On Jan. 30, the New York Times published an article, “How the Search for COVID-19 treatments Faltered While Vaccines Sped Ahead.” The article bemoaned the fact that “nearly a year into the coronavirus pandemic, as thousands of patients are dying every day in the United States and widespread vaccination is still months away, doctors have precious few drugs to fight the virus.”
According to the Times:
“The government poured $18.5 billion into vaccines, a strategy that resulted in at least five effective products at record-shattering speed. But its investment in drugs was far smaller, about $8.2 billion, most of which went to just a few candidates, such as monoclonal antibodies. Studies of other drugs were poorly organized.
“The result was that many promising drugs that could stop the disease early, called antivirals, were neglected. Their trials have stalled, either because researchers couldn’t find enough funding or enough patients to participate.”
The article also pointed out that in many cases, “researchers have been left on their own to set up trials without the backing of the federal government or pharmaceutical companies.”
The Times article was informative, but it failed to answer the most basic and important question: Why did this happen?
The answer to that question is fairly simple. And the situation we find ourselves in now was as preventable as it was predictable.
As far back as March 2020, Children’s Health Defense was well aware of the direction our federal agencies were headed. That’s when we ran this short video and accompanying article posing this question: “How should America respond to the coronavirus pandemic? With therapeutic drugs or a vaccine?”
In our article, published March 27, we cited a March 16 MSNBC interview conducted by Rachel Maddow with Dr. Ian Lipkin, director of the Center for Infection and Immunity at Columbia School of Public Health. In the interview, Lipkin acknowledged that our national priorities for tackling the pandemic were being driven by a desire to create new patents and in turn, new profits.
Lipkin told Maddow:
“We are not investing as much in tried and true classical sort of methods, repurposing drugs and strategies that have already been shown to work. Most of our investment is in things which are sexy, new and patentable.”
The first batch of the Moderna vaccine was completed within 42 days of the company obtaining genetic information on the coronavirus.
NIAID, which operates under the National Institutes of Health (NIH) and is directed by Dr. Anthony Fauci, is a joint patent holder with Moderna on its COVID vaccine. Through royalties, Fauci’s agency and employees stand to profit immensely.
The NIH Office of Technology Transfer FY 2014 annual report explains how royalties collected on product sales, primarily drugs and biologics, accounted for 84% of the $138 million in royalties collected by NIH in 2014. The three best-selling products utilizing technology licensed from NIH that year were a novel protease inhibitor for the treatment of HIV-1, Merck’s Gardasil vaccine and AstraZeneca’s Synagis, a monoclonal antibody for the treatment of respiratory syncytial virus (RSV) in infants.
In December 2020, the U.S Food and Drug Administration (FDA) approved Moderna and Pfizer COVID vaccines for emergency use in the U.S. The secretary of the U.S. Department of Health and Human Services then made the official emergency use declarations for the Moderna and Pfizer vaccines.
The FDA’s emergency use approval paved the way for the NIAID and Fauci to start cashing in on the vaccines.
The answer lies in FDA regulations for approving a drug, including a COVID vaccine, for emergency use. Section 564 §360bbb-3 of the Federal Food, Drug, and Cosmetic Act states that the FDA commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases only when “there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition.”
In other words, if non-vaccine therapeutics for COVID, such as vitamin C, vitamin D, zinc or the inexpensive treatment protocol developed by the Front Line COVID-19 Critical Care Alliance had been approved as viable treatments for COVID, the experimental mRNA Moderna and Pfizer vaccines wouldn’t have been eligible for Emergency Use Authorization by the FDA.
Instead, Moderna and Pfizer would have been required to go through the normal licensing procedure for vaccines, including more extensive safety testing. That would have taken longer, and perhaps led to safety concerns that might have kept them from ever being approved. Either scenario would have cut into profits for NIAID and the vaccine makers and jeopardized millions of dollars in royalties.
As we wrote in March 2020:
“In light of the immunity from liability guaranteed by the PREP (Public Readiness and Emergency Preparedness) Act during declared emergencies, fast-tracked vaccines are a sweetheart deal for both biopharma and government. A safer and common-sense approach would direct resources toward examining the merits of existing therapeutics that can be put to immediate use. The government must not allow Big Pharma and biotech companies to cash in on this catastrophe with speculative, patentable vaccines at the expense of the therapeutics needed to save lives now.”
Unfortunately, the fast-tracked vaccine ship has sailed, and we are now just beginning to see the consequences of the government’s decision to put all of its eggs in the vaccine basket in the form of thousands of vaccine injury reports, including possible hundreds of deaths since Jan. 22.
The post New York Times Explains the How But Not the Why Behind Lack of COVID Treatments appeared first on Children’s Health Defense.
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