Remdesivir Doesn’t Save Lives: Why Did The FDA Approve It As COVID Treatment? Profiteering & Connections Trump Health Benefits of $3,200 Per Treatment Drug Denounced by World Health Organization

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“This will be the standard of care,” Dr. Anthony Fauci announced at the White House on April 29, 2020, about the anti-viral drug remdesivir. “Whenever you have clear cut evidence that you have a drug that works, you have an ethical obligation to immediately let the people in the placebo group know so that they can have access.” The director of the National Institute of Allergy and Infectious Diseases added the results prove “that a drug can block this virus.”

The announcement came on the same day of the publication of a study in the prestigious medical journal The Lancet, which showed no statistically significant benefit from remdesivir in 237 adult patients admitted to 10 hospitals in China for severe COVID-19. A draft document of the study was accidentally published by the World Health Organization on its trials database on April 23 – six days before Fauci’s glowing recommendation.

One might assume this report would have set off alarm bells, but when Fauci was asked about the damning China study, he dismissed it as “underpowered” and “not an adequate study and everybody in the field feels that.”

Fauci’s recommendation was partially based on a study by the drug’s manufacturer, Gilead Sciences, which crucially did not compare the drug to a placebo. Without a placebo reference, there’s no way to tell how well remdesivir works. And most importantly, the study didn’t show that remdesivir reduced deaths.

Gilead’s study of 53 patients, “Compassionate Use of Remdesivir for Patients with Severe Covid-19,” was published in the New England Journal of Medicine on April 10. It disclosed 60% reported adverse events, including increased hepatic enzymes, diarrhea, rash, renal impairment, and hypotension. Serious adverse events were reported by 23% of patients. They included multiple-organ-dysfunction syndrome, septic shock, acute kidney injury, and hypotension. Seven of the patients died after the completion of remdesivir treatment.

“The data from this paper are almost uninterpretable,” Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, told Bloomberg. “There is some evidence suggesting efficacy, but we simply do not know what would have happened to these patients had they not been given the drug.”

Professor Didier Raoult, head of IHU Méditerranée Infection, Marseille’s  university hospital, posted on Twitter on April 30, 2020: “Could Anthony Fauci explain why the investigators of the NIAID remdesivir trial did change the primary outcome during the course of the project (16th April)? Removing ‘death’ from primary outcome is a surprising decision.”

In unraveling the murky trail of how a remarkably expensive drug was sold to the American public by Fauci and the Trump White House, a drug that has been found to have limited effectiveness and may actually be harming patients, and when much cheaper drugs exist, one would be hard-pressed to comprehend how Gilead Sciences got away with it. It is also worthy of scrutiny – how the major media bought into the hype and barely covered any counter reports.

Look up FDA-approved drugs to treat hospitalized patients with COVID-19, and you would find only one drug remdesivir, sold under the brand name Veklury. The monoclonal antibody drug Actemra was added under emergency use for certain patients in June 2021. Actemra is not approved as a treatment for COVID-19.

Hawaii’s KITV4 reported in October 2020: “7 out of 10 patients in Hawaii hospitalized with COVID-19 are being treated with a drug called Remdesivir. Hilton Raethel, president and CEO of Healthcare Association of Hawaii says it’s costly but effective.”

The recommendation of remdesivir to treat COVID-19 came from the National Institutes of Health Panel on COVID-19 Treatment Guidelines. Seven people on the panel had financial ties to Gilead. They include Daniel Campbell, who is on the advisory board of Gilead, and David Glidden and Eric Darr, who are consultants for Gilead.

In late June 2020, the US government purchased 500,000 treatment courses of remdesivir, which was basically the world’s supply for three months. The cost for a course – around $3,200 per treatment of six doses. It’s priced at $2,340 for countries beyond the US. (Generics manufacturers in India copied the design and priced it at $53 per vial, or $320 for a course of treatment).

