Does viewership of a heavily edited video make it true? I have seen the famed Project Veritas video numerous times and know it’s been viewed millions of times. There is a constant swirl of noise around the video’s authenticity, the virus’s origin, gain of function (GOF) research and the speed of development of varied Covid vaccines. We will need to address the media credibility challenge more and more as technologies enable rapid evaluation of pathogen threats and the ability for innovators to respond speedily. Especially as packs of vigilante journalists are running wild and unchecked.

Wild, Unverified News is Nothing New

Wild, unverified news is nothing new. However, the speed at which it travels, thanks to technology, is the fodder for conspiracy theorists to create societal chaos. Remember, browsing magazines and papers at the supermarket check-out. The National Enquirer, the entertaining American tabloid newspaper with the wildest headlines, was a welcomed way to pass the time as the long line closed in on the cashier’s conveyor belt.

As leading daily business newspapers increasingly compete for readers and advertising dollars, they have forged ahead with digital access alternatives — often accessible only behind a paywall. Truth — verified information — suddenly comes at a (monthly subscription) cost. In most communities, gone is the young teen on their bicycle riding by and throwing your daily news onto a stoop. Yet, newspapers — the New York Times, Wall Street Journal, Washington Post, and all major newspapers always required you to pay a subscription. You tipped the paper delivery — but you paid for the truth.

Even Major Media Can Wander into the Swamp

All media can succumb to the temptation to follow some well-known “titled” pundit with an axe to grind. Remember the swamp created some years ago by a noted Midwestern physician who questioned a Food and Drug Administration-approved for-market cholesterol drug with a baseless theory causing countless people to go off their medications? His words and honed soundbites were covered by most top-tier newspapers and magazines and were amplified by headlines such as “Do Cholesterol Drugs Do Any Good?” Thankfully his pet-peeve theories were soon proven without merit. But how about the countless patients who listened, read and suffered? At what cost — some, their lives. This deadly chaos is still happening thanks to supposed investigational groups that seek to rally the mob.

We expect societal salvation at warp speed. We want life-saving solutions from pharma, policies that prop up the economy from the White House, and public health direction from CDC. When do we want it? We want it now! However, these wild, unchecked and verified videos and news sources — sometimes the voices of individuals with either no first-hand knowledge or with a desire for 15 minutes of fame — add to the pandemic of public health confusion. It is time that we awoke to the reality that conspiracy theorists are allies to the deadly virus that has taken more than six million lives worldwide.

Speed and Sensationalism

Sadly, the rapid popularity of this video is endemic to a society that thirsts for sensationalism and, at the same time, will require immediate medical solutions to future public health threats. It opens the door to these sorts of news grabbers. Media also relies on speed and speculation to attract audiences. However, as it did this time, it must now rally to reject the urge to “cover speculative and dirty news.” This specific video — its yet unproven comments — is woven into the public health risk we now face. The perfect storm of the desire for immediacy and not stopping to ask a critical question of what we see and hear: “Is it true?”

If you don’t pay, perhaps you don’t care. Or you don’t worry if the grabbing headlines that make extraordinary claims are verified or “Veritas.” For science, public health professionals, health communicators and innovators, that is a significant, life-threatening problem. At this point, “I heard it on the news” or “I saw it posted on Twitter” is akin to historical fact. Even if one person says something — a stretch of the imagination without validation — we’re inclined to believe it as “fact.”

Medicine has always been about risk/risk and risk/benefit. The risk of possible side effects alongside the risk of a deadly disease. The benefit of not dying alongside the risk of the unknown. We seem to forget what the world looked like during the COVID lockdown — mental anguish, a collapsing world economy, and ERs straining under the weight of dying patients. We celebrated clinical solutions that reduced the steady death count globally. Now, we look to poke holes in the heroes who saved lives. Enough.

Enough with (Non) Entertaining Lies

The societal desire for “I want it now” invites these sensational moments. But the ability of conspiracy theorists to rally millions of followers or readers to do more than question — to attack science and scientists — has been weaponized to make unverified video footage into the material that political leaders use for self-agenda soapbox speeches and grandstanding TV celebrities to attract viewers as if they don’t have a self-serving agenda. Project Veritas is just the newest digital version of the supermarket tabloid. Based on its track record of lies and more lies, it’s amusing. Not as the Latin translation suggests – truth.

Urgency is a double-edged sword for drug developers, pharma manufacturers, regulators and reporters. Tribal thirst for sensationalism — at all costs and speed — must never be allowed to crush the spirits of scientists who toil at lab benches trying to save lives. That would be too terrible a toil for all.

Yes, cost and speed are framing what some jump to believe as the truth. If so, without letting dedicated journalists and scientists do their jobs, people’s lives will be placed at risk again and again.

The post Covid, Conspiracies and Chaos — Media and Medicine Take Note appeared first on Medika Life.

To clarify upfront, there is no world in which the Covid shots can be compared to a vaccine. They are simply a more complex version of the flu jab you get every year if influenza poses a risk to you. Will you still catch the seasonal variety doing the rounds despite being jabbed? Absolutely, flu shots reduce the risk of flu illness between 40% and 60%, and the ensuing symptoms should be far less severe. The influenza jabs are also referred to as vaccines in literature, but they are not a vaccine either, and take advantage of the term vaccine in much the same way the Covid treatments do.

The influenza shot is also not without risk of serious adverse events (SAEs). Doctors see these SAEs frequently, but the benefits to frail and elderly community members susceptible to secondary infections from the flu virus far outweigh these risks, which are rendered negligible in an elderly or immune-compromised patient population.

Interestingly, the highest levels of protection from flu shots are enjoyed by healthy individuals, not the frail, elderly or immune compromised. Why? Well, their immune response to the jab is more robust, producing more antibodies. Ironic when you consider it is the latter patient population most in need of protection. It would be interesting to see if this response is echoed in the Covid inoculations.

Why were the Covid treatments mislabeled as “vaccines”?

This million-dollar question and one I will examine in depth in this article. Rather than looking to a single factor to explain why these treatments hijacked the term vaccine, the motivations and justifications are far more complex and additional factors combined to create what history may very well view as our greatest medical failure.

