NYC: Is Safety Being Sacrificed?

In the Spring of 2020, every evening at 7pm Manhattanites would lean out their windows or stand on their balconies banging pots and pans, blowing horns, applauding, and making any cheering noise they could acknowledging New York City’s first responders just for doing their job. At that time, an ambulance siren would sound every ten minutes for a victim of Covid 19.  The ambulance drivers and EMT’s of New York City worked continuously during the peak of the pandemic. Now, those first responders, firemen, police officers, and sanitation workers are just some of the New York City employees protesting a vaccine mandate put into place by New York City’s Mayor Bill de Blasio. The mandate takes effect at 5pm on Friday, October 29.  If any of the 160 thousand employees of the city of New York do not comply with the vaccination requirement they won’t be getting a paycheck. According to The New York Times, the head of New York’s Emergency Medical Service’s worker’s union, Oren Barzilay said: “The mayor seems to have forgotten the sacrifices we made during the pandemic.” Mayor de Blasio insists if there is a shortfall of workers, vacations will be canceled, and workers who have complied with the mandate will be forced to work overtime.

Up until October 20, it was acceptable for city workers to get tested weekly as opposed to getting vaccinated. This past Thursday, NYC Municipal workers protested outside Gracie Mansion, de Blasio’s official residence. The protesters insisted they’re not anti-vaccine, just anti-mandate. The mayor is enforcing the mandate saying that as of Monday, November 1, if any unvaccinated municipal worker shows up for work, they will be put on unpaid leave. Mayor de Blasio is offering a $500 bonus for any worker who gets vaccinated before the deadline.

As of Friday, October 29, 2021, 80% of the New York City Police Force has been vaccinated and 72% of New York City Firemen have complied with the mandate. New York City has the largest fire department in the United States. Both the Uniformed Fireman’s Association, the firefighter’s union, and the Patrolmen’s Benevolent Association, the NYPD union, filed lawsuits trying to prevent the mandate. Their lawsuits were rejected by a state judge. The main complaint was that the city gave municipal workers only 9 days to get vaccinated. Now, the unions are in negotiations for an extension.

But New York City is already starting to see the effects of a slowdown by municipal workers.  Parts of the city are lacking timely garbage pick-up and the head of the New York City Detectives union (The Detective’s Endowment Association) Paul DiGiacomo, has predicted a possible mass retirement. “It won’t be easy to obtain and replace those people,” he said in an interview on NY’s 1010 WINS news radio. DiGiacomo also said de Blasio is enforcing the mandate for his own “political purpose.”

TrialSiteNews has reported on Chicago’s vaccine mandate for their police department and the questions about safety in Chicago where the murder rate has climbed 56%. The Chicago mandate has already resulted in about two dozen firefighters and EMT’s being placed on a “no pay” status. In the meantime, the Chicago Police Union is still challenging the mandate in court.

Like Chicago, New York City is now facing a potential safety problem. Now that a vaccine is mandated in New York, the same questions asked about Chicago are now applicable to New York. What’s more important, vaccine mandates or protecting the public?

THE IMPORTANT PLAYERS IN MEDICINE ARE NOT HOLDING FEDERAL HEALTHCARE AGENCIES ACCOUNTABLE FOR THEIR ACTIONS doctrumpet October 29, 2021

There are four major trials of ivermectin for early COVID, one completed and three (3) in progress. Patients received about 20% of the ivermectin dosage they should have in the completed Together Trial in which it showed possible mild benefit. Principal investigator, Dr. Edward Mills, announced that ivermectin showed “absolutely no benefit” but the actual data showed otherwise. Was Dr. Mills biased? ACTIV-6, COVID-OUT, and PRINCIPLE are using even lower doses of ivermectin than the Together trial, clearly absurd and suspicious for corruption.

Who will Share the Truth?

Many physicians are anxiously awaiting the results of these trials. They deserve to know what is going on but will major medical journals report the underdosing in all the trials? The editors in chief of NEJM, JAMA, the Annals of Internal Medicine, CHEST, British Medical Journal, and the Lancet have been informed. The president elect, treasurer and head of ethics for the ACP have been told. The president, president elect, and CEO of the Infectious Disease Society of America have been told. 15 board members of the American Medical Association have been told. So has the principal investigator of ACTIV-6 and WCG IRB. The principal investigator of COVID-OUT at the University of Minnesota has been told. So has the the PRINCIPLE group in London. Moreover, the president of NIH and deputy chairman of NIAID have been told.  

The Response 

After numerous email communications with associated letters articulating the situation this was the response obtained:  “At this time, the issues you have raised regarding dosing are under active consideration by those involved in oversight of the study.  There is not much more we can say at present but anticipate the study team may have something to say in the future.”

It’s been 11 weeks since Together was reported and patients are still being randomized to placebo or a dose of ivermectin they know doesn’t work. 

