Posted on 08/19/2020 11:37:16 AM PDT by SeekAndFind
On July 6, a team of doctors from Henry Ford Hospital, supported by physicians from Baylor University Medical Center, submitted an urgent request to the Food and Drug Administration (FDA) to reauthorize use of hydroxychloroquine (HCQ) for early treatment of COVID-19. Since that day, more than 25,000 more Americans have died from the virus as COVID-19 continues to burn through communities across America. If the results of a recent Henry Ford Hospital study are accurate, at least half of these patients might have been saved by HCQ.
Since the pandemic from China first hit America with brute force early in March, it has become apparent to physicians that the medicine works best when as with any anti-infective agent it is given early in the course of the infection. Moreover, hospitalization can be avoided if treatment starts within the first day of symptoms.
While HCQ alone has been found by numerous studies to reduce mortality rates, severity of symptoms, and length of hospital stays, it also can be combined with zinc and either azithromycin or doxycycline, followed by corticosteroids (prednisone, dexamethasone), and in some cases anticoagulants all working together for improved outcomes. For each one of these drugs, there is both a good scientific rationale and either early clinical trials completed or planned with sufficient promise.
Of these drugs, only HCQ was singled out as a political football early in spring right after President Trump urged the medical community to consider HCQ. At the time, one of Trumps top medical advisers, Dr. Anthony Fauci stated that if a COVID-19 patient were under his care, he would use HCQ, preferably in a clinical trial protocol. Fauci, however, has since backed away from that statement and his opposition has become a rallying cry of the left-leaning mainstream medias Hydroxy Hysteria.
The politicization of HCQ is an ongoing tragedy. The Federal Emergency Management Agency (FEMA) has more than 60 million HCQ tablets sitting in its warehouses. Absent a new Emergency Use Authorization, FEMA cannot ship this valuable medicine for appropriate off-label treatment of COVID-19 patients. Nor can hospitals or clinics easily recruit patients for the kind of randomized clinical trials needed to ultimately settle the question of how HCQ might best be used in the fight against COVID-19. Should it be purely in early treatment, as a prophylactic for health care workers or senior home patients at risk, in outpatient versus hospital settings, or in other settings?
Positive HCQ studies have been dismissed in medical journal editorials as flawed because they were observational rather than randomized. The few randomized trials of HCQ reported to date have been a debacle because of the failure to distinguish clearly between early treatment (one to seven days after the onset of symptoms), when the medicine should work, versus later treatment, when it is unlikely to help. To make matters worse, in a classic statistical type two error, many of the preventive and early illness trials of HCQ changed primary endpoints, reduced sample sizes, and became unable to see the benefit of HCQ, if indeed it was there.
For example, the University of Minnesota, in a collaboration with other centers, published randomized prevention and early treatment trials. While both trials were stopped early and thereby had small samples, both made definitive claims that HCQ was not effective. However, careful review of their data shows just the opposite numerically (but not statistically significant) lower numbers of infections and hospitalizations in those who were randomized to HCQ.
Further clouding the issue, the National Institutes of Health opened an outpatient trial of HCQ and azithromycin in May but closed it in June, stating they could not recruit subjects into the study. This was a highly disingenuous claim, given the overwhelming numbers of COVID-19 patients desperate for treatment.
My own conclusion from a review of the literature is that HCQ has not failed the randomized trials, but researchers have failed HCQ. Many doctors who understand the science and the threats to validity in the HCQ literature continue to prescribe HCQ appropriately off-label to COVID-19 victims at home, in senior centers, and early in the hospital. The Association of American Physicians and Surgeons is suing the FDA for access to HCQ.
In thinking carefully about all the negative news that you may have heard about HCQ, keep in mind this drug has been used in the U.S. since 1955. It has a completely established safety record for lupus, rheumatoid arthritis, and malaria prevention and treatment. Prescribed under a physicians good judgment, it is unlikely to cause harm.
So how did HCQ become considered dangerous? The first false safety concerns arose early in the pandemic in reports that doctors prescribed HCQ not in an early treatment setting at the first sign of symptoms but rather in a late-stage setting to more severely ill patients in the hospital. This form of treatment bias that is, giving medicine to the sickest before death created a false association between HCQ and mortality. Unfortunately, the mainstream media picked up on these reports and did great damage by promulgating a false narrative without understanding the epidemiological underpinning of confounding by indication.
In what would be a death blow to public trust of HCQ, the prestigious Lancet journal published a massive worldwide study that purported to show excessive deaths in patients treated across six continents only to have the paper later retracted. The New England Journal of Medicine had a similar unprecedented retraction more evidence of HCQ becoming a political football in medical science. While the studies were fraudulent and discredited within a few weeks, the media coverage, and earlier flawed studies, led both the FDA and World Health Organization (WHO) to withdraw endorsements of the drug for COVID-19 treatment.
We now know, based on the large New York and Detroit experiences at Ford and Mt. Sinai hospitals, that HCQ is safe. To date, there has not been a single credible report that the medication increases the risk of death in COVID-19 patients when prescribed by competent physicians who understand its safety profile.
It is time for the FDA and state medical boards to support the use of HCQ in conjunction with other commonly used drugs steroids and antithrombotics against COVID-19, treated early at home to help avoid hospitalization and death. As President Trump has said, what have you got to lose by reinstating an Emergency Use Authorization? As to what might be gained, appropriate research and prescription (combined with other medications) could spare hundreds of thousands of hospitalizations and save tens of thousands of American lives.
Peter A. McCullough, MD, MPH, is vice chairman of medicine at Baylor University Medical Center and a professor of medicine at Texas A&M College of Medicine in Dallas. An internist, cardiologist and epidemiologist, he is the editor in chief of Cardiorenal Medicine and Reviews in Cardiovascular Medicine. He has authored over 500 cited works in the National Library of Medicine.
