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Tuesday, July 11, 2023

In NYC ‘public health’ normalizes zombie drug tranq

 As if tranq, the “zombie” drug that literally rots human flesh, weren’t horrifying enough, high-minded New York Democrats are encouraging users to keep right at it. 

This is the logical endpoint of so-called “harm reduction.”

The city Health Department is blasting out an ad campaign about tranq (official name xylazine) — an animal tranquilizer that causes pus-oozing lesions.

Tranq now taints huge amounts of street drugs, adding even more risk of death and injury to fentanyl use.

But the city isn’t pushing anyone to try to kick the habit — that would be stigmatizing!

Instead, the ads tell junkies to bring their drugs to an overdose-prevention center so they “can use them under supervision.”

In other words: Go ahead and kill yourselves! We’ll take a taxpayer-funded front row seat!

Remember: Mostly what the supervision sites can do is try and revive you if you OD.

Tranq user, John Dulanie, sits on the steps of the Post Office above Penn Station
The New York City Health Department is blasting out an ad campaign about tranq (official name xylazine) — an animal tranquilizer that causes pus-oozing lesions.
J.C. Rice

The pustulent, necrotic sores tranq causes?

Oh well

The spiral downward from drug abuse?

Don’t stigmatize!

This, even as city special narcotics prosecutor Bridget Brennan warns that, thanks to tranq, “our black-market drug supply in the city is probably the most dangerous that I’ve ever seen.”

Penn Station
Tranq now taints huge amounts of street drugs, adding even more risk of death and injury to fentanyl use.
J.C. Rice

Even the addicts the campaign is aimed at see it as absurd: “They ain’t showing us how to keep ourselves safe,” fretted one.

“That’s a pretty weird way [for the city] to approach it. There’s not too many positives” when it comes to tranq, said another. 

The big lie here, of course, is the favorite claim of harm-reducers: that prodding addicts to feed their monkey will somehow magically reduce the number of bad drug outcomes. 

It’s insane on its face. 

But if you really need proof, just look at San Francisco

There, harm-reduction policies helped create an open-air drug market in the Tenderloin so bad the mayor declared a state of emergency. 

Or New York itself, hell-bent on safe injection sites, drug-kit vending machines and more even as overdoses killed over 3,000 New Yorkers in the 12 months ending August 2022. 

That’s up from about 2,670 the previous year, itself a massive jump

Mayor Eric Adams shows real brains and courage in hitting out at other lefty shibboleths

But on this he and Health Department chief Ashwin Vasan are shamefully following the example of Bill de Blasio.

Fentanyl kills.

Tranq rots your body away before it kills you. 

If a city campaign advocates for anything but actual treatment, it’s not truly about public health, but only progressive fantasies.

https://nypost.com/2023/07/11/in-nyc-public-health-normalizes-zombie-drug-tranq/

Kudlow: Bad-boy behavior from Biden

 Let me start with this: Joe Biden is in a heap of trouble.  He faces bribery charges at home that are based on fact, not fiction. This is no Hillary Clinton campaign made-up story.   

This is senior whistleblowers and bank accounts from the Treasury and audio tapes that have surfaced from FBI reports, even though the FBI has tried desperately to cover them up.  Meanwhile, Mr. Biden has chosen to boycott the NATO dinner tonight, which is unheard of for a U.S. president, leading not only the largest country and the biggest military powerhouse in the alliance, but also its principal financier.   

He's saying "no" to Ukraine NATO membership – OK, he may have a point there – but he's not even going to talk to Zelenskyy and the others about this decision.  This bad-boy behavior comes right after his Treasury Secretary Janet Yellen was caught on camera bowing and scraping before the number two Chinese communist.   

So, let me get this right: we're bowing to the Chinese, and boycotting our allies? Does anybody get that? Does anybody understand that? Mr. Biden faces a slumping econobmy and a sticky inflation problem, as real wages keep sinking and the middle class, blue collar working folks are in full revolt.   

U.S. President Joe Biden

WASHINGTON DC, UNITED STATES - JUNE 26: US President Joe Biden attends the The Broadband Event at the White House in Washington D.C., United States on June 26, 2023.  ((Photo by Celal Gunes/Anadolu Agency via Getty Images) / Getty Images)

Witness the UAW leadership, which is skewering President Biden because of severe cuts to auto workers' wages, resulting from Biden's radical climate policies.  UAW President Shawn Fain blasted Biden climate policies, "there have been clear winners and losers and the same people who've always won, the corporate elite, and the billionaire class, seem to think they can keep calling the shots."   

