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Florida Family Fighting For Ivermectin: Appeals Court Expedites Case

Florida Family Fighting For Ivermectin: Appeals Court Expedites Case

Authored by Nanette Holt via The Epoch Times (emphasis ours),

Florida’s First District Court of Appeal has expedited the process to decide a lawsuit filed by the family…

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Florida Family Fighting For Ivermectin: Appeals Court Expedites Case

Authored by Nanette Holt via The Epoch Times (emphasis ours),

Florida’s First District Court of Appeal has expedited the process to decide a lawsuit filed by the family of a COVID-19 patient on a ventilator at a Jacksonville hospital.

The U.S. Food and Drug Administration has warned against taking ivermectin for COVID-19, because it is "horse medication." However, ivermectin packaged for human use (as shown here) has been widely prescribed for decades for a range of maladies, including for treatment of lice, other parasites and viruses. (Nanette Holt/The Epoch Times)

Attorneys for Mayo Clinic Florida have until 10 a.m. Jan. 13 to respond to the appeal filed by the family of 70-year-old Daniel Pisano.

Then the family’s attorneys will have until Jan. 14 to file additional arguments. At that time, a three-panel judge could be appointed to decide the case.

Mayo Clinic has said Pisano, who has been on a ventilator 22 days, has a slim chance of survival.

But an outside doctor, who is not affiliated with Mayo Clinic, testified in an emergency hearing Dec. 30 that there’s still a good chance to save him—although there’s no time to delay, the physician said.

Chris and Lauren Pisano (R) were elated when his parents Daniel and Claudia decided to move from North Carolina to Florida in early December, and bought a lot where they planned to build a home nearby to be close to their only two grandsons. (Courtesy of Chris Pisano)

In a desperate attempt to save their loved one, the Pisano family has begged Mayo Clinic to try a protocol widely used by independent physicians around the country and developed by the Front Line COVID-19 Critical Care Alliance.

Mayo Clinic officials have refused and attorneys have fought the family’s wishes vigorously in court.

Claudia Pisano, Daniel Pisano’s wife of 51 years, and their son, Chris, have power of attorney and legally have the right to ask for the treatment of their choice, their attorneys have argued. But Daniel Pisano is declining fast and running out of time, they say.

The family’s trusted doctor, Dr. Eduardo Balbona of Jacksonville, testified that in order to save him the hospital must quickly allow treatment—with ivermectin and other drugs and supplements—he’s used to help dozens of critically ill COVID-19 patients recover.

Being on the ventilator is doing harm to Pisano and other patients fighting COVID-19, Balbona testified.

After considering the testimony in the three-hour hearing, Judge Marianne Aho, of Florida’s Fourth Judicial Circuit, denied the family’s plea to force Mayo Clinic doctors to step aside and let Balbona treat their dying loved one.

Aho wrote, “An individual’s right to privacy is one of self-determination, the right to accept or refuse. It is not a right to demand a particular treatment. It is not a right to substitute one’s judgment as to which treatments must be made available by others. There is no right, constitutional or otherwise, of a patient to substitute one’s judgment for a medical professional.”

The family disagrees saying the Florida Patient’s Bill of Rights gives them the right to choose between treatment options and they’ve offered to release Mayo Clinic from all liability in following through with that care. They filed an appeal Jan. 9.

After Mayo Clinic submits a response by Jan. 13, attorneys for the family will have until 3 p.m. on Jan. 14 to add to their arguments.

Meanwhile, on Jan. 12 Daniel Pisano clung to life in a drug-induced coma, on a ventilator, and on his sixth day of dialysis for kidneys that have shut down.

Doctors monitoring his chart for the family through an online portal say his lab work suggests internal bleeding, says attorney Nick Whitney, of the AndersonGlenn law firm in Jacksonville.

For days, Chris and Claudia Pisano have begged Mayo Clinic to do a CT scan to identify the cause of the bleeding.

Mayo has refused, saying the CT scan is not medically appropriate,” Whitney says.

Mayo Clinic officials have not responded to requests for comment. Attorneys for the hospital have asked for their filings in the case be sealed from pubic view, citing privacy concerns.

The Mayo Clinic logo at Mayo Clinic Square, Minneapolis, Minn., on June 24, 2018. (Tony Webster via Wikimedia Commons)

The family’s search to find a hospital able to take Daniel Pisano has led only to dead-ends, Whitney said.

Still the Pisanos hope to continue raising money through donations to keep their legal fight going and to be able to pay$40,000 to $50,000 for air ambulance transport.

As of Jan. 12, 142 donors had given more than $28,000 toward the effort.

