Stupidity Reigns on Day 1 of Pfizer–BioNTech COVID-19 Vaccination

This is a PRIME EXAMPLE of STUPIDITY in the FDA, which should be ELIMINATED.

It’s also a prime example of stupid people.

You wouldn’t think stupid people would be in healthcare, would you?

And yet…

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StatNews.com
Labeling Confusion Led To Wasted Doses Of Pfizer COVID-19 Vaccine
By Olivia Goldhill @OliviaGoldhill
December 16, 2020

With the COVID-19 vaccine in short supply, hospital pharmacists found themselves in the unexpected position of throwing away one in every six doses of the first Pfizer-BioNTech vaccines distributed this week in the United States.

The confusion came over labeling: The vaccine comes in vials labeled as containing enough for five doses. But pharmacists discovered that, after thawing and mixing the contents with a dilutent, each vial contained enough vaccine for six doses. Without explicit approval from the manufacturer, that final dose had to be discarded.

“It was overtly clear early on there’s some extra volume,” said Russell Findlay, Pharmacy Manager at University of Utah Health. His colleagues called Pfizer on Tuesday to ask if they could use the extra dose, said Findlay, but the company wouldn’t give a definitive answer.

Pharmacists and executives at several health care systems said

Should the Vitamin & Food Supplement Industry be more regulated?

If a container says there are a dozen eggs in it, there should be 12 eggs.

If a container says the contents are a pint, there should be 16 ounces.

If a container says the weight of a product is 5 pounds, it should weigh 5 pounds.

And if a container says that each pill has 45 milligrams of a certain ingredient, each pill should contain 45 milligrams of that ingredient.

Pretty straight forward stuff, eh?

But, were you aware that some of the vitamins and other food supplements you may take are not as highly regulated as either over-the-counter or even prescription medicines?

For example, there is so little oversight for standards in the vitamin and food supplement industry that

Should you drink Bottled Water?

Hello?

Pure & safe drinking water is but one thing taxes are used to provide to the general public.

Hello? Anybody home?

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Bottled Water Vs. Tap Water

Remember the drinking fountain, that once ubiquitous, and free, source of H2O? It seems quaint now. Instead, bottled water is everywhere, in offices, airplanes, stores, homes and restaurants across the country.We consumed over eight billion gallons of the stuff in 2006, a 10 percent increase from 2005. It’s refreshing, calorie-free, convenient to carry around, tastier than some tap water and a heck of a lot healthier than sugary sodas. But more and more, people are questioning whether the water, and the package it comes in, is safe, or at least safer than tap water — and if the convenience is worth the environmental impact.

What’s in That Bottle?
Evocative names and labels depicting pastoral scenes have convinced us that the liquid is the purest drink around. “But no one should think that bottled water is better regulated, better protected or safer than tap,” says Eric Goldstein, co-director of the urban program at the Natural Resources Defense Council (NRDC), a nonprofit organization devoted to protecting health and the environment.

More than 25% of bottled water comes from a public source. – Dave Robertson/Masterfile

Yes, some bottled water comes from sparkling springs and other pristine sources. But more than 25 percent of it comes from a municipal supply. The water is treated, purified and sold to us, often at a thousandfold increase in price. Most people are surprised to learn that they’re drinking glorified tap water, but bottlers aren’t required to list the source on the label.This year Aquafina will begin stating on labels that its H2O comes from public water sources. And Nestlé Pure Life bottles will indicate whether the water comes from public, private or deep well sources. Dasani acknowledges on its website, but not on the label itself, that it draws from local water.

Labels can be misleading at best, deceptive at worst. In one notorious case, water coming from a well located near a hazardous waste site was sold to many bottlers. At least one of these companies labeled its product “spring water.” In another case, H2O sold as “pure glacier water” came from a public water system in Alaska.

Lisa Ledwidge, 38, of Minneapolis, stopped drinking bottled water a couple of years ago, partly because she found out that many brands come from a municipal supply. “You’re spending more per gallon than you would on gasoline for this thing that you can get out of the tap virtually for free,” she says. “I wondered, Why am I spending this money while complaining about how much gas costs? But you don’t ever hear anyone complain about the price of bottled water.” Ledwidge says she now drinks only filtered tap water.

