FDA Approved Remdesivir for 28 day old babies
By Meryl Nass, MD | April 30, 2022
Remdesivir is an IV drug. Therefore, for the past 2 years it was almost exclusively used in hospitalized patients, not outpatients.
Royalties go to Gilead, but a portion go the the NIAID, Tony Fauci’s agency and to the US Army, which assisted with its development.
Remdesivir received an early EUA (May 1, 2020) and then a very early license (October 22, 2020) despite a paucity of evidence that it actually was helpful in the hospital setting. A variety of problems can arise secondary its use, including liver inflammation, renal insufficiency and renal failure. Here is a list of articles revealing its kidney toxicity:
https://pubmed.ncbi.nlm.nih.gov/33340409/
WHO recommended against the drug on November 20, 2020.
Few if any other countries used it for COVID apart from the US. A large European trial in adults found no benefit. The investigators felt 3 deaths were due to remdesivir (0.7% of subjects who received it.)
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00485-0/fulltext
However, on April 22, 2022 the WHO recommended the drug for a new use: early outpatient therapy in patients at high risk of a poor COVID outcome:
https://www.who.int/news-room/feature-stories/detail/who-recommends-against-the-use-of-remdesivir-in-covid-19-patients
Monoclonal antibodies are only effective at the beginning of illness, as they fight the virus. After about ten days, there is no more live virus and then a later phase of the disease occurs, due to an overactive immune response. Antiviral drugs do not work during the second stage, but immune modulators do. Steroids and ivermectin are effective therapies at this stage.
Outpatient infusion centers were set up to provide monoclonal antibodies to patients at the start of COVID to those who were at high risk of a bad outcome. But now the centers are shuttered as none of them work against current COVID variants. Outpatient infusions will now be available for remdesivir, which is an antiviral drug, as a replacement.
So a new way to use remdesivir has been developed: early, when it might actually work. WHO says it does. Was WHO bought off or will it actually have a positive impact? Who knows yet?
The vast majority of COVID patients are not hospitalized until they are in the second stage of illness, which is when remdesivir, HCQ and other antivirals are not very effective, since there is no more live virus. (HCQ has some immunomodulatory actions which may explain its mild benefit at this late stage.)
The US government, which has made a series of ineffective and harmful recommendations regarding the response to COVID, has just added another harmful recommendation to the list.
The FDA just licensed Remdesivir for children as young as one month old. Both hospitalized children and outpatients may receive it. The drug might work in outpatients, but the vast majority of children have a very low risk of dying from COVID. If 7 deaths per thousand result from the drug, as the European investigators thought in the study of adults cited above, it is possible it will harm or kill more children than it saves.
Shouldn’t the FDA have waited longer to see what early outpatient treatment did for older ages? Very little has been published on children and remdesivir. FDA said very little about the approval.
When we look at the press release issued by Gilead, we learn the approval was based on an open label, single arm trial in 53 children, 3 of whom died (6% of these children died). 72% had an adverse event, and 21% had a serious adverse event.
https://investors.gilead.com/news-releases/news-release-details/vekluryr-remdesivir-first-and-only-approved-treatment-pediatric
I heard that some nurses refer to the drug as “Run, death is near.”
Based on the paucity of information FDA released with its Remdesivir approval, it appears that FDA knows very little about the drug’s benefit in children, and our children will be the guinea pigs. If we let them.
US weapons supply to Ukraine prepped in January
© Congress.gov/screenshot
Samizdat | April 29, 2022
A scheme to send US weapons to Ukraine, using the “lend-lease” formula pioneered during WWII to skirt neutrality laws, was officially approved by Congress this week. However, it was put together all the way back in January – more than a month before Moscow recognized the Donbass republics as independent and sent troops into Ukraine.
Republican Senator John Cornyn introduced the Ukraine Democracy Defense Lend-Lease Act, also known as S.3522, on January 19, 2022. This is according to the official Congress.gov page for the bill. On the same date, it was co-sponsored by senators Benjamin Cardin, Jeanne Shaheen and Roger Wicker.
Senators Richard Blumenthal and Lindsey Graham endorsed it the very next day, January 20. Other endorsements trickled in over the following weeks, with a total of 14 senators on board by February 9, again according to Congress.gov.
Russia did not recognize the independence of Donetsk and Lugansk until February 21. The “special military operation” to demilitarize Ukraine began on what was already February 24 in Washington.
Oddly enough, the Senate Foreign Relations Committee only took up Cornyn’s proposal on April 6. It was approved unanimously, proposed on the floor by Majority Leader Chuck Schumer and adopted by voice vote – whereupon it sat in limbo for weeks while the Democrat-dominated House was on vacation. On Thursday, after an hour of pro-forma debate, the House approved it in a 417-10 vote. Every single Democrat voted in favor, while all 10 dissenters were Republicans.
