Tag: big pharma

Lab Administers A.I.-Designed Drug to First Patient

Hong Kong- and New York-based Insilico Medicine on Tuesday announced a drug for treating idiopathic pulmonary fibrosis (IPF) designed by generative artificial intelligence (A.I.) has advanced to Phase 2 clinical trials, which means the drug has been administered to its first human patient.

IPF is a chronic lung disease that makes it more difficult to breathe, starving the body of much-needed oxygen. IPF is currently regarded as incurable, but treatable. 

“Generative A.I.” is the level of artificial intelligence that can accept fairly broad commands from a human user and create a complex finished product. Such A.I. systems grow more powerful and useful as they “learn” by accumulating information. DALL-E, the computer art program that can fulfill instructions like “Show me what the Peanuts characters would look like if Picasso drew them” is a popular example.

Creating a new medicine is a daunting task. The design stage includes a great deal of labor-intensive research that could hopefully be completed more quickly by A.I.

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Pfizer Vaccine Batches in the EU Were Placebos, Say Scientists

Scientists have uncovered startling evidence that a substantial portion of the batches of the Pfizer-BioNTech COVID-19 vaccine deployed in the European Union may in fact have consisted of placebos – and that the German regulator knew this and did not subject them to quality-control testing.

The scientists, Dr. Gerald Dyker, Professor of Organic Chemistry at the Ruhr University Bochum, and Dr. Jörg Matysik, Professor of Analytical Chemistry at the University of Leipzig, are part of a group of five German-speaking scientists who have been publicly raising questions about the quality and safety of the BioNTech vaccine (as it is known in Germany) for the last year and a half.

They recently appeared on the Punkt.Preradovic online programme of the German journalist Milena Preradovic to discuss batch variability. Their starting point was the recent Danish study showing enormous variation in the adverse events associated with different batches of the Pfizer-BioNTech vaccine, or BNT162b2 per its scientific codename. The below figure from the Danish study illustrates this variation.

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Pandemic Leaders Were Biodefense Puppets and Profiteers

Scandalous incompetence. Profound stupidity. Astounding errors. This is how many analysts – including Dr. Vinay Prasad, Dr. Scott Atlas, and popular Substack commentator eugyppius – explain how leading public health experts could prescribe so many terrible pandemic response policies.

And it’s true: the so-called experts certainly have made themselves look foolish over the last three years: Public health leaders like Rochelle Walensky and Anthony Fauci make false claims, or contradict themselves repeatedly, on subjects related to the pandemic response, while leading scientists, like Peter Hotez in the US and Christian Drosten in Germany, are equally susceptible to such flip-flops and lies. Then there are the internationally renowned medical researchers, like Eric Topol, who repeatedly commit obvious errors in interpreting Covid-related research studies. [ref]

All of these figures publicly and aggressively promoted anti-public health policies, including universal masking, social distancing, mass testing and quarantining of healthy people, lockdowns and vaccine mandates.

It seems like an open-and-shut case: Dumb policies, dumb people in charge of those policies. 

This might be true in a few individual cases of public health or medical leaders who really are incapable of understanding even high school level science. However, if we look at leading pandemic public health and medical experts as a group – a group consisting of the most powerful, widely published, and well-paid researchers and scientists in the world – that simple explanation sounds much less convincing. 

Even if you believe that most medical researchers are shills for pharmaceutical companies and that scientists rarely break new ground anymore, I think you’d be hard-pressed to claim that they lack basic analytical skills or a solid educational background in the areas they’ve studied. Most doctors and scientists with advanced degrees know how to analyze simple scientific documents and understand basic data. 

Additionally, those doctors and public health professionals who were deemed experts during the pandemic were also clever enough to have climbed the academic, scientific, and/or government ladders to the highest levels.

They might be unscrupulous, sycophantic, greedy, or power-mongering. You might think they make bad moral or ethical decisions. But it defies logic to say that every single one of them understands simple scientific data less than, say, someone like me or you. In fact, I find that to be a facile, superficial judgment that does not get to the root cause of their seemingly stupid, incompetent behavior.

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Merck accused of downplaying early evidence of drug’s brain impact

An early magazine advertisement for Merck’s breakthrough asthma and allergy medicine, Singulair, featured a happy child, hanging upside-down from a tree. Asthmatic kids could now breathe easier, the text assured, and side effects were “usually mild” and “similar to a sugar pill.”

When the drug launched in 1998, its label said the drug’s distribution in the brain was “minimal,” with no mention of psychiatric side effects.