Goodbye Practice of Medicine

The pandemic has seen a lot of controversial decisions by our federal healthcare agencies. By and large physician healthcare organizations have rubber-stamped everything the government does. The AMA went public that ivermectin should only be used in trials.  All fear their members will never see grant money from NIH or drug companies again if they misspeak. 

Medical journals rarely say anything controversial. JAMA printed the infamous Lopez Medina study sponsored by 5 drug company competitors of ivermectin which 100 experts demanded be retracted but wasn’t. Many individual physicians speak their minds often to consequences. No one with clout will stand up to Dr. Anthony Fauci et al. even when their decisions are absurd. On that topic, numerous researchers have informed us off-record that to go up against Fauci is to lose any hope of NIH funding. 

Dosed for Failure 

In Together, ivermectin was dosed initially at one day of 0.4 mg/kg on an empty stomach. When challenged that it was ridiculous, principal investigator, Dr. Edward Mills increased it to 3 days which is still ridiculous. Fluvoxamine was given for 10 days. Ivermectin is 2.6 times better absorbed with a meal. For the delta variant, patients should receive 0.6 mg/kg with food for 5 days or until cured per the FLCCC Alliance. There is much evidence of the safety of this dosing on the FLCCC Alliance website. One might think that Dr. Mills’ mentor, Bill Gates, Dr. Fauci’s friend, might have had something to do with it. Yes, that sounds conspiratorial, and, no, we are not conspiracy theorists here. 

Here is a review of the ivermectin portion of Together. By COVID Analysis. Analysis of Ivermectin in Together 

Hiltzik the Hack

The newspapers, who would have no idea how to review a study, gleefully leaped to ring the death knell of ivermectin.  Michael Hiltzik, the business reporter for the LA Times, had written an article very critical of ivermectin after Together was reported. When I told him of the problems in the trial and that ivermectin was being underdosed in all 4 major trials his response was:

“Thanks for writing. It’s crystal clear that no evidence exists for the efficacy of ivermectin against COVID. My feeling is that any physician who prescribes it for that purpose should have his license scrutinized.”

For a TrialSite review of Mr. Hiltzik’s writing, follow the link.

Media Blackout

Together was presented to NIH 8/6/21. NIH did not comment on the obviously absurd way they treated Ivermectin patients. There has been little to nothing in the press or in medical journals about the problems with the study. It has not been officially peer-reviewed. Dr. Mills attacked ivermectin proponents and showed a high level of bias. One hopes when the ivermectin portion of Together is peer-reviewed, Dr. Mills will be cited for investigator misconduct.

The Test: And We Are Watching

The important people in medicine have had this information only a few days. We will find out who is willing to stand up for honor and integrity, who will stand up for right and wrong and who will stand up for physicians and patients. 

The power of medical journals and physician organizations is limited by how much they can induce physicians to respond. I don’t have a lot of faith in physicians right now. They wouldn’t use repurposed drugs that might have worked on sick COVID patients. Our totalitarian medical system has them afraid of being called before a medical board if big brother doesn’t like what they do. 

I hope someone in medicine will stand up but I’m not holding my breath until someone does. You are better off going to your congressmen and senators about the obvious corruption. NIH is spending millions of taxpayer dollars to intentionally make ivermectin fail. Maybe they will pay attention.

2021 COVID-19 Vaccine Rollouts are Associated with Worldwide Increases in COVID-19 Death Rates above 2020 Levels

Scatterplots contributed by Jessica Rose, PhD, MSc., BSc.

Abstract:  COVID-19 vaccines are not preventing a rise in COVID-19 deaths. In fact, as of October 10th, 2021, COVID-19 death rates following vaccine rollouts are higher in 70% of the 178 countries for which we were able to obtain vaccination rollout dates and number of total vaccine doses administered.  COVID-19 vaccine rollouts have not slowed the rate of serious COVID-19 disease or COVID-19 deaths caused by SARS-CoV-2 viral variants.

Background:  In the United States, COVID-19 mRNA and vector-DNA Vaccines have the highest reported post vaccine death rate of any vaccine in history in the U.S. Center for Disease Control (CDC)’s vaccine adverse events reporting system (VAERS)1.

