FDA Withholding Effective Covid Drug


As the pandemic lingers on, with increasing numbers of new Covid cases among the unvaccinated, every available treatment is needed. That’s why the FDA’s failure to approve a promising, safe, effective, long-in-use medication for this new application doesn’t make sense.

David R. Henderson and Charles L. Hooper, writing in The Wall Street Journal, tell us there is an effective treatment of Covid and the FDA refuses to approve it. Henderson is a research fellow at the Hoover Institute of Stanford University and was senior health economist with President Reagan’s Council of Economic Advisors. Hooper is president of Objective Insights, a firm that consults with pharmaceutical clients.

They tell the saga of ivermectin, a medication approved and certified by the FDA in 1996 as an antiparasitic. Ivermectin is on the World Health Organization’s List of Essential Medicines to prevent river blindness and other diseases caused by parasites. A group of 10 doctors who call themselves the Front Line Covid-19 Critical Care Alliance calls ivermectin “one of the safest, low-cost, and widely available drugs in the history of medicine.”

Yet the FDA statement about the same drug uses words such as “dangerous, serious harm, very dangerous, seizures, highly toxic, coma and even death.” How could they use such derogatory language to describe a drug they approved in 1996?

Ivermectin fights 21 viruses, including SARS-CoV-2, which causes Covid-19. A single dose of ivermectin reduced the viral load of SARS-CoV-2 in cells by 99.8% in 24 hours and 99.98% in 48 hours, according to a June 2020 study published in the journal Antiviral Research. Some 70 clinical trials are currenting evaluating the use of ivermectin for treating Covid-19. The statistically significant evidence suggests that it is safe and works for both treating and preventing the disease.

One study of 115 patients with Covid-19 who received a single dose of ivermectin showed none developed pneumonia or cardiovascular complications, while 11.4% of those in the control group did. Those receiving ivermectin developed fewer respiratory distress episodes (2.6% v. 15.8%); fewer required oxygen therapy (9.6% v. 45.9%); fewer required antibiotics (15.7% v. 60.2%); and fewer entered intensive care units (0.1% v. 8.3%). Ivermectin-treated patients tested negative faster (4 days v. 15 days) and stayed in the hospital nine days on average instead of 15 days. Ivermectin patients had a 13.3% mortality versus the control group mortality of 24.5%.

In addition to these impressive numbers for treatment of Covid-19, ivermectin has shown the ability to prevent Covid-19. One study looked at what happened after the drug was given to family members of confirmed Covid-19 patients. Less than 8% became infected versus 58.4% of those untreated. Among 200 healthcare workers and others at high risk of exposure, only 2% of those given ivermectin developed Covid-19 infection while 10% of the control group did.

The authors say the FDA’s claims that ivermectin isn’t safe is belied by the historical evidence. Over four billion doses have been administered since 1998 with only 28 cases of serious neurological adverse events, according to an article published this year in the American Journal of Therapeutics. The same study found ivermectin safe for use in pregnant women, children, and even infants.

If science was the only consideration for the FDA this drug would have been approved already. But this same FDA has been maddeningly slow to approve the Covid-19 vaccines except on an “Emergency Use Authorization” basis, which accounts for the hesitancy of many Americans to receive the vaccines. This despite over 300 million doses of the vaccines given in this country alone.

It is clear that the FDA, and its federal counterpart the CDC, are being controlled by the White House and subservient to their political agenda. It is not clear why that agenda refuses to give the American people the scientific truth without political spin.

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