Merck’s early safety claims later faced intense scrutiny amid reports over two decades that patients, including many children, had died by suicide or experienced neuropsychiatric problems after taking the drug. The FDA in 2020 ordered its most serious warning, known as a “black box,” on Singulair’s label. And Merck now faces a raft of lawsuits alleging it knew from its early research that the drug could impact the brain and that it minimized the potential for psychiatric problems in statements to regulators.

The lawsuits cite the research of Julia Marschallinger, a cell biologist who has studied the drug along with colleagues at the Institute of Molecular Regenerative Medicine in Austria. That team found in 2015 that the drug’s distribution into the brain was more significant than its label described. The FDA cited Marschallinger’s work when it ordered Singlair’s black-box warning label.

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Big Pharma Is Bleeding Horseshoe Crabs Dry to Meet Growing Demand for Vaccines

The pharmaceutical industry is depleting horseshoe crab populations along the U.S. Atlantic coast with limited accountability — and serious environmental consequences, NPR reported this week.

Drugmakers use a product derived from horseshoe crab blood to test vaccines, injectable medicines and medical devices before injecting them into humans. The product tests for the presence of endotoxins, a toxin found in some bacteria that can cause inflammation, fever, sepsis or death.

The horseshoe crabs’ bright blue blood contains a substance called limulus amebocyte lysate (LAL) that detects the harmful bacterial toxins and captures them in blood clots. No other natural substance is known to work as well to detect the toxins.

A synthetic alternative exists, but unlike in some other countries, U.S. regulators have not established standards for its use industry-wide.

That means the key medical test is dependent on a single animal, whose already precarious existence — the International Union for the Conservation of Nature in 2016 listed horseshoe crabs in the U.S. as vulnerable to extinction — can be further threatened by events like the COVID-19 pandemic demand for mass vaccine production.

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Drug And Food Shortages Are Here, And They Will Get A Lot Worse…

Once the pandemic subsided, global supply chains were supposed to return to normal.  But now “hundreds of drugs” are in short supply in the United States, and even CNN is admitting that we are in the midst of “the worst food crisis in modern history”.  As I did research for this article, I was stunned by what I discovered.  Things are worse than I realized.  I knew that a lot of drugs were in short supply, but it turns out that there have been shortages of many of our most basic antibiotics since last October, and now Pfizer is telling us that several types of penicillin will completely run out later this year…

Pfizer will run out of several doses of penicillin, which treat syphilis, strep throat, and other infections, later this year as shortages ripple across the US supply chain.

The company anticipates running out of the children’s dose of the syphilis drug Bicillin L-A by the end of June, according to a letter Pfizer posted Tuesday on the Food and Drug Administration’s website. The company says it’s prioritizing production of larger doses of Bicillin L-A, which is recommended for pregnant people with syphilis because it is the only drug that can pass through the placenta and also treat the fetus.

A different Pfizer penicillin, Bicillin C-R that treats other bacterial infections but not syphilis, is expected to run out in the third quarter, which ends Sept. 30. Pfizer’s penicillin has been in shortage since April.

Of course there are growing shortages of many other commonly used drugs.

For example, one recent survey discovered that most cancer centers in the U.S. “are reporting shortages of commonly used chemotherapy drugs”…

A recent survey found that a majority of cancer centers are reporting shortages of commonly used chemotherapy drugs used to treat a wide variety of cancers.

Much of the current shortage stems from the temporary closure of a drug manufacturing facility in India that happened after the Food and Drug Administration (FDA) found issues in the plant’s quality control.

After I first read that, I immediately had one burning question come to mind.

Why in the world are we having our chemotherapy drugs manufactured in India?

Once the war between the U.S. and China starts, it is going to be exceedingly difficult to get things shipped across the Pacific.

So what are we going to do then?

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The Four Pillars of Medical Ethics Were Destroyed in the Covid Response

Much like a Bill of Rights, a principal function of any Code of Ethics is to set limits, to check the inevitable lust for power, the libido dominandi, that human beings tend to demonstrate when they obtain authority and status over others, regardless of the context.

Though it may be difficult to believe in the aftermath of COVID, the medical profession does possess a Code of Ethics. The four fundamental concepts of Medical Ethics – its 4 Pillars – are Autonomy, Beneficence, Non-maleficence, and Justice.

Autonomy, Beneficence, Non-maleficence, and Justice

These ethical concepts are thoroughly established in the profession of medicine. I learned them as a medical student, much as a young Catholic learns the Apostle’s Creed. As a medical professor, I taught them to my students, and I made sure my students knew them. I believed then (and still do) that physicians must know the ethical tenets of their profession, because if they do not know them, they cannot follow them.

These ethical concepts are indeed well-established, but they are more than that. They are also valid, legitimate, and sound. They are based on historical lessons, learned the hard way from past abuses foisted upon unsuspecting and defenseless patients by governments, health care systems, corporations, and doctors. Those painful, shameful lessons arose not only from the actions of rogue states like Nazi Germany, but also from our own United States: witness Project MK-Ultra and the Tuskegee Syphilis Experiment.

