The global pandemic has spurred several arms of science into action, with researchers seeking to discover how the virus works and to uncover the best testing, vaccinations and treatments. The biomedical community has been working on antiviral interventions, including remdesivir.
A precursor to the drug was initially evaluated during the Ebola outbreak several years ago. Remdesivir was developed using taxpayer money that Public Citizen estimates reached at least $ 70.5 million, based on publicly available data.1 They also believe the number is likely higher.
A 2017 report noted that the Department of Defense “is cost sharing with Gilead Biosciences for continued development of this product.”2 At the time it was labeled GS-5734.3
Public Citizen reports the DOD granted Gilead Biosciences $ 34.5 million.4 Additionally, the NIH led the Ebola trials using remdesivir, which opened the door for research into the use with COVID-19. The NIH granted nearly $ 700 million to groups for coronavirus research, including $ 6 million to the University of North Carolina to move the development of the drug forward.
Despite the large amount of taxpayer money poured into research and development from sources other than itself, the company has set a price of more than $ 3,100 for a single course of treatment.5
While most see this as one example of how Big Pharma is again fleecing the public, NPR justified the pricing process by commenting that the price was determined only: “after months of speculation as the company tried to figure out how to balance profit and public health needs in the middle of a pandemic.” Gilead claims this to be a fair price that will give everyone access:6
“At the level we have priced remdesivir and with government programs in place, along with additional Gilead assistance as needed, we believe all patients will have access.”
Remdesivir Lowers Viral Load at an Enormous Health Cost
Yet, this curiously high price tag is on a drug that has not produced adequate results and has not been proven to reduce the potential for death in those with severe disease. Worse, the so-called “clear-cut, significant, positive effect in diminishing the time to recovery”7 of remdesivir with COVID-19 comes with an additional price tag that may include renal failure requiring a kidney transplant.
In a paper published in the International Journal of Infectious Diseases, scientists reported on five of the first patients treated in France with remdesivir.8 French authorities allowed for the “compassionate-use” treatment of the drug, which is still being studied.
In the paper, the authors describe the outcome for the first five patients admitted with severe pneumonia to the University Hospital of Bichat, Paris, France. Following the administration and encouraging results of a recent clinical study and two case reports, five patients admitted to the hospital were treated with the drug.
Criteria included signs of severe illness and clinical aggravation of a patient’s symptoms. All patients received a loading dose of 200 mg and a planned daily maintenance of 100 mg for 14 days, unless the drug was otherwise stopped for side effects. The team also collected nasopharyngeal and lung samples, which were tested for viral and bacterial growth. These were the results:
• Case 1 — A 31-year-old man from Wuhan, China, started on the drug on illness Day 11. It was stopped four days later because of liver alterations and a maculopapular rash. The liver abnormalities improved after discontinuing the treatment.
• Case 2 — An 80-year-old man from China was given remdesivir for two days. It was discontinued when his kidneys failed. The gentleman received the drug again as the disease severity persisted and progressed. He died nine days later.
• Case 3 — A 39-year-old man with obesity and obstructive sleep apnea received eight doses of remdesivir, which was stopped because of liver enzyme alterations and the same kind of rash as was seen in Case 1. This resolved after the drug was discontinued. The gentleman was discharged on day 20.
• Case 4 — A 76-year-old man from France with a history of chronic kidney injury received remdesivir for nine days without side effects. He was discharged on illness day 23.
• Case 5 — A 70-year-old man with a history of chronic obstructive bronchopneumopathy was admitted with acute respiratory distress syndrome. Remdesivir was given for two days and discontinued because he suffered acute kidney injury, requiring a kidney transplant. His disease progressed and he died.
The team recorded four of the five patients with major side effects, including kidney failure that would have required a transplant had the patients lived. A second study included 53 patients who were also treated under the compassionate use, funded by Gilead Sciences.9
The company recorded 36, or 68%, demonstrated clinical improvement. This was measured by improvement in oxygen transport, extubation from mechanical ventilation or discharge. During the study period, although 36 showed clinical improvement, only 25 were discharged.
As an added note, the authors of the International Journal of Infectious Diseases studies10 mentioned that they had “waived the need for informed consent from individual patients” — which implies that the patients had no idea they were being given an experimental drug. Also intriguing is that the authors casually noted that “12% of the patients in the remdesivir group discontinued remdesivir due to adverse events, versus 5% in the placebo group.”
In other words, more than twice as many patients in the remdesivir group stopped their treatments due to adverse events than those receiving placebos. The authors ended with the comment, “A particular attention should be given to hepatic and kidney function when administrating this treatment.”
NIH Treatment Guidelines Produced by Experts?
The NIH brought together a panel of experts, including doctors and statisticians, to develop guidelines to treat coronavirus in the U.S.11 The guidelines are intended to be based on published, peer-reviewed data and to incorporate preliminary data from pre-published studies and the panelists’ clinical expertise.