Since news of the case began spreading other families facing similar heartbreak have reached out to Whitney and to Jeff Childers, of Childers Law in Gainesville, another attorney on the Pisano legal team.

And on Jan. 12, a patient was driving from Chicago to Florida to meet with Balbona.

Whitney said it’s not easy for patients to find a doctor like Balbona willing to step up and make an alternative treatment plan for a patient hospitalized with COVID-19. And that’s the first step, he’s told those who have contacted him.

Families desperate for help say they don’t know where to turn, he said.

When they reach out for help through independent doctors, they’re told that the person can’t take on more cases, he added.

The bottleneck, in my opinion, is that physicians who are willing to do this are overwhelmed,” Whitney said. “There’s a need for intensive care physicians to come forward and say they’re willing to treat with ivermectin.”

The U.S. Food and Drug Administration has posted strict warnings against using ivermectin to treat COVID-19.

More than 90 peer-reviewed studies have been published, which supporters say demonstrates the drug’s efficacy at treating patients suffering from COVID-19.

Claudia Pisano is fighting to try to save the life of her husband of 51 years, Daniel, by asking a judge to order Mayo Clinic to allow treatment with ivermectin. (Photo courtesy of Chris Pisano)

Part of the frustration families face when they’re seeking alternative treatments for COVID-19 surrounds the Right to Try Act signed into law May 30, 2018.

It gives patients access to some unapproved treatments, if they have been diagnosed with life-threatening diseases or conditions, have tried all approved treatment options, and are unable to participate in a clinical trial to access certain unapproved treatments, according to the FDA.

But ivermectin and other drugs used as part of the FLCCC protocol for treating COVID-19 have already been approved by the FDA for some uses, so they don’t qualify to be used under the Right to Try Act.

Right to Try only applies to experimental medications,” says Childers. “It says nothing about FDA-approved meds like fluvoxamine, ivermectin, or hydroxychloroquine.”

The Mayo Clinic is a nonprofit American academic medical center employing more than 4,500 physicians and scientists and 58,400 other staff members across campuses in Florida, Minnesota, and Arizona.

Tyler Durden Thu, 01/13/2022 - 21:40

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About 35% of People Who Received Placebo in Vaccine Trials Report Side Effects and More COVID-19 News

According to a recent study conducted by researchers at Harvard Medical School and Beth Israel Deaconess Medical Center, 76 percent of the adverse side effects (such as fatigue or headache) that people experienced after receiving their first COVID-19…

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About 35% of People Who Received Placebo in Vaccine Trials Report Side Effects and More COVID-19 News

The placebo effect is where a person who received a placebo instead of a drug or vaccine shows clinical signs, positive or negative, associated with the actual treatment. Much has been made about the side effects of the COVID-19 vaccines, but a new study found a startlingly high number of adverse events associated with people who received placebos in clinical trials. For that and more COVID-19 news, continue reading.

COVID-19 Vaccine Side Effects: Real or Placebo Effect?

A recent study out of Harvard Medical School and Beth Israel Deaconess Medical Center evaluated 12 COVID-19 vaccine trials with a total of 45,380 participants. The study found that 76% of the adverse side effects reported, such as fatigue or headache, after the first shot were also reported by participants who received a placebo. Mild side effects were more common in people receiving the vaccine, but a third of those given the placebo reported at least one adverse side effect. The statistics from the study showing that 35% of placebo recipients reported adverse side effects is considered unusually high. Several experts suspect that there’s such a high report of adverse events because of the amount of misinformation found on social media about the dangers of the vaccines and the amount of media coverage.

This is not to say that the adverse side effects felt by people who received the vaccines are all in their heads. People do have side effects to vaccines, but this study reports on an unusually high level of the placebo effect. Nocebo is used to describe a negative outcome associated with the placebo.

Source: BioSpace

“Negative information in the media may increase negative expectations towards the vaccines and may therefore enhance nocebo effects,” said Dr. Julia W. Haas, an investigator in the Program in Placebo Studies at Beth Israel Deaconess and the study’s lead author. “Anxiety and negative expectation can worsen the experience of side effects.”

Four Factors for Long COVID

A study published in Nature Communications identified specific antibodies in the blood of people who developed long COVID. Long COVID is not well understood and has a range of up to 50 different symptoms, and it is difficult to diagnose because there is no one test for it. The study, conducted by Dr. Onur Boyman, a researcher in the Department of Immunology at University Hospital Zurich, compared more than 500 COVID-19 patients and found several key differences in patients who went on to present with long COVID. The most obvious was a significant decrease in two immunoglobulins, IgM and IgG3. The study found that a decrease in these two immunoglobulins, which generally rise to fight infections, combined with other factors, such as middle age and a history of asthma, was 75% effective in predicting long COVID.