2

41% Increase in US all-cause mortality in 2021 since COVID vaccine rollout 

In the United States and in other countries around the world, there has been increased all-cause mortality in 2021 since COVID vaccine rollouts began than in 2020.  COVID-19 mRNA and DNA-vector vaccines create antibodies surrounding internal organs by having the body create billions to trillions of spike proteins specific to the original SARS-CoV-2 variant. As shown in the Israeli and UK data, the current COVID-19 spike protein vaccines provide no protection against infectiousness, symptomatic illness, or being hospitalized with the current immune-escape Delta variant.  Insufficient nasal and oral mucosal immunity against the Delta variant is created by current COVID-19 vaccine injections, so the vaccinated spread the Delta virus and carry viral loads 251 times higher than the previous Alpha variants in nasal and oral cavities.3,4

Vaccine Rollouts worldwide are followed immediately by increased COVID Deaths of the elderly & about 4 months later by the rise of an immune escape Delta variant

Delta variant prevalence (seen as a green line in charts below) is recorded to occur in vaccinated and unvaccinated hospitalized COVID-19 patients roughly four (4) months after initial COVID-19 vaccine roll-out dates due to vaccine-induced selective pressure.5 As seen in both Israel and the UK data, vaccination rollouts coincide with larger weekly rates of reported COVID-19 deaths per million than occurred during the 2020 COVID-9 pandemic period. During the beginning of vaccine rollouts there are all-cause mortality rises in deaths of the elderly. The larger rise in Israeli COVID-19 weekly death rates is than in the UK may have occurred because Israel gave the 2nd vaccine doses more quickly to the entire population, whereas the UK the adult population were all given the 1st dose and given more time before taking the 2nd dose.  Israeli’s more numerous booster doses produced another larger COVID-19 death rate increase than the UK saw.

A large increase in all-cause mortality occurred in persons 65 years and older in Southern United States at the beginning of COVID-19 vaccine rollouts. In the United States, all-cause mortality for 24 to 64 year-olds is higher in 2021 than in 2020, concomitant with COVID-19 mRNA and vector-DNA vaccine rollouts.

Worldwide Data Show COVID-19 Vaccines are Associated with Increased Risk of COVID-19 Deaths

We collected COVID-19 deaths per million data from Our World in Data6 and collected COVID-19 vaccine rollout dates and number of doses per 100 people from Covid vaccines: How fast is progress around the world? The Visual and Data Journalism Team BBC News7 and analyzed it using R programming language.  We generated scatterplots comparing the COVID-19 death rates prior to and post COVID-19 vaccine  roll-out dates in each  country. Each country in the scatterplot is randomly assigned a color and the size of the text increases with the number of vaccine doses per hundred individuals. The regression line of the data set  in addition to the line with slope 1 that passes through   the origin (y=x) to make it easy to see that countries plotted above this 45 degree line have a higher COVID-19 death rates after COVID-19 vaccine rollouts; and countries plotted below this 45 degree line have lower COVID-19 death rates post COVID-19 vaccine rollouts .1 

The plot below shows COVID-19 death rates per million persons both before and after COVID-19 vaccine roll-out dates for 17 different COVID-19 vaccines in 178 countries, as of October 10, 2021.  It includes 10 months of data pre-rollouts and at most 9.5 months post-rollouts, depending on the begin date of country COVID-19 vaccine rollout. COVID-19 deaths per million were obtained from Our World in Data.8 COVID-19 vaccine rollout dates and number of doses per 100 people were collected from Covid vaccines: How fast is progress around the world?9 and plotted using the R programming language.  Each country in the plot is represented by a dot, randomly assigned a color. The size of its country name increases with its number of vaccine doses per hundred persons. The regression line shows the overall relationship of COVID-19 Death rates pre and post vaccination rollouts for these countries. The line with slope one (1) passing through the origin (y=x) is shown to make it easy-to-see countries plotted above this 45-degree line have higher COVID-19 death rates after vaccination roll-outs; and countries plotted below the 45-degree line have lower COVID-19 death rates after vaccine roll-outs.1    Overall, it can be visually seen that COVID-19 vaccines do not lower COVID-19 death rates, and, in fact, are associated with increased COVID-19 death rates in 70% of the 178 countries plotted.  

Many countries having relatively small pre- and post-vaccination rollout COVID-19 death rates cannot be seen in this plot of 178 countries, so the next plot shows just the lower corner of the plot for countries having less than 50 COVID-19 deaths both before and after COVID-19 vaccination rollouts.

Some of the countries having lower COVID-19 death rates post vaccine rollout as of October 10, 2021, have already moved up to the 45 degree line and have an equally large COVID-19 death rate today as before their vaccine rollouts.  For example, on October 10th, the date of the data pictured above, Australia had a lower COVID-19 death rate of 21.4 per million post-COVID-19 vaccination rollout than its initial rate of 35.25 before. However, by October 28th, Australia’s post vaccine rollout reported COVID-19 death rate rose a rate of 30.26 COVID-19 deaths per million since its vaccine rollout began on February 21, 2021, almost equal to before it began COVID vaccinations with mRNA and vector DNA vaccines. Because Australia did not begin its vaccination rollouts until end of the 3rd week in February, the comparison is for a shorter time period post-vaccine-roll-out. Thus, Australia’s post-vaccine rollout COVID-19 deaths per million per month is actually higher now than its pre-vaccination period and has moved almost to the line. 