Supporters and critics alike have made much of the proposal, named after a WWII-era scheme to bypass neutrality laws limiting US arms exports. President Franklin Delano Roosevelt concocted lend-lease in March 1941, months before the US entered WWII, to send billions of dollars worth of weapons to Britain, and later the Soviet Union and other countries.
Cornyn’s bill, by contrast, suspends two existing US laws to make it easier for the White House to ship all sorts of weapons to Ukraine. It eliminates the five-year limitation on the program duration, suggesting the US hopes the conflict goes on for a long time – but also conditions the aid on Ukraine eventually repaying the “lease” or returning the gear if in working condition.
Cornyn has so far not revealed what might have motivated him to introduce the scheme to “protect civilian populations in Ukraine from Russian military invasion” before any military operations began.
The motivations of his first co-sponsor, Cardin, are more obvious. He is the architect of a series of anti-Russian laws, starting with the 2012 Magnitsky Act, the 2016 Global Magnitsky Act, and the 2017 CAATSA law, which tied the hands of the Trump administration in dealing with Russia.
In January 2018, at the height of the “Russiagate” craze, Cardin published a report he commissioned from the Democratic staff on the Senate Foreign Relations Committee, accusing Russia of an “assault” on “democratic and transatlantic institutions and alliances,” using “disinformation, cyberattacks, military invasions, alleged political assassinations, threats to energy security, election interference, and other subversive tactics.”
Russia attacked the neighboring state in late February, following Ukraine’s failure to implement the terms of the Minsk agreements, first signed in 2014, and Moscow’s eventual recognition of the Donbass republics of Donetsk and Lugansk. The German- and French-brokered protocols were designed to give the breakaway regions special status within the Ukrainian state.
The Kremlin has since demanded that Ukraine officially declare itself a neutral country that will never join the US-led NATO military bloc. Kiev insists the Russian offensive was completely unprovoked and has denied claims it was planning to retake the two republics by force.
D.C. Schools Can’t Vaccinate Kids 11 and Up Without Parents’ Consent Until Lawsuits Settled
The Defender | April 28, 2022
A preliminary injunction prohibiting the mayor of the District of Columbia, the D.C. Department of Health and D.C. public schools from enforcing the D.C. Minor Consent for Vaccination Amendment Act of 2020 (D.C. Minor Consent Act) will remain in place after the defendants declined to file an appeal within the required 30-day period.
The preliminary injunction reverts D.C. to the standard age of consent of 18, at least until the conclusion of the case.
The injunction stemmed from two lawsuits filed against the D.C. Minor Consent Act, which allows children 11 and older to consent to vaccinations without their parents’ knowledge or consent.
The law, passed on Dec. 17, 2020, specifically targets children whose parents filed religious exemptions for their children.
“This is a significant legal victory,” said Rolf Hazlehurst, senior staff attorney for Children’s Health Defense (CHD). “But the legal battle is by no means over.”
D.C. is the legal testing ground for mandatory vaccinations, according to Hazlehurst, which makes this a “high-stakes” battle.
“The defendants and other states are twisting and distorting the ‘mature minor’ doctrine to push the limits of government overreach at the expense of parental rights,” Hazlehurst said. “They will not abandon this tactic or their assault upon our children or parental rights.”
The two lawsuits challenging the D.C. Minor Consent Act include one filed by CHD and the Parental Rights Foundation and a second brought by Informed Consent Action Network.
Both lawsuits sought a preliminary injunction to immediately prohibit D.C. schools and public health officials from enforcing the law until the lawsuits are concluded.
During oral arguments on March 3, Hazlehurst argued the D.C. Minor Consent Act violates the Supremacy Clause of the U.S. Constitution because it contains multiple provisions that strip away the meager protections guaranteed to parents under the National Childhood Vaccine Injury Act of 1986.
Hazlehurst also argued the law violates the right to freedom of religion guaranteed by the First Amendment to the U.S. Constitution.
Hazlehurst told the court the mayor of D.C. created a “pressure-cooker environment,” enticing and psychologically manipulating minor children to defy their parents and take vaccinations against their parents’ will.
To make his point, Hazlehurst relied on a drawing, “Peer Pressure,” by a child of one of the plaintiffs. The drawing depicts the dilemma children face at school when they don’t want to get the COVID-19 vaccine.
On March 18, the U.S. District Court for the District of Columbia ordered the preliminary injunction.