Ping as per your request
What an excellent article!!!!!
This is definitive in my opinion.
Who can push this - our own doctors? Senators? Congressmen?
It makes me so very sad and angry that lives have been and are being lost needlessly by the thousands!!!!!
Thanks for the ping, Seek and Find
If it works for some, but not others, so be it.
How ethical is a protracted randomized study when the control patient dies.
this was posted yesterday re states banning HCQ——
Is HCQ banned in your state? (probably not)
Various Sources - links inside | 8/18/2020 | States
Posted on 8/18/2020, 10:48:11 AM by Pollard
Due to an earlier thread where someone was voicing their anger towards President Trump seemingly not doing anything to allow people to have access to hcq, I decided to do the state by state research into which states have banned hcq and which ones haven’t.
The results are fairly surprising considering a group of doctors had a two day summit in DC campaigning for access to hcq. There are rules but not much for outright bans.
Most of the info comes from lupus.org (https://www.lupus.org/advocate/state-action-on-hydroxychloroquine-and-chloroquine-access) but in some cases I went to the state websites using links found on the above lupus.org state by state guide page.
Reckless disregard for human life!
If we applied the same standards used at the Nazi trials in Nuremberg, Fauci & Cuomo would be stretching ropes in some prison courtyard. Fauci for his constant negative comments re. LIFESAVING HCQ and Cuomo for sending all those old-timers into the COVID rich retirement homes.
Bump, because I really believe the anti hcq movement has needlessly killed and continues to kill thousands of people in the USA. If the truth of this becomes widespread it will be a huge wake up call highlighting the destructive ruthlessness of the left.
“””Who can push this - our own doctors? Senators? Congressmen?”””
It seems we all need to begin a concerted effort to first contact our personal doctor and ask them if they will prescribe HCQ should I be tested positive. And then start posting the results of that conversation on FR.
Then move on to sending reports like this one to our State Senator and Representative and Governor asking them if doctors in our state are allowed to prescribe HCQ should I test positive for covid.
Make them squirm.
bkmk
Reckless disregard for human life!
If we applied the same standards used at the Nazi trials in Nuremberg, Fauci & Cuomo would be stretching ropes in some prison courtyard. Fauci for his constant negative comments re. LIFESAVING HCQ and Cuomo for sending all those old-timers into the COVID rich retirement home.
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Totally true; indeed, hydroxys life saving efficacy is exactly why the DemonShits and their media accomplices so hate the hydroxy treatments. They desperately crave to do anything that will stop Trump. The COVID hysteria is the ideal thing because its shut down the great Trump rallies. Now, enter hydroxy, and theres an effective, safe, cheap treatment for the disease that will make it no different than any other treatable disease, like flu, that can, and does, occasionally kill some people, but thats no modern version of the Black Death. POOF! there goes all the justification for the lockdowns and other petty tyrannies that weve been harassed by, we can return to normal, the economy will start booming, and the Trump rallies will resume. IOW a total disaster for the DemonShits that theyll do anything to prevent, including killing thousands of the most vulnerable Americans.
If you think it is not banned in your state...ask your doctor if he will prescribe it immediately if you show symptoms or have a POS test result.
The answer may surprise you.
If you have to be hospitalized to get it...its too late
Well I have forwarded this article to my personal physician with whom I have previously talked about this subject.
He said he would prescribe the HCQ / Zinc / zyrithromyecin (sp?) regimen for me if I became ill with the symptoms of COVID19 BUT THE PHARMACIES (IN NC) WON’T FILL IT!
I don’t know where to go with this in terms of reaching whatever Board regulates the pharmacies in NC.
But I do know my Senator’s office address and he is up for re-election (Tillis) so can forward this to him.
And have shared this on my facebook page. (something we can all do if we participate in that).
These doctors need to band together and push this!!!!
This
Bookmark so disturbing.
Praying GOD exposes and brings to swift justice everyone behind prohibiting its usage.
Yes, HCQ is still available for Lupus patients. So no, it has “not been banned.” The reality of the situation is that use for Covid-19 has been greatly discouraged. The doctors that I have talked to in two states just wish I would go away.
FDA language indicates that HCQ may be used in a hospital setting. It implies that it can not be used outside of a hospital setting.
HCQ should be used shortly after the onset of symptoms - to prevent people from going to the hospital! It’s a nice catch-22. You can’t use it when it will help, but with your doctor’s permission, you can use it when it can do no good.
Each states regulates medicine. Was there any state, in the Lupus org website you referenced, that was positive about using HCQ early in treating COVID-19?
President Trump should see to it that FDA language be revised to encourage the prescription of HCQ by doctors shortly after a diagnosis of COVID-19. Then some state, perhaps Florida or Texas, should encourage doctors to prescribe HCQ and pharmacies to fill prescriptions.
Many lives could be saved. But at this point it’s all about politics. We know the left will continue to roll out more hateful, stupid accusations at Trump. Too many to keep track of. Add this one to the list: President Trump is emancipating Doctors and patients so that they can take action to save lives. Note: HCQ use is not mandated, in contrast to masks, closing church services, etc.
The Democratic party, press and others have made HCQ use the sword that they are willing to fall upon. Call their bluff!
TDS Kills!
Yes it does!
azithromycin +zinc + HCQ
Trump needs to end this HCQ BS NOW!! These damn government departments FDA, CDC have NO RIGHT to hold back this medication APPROVED by the FDA for decades this has to STOP NOW!!! Trump NEEDS to EO HCQ as right to try same as he did with the cancer medications NOT approved by the FDA!! Fauci is a deep state bureaucrat that wants Trump to lose this election AT ALL COSTS including American lives!! Fauci needs to be FIRED!!
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