The 4 Pillars of Medical Ethics protect patients from abuse. They also allow physicians the moral framework to follow their consciences and exercise their individual judgment – provided, of course, that physicians possess the character to do so. However, like human decency itself, the 4 Pillars were completely disregarded by those in authority during COVID.

The demolition of these core principles was deliberate. It originated at the highest levels of COVID policymaking, which itself had been effectively converted from a public health initiative to a national security/military operation in the United States in March 2020, producing the concomitant shift in ethical standards one would expect from such a change. As we examine the machinations leading to the demise of each of the 4 Pillars of Medical Ethics during COVID, we will define each of these four fundamental tenets, and then discuss how each was abused.

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Secret limits to stop ‘suspicious’ Xanax and Adderall orders are forcing some legitimate patients to scramble

Patients diagnosed with conditions like anxiety and sleep disorders have become caught in the crosshairs of America’s opioid crisis, as secret policies mandated by a national opioid settlement have turned filling legitimate prescriptions into a major headache.

In July, limits went into effect that flag and sometimes block pharmacies’ orders of controlled substances such as Adderall and Xanax when they exceed a certain threshold. The requirement stems from a 2021 settlement with the US’s three largest drug distributors — AmerisourceBergen Corp., Cardinal Health Inc. and McKesson Corp. But pharmacists said it curtails their ability to fill prescriptions for many different types of controlled substances — not just opioids.

Independent pharmacists said the rules force them come up with creative workarounds. Sometimes, they must send patients on frustrating journeys to find pharmacies that haven’t yet exceeded their caps in order to buy prescribed medicines.

“I understand the intention of this policy is to have control of controlled substances so they don’t get abused, but it’s not working,” said Richard Glotzer, an independent pharmacist in Millwood, New York. “There’s no reason I should be cut off from ordering these products to dispense to my legitimate patients that need it.”

It’s unclear how the thresholds are impacting major chain pharmacies. CVS Health Corp. didn’t provide comment. A spokesperson for Walgreens Boots Alliance Inc. said its pharmacists “work to resolve any specific issues when possible, in coordination with our distributors.” 

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The Biden Administration’s Strange, Secret Effort to Bail Out Moderna

American taxpayers have already given Moderna $10 billion for its coronavirus vaccine. If the Biden administration gets its wish, that tab could soon grow.

In a court filing last month, Department of Justice lawyers offered to “relieve” Moderna of any liability it faces from a lawsuit that accuses the drug company of failing to pay licensing fees for technology it used to develop its vaccine during “Operation Warp Speed.” Moderna has argued that the federal government should be on the hook for any legal settlement because of a stipulation in its contract that protects the company from patent litigation. The government had stayed silent on the matter until last month, when Justice Department lawyers said that any liability that Moderna faces should “transfer” to the United States government, citing a World War I-era law that protects federal contractors from patent disputes.

While the judge handling the case recently denied the request, Moderna and the federal government could appeal the decision and put taxpayers on the hook for any legal payout. Genevant, one of the companies that sued Moderna, has already accused the drug maker of “trying to shift responsibility for its patent infringement to the U.S. taxpayer.”

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NewsGuard Misinfo Watchdog: Contracts with DOD, WHO, Pfizer, Microsoft and AFT

NewsGuard is a self-appointed misinformation watchdog. It seems to be just one more way Americans are not allowed to think for themselves. Co-CEOs Steven Brill and Gordon Crovitz claim it is the “librarian for the internet.” Set up specifically to rate online journalistic integrity, Brill states NewsGuard provides services that “explain to people something about the reliability and trustworthiness and background of those who are feeding them the news.” Eric Effron is the organization’s Editorial Director.

Brill is a Yale graduate and lawyer who has authored multiple best-selling books and was, among other things, CEO of Verified Identity Pass, Inc., the first U.S. biometric Voluntary Credentialing Program that went bankrupt in 2009. It was the parent company of CLEAR which went back online in 2010 and then went public in 2021.

According to MintPressNews, “Crovitz held a number of positions at Dow Jones and the Wall Street Journal, eventually becoming executive vice president of the former and the publisher of the latter before both were sold to Rupert Murdoch’s News Corp in 2007. He is also a board member of Business Insider, which has received over $30 million from Washington Post owner Jeff Bezos in recent years.”

Crovitz’s alliances might account for the organization’s favorable 100 ratings for WSJ and the Washington Post. He is also a contributor “to books published by the American Enterprise Institute and Heritage Foundation,” which are also favorably rated by NewsGuard.

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