There are many possible mathematical explanations or theories that could be tested statistically, for why some countries have been able to keep their COVID-19 death rates lower than the world’s average world’s rate of 635.6 per million as of October 28th.  Perhaps countries having lower COVID-19 death rates post-vaccine rollouts have vaccinated fewer persons; or are using more traditional, less dangerous vaccines; or are making early, effective treatments available such as hydroxychloroquine and ivermectin that are being used in countries reporting very low COVID-19 death rates such as China, Nicaragua, and the Congo. 

CONCLUSION:  COVID-19 vaccinations are not associated with decreases in COVID-19 death rates and, thus, do not reduce serious hospitalized COVID-19 case rates.  Overall, numerical data show COVID-19 vaccine rollouts are associated with increased COVID-19 illnesses and deaths.

1. Anyone can check the current death report numbers, by using this web site URL: https://medalerts.org/vaersdb/findfield.php?TABLE=ON&GROUP1=AGE&EVENTS=ON&VAX=COVID19&DIED=Yes

2. CDC VAERS analysis submitted to FDA by Josh Guetkow PhD. David Wiseman PhD. Paul E. Alexander PhD. Herve Selegmann PhD.

3. Study: Fully Vaccinated Healthcare Workers Carry 251 Times Viral Load, Pose Threat to Unvaccinated Patients, Co-Workers. August 23, 2021. Transmission of SARS-CoV-2 Delta Variant Among Vaccinated Healthcare Workers, Vietnam https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3897733

4. The Covid mRNA and DNA vaccines do not provide any mucosal immunity that would do more to prevent infections and spread of COVID disease. Mucosal Immunity in COVID-19: A Neglected but Critical Aspect of SARS-CoV-2 Infection Michael W. Russell, Department of Microbiology and Immunology, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY, United States

5. “Vaccine escape” variants are mentioned in the DOHERTY MODELLING report in table of contents and p. 8.

6. https://ourworldindata.org/covid-vaccinations

7. https://www.bbc.com/news/world-56237778

8. https://ourworldindata.org/covid-vaccinations

9. By the Visual and Data Journalism Team by BBC News https://www.bbc.com/news/world-56237778

References in addition to Footnotes:

10/19/21   81 Research Studies Confirm Natural Immunity to COVID ‘Equal’ or ‘Superior’ to Vaccine Immunity.  The Brownstone Institute lists 81 of the highest-quality, complete, most robust scientific studies and evidence reports/position statements on natural immunity as compared to the COVID-19 vaccine-induced immunity.  https://childrenshealthdefense.org/defender/research-natural-immunity-covid-brownstone-institute/ 

10/07/21 Fully Vaccinated Countries Had Highest Number of New COVID Cases, Study Shows.  The authors of a study published Sept. 30, in the European Journal of Epidemiology Vaccines said the sole reliance on vaccination as a primary strategy to mitigate COVID-19 and its adverse consequences “needs to be re-examined.”

Army physician warns about toxic ingredients in COVID shots. Sep 27, 2021 ‘Use of mRNA vaccines in our fighting force presents a risk of undetermined magnitude in a population in which less than 20 active-duty personnel, out of 1.4 million, died of the underlying SARs- CoV-2.’ Physician and Army Lieutenant Colonel Theresa Long.  To try and steer the Department of Defense to policies that protect military personnel from dangerous COVID vaccines and defend our national defense.  The AFFIDAVIT OF LTC. THERESA LONG M.D. IN SUPPORT OF A MOTION FOR A PRELIMINARY INJUNCTION ORDER. September 24, 2021 

Dr. Joel Hirschhorn: Nearly Two Million Americans Dead from COVID Vaccines, Infections, and Collateral Impacts  October 27, 2021

Medical Bombshell: Pfizer Vax Attacks Human Blood Creating Clots Under Microscope. Oct 26, 2021 Highly respected medical doctor and inventor, Richard Fleming, has released a 32-minute detailed presentation documenting his shocking findings. In late 2020, before the Pfizer shot had even been rolled out, top scientists and experts around the world warned the Pfizer and Moderna shots posed extreme risk of causing blood clots, myocarditis and other cardiovascular problems. One year later, Pfizer and Moderna have been forced to issue warnings confirming their controversial MRNA vaccines can indeed cause a long list of problems not just limited to the cardiovascular system. Now, research scientist, Dr. Richard Fleming, has tested the Covid-19 Pfizer vaccine on fresh human blood samples in-vitro and made a string of nightmare discoveries confirming the medical community’s findings. To find out more about this ground-breaking research, visit Fleming-Method.com

Israeli Mathematician Says Vaccination Causing Surge in Youth Deaths.  October 20, 2021

22 Studies and Reports that Raise Profound Doubts about Vaccine Efficacy for the General Population By Paul Elias Alexander   October 28, 2021

New Lancet Study From Sweden Shows Vaccine Effectiveness Against Infection Dropping to Zero and Sharp Decline Against Severe Disease As Well. October 28, 2021.

