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Coronavirus Drug: French Researcher Reports Successful Trial Using Malaria Medicine

Democratic NY City councilman says hydroxychloroquine saved his life, thanks Trump for advocating drug

Postby smix » Wed Aug 12, 2020 8:02 pm

Democratic NY City councilman says hydroxychloroquine saved his life, thanks Trump for advocating drug
The Blaze

URL: https://www.theblaze.com/news/councilma ... oronavirus
Category: Politics
Published: August

Description: The drug hydroxychloroquine was instantly transformed into a political football the moment President Donald Trump said that the malaria medication "could be a game changer" at a coronavirus press briefing on March 19. Since being hopeful about the drug, Trump's adversaries have been completely against hydroxychloroquine, while his supporters are optimistic that the medicine could help fight against COVID-19. A Democratic politician has come out to proclaim that hydroxychloroquine saved his life after a near-death battle with coronavirus. Democratic New York City Councilman Paul Vallone credits hydroxychloroquine with saving his life as he fought against the lethal respiratory disease. Vallone, who represents Queens, told the New York Post that HCQ "basically saved me." Vallone was extremely ill with coronavirus in March. The situation was dire because he already suffers from sarcoidosis, an incurable auto-immune disease that mostly affects the lungs and lymph glands. "We were in panic mode when I went down because I didn't have a lot of immune response," Vallone said. "I needed something to stay alive." "I couldn't breathe, very weak, couldn't get out of bed," he said. "My doctor prescribed it. My pharmacy had it. Took it that day and within two to three days I was able to breathe." Vallone took hydroxychloroquine with a flu Z-pack and "within a week" he was back on his feet. "At that time, there was only fear and panic, he offered hope in a possible treatment when there was none," Vallone said of Trump's endorsement of hydroxychloroquine. "With my sarcoidosis and then my COVID symptoms, it basically saved me. For that my family will always be thankful." Vallone's brother Peter, a former city councilman and a current civil court judge in Queens, touted the drug in a Facebook post. "I guess all those doctors who are prescribing it are right. This drug is already on the market and the patent is up so it's cheap. A new drug won't be. So big money does not want this drug to be used. Always follow the money," Peter Vallone wrote on May 12. He attached a link to a study from New York University's Grossman School of Medicine that found patients given the antimalarial drug hydroxychloroquine along with zinc sulphate and the antibiotic azithromycin were 44% less likely to die from the coronavirus. "[It] saved my life," Paul Vallone wrote in the comments. Vallone isn't the only Democratic politician to have thanked Trump for touting hydroxychloroquine. Democratic State Rep. Karen Whitsett from Michigan declared that hydroxychloroquine saved her life. "It has a lot to do with the president ... bringing it up," Whitsett said in April. "He is the only person who has the power to make it a priority." In May, Trump said he had been taking the medication as a preventative measure. Hydroxychloroquine studies have shown mixed results, some claiming there are no benefits, while other research finds HCQ as a promising treatment for COVID-19, especially as when taken early in the onset of the disease. Last month, a video of front-line doctors advocating treating COVID-19 with hydroxychloroquine was deleted from Twitter, Facebook, and YouTube. Donald Trump. Jr. was suspended from Twitter for sharing the video. Dr. Simone Gold, one of the front-line doctors touting HCQ, spoke with Glenn Beck recently. She talks about being fired from the two hospitals where she worked after the video went viral.

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FDA denies Henry Ford Health request to use hydroxychloroquine for COVID-19 patients

Postby smix » Tue Aug 18, 2020 2:38 pm

FDA denies Henry Ford Health request to use hydroxychloroquine for COVID-19 patients
Detroit Free Press

URL: https://www.freep.com/story/news/health ... 360940001/
Category: Politics
Published: August 13, 2020

