. Department of Health and Human Services and the Defense Department awarded the company funding to expand its manufacturing capacity here in the U.S.

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Doctors do more harm than good

We now spend more on health care than ever before, and the medical profession is apparently more scientific and better equipped than ever before, so there is a savage irony in the fact that we have now reached the point where, on balance, well-meaning doctors in general practice and highly trained, well-equipped specialists working in hospitals do more harm than good. The epidemic of iatrogenic disease which has always scarred medical practice has been steadily getting worse and today most of us would, most of the time, be better off without a medical profession.

Most developed countries now spend around 8% of their gross national products on health care (the Americans spend considerably more – around 12-14%) but through a mixture of ignorance, incompetence, prejudice, dishonesty, laziness, paternalism and misplaced trust doctors are killing more people than they are saving and they are causing more illness and more discomfort than they are alleviating.

Most developed countries now spend around 1% of their annual income on prescription drugs and doctors have more knowledge and greater access to powerful treatments than ever before, but there has probably never been another time in history when doctors have done more harm than they do today.

It is true, of course, that doctors save thousands of lives by, for example, prescribing life-saving drugs or by performing essential life-saving surgery on accident victims.

But when the medical profession, together with the pharmaceutical industry, claims that it is the advances in medicine which are responsible for the fact that life expectancy figures have risen in the last one hundred years or so they are wrong. It is, for example, commonly claimed that modern scientific medicine has led to improvements in life expectancy in most developed countries from around 55 at the start of the century to over 70 today.

The evidence, however, does not support this claim.

Any (small) improvement in life expectancy which has occurred in the last hundred years is not related to developments in the medical profession or to the growth of the international drug industry. However, the increase in iatrogenesis is related to both these factors.

Whichever facts you look they at seem to support my contention that although doctors may do a limited amount of good, they do a great deal more harm.

If doctors really did help people stay alive then you might expect to find that the countries which had the most doctors would have the best life expectation figures. But that isn’t the case at all.

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Pharma companies ‘bribed NHS doctors to use infected blood products’ that gave patients HIV and hepatitis C

Pharmaceutical companies have been accused of bribing NHS doctors to use infected blood products that gave people HIV and hepatitis C in the 1970s and 1980s.

NHS hospitals were offered money to buy blood products from US pharma giants, who were known to have paid high-risk donors for their plasma, the Telegraph has reported. 

Around 1,250 people with haemophilia were infected with HIV and another 5,000 contracted hepititis C after they were given the blood-clotting drug Factor VIII. 

Now a letter dated from January 1981 reveals that St Thomas’ Hospital in London was offered £8,500 (around £41,000 today) in rebates for buying Factor VIII made in the US. 

The letter – which has been published in the book The Poison Line by Cara McGoogan – shows that doctors were offered to purchase four million units of Factor VIII produced by Bayer and Baxter Healthcare in return for monetey incentives.

Jason Evans, director of the campaign group Factor 8, told the Telegraph: ‘Doctors were literally offered cash to use dangerous products.

‘In my opinion, on behalf of the pharmaceutical companies, this basically amounts to bribery.’

The haemophilia centre at St Thomas’ – run by Dr Geoffrey Savidge – was known to have some of the highest rates of Factor VIII use per patient in the UK, according to Professor Edward Tuddenham.

The leading haematologist and emeritus professor at the Royal Free in London said: ‘Dr Savidge was known for years for using American concentrate. He had very well-equipped laboratories.’

Although Dr Savidge died in 2011, an earlier inquiry in 2007, found that ‘he used almost exclusively commercial products but he shouldn’t have done.’

Around 3,000 people died due to the infected blood scandal in the 1970s and 1980s which has been dubbed the biggest treatment disaster in NHS history. 

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Personalised medicine will make drug experimentation on populations the norm

In June 2023, the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) announced it will be the first drug safety regulator in the world to pilot its own genetic “biobank,” to better understand how a patient’s genetic makeup can impact the safety of their medicines.

