Tag: big pharma

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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Bayer Admits It Paid “Millions” in HIV Infection Cases — Just Not in English

To read the English-speaking media, you’d never know that Bayer (BAYRY) just paid “tens of millions” of dollars to end a three-decade long scandal in which the company sold HIV-contaminated blood products to haemophiliacs, thousands of whom later died of AIDS.

Ironically, Bayer’s new haemophilia iPhone app got some coverage, as did Bayer’s haemophilia research grant to the University of Florida. But you have to pick through the French and Italian news media to find out that Bayer is finally writing checks to people who got AIDS because, in the 1980s, the Cutter Biological unit of Bayer ignored federal law to recruit prisoners, intravenous drug users, and high-risk gay men as donors of the blood Cutter then used to make Factor VIII and IX, the clotting product that haemophiliacs need in order to not bleed to death. Agence France Press reported (via a Google translation):

The German group Bayer and three other labs will pay tens of millions of euros to hemophiliacs who accused them of having sold in the 1980s blood products contaminated with HIV, a source close to the deal told AFP.

The figure of tens of millions of euros in compensation “is not totally wrong,” she added. Bayer and the U.S. company Baxter are the two main parties to the agreement, she said.

A company spokesperson said:

However, “the company accepts no responsibility” in this case, and “continues to insist it has always acted responsibly and ethically.”

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The 9-question survey many doctors use to diagnose depression was actually created by an antidepressant manufacturer

If your doctor suspects you might have depression, there’s a go-to questionnaire they might pull out with nine questions to answer about how you’ve been feeling over the past two weeks.

The questions touch on a range of potential issues, from sleep disturbances, to appetite changes, concentration issues, and your general enjoyment of life.  

Many experts say this tool, called the PHQ-9, was never meant to be a definitive diagnostic test aimed at diagnosing mental health issues. It was designed as a first-ditch screening tool; a conversation starter between doctor and patient.

But for primary care physicians strapped for time in the exam room, it is often used as a stand-in for a more in-depth clinical evaluation — a go-to prescribing tool for antidepressants.

Critics say the issue is that it this tool was developed by Pfizer, shortly after Zoloft came on the market. 

“These forms have a very low criteria for anxiety and depression,” UK-based psychotherapist James Davies, co-founder of the Council for Evidence-based Psychiatry, told the Telegraph in 2017. “It’s about getting people in and out of the door in 10 minutes,” often, with a prescription in hand. 

As reporter Olivia Goldhill details in a wide-ranging Stat report out this week, the marketer who first dreamed up the idea for what later became the PHQ-9 — the quick tool that ultimately made many primary care doctors more comfortable prescribing antidepressants from exam rooms worldwide — was a “marketing man” working for Pfizer. Howard Kroplick convinced the company to invest in the pricey research required to develop the now-ubiquitous questionnaire. 

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The sick reality: Drugs advertised most on TV have LEAST health benefits, according to analysis of $6bn-a-year industry

The drugs that are advertised most on TV are also the least effective, according to a major analysis.

Johns Hopkins University researchers found that spending on promoting prescription drugs rose from $1.3 billion in 1996 to $6 billion in 2016. Ninety-two of 135 drugs included in the study, or nearly 70 percent, were deemed to have little health benefits. 

Dr Michael DiStefano, the lead author of the study, said: ‘The findings suggest that shifting promotional dollars to direct-to-consumer advertising potentially reflects a strategy to drive patient demand for drugs that clinicians would be less likely to prescribe.’

‘When a consumer sees these advertisements on TV or social media, they should really question if it’s the best drug for them and have a conversation with their provider.’

The findings come amid lingering ethical questions regarding TV drug advertising and come just weeks after a Harvard study found a similar discrepancy between the amount spent on medical adverts and the benefit the medicines provide to patients.

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