In obtaining the preliminary injunction, the plaintiffs overcame a high legal hurdle that the “threatened injury must be certainly impending” as established by the U.S. Supreme Court precedent Clapper v. Amnesty Int’l, Hazlehurst said.
The court also ruled the plaintiffs in both lawsuits have legal standing based on preemption because the D.C. Minor Consent Act conflicts with the National Childhood Vaccine Injury Act.
In CHD’s case, U.S. District Judge Trevor N. McFadden made the additional finding that the plaintiffs have standing based upon the fact that they are likely to succeed on the merits that the law violates the free exercise of religion clause in the First Amendment.
“This preliminary injunction is part of ongoing litigation in an extremely important national precedent-setting case,” said Hazlehurst. “The rights of parents to decide what is best for their children’s health is at stake. Government can’t be allowed to make such decisions for minor children.”
The D.C. Minor Consent Act contains several provisions designed to deceive parents by hiding the fact that their children have been vaccinated against their parental judgment, authority or religious convictions.
The law requires healthcare providers to falsify records by leaving the child’s school vaccination records blank.
It also allows doctors to bill parents’ insurance companies for vaccines administered to children against their parents’ written directive. However, insurance companies may not send parents of those children an explanation of benefits.
US dusts off WWII scheme to arm Ukraine
Samizdat | April 28, 2022
The US House of Representatives has approved a bill that would remove several constraints on sending weapons to Ukraine amid the ongoing Russian offensive. Adopted by the Senate earlier this month, the “Ukraine Democracy Defense Lend-Lease Act” revives the program Washington used to send military equipment to belligerents in WWII while officially staying neutral.
The final vote on Thursday afternoon was 417-10, with three members not voting. All of the Democrats voted in favor, while all of the ten members opposed were Republicans.
Introduced by Senator John Cornyn (R-Texas), the bill was passed by the Senate on April 6, but the Democrat-dominated House adjourned for a two-week Easter recess before taking it up.
It authorizes the White House to “lend or lease defense articles” to Ukraine or any “Eastern European countries impacted by the Russian Federation’s invasion of Ukraine to help bolster those countries’ defense capabilities and protect their civilian populations from potential invasion or ongoing aggression.”
Cornyn’s bill does not create a new program, but rather makes it easier for President Joe Biden to send weapons to Kiev by suspending limitations imposed by two existing laws, one of which caps the length of the aid at five years.
However, the whole thing is conditioned on Ukraine having to pay for the “return of and reimbursement and repayment for defense articles loaned or leased” to it. Kiev’s ability to make such payments is questionable, since the Ukrainian government is currently asking the US and the EU for $7 billion per month just to keep paying salaries and pensions.
The lend-lease bill is separate from the ongoing US effort to send Kiev weapons from the Pentagon stockpiles. Biden has already blown through almost $3.5 billion authorized by Congress for the purpose, and is seeking more funding. However, it risks being held up if the Democrats insist on bundling it with their Covid-19 funding plan, as Republicans have warned they would only support a stand-alone bill.
“We don’t have the mechanism yet,” White House press secretary Jen Psaki told reporters on Tuesday.
The original lend-lease was enacted by President Franklin Delano Roosevelt in March 1941 – nine months before the US entered WWII – and amounted to $50.1 billion (980 billion in 2022 dollars) by September 1945, when the program ended. Most of the weapons and equipment went to the UK ($31.4 billion) with a $11.3 billion share going to the Soviet Union and another $7.4 billion to other countries. In theory, the aid was supposed to be repaid or returned, but the US accepted the lease of military bases abroad instead.
Biden’s Mammoth $33BN Ukraine Package Includes Help With Wartime Propaganda
By Tyler Durden | Zero Hedge | April 28, 2022
Politico’s Christopher Miller noted earlier that the record-smashing $33 billion spending package that the White House is proposing for Ukraine actually “dwarfs the annual defense budgets of most nations.” To which we naturally asked: how many billions of dollars does it take to turn a ‘proxy’ war into a ‘direct conflict’?
For starters it’s clear that such a massive amount of taxpayer money means that Washington clearly doesn’t expect that the war will end anytime soon, as multiple US defense and intelligence officials have recently testified. In fact General Mark Milley, the chair of the Joint Chiefs of Staff, told the House Armed Services Committee during the first week of this month that he sees this as a “very protracted conflict” to come that will be “at least measured in years.”
Biden in his Thursday rollout remarks described that the new aid package “begins the transition to longer-term security assistance.” But interestingly as part of this assistance, a key area that the US will fund is what’s essentially information warfare…
Independent journalist and media commentator Michael Tracey has pointed out…
White House fact-sheet says part of the mammoth $33 billion spending package it’s requesting for Ukraine will be to “support independent media.” Because nothing screams “independent” like being directly funded by the US Government as part of its “information warfare” initiative.