In response, Senators Elizabeth Warren and Bernie Sanders slammed the Trump administration for giving Gilead Sciences a “windfall” deal. “Outside analysts have concluded that ‘The deal is amazingly good for Gilead’s executives and shareholders and amazingly bad for everyone else – bad for taxpayers, terrible for public health, and unethical,’” the lawmakers reported.

In a press conference, U.S. Rep. Lloyd Doggett announced, “Gilead is overcharging on a drug that was saved from the scrap heap of failed drugs only because of taxpayer-funded research.”

In a report, Public Citizen disclosed that that public financial support for remdesivir’s development totaled at least $70 million, through federal grants and clinical trials, and pushed for Gilead to price the treatment at $1 a day. Gilead’s price is 10 times higher than the cost-effective benchmark price ($310) suggested by the Institute for Clinical and Economic Review (ICER), given that no mortality benefit has been demonstrated for remdesivir.

A Columbia Journalism review reported – No study has shown that the drug improves mortality rates in a statistically significant manner, only a modest improvement in time to recovery – and researchers aren’t agreed even on that.”

The patent rights group Knowledge Ecology International (KEI) filed a Freedom of Information Act request to view the grants and clinical trials related to remdesivir. The National Institutes of Health (NIH) denied KEI’s request for expedited processing, stating that KEI had not demonstrated a “compelling need.”

In October 2020, the group sued the NIH because it had failed to respond. They disclosed that the ​U.S. Army, the Centers for Disease Control and Prevention and the National Institutes of Health/National Institute Allergies and Infectious Diseases either conducted or funded much of the preclinical and clinical development of remdesivir.

KEI reported in March 2020, the FDA had given Gilead a patent monopoly on remdesivir for seven years, under “orphan status” designation, as COVID-19, at the time, was a “rare disease or condition.” The patent monopoly means the FDA is not allowed to register a generic version for use for COVID-19 for seven years. The FDA told KEI, information about the patent application was “confidential.”

The Intercept discovered that Gilead had exploited a loophole that grants orphan drug status if a company files for it before the official number of cases hits 200,000.

The monopoly decision was blasted by KEI as it handed “Gilead an incredible monopoly on a potential treatment for a global pandemic, and giving them the power to charge incredibly high, national-budget breaking prices for remdesivir. “It is appalling that the FDA would hand over such a powerful monopoly in such an unprecedented time.”

On October 23, 2020, remdesivir received full approval by the FDA – one week after the World Health Organization reported their Solidarity trial among 11,266 adult patients, across 500 hospitals in more than 30 different countries, which revealed remdesivir had little to no effect on a COVID patients’ chances of survival. Gilead dismissed the WHO findings, as, at that time, they hadn’t been peer-reviewed.

Marie-Paule Kieny, director of research at the French medical research agency INSERM and a former WHO officer, reported: “It’s appalling to see how Gilead tries to badmouth the Solidarity trial. “Pretending the trial has no value because it is in low-income countries is just prejudice.” WHO’s chief scientist Soumya Swaminathan pointed out that nearly 50% of the Solidarity trial patients were from Canada and Europe

Reporting on the FDA’s full approval USA Today noted: “The U.S. Food and Drug Administration late Friday allowed the drug remdesivir to be used on all patients hospitalized with COVID-19, although no published research supports such widespread use.”

Dr. Peter Bach, an epidemiologist and director of Memorial Sloan Kettering Cancer Center’s Center for Health Policy and Outcomes, called the FDA approval “astonishing” in a tweet, criticizing the trials the decision was based on.

“Of the three included studies, one lacked control, two lacked blinding, all three lacked inclusion of current standard of care, results mixed. An entirely negative real-world (randomized controlled trial) was larger than these put together,” Bach tweeted. “‘Effective’? What?”

Cardiologist Dr. Eric Topol, at the Scripps Research Institute in La Jolla, California said, “It seems to be a pattern of approval without science, without data, without evidence. Topol said he was appalled by the expanded approval of the drug. “There are no data to support wide use of remdesivir. This is extraordinary.”

