Can Hydroxychloroquine Save Lives and The Economy?
By Rick Hayes
How can Hydroxychloroquine be considered a miracle cure by highly respected doctors who are successfully treating patients while White House coronavirus advisor Dr. Anthony Fauci and the FDA consider it ineffective and potentially dangerous?
The drug, Hydroxychloroquine, is no stranger to the medical community. It has been around since it was first approved in 1955 by the U.S. Food and Drug Administration. Historically, it has enjoyed a reputation as generally safe and well-tolerated in patients treated for chronic inflammatory conditions. And for years, Hydroxychloroquine has been used to successfully treat autoimmune diseases such as lupus, rheumatoid arthritis, and treat and prevent malaria.
According to Fauci, the only proper way to see if Hydroxychloroquine is an effective treatment of coronavirus disease is to undergo a long and arduous trial that is "randomized and controlled." A testing procedure, Fauci calls "The gold standard."
"That's a lie," said Dr. Harvey Risch, a distinguished cancer epidemiologist at the Yale School of Public Health. According to Risch, "Randomized and controlled trials are not the gold standard since they have been shown to have flaws."
Risch cited a paper published in the New England Journal of Medicine on August 3, 2017, by a former head of the CDC, Dr. Thomas Friedman. In it, Friedman wrote, "Despite their strengths, Randomized Controlled Trials have substantial limitations." He stated that randomized and controlled trials had weaknesses in the use against infectious disease outbreaks, for which public health decisions must be made quickly based on limited and often imperfect available data and that they are generally impractical for rare diseases.
Risch noted that at this point, determining who has COVID-19 is more accurate based on clinical grounds than on testing. For example, Risch stated that today, on clinical grounds, a person under the age of 60 experiencing mild shortness of breath after walking across a room has a 95% chance of having the disease.
In addition, Risch disagreed with Fauci that to receive FDA approval, Hydroxychloroquine needs to be tested using randomized and controlled trials. "The FDA approves many medications without going through randomized and controlled trials," said Risch, who provided a recent FDA publication as evidence of what the FDA criteria are to gain approval.
The July 29, 2020, document that Risch said has since been taken down from the FDA website stated that the criteria used for Emergency Use Authorization (EUA) approval is that the drug, "May be effective."
However, the FDA determined that Hydroxychloroquine was unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. The FDA also mentioned the ongoing serious cardiac adverse events and other potentially dangerous side effects, and that the potential benefits of Hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.
"Not true," said Risch, who emphasized that Hydroxychloroquine is known to be a safe, proven life-saver and that it has been unjustly misrepresented to the public by a politicized regulatory system that is picking favorites at the expense of American lives.
Risch emphasized that the 45,000 American lives lost in July could have been saved if the FDA did not revoke Emergency Use Authorization for Hydroxychloroquine on June 15. "There is no question that Hydroxychloroquine satisfies the (FDA's) criteria for Emergency Use Authorization." said Risch, "Nobody would argue that Hydroxychloroquine doesn't satisfy (the requirement) that it may be effective."
As for the serious cardiac adverse events mentioned by the FDA, Risch pointed out that it was the significant defects in the FDA's testing procedures that caused the cardiac events to be wrongfully attributed to Hydroxychloroquine.
Risch cited the evidence found by Dr. Vladimir Zelenko, a family doctor from Monroe, New York, who has reported having a 99.7% COVID survival rate for his patients. Zelenko said the adverse cardiac events mentioned by the FDA were found in patients treated inside a hospital and in the later stages of the disease. Zelenko emphasized that he is focused on treatment on an outpatient only basis and exclusively in the early stages.
Zelenko stated that he asked top electrophysiologists (Doctors who specialize in heart rhythm problems) if they had ever seen the cardiac issues mentioned by the FDA. According to Zelenko, electrophysiologists said they did not see any of the cardiac problems mentioned by the FDA in an outpatient setting. He said these specialized doctors saw some cardiac issues in the hospital settings but that it was unclear if Hydroxychloroquine or an already damaged heart from the virus was the cause.
Both Zelenko and Risch emphasized the need to keep patients out of the hospital because, as Risch put it, "COVID-19 becomes a different disease in the hospital setting." They emphasized that Hydroxychloroquine's success comes from following the specific protocol, which starts with treating patients early. Zelenko asserted that he treats patients within the first five days of clinical diagnosis, even before any test results are received. And that he applies a three-drug approach using Hydroxychloroquine, the antibiotic azithromycin, and zinc sulfate with Zinc being the most crucial element.
Zinc is the "virus killer," said Zelenko, but Zinc on its own cannot enter the compromised cells. So, Hydroxychloroquine is used as a transporter that opens up channels that allow Zinc to enter the cells and interfere with a virus enzyme known as RNA used for virus replication.
Both Zelenko and Risch agree that if approved and administered under the FDA's Emergency Use Authorization, Hydroxychloroquine could immediately save thousands of lives and allow for the rapid start to the economy.
Risch stated that the data is clear that Hydroxychloroquine is safe and saves lives when properly administered and should immediately be made available to Americans. He added that the FDA and Dr. Fauci were being deceptive regarding "randomized and controlled" trials being the only way drugs are approved.
One of the glaring reasons Hydroxychloroquine may have been revoked is that it costs only $20 per treatment. In contrast, the drug remdesivir, which also works, but in hospital settings, costs insurance companies over $3,000 per patient.
Aside from providing hard facts and supportive scientific data, Zelenko appealed to man's sense of justice when he said, "We need to focus on the truth and medical information that needs to be spread without corruption. It's so sad, science that used to represent objective truth has become nothing more than a puppet for politics and big pharma interests."
(c) R. Hayes. 8/2020