The panel is charged with looking at two categories of therapies. The first are antivirals intended to target the virus directly. The second are immune-based options and host modifiers, which affect the natural immune response.
The panel’s conclusions are published online at a website supported by the NIH, which is considered a living document intended for information from panel discussions and conclusions, including clinical data and ongoing trials for therapies.12
The members of this highly influential panel had to disclose financial conflicts they may have.13 Those disclosures are published by the NIH and reveal interesting information. There are 53 experts on the panel, eight of whom declared financial benefits from research support or consulting fees originating from Gilead Biosciences, the manufacturer of remdesivir.
However, the links to pharmaceutical and biotech companies whose bottom lines are impacted by the pandemic don’t stop there. In the group, 40 did not declare any financial support, while 13 did. All 13 had ties to at least one pharmaceutical, while three had ties to three or more companies. The various types of businesses included biotechnology organizations, a blood research laboratory and a flu vaccine company. The types of jobs that garnered the financial support included:
- Research Support — 10
- Consultant — 7
- Advisory board or stockholder — 7
- Honoraria — 1
- Employee or Spouse an Employee — 2
Remdesivir Studies Lack Positive Results
Although Gilead Biosciences continues to move forward in their distribution of remdesivir, the scientific evidence has not supported its use. In this video, Del Bigtree from Highwire Talk and CEO of Informed Consent Action Network, outlines the problems with three published studies evaluating the effectiveness of the drug.
In one study published in the New England Journal of Medicine, the scientists changed the end point measurements for the study,14 moving all to secondary outcome measures except the number of days to recovery, which was the single primary outcome measure at the conclusion of the study.15 The trial was also funded by the National Institute of Allergy and Infectious Diseases (NIAID), of which Dr. Anthony Fauci is director.16
There were significant problems with the research design, and consequently the data, that I discuss in “The New COVID-19 Medication Isn’t Backed by Results.” The release of the study generated enthusiasm and triggered immediate action across many countries, including the U.S.
The U.S. Food and Drug Administration issued an emergency use authorization on May 1, 2020, since the drug had not yet been approved for use in the U.S. This opened the door for compassionate use of the drug. In the statement the FDA said:17
“While there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, the investigational drug was shown in a clinical trial to shorten the time to recovery in some patients.”
One team evaluated the use of the drug in those with severe disease enrolling patients who were 18 years and older with lab-confirmed infection. The study was published in The Lancet and concluded the drug was “not associated with statistically significant clinical benefits.”18
The links between the NIH, Fauci and Gilead Biosciences is a demonstration of the importance of financial ties in scientific research and the development of public policy. As mentioned above, the NIH, NIAID, Department of Defense, and countries around the world funded the study published in the New England Journal of Medicine, essentially declaring remdesivir a success.
When you consider that Fauci, by virtue of being NIAID’s director, has a vested interest in the development of remdesivir, and that it was he who declared the results to be “highly significant,” it certainly suggests that he, too, should be declaring a conflict of interest in remdesivir’s fate.19 When he was asked about the results of the study published in The Lancet, which had to be stopped because of serious adverse events, Fauci disregarded the evidence as “not adequate.”
Health Choices That Make a Difference
Some health experts and the media are crying out over the number of new cases of COVID-19 being diagnosed each day, encouraging citizens to stay in place and wait for a vaccination. However, I recommend that you proactively work to support your immune system in ways that research has demonstrated reduce your risk of severe disease.
You can find a number of simple, yet significant strategies on my Coronavirus Resource Page, including proper hand-washing, getting adequate sleep and staying hydrated. However, it has become more apparent with every passing week that optimizing your vitamin D level will be the easiest, least expensive and most beneficial strategy you can use to minimize the risk of severe disease.
Health authorities have been warning of a second wave of the disease that is expected in the fall. This means the best time to start addressing your vitamin D level is right now. You can read more about the importance of Vitamin D and how the body uses it to combat coronavirus and other infectious diseases in “The Most Important Paper Dr. Mercola Has Ever Written.”
It is my hope that you spread the word about the significance of this to your friends and family. An important part of the strategy is to share the information with influencers in the Black community, as this group historically as had low levels of vitamin D — therefore putting them at greater risk of acquiring the coronavirus.
People in nursing homes and skilled nursing facilities, along with the elderly also have notoriously low levels of vitamin D that put them at greater risk of severe COVID-19 and flu, as well. Within my report I go into detail about how to raise your levels between 60 ng/mL and 80 ng/mL by fall.
You’ll find a quick summary of the key steps in the article linked above including how to get tested, why you should get tested and how to assess your individualized vitamin D dose to raise your level. With this data you can help significantly reduce your risk of severe disease.