Remember, Joe Biden's supposed to be the "union president." Now, a study by the liberal left "Good Jobs First", funded by labor unions, concluded that "EV plants will each receive more than a billion dollars a year from the U.S. government, with no requirement to pay good wages to production workers."   

Actually, the badly misnamed "Inflation Reduction Act" that the UAW opposes -- that is really a massive Green New Deal climate giveaway to big corporations, Biden political donors and various Democratic woke and DEI interest groups -- is also a fiscal fiasco.   

Recently, the Joint Tax Committee has re-estimated the cost of all the massive "greeny" tax credits from a $400 billion price-tag to a $790 billion price-tag.  The Penn Wharton economic model has put it at $1.2 trillion.  

Anyway, House Republicans wisely have tried to pair back this monstrosity. So far, they haven't had much luck.  At the same time, the House did pass H.R. 1, which would have reopened the fossil fuel spigots through more drilling, leasing, permitting, pipelining, refining, and LNG exporting.   

Let's face it. The U.S. has the cleanest natural gas and oil for that matter. Over the last 10 years, U.S. carbon emissions have dropped 1.2 billion tons -- by far, the biggest carbon decline of any industrialized country. China, India, Russia and Saudi Arabia have led the way toward carbon increases.   

Now, the GOP wants to roll back subsidies, stop ESG and decarbonization banks and investment managers. This would place fossils on a more even playing field with renewables for an all-of-the-above energy policy that would once again lead to American energy dominance around the world.   

Believe it or not – this is so wonderful – a recent study from Joe Biden's own Council of Economic Advisors and Office of Management & Budget shows that a 2.2℉ increase in climate warming over the past 120 years has had a miniscule, miniscule impact on American GDP and did not stop progress in virtually every area of life.   

Another 2℉ warming increase over the next 80 years, according to their study, will similarly have virtually no impact on the economy.  That is the Biden CEA and OMB, but I don’t think he ever talks to them and I know he didn’t read their report.  

Finally, American ingenuity and technological advances will make all these energy sources cleaner, cheaper and more accessible. If we just let free-market policies proliferate and stop the top-down central planning that has so badly failed – something weirdly called "Bidenomics."

https://www.foxbusiness.com/media/larry-kudlow-bad-boy-behavior-from-biden

Sanders' Medicare-For-All Would Destroy America's Health-Care

 by Scott Atlas via RealClearPolitics.com,

Trust in public health has been shattered in the wake of COVIDConfidence in government health authorities has plummeted – 64% rate the FDA as “only fair or poor” and 58% rate the CDC the same.

Ironically, and in defiance of Americans demanding more health autonomy, Sen. Bernie Sanders has put forth a radical Medicare-for-All 2023 bill to impose the ultimate government control over health care – single-payer, socialized medicine. It not only controls the allocation of all medical care, but it explicitly outlaws private insurance competition with the government and creates a new “Office of Health Equity” that forces an extremist ideology on American taxpayers.

Sanders writes that his justification is “to end the international embarrassment of the US being the only major country that does not guarantee healthcare.”

Pretending that labeling people “insured” means “guaranteed care” is gaslighting Americans. In England’s NHS with its guarantees, a record-setting 7.4 million patients are on NHS waiting lists; over 371,000 patients are now waiting more than one full year, even after initial diagnosis and referral. In Canada’s single-payer system, the 2022 median wait from GP referral to first treatment, after already seeing a doctor, was about 7 months.

Even seriously ill patients referred for “urgent treatment” wait months after their doctors recommend treatment. In England’s NHS, more than 41% of cancer patients wait more than two months after GP referral for their first “urgent treatment” and 49% wait more than four months for their recommended brain surgery. Canadians with already diagnosed heart disease wait a median of 16.4 weeks for their first treatment; for neurosurgery after already seeing a doctor, they wait 58.9 weeks – more than one year. 

All U.S. wait times are far shorter and have remained so – even comparing the lowest priority visits, including healthy check-ups, to seriously ill patients in single-payer countries. Current waits in the U.S. for all five surveyed specialties, regardless of insurance, average only 26 days. While Canadians wait 48 weeks to see an orthopedist after referral from their GP, Americans wait only 16.9 days; Canadian women wait 15.7 weeks for their OB-GYN appointment after referral for illness, while American women wait 31 days for their non-urgent check-up. 