Dr. Mobeen Syed aka “Dr. Been” has become a sensation on YouTube educating millions on various medical topics during this difficult pandemic including refreshingly sincere lessons on topics such as ivermectin. Most recently the online doc raised concern over the inconsistent criteria applied in ivermectin and molnupiravir trials in the quest to get authorization for the treatment of COVID-19. TrialSite has covered Dr. Been’s previous examinations of potential COVID treatments, including how his YouTube channel was censored for discussing information related to hydroxychloroquine, remdesivir, and ivermectin.

In a YouTube video streamed on October 7, 2021, Dr. Been contrasts the methods used by the FDA and CDC for approval of COVID treatments. Dr. Been emphasizes the lack of impartiality, and preferential treatment in the recommendation guidelines by the FDA and CDC.

He claims that there are clear signs of preferential allowances in the molnupiravir trial and in other recommended drugs (remdesivir, bamlanivimab) when applying for emergency use authorization (EUA). Meanwhile, ivermectin clinical trials are repeatedly disqualified.

Recap of Molnupiravir Timeline

Previously, TrialSite news reported on researchers at Emory University who discovered molnupiravir in 2014. With time, it demonstrated efficacy against several viruses including coronaviruses.

In-vitro studies for molnupiravir on human cells against SARS-CoV-2 were done in 2020. After combining Phase II & III study in their clinical trials, Merck halted clinical trial expansion in October 2021. The pharmaceutical company declared efficacy had been demonstrated, and they were now ready for an EUA.

Double standards? A closer look at Acceptable Study Trials

Dr. Been’s YouTube video clarifies several questions by a comparison with study trials from other drugs.

Is one study trial sufficient for an EUA?

The fact that a single trial is being considered to grant molnupiravir an EUA is sending signals of preferential treatment. But, this is not a precedent: bamlanivimab was also granted EUA on the basis of a single trial in November 2020.

But Dr. Been raises another concern related to an amendment of the EUA granted for bamlanivimab in September 2021. The BLAZE-1 trial researched bamlanivimab and etesevimab used together in treatment of early or mild infection with COVID-19; the BLAZE-2 trial investigated bamlanivimab alone as post-exposure prophylaxis.

From there, the FDA concluded that “it is reasonable to expect that bamlanivimab and etesevimab together may be safe and effective for post-exposure prophylaxis,” despite no data supporting this specific drug combination used for this indication. The FDA granted approval for combining two drugs bamlanivimab plus etesevimab for post-exposure prophylaxis of COVID-19.

Dr. Been also draws attention to the fact that authorizing bodies criticize poor studies for lack of balance in participants. The Blaze-2 study used by FDA had this particular fault-number of participants testing negative in treatment group far outnumbered participants testing positive 966:209 respectively.

Quality of Evidence

Dr. Been suggests that the FDA’s position on quality of evidence is inconsistent when it comes to COVID-19.

For example, open label trials allow the investigator and participants to know who is receiving treatment or placebo. The use of open-trials leaves room for bias and is criticized as low-quality evidence, but these trials were accepted in support of remdesivir’s EUA. Remdesivir also drew criticism from meta-analyses and a WHO study for its lack of effectiveness, specifically in patient survival. Nevertheless, remdesivir is still approved for COVID-19, while ivermectin fails to get the nod, despite numerous double-blinded trials – a higher standard than open trials.

Dr. Been points to the ubiquitous problem of low quality of evidence, using a study analyzing Infectious Diseases Society of America (IDSA) clinical practice guidelines. The study contends that the IDSA failed to comply with adequate standards for recommendation using high-quality evidence.  For instance, low-quality evidence from non-randomized studies and expert opinions was used to support 50% of recommendations. Observational studies were used in 31%, while only 16% of recommendations were based on one or more randomized controlled trials.

It should be noted, however, that the study presented by Dr. Been on this point was published in 2010 and may not accurately represent current conditions.

Another question raised was the use of pre-print data in assessing drug efficacy and safety. A pre-print dated September 30, 2021 was referenced in a CDC article on the effectiveness of the AstraZeneca-Oxford vaccine (ChAdOx1) against SARS-CoV-2. At the time of reference, it was not peer-reviewed, a disqualifier that has continually been used against other orphan drug studies.

Do We Use Drugs Proven Ineffective in Other Studies?

Typically, if a reliable study proves that a drug is ineffective against a particular indication, the drug is precluded from use against that indication. TrialSite reminds the World Health Organization (WHO) rejected the use of remdesivir due to the results of the Solidarity trial indicating no clinical benefit in October 2020.

Nevertheless, the drug was still granted an EUA by the FDA later that month. Additionally, a July 2021 Bayesian re-analysis showed three comparable studies of remdesivir having “statistically non-significant results”. The results of these studies have not precluded the use of remdesivir in treatment of patients with COVID-19.