75% of COVID-19 ICU Survivors Show Symptoms a Year Later

A study out of the Netherlands found that a year after being released from an intensive care unit (ICU) for severe COVID-19, 75% of patients reported lingering physical symptoms, 26% reported mental symptoms, and up to 16% noted cognitive symptoms. The research was published in JAMA. The research evaluated 246 COVID-19 survivors treated in one of 11 ICUs in the Netherlands. The mental symptoms included anxiety (17.9%), depression (18.3%), PTSD (9.8%). The most common new physical symptoms were weakness (38.9%), stiff joints (26.3%), joint pain (25.5%), muscle weakness (24.8%), muscle pain (21.3%) and shortness of breath (20.8%).

Pennsylvania Averaging Most COVID-19 Deaths Per Day in a Year

In general, COVID-19 deaths are dropping across the country. However, in two states, Pennsylvania and New Jersey, the numbers are increasing. Pennsylvania is averaging 156 COVID-19 deaths per day over the past seven days, which is a 17% uptick compared to two weeks ago. The number of deaths per day in Pennsylvania is below what was hit in January 2021, largely due to the availability of vaccines. New Jersey averages 111 deaths from COVID-19 per day, an increase of 61% over the last two weeks and the highest since May 2020. Similarly, New Jersey cases and hospitalizations are declining.

Omicron Surge: Shattering Cases and Hospitalizations, but Less Severe

According to the CDC, although the current Omicron surge is setting records for positive infections and hospitalizations, it’s less severe than other waves by other metrics. Omicron has resulted in more than 1 million cases per day in the U.S. on several occasions, and reported deaths are presently higher than 15,000 per week. However, the ratio of emergency department visits and hospitalizations to case numbers is lower compared to COVID-19 waves for Delta and during the winter of 2020–21. ICU admissions, length of stay, and in-hospital deaths were all lower with Omicron. They cite vaccinations and booster shots as the likely cause. Although the overall result is that Omicron appears less severe, it’s not completely clear if that’s because the viral variant doesn’t infect the lower lung as easily as other variants, or because so much of the population has either been vaccinated or exposed to the virus already. It is clearly far more infectious than other strains, which is placing a real burden on healthcare systems. The number of emergency department visits is 86% higher than during the Delta surge.

J&J Expects Up to $3.5 Billion in COVID-19 Vaccine Sales This Year

Johnson & Johnson projected annual sales of its COVID-19 vaccine for 2022 to range from $3 billion to $3.5 billion. This was noted during the company’s fourth-quarter 2021 report. In December 2021, the U.S. Centers for Disease Control and Prevention recommended the PfizerBioNTech or Moderna shots over J&J’s due to a rare blood condition observed with the J&J shot. By comparison, Pfizer and BioNTech project their vaccine will bring in $29 billion in 2022, after having raked in almost $36 billion in 2021. Moderna expects approximately $18.5 billion this year, with about $3.5 billion from possible additional purchases. Although final figures for Moderna aren’t in yet, they projected 2021 sales between $15 and $18 billion.

BioSpace source:

https://www.biospace.com/article/about-35-percent-of-people-receiving-placebo-in-vaccine-trials-report-side-effects-and-more-covid-19-news

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COVID-19 cases at highest ever in Americas – regional health agency

New cases of COVID-19 in the Americas in the past week were the highest since the pandemic began and the very contagious Omicron variant has clearly become the predominant strain, the Pan American Health Organization said on January 26.

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COVID-19 cases at highest ever in Americas – regional health agency

BRASILIA, Jan 26 (Reuters) – New cases of COVID-19 in the Americas in the past week have been the highest since the pandemic began in 2020 and the very contagious Omicron variant has clearly become the predominant strain, the Pan American Health Organization said on Wednesday.

There were more than 8 million new cases, 32% higher than the previous week, while fatalities throughout the region also increased by 37%, with 18,000 new deaths caused by COVID-19.

The United States continues to have the highest number of new infections, although cases decreased by nearly 1 million over the last week, the regional health agency said.

Mexico’s southern states have seen new infections triple and Brazil has seen new cases surge 193% over the last seven days, PAHO said in weekly briefing.

Medical workers take care of patients in the emergency room of the Nossa Senhora da Conceicao hospital that is overcrowding because of the coronavirus outbreak, in Porto Alegre, Brazil, March 11, 2021. REUTERS/Diego Vara

Children in the Americas are facing the worst educational crisis ever seen in the region, with millions of children yet to return to classes, according to PAHO, which recommended that countries try to get them safely back to school to protect their social, mental and physical wellbeing.