The pandemic lockdowns further highlighted the abject failure of single-payer systems. The UK’s Institute for Public Policy projected it will take seven years for missed cancer chemotherapy and twelve years for missed radiation therapy backlogs to clear. Many will die waiting. And despite the marketing that the NHS is a badge of national pride, satisfaction by the British fell to 29% and dissatisfaction rose to 51% – the worst since the first survey 50 years ago. Is it any wonder that we are finally seeing UK media call out the nation’s “reluctance to admit just how bad the reality is”?

The consequences of single-payer restrictions are clear – patients in those systems have suffered worse outcomes from all the most common serious diseases. For decades, the U.S. has had consistently superior survivals from cancer than single-payer systems, a fact Europeans begrudgingly admit (“Europeans are way, way more likely to die of cancer than Americans… Turns out the US is actually doing something right when it comes to health care”), as well as best treatment outcomes for diabetes, high blood pressurestroke and heart disease. Should Americans ignore that over a 16-year period, more than 44,000 additional Canadian women died due to Canada’s wait times for treatment?

And it’s not only long waits for doctors that cause worse outcomes. Americans benefit from the broadest usage of screening tests for early cancer detection; widest access to safer, more accurate MRI and CT technology and critical care ICU beds; and fastest access to new, life-saving drugs. I doubt that cancer patients in single-payer systems were bragging about their “guarantees” when drug availability within two years of approval of the world’s 54 new cancer drugs lagged in the UK (38/54), Australia (15/54), France (23/54), and Canada (29/54), while U.S. patients had access to almost all (51/54).

As part of his gaslighting, Sanders won’t admit that countries with decades of single-payer experience now shift patients to the private sector to hide single-payer failures. According to the Nuffield Trust, NHS has increasingly paid for private care, ballooning by 70% to over £9.7 billion, because the NHS itself cannot deliver. Originally a negligible amount, the share of NHS money funneled to private doctors has increased to 45% of cataract surgeries and to 50% of hip and knee replacements. Sweden also relies on private care, privatizing pharmacies and a growing fraction of primary care facilities, while increasing spending on private-care contracts by 50% in the past 15 years. More and more individual Brits choose to pay for private care, on top of their NHS taxes; more than 690,000 Swedes now carry private health insurance, an increase of 42% since 2011. Governments of Finland, France, Ireland, Italy, the Netherlands, Norway, Portugal, Spain, Sweden, and Denmark with single-payer all shift taxpayer money to buy private care, sometimes even outside the countryto solve their scandalous failures. Did Sanders already forget that our own single-payer system, the VA, was forced to shunt patients to private care to address its failures? 

Sanders must not care that abolishing private insurance will also abruptly end access to timely medical care for seniors currently on Medicare, because that access depends on payments from private insurance. Medicare pays hospitals and doctors below the cost of delivering health care – 60% of what private insurance pays for in-patient services, and 60-80% for physician services. The private insurance used by more than two-thirds of Americans pays 140% over the cost of care, allowing hospitals to stay in business. Even with private insurance intact, CMS has repeatedly issued dire warnings about losing access and quality of care for Medicare patients, calculating that most hospitals, skilled nursing facilities, and in-home care providers already lost money per Medicare patient. Given that 80% of seniors on Medicare also buy private insurance to replace or supplement traditional Medicare via employers, Medicare Advantage’s private options, or MediGap, I wonder what seniors will think of their Medicare once Sen. Sanders forces them to rely on it, forbidding them from supplementing it with private coverage?

Government-run health care has failed the world over. It’s time for individuals to stop politicians from disregarding facts while recklessly imposing their power, and instead demand control of the health care dollar and choices on how to spend it. And let’s be honest about yet another immorality hidden by Sen. Sanders: As with the harms from government lockdowns during COVID, it’s the poor and working class who will be stuck with single-payer health care, because only they will be unable to afford to circumvent that system.

https://www.zerohedge.com/political/bernie-sanders-medicare-all-would-destroy-americas-health-care

Fresenius Kabi Intros New Presentation for Fentanyl Citrate Injection, USP in Simplist® Ready-to-Administer Prefilled Syringes

 Fresenius Kabi announced today the launch and immediate availability in the U.S. of Fentanyl Citrate Injection, USP in 100 mcg per 2 mL Simplist® ready-to-administer prefilled syringes, the only 100 mcg per 2 mL presentation available on the market in a manufacturer-prepared prefilled syringe.