Description: Weeks after the U.S. Food and Drug Administration revoked emergency use authorization of hydroxychloroquine to treat COVID-19, saying the drug doesn't help coronavirus patients and has potentially dangerous side effects, Henry Ford Health System filed for permission to continue using it. The Detroit-based health system told the Free Press this week that it sought emergency use authorization July 6 to resume treating some COVID-19 patients with the drug, which is commonly used as an anti-malarial medication and for people with autoimmune diseases like lupus. The request came four days after Henry Ford published a controversial study in the International Journal of Infectious Diseases that suggested hydroxychloroquine slashed the COVID-19 death rate in half. The peer-reviewed observational study contradicted other published reports that showed the drug doesn't help coronavirus patients and could cause heart rhythm problems in some people. The FDA denied Henry Ford's request this week. "The U.S. Food and Drug Administration informed us that it would not grant our request for an emergency use authorization for hydroxychloroquine for a segment of COVID-19 patients meeting very specific criteria," said Dr. Adnan Munkarah, Henry Ford's executive vice president and chief clinical officer, in a statement. The patients who would have received the drug would have had to meet the same criteria as those who were enrolled in Henry Ford's initial study:
* Age 18 or older
* Have a positive COVID-19 test
* Be admitted to any of its six hospitals
* Be low risk for heart complications based on an electrocardiogram algorithm. A QT interval higher than 500 milliseconds was considered an elevated cardiac risk.
Henry Ford's study was widely criticized because it was observational, retrospective and not randomized or controlled. Additionally, the health system used hydroxychloroquine in combination with dexamethasone, a steroid, which has been known to improve outcomes for people with COVID-19.
Hope, and conflicting research
Early in the pandemic, hydroxychloroquine looked like it could be a promising treatment for COVID-19, but use of the drug quickly became political. A French study published March 20 suggested the drug helped people with coronavirus, reporting it "is significantly associated with viral load reduction/disappearance in patients with COVID-19." Positive outcomes, it noted, were improved when used in combination with the antibiotic azithromycin. The next day, President Donald Trump tweeted that hydroxychloroquine and azithromycin "have a real chance to be one of the biggest game changers in the history of medicine." Encouraged by those preliminary findings, researchers around the world began to launch their own investigations of the drug, and the FDA issued an emergency use authorization March 28 to allow doctors to begin treating patients with it in hospitalized settings outside clinical trials. Henry Ford Health System was among many nationally and across the state to begin using hydroxychloroquine in that way. Michigan Medicine, the Detroit Medical Center and McLaren Health Care also used it. In early April, both Michigan Medicine and Henry Ford announced they would enroll patients in studies testing the effectiveness of hydroxychloroquine for the treatment of coronavirus. Henry Ford’s study was a retrospective analysis of 2,541 patients hospitalized between March 10 and May 2, 2020 across its six hospitals. In the weeks that followed, more research suggested that the drug might not help coronavirus patients and could cause some harm. An April 23 preliminary review of 368 novel coronavirus patients at U.S. Veterans Health Administration hospitals suggested that the use of hydroxychloroquine — with or without azithromycin — did not reduce the likelihood of needing a mechanical ventilator and it may actually have made patients more likely to die. And a review of the initial French study found it was flawed and overstated the benefits of hydroxychloroquine treatment. The review also showed that patients who had bad outcomes after using the drug were dropped from the study, skewing the results. Still, Trump continued to publicly praise the drug's effectiveness, and spoke at White House Coronavirus Task Force news conferences about how he was taking it himself with hopes it would prevent him from contracting the virus. With evidence mounting, the FDA issued a warning in late April, urging caution about using hydroxychloroquine in COVID-19 patients. "Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19," it said. "They are being studied in clinical trials." The drugs, it warned, "can cause abnormal heart rhythms such as QT interval prolongation and a dangerously rapid heart rate called ventricular tachycardia. ... Patients who also have other health issues such as heart and kidney disease are likely to be at increased risk of these heart problems when receiving these medicines." But the federal agency didn't revoke emergency use authorization of hydroxychloroquine until June 15, writing: "In light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use." The World Health Organization announced June 17 that it would stop testing hydroxychloroquine in coronavirus patients through its Solidarity Trial. The National Institutes of Health halted its hydroxychloroquine study a few days later. The FDA's Adverse Events Reporting System logged 9,363 reports of bad reactions to hydroxychloroquine and related medications just in the first eight months of this year. Of them, 8,936 were classified as serious reactions in which 402 people died. Comparatively, in all of 2019, there were 8,059 reports of adverse reactions to the drug, and 6,982 were considered serious; 146 people died.
The politics of hydroxychloroquine
When Henry Ford Health System published its hydroxychloroquine study in early July showing success in the treatment of COVID-19 — cutting the mortality rate from 26% among those who did not receive the medicine to 13% among those who did — it was met with skepticism by many in the medical community. Among the critics was Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Disease, who called the study "flawed" in his testimony in late July at a congressional hearing on the federal government's efforts to control the pandemic.