Comparison of Molnupiravir and Ivermectin

Dr. Been went on to compare the evidence surrounding the use of molnupiravir and ivermectin in COVID-19 treatment. The results are summarized in the table below:

Criteria Molnupiravir Ivermectin

Supporting evidence One trial – Phase II & III combined 65 studies

Peer review No peer reviewed studies as it seeks EUA 45 peer-reviewed studies

Funding Federal funds Federal Funds ACTIV-6*

Disrupts viral replication Yes Yes

Interferes with viral binding to ACE2 No Yes

Enhances interferon (IFN) levels No Yes

Anti-inflammatory None indicated in available data Yes

Claims of efficacy Study recruitment halted with claims of efficacy Efficacy shown in numerous

clinical trials

Mass production Not yet Yes

Cost $70/pill pennies/pill

EUA Moving towards EUA No EUA

Intent to use Conditional Govt. Placed orders before trial Not to be used for COVID-19

Physicians penalized

Mainstream media response Positive Attacked, use in COVID-19 barred.

Technical Information taken from Mahmud et al. study and Merck Ridgeback statement.

*TrialSite advisor Michael Goodkin as well as several others have declared that the NIH embrace of ivermectin in the ACTIV-6 trial is questionable—the dosage regimen appears too low for success, and we note the decision to include was late in the pandemic.

Impossible Expectations? 

As previously reported on TrialSite, molnupiravir has received incredible perks compared to other trial drugs including conditional orders prior to clinical trial and governmental funding. Though both ivermectin and molnupiravir demonstrate anti-viral efficacy against SARS-CoV-2, ivermectin studies are repeatedly sidelined and disqualified.

TrialSite has previously reported on the tactics of disinformation at play, including manufacturing uncertainty about science that, under other circumstances, would be considered clear-cut.

CNN demands killing healthy trees to save the planet; Evergrande collapse risks global financial chaos

In the latest eco-lunacy coming from the lamestream media, CNN is now calling for healthy trees to be cut down and buried in mass graves in order to save the planet. (It's true. Link below.) This is claimed to be a way to reduce CO2 concentrations in the atmosphere, even though CO2 is precisely the gaseous nutrient that turns the planet green and helps reforest the world. (Yes, CO2 is good for re-greening the planet, even according to NASA.) The problem with trees, says CNN, is that when they die, they rot and release CO2 back into the atmosphere. In order to stop this, trees can't be allowed to die on their own, claims CNN. Instead, they must be chain sawed to death then buried in mass graves or sunk to the bottom of lakes in order to preserve the CO2 they contain. This means the eco-lunatics who once drove metal spikes into trees to stop logging operations will probably begin cutting down trees with chainsaws while chanting "GAIA!" In California, of course, they will be limited to battery-powered chainsaws which are recharged by electricity largely generated from coal and other fossil fuels. From the CNN article demanding we cut down healthy trees: ...[S]cholars have proposed chopping down trees or collecting fallen logs and intentionally stowing them away. That could mean sinking them to the bottom of lakes, interring them in abandoned mines or burying them in specially dug trenches. How are those trenches / mass graves going to be dug? By burning fossil fuels to power bulldozers and excavators, of course. This level of dangerously delusional thinking could only come from CNN. Let's burn diesel fuel to build mass graves to bury healthy trees after chopping them down with gas-powered chainsaws, all in an effort to "save the planet." I have a better idea. Why don't the eco-lunatics just bury themselves and let the forests go on living? Only the lunatic Left could pretend that men can have babies and cutting down healthy trees is good for "greening" the planet. Their Green New Deal is truly just an eco-terrorist suicide cult. Full details in this podcast report (13 minutes): Brighteon.com/a2be818a-ea21-476c-8d9a-b442aef374d9

State of Florida Sues Biden over Vaccine Mandate

Florida’s Governor Ron DeSantis launched a lawsuit against the Biden Administration’s order requiring employees of federal contractors to be vaccinated by December 8, following through on a promise to take legal action to stop federal overreach and making Florida the first state in the nation to hold the President accountable. The lawsuit seeks an immediate end to the unlawful requirement that federal contractors ensure that all employees have received a mandated injection. The Governor was joined at the announcement by Attorney General Ashley Moody, as well as Floridians who have faced or are facing consequences as a result of vaccine mandates. The lawsuit can be found here.

 DeSantis Makes Move

“Just months ago Joe Biden was saying that it wouldn’t be appropriate or lawful for the federal government to mandate these COVID shots,” said Governor Ron DeSantis. “But now we have somehow gone from 15 days to slow the spread to 3 jabs to keep your job. The federal government is exceeding their power and it is important for us to take a stand because in Florida we believe these are choices based on individual circumstances.”

Last week, Governor DeSantis announced a Special Session of the Florida Legislature to provide protections for employees and defend the right of parents to opt their children out of school masks and quarantine mandates. The Governor has been working closely with the House and Senate as we move forward and the dates of the Special Session will be announced this week.