The controversy isn’t simply about tap vs. bottled water; most people drink both, knowing the importance of plenty of water. What they may not know is that some bottled water may not be as pure as they expect. In 1999 the NRDC tested more than 1,000 bottles of 103 brands of water. (This is the most recent major report on bottled water safety.) While noting that most bottled water is safe, the organization found that at least one sample of a third of the brands contained bacterial or chemical contaminants, including carcinogens, in levels exceeding state or industry standards. Since the report, no major regulatory changes have been made and bottlers haven’t drastically altered their procedures, so the risk is likely still there.

The NRDC found that samples of two brands were contaminated with

More May Be at Risk as U.S. Meningitis Outbreak Widens

Welcome back to the world of “de-regulation”! You know… the one that existed before the FDA was created.

Now, do you really want it to be like that?

Probably not.

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More drugs from the pharmacy at the center of a meningitis outbreak may be contaminated, putting additional people at risk of contracting the deadly infection, U.S. regulators said.

Any drug meant to be injected that was manufactured by New England Compounding Center may be tainted, the Food and Drug Administration said yesterday on its website. The agency doesn’t know how many people may have received potentially tainted shots, Sarah Clark-Lynn, a spokeswoman for the FDA, said in an e-mail. The agency is working with the Framingham, Massachusetts-based pharmacy to gather more information about product distribution, she said.

The fungal meningitis outbreak that began with a steroid used for back pain has led to 214 infections in 15 U.S. states, killing 15 people, the Centers for Disease Control and Prevention said. A second steroid to treat inflammation manufactured by the pharmacy has been linked to

Toughen Up, Son… it’ll do you some good.

I happen to enjoy friendship with a young family whose matriarch was at first, overjoyed at the prospects of their firstborn obtaining gainful employment in this tough economy.

Their son, who in this post is identified as Young Man, is a recent high school graduate, and demonstrates musical talent.

Recently she posted the following on her FaceBook page:

“Did you know if you work at McDonalds you are pretty much forced to *eat* McDonalds? 😦 The breakroom has only a table & chairs. No fridge to keep your food cool or microwave to heat it up. So, unless you are able to drive yourself to work & carry your food in a cooler in your car, then you have to eat there. Plus, you only get 30 minutes. This makes me upset! I’m trying to convince -*- to apply elsewhere…”

I found the numerous responses fascinating, which are as follows – my response is last, italicized and emboldened.

Pharmaceutical Firms Lie, Cheat & Steal from America’s Elderly, Orphans, Poor and Helpless

A few points for the reader to consider:
This fraud was national in scope, involving a $3 BILLION settlement, of which the North Carolina Attorney General was able to recoup $31.8M. Pfizer, Abbott, Johnson & Johnson, Forest Labs, Eli Lilly, Astrazeneca have also all plead guilty to deceptive and fraudulent marketing. It’s very likely a drop in the bucket in comparison with the greater scope.

The four most expensive Pharmacy frauds in the United States history have occurred since George W. Bush oversaw the rewriting of the Medicare Part D drug benefit in 2003. In order of their value, they are:
GlaxoSmithKline – $3 Billion, 2012
Pfizer – $2.3 Billion, 2009
Abbott Laboratories – $1.5 Billion, 2012
Eli Lilly – $1.4 Billion, 2009

The so-called “doughnut hole” in the Medicare prescription Part D drug plan was closed by President Obama. That “doughnut hole” was created under the George W. Bush administration, who caved in to lobbyists from BIG PHARMA, and allowed them to write much of that aspect of the 2003 revision of the Medicare Part D law (also known as the Medicare Prescription Drug, Improvement, and Modernization Act (MMA), and refused to allow Medicaid the opportunity to bargain for prices with pharmaceutical firms.

Advertising is expensive. Advertising for medications on television, radio, Internet, magazines, billboards, buses, and any other place where advertising is sold, is illegal in some nations. It was once illegal in the United States, until the 1980’s when the FDA OK’d it under pressure from the Reagan administration.

IMS Health, a medical data firm, calculates that drug companies’ business in the United States alone earns more than $300 billion a year.

Last year, GSK had $20 Billion gross profits on $27 Billion in revenue. So don’t let anyone EVER fool you into believing that drug companies don’t make enough money, don’t have enough profits, or enough profit margin.

Pharmaceutical companies spent

Blood thinners Pradaxa & Xarelto exceedingly more dangerous & costly than Coumadin/Warfarin

If you’re presently taking the “blood thinner” medications in this news item, it may be in the best interest of your health, and life, to reconsider and stay with warfarin/coumadin.

