Tag Archives: Remdesivir

Where Do You Stand?

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By James Howard Kunstler

Source: Kunstler.com

The public health bureaucrat who styles himself as “the Science” is at it again. In his quest to eliminate the control group for his experiment in hazardous mRNA injections, Dr. Anthony Fauci reiterated his warning that the nation faces “a crisis of the unvaccinated.” Omicron is upon us, he told a US Chamber of Commerce meet-up this week, and the hospitals will soon be overwhelmed by the unvaxxed.

Oh really? In fact, the gravest threat to America’s public health is… Dr. Tony Fauci and his debauchery of medical science. This will surely come as a surprise to readers of The New York Times, who see in the two-year (so far) Covid-19 event a splendid opportunity to hasten the destruction of the US economy and our culture in order to consolidate their own power to coerce and control the population. Clear the offices! Shut down the social spaces! Make ordinary business as difficult as possible! Cancel Christmas! That’ll git’er done!

In fact, Dr. Fauci is likely responsible for a preponderance of the total 802,000 US Covid deaths — putting aside the number of people who actually died from highway accidents, cancer, diabetes, old age, and other causes, but were listed as covid deaths by hospital accounting personnel avid for federal subsidy cash.

It was Dr. Fauci who organized the suppression of easily marshaled and inexpensive early treatments for the disease, namely hydroxychloroquine, ivermectin, fluvoxamine, budesonide, azithromycin, monoclonal antibodies, Vitamin D, etc. It was Dr. Fauci who promoted the protocol of sending sick patients home from the ER without any treatment to await the further development of fatal clotting in their lungs. It was Dr. Fauci who designated the drug remdesivir — which he developed years ago for hepatitis-C (it did not work) with a financial stake in the patents — as the primary inpatient treatment for Covid-19. And then it turned out that remdesivir destroys patients’ kidneys and is ineffective anyway in late treatment of the disease when viral loads wane and spike proteins have already created the fatal capillary clots in the alveoli of the lungs and in other organs.

It’s Dr. Fauci who is responsible for the emergency use authorization on the mRNA “vaccines” that may have killed hundreds of thousands more Americans — based on the CDC’s VAERS system and statistical analysis of its inherent under-reporting at only 2.2 percent of all actual events— and you can add multiples more in non-fatal adverse reactions, including permanent disabilities. It’s Dr. Fauci who finagled the inadequate and botched trials of the mRNA vaccines in order to rush them into use. And now it’s Dr. Fauci who wants to vaxx up all the children in America, despite evidence that the mRNA shots permanently disable children’s innate natural immune systems and can cause lasting heart, blood vessel, brain, and reproductive damage, and also despite the fact that few children are susceptible to serious Covid illness in the first place.

The omicron moment may be the power-mad little weasel’s last stand. Reports so far indicate that omicron is a mild form of the virus. The one death reported to date did not include any information about the patient’s co-morbidities. For all we know, it was a motorcycle wreck with an omicron-positive label slapped on.

Dr. Fauci is now warning that America’s hospitals will be overwhelmed (and that it will be the fault of the unvaxxed). Consider this: He predicted the same thing for the first wave of the virus in the winter of 2020 and then the giant emergency hospital set-up in New York’s convention center was never used, nor was the US naval hospital ship brought up for Covid duty. Consider also: going forward, there may be more deaths from the delayed pernicious effects of the vaxxes — namely, the spike proteins which are now observed to linger in the organs and blood vessels as long as fifteen months after the shot — than deaths from the Covid-19 virus itself.

By the way, while Dr. Anthony Fauci may represent the leadership of the corrupt US public health bureaucracy, we cannot let the medical establishment itself off-the-hook for this epic fiasco of crisis mis-management. There are roughly a million doctors in America, and all but a tiny fraction of them have gone along with Dr. Fauci’s wrongful and harmful edicts. The doctors were the ones who flushed sick people out of their ERs without treatment. The doctors had to be forced by court orders to administer useful non-vaxx treatments to sick patients. The doctors continue to administer remdesivir despite its obvious toxicity and uselessness. US doctors went along with the lockdowns and the destruction of livelihoods, households, and futures. Doctors appear to support vaxx “passports” and other coercive measures. And now US doctors are going along with the malevolent effort to vaxx-up all the kids.