“Governor DeSantis has made it abundantly clear that we have a responsibility to fight back against unconstitutional federal overreach and that is exactly what we will accomplish through this lawsuit and during the upcoming Special Session,” said Lieutenant Governor Jeanette Nuñez. “We look forward to working with Senate President Simpson and House Speaker Sprowls to empower parents, provide protections for employees, and further protect our rights and liberties that we hold dear as Floridians.”

Constitutional Violations?

“I have never seen such blatant disregard for the Constitution or the laws governing our country,” said Attorney General Ashley Moody. “President Biden does not have the authority to force millions of Americans to receive a shot, nor does he have the ability to punish Florida economically for not abiding by his authoritarian, unlawful, and unconstitutional executive order. I promised to challenge this gross abuse of power and to stand up for hardworking Floridians and that is exactly why I am suing this president and his reckless administration. As Attorney General, I have an obligation to defend the rule of law, Florida’s workers, and our state against heavy-handed federal overreach.”  

“These federal mandates through the contractor relationship are creating a system that is forcing our vendors to make a choice between keeping their jobs and providing for their families or taking a jab that might not meet their own personal health needs, religious needs, or whatever it may be,” said Robert Doyle, Director of the Florida Division of Blind Services. “This is not a conversation about a vaccine. This is a conversation about federal overreach. This is a conversation about a mandate that disenfranchises people from their opportunity to pursue their goals and the American Dream. I am extremely troubled by the federal government’s actions trying to interfere with the personal healthcare decisions of our citizens and the clients that we serve. The federal government is threatening the livelihoods, the dignity, the self-respect, and the self-direction of our blind entrepreneurs. I thank Governor DeSantis for what he is doing, for standing up for the blind, and for standing up for all of the folks of Florida.”

 Real-World Impact

“I’m living with this looming date that could cause me to lose my job,” said TJ McCormick, who is visually impaired and is licensed by the Division of Blind Services as a vending and food service provider and operates in federal buildings in Tampa. “I’m a Randolph Sheppard vendor for the State of Florida. This program provides people with visual impairment a means to employment and to make money for their families. Over this last year, my customers and I have all grown so close, I think of them as my friends and family. They depend on me and I depend on them. I want to choose to work. For us to not have a choice [about getting vaccinated] is wrong.”

“My husband has been a hardworking, faithful employee with his company for 10 years and has a master’s degree,” said Olivia Gregg. “He works tirelessly to be the sole income for our family, so I can care [for] and raise our kids. This mandate has created a lot of uncertainty for our family and our future. The possibility of my husband’s job being gone in roughly five weeks is terrifying. We are living in constant fear, questioning our family’s future every single day. It shouldn’t be between a vaccine or a livelihood.”

“Governor DeSantis, I appreciate you standing up, not just for me, not even just for these people here, but we’re talking about every U.S. citizen, whether they were unvaccinated or vaccinated,” said John Freeland, a personal trainer and fitness coach from Palm Beach County. “Because the federal government, the current people in that position, are overstepping their bounds. They are choosing what they think we should all do without having our own personal choice. We are America. We are the land of the free and that capability of making our own choices is being stripped away.”

“These mandates are putting a lot of flux in play,” said Hy Hetherington, CEO of HLP Integration, an information management firm. “This [mandate] is going to affect a large percentage of the people that we have here in Lakeland. To humanize what we’re talking about today, these people care about the mission. They are sitting with us and working with us because they care about serving their fellow veterans. Now we’re putting them in a position where we can’t tell them that you’re going to still have a job doing that incredibly important work. That’s a really scary place for them. It’s a really scary place for their families. As an employer who is incredibly passionate about our veterans, I’m equally as passionate about my employees and I have to ensure throughout this that I take care of both.”

Call to Action: TrialSite will monitor the situation.

Texas A&M Discovered Inhaled Therapeutic Targeting COVID-19: A Possible Blockbuster?

Texas A&M University Health Science (Texas A&M Health) and the University of Texas MD Anderson Cancer Center report progress on a recent Phase 2 clinical trial testing PUL-042. PUL-042 is an inhaled therapeutic that might provide broad protection against several life-threatening respiratory infections. The two organizations collaborated with the study sponsor, Houston-based biotechnology company Pulmotect, Inc. to perform the trial. Results show that the investigational product shows promising efficacy targeting COVID-19.

TrialSite offers a brief breakdown of the updates of this promising nasal therapy for SARS-COV-2, the virus behind COVID-19. Recently, Lindsey Hendrix writing for Texas A&M University Health Science Center, shared promising updates.

What is the company’s hypothesis?

The inhaled version of an investigational product called PUL-042 stimulates the innate immune system of the lungs, protecting against a wide variety of respiratory pathogens. The scientists behind it think PUL-042 could be directed against all existing and future variants of the COVID-19 virus, as well as future pandemics. Based on the promising results from this trial and remarkable activity in pre-clinical models, PUL-042 also has potential for use in other patient populations.