Of course, going back to at least 2014 the US government has funded such Ukraine initiatives as “citizen journalism” to push back against ‘Russian influence’ in the country.
As WikiLeaks has documented long ago, there was similarly heavy State Department and US intelligence funding of “independent” and “opposition” media in Syria in the lead-up to and during the decade-long war to try and overthrow Assad.
But this marks a huge expansion of the United States much more directly assisting Ukraine in its media and wartime propaganda efforts. The White House fact sheet detailing the scope of the security aid package spells out in a bullet point:
- Counter Russian disinformation and propaganda narratives, promote accountability for Russian human rights violation, and support activists, journalists, and independent media to defend freedom of expression.
This as “freedom of expression” is often suppressed at home, ironically enough especially targeting independent media outlets.
Also of little comfort to the US taxpayer in terms of a potential eventual path to WW3 between two nuclear armed powers is this section under a header titled Help Ukraine Defend Itself Over the Long-Term…
- A stronger NATO security posture through support for U.S. troop deployments on NATO territory, including transportation of U.S. personnel and equipment, temporary duty, special pay, airlift, weapons system sustainment, and medical support.
Ultimately this means hundreds of millions will go toward propping up “independent media” which will actually in truth be US-state funded pro-NATO information efforts.
‘US to give Ukraine more intelligence’
Samizdat | April 28, 2022
The US Director of National Intelligence Avril Haines has reportedly lifted more restrictions on intelligence-sharing with Ukraine, sources told Bloomberg on Wednesday, adding that the expanded access is aimed at helping Kiev seize the breakaway republics in Donbass.
The source claimed Haines told Congress about the expanded intel-sharing after Congressman Mike Turner (R-Ohio), the chief Republican on the House Intelligence Committee, insisted in a classified letter that the Biden administration remove any restrictions on sharing intelligence.
Turner has long criticized the administration’s backing of Ukraine as insufficiently forceful, arguing for more weapons to be sent to Kiev by claiming this would somehow prevent an “actual direct conflict” between the US and Russia. However, Moscow has called for the US and Europe to stop arming Ukraine, claiming that the growing pile of arms sent Kiev’s way amounts to a proxy war against Russia.
Republicans from the Senate Intelligence Committee had previously urged Haines to “proactively share intelligence with the Ukrainians to help them protect, defend, and retake every inch of Ukraine’s sovereign territory” – a category, they argued, that includes the Crimea peninsula and the Lugansk and Donetsk republics of Donbass.
Last week, the US reportedly lifted some of its geographic limits on transferring “actionable information,” of the sort used in making split-second decisions on the field of battle, allegedly removing language related to specific locations in eastern Ukraine. However, the directive continues to limit information regarding military forces and potential targets across the border in Russia or Belarus.
The White House has previously held back on sharing such information “because that steps over the line to making us participating in the war,” Congressman Adam Smith (D-Washington), who chairs the House Armed Services Committee, said last month. The administration has also refused to give Ukrainian President Volodymyr Zelensky the no-fly zone he initially demanded, viewing it as an escalation that would directly involve the US and NATO in the war.
However, some members of Congress have been more hawkish in their approach. Turner made a point last month of asking the NATO commander for Europe, General Tod Wolters, if he was “satisfied” with the speed at which information was reaching Ukraine.
Wolters replied that he was “comfortable” but would like to see it “speed up,” adding that he would “say that even if it occurs in one second, I want it tomorrow to be in a half a second.”
Biden regime seeks $33 billion more for Ukraine
Samizdat | April 28, 2022
US President Joe Biden has asked Congress for an additional $33 billion in funding to prop up Ukraine in the ongoing conflict with Russia. A vast part of the massive package is destined for additional military and security aid, while the rest will be used for economic and humanitarian assistance.
“The Administration is requesting $20.4 billion in additional security and military assistance for Ukraine and for U.S. efforts to strengthen European security in cooperation with our NATO allies and other partners in the region,” the white House said in a statement.
Unveiling the package during his speech at the White House, Biden said it was “critical” for the lawmakers to adopt it. “We need this bill to support Ukraine and its fight for freedom,” he said, admitting the price was not “cheap.” “But caving to aggression is going to be more costly if we allow it to happen,” he stressed.
The US administration wants the aid package to get designated as emergency spending, so that it does not have to be offset by spending cuts elsewhere. Apart from the massive aid package for Ukraine, Biden is also seeking new powers to target wealthy Russians the US administration believes to be ‘oligarchs.’