Dr. Topol posted on Twitter – “If FDA had put Remdesivir out to an external panel review it would never have received a full approval.”

Remdesivir was initially FDA-approved for COVID-19 principally on the basis of one double-blind, randomized control trial. In contrast, results from a larger randomized control trial conducted by the WHO found no significant difference in mortality between patients treated with remdesivir compared to those treated with the standard-of-care prompting the global organization to recommend against using remdesivir for COVID-19.

In late August 2020, the WHO noted a disproportionately high number of reports of liver and kidney problems in patients receiving remdesivir compared with patients receiving other drugs for COVID-19.

At the end of October 2020, Gilead announced that remdesivir had already earned nearly $900 million in the third quarter. Sales were bolstered by the European Commission signing a contract with Gilead – before the WHO report – for 500,000 treatment courses, a deal potentially worth more than $1 billion.

The WHO reported near the close of November 2020: “The antiviral drug remdesivir is not recommended for patients admitted to hospital with Covid-19, regardless of the severity of their disease, as there is currently no evidence that it improves the survival or that it avoids being placed on artificial ventilation.” The decision arrived after the opinion of its panel of experts, whose conclusions were published in the medical journal BMJ. The experts also stressed “the possibility of significant side effects” of the drug.

Commenting on the WHO study, University of Oxford Prof. Peter Horby told CNN, “Remdesivir is an expensive drug that must be given intravenously for five to ten days, so this recommendation will save money and other healthcare resources.”

So how did this dodgy drug get emergency approval? Remdesivir was FDA-emergency approved principally on the basis of one double-blind, randomized control trial.

Remdesivir had previously been touted as an aid for Ebola. After a study showed it didn’t work, it was repositioned as an emergency COVID treatment. Drug repositioning involves repurposing an active pharmaceutical ingredient that is already on the market for a new indication.

A review, “Why Remdesivir Failed: Preclinical Assumptions Overestimate the Clinical Efficacy of Remdesivir for COVID-19 and Ebola” was published in Antimicrobial Agents and Chemotherapy, on July 12, 2021. “The clinical efficacy of remdesivir for COVID-19 remains contentious, as several trials have not found statistically significant differences in either time to clinical improvement or mortality between remdesivir-treated and control groups.

“Similarly, the inability for remdesivir to provide a clinically significant benefit above other investigational agents in patients with Ebola contrasts with strong, curative preclinical data generated in rhesus macaque models. For both COVID-19 and Ebola, significant discordance between the robust preclinical data and remdesivir’s lackluster clinical performance have left many puzzled. Had the limitations of in vitro drug efficacy testing and species differences in drug metabolism been considered, the underwhelming clinical performance of remdesivir for both COVID-19 and Ebola would have been fully anticipated.”

During a 2018 Ebola outbreak in the Democratic Republic of the Congo, remdesivir was dropped from clinical trials after it was found to be less effective at improving survival rates than two monoclonal antibody therapies.

The mortality rate in the remdesivir treatment group was 53% – the highest death rate of the drugs being tested. One patient died after receiving remdesivir. The Congo Ebola clinical trial was sponsored by the National Institute of Allergy and Infectious Diseases, of which Fauci is the director.

Fast forward to the Chinese study. Remdesivir was stopped early in 18 patients because of side effects including liver damage, low blood pressure, nausea, and vomiting. After a month, 13.9% of the patients on remdesivir had died compared to 12.8% of those in the control group. The difference was seen as not statistically significant.

The controversial drug was highlighted in a Science magazine expose, published in October 2020, with the sub-heading – “The Food and Drug Administration held no advisory meeting, and the European Union signed contract without knowing of failed trial.”

“The EU and U.S. decisions pave the way for Gilead’s drug into two major markets, both with soaring COVID-19 cases,” Science reported. “Both decisions baffled scientists who have closely watched the clinical trials of remdesivir unfold over the past 6 months -and who have many questions about remdesivir’s worth.