What is PUL-042

Pulmotect’s lead investigational product, PUL-042 is a clinical-stage inhaled therapeutic that stimulates the innate immune system in the lungs to provide immediate and effective protection in animal models against all major classes of pathogens, the company reports on its website.

The company positions the drug as a first in its class, a synergistic combination of two toll-like receptor agonists. The therapy triggers the innate immune system of the surface of the lungs to inhibit and kill a wide range of respiratory pathogens.

What is the science behind targeted therapy?

Pulmotect describes on its website that when microbes (including viruses) land on the epithelial cells of the lung lining, they are destroyed on-contact by antimicrobial peptides and reactive oxygen species (ROS), which are released by epithelial cells. 

Activation of the innate immune system also triggers a response from the adaptive immune system. In preclinical models, the company reports that PUL-042 demonstrates protection against a broad range of respiratory pathogens in preclinical models, including the coronaviruses that cause MERS and SARS. 

With robust pre-clinical protection shown against multiple pathogens even in models with immunocompromised animals and favorable tolerability demonstrated in clinical trials to date, PUL-042 could offer a broad-spectrum therapy for responding to epidemics and pandemics including current and future SARS-CoV-2 variants and it has potential use for multiple other indications.  

So, to summarize, the innate immune system represents the human body’s first line of defense against invading pathogens. When germs and foreign substances enter the body, the innate immune system responds quickly to fight them off. PUL-042, the first drug in its class, is composed of two small synthetic molecules and works by stimulating specific innate immune receptors in the lung lining within minutes. Protection only lasts for about three to five days, but it can be repeatedly administered once every few days.

A Texas A&M discovery

PUL-042 was discovered by Magnus Hӧӧk, a distinguished professor at the Texas A&M Health Institute of Biosciences and Technology, and Dr. Burton Dickey, chair of the pulmonary department at MD Anderson Cancer Center.

“The lungs are the point of entry for many viruses and bacteria. By activating the innate immune defense of the lungs, PUL-042 can provide effective protection against a wide range of deadly pathogens,” Hӧӧk said. “We believe that if we had this therapy available in December of 2019, we could have prevented the COVID-19 pandemic and avoided the 6 million lives lost.”

What are the results from recent Phase 2 clinical trial?

Results from a recent phase 2 clinical trial conducted through Houston-based biotechnology company Pulmotect, Inc. showed that it may be an effective treatment for COVID-19 and other respiratory illnesses.

Patients in the trial treated with inhaled PUL-042 showed improvement in cough and shortness of breath more quickly than those who received a placebo treatment. According to this venture founded in 2007, participants in this study experienced fewer hospitalizations and intensive care admissions.

The study randomized 101 patients with early diseases in the United States. The sponsor reported the investigational product was “well tolerated when administered as a single dose on Day 1, Day 3, and Day 6 of the trial with 28 days of patient follow up.”

In a recent press release, the company shared that two of the study patients were hospitalized with deterioration from pre-treatment of two or more points on the Ordinal Scale for Clinical Improvement. A total of three (3) patients were hospitalized due to progressing COVID-19, two in the placebo group—both required intensive care treatment for 5 days and 9 days, and one patient in the study drug group was hospitalized for four days. They did not require intensive care.

Note this data is not peer-reviewed yet, so cannot be cited as a certainty.

Clinical Trials Attracts DoD Funding

The Food and Drug Administration approved Pulmotect to begin two human clinical trials of PUL-042 last year, one focused on protection and another on treatment for COVID-19. Funding support for the trials was provided by the U.S. Department of Defense.

The company announced back in January 2021 that it received $6 million to conduct two clinical trials.

Broad Antiviral Applicability?

According to Dr. Colin Broom, CEO of  Pulmotect “We have not found a virus PUL-042 cannot work against in the lungs, in animal studies.” Broom continued “As an easily administered inhaled therapy, PUL-042 could have value in reducing the impact of COVID-19 irrespective of the development of further variants. It also has potential utility for other patient populations which we plan to explore, including immunosuppressed cancer patients.”

The Sponsor

Houston-based Pulmotect was founded by Hӧӧk and colleagues at Texas A&M to commercialize this intellectual property. The biopharma develops products that boost the innate immune system to protect against a wide range of lung infections.

Formed in 2007, according to Crunchbase, Pulmotect has raised at least $28.4 million.

About Texas A&M Health Center

Part of Texas A&M University, Texas A&M Health Center offers health professions research and education in a range of categories from biomedical sciences to medicine and dentistry, and pharmacy. The academic medical center was established in 1999 as an independent institution of the Texas A&M University System—receiving accreditation in December 2002.

The center includes the Institute of Biosciences and Technology at Houston. Texas A&M offers extensive research capability.