American doctors have proven to be cowards, cravens, zombies, and fools facilitating Dr. Fauci’s evil campaign — in concert with the rapacious pharmaceutical industry and a government in thrall to sinister forces that seek to destroy the country. The doctors have disgraced and dishonored themselves. The doctors have probably undermined their own vocations, as well as the entire armature of US health care, which they have allowed to become history’s worst racketeering operation. You can be sure it is going to collapse now, along with the equally degenerate financial system and, alas, much of the on-the-ground daily business of our country. For that you can also blame the geniuses behind “Joe Biden.”

The question is: will the people of this land submit to continued coercion and to the engineered demolition of their lives? So far, we have not rolled over like the pathetically servile Europeans and Australians. Here, there is apparently some will to resist further pushing around by this demonic elite. Several federal judges recently defined clear constitutional red-lines in their published decisions against the vaxx mandates.

Plenty of ordinary citizens are furious over the insidious and insane incursions of the political Wokery hitched to the Covid emergency — the race and gender hustles, the efforts to rig elections, the absurd spending programs aimed at countless grifting operations, the disastrous monetary inflation, and the invasion of opportunists from all over the world across our border with Mexico. Even at Christmas time, with all its transient preoccupations, it’s not too much to ask: where do you stand?

Remdesivir for Covid-19: $1.6 Billion for a “Modestly Beneficial” Drug?

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By Elizabeth Woodworth

Source: Global Research

The U.S. Department of Health and Human Services has recently “bought” all of Gilead Science’s Remdesivir for $1.6 billion. “500,000 doses at $3,200 per patient – to be available to American hospitals but not for other countries”[6] 

That’s $1.6 billion tax dollars for a virtually untested drug showing only marginal efficacy in the hospital setting.

How could such a thing happen?

Introduction

If you believe an urgent call from the Yale School of Public Health that was recently published in the American Journal of Epidemiology— the top epidemiology journal in America — hydroxychloroquine (HCQ) + azithromycin is the quickest and most effective way to halt the Covid-19 pandemic.[1]

According to this Yale statement, hydroxychloroquine – a cheap, natural anti-malarial tree-bark known as quinine for 400 years – is highly effective during Phase 1 of Covid-19, while the virus is loading into the body.

As the first line of defense, it should be immediately, freely, and widely available to symptomatic high-risk patients – through doctors’ offices, outpatient clinics, and hospitals across the land.

Indeed, under the directorship of Dr. Anthony Fauci, a National Institute of Allergy and Infectious Diseases (NIAID) a clinical trial had been launched on May 14 to look into it.[2]

The HCQ + azithromycin protocol is being used successfully by France’s top, award-winning microbiologist, Dr. Didier Raoult.  He is director of the Infectious and Tropical Emergent Diseases Research Unit in Marseille (Institut Hospitalo-Universitaire) (IHU), with 200 staff.  Raoult, now almost a celebrity in France, has recently published his protocol and results, showing an overall 1.1% case fatality rate.[3]

The same protocol has also been highly successful in China, India, Senegal, and Brazil.[4]

So why suddenly is the U.S. government and the media ignoring recommendations from these top specialists,[5] and waiting, instead, until people get very sick and hospitalized to treat them with the relatively untested drug, Remdesivir, which is administered intravenously?

Why has the U.S. Department of Health and Human Services just bought up all the Remdesivir it could order – 500,000 doses at $3,200 per patient – to be available to American hospitals but not for other countries?[6]

To put Remdesivir’s cost in perspective, the CDC reports that the flu vaccine costs from $12-$18 a dose.[7]

The government, in order to justify its mind-boggling price, would need to show exceptional efficacy in saving lives. Efficacy, that is, once the disease has been allowed, through failure to use the HCQ + azithromycinearly preventive approach, to advance to Phase 2 (the dangerous inflammatory period) and Phase 3 (ICU ventilator intubation, often leading to death).[8]

What do studies say about the efficacy of remdesivir?