Firstly, the term mislabeled is indicative of an error, committed unintentionally. There was both intent and purpose in labelling these Covid therapies as vaccines. It was an intentional, and as I will show you in the article, calculated appropriation of the term to benefit from the trust medicine had established over generations in the word, vaccine. There were also important legal ramifications and the influenza shots had paved the way for further exploitation.

The Promise

Struck with what appeared to be the worst pandemic we had faced in a century, we existed for months in a state of fear, a fear that was carefully nurtured and managed by mainstream media, as we were later to discover, at the behest of groups like SAGE. Our Presidents and Prime Ministers, aware of their tenuous positions, offered salvation. They required a salve to soothe the populace and it took the form of a promised “vaccine” to protect you against a disease that led to a really nasty end.

Pharma was instructed to produce this miracle cure in record time. As early as February and March of 2020, three months after the initial outbreak in Wuhan, we had already been primed for the vaccine. Our expectations were set and anything other than a vaccine would have represented failure. Why? Well, because we all knew and accepted the fact that vaccines, traditionally offered complete protection against the targeted virus. It was what vaccines did, prior to the pandemic. The promised vaccine became a lifeline to many, including overtaxed and exhausted medical staff.

The Legality

Consider the fact that the original SARS virus had been with us for nearly two decades. Despite this, we had failed to produce a vaccine against it, a virus that had the potential to infect on a global scale. We understood the genetic make up of SARS intimately, even using it in illicit Gain of Function (GOF) research funded by the NIH, and performed in the very laboratory in Wuhan in China that came to represent Ground Zero for the pandemic. Yet, despite this, we still had no vaccine. At least, not officially.

In less than a month after sequencing the SARS-COV2 virus (early January of 2020), Moderna had a working mRNA vaccine. In late January of 2020, 28 days after receiving the sequencing (yes, that early), they approached the Whitehouse and CDC to begin Phase 1 trials for their so called vaccine candidate. If you’re thinking to yourself, this all seems highly suspect, then you’re not alone. Forget Warp Speed, this was interdimensional travel.

Not only was a huge headache which had plagued the mRNA industry for a decade involving a stable delivery mechanism for the the Messenger RNA solved, but Moderna had also unpicked the SARS-COV2 virus’s genetic structure and figured out how best to “stop” it by exploiting the spike protein and how it bonded with our ACE2 receptors. All in all, 28 days later, science had created a novel medicine. Either fantastically impressive or highly dubious, we may never know for certain.

To ensure maximum uptake of the new Covid treatment, whatever the motivation may have been for mass vaccination (the public narrative falsely suggested that the shot was ostensibly to reduce infection and transmission), it was essential to adopt a delivery strategy that would allow for the enforcement of the public’s use of the treatment. Vaccines are the only treatments we legally enforce on our populations. Take childhood vaccines. No vaccines, no schooling. Take travel. Visas are often dependent on certain vaccines. Some employers require you to receive certain vaccines.

Most of this legislation had been indirect, so in effect, you were not left feeling you were being coerced to vaccinate. Prior to 2021, the legal manipulations to ensure we abided by vaccine regimens were far more subtle. Post 2021, that rapidly went right out the window as governments engaged in and encouraged mandating the Covid treatments by any and every means. That despite the fact that even the FDA and the Federal government had published legal advice prior to the pandemic stating that Emergency Use Authorization medicines could not be mandated.

Back on 2021, Dr. Amanda Cohn, the executive secretary of the CDC’s Advisory Committee on Immunization Practices, was asked if Covid-19 vaccination could be required, Her answer was emphatic.

“ under an EUA, “vaccines are not allowed to be mandatory. So, early in this vaccination phase, individuals will have to be consented and they won’t be able to be mandatory.” Cohn later affirmed that this prohibition on requiring the vaccines applies to organizations, including hospitals.”

Releasing an inadequately tested and trialed medical treatment to the public is a desperate and unethical (many will argue illegal) act fraught with potential legal ramifications, the health ones aside. Particularly if said treatments are essentially genetic therapies employing a novel mechanism of action capable of producing unknown long-term effects. Pharma (in particular Moderna and Pfizer/BionTech) sought legal immunity from any government that purchased their treatments to avoid this legal minefield sought legal immunity from any government that purchased their treatments. If you took their treatment (one the very same governments insisted you use) and suffered any adverse events, you were essentially on your own.

These indemnities issued to Moderna and Pfizer spoke volumes to the potential risk they were exposing patients to. Interestingly, even after these treatments were issued full licenses by the FDA, that immunity persisted. Again, there is established precedent in the vaccine industry to issue this type of blanket immunity to pharma companies. Only in the vaccine industry. Sell your experimental treatment as anything other than a vaccine and you’re on shaky ground if the wheels come off.

For this reason, and none other, all the new mRNA based influenza jabs you will receive in the future will be labelled as vaccines. While this hasn’t yet transpired, please bookmark this and revisit the article in a years time.

Coercing the flock

It soon became apparent, by mid-2021, that the willing participation of the public to meet the required levels of immunity (remember, we were still being sold the no transmission and almost complete immunity playbook) wasn’t going as smoothly as planned. People had begun questioning the efficacy of the treatments and the side effects of mRNA treatments and traditional vaccines. Conspiracy theories abounded, some founded in science and others originating in the minds of grifters, intent on their moment of fame. Others were simply concerned about the safety and ethical motives for vaccinating the healthy segments of our populations.

Mandates were imposed, almost unanimously, by governments across the globe. Some, like the Australians, took it to the extremes, while in the U.S. you risked your work, access to basic retail services, your apartment and the very roof over your head if you chose not to “vaccinate”. Air and other public travel was restricted to the vaccinated. With hindsight, the ridiculousness of the travel restrictions, given the inefficacy of the Covid shots at preventing transmission, becomes almost laughable. Almost.

Consider how many at-risk vaccinated people contracted the virus and developed Covid, in some instances fatally, simply for the fact they believed they were protected.

Again, none of the tragedies above would have had a legal leg to stand on without the involvement of the term vaccine, coupled with a public narrative of protecting your fellow man. Shame those who wouldn’t comply and you turn society against them. It is the ultimate shameless form of coercion and manipulation and it was globally adopted. Creating a “vaccine” was key to the success of the narrative sold to the public. It was, in point of fact, the only option.

So mRNA based Covid treatments are not vaccines?

Absolutely not. If you still have trouble wrapping your head around this, allow me to summarize.