“I’m also sending to Congress a comprehensive package that will enhance our underlined effort to accommodate (sic) the Russian oligarchs and make sure we take their ill-be-gotten gains. We’re going to accommodate them, we’re going to seize their yachts, their luxury homes, their ill-begotten gains,” Biden stated, struggling with the world “kleptocracy” to describe those wealthy Russians to be targeted. “These are bad guys,” he said eventually.
If enabled, the proposed powers would allow US authorities to “streamline the process for seizure of oligarch assets,” to sell these and to funnel the proceeds to Ukraine.
The US alone has funneled more than $3 billion in military aid to Ukraine since the ongoing conflict broke out late in February. Washington’s allies poured in lavish economic and military aid to Kiev as well, with certain Western officials – including British PM Boris Johnson and top EU diplomat Josep Borrell – openly stating they wanted Ukraine to beat Russia on the battlefield.
Moscow has repeatedly warned the West against ramping up aid for Kiev, stating that this would only prolong the ongoing conflict and inflict further damage on Ukraine, as well as suffering on the country’s people.
How Selling the ‘Russia-China’ Threat Serves the US
By Salman Rafi Sheikh – New Eastern Outlook – 27.04.2022
Today, if there is one issue in the United States that draws equal support from both the Republicans and the Democrats, it is the fact that China presents the most serious threat to the US global supremacy. Related to this is the other point of agreement i.e., developing a global coalition against China. The Trump administration’s Secretary of State, Mike Pompeo, was on a mission throughout his tenure to build that coalition. The Biden administration, too, has devoted itself to the same task. Indeed, the level of deterioration we have seen in the US-China relations during the Biden era surpasses the trouble that the Trump administration caused. The same holds true about US geopolitics vis-à-vis Russia. The ongoing Russian military operation in Ukraine has allowed the US to cement its position vis-à-vis Europe.
One very useful way for the US to maintain its hegemony is through the sale of its weapons to its allies. Selling weapon systems is a multi-dimensional activity. On the one hand, the US makes billions of dollars by selling weapons. On the other hand, by selling its weapon systems to its allies, the US enhances these countries’ dependence on the US. All of this is achieved, first and foremost, by selling the China-Russia threat to the world. It is, therefore, not surprising to see that ever since the beginning of tensions between Russia and Ukraine – which began because of the US push to expand NATO to Eastern Europe to encircle Russia – the US military-industrial complex’s finances have jumped massively.
As reports in the US media have indicated, ever since the breakout of the Russia-Ukraine war, market shares of major US military companies have jumped massively, with Lockheed Martin’s registering a growth of 25% while Raytheon’s shares have gained 16.4% in the same period. For these companies, the US-created crisis is, thus, a major business opportunity. This was indeed confirmed in so many words by James Taiclet, the CEO of Lockheed Martin himself.
On January 25, in an ‘earning call’ meeting with investors, the Lockheed CEO told his that,
“If you look at the evolving threat level and the approach that some countries are taking … especially Russia today, these days, and China, there’s renewed great power competition that does include national defense and threats to it … And the contribution we can make at Lockheed Martin is to increase the efficiency and the reliability of our products that we have today for our customer. And secondly, to try to bring this 21st century digital technology to the enterprise in a way that allows us to keep up with the adversaries while we’re developing even newer and more advanced systems.”
They are minting money already in ways that complement the overall political economy of the US. The US has been providing military assistance to Ukraine – weapon systems that are supplied directly by these companies. Military assistance worth millions of dollars being provided to Ukraine is part of the total aid package of $13.6 billion for Ukraine. This aid makes the US, on the one hand, the sole ‘protector’ of Europe, and on the other, paves the way for other countries to rely more and more on the US for their defence needs. As it stands, many countries in Europe – including Germany – have adjusted their defence policies. Germany is even buying F-35 jets, thus creating many more business opportunities for the US military-industrial complex.
The exponential growth the US military-industrial complex is experiencing is not tied to the Russia-Ukraine conflict alone. The US has been effectively selling the China threat to countries that are relevant, e.g., Australia.
As some recent reports indicate, Australia is all set to purchase more weapon systems from the US to shield itself against the ‘China threat.’ On April 5, Australia’s Defense Minister Peter Dutton, referring to the ‘Russia-China threat’, said that they will be spending US$2.6 billion to increase Australia’s deterrence to potential adversaries. To quote him, “There was a working assumption that an act of aggression by China toward Taiwan might take place in the 2040s. I think that timeline now has been dramatically compressed.”
Given the so-called ‘imminent’ nature of the Chinese attack, Australia’s FA-18F Super Hornet fighter jets would be armed with improved U.S.-manufactured air-to-surface missiles by 2024.
