Posts Tagged ‘FDA’
Posted by Warm Southern Breeze on Tuesday, August 10, 2021
Summer just doesn’t get any better, does it?
First, the COVID-19, and then, just when you think it’s safe to go in the water… delta variant emerges.
Back to square one.
And now, as if sunburn wasn’t enough, there’s cancer-causing sunscreen.
It’s almost like the bizarre reducēs in the 1993 Bill Murray movie “Groundhog Day.” By the way, the word “reducēs” (pronounced ree – doo – sees), is the nominative, accusative, and vocative masculine and feminine plural cases of “redux.” So now, you know.
Surely, by now, you’ve heard, or read, the news:
Carcinogenic substances, including benzene – a highly flammable industrial chemical – have been found in independent laboratory analyses performed upon 294 unique batches of sun care products from 69 different companies by Valisure a privately held New Haven, CT-based pharmaceutical analytical services company.
On May 25, 2021, Valisure published the laboratory findings that 78 sun screen and after-sun skin care products in which they found benzene, and in part, wrote that,
“Valisure LLC has tested and detected high levels of benzene, a known human carcinogen, in several brands and batches of sunscreen, which are Read the rest of this entry »
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Posted in - Business... None of yours, - Did they REALLY say that?, - Do you feel like we do, Dr. Who?, - She blinded me with SCIENCE!, End Of The Road, WTF | Tagged: benzene, Big Business, cancer, carcinogen, FDA, greed, money, poison, power, summer, sun screen, Wall Street, wealth | Leave a Comment »
Posted by Warm Southern Breeze on Thursday, December 17, 2020
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…
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 Read the rest of this entry »
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Posted in - Did they REALLY say that?, - Do you feel like we do, Dr. Who?, - Read 'em and weep: The Daily News | Tagged: coronavirus, COVID-19, FDA, Food and Drug Administration, Pfizer, stupidity, vaccine, waste | Leave a Comment »
Posted by Warm Southern Breeze on Thursday, August 13, 2020
https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-newport-red-onions-july-2020
Red onions grown by Thomson International, Inc. of Bakersfield, CA have been ID’d as potentially contaminated by the Salmonella Newport infection.
Also recalled are all varieties of onions that could have come in contact with potentially contaminated red onions, due to the risk of cross-contamination.
Recalled products include red, yellow, white, and sweet yellow onions shipped nationwide from May 1, 2020 to August 1, 2020, sold under the following brand names: Read the rest of this entry »
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Posted in - Business... None of yours, - Do you feel like we do, Dr. Who?, - My Hometown is the sweetest place I know, - Read 'em and weep: The Daily News | Tagged: Bakersfield, CA, California, FDA, food, onions, recall, safety, Salmonella | Leave a Comment »
Posted by Warm Southern Breeze on Saturday, December 22, 2018
I’m way ahead of the power curve on that one.
I’ve been washing almost EVERYTHING with a wee bit of soap, water, and common unscented household bleach for a very long time. And I mean EVERYTHING. Including mushrooms.
Blueberries? Yup. Cherries? Yup. Strawberries? Yup. Melons? Yup. Grapes? ESPECIALLY! And yes, that includes avocados.
Frankly, you should Read the rest of this entry »
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Posted in - Did they REALLY say that?, - Do you feel like we do, Dr. Who? | Tagged: avocado, disease, FDA, germs, health, healthy, wash | Leave a Comment »
Posted by Warm Southern Breeze on Saturday, November 17, 2012
Hello?
Pure & safe drinking water is but one thing taxes are used to provide to the general public.
Hello? Anybody home?
—
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 Read the rest of this entry »
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Posted in - Even MORE Uncategorized!, - Lost In Space: TOTALLY Discombobulated | Tagged: Bottled water, commerce, FDA, Food and Drug Administration, health, International Bottled Water Association, Natural Resources Defense Council, NRDC, NSF International, Peter Gleick, public, Reader's Digest Association, safety, Tap water, taxes, water | Leave a Comment »
Posted by Warm Southern Breeze on Wednesday, October 17, 2012
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.
—
More May Be at Risk as U.S. Meningitis Outbreak Widens
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 Read the rest of this entry »
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Posted in - Do you feel like we do, Dr. Who?, - Lost In Space: TOTALLY Discombobulated, - Read 'em and weep: The Daily News | Tagged: Centers for Disease Control and Prevention, FDA, Food and Drug Administration, Framingham Massachusetts, Meningitis, NECC, New Hampshire, news, Thomas Aquinas | Leave a Comment »
Posted by Warm Southern Breeze on Saturday, September 8, 2012
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 Read the rest of this entry »
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Posted in - Politics... that "dirty" little "game" that first begins in the home., - Read 'em and weep: The Daily News | Tagged: abuse, BIG MONEY, Big Pharma, Bupropion, corruption, FDA, Food and Drug Administration, fraud, George W. Bush, GlaxoSmithKline, GOP, lobbyist, Medicaid, North Carolina, Paroxetine, Paxil, Political corruption, Republican, Ronald Reagan, Roy Cooper, United States, waste, wealth, Wellbutrin | Leave a Comment »
Posted by Warm Southern Breeze on Saturday, July 28, 2012
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?