There are three main studies that have examined remdesivir as a treatment for Covid-19:

  1. The first, a study of seriously ill patients, was originally reported in the New England Journal of Medicine on April 10, 2020. Treated with “compassionate-use” remdesivir, clinical improvement was observed in 36 of 53 patients (68%).

The article was co-authored by 56 people, some of whom were on the staff of remdesivir’s producer, Gilead Sciences.[9] The study was funded by Gilead, and writing assistance was provided by David McNeel, also of Gilead.[10]

The following day, April 11, the Science Media Centre published expert reactions to the compassionate study from five British university professors. These assessments were not encouraging: “the research doesn’t prove anything at this point;” “the data is almost uninterpretable;” the research should be treated “with extreme caution.”[11]

  1. A Wuhan, China randomized, double-blind, placebo-controlled trial of 237 patients was accidentally leaked by the World Health Organization and published in The Lancet. It showed no statistically significant clinical benefits from remdesivir:

“The antiviral medicine remdesivir from Gilead Sciences failed to speed the improvement of patients with Covid-19 or prevent them from dying, according to results from a long-awaited clinical trial conducted in China.” [12]

This Lancet study also found that some 14% of patients in the treatment group died after 28 days, compared to 13% in the group that did not receive the treatment.

And it further reported that “remdesivir was stopped early because of adverse events in 18 (12%) patients versus four (5%) patients who stopped placebo early.”[13]

  1. The preliminary results of a NIAID remdesivir trial of 1063 patients showed a “modest” benefit in a controlled clinical trial:

“The infected people who received remdesivir, an experimental drug made by Gilead Sciences that cripples an enzyme several viruses use to copy their RNA, recovered in an average of 11 days versus 15 in patients who received a placebo. ‘Although a 31% improvement doesn’t seem like a knockout, 100% [success], it is a very important proof of concept,’ said Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases (NIAID).”[14]

Health Policy Watch reported that “the death rate was 8% in the group that received remdesivir compared to 11.6% in the control group, although this result was not statistically significant.” Dr. Fauci told reporters that “what [this trial] has proven is that a drug can block the virus.”[15]

The excerpt below from a June 24 article in the British Medical Journal assesses the problems in the foregoing studies. (One of the four co-authors, Fiona Godlee, is the editor-in-chief of the BMJ):

“A serious imbalance in covid-19 research strongly favours the study of drug treatments over non-drug interventions, with many studies too small or too weak to produce reliable results.  Equally concerning is the release of partial or preliminary findings before peer review—often through commercial press releases—that is distorting public perceptions, ongoing evaluations efforts, and political responses to the pandemic.

Remdesivir is a key example. The antiviral drug, made by US company Gilead, was unapproved at the start of the pandemic, but in early April the New England Journal of Medicine published a small descriptive study of a compassionate use scheme for patients with covid-19. Gilead funded the study, a third of the authors were Gilead employees, and Gilead’s press release reported “clinical improvement in 68% of patients in this limited dataset.”  Despite being a non-randomised, uncontrolled, company funded study of just 53 patients, media headlines described “hopeful” signs and reported “two thirds” of patients showing improvement.[16]

Two weeks later, the Lancet published a randomised placebo controlled trial of remdesivir from China, finding no statistically significant clinical benefit in the primary outcome of time to clinical improvement. Twelve per cent of participants taking remdesivir stopped treatment early because of adverse events, compared with 5% taking placebo. The trial was stopped before meeting recruitment targets.”[17]

To summarize, the only study demonstrating even marginal efficacy for remdesivir shows it to reduce hospital recovery times 31%, from 15 days to 11 days.

What is the justification for spending $3,200 tax dollars per Covid-19 patient to save four days in hospital, unless it is to shorten hospital stays, thereby saving the average U.S. bed cost of approximately $2000 per day, while delaying hospital saturation that could leave some people untreated to die?

Leaving people untreated to die could cause civil unrest, which may be the covert political reason for spending the $1.6 billion.

None of the studies mention side effects of the drug. In the China study, kidney injury led to discontinuation for one patient, and in its use for ebola, liver risks were identified.[18]

How much does it cost to produce remdesivir?