• The mRNA shots do not prevent transmission. You are still able to spread the virus once you’ve been infected.
• The mRNA shots do not prevent infection. You will still develop Covid, unlike those vaccinated against polio.
• The mRNA shots do not prevent death, they only reduce the chances of developing serious symptoms and we are uncertain of the exact percentage of their efficacy.
• The mRNA treatments require repeated doses every few months to ensure “protection” against new variants. Sounds suspiciously reminiscent of another jab, the influenza shot – also not a vaccine.

Don’t expect pharma, medicine, science and politicians to acknowledge publicly they have made mistakes. There is no walking this back and that in part, is why the narrative still continues, seemingly in its own “information vacuum”, one that appears impervious to emerging data on safety. While this article isn’t about discussing virus origins, intent and other plausible alternatives to the publicly offered narrative, these exist and cannot be discounted.

Perhaps the most important thing we can take away from this is that as of January 2023, there are zero human beings on the planet vaccinated against Covid. It is time to recognize this and to stop referring to ourselves as two camps, the #vaxxed and #unvaxxed.

Missed Part 3 of the Covid Files on mRNA? Catch up here or read Part 5, On the Origin of Covid. With apologies to Darwin here

The post When is a Vaccine not a Vaccine? appeared first on Medika Life.

Ask a room full of people any of the above and a lot of hands would go up. They would, of course, all be wrong. The reasons are relatively simple and straightforward, the logic undeniable and yet millions of Americans still pursue these drugs, in some instances forfeiting their lives in the process.

To understand why the evidence for the success of these drugs as a treatment for Covid isn’t compelling, we need to establish a few facts first. For instance, take the following question. Just how much risk is there of Covid killing you? It seems like a simple question to answer, but in truth, it is anything but.

Case Fatality Rates, CMR, and IFR

The probability that someone dies from a disease doesn’t just depend on the disease itself, but also on the treatment they receive, and on the patient’s own ability to recover from it. This makes interpreting data complex and very nuanced.

Catching SARS-CoV2 and developing Covid isn’t a death sentence, not for most of the people who contract it. Global figures based on PCR testing reflect over 222 million cases to date. Of these cases, 4.5 million have proved fatal. The press will tell you this works out roughly at a risk ratio of around 2%, commonly referred to as the Case Fatality Rate (CFR), where the number of deaths is divided by the number of cases. The press is wrong.

Not to be confused with the Crude Mortality Rate (CMR), CFR is far from perfect in determining your personal risk from Covid. There are a few problems using CFR, the most obvious being the reported number of infected in a population. Cases could underreport infections as not everyone is tested and some patients present as asymptomatic (no symptoms).

CFR can decrease or increase over time, as responses change; and that it can vary by location and by the characteristics of the infected population, such as age, or sex. For instance, older populations would expect to see a higher CFR from COVID-19 than younger ones. For similar reasons, the Crude Mortality Rate or CMR is also not a reliable indicator.

So if neither the CFR nor CMR are a good indicator for risk, where do we turn. The scientific community (not the press and media) uses another measure called the Infection Mortality Rate, or IMR. This is the number of deaths from a disease divided by the total number of cases. If 10 people die of the disease, and 500 actually have it, then the IFR is [10 / 500], or 2%.

Confused?

To work out the IFR, we need two numbers: the total number of cases and the total number of deaths, but some of you may already have figured out that we don’t know the true number of cases and probably never will. We cannot test everyone and many are, as discussed earlier, asymptomatic, so researchers will use a ‘best guess’ in their calculation. Far from ideal, but we have no other method.

Despite what some press and media reports imply, the CFR is not the same as, or, even similar to the IFR. If the CFR is 2% then in reality the IFR for Covid will be far lower. For the purposes of this piece, let’s assume it to be 1%. For every 100 confirmed Covid cases, 1 patient will die.

And that is where the rub lies for treatments of the infection, particularly treatments that rely on early-stage administration. Drugs like hydroxychloroquine and ivermectin and treatments like monoclonal antibody infusions. It is only possible to tell if these drugs work in a clinical setting.

Pepsi® is the miracle cure

If all the 100 infected patients were to self-administer Pepsi® at home, 99 would statistically survive and 1 patient would die. People would sing the praises of Pepsi® and stores would be looted as a naive population stockpiled Pepsi®, just in case. The unfortunate patient who died would have had to stop drinking Pepsi®. Being intubated has its drawbacks.

The press and general public would of course be able to extrapolate these data and expand them to reach the following conclusions. Pepsi® is effective against Covid, offering you up to 99% protection. It isn’t an effective treatment in the late stages of the disease, so make sure you order your Pepsi® early from Americas’ Frontline Doctors (AFLDS). Sound familiar?

Obviously the above is an analogy, please don’t rush out and buy Pepsi® in the mistaken belief it will help your body combat Covid. The point is that exactly the same principle applies to ivermectin and hydroxychloroquine. If 99 out of 100 people were going to survive no matter what, then arguably you could ascribe their recovery to literally anything, including Pepsi®, Coke, Dr. Pepper’s, or tap water.

There are however mouth-watering sums of money to be made out of a gullible public that has in large part lost confidence in the system. A public that is in many ways its own worst enemy, spreading news of miracle cures online and belittling science and themselves in the process.

If you are one of the true believers, I hope you’re still reading and I’d recommend reading the above again. Let it really sink in.

Clearly, this problem isn’t merely limited to ivermectin and hydroxychloroquine. It affects all early-stage treatments and there are carefully controlled situations where the real efficacy of the treatments can be assessed and monitored, but these are also fraught with pitfalls.

Is there any way of proving that drugs or treatments do help?

Yes and no. Speak to almost any frontline doctor that’s been embedded in the Covid wards since the start of the pandemic and they’ll tell you the following. HCQ and ivermectin make no difference to the mortality rate of patients in their wards.

This, you can correctly argue, could simply be because the patient is too far gone by the time they are admitted for the drugs to have any effect. True, but in that case, please refer to the preceding argument.

Ideally, patients would need to be identified in the early stages of infection, treated with the drugs, and then have the viral load in their systems monitored. This method assumes that we have established viral loads across all patient populations and variants. We cannot identify deviations from the disease’s natural progression without these control data.