Fresenius Kabi Fentanyl Citrate Injection, USP is the most recent manufacturer-prepared product available in the company’s proprietary, ready-to-administer portfolio of Simplist prefilled syringes, designed for efficient medication delivery and ease of use, to help eliminate steps where errors can occur.1 Fresenius Kabi currently has 14 products in 25 presentations in its Simplist portfolio.

Fentanyl citrate is currently listed as in shortage by the U.S. Food and Drug Administration.

"Fresenius Kabi is pleased to add this presentation of Fentanyl to our portfolio of Simplist prefilled syringes, further demonstrating our commitment to patient safety and combating drug diversion," said John Ducker, president and CEO of Fresenius Kabi USA. "By offering this critical care product in secure and convenient ready-to-administer packaging, we are helping frontline health care professionals administer this prescription safely and confidently by helping to minimize administration errors and reduce drug waste.”

Ready-to-administer (RTA) medication systems are recommended by the Joint Commission,2 the Institute for Safe Medication Practices (ISMP),3 the American Society of Health-System Pharmacists (ASHP),4 and the Anesthesia Patient Safety Foundation (APSF).The use of RTA syringes have proven to provide efficiencies that allow medical staff to focus on their patients and in one case study, reduce fentanyl citrate waste events by 42 percent.6

Simplist Fentanyl Citrate Injection, USP is formulated, filled, and packaged in the U.S. using fully automated state-of-the-art technology. The company has invested nearly $1 billion on an advanced manufacturing and distribution network dedicated to serving U.S. hospitals, clinics and health systems. To learn more about how Fresenius Kabi is strengthening America’s supply chain of care for essential medicines, please visit MoreInAmerica.com.

To learn more about the Simplist portfolio with pharmacy clinical education support, please visit www.simplist-us.com.

INDICATIONS AND USAGE

Fentanyl Citrate Injection, for intravenous or intramuscular use, is indicated for:

  • Analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance and in the immediate postoperative period (recovery room) as the need arises.
  • Use as an opioid analgesic supplement in general or regional anesthesia.
  • Administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia.
  • Use as an anesthetic agent with oxygen in selected high-risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures.

Fentanyl Citrate Injection should be administered only by persons specifically trained in the use of intravenous anesthetics and management of the respiratory effects of potent opioids. Ensure that an opioid antagonist, resuscitative and intubation equipment, and oxygen are readily available.

https://www.biospace.com/article/releases/fresenius-kabi-introduces-new-presentation-for-fentanyl-citrate-injection-usp-in-simplist-ready-to-administer-prefilled-syringes/

Jupiter Wellness Postpones Spinoff

  Jupiter Wellness, Inc. (Nasdaq: JUPW) (the “Company” or “Jupiter Wellness”), today announced that the payment date for the distribution of shares of common stock, par value $0.0001 per share (“SRM Common Stock”), of SRM Entertainment, Inc. (“SRM”), currently a majority-owned subsidiary of the Company, to effect the spin-off of the SRM business has been delayed. The previously announced distribution to be paid on or about July 12, 2023, and the previously announced trading date of SRM Common Stock on the Nasdaq Capital Market (“Nasdaq”) of on or about July 13, 2023, has been delayed until SRM’s Registration Statement on Form S-1 (Filed No. 333-272250), as amended, relating to shares of SRM Common Stock (the “Registration Statement”), has been declared effective by the U.S. Securities and Exchange Commission (the “SEC”) and the listing of the SRM Common Stock on Nasdaq has been approved by Nasdaq. The previously announced record date of July 7, 2023, will remain the same.

The Company remains intent on effectuating the distribution as soon as it may do so in compliance with federal securities laws and appropriate regulatory approval. The Company will update its stockholders with respect to the distribution payment date when circumstances so permit.

https://finance.yahoo.com/news/jupiter-wellness-inc-announces-postponement-200500977.html

ImmuCell Prelim Sales Results for Q2

 ImmuCell Corporation (Nasdaq: ICCC) (“ImmuCell” or the “Company”), a growing animal health company that develops, manufactures and markets scientifically proven and practical products that improve the health and productivity of dairy and beef cattle, today announced preliminary, unaudited sales results for the second quarter of 2023, which ended June 30, 2023.

