At the Presidential Briefing on April 30, Dr. Anthony Fauci announced early results, prior to peer-review, of one clinical trial using remdesivir, an intravenous (IV) experimental antiviral medicine in patients hospitalized with SARS-CoV-2 (COVID-19). At the “warp speed” currently in vogue for the Fauci-led push to a new vaccine, the very next day the FDA issued a Emergency Use Authorization for remdesivir to be used for IV treatment in seriously ill hospitalized US patients. To announce the emergency approval, President Trump met with the CEO of the drug’s manufacturer, Gilead Sciences, in the Oval Office.
Such rapid emergency use authorization is quite unusual with the FDA. Unlike the experimental remdesivir with no prior FDA approval, hydroxychloroquine (HCQ) was first approved in 1955 for malaria, and later FDA-approved for Lupus and rheumatoid arthritis. HCQ has been used in hundreds of millions of prescriptions around the world over the last 65 years. But it took two months from reports that China and South Korea were having success treating the novel coronavirus with HCQ before the FDA issued its March 28 Emergency Use Authorization for HCQ use in hospitalized COVID-19 patients.
In truth the recent “emergency authorization” for HCQ did not expand its availability but imposed restrictions to prevent non-hospitalized patients from accessing the government’s stockpile of the drug.
Democrat Governors Cuomo (NY), Sisolak (NV), and Whitmer (MI), then led the movement with the most restrictive orders limiting HCQ to hospital use, but this has tragically expanded in some form to all but four states.
For decades of clinical use, HCQ has shown an impressive overall safety record. CDC website states HCQ has relatively minor side effects overall. Irregular heart rhythm and or retinopathy occur rarely, usually with high doses used long term. FDA shows only 62 cardiac deaths attributed to HCQ out of more than 50 million prescriptions, 0.000124%, or 1.2 out of each 1 million prescriptions. Rheumatology guidelines for Lupus and Rheumatoid Arthritis do not even require baseline electrocardiograms before prescribing HCQ, since the risk is historically minimal.
Approximately $70 million in US taxpayer funding began Gilead’s partnership with the US Army, CDC, and NIH to develop remdesivir initially for treating Ebola, but it failed to show benefit and was shelved. Yet it is primarily Gilead shareholders who will benefit from remdesivir sales for COVID-19.
Early results of the first clinical trial of remdesivir against placebo in coronavirus were announced at the White House April 30, and showed modest benefits, according to The New York Times. Patients given remdesivir were discharged 4 days sooner than patients given placebo, though no criteria were given for determining improvement.
There was no statistical difference in the death rate of patients in the trial. However, about 25% of patients receiving remdesivir had potentially severe side effects, including multiple organ dysfunction, septic shock, acute kidney injury, low blood pressure. Gilead’s own press release revealed the side effect of acute respiratory failure in 6% of patients in the remdesivir 5-day treatment group, and 10.7% of patients in the 10-day treatment group, clearly ominous findings with a drug designed to treat respiratory failure caused by COVID-19.
Dr. Steven Nissen, Cleveland Clinic cardiologist who has conducted dozens of clinical trials explained to The New York Times: “The disclosure of trial results in a political setting, before peer review or publication, is very unusual. Scientists will need to see figures on harms associated with the drug in order to assess its benefits…This is too important to be handled in such a sloppy fashion.”
Dr. Michele Barry, a global health expert at Stanford University, expressed concern about Dr. Fauci’s overly enthusiastic praise for remdesivir: “It is unusual to call a drug the ‘standard of care’ until peer review of data and publication, and before studies have shown benefit in mortality.”
The leading communicable disease specialist in France, Professor Didier Raoult asked about another odd aspect of the remdesivir trial: “Could Anthony Fauci explain why the investigators of the NIAID remdesivir trial did change the primary outcome during the course of the project?” Death as the primary outcome was moved to a secondary outcome, and days to recovery became the primary trial outcome. Changing the primary outcome for a clinical trial before trial results are completed is also highly unusual, a process researchers call “p-hacking.”
In contrast, the multi-country compilation of evidence on hydroxychloroquine and azithromycin in treatment of COVID-19 (updated April 27, 2020) has consistently shown that these older medicines prevent infections, significantly reduce severity of illness once exposed, reduce viral load and duration of infectivity, reduce number of hospitalizations, reduce ventilator use and markedly reduce deaths. The data is far beyond “anecodotal” as Dr. Fauci dismissively called it.
Money appears to be trumping medical wisdom in the recent enthusiasm for remdesivir based on just one study with modest results. One naturally wonders if this may have anything to do with the fact that the “world’s largest asset manager,” BlackRock, owns nearly 10% of all Gilead stock? BlackRock’s influence in DC is legendary, and it recently was awarded the financial crown jewel of administering the Federal Reserve’s $4.5 Trillion COVID loan bail out program.
Is someone stacking the deck in Gilead’s favor? Fully nine of the experts on the NIH COVID 19 Panel recommending treatment options have disclosed financial support from Gilead Sciences, maker of remdesivir. Why did these nine experts not recuse themselves? It raises the question of financial conflicts of interest affecting medical decisions when they recommend against HCQ, the older, safer, cheaper medicine used successfully for COVID-19 yet then recommend for use of remdesivir, the new, expensive experimental medicine on the basis of one clinical trial not yet peer reviewed.
Hydroxychloroquine on the other hand has been off patent for decades, and is available from a dozen US generic manufacturers, and also produced in China, India, Israel and other countries. HCQ costs the patient on average less than $10.00 (range 37-63 cents per tablet), for the usual 5-7 day course of treatment recommended worldwide in COVID-19. Remdesivir costs upwards of $1000, plus has added costs of having to be hospitalized to receive it.
In addition to HCQ’s low cost, major pharmaceutical companies (Novartis, Bayer, Teva, and others) have donated nearly 50 million doses to the National Stockpile.
Tragically for Americans sick with COVID-19, most of this medicine still sits in warehouses due to State Governors intervening and overruling FDA policy allowing doctors to use HCQ off-label for outpatients when it has greatest effect.
The bottom line? Once again patient lives are being sacrificed on the altar of financial interests and elite DC powerbrokers instead of being entrusted to the judgment of patients own physicians who know them best. We are witnessing the deadly consequences of bureaucrats and governors practicing medicine without a license.
Money over medical wisdom, and politics above patients: two viruses more lethal than COVID-19.