Sadly, a trial of this nature would be unable to correctly identify if the treatments actually ‘cure’ the patient or if they simply speed up the patient’s natural ability to recover. Something, let’s remind ourselves, 99 out of 100 were going to do in any case. Again, this problem isn’t mutually exclusive to ivermectin and HCQ, it affects the assessment of all Covid treatments.

To be able to confirm without a doubt that a treatment is effective against the onset of death from Covid, the treatment would need to prove effective in reducing mortality in admitted patients. That is the gold standard and doctors will tell you, it doesn’t apply to either ivermectin or hydroxychloroquine.

Sorry.

Vaccines however do work. That 1% can be reduced to 0.05% if you simply get vaccinated. That’s a proven fact.

The post The Simple Truth Ivermectin and HCQ Supporters Fail to Acknowledge appeared first on Medika Life.

Immunologists have determined the process driving life-threatening inflammation, lung damage and organ failure in patients with COVID-19, sepsis and other inflammatory disorders suggesting possible treatment using existing drugs.

Date of Release: Nov. 18, 2020

MEMPHIS, Tenn /PRNewswire/ — The COVID-19 pandemic continues to cause significant illness and death while treatment options remain limited. St. Jude Children’s Research Hospital scientists have discovered a potential strategy to prevent life-threatening inflammation, lung damage, and organ failure in patients with COVID-19. The research appeared online in the journal Cell.

The scientists identified the drugs after discovering that the hyperinflammatory immune response associated with COVID-19 leads to tissue damage and multi-organ failure in mice by triggering inflammatory cell death pathways. The researchers detailed how the inflammatory cell death signaling pathway worked, which led to potential therapies to disrupt the process.

“Understanding the pathways and mechanism driving this inflammation is critical to develop effective treatment strategies,” said corresponding author Thirumala-Devi Kanneganti, Ph.D., vice chair of the St. Jude Department of Immunology. “This research provides that understanding. We also identified the specific cytokines that activate inflammatory cell death pathways and have considerable potential for treatment of COVID-19 and other highly fatal diseases, including sepsis.”

COVID-19, cytokines, and inflammatory cell death

COVID-19 is caused by the SARS-CoV-2 virus. The infection has killed more than 1.2 million people in less than one year and sickened millions more.

The infection is marked by increased blood levels of multiple cytokines. These small proteins are secreted primarily by immune cells to ensure a rapid response to restrict the virus. Some cytokines also trigger inflammation.

The phrase cytokine storm has been used to describe the dramatically elevated cytokine levels in the blood and other immune changes that have also been observed in COVID-19, sepsis and inflammatory disorders such as hemophagocytic lymphohistiocytosis (HLH). But the specific pathways that initiate the cytokine storm and the subsequent inflammation, lung damage and organ failure in COVID-19 and the other disorders was unclear. The cellular and molecular mechanisms that comprehensively define cytokine storm was also lacking.

Kanneganti’s team focused on a select set of the most elevated cytokines in COVID-19 patients. The scientists showed that no single cytokine induced cell death in innate immune cells.

The St. Jude investigators then tried 28 cytokine combinations and found just one duo that, working together, induced a form of inflammatory cell death previously described by Kanneganti as PANoptosis. The cytokines are tumor necrosis factor (TNF)-alpha and interferon (IFN)-gamma. PANoptosis is a unique type of cell death that features coordination of three different cell death pathways—pyroptosis, apoptosis and necroptosis. PANoptosis fuels inflammation through cell death, resulting in the release of more cytokines and inflammatory molecules.

The investigators showed that blocking individual cell death pathways was ineffective in stopping cell death caused by TNF-alpha and IFN-gamma. A closer look at proteins that make up the pathways identified several, including caspase-8 and STAT1, that were essential for PANoptosis in response to these cytokines. Deleting those proteins blocked PANoptosis in innate immune cells called macrophages.

Potential for repurposing TNF-alpha and IFN-gamma blockers to treat COVID-19

Because TNF-alpha and IFN-gamma are produced during COVID-19 and cause inflammatory cell death, the investigators questioned whether these cytokines were responsible for the clinical manifestations and deadly effects of the disease. They found that the TNF-alpha and IFN-gamma combination triggered tissue damage and inflammation that mirror the symptoms of COVID-19 along with rapid death.

Neutralizing antibodies against TNF-alpha and IFN-gamma are currently used to treat inflammatory diseases in the clinic. The investigators found that treatment with these antibodies protected mice from death associated with SARS-CoV-2 infection, sepsis, HLH and cytokine shock.

“The findings link inflammatory cell death induced by TNF-alpha and IFN-gamma to COVID-19,” Kanneganti said. “The results also suggest that therapies that target this cytokine combination are candidates for rapid clinical trials for treatment of not only COVID-19, but several other often fatal disorders associated with cytokine storm.”

Added co-first author Rajendra Karki, Ph.D., a scientist in the Kanneganti laboratory: “We were excited to connect these dots to understand how TNF-alpha and IFN-gamma trigger PANoptosis.” Co-first author Bhesh Raj Sharma, Ph.D., a scientist in the Kanneganti laboratory, added: “Indeed, understanding how PANoptosis contributes to disease and mortality is critical for identifying therapies.”

Redefining cytokine storm

Based on this fundamental research, Kanneganti and her colleagues have proposed a definition of cytokine storm that puts the cytokine-mediated inflammatory cell death via PANoptosis at the center of the process. The researchers noted that PANoptosis results in the release of more cytokines and inflammatory molecules, which intensifies systemic inflammation.

“We have solved a major piece of the cytokine storm mystery by characterizing critical factors responsible for initiating this process, and thereby identifying a unique combination therapy using existing drugs that can be applied in the clinic to save lives,” Kanneganti said.

The other authors are Shraddha Tuladhar, Parimal Samir, Min Zheng, Balamurugan Sundaram, Balaji Banoth, R. K. Subbarao Malireddi, Patrick Schreiner, Geoffrey Neale, Peter Vogel and Richard Webby, of St. Jude; and Evan Peter Williams, Lillian Zalduondo and Colleen Beth Jonsson, of the University of Tennessee Health Science Center.

The research was supported in part by grants (AI101935, AI124346, AR056296, CA253095) from the National Institutes of Health; and ALSAC, the awareness and fundraising organization of St. Jude.