fauci-pelosi.jpg

Patients in the Henry Ford study, Fauci said, were given corticosteroids, which are known to be of a benefit to people with COVID-19. And it wasn't randomized or placebo-controlled, the gold standard for medical studies. Yet, Henry Ford's hydroxychloroquine research was hailed by the president as proof that the drug he touted from the beginning of the COVID-19 crisis works. Trump took to Twitter on July 6 — the same day Henry Ford asked the FDA for authorization to resume using hydroxychloroquine in COVID-19 patients — alleging Democrats disparaged the drug for political reasons. The next day, Dr. Steven Kalkanis, Henry Ford Health System's chief academic officer and senior vice president, told the Free Press that medicine shouldn't be political. "We're scientists, not politicians," Kalkanis said. "We've never had a preconceived agenda with this study or any study regarding hydroxychloroquine. We simply wanted to use the resources and the opportunity of COVID, given that Detroit was such a hard-hit region, to find out which treatments worked and which treatment didn't. "So early on, we embarked on several different studies, and we wanted to let the data lead us to what is appropriate for patients. We stand behind the results of our study. We found that, you know, among 2,500 patients, the use of hydroxychloroquine cut the death rate in half." Last week, Henry Ford issued an open letter about its study, saying, "the political climate that has persisted has made any objective discussion about this drug impossible." The health system said in the letter that it will no longer comment outside the medical community on the use of hydroxychloroquine to treat novel coronavirus. "We are deeply saddened by this turn of events," said the letter, signed by both Munkarah and Kalkanis. "Like all observational research, these studies are very difficult to analyze and can never completely account for the biases inherent in how doctors make different decisions to treat different patients. Furthermore, it is not unusual that results from such studies vary in different populations and at different times, and no one study can ever be considered all by itself." Trump has continued to support the use of hydroxychloroquine, saying in a July 28 White House news briefing that he believes in its benefit and that "many doctors think it is extremely successful." "I took it for a 14-day period, and I’m here. Right?" he said. "I’m here. I happen to think it’s — it works in the early stages. I think front-line medical people believe that, too — some, many. And so we’ll take a look at it. ... It’s safe. It doesn’t cause problems. I had no problem. I had absolutely no problem, felt no different. Didn’t feel good, bad, or indifferent." Henry Ford is continuing with another research study of hydroxychloroquine that was announced in April in conjunction with Detroit Mayor Mike Duggan. Called the WHIP COVID-19 study, it's the first large-scale U.S. study to investigate whether using the drug can prevent coronavirus among 3,000 health care workers and first responders. "The decision does not impact the ongoing WHIP COVID-19 study, a randomized, double-blind investigation of hydroxychloroquine as a preventive treatment," Munkarah said. The outcome of that research has yet to be published.
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Why Are Medical Authorities Playing Games With COVID Treatments?

Postby smix » Fri Aug 28, 2020 7:26 pm

Why Are Medical Authorities Playing Games With COVID Treatments?
The Federalist

URL: https://thefederalist.com/2020/08/27/wh ... reatments/
Category: Politics
Published: August 27, 2020

Description: We can no longer avoid questions about the elevation of Remdesivir and suppression of hydroxychloroquine.

pelosi-hillary.jpg
Deplorables are asking too many questions.