It urged parents to get their children vaccinated.

Many countries have already authorized and are safely administering COVID vaccines to adolescents, PAHO said.

Last week, the WHO’s expert group on immunization authorized the COVID vaccine developed by Pfizer Inc (PFE.N) for children aged 5 to 12 years, offering a roadmap for countries to roll out vaccines for them, the regional agency said.

Reporting by Anthony Boadle; Editing by David Gregorio

Our Standards: The Thomson Reuters Trust Principles.

 

Reuters source:

https://www.reuters.com/world/americas/covid-19-cases-highest-ever-americas-says-regional-health-agency-2022-01-26

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Cortexyme Crashes as Key Alzheimer’s Asset Hit with Clinical Hold

South San Francisco-based Cortexyme Inc. received a letter from the U.S. Food and Drug Administration on January 25 placing a full clinical hold on the Investigational New Drug application for the company’s lead clinical asset atuzaginstat, which is…

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Cortexyme Crashes as Key Alzheimer’s Asset Hit with Clinical Hold

South San Francisco-based Cortexyme, Inc., received a setback in its latest research efforts. The company announced that it received a letter from the U.S. Food and Drug Administration on January 25, placing a full clinical hold on the Investigational New Drug application for lead clinical asset atuzaginstat, which is in development for the treatment of Alzheimer’s disease.

Cortexyme said it plans to provide additional updates pending further talks with the FDA.

Meantime, on the stock market, shares of Cortexyme dropped sharply in premarket trading Wednesday following the announcement. Company shares, which closed Tuesday at $9.06, fell to $6.47, a drop of 29.6%.

The company’s lead program targets an infectious pathogen called P. gingivalis found in the brains of Alzheimer’s patients, and other organs, which is tied to degeneration and inflammation.

Following the FDA’s action, Cortexyme is immediately cutting expenses to ensure cash flow through 2024. The company intends to rationalize operations, which will enable continued support for planned clinical milestones. A top priority will be development of its next-generation gingipain inhibitor, COR588, also being investigated in Alzheimer’s disease. The company is completing a Phase 1 study and expects results in the second quarter of 2022.

Source: BioSpace

The company also plans to look into strategic alternatives for its coronavirus program and assess possibilities for atuzaginstat outside of the Alzheimer’s indication. In its statement, Cortexyme let investors know that a more detailed update on its project pipeline and expected milestones for 2022 would be forthcoming.

In November, Cortexyme presented data from its Phase II/III GAIN trial at the 14th Clinical Trials on Alzheimer’s Disease Conference (CTAD). The 643-participant study was the first large trial to test the efficacy of an oral small-molecule targeting P. gingivalis in mild to moderate Alzheimer’s patients. It failed to reach statistical significance in its co-primary cognitive and functional endpoints at the end of treatment across the overall trial population. However, the data did show that treatment with atuzaginstat slowed cognitive decline compared to placebo in participants with Alzheimer’s disease and P. gingivalis infection.

“Our ability to identify the right population in historically hard to treat mild to moderate Alzheimer’s patients, along with finding an efficacious dose with a differentiated safety profile, is important progress toward a breakthrough treatment for Alzheimer’s disease,” said Cortexyme Chief Medical Officer Michael Detke, M.D., Ph.D. at the time.

Marwan Sabbagh, M.D., FAAN, lead investigator of the GAIN Trial and professor of neurology at the Barrow Neurological Institute, added, “The GAIN Trial achieved several significant advancements for the Alzheimer’s field, first by clinically confirming that P. gingivalis is a key upstream driver of disease progression. Further, the data demonstrated a compelling risk-benefit profile with a clinically significant treatment response in an easily identifiable population of patients.”

He further stated, “When coupled with the convenience of oral dosing, atuzaginstat offers the potential to fill a huge gap in the underserved mild to moderate Alzheimer’s population in as many as half those patients.”

In August 2021, Cortexyme presented data from the same study at the Annual Biomarkers for Alzheimer’s Disease Summit. The data showed evidence of P. gingivalis infection of the central nervous system in trial participants. P. gingivalis is the same bacterial strain that is responsible for chronic periodontitis.

Cortexyme CEO and Co-Founder Casey Lynch said at the time, “Today marks a major milestone toward a comprehensive understanding of Alzheimer’s and slowing of disease progression. The evidence from the GAIN trial advances our ability to identify the right patients, impact an upstream target and improve patient outcomes.”

BioSpace source:

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