Preliminary, Unaudited Total Sales Results:

 

2023

2022

($ Decrease)

(% Decrease)

During the Three-Month Periods Ended June 30,

$3.53 million

$3.86 million

($328,000

)

(9

%)

 

 

 

 

 

During the Six-Month Periods Ended June 30,

$6.98 million

$9.86 million

($2.88 million

)

(29

%)

 

 

 

 

 

During the Twelve-Month Periods Ended June 30,

$15.69 million

$20.46 million

($4.77 million

)

(23

%)

Sales during the three, six and twelve-month periods ended June 30, 2023 were below the comparable periods ended June 30, 2022 in large part because of the previously disclosed production slowdown implemented during the first quarter of 2023 to remediate contamination events impacting the Company’s manufacturing process. Second quarter sales increased modestly over the $3.45 million of sales recorded during the first quarter of 2023. Second quarter of 2023 sales could have increased by more but narrowly missed benefiting from approximately $543,000 worth of finished goods inventory (valued at approximate sales value) that did not ship until the beginning of July due to cold chain shipping requirements and the July 4th holiday schedule. As of June 30, 2023, the backlog of orders was equal to approximately $8 million, representing a significant increase from approximately $2.5 million as of December 31, 2022.

During the four-month period ended June 22, 2023, the standard quality control test of incoming milk batches met specifications approximately 95% of the time, while approximately 2.5% failed with the balance currently pending final testing and disposition. The two subsequent standard quality control tests at the middle and end of the production process have continued to be within specification 100% of the time.

“This data supports our belief that our remediation efforts have been successful and gives us confidence as we return to full production,” commented Michael F. Brigham, President and CEO of ImmuCell. “For the month of June 2023 alone, production output - which includes the approximate sales value of about $543,000 worth of finished goods inventory that did not ship until the beginning of July 2023 - increased to approximately $1.91 million in comparison to the monthly average of approximately $1.08 million during the first five months of the year. We believe that this is a positive indicator for the second half of 2023.”

“In addition, we continue to work to achieve FDA approval to commercialize Re-Tain®,” Mr. Brigham concluded. “As disclosed on June 28, 2023, we expect to make our third submission of the CMC Technical Section by the end of July 2023. When made, this submission will be subject to a six-month review by the FDA.”

Conference Call:
Since the first quarter of 2020, the Company has been providing a preliminary look at its top line results soon after the close of the quarter. The Company expects to provide this prompt, preliminary report on product sales until further notice going forward. The Company will host a conference call on Friday, August 11, 2023 at 9:00 AM ET to discuss the full financial results for the quarter ended June 30, 2023. Interested parties can access the conference call by dialing (844) 855-9502 (toll free) or (412) 317-5499 (international) at 9:00 AM ET. A teleconference replay of the call will be available until August 19, 2023 at (877) 344-7529 (toll free) or (412) 317-0088 (international), utilizing replay access code #5465238. Investors are encouraged to review the Company’s updated Corporate Presentation slide deck that provides an overview of the Company’s business and is available under the “Investors” tab of the Company’s website at www.immucell.com, or by request to the Company.

https://finance.yahoo.com/news/immucell-announces-preliminary-unaudited-sales-200500306.html

Pulmatrix Applies to Initiate a Phase 2 Trial of Investigational Drug to Treat Acute Migraine

 Pulmatrix  Inc. ("Pulmatrix" or the "Company") (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and central nervous system disease, today announced the submission of an investigational new drug ("IND") application to the United States Food and Drug Administration ("FDA") for PUR3100, an orally inhaled dry powder formulation of dihydroergotamine ("DHE"), under development to treat acute migraine. The PUR3100 formulation uses Pulmatrix's novel, proprietary dry powder delivery technology, iSPERSE™ to deliver DHE directly into the lungs using a dry-powder inhaler.

Pulmatrix's IND includes a Phase 2 clinical protocol where safety and preliminary efficacy of PUR3100 will be investigated in patients with acute migraine. The Phase 1 study data were presented at the American Headache Society 65th Annual Meeting in June 2023. Results showed that the pharmacokinetics ("PK") of PUR3100 were similar to the PK of intravenous ("IV") DHE with fewer side effects.

https://www.biospace.com/article/releases/pulmatrix-announces-submission-of-ind-application-to-fda-to-initiate-a-phase-2-trial-of-investigational-drug-pur3100-to-treat-acute-migraine/