—
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 Read the rest of this entry »
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Posted in - Do you feel like we do, Dr. Who?, - Read 'em and weep: The Daily News | Tagged: afib, Anticoagulant, atrial fibrillation, Blood, blood thinner, Boehringer Ingelheim, Bristol-Myers Squibb, cardiologist, cardiology, Cedars-Sinai Medical Center, cost, costly, coumadin, Dabigatran, danger, dangerous, deaths, expense, expensive, FDA, Food and Drug Administration, health, healthcare, inexpensive, Johnson, money, Pradaxa, risk, stroke, tested, time tested, true, warfarin, Xarelto | Leave a Comment »
Posted by Warm Southern Breeze on Friday, June 15, 2012
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.
—
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 Read the rest of this entry »
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Posted in - Do you feel like we do, Dr. Who?, - Read 'em and weep: The Daily News | Tagged: afib, Anticoagulant, atrial fibrillation, Bayer, Boehringer Ingelheim, cardiac, Cedars-Sinai Medical Center, Dabigatran, FDA, Food and Drug Administration, health, healthcare, heart, Johnson, medication, medicine, news, Pradaxa, R&D, Rivaroxaban, Xarelto | Leave a Comment »
Posted by Warm Southern Breeze on Wednesday, May 9, 2012
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. Read the rest of this entry »
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Posted in - Even MORE Uncategorized!, - Read 'em and weep: The Daily News | Tagged: children, CLEVELAND, compromised immune system, elderly, FDA, food, Food and Drug Administration, frail, health, helath, India, infants, Listeriosis, moon, Moon Fishery, New Jersey, New York, Ohio, poisoning, Pregnancy, public health, safety, Salmonella, Tuna, United States, United States Food and Drug Administration, women, Yellowfin tuna | Leave a Comment »
Posted by Warm Southern Breeze on Monday, August 30, 2010
Recently, the U.S. Food and Drug Administration announced a recall of millions of poultry eggs after finding evidence of widespread contamination.
Here’s the official web page to determine if your groceries were involved.
Read the rest of this entry »
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Posted in - Read 'em and weep: The Daily News, - Uncategorized | Tagged: egg, FDA, food, health, recall, safety | Leave a Comment »
Posted by Warm Southern Breeze on Monday, January 11, 2010
“Simponi can lower your ability to fight infections, including tuberculosis. Serious and sometimes fatal events can occur – such as infections, cancer in children and adults, heart failure, nervous system disorders, liver or blood problems and allergic reactions. Before starting Simponi, your doctor should test you for TB and assess your risk of infections, including fungal infections, and hepatitis B.”
– from a teevee commercial/advertisement for a once-a-month, self-injectable “drug/medicine” branded “Simponi” purported to treat rheumatoid arthritis
“SIMPONI™ can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting SIMPONI™ and will monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB. Tell your doctor if you have been in a region (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are common. Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. For children and adults taking TNF blockers, including SIMPONI™, the chances for getting lymphoma or other cancers may increase. You should tell your doctor if you have had or develop lymphoma or other cancers.”
– from the http://www.simponi.com/ website
The word “medication” can be simply defined as “a compound or preparation used for the treatment or prevention of disease,” while the word “cure” can be simply defined as to “relieve (a person or animal) of the symptoms of a disease or condition.”
Should a “cure” cause disease?
What the hell was the FDA thinking when they approved this “medicine”?
What sense does it make to create a “medicine” for which the company knows causes cancer? Is that not a class action lawsuit waiting to happen? Would the American Cancer Association approve this medication?
Would YOU recommend this “medicine” to your family and friends?
Would YOU take this “medicine”?
Should this “medicine” be banned?
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Posted in - Did they REALLY say that? | Tagged: adults, allergy, arthritis, Big Pharma, cancer, children, crazy, cure, disease, disorders, doctor, FDA, fungal, health care, healthcare, heart failure, hepatitis, idiocy, infections, injection, medication, medicine, pharma, pharmaceutical, RA, rheumatoid, Simponi, stoopid, stupid, TB, teevee, television, treatment, tuberculosis | Leave a Comment »