The Institute for Clinical and Economic Review (ICER) is a non-profit organization seeking to improve healthcare value through clinical and cost-effective analyses.[19]

In a May 1, 2020 study, the ICER calculated that the cost of producing the remdesivir “final finished product,” including the pharmaceutical ingredients, formulation, packaging, and a small profit margin, was $9.32 US for a 10-day course of treatment.  They rounded this up to $10.[20]

Dr. Fauci’s NIAID Clinical Trial Evaluating Hydroxychloroquine and Azithromycin Closes Early

On June 20, 2020, nine days before the Department of Health and Human Services announced its $1.6 billion purchase of remdesivir on June 29, its NIAID branch closed a clinical trial that had been launched May 14 to investigate whether the inexpensive combination, hydroxychloroquine plus azithromycin, might be an effective treatment when given early in the course of the disease.[21]

The Department of Health and Human Services knew that hydroxychloroquine (aka chloroquine) was effective against coronavirus because chloroquine was tested against the SARS-1 virus during the outbreak in 2002. This work was written up in 2005, under the auspices of the U.S. Centers for Disease Control in Atlanta, which reports to the Department of Human Health and Services.[22]

Truth, as the saying goes, is stranger than fiction.

Who was responsible for this debacle?

Dr. Fauci has served in the National Institutes of Health under six presidents.

Were these bizarre decisions carried out under his authority? Or were they forced upon him from higher up?  Or has he become a victim of regulatory capture[23] by the drug industry?

Whatever the answer, this unprecedented fleecing of the American public should have been shouted from the rooftops, had there been a functioning US media.

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Notes

[1] Harvey A. Risch, “Early Outpatient Treatment of Symptomatic, High-Risk Covid-19 Patients that Should be Ramped-Up Immediately as Key to the Pandemic Crisis,” Amer. J. Epid, 27 May 2020 (https://academic.oup.com/aje/advance-article/doi/10.1093/aje/kwaa093/5847586). Risch is Professor at the Yale Schools of both Medicine and Public Health.

[2] National Institute of Allergy and Infectious Diseases, “NIH Begins Clinical Trial of Hydroxychloroquine and Azithromycin to Treat COVID-19,” 14 May 2020 (https://www.niaid.nih.gov/news-events/nih-begins-clinical-trial-hydroxychloroquine-and-azithromycin-treat-covid-19).

[3] Jean-Christophe Lagier, et al, “Outcomes of 3,737 COVID-19 patients treated with hydroxychloroquine/azithromycin and other regimens in Marseille, France: A retrospective analysis,” Travel Medicine and Infectious Disease, 25 June 2020 (https://www.sciencedirect.com/science/article/pii/S1477893920302817). Rault has 2,300 indexed medical journals in print.

[4] The group “COVEXIT.com – News About Hydroxychloroquine & Other COVID-19 Treatments,” was founded March 29, 2020 by Jean-Pierre Kiekens. It keeps daily track of successful Covid treatments worldwide (https://www.facebook.com/groups/covexit)

[5] Elizabeth Woodworth, “The Media Sabotage of Hydroxychloroquine Use for COVID-19: Doctors Worldwide Protest the Disaster,” Global Research, 30 June 2020 (https://www.globalresearch.ca/media-sabotage-hydroxychloroquine-covid-19-doctors-worldwide-protest-disaster/5717382).

[6] US Department of Health and Human Services, “Trump Administration Secures New Supplies of Remdesivir for the United States,” June 29, 2010 (https://www.hhs.gov/about/news/2020/06/29/trump-administration-secures-new-supplies-remdesivir-united-states.html).

[7] Centers for Disease Control and Prevention, Vaccines for Children Program, “CDC Vaccine Price List,” updated 1 July 2020 (https://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/index.html#adflu).

[8] Dr. Raoult identified the three stages of Covid-19 while treating 3,737 patients with HCQ+azithromycin at his own clinic: “At the first viral stage, one must give medicines against the virus, in the second inflammatory phase, one needs to give medications against that [inflammatory] reaction, and then in the third phase, it’s work to be done in intensive care units.” Summarized from Didier Raoult, at: “The Marx Brothers are Doing Science: the Example of RECOVERY,” 9 June 2020 (http://covexit.com/professor-raoult-compares-the-oxford-recovery-trial-academics-to-the-marx-brothers/).