St. Jude Children’s Research Hospital

St. Jude Children’s Research Hospital is leading the way the world understands, treats and cures childhood cancer and other life-threatening diseases. It is the only National Cancer Institute-designated Comprehensive Cancer Center devoted solely to children. Treatments developed at St. Jude have helped push the overall childhood cancer survival rate from 20% to 80% since the hospital opened more than 50 years ago. St. Jude freely shares the breakthroughs it makes, and every child saved at St. Jude means doctors and scientists worldwide can use that knowledge to save thousands more children. Families never receive a bill from St. Jude for treatment, travel, housing and food — because all a family should worry about is helping their child live. To learn more, visit stjude.org or follow St. Jude on social media at @stjuderesearch.

SOURCE St. Jude Children’s Research Hospital

The post St. Jude scientists identify possible COVID-19 treatment in the lab appeared first on Medika Life.

Yet, a study released today should — once and for all — finally shut the coffin closed on hydroxychloroquine and COVID-19. The study — the Prevention and Treatment of COVID-19 With Hydroxychloroquine (PATCH) Study — was a randomized, double-blind, placebo-controlled clinical trial was conducted at 2 tertiary urban hospitals in Pennsylvania.

They enrolled full-time hospital-based healthcare workers (physicians, nurses, certified nursing assistants, emergency technicians, and respiratory therapists) between April 9, 2020 to July 14, 2020. They planned to enroll 200 subjects.

The trial randomized 132 healthcare workers to take 600 mg of hydroxychloroquine or placebo once a day for 8 weeks, and they tested whether this treatment will prevent infection with SARS CoV-2.

The study found absolutely no difference between the groups (6.3% for hydroxychloroquine vs 6.6% for placebo). In fact, because of futility, the trial was stopped early. This is why they only randomized 132 subjects rather than the planned 200.

This should be the end of hydroxychloroquine for COVID-19.

Now, it is understandable — given the novelty of the disease and the frightening nature of its effects on patients — that clinicians wanted to try anything and everything to treat COVID-19. If there was a treatment that may help, clinicians were using it. That’s how hydroxychloroquine started.

Yet, we need to make sure that any treatment we are administering, especially one with potential significant side effects like hydroxychloroquine, actually works. That’s where randomized trials come in. They are the best way to test whether a treatment actually works.

This study was a very good trial: it was randomized, which means that the subjects were randomly assigned to the two groups. It was double-blind, which means that the investigators and the subjects didn’t know if they received treatment or placebo. And it had a placebo group.

And it showed no effect of hydroxychloroquine.

Indeed, as the study authors rightly note, the study had some important limitations:

Our study was likely established with insufficient power. Given the small sample size, we cannot exclude the possibility of an undetected modest potential prophylactic effect of hydroxychloroquine.

We did not attempt to quantify the frequency of participant exposure or specific timing of exposures.

The cohort largely comprised young healthy HCWs and thus may not be generalizable to other populations with increased risk because of advanced age or additional comorbidities.

Both study hospitals were located in Philadelphia and may not be representative of COVID-19 prevalence and exposure risk in other geographical areas.

We cannot exclude the possibility that a lower or intermittent dose of hydroxychloroquine would be more effective at prevention, although a recent preclinical investigation in a COVID-19 macaque model did not find differences in antiviral activity with varied hydroxychloroquine dosing.

Despite these limitations, I think the study is quite an important contribution to the literature surrounding hydroxychloroquine and COVID-19. There are other ongoing prophylaxis trials, and I’m eagerly awaiting those results as well.

There are some who say that hydroxychloroquine helps zinc work its effect on SARS CoV-2. I looked this up on UpToDate, a clinical resource that I frequently use to keep me apprised on the latest literature, and there is no mention of hydroxychloroquine in combination with zinc. There are other trials around the world being conducted currently testing zinc in a number of combinations. That said, here is what the authors wrote about hydroxychloroquine:

According to a preliminary, unpublished report from a large randomized trial evaluating a number of potential therapies for hospitalized patients with COVID-19, there was no difference in 28-day mortality among 1561 patients who were randomly assigned to receive hydroxychloroquine compared with 3155 patients who received standard care (26.8 versus 25 percent, rate ratio 1.09, 95% CI 0.96–1.23); hydroxychloroquine also did not decrease length of hospital stay. Based on these data, the hydroxychloroquine arm of the trial was closed.

The World Health Organization also terminated the hydroxychloroquine arm of its large SOLIDARITY trial, and the United States National Institutes of Health terminated its trial of hydroxychloroquine in hospitalized patients; each cited a lack of benefit based on preliminary data from the trials.

So, to me, this prophylaxis trial — along with other big studies — should finally put to rest hydroxychloroquine for Covid-19. It simply doesn’t work.

And…if hydroxychloroquine really worked, President Trump would have gotten it. He has received monoclonal antibodies, remdesivir, and other therapies. Hydroxychloroquine was not on the list.

References:

1. RECOVERY trial investigators. No clinical benefit from use of hydroxychloroquine in hospitalised patients with COVID-19. https://www.recoverytrial.net/news/statement-from-the-chief-investigators-of-the-randomised-evaluation-of-covid-19-therapy-recovery-trial-on-hydroxychloroquine-5-june-2020-no-clinical-benefit-from-use-of-hydroxychloroquine-in-hospitalised-patients-with-covid-19
2. NIH halts clinical trial of hydroxychloroquine https://www.nih.gov/news-events/news-releases/nih-halts-clinical-trial-hydroxychloroquine
3. WHO. “Solidarity” clinical trial for COVID-19 treatments: Update on hydroxychloroquine. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments
4. Hydroxychloroquine in patients with mainly mild to moderate coronavirus disease 2019: open label, randomised controlled trial.
   Tang W, Cao Z, Han M, et al. BMJ. 2020;369:m1849. Epub 2020 May 14.
5. Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19. Cavalcanti AB, Zampieri FG, Rosa RG, et al. N Engl J Med. 2020

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SAN RAFAEL, Calif. /PRNewswire/ — Parnell Pharmaceuticals announced that it has developed what will be the first antiviral nasal spray in the United States.  Nomovid™ Nasal Spray will be easy-to-use, low-cost and can be quickly made available over-the-counter for consumers.