“The Yellow Card biobank, which will contain genetic data and patient samples … forms part of a long-term vision for more personalised medicine approaches … [to] enable doctors to target prescriptions using rapid screening tests, so patients … receive the safest medication for them, based on their genetic makeup,” a press release said.

In February 2024, as a personalised medicine project, the MHRA began recruiting patients who have experienced excessive bleeding after taking blood thinners to establish whether they have any special genetic traits which predispose them to excessive bleeding.

It may sound exciting however, personalised genetic medicine is a step towards an era where drug use and experimentation on populations become the norm.

As Dr. Guy Hatchard notes, whilst most pharmaceutical drugs entail adverse reactions and unanticipated side effects, drugs that are tailored to genetic characteristics may potentially have even more serious consequences and long-term adverse outcomes. This is because genetic systems are involved in all the functions of the physiology, its organs, bio-molecular messaging and overall immunity.

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Prescription Drugs Are the Leading Cause of Death

Overtreatment with drugs kills many people, and the death rate is increasing. It is therefore strange that we have allowed this long-lasting drug pandemic to continue, and even more so because most of the drug deaths are easily preventable. 

In 2013, I estimated that our prescription drugs are the third leading cause of death after heart disease and cancer,1 and in 2015, that psychiatric drugs alone are also the third leading cause of death.2 However, in the US, it is commonly stated that our drugs are “only” the fourth leading cause of death.3,4 This estimate was derived from a 1998 meta-analysis of 39 US studies where monitors recorded all adverse drug reactions that occurred while the patients were in hospital, or which were the reason for hospital admission.5

This methodology clearly underestimates drug deaths. Most people who are killed by their drugs die outside hospitals, and the time people spent in hospitals was only 11 days on average in the meta-analysis.5 Moreover, the meta-analysis only included patients who died from drugs that were properly prescribed, not those who died as a result of errors in drug administration, noncompliance, overdose, or drug abuse, and not deaths where the adverse drug reaction was only possible.5 

Many people die because of errors, e.g. simultaneous use of contraindicated drugs, and many possible drug deaths are real. Moreover, most of the included studies are very old, the median publication year being 1973, and drug deaths have increased dramatically over the last 50 years. As an example, 37,309 drug deaths were reported to the FDA in 2006 and 123,927 ten years later, which is 3.3 times as many.6 

In hospital records and coroners’ reports, deaths linked to prescription drugs are often considered to be from natural or unknown causes. This misconception is particularly common for deaths caused by psychiatric drugs.2,7 Even when young patients with schizophrenia suddenly drop dead, it is called a natural death. But it is not natural to die young and it is well known that neuroleptics can cause lethal heart arrhythmias. 

Many people die from the drugs they take without raising any suspicion that it could be an adverse drug effect. Depression drugs kill many people, mainly among the elderly, because they can cause orthostatic hypotension, sedation, confusion, and dizziness. The drugs double the risk of falls and hip fractures in a dose-dependent manner,8,9 and within one year after a hip fracture, about one-fifth of the patients will have died. As elderly people often fall anyway, it is not possible to know if such deaths are drug deaths.

Another example of unrecognised drug deaths is provided by non-steroidal anti-inflammatory drugs (NSAIDs). They have killed hundreds of thousands of people,1 mainly through heart attacks and bleeding stomach ulcers, but these deaths are unlikely to be coded as adverse drug reactions, as such deaths also occur in patients who do not take the drugs. 

The 1998 US meta-analysis estimated that 106,000 patients die every year in hospital because of adverse drug effects (a 0.32% death rate).5 A carefully done Norwegian study examined 732 deaths that occurred in a two-year period ending in 1995 at a department of internal medicine, and it found that there were 9.5 drug deaths per 1,000 patients (a 1% death rate).10 This is a much more reliable estimate, as drug deaths have increased markedly. If we apply this estimate to the US, we get 315,000 annual drug deaths in hospitals. A review of four newer studies, from 2008 to 2011, estimated that there were over 400,000 drug deaths in US hospitals.11

Drug usage is now so common that newborns in 2019 could be expected to take prescription drugs for roughly half their lives in the US.12 Moreover, polypharmacy has been increasing.12 

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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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