The magazine discovered the “FDA never consulted a group of outside experts that it has at the ready to weigh in on complicated antiviral drug issues. That group, the Antimicrobial Drugs Advisory Committee… review all available data on experimental treatments and make recommendations to FDA about drug approvals – yet it has not convened once during the pandemic.

“The European Union, meanwhile, decided to settle on the remdesivir pricing exactly one week before the disappointing (WHO) Solidarity trial results came out. It was unaware of those results, although Gilead, having donated remdesivir to the trial, was informed of the data on 23 September and knew the trial was a bust.”

“This is a very, very bad look for the FDA, and the dealings between Gilead and EU make it another layer of badness,” said cardiologist Dr. Eric Topol.

In late 2020, a review, “Remdesivir and Acute Renal Failure,” by French researchers in Clinical Pharmacology & Therapeutics, using the WHO’s VigiBase data, found a link between remdisivir and acute renal (kidney) failure. Between February 1, 2020, and August 7, 2020, 138 cases of the broad SMQ “acute renal failure” associated with remdesivir were reported in VigiBase. The most often specifically reported effects were acute kidney injury.

Another group of French researchers also uncovered serious kidney issues with remdesivir. Published in Kidney International journal, they reported: “Our findings, based on postmarketing real-life data from >5000 COVID-19 patients, support that kidney disorders, almost exclusively AKI (acute kidney injury), represent a serious, early, and potentially fatal adverse drug reaction of remdesivir.” They noted that kidney injuries were observed in animal studies during remdesivir’s development. The European Medicines Agency reported its safety panel found no evidence that remdesivir caused kidney problems.

In April 2021, Public Citizen urged the FDA to convene an expert panel to discuss rescinding approval for Gilead’s remdesivir as a COVID-19 treatment. They announced: “The FDA approved the drug despite being aware of evidence from a major clinical trial that raised substantial doubts about whether the drug provides clinically meaningful benefit and without convening a public advisory committee meeting, as the agency routinely does prior to approving such new drugs.”

The FDA responded – “Due to the rigorous design of the ACTT-1 clinical trial in which Veklury (remdesivir) demonstrated a robust, statistically significant treatment benefit compared to placebo for the clinically meaningful primary efficacy endpoint of time to recovery, we determined that there were no issues that necessitated referral to an advisory committee. The FDA carefully considered the results from (the W.H.O.’s) Solidarity and concluded that they do not refute the persuasive evidence of effectiveness from the randomized, placebo-controlled ACTT-1 trial.”

An article by French sociologist Laurent Mucchielli in the Journal of Sociology, examining corruption in science, noted that Gilead “over the last 10 years or so, has developed a strong strategy of influence peddling and many members of the public authorities are in a potential conflict of interest situation. The Covid-19 debate conforms to a well-worn pattern of behaviour: public backlash over the transgressions of wealthy corporate actors, government regulatory responses insisting on greater levels of transparency, corporate circumvention of said regulations, resulting in the continuation of fraud and corruption.”

Mucchielli revealed that Gilead is estimated to have spent $65 million over the last seven years to establish its influence in France, both with practitioners and institutions. He concluded “fraud persists and corruption is still at play.”

At the European Parliament, French politician Virginie Joron requested the European Anti-Fraud Office open an investigation into remdisivir and “Gilead’s falsification, concealment and adulteration of information it provided to the Commission.”

German physician and epidemiologist Dr. Wolfgang Wodarg, warned in an interview with the German Corona Committee that “remdesivir is very toxic. It was very dangerous in Ebola.” Referencing the poor outcome with the Ebola trial, he said, “if you give remdesivir a healthy person he will ultimately be damaged.” Dr. Paul Marik, Professor of medicine at Eastern Virginia Medical School, has called remdesivir a “particularly useless drug.”

In May 2021, chairman of New Delhi’s Ganga Ram Hospital, Dr D.S. Rana, told news agency ANI, that remdesivir is being considered to be dropped from Covid-19 treatment as there is no evidence of its effectiveness in treating COVID patients.