Nomovid is based upon a substance licensed by Parnell from New Mexico Tech University to treat drug-resistant bacteria and fungi such as MRSA and Candida auris.  Parnell had been taking the necessary steps to enter the FDA approval process for the MRSA indication until it reportedly saw very positive results against COVID-19.  The company is now filing for the COVID-19 indication instead.

“Our product is based upon existing FDA approvals of the active ingredient for use in intravenous  and inhalation formulations for other indications. It’s also approved for inactive use, and is used in hundreds of cosmetic products today.” said Dr. Francis Parnell, Chairman and C.E.O. of Parnell Pharmaceuticals.  “It isn’t some newly-created entity where its use hasn’t already been documented and approved.  Since the nose is the main route of entry into the body of Sars-CoV-2, we have prepared it in a nasal spray.” Parnell said.

The company has submitted a White Paper to the U.S. government program Operation Warp Speed, seeking funding and an Emergency Use Authorization, which will allow the product to be manufactured and distributed while doing the necessary Phase III Clinical Trials.

About Parnell Pharmaceuticals

Parnell Pharmaceuticals, Inc. is a closely held, private pharmaceutical company founded in 1986 and headquartered in San Rafael, California with an office in Dublin, Ireland. The company develops, manufactures, and markets prescription and OTC drug products that maintain and restore mucosal and skin integrity.  The products are natural-based and patented for oral and nasal care, personal care, and anti-infective use.  Parnell products, including Mouth Kote® Dry Mouth Spray and Pretz® Nasal Spray, are marketed and distributed in North America and Europe.

parnellpharm.com

SOURCE Parnell Pharmaceuticals, Inc.

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Date of Release: Sept. 11, 2020

TAIPEI and SAN DIEGO /PRNewswire/ — Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company focused on next generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, announced today that the first patient with severe COVID-19 demonstrated remarkable recovery after treatment with the Company’s investigational drug, Silmitasertib.

On August 27, 2020, the Food and Drug Administration (FDA) approved the first emergency IND and authorized use of Silmitasertib in a patient with severe COVID-19 pneumonia requiring supplemental oxygen. The patient had been treated with multiple therapeutics, including Remdesivir, Dexamethasone, Ceftriaxone, Azithromycin and Enoxaparin within two weeks, but remained hypoxic and required up to 2 liters of supplemental oxygen daily. As none of the available therapeutics worked well for this patient, the investigator decided to try Senhwa’s investigational drug, Silmitasertib.  Within 24 hours of the first dose the patient showed significant clinical improvement and the oxygen requirement was weaned to room air. The patient was discharged from the hospital five days after starting Silmitasertib.

Marilyn Glassberg Csete, MD, Chief of Pulmonary, Critical Care, and Sleep Medicine at University of Arizona College of Medicine/Banner – University Medical Center Phoenix and Esa Rayyan, DO, her co-investigator, are now looking for five to ten more patients with severe COVID-19 to treat with Silmitasertib with a plan for a randomized clinical trial in the near future.

“This is the first person in the world to receive Silmitasertib for this novel coronavirus, and it seems to have worked,” said Dr. John Soong, the Chief Medical Officer of Senhwa Biosciences. “It is only one case, and it is still early to know how well the treatment will do in others, but if the same result is repeated in other patients, it will give us an opportunity to significantly reduce the average time of COVID-19 patient hospitalization and reduce the burden on healthcare systems,” Soong added.

“This first patient that received Silmitasertib was discharged in five days! We are encouraged by the patient’s strong response to Silmitasertib and will make every effort to provide our drug to critically ill COVID-19 patients,” said Benny T. Hu, Chairman of Senhwa Biosciences.

Banner – University Medical Center Phoenix is also planning to start a Phase 2, Investigator-Initiated Trial (IIT) of 40 patients. Another Phase 2 IIT will be conducted at the Center for Advanced Research and Education (CARE) in Gainesville, Georgia. The CARE trial will seek to enroll 10 patients once it is approved by the FDA.

About Silmitasertib
Silmitasertib is a first-in-class small molecule drug that targets CK2 and acts as a CK2-inhibitor. Silmitasertib is safe and well-tolerated in humans.  To date, three Phase I trials of Silmitasertib in cancer patients have been completed; currently, there are one ongoing Phase I and two ongoing Phase II studies of Silmitasertib.  In December 2016, Silmitasertib was granted Orphan Drug Designation by the US FDA for the treatment of Cholangiocarcinoma. In July 2020, Silmitasertib was granted Rare Pediatric Disease Designation (RPD) in Medulloblastoma by the US FDA. An eIND was granted by the US FDA on August 27, 2020 to Dr. Rayyan for use in the COVID patient treated at BUMCP.

About Senhwa Biosciences, Inc.
Senhwa Biosciences, Inc. is a leading clinical stage company focusing on developing first-in-class, next generation DDR therapeutics for patients with unmet medical needs in oncology.  Headquartered in Taiwan, with an operational base in San Diego, California, Senhwa is well positioned to oversee the development of their compounds.

Development is currently focused on two lead products Silmitasertib (CX-4945) and Pidnarulex (CX-5461) with novel mechanisms of action and for multiple indications.  Clinical trials are ongoing in Australia, Canada, United States, Korea, and Taiwan, with more currently in development. 

Visit Senhwa Biosciences for more details: www.senhwabio.com

The post Is Silmitasertib the Covid-19 Treatment Breakthrough We’ve Been Waiting for? appeared first on Medika Life.

Clinicians the world over were trying to do all that they can to help their patients suffering from COVID-19 get better. From this deep desire to help came the push for treatments such as hydroxychloroquine and now convalescent plasma.

Just because we can do something, does not mean we should do it. If a treatment can cause more harm than good, then it should not be administered, even if it “makes sense” from a logical perspective.

Well-conducted, reliable randomized studies take time, and given the breathtaking speed this pandemic is affecting the world, it is hard to wait until good data comes out either in favor or against a particular treatment.

“These trial results from diverse clinical and geographic settings suggest that in the absence of compelling contraindications, a corticosteroid regimen should be a component of standard care for critically ill patients with COVID-19.” — JAMA

Well, finally, science has provided us with an answer as to what seems to work really well for COVID-19. On September 2, multiple studies were published in JAMA with respect to steroids and outcomes in COVID-19. The most important one was a meta-analysis, which is a study of multiple randomized trial data combined, showing a statistically significant improvement in mortality for steroids in COVID-19.