In addition to this, Australia has also hired Raytheon Technologies and Lockheed Martin to help build guided weapon systems in the country. As reports indicate, the Australian government is planning on spending US$761 million to build a system of guided missiles.
This partnership with the US military-industrial complex is in addition to AUKUS allies’ April 5 statement that showed cooperation in the field of “hypersonics and counter-hypersonics, and electronic warfare capabilities, as well as to expand information sharing and to deepen cooperation on defense innovation.”
Importantly enough, this renewed cooperation comes against the backdrop of what the statement called “Russia’s unprovoked, unjustified, and unlawful invasion of Ukraine”, showing how the US, alongside its time-tested ally, continues to sell the ‘Russian threat’ across the Pacific to maintain what the US calls a “free and open” Pacific Ocean.
However, as the details of the profits and contracts that the US companies are generating through these very crises shows that, for the US, it is never about doing anything to maintain a ‘free’ system.’ On the contrary, it is always about benefitting the US, both geopolitically and economically.
More contracts for the US military companies means more business, which means more jobs for the Americans in those companies. The more these countries buy weapons from the US, the greater their reliance on the US for their defense and survival. This is how Washington aims to maintain its supremacy.
Salman Rafi Sheikh is a research-analyst of International Relations and Pakistan’s foreign and domestic affairs.
FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy
By Madhava Setty, M.D. | The Defender | April 27, 2022
The U.S. Food and Drug Administration (FDA) on Monday approved the use of the antiviral therapy, remdesivir, to treat COVID-19 in infants four weeks and older.
Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a press release:
“As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population.
“Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”
According to the press release, the FDA’s decision to approve the therapy, marketed under the name Veklury, is supported by a clinical study conducted on infants 4 weeks and older weighing a minimum of 6.6 pounds.
The study is underway and will not be completed until February 2023. There are no published results.
However, Gilead Sciences, maker of remdesivir and sponsor of the study, provided the following details in a company press release:
- A total of 53 hospitalized pediatric patients were enrolled in the clinical study.
- 72% suffered adverse events.
- 21% suffered serious adverse events determined to be unrelated to the drug.
- Three children died from either underlying conditions or COVID-19.
Nevertheless, Gilead Science assured that “no new safety signals were apparent for patients treated with Veklury.”
The study was of single-arm, open-label design.
A single-arm study has no control group, making it impossible to compare its effectiveness against standard of care.
Open-label means participants and investigators were aware they were receiving the drug, making it impossible to separate placebo from drug effect.
Studies show little or no benefit
Beyond the absence of any publicly available data on the efficacy and safety of this drug in humans of this age, available studies on older subjects indicate remdesivir offers no more than a meager benefit to those who survive its use.
In fact, this is why the World Health Organization (WHO) in November 2020 recommended against the use of remdesivir to treat COVID-19. The WHO only recently (April 22, 2022) updated its recommendation to support the drug’s use in patients who are at high risk for hospitalization.
Nevertheless, the FDA explains its long-standing support of remdesivir use in adults here, citing six studies that had the greatest impact on the agency’s position.
Here is a summary of the findings of each study from the FDA’s webpage:
- ACTT-1 Trial: Time to clinical recovery was shortened from 15 days to 10 through the use of remdesivir. There was no difference in mortality. The drug was no better than placebo when administered to patients who required high-flow oxygen, non-invasive respiratory support, mechanical ventilation or extracorporeal membrane oxygenation at baseline. A benefit was seen only in patients who required low levels of supplemental oxygen.
- Discovery Trial: There was no clinical benefit of remdesivir in hospitalized patients who were symptomatic for >7 days and who required supplemental oxygen. There was no difference in mortality between remdesivir and standard of care. Investigators judged three of 429 participants who received remdesivir died from the drug.
- WHO Solidarity Trial: Remdesivir did not decrease in-hospital mortality or the need for mechanical ventilation compared to standard of care. Four hundred and forty patients in this study were also enrolled in the Discovery trial above.
- Journal of the American Medical Association (moderate disease): After 10 days of treatment with remdesivir, clinical status was not significantly different from standard of care.
- New England Journal of Medicine (severe disease): No difference between five and 10 days of remdesivir treatment. No placebo group, thus “the magnitude of benefit cannot be determined.”
- PINETREE study: Three consecutive days of IV remdesivir resulted in an 87% relative reduction in the risk of hospitalization or death when compared to placebo.
As demonstrated, the first five studies used to justify the FDA’s approval of remdesivir showed little, if any, benefit to hospitalized patients with moderate or severe disease.