At least with warfarin/coumadin, we have an antidote, and it has far fewer risks associated with it.

In short, it has evidence for greater safety.

Here’s the long & short of it:
Deaths associated with Warfarin/Coumadin in 2011 = 72
Deaths associated with Praxaxa in 2011 = 542

There was NO OTHER MEDICINE with such a high rate of death associated with death.

Annual Cost of Medicine: Pradaxa & Xarelto = $3,000
Annual Cost of Medicine: Coumadin/Warfarin = $200

You do the math.

Wanna’ be a statistic?

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Insight: Top heart doctors fret over new blood thinners

By Ransdell Pierson
NEW YORK | Thu Jun 14, 2012 1:37pm EDT

(Reuters) – For millions of heart patients, a pair of new blood thinners have been heralded as the first replacements in 60 years for warfarin, a pill whose hardships and risks have deterred many from using the stroke-prevention medicine.

A sign is seen at the entrance of an anti-coagulation clinic at the Staten Island University Hospital in Staten Island, New York May 7, 2012. For millions of heart patients, a pair of new blood thinners have been heralded as the first replacements in 60 years for warfarin, a pill whose hardships and risks have deterred many from using the stroke-prevention medicine. Picture taken May 7, 2012. REUTERS/Allison Joyce

But growing complaints of risks and deaths tied to the new crop of drugs have made some top U.S. cardiologists hesitant to prescribe them. Some are proposing a more rigorous monitoring regimen for when they are used.

Most concerns revolve around Pradaxa, a twice daily pill from Boehringer Ingelheim that was approved by the U.S. Food and Drug Administration in October 2010 to prevent strokes in patients with an irregular heartbeat called atrial fibrillation. It was the first new oral treatment for that use since warfarin was introduced in the 1950s.

“The good news is you now have an alternative to warfarin,” said Dr. Alan Jacobson, director of anti-coagulation services at the Veterans Administration (VA) healthcare system in Loma Linda, California. “The bad news is you can kill a patient as easily with the new drug as you could with the old drug” if it is not handled properly.

“The average patient doesn’t understand anything

Pradaxa & Xarelto: Are they worth the risks & costs?

What dangers lurk ahead for new “blood thinner” medications?

Could we unwittingly be participating in our own destruction?

Not only that, but these new medications are exorbitantly expensive, as well.

Are they worth it in the long run?

Should we continue to use the ready stand-by?

The new meds have no antidote. The old one does.

Too little too late, or too much too soon?

Are we playing with fire?

Only time will tell.

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Insight: Top heart doctors fret over new blood thinners

6:50am EDT, 14 June 2012

By Ransdell Pierson

NEW YORK (Reuters) – For millions of heart patients, a pair of new blood thinners have been heralded as the first replacements in 60 years for warfarin, a pill whose hardships and risks have deterred many from using the stroke-prevention medicine.

But growing complaints of risks and deaths tied to the new crop of drugs have made some top U.S. cardiologists hesitant to prescribe them. Some are proposing a more rigorous monitoring regimen for when they are used.

Most concerns revolve around Pradaxa, a twice daily pill from Boehringer Ingelheim that was approved by the U.S. Food and Drug Administration in October 2010 to prevent strokes in patients with an irregular heartbeat called atrial fibrillation. It was the first new oral treatment for that use since warfarin was introduced in the 1950s.

“The good news is

Hospitals get ready… set… go… Wireless!

The revolution will not be televised.

It will be handheld.

Because the future is now.

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Medical Devices in Hospitals to Go Wireless

FCC Is Expected to Vote to Open Up Spectrum, Easing Patient Monitoring and Making Product Development Less Risky

Hospitals are getting ready to cut the cord.

In place of knots of wires stuck to patients to monitor their blood pressure, heart rate, oxygen level and body temperature, doctors and the companies that supply them hope to use Band-Aid-like sensors to accomplish the same task wirelessly.

The Federal Communications Commission is expected to vote Thursday to open up spectrum for wireless medical devices, raising the possibility of easier hospital-patient monitoring, fewer tubes in emergency rooms, and more remote monitoring at home.

The shift will make it easier to track patients’ conditions, improving the odds that health problems will be caught before they become an emergency, analysts and clinicians say.