Finally, science has triumphed over hype.

While the meta-analysis studied three different steroids — hydrocortisone, methylprednisolone, and dexamethasone — the strongest data indicated that dexamethasone had a 36% reduced risk of death. This data is pretty robust and reliable, and as the authors wrote:

These trial results from diverse clinical and geographic settings suggest that in the absence of compelling contraindications, a corticosteroid regimen should be a component of standard care for critically ill patients with COVID-19.

In the beginning, I admit that I was more skeptical about using steroids in COVID-19. The initial expert consensus was not to use them, as they could be harmful. Again, I didn’t want to do more harm than good. Indeed, the data with steroids and influenza are actually not good.

But now, with this data, there should be no more hesitation. Unless there is a contraindication, steroids should be part of the standard treatment for COVID-19. It doesn’t mean that it is guaranteed to work. At the same time, we should do all that we can — without known harm — to help our patients suffering from COVID-19. And it seems steroids should be part of that plan.

The post The Data Are In: Steroids Should Be Standard Of Care For COVID-19 appeared first on Medika Life.

Finding a magic cure is a surefire way to get reelected in the middle of a global pandemic. The entire world is waiting for a reliable vaccine or an effective medication to treat Covid-19.

China and Russia have already approved the limited use of COVID-19 vaccines without clinical trial data. What is to stop President Donald Trump from setting up a perfect “made for television” moment by releasing a Covid-19 vaccine just before the election?

Donald Trump is likely to release a Covid-19 vaccine under the emergency use authorization (EUA) before completing phase 3 data indicating the vaccine is safe and effective. He is expected to release the vaccine in October.

An October surprise would look good on TV but not permit enough time to discover if the vaccine works or causes harm before we cast our votes.

What is the evidence for EUA vaccine release?

The Trump administration has tested the waters. Recent EUAs have been approved for Remdesir, Convalescent Plasma, and Rapid Antigen testing. The FDA revoked a previously EUA for Hydroxychoroquin after studies showed the benefits did not outweigh the risk.

An August 27th letter from CDC director Robert Redfield urges state governors to expedite “applications for these distribution facilities and, if necessary, asks that you consider waiving requirements that would prevent these facilities from becoming fully operational by November 1, 2020.”

The US government has partnered with McKesson Corp. to distribute coronavirus vaccines to state and local health departments. We have also invested in eight different COVID-19 vaccines.

Stephen Hahn, the FDA director, published an article in JAMA stating a COVID-19 vaccine will be reviewed “under either the traditional Biologics License Application (BLA) review process or under the Emergency Use Authorization (EUA) program.”

The writing is on the wall for the Covid-19 EUA vaccine release.

How EUA works?

Countries like the United States create regulatory pathways for emergency use of vaccines and therapeutics outside of a clinical trial in the event of a public health, military, or national security emergency.

The EUA grants liability protection to pharmaceutical companies. The EUA also ends once the emergency or threat has resolved.

FDA director Stephen Hahn set the goals for a Covid-19 vaccine in a Washington Post Op-Ed stating, “any authorized or approved Covid-19 vaccine would need to show that it prevents the disease or decreases its severity in at least 50 percent of people who are vaccinated.”

What is the harm with releasing a Covid-19 vaccine under the EUA?

Andy Slavitt, the former Medicare and Medicaid director for President Barack Obama summarized the issue stating, “Done right, vaccines end pandemics. Done wrong, pandemics end vaccines.”

Vaccines require trust. We rely on regulatory agencies to oversee the clinical trials to ensure a potential vaccine is safe and effective. If we can not trust our regulatory agencies to rely on science and protect the public from political pressure, we have a potential disaster recipe.

Various governmental agencies carefully govern clinical trials. Dating back to the infamous Tuskagee study in which black men were injected with syphilis without consent, strict guidelines were put into place for ethical clinical research.

Drug trials go through three phases:

1. Phase 1 trials focus on safety and dosage.
2. Phase 2 trials evaluate efficacy and side effects.
3. Phase 3 trials are large trials seeking to prove a drug or vaccine works better than what is already available and to confirm efficacy and monitor for adverse reactions.

Releasing a vaccine without proving it does what it is supposed to do and does not cause harm is crucial to establishing trust. Without validation, we risk losing the public trusts in a Covid-19 vaccine as well as vaccines in general.

The World Health Organization (WHO) Solidarity Vaccines Trials Expert Group highlighted the dangers in an editorial published in The Lancet. An unproven or harmful vaccine could worsen the pandemic.

Vaccine makers pledge not to see FDA approval without data

In a bizarre twist, vaccine manufacturers have jointly pledged not to send a vaccine to the FDA approval without safety and efficacy data. Pfizer Inc., Moderna Inc., Johnson & Johnson, GlaxoSmithKline Plc, Sanofi, and potentially others are among the companies working together to avoid losing the public trust.

This joint pledge implies the vaccine manufacturers believe the FDA under the Trump administration can not be considered reliable to oversee the approval process.

Vaccine makers are taking a public stance against getting their own product to market.

Rushing medication to market can have grave consequences

The entire world waits on pins and needles for a magic bullet to stop COVID-19 dead in its tracks. We cheer on researchers working around the clock to find a solution, a vaccine, or a cure.

Despite our enthusiasm, we must take a cautious approach to medical research. We can not lose the public’s trust.

The FDA and CDC have made crucial mistakes cowering to political pressure. It is not too late to let the career scientists lead the way.

The post What Happens If Trump Releases a Vaccine Before Election Day? appeared first on Medika Life.

Colchicine also being evaluated as a treatment to prevent complications and death related to severe cases of COVID-19 by the Montreal Heart Institute

DATE OF RELEASE: Aug. 29, 2020

MONTREAL/PRNewswire/ — Data presented today at the virtual European Society of Cardiology (ESC) Congress late-breaking science session from the COLchicine Cardiovascular Outcomes Trial (COLCOT) shows that a daily dose of colchicine (0.5mg) on top of standard of care significantly reduces the risk of a first ischemic cardiovascular event by nearly half (48%) when given to patients within three days following a heart attack, also known as a myocardial infarction (MI)¹. These data have also been published simultaneously in the European Heart Journal¹.