This is in contrast to the sufficiently proven benefit of off-label use of the previously licensed medications hydroxychloroquine and ivermectin.
Only the PINETREE study investigated the benefit of remdesivir for outpatient use. In that study, the drug provided a substantial benefit in preventing hospitalization when given in three separate doses over three days.
However, only eight individuals under the age of 18 were enrolled in the study, and none were younger than 12.
The primary endpoint, a composite of COVID-19-related hospitalization or death from any cause, did not occur in the under-18 group.
In other words, the study — funded by Gilead Sciences — showed the drug offered no benefit in this cohort.
Nevertheless, in reporting on the FDA’s approval of remdesivir for infants and young children, CNN found someone to support the FDA’s decision.
CNN wrote:
“The FDA’s approval of remdesivir for young children is ‘great,’ said Dr. Daniel Griffin, an instructor in clinical medicine and associate research scientist in the Department of Biochemistry and Molecular Biophysics at Columbia University.”
Safety ‘not established’ in pediatric patients
Not only is there scant evidence that remdesivir is an effective treatment for COVID-19, the drug’s safety is debatable.
With regard to its use in infants, even the FDA must acknowledge nobody knows how safe it is.
After all, the manufacturer’s label states:
“The safety and effectiveness of VEKLURY (remdesivir) have not been established in pediatric patients younger than 12 years of age or weighing less than 40 kg.”
With regard to pharmacokinetics (where the drug distributes in the body) the label states:
“The pharmacokinetics of VEKLURY in pediatric patients have not been evaluated.”
An indictment of the drug regulatory process
Let’s reflect on what the director of the FDA’s Center for Drug Evaluation and Research said regarding the approval of remdesivir for treating COVID-19 in infants 4 weeks and older:
“As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population. Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”
To summarize:
- Some children do not have a vaccination option.
- They need a safe and effective treatment.
- The FDA meets that need by approving a drug with no safety and efficacy record in children.
Safety and efficacy apparently can be conveniently established by fiat, not evidence.
In the end, the FDA’s approval of remdesivir is not an assurance of the drug’s safety and efficacy but an indication the agency is no longer interested in protecting the public from potentially harmful and ineffective therapies — or, in other words, in doing its job.
There will undoubtedly be doctors like Griffin who welcome this approval.
However, I don’t believe every pediatrician will accept the FDA’s guidance so readily.
It’s not easy to place an intravenous line to administer remdesivir in the tiny vein of an irritable baby coming from home with a positive rapid test. And then do it again the next day. And the day after that.
At some point, clinicians’ sensibilities will be challenged enough to compel them to actually examine how the FDA arrived at its conclusions.
Guidelines are meaningless if doctors choose not to abide by them.
Madhava Setty, M.D. is senior science editor for The Defender.
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Putin warns the US to back off in Ukraine
BY M. K. BHADRAKUMAR | INDIAN PUNCHLINE | APRIL 27, 2022
The Western narrative of the two-month old war in Ukraine imbued with the rhetoric of “democracy versus autocracy,” has dramatically changed with the assertion by the US Secretary of Defence Lloyd Austin at a news conference in Poland Monday following his and Secretary of State Antony Blinken’s trip to Kiev, that Washington wants to “to see Russia weakened.”
David Sanger at the New York Times noted that Austin was “acknowledging a transformation of the conflict, from a battle over control of Ukraine to one that pits Washington more directly against Moscow.” But this is not really a transformation. Sanger’s colleague at the Washington Post, David Ignatius, had written over three months ago that the Biden Administration was working on a road map to get Russia bogged down in Ukraine and attrition it in a way that it becomes a much diminished power on the world stage.
For the Kremlin, most certainly, Austin’s remark would not have come as surprise. As recently as on Monday, President Vladimir Putin repeated at a meeting in the Kremlin that the US and its allies have sought to “split Russian society and destroy Russia from within.” Putin revisited the topic again on Wednesday pointing out that “the forces that have been historically pursuing a policy aimed at containing Russia just don’t need such an independent and large country, even enormously large, in their view. They believe that its very existence poses a threat to them.”
In fact, several perceptive Western observers had estimated that the Kremlin has effectively fallen into a trap laid by the US that is intended to bring down Putin’s regime. Come to think of it, that famous gaffe on 26 March wasn’t a gaffe after all, when President Biden, speaking in Warsaw, had blurted out the impromptu, unscripted remark: “For God’s sake, this man (Putin) cannot remain in power.”
All the same, Austin’s remark signifies that a dramatic change is taking place in the geopolitical situation, which could have positive or negative results. On Monday, Russian Foreign Minister Sergey Lavrov warned the West that staying involved in the Russia-Ukraine war posed “serious” and “real” risks of a World War III and “we must not underestimate it.”