Wireless Hospitals

While wireless technology has boomed for phones and computing, it has been slower to take hold in the medical sphere. Hospitals have

FDA Announces Food Recalls

To ensure public health and safety, the United States Food and Drug Administration has recently announced recalls of certain food items.

And, if you can imagine it – believe it or else – there are politicians and people who say the FDA should be eliminated. Hint: They’re “TEA Party,” Libertarian or Republican. And you know what their argument is? It’s not in Constitution.

Honestly, that stupefies me. It boggles my imagination.

Following are the two most recent recall announcements.

One reason why medications are so expensive

Big Pharma justifies charging high prices by citing costs associated with Research & Development, and the lengthy process in obtaining Food & Drug Administration approval for new medications.

In some respect, there is validity to such assertions and claims.

However, a problem arises when the term for proprietary ownership of the formula is nearing expiration, and the firm then makes a minor modification to the medication – sometimes, only just changing the pill shape, or color – and then calls it “new,” which allows them to re-initiate another claim for unique ownership.

That is abuse.

However, more than anything, perhaps there is some warrant to discussing a more expedited pathway for FDA approval, which also guarantees patient safety.

Another reason, not mentioned here, is advertising.

Not only does advertising co$t lot$ of money, there is a legitimate concern that advertising to patients to get them to ask for medications from their physicians is not only an ethical lapse, but a medical one, as well. There’s a very good reason why it’s called “evidence based medicine,” rather than “advertising pushed medicine.”

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Want to cut health care costs? Start here.

Posted by Sarah Kliff at 09:00 AM ET, 04/21/2012

Every year, Americans pay $700 million more for cholesterol-lowering drugs than they need to. The reason? Abbott Laboratories.

(Photo illustration by The Washington Post; Original image from istockphoto.com)

Abbott Labs is a pharmaceutical company based in Illinois. About a decade ago, in 2000, it faced a problem. The company had recently acquired exclusive rights to sell Tricor-1, a cholesterol-fighting drug. It was profitable, which was nice, but the best part was this: It was a name-brand drug and Abbott was the only company with rights to sell it.

Drug exclusivity does not, however, last forever: After a name-brand drug has five years on the U.S. market, generics are allowed to come in and compete. That’s what a generic pharmaceutical company wanted to do with Tricor-1. Novopharm submitted an application to the Food and Drug Administrationto produce a generic version of the drug.That was bad news for Abbott Labs: With generics tending to sell at about 80 percent less than brand-name drugs, the new medication had the potential to seriously undercut its Tricor-1 business.

Abbott Labs was able to delay Novopharm by a bit, a story that health-care researchers recount in a recent Annals of Internal Medicine article. The company filed a patent infringement lawsuit that

Get government out of our daily lives!

This morning, as I was going about my morning routine, it occurred to me in that process that I am

Aresenic in my baby & family’s food is not regulated?

Next time you’re in the voting booth, be sure to thank the Republicans! (By not checking the boxes next to their names.)

In Rice, How Much Arsenic Is Too Much?

by Nancy Shute
– February 24, 2012The news that some rice-based foods are surprisingly high in arsenic has left rice lovers wondering how the heck we’re to know what’s safe to eat.Since Dartmouth College researchers reported last week that a toddler formula and energy bars sweetened with organic brown rice syrup tested high for arsenic, readers of The Salt have had lots of questions about how one might find out the arsenic content of rice-based foods, and figure out what’s safe.

GAO IDs Billion$ in federal wa$te

In a recently released report, the Government Accountability Office (formerly known as the Government Accounting Office), has identified Billions of dollars of waste in federal programs, many of which are described as “duplication, overlap, or fragmentation could potentially save billions of taxpayer dollars annually and help agencies provide more efficient and effective services.”

Oklahoma Senator Tom Coburn (R), said that by implementing the suggested changes – such as through consolidation, “We could save taxpayers hundreds of billions of dollars every year without cutting services.”

Some examples of streamlining include consolidating responsibilities within agencies, such as with catfish, for example. The United States Department of Agriculture (USDA) has responsibility for monitoring catfish, while the Food and Drug Administration (FDA) also has responsibility for oversight of the seafood industry. As well,

Are Frankenfoods in your future?

South Carolina Doctor’s laboratory grows test tube “meat.”

South Carolina scientist works to grow meat in lab

By Harriet McLeod – Sun Jan 30, 10:00 am ET

CHARLESTON, South Carolina (Reuters) – In a small laboratory on an upper floor of the