The French virologist Dr. Didier Raoult, who early in the pandemic successfully treated COVID-19 patients with hydroxychloroquine, has issued an “expression of concern” excoriating the prestigious New England Journal of Medicine for publishing dubious studies. In trenchant terms, Raoult calls out the journal for publishing studies with such egregious flaws that the practices would not pass muster at his teaching hospital in Marseille. He highlights, for instance, the most obvious limitation of a widely touted study claiming to show that hydroxychloroquine treatment does not prevent COVID-19: Less than 3 percent of the study participants had a confirmed diagnosis. The RECOVERY trial, published in the journal and celebrated for showing that dexamethasone improves survival in hospitalized patients, was no major breakthrough. Anti-inflammatory steroids help patients in respiratory distress, and hospital protocols that include steroids in COVID-19 treatment were already the norm elsewhere. Why even run such a study, asks Raoult, let alone withhold treatment from patients in the control group? Scandalously, in another arm of the study, these investigators overdosed patients with toxic levels of hydroxychloroquine, then dismissed the drug as useless.
Failures of Remdesivir
Contrast that to the receptiveness to Remdesivir. Following the journal’s publication of preliminary findings, the experimental drug was declared a “game changer.” The trial, however, showed only modest results. When the main outcome measure, a reduction in deaths, failed to reach statistical significance, a secondary outcome, time to hospital discharge, was elevated as a measure of recovery. Hospital stays were shortened from 15 to 11 days on average. A companion study of patients treated with Remdesivir for either five or 10 days, however, should give pause. A four-fold higher rate of acute kidney injury occurred with the longer treatment, an outcome not readily discerned when major and minor adverse events are reported in aggregate. Did the journal editors or peer reviewers express any concern? One hears nothing of this finding from the medical establishment, the regulatory agencies, nor the news media. By contrast, an observational study of severely ill hospitalized patients, in which hydroxychloroquine statistically halved the death rate even after correcting for factors such as steroid use, was pronounced “flawed.” Thus Remdesivir, a failed Ebola drug repurposed for COVID-19, is declared the standard of care by a National Institutes of Health (NIH) panel, the members of which have financial ties to the manufacturer, Gilead Sciences. The same panel duly notes the hydroxychloroquine study results yet “recommends against” using the drug except in clinical trials. Sadly, this phenomenon is not new. Fifteen years ago, a survey of 200 expert panels that issued practice guidelines found that a third of the members had a financial interest in the drug under consideration.
Effectiveness of Hydroxychloroquine
Antiviral drugs such as Remdesivir and hydroxychloroquine work best early in the disease, as they block cell infection, viral replication, or both. Although Remdesivir should stop the virus from replicating, one study found it failed to reduce viral loads. By contrast, hydroxychloroquine (ideally given with zinc) reduces viral loads and helps prevent COVID-19 from developing into a serious illness. Moreover, the hysteria over hydroxychloroquine’s safety is hyperbole: Decades of evidence indicate safe use under a doctor’s care. A hospital study to address this specific issue found the drug to be safe for COVID-19 patients with cardiovascular disease, the very patients for whom there may be a concern. Suppressing early treatment with hydroxychloroquine based on the lack of randomized prospective trials is unwarranted. Dr. Thomas Frieden, former head of the Centers for Disease Control and Prevention, argued against excessive reliance on such data while discounting other worthwhile and sometimes superior evidence. If the need for a large prospective trial on hydroxychloroquine is the main roadblock, why hasn’t the NIH already sponsored one? Multinational coalitions have called for such a study. No doubt the American public would consider this a worthy use of taxpayer money. Few people recognize that most of the funding for clinical trials comes from the pharmaceutical industry and that the industry deeply influences their conduct. Nor is it widely known that two-thirds of the Food and Drug Administration’s (FDA) budget for evaluating prescription drugs comes from the industry it regulates. Even less apparent is that federal legislation allows institutions supported by federal grants to patent and license new products. Investigators are handsomely remunerated through consulting fees, equity in the pertinent companies, and patent and royalty agreements.
Follow the Money
The National Institute of Allergy and Infectious Diseases, a branch of the NIH led by Dr. Anthony Fauci, sponsored the multicenter trial of Remdesivir. Remdesivir is experimental, expensive, scarce, and administered by intravenous injection. Hydroxychloroquine is off-patent, cheap, widely available, and taken orally. Yet the FDA granted an emergency use authorization for Remdesivir but revoked such authorization for hydroxychloroquine and will not allow the hospitals that saved patients to keep using it. Why stymie a treatment that is pragmatic, affordable, helps ill patients, and could reduce the need for hospitalization? Spurred by such obvious considerations, a current lawsuit demands that the FDA remove its hydroxychloroquine restrictions. Three U.S. senators now request that the FDA provide evidence to justify its apparent conclusion that the drug is unsafe or ineffective when used early under a doctor’s care. Pharmaceutical giants such as Gilead Sciences have major stakes in the global financial industry. Drug companies are known to promote their products and marginalize naysayers by covertly controlling the public narrative. Independent journalist Sharyl Attkisson attempted to examine the controversy in depth, but Fauci and Gilead Sciences declined her interview requests. What to make of this state of affairs? Dr. Marcia Angell, former editor of the New England Journal of Medicine, offers this sobering assessment:
It is simply no longer possible to believe much of the clinical research that is published, or to rely on trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.

When will we witness unblemished science, probing journalism, and a true commitment to the common good? Alas, Dr. Raoult, they abuse our patience indeed.
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