Negative reports continue to mount. On June 3, 2021, IHU Méditerranée Infection Professor Raoult posted on Twitter – “The drug that is toxic to the heart and causes arrhythmias is remdesivir, not hydroxychloroquine, according to this analysis carried out by pharmacologists in Paris using data from the WHO. The truth finally comes out!”

Professor Raoult was referencing a review in Clinical Microbiology and Infection, in May 2021, “Serious bradycardia and remdesivir for coronavirus 2019 (COVID-19): a new safety concerns.” “In recent clinical trials some cardiac arrhythmias were reported with use of remdesivir for COVID-19. We found 302 cardiac effects including 94 bradycardia (31%) among the 2603 reports with remdesivir prescribed in COVID-19 patients.

Most of the 94 reports were serious (75, 80%), and in 16 reports (17%) evolution was fatal. The use of remdesivir was associated with an increased risk of reporting bradycardia.” Bradycardia can be life-threatening if the heart is unable to maintain a rate that pumps enough oxygen-rich blood throughout the body.

The French review referenced the initial 2020 Chinese study that Fauci dismissed. “In the first COVID-19 clinical trial, another cardiac arrest was reported in a patient exposed to remdesivir.” On the study that gave the green light for the FDA: “In the Adaptive Covid-19 Treatment Trial (ACTT-1), more cardiac arrhythmias occurred with the use of remdesivir than with placebo (8% versus 2%).”

And most tellingly, “Among these cardiac reports, we found bradycardia reports mainly from the United States (93%).” At the time, the US was the only nation where remdesivir was being used to treat COVID-19.

Interestingly, bradycardia related to Covid-19 is a commonly reported complication. Bradycardia in Covid-19 patients might happen despite no prior history of occurrence. High incidence of cardiac arrhythmias has become a part of cardiac manifestations related to Covid-19 infection.

On June 9, 2021, Professor Raoult posted a comparative table between remdesivir and hydroxychloroquine, showing hydroxychloroquine is easily more beneficial for COVID. “What happened to make remdesivir preferred? Blindness? Stupidity? Corruption ? Inability to recognize mistakes? Something else?”

A Norwegian study published in July 2021, in the Annals of Internal Medicine, looked at the impact of remdesivir and hydroxychloroquine on mortality. They found there were no significant differences among the treatment groups regarding mortality during hospitalization. “The lack of antiviral effect was not associated with symptom duration, level of viral load, degree of inflammation, or presence of antibodies against SARS-CoV-2 at hospital admittance,” according to the researchers.

Dr. Andreas Barratt-Due, at the immunology department at the University of Oslo, suggested the findings should “probably (make) the FDA reconsider its decision” regarding remdesivir.

Also in July 2021, a review by Dr. Michael Ohl, associate professor of internal medicine in the University of Iowa Carver College of Medicine, found that not only was remdesivir not associated with improved survival, but it was associated with longer patient hospital stays, without clear improvements in survival. The observational study tracked outcomes for 2,344 hospitalized adults with COVID-19 in 123 VA hospitals. Dr. Ohl reported, “clinicians may have been keeping people in hospital to complete five- and 10-day remdesivir courses, contributing to longer length of stay.”

A Japanese study published in early September 2021, found there is limited evidence regarding its effect in the early stage of non-severe COVID-19 cases. It had no positive effect on the clinical outcome and reduction of IMV/ECMO (invasive mechanical ventilation or extracorporeal membrane oxygenation) requirement.

As America continues to march on widely dispensing remdesivir, a Phase 3 DisCoVeRy clinical trial published in The Lancet Infectious Diseases on September 14, 2021, compared remdesivir plus standard of care versus standard of care alone. The French researchers concluded: “No clinical benefit was observed from the use of remdesivir in patients who were admitted to hospital for COVID-19, were symptomatic for more than 7 days, and required oxygen support.”

They noted: “Three deaths (acute respiratory distress syndrome, bacterial infection, and hepatorenal syndrome) were considered related to remdesivir by the investigators.” The randomized, controlled trial was conducted in France, Belgium, Austria, Portugal, and Luxembourg.