[9] Jonathan Grein, and 55 other authors, “Compassionate Use of Remdesivir for Patients with Severe Covid-19,” New England Journal of Medicine, 11 June 2020 (https://www.nejm.org/doi/full/10.1056/NEJMoa2007016), “Editor’s Note: This article was published on April 10, 2020, at NEJM.org.”

[10] Jason D. Goldman, et al., “Remdesivir for 5 or 10 days in Patients with Severe Covid,” New England Journal of Medicine, no date in header (https://www.nejm.org/doi/pdf/10.1056/NEJMoa2015301?articleTools=true). Sidebar:“This article was published on May 27, 2020, at NEJM.org.”

[11] Prof. Duncan Richards et al., “Expert reaction to a study about compassionate use of remdesivir for patients with severe COVID-19,” Science Media Centre, 11 April 2020 (https://www.sciencemediacentre.org/expert-reaction-to-a-study-about-compassionate-use-of-remdesivir-for-patients-with-severe-covid-19/).

[12] Ed Silverman, et al, “New data on Gilead’s remdesivir, released by accident, show no benefit for coronavirus patients. Company still sees reason for hope,” StatNews, 23 April 2020 (https://www.statnews.com/2020/04/23/data-on-gileads-remdesivir-released-by-accident-show-no-benefit-for-coronavirus-patients/).

[13] Yeming Wang, et al., “Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial,” The Lancet, 16 May 2020 (original online publication 29 April 2020) (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31022-9/fulltext).

[14] Jon Cohen, “Large trial yields strongest evidence yet that antiviral drug can help COVID-19 patients,” Science, 29 April 2020 (https://www.sciencemag.org/news/2020/04/large-trial-yields-strongest-evidence-yet-antiviral-drug-can-help-covid-19-patients).

[15] Grace Ren, “Conflicting Remdesivir Trial Results Released; Experts Urge More Research,” Health Policy Watch, 29 April 2020 (https://healthpolicy-watch.news/first-remdesivir-rct-shows-no-significant-clinical-benefit-for-severe-covid-19-patients-but-experts-urge-for-more-research/).

[16] Christopher Rowland, “Gilead’s experimental drug remdesivir shows ‘hopeful’ signs in small group of coronavirus patients,” Washington Post, 10 April 2020 (https://www.washingtonpost.com/business/2020/04/10/gileads-experimental-drug-remdesivir-shows-hopeful-signs-small-group-coronavirus-patients/).

[17] Ray Moynihan et al.,“Commercial influence and covid-19,” BMJ2020;369:m2456 (Published 24 June 2020) (https://www.bmj.com/content/369/bmj.m2456).

[18] Crystal Phend, “Remdesivir Safety Forecast: Watch the Liver, Kidneys,” Medpage Today, 19 May 2020 (https://www.medpagetoday.com/infectiousdisease/covid19/86582).

[19] https://en.wikipedia.org/wiki/Institute_for_Clinical_and_Economic_Review

[20] Melanie D. Whittington and Jonathan B. Campbell, “Alternative Pricing Models for Remdesivir and Other Potential Treatments for COVID-19,” Institute for Clinical and Economic Review, 1 May 2020 (https://icer-review.org/wp-content/uploads/2020/05/ICER-COVID_Initial_Abstract_05012020-3.pdf).

[21] National Institute of Allergy and Infectious Diseases, “BULLETIN—NIH Clinical Trial Evaluating Hydroxychloroquine and Azithromycin for COVID-19 Closes Early,” 20 June 2020 (https://www.niaid.nih.gov/news-events/bulletin-nih-clinical-trial-evaluating-hydroxychloroquine-and-azithromycin-covid-19).

[22] Martin J. Vincent et al., “Chloroquine is a potent inhibitor of SARS coronavirus infection and spread,” Journal of Virology, 22 August 2005 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1232869/).

[23] “Regulatory capture is a theory that regulatory agencies may be dominated by the interests they regulate and not by the public interest.” In: Will Kenton, “Regulatory Capture,” Investopedia, 23 October 2019 (https://www.investopedia.com/terms/r/regulatory-capture.asp).