The FDA granted Emergency Use Authorization (EUA) for hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ) for the treatment if COVID-19 back in late March 2020. However, the EUA was revoked in mid-June 2020, due to concerns of efficacy and evidence of cardiac adverse events. The drug was approved by the FDA for use against malaria in 1955, and the CDC (Centers for Disease Control and Prevention) “has no limits on the use of hydroxychloroquine for the prevention of malaria,” as stated on the Center’s website.
The Association of American Physicians and Surgeons (AAPS), a politically active, conservative non-profit that has previously promoted several scientifically discredited ideas, such as the link between vaccination and autism, filed a lawsuit against the FDA in June, even before the EUA was revoked, claiming that the FDA was still blocking access to the drug for Americans. The organization later asked a court to issue an injunction to force the FDA and Department of Health and Human Services (HSS) release to the public nearly 100,000 doses of the drug which had been donated to the agencies.
Along with the injunction, the AAPS provided a chart that shows the fatality rate of COVID-19 in countries that “allow and encourage” HCQ use, such as South Korea and Israel, compared with countries that “banned or discouraged” HCQ use, which include the U.S. and several European nations. There is a clear divide on the chart showing the former group with fatality rates below 4.0% and the latter with rates over 5%. Only 15 countries were included in the chart and statistics were not provided, making it difficult to determine the causality of discrepancy in fatality rates.
Even before the revocation of the EUA, on June 4, 2020, 2 large studies published in The Lancet and the New England Journal of Medicine were retracted. These studies had found increased rates of cardiac adverse events, but the data was later found to lack veracity. A New York Times article, published on July 27, 2020, found that the source of the data was unable to be verified after independent review.
Early in June 2020, a double-blind, randomized, placebo-controlled trial found no significant benefit of the drug compared with placebo as a postexposure prophylaxis for COVID-19.
However, a large, retrospective, observational study, that we reviewed in a recent posting at OTW found that treatment with HCQ resulted in 50% reduced mortality. The AAPS has cited this study as new evidence in its suit against the FDA. “Countries with underdeveloped health care systems are using HCQ early and attaining far lower mortality than in the United States, where [HHS and the FDA] impede access to HCQ,” the group wrote in its filing. It is clear that the studies are conflicting, which make drawing a conclusion on the efficacy and safety nearly impossible. The pollical injection by the President and his Advisor, Peter Navarro, Ph.D., only increases the potential sources for bias on both sides of the discussion.
I strongly concur with your lawsuit discerning the FDA’s revoking the EUA for hydroxychloroquine for concerns of lack of fracture he and evidence of cardiac adverse events.
Hydroxychloroquine has been here for more than 50 years, its pharmacology as well as mechanism of action and its adverse effects are well known because it has been used for so many years and its actual use in treating inflammatory diseases like lupus and arthritis and many others.
It was tested and the previous Covid virus epidemic and was shown to be very promising however the Covid virus epidemic went away so no more testing.
Since the Covid-19 virus is a very new virus there is no studies to prove effectivenness one way or the other. We did not be difficult to have clinical trials that proved effectiveness and safety in a novel virus
It was absolutely very political
Hydroxychloroquine makes excellent sense. Adding antibiotic such as azithromycin 500 mg every day for 5-7 days, as antibiotics are anti-inflammatory and well known that viral infections increase the risk for secondary bacterial infections
And third element is steroids. I personally like Celestone Soluspan and I also get that with my treatment plan plus other medications as appropriate with there known medical comorbidities.
Stressed the importance of adequate rest and nutrition
To be effective for sure the regimen has to be started ASAP. When the Covid virus test can take up to 4 days before you get the results back, that is 4 days that are essential and its effectiveness. After treat ASAP
Cannot wait 4 days for test results, they now have results that you can get in 15 minutes is not readily assessable
Nevertheless the regimen is extremely safe and extremely effective. There is no downside to starting the regimen and if the test turns up negative it can be discontinued
In my practice this as worked every time.
A good example do not tell my patients is the flu. He been with immunizations you can get the flu if it is not the right strain that is going around.
So diagnosing extremely early, getting started on Tamiflu or Xofluza within the first 24-48 hours absolutely stops the flu in his tracks plus I give a appropriate antibiotic and I give them injections of Celestone Soluspan and it works extremely well
The key is that it is absolutely essential to jump on it ASAP
If you weight for 5 days just watch it is well balanced and opportunity lost to help these patients.
The FDA, CDC. National Institutes of Health have all been complicit in spreading erroneous information, the social media has also been complicit in this. However they are not physicians.
Shame on physicans who does not take a stand. Physicians are the absolutely best trained individuals on person to treat patients and add to that years of experience face to face with patients we know what works with her patients.
We know what works with her patients we do the history, we do the physical and we do the assessment face to face.
Our patients are why we are here. Our first duty is to our patients. Not the bureaucracy
And my case before going to medical school I practiced pharmacy for 8 years, so I absolutely know medications backwards and forwards
So I many patients have died because they were not treated with hydroxychloroquine/azithromycin and steroids at the very begining
The FDA once they have release medication for FDA dictated reason it could now be used for non-FDA indications by the physician community for any reason that it could work.
The FDA cannot and does not have any authority over physicians practice
Neither does the CDC. Neither does the NIH, neither does Governors and bureaucracy
Thank you for what you are doing