To be sure, the conflict is slowly but steadily turning into a new phase. Foreign fighters and soldiers from NATO regular units are increasingly beefing up the depleted Ukrainian army’s front lines.
That said, the optics also need to be understood. Austin’s war cry comes soon after Mariupol fell to the Russian forces. A couple of thousands Ukrainian nationalists and a few hundred military personnel from NATO countries are trapped in an underground labyrinth at the Azovstal complex in the city, which Russian forces have sealed off. It has been a severe blow to the US’ prestige.
The Russian special operation is on track — “grinding” the Ukrainian forces to the ground, to borrow the graphic expression from UK prime minister Boris Johnson. On Monday, Russian high-precision missiles hit at least six railway substations in Western Ukraine destroying railway facilities in Krasnoe, Zdolbunov, Zhmerinka, Berdichev, Kovel, Korosten, which were meant to be key transshipment points for the supply of Western weaponry to the Ukrainian forces in the Donbas region. Rail communication in several western regions of Ukraine is effectively blocked.
Reports from the east show that Ukrainian forces are suffering heavy losses. Russian forces have taken the city of Kremennaya and are approaching the town of Lyman, which would give them control of a direct road to Slavyansk from the east.
Austin’s hyped up rhetoric notwithstanding, Ukraine is not only not showing any signs of winning but keeps bleeding, and the territory under the actual control of the Ukrainian government is steadily shrinking. US officials admit that the Pentagon lacks the ability to track the weapons that are going in. Yet, the Biden administration has so far spent around $4 billion on Ukraine. Therein hangs a tale. Who are the real beneficiaries of the US supplies? The level of corruption in Ukraine is legion.
The plain truth is that it will be many weeks or months before meaningful volumes of heavy weapons could be delivered to Ukrainian combat units but in the meanwhile, the Battle of Donbass will be fought almost entirely on the basis of the current strength on the ground. In a detailed analysis this week, a former colonel in the US Army and prolific media commentator Daniel Davis concluded: “It will take too long for Western governments to come up with a coherent equipping plan and then prepare, ship, and deliver the kit to its destination in a timeframe that could provide Kyiv’s troops the ability to tip the balance against Russia.”
The bottom line is this: The Biden Administration’s geopolitical agenda is to prolong the military conflict, which apart from weakening Russia militarily and diplomatically, turns Europe into a battlefield and makes the continent heavily dependent on the US leadership for a very long time to come. For Biden, the war provides a useful distraction in US politics in an election year.
Austin hosted a conference of the US’ allies on Monday at the American base in Germany to form a monthly contact group on Ukraine’s self defence to coordinate the “efforts to strengthen Ukraine’s military for the long haul.” It has the ominous look of a “coalition of the willing.” Even Israel was recruited. But the US is underestimating the steely Russian resolve to fully realise the objectives behind the special operation in Ukraine. Moscow will not brook any roadblocks, no matter what it takes.
Putin issued a stern warning today: “If someone from outside moves to interfere in the current developments, they should know that they will indeed create strategic threats to Russia, which are unacceptable to us, and they should know that our response to encounter assaults will be instant, it will be quick.”
He was explicit that Russia has military capabilities that the US cannot match. “We have all the tools to do it, the tools that others can’t boast of at the moment, but as for us, we won’t be boasting. We will use them if the need arises and I would like everyone to be aware of it. We have made all the necessary decisions in this regard,” Putin warned.
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Lies are Unbekoming | October 17, 2026
On June 10, 1975, Dr. Chester Stock, a vice president at Memorial Sloan-Kettering Institute for Cancer Research, wrote to a Canadian nurse named Rene Caisse: “Enclosed are test data in two experiments indicating some regressions in sarcoma 180 of mice treated with Essiac.” The sentence sat in a letter from one of the world’s largest private cancer research centers, concerning an herbal tea an elderly English woman had learned from an Ojibwa medicine man at a northern Ontario mining camp in the 1890s. The tests were terminated the following year after Sloan-Kettering admitted, in sworn affidavit three years later, that they had prepared the injectable solution improperly from the dried material supplied — freezing and thawing the herb rather than boiling it as Rene had instructed. By the time Calling of an Angel was published in 1988, Rene Caisse had been dead for a decade, having treated thousands of cancer patients across fifty-six years in her Bracebridge, Ontario kitchen, never charging a fee, and refusing every offer — from Memorial Sloan-Kettering, the National Cancer Institute, Merck, Parke Davis, and private corporations dangling contracts up to $1 million — to release her formula before the medical establishment admitted her remedy had merit. … continue
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