The primary efficacy endpoint for COLCOT was a combination of cardiovascular death, resuscitated cardiac arrest, myocardial infarction, stroke, or urgent hospitalization for angina requiring coronary revascularization². After a median follow-up of almost two years, there was a significant reduction of 48% in the incidence of the primary endpoint for patients in whom colchicine was started 1. The beneficial effects of starting early colchicine treatment were also demonstrated for urgent hospitalization for angina requiring revascularization (HR=0.35), all coronary revascularization (HR=0.63) and the composite of cardiovascular death, resuscitated cardiac arrest, myocardial infarction or stroke (HR=0.55, all p<0.05), with reductions of 65%, 37% and 45% respectively ¹.

“Colchicine is a remarkably cost-effective and well-tolerated medication with anti-inflammatory and immunomodulatory properties,” said Dr. Jean-Claude Tardif, Director of the Research Center at the Montreal Heart Institute, Professor of Medicine at the University of Montreal, and COLCOT and COLCORONA primary investigator. “These new data not only support the benefits of colchicine in patients with coronary disease but strengthen our belief that the drug may also be a significant asset in the global fight against COVID-19 by reducing inflammatory storms in patients with the disease, preventing hospitalizations and even deaths.”

Additional pharmacogenetic data from COLCOT, also presented during the ESC virtual late-breaking session today, examined the role of genetic markers in identifying patients that may benefit from colchicine treatment following an MI³. Considering that patients receive long-term treatment with multiple drugs after a heart attack, prediction of those unlikely to benefit from a specific medication is necessary to decrease polypharmacy. These data show that there are credible genetic variants associated with cardiovascular endpoints and gastrointestinal disorder in patients treated with colchicine and that some patients might achieve a better response, with the potential for a more personalized approach to inflammation reduction for cardiovascular prevention³.

Colchicine, a potential drug to fight COVID-19

In addition to these meaningful results from COLCOT, colchicine is also being evaluated in the COLCORONA clinical trial. This multi-center, contact-less, at home study aims to determine the therapeutic benefit of colchicine as a treatment to prevent complications and death related to COVID-19. COLCORONA is one of the few current studies of COVID-19 infection in which non-hospitalized individuals can participate.

The significance of the COLCOT data and treatment with colchicine following a myocardial infarction has now been highlighted in four late-breaking science sessions at the AHA, ACC and ESC respectively over the last 10 months^1,2,3,4. These data show that not only is colchicine significantly effective in reducing the risk of first and total ischemic cardiovascular events by 23% and 34% respectively overall, but that adding colchicine 0.5mg daily to standard of care therapy following a myocardial infarction is economically dominant and may help generate significant cost-savings for healthcare systems^1,2,4.

About the COLchicine Cardiovascular Outcomes Trial (COLCOT)

Colchicine is an orally administered anti-inflammatory medication that is currently indicated for the management of pericarditis, gout, familial Mediterranean fever. COLCOT, published in the New England Journal of Medicine, was a randomized, double-blind, placebo-controlled, investigator-initiated trial comparing colchicine 0.5 mg once daily with placebo on top of standard of care in a 1:1 ratio across 167 sites in 12 countries².

About the COLCORONA Trial

COLCORONA is a randomized, double-blind, placebo-controlled clinical trial. It was initiated by Dr. Jean-Claude Tardif, Director of the MHI Research Center and Professor of Medicine at the University of Montreal and aims to determine if colchicine may prevent the phenomenon of major inflammatory storm observed in adults suffering from serious complications linked to COVID-19. The clinical trial requires the recruitment of 6000 patients who meet all the inclusion criteria and none of the exclusion criteria. Patients are randomly assigned to either colchicine or a placebo for 30 days. Evaluations by phone or videoconference then take place 15 and 30 days after the randomization. The study is monitored by a data monitoring committee (DMC) that includes experienced clinical researchers.

About the Montreal Heart Institute

Founded in 1954, the Montreal Heart Institute constantly aims for the highest standards of excellence in the cardiovascular field through its leadership in clinical and basic research, ultra-specialized care, professional training and prevention. It houses the largest research center in Canada, the largest cardiovascular prevention center in the country, and the largest cardiovascular genetics center in Canada. The Institute is affiliated with the University of Montreal and has more than 2,000 employees, including 245 doctors and more than 85 researchers.

About the Montreal Health Innovations Coordinating Center (MHICC)

The Montreal Health Innovations Coordinating Center (MHICC) is a leading academic clinical research organization and an integral part of the Montreal Heart Institute (MHI). The MHICC possesses an established network of collaborators in over 4,500 clinical sites in more than 30 countries. It has specific expertise in precision medicine, low-cost high-quality clinical trials and drug repurposing.

References:

1. Bouabdallaoui N, Tardif J-C, Walters D, et al. Time-to-treat initiation of colchicine and cardiovascular outcomes after myocardial infarction in the Colchicine Cardiovascular Outcomes Trial (COLCOT). Eur Heart J: Available at https://academic.oup.com/eurheartj/issue
2. Tardif J-C, Kouz S, Waters D, et al. Efficacy and safety of low-dose colchicine after myocardial infarction. N Engl J Med 2019; 381:2497-2505 DOI: 10.1056/NEJMoa1912388
3. Dube M-P, Legault M-A, Lemacon A, et al. Pharmacogenomics of the Efficacy and Safety of Colchicine in COLCOT. Presented by Dr. Dube at the virtual European Society of Cardiology Annual Scientific Sessions (ESC 2020), August 31, 2020.
4. Samuel M, Tardif J-C, Khairy P, et al. Cost-Effectiveness of Low-Dose Colchicine after Myocardial Infarction in the Colchicine Cardiovascular Outcomes Trial (COLCOT), Eur Heart J Qual Care Clin Outcomes. 2020 May 14;qcaa045. doi: 10.1093/ehjqcco/qcaa045.

Information about pharmaceutical products (including products currently in research) which is included in this press, release is not intended to constitute an advertisement or medical advice.

Contacts:

For COLCOT & Canadian/International media
Camille Turbide
Camille.turbide@gmail.com
+1 514 755 5354

For COLCORONA & U.S. media
Christy Maginn
Christina.Maginn@havas.com
+1 703 297-7194 

SOURCE Montreal Heart Institute

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