In February this year, Gilead forecast 2021 sales of up to $3 billion for remdesivir. Interviewed by NBC News senior business correspondent Stephanie Ruhle, Gilead CEO Daniel O’Day cheerily announced in April: “One out of two (COVID) patients in the hospital are receiving remdesivir.”

Gilead also produces the very expensive drug Harvoni for Hepatitis C. An eight-week treatment course costs approximately $65,000, while a 12-week course costs $98,500. Investigative journalist Dilyana Gaytandzhieva revealed Gilead paid $178 million to US doctors and hospitals to promote its drugs despite patient deaths from the antiviral Harvoni.

Gilead also produces the HIV drug Truvada, which costs $6 to manufacture, and costs almost $2,000 a month in the U.S.

It’s worth remembering that Gilead co-developed the flu drug, Tamiflu. A U.K. report disclosed a landmark Cochran analysis found that during the swine flu outbreak in 2009, hundreds of millions of British pounds was wasted on the drug that worked no better than paracetamol (tylenol).

One of the report’s authors, Carl Heneghan, Professor of Evidence-Based Medicine at the University of Oxford, told the BBC: “I think the whole £500 million ($680 million) has not benefited human health in any way and we may have harmed people.”

Dr. Fiona Godlee, editor-in-chief of the BMJ, published an editorial: “Covid-19: The lost lessons of Tamiflu,” in Dec 30, 2020. Dr. Godlee wrote: “The history of the covid-19 pandemic will be strewn not only with lost lives and livelihoods but with the bloated carcasses of treatments hyped and bought at great expense, only to be found wanting.

“The remdesivir story shares many common features with the saga of Tamiflu, the drug that cost the world billions of dollars during the 2009 swine flu pandemic. Both drugs had failed in earlier settings. At the start of the pandemics both were hyped on limited, poor quality research, mainly funded by drug companies. Both were bought in large amounts by governments without data to back up their purchase. Both have harms that have been inadequately researched and reported.”

Besides the drug’s limited efficacy, the Trump administration’s embrace of Gilead’s remdesivir is quite astonishing considering the company’s legal challenges.

Gilead was sued by the by the Justice Department in 2019 for patent infringement, asserting that Gilead made billions of dollars on HIV prevention therapy while repeatedly ignoring government patents for Truvada.

In 2019, Gilead was hit with a whistle-blower suit accusing it of paying healthcare providers to boost sales of its hepatitis and HIV drugs. Also in 2019, a federal class action lawsuit against Gilead, alleged the company violated antitrust laws and established an HIV treatment monopoly.

Then on September 23, 2020, The Department of Justice announced that Gilead had been fined $97 million, following an FBI investigation. The company agreed to pay $97 million to resolve claims that it violated the False Claims Act by illegally using a foundation as a conduit to pay the copays of thousands of Medicare patients taking Gilead’s pulmonary arterial hypertension drug, Letairis.

The same week, the nation’s two largest pharmacy chains, CVS and Rite Aid sued Gilead in a civil antitrust suit for suppressing and delaying generic competition for some of Gilead’s HIV-fighting medications and other drugs. According to the lawsuit, Gilead and Bristol-Myers used “reverse payments” to force insurers and consumers to overpay hundreds of millions of dollars for the drugs. Gilead CEO Daniel O’Day has been charged in the suit of “anticompetitive behavior” that forced insurers and consumers to overpay for its HIV drugs.

Public Citizen’s Zain Rizvi told The Intercept: “Gilead is notorious for price gouging.”

Gilead is now formulating an oral version of remdesivir, which the company reports can “significantly improve outcomes in SARS-CoV-2 infected mice.”

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Jon Woodhouse

Jon Woodhouse is the Managing Editor of The Maui Independent. Moving to Maui 36 years ago, he feels blessed daily to live here. He writes weekly for The Maui News and has worked for the Department of Education since 2001.

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