Hydroxychloroquine and the danger of acting without evidence…

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Watch “The case for Hydroxychloroquine: What China says【中英文字幕】闫丽梦博士:羟氯喹虽不是神药,但是能救命!中共在研发更可怕的病毒!陈薇去武汉就是为了销毁证据!” on YouTube
Posted on August 3, 2020 by weehingthong

All anecdotal evidence. They never explain that HCQ tamps down the immune system. So, for those who say it’s a preventive how can it work if your antibodies & T cells are being held at bay by the drug? … Continue reading →

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Only in America: Dr Stella Immanuel (Trump’s new favorite Covid-19 doctor), Hydroxychloroquine and America’s Frontline Doctors…
Posted on July 29, 2020

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Fall out from the scrutiny of Surgisphere…
Posted on June 6, 2020

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Retraction: Hydroxychloroquine or chloroquine with or without a macrolide for treatment of Covid-19: a multinational-registry analysis.
Posted on June 5, 2020

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Under scrutiny: Surgisphere, whose data changed the policy of WHO and some governments regarding hydroxychloroquine in the treatment of Covid-19…
Posted on June 4, 2020

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Malaysia uses hydroxychloroquine to treat Covid-19, and the mortality rate on 9 April 2020 was 1.58%.
Posted on June 3, 2020

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Chloroquine, Hydroxychloroquine and Covid-19…
Posted on March 30, 2020

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On Hydroxychloroquine

This is an excerpt from:

By Susan Dominus

  • Aug. 5, 2020
    Updated 4:45 p.m. ET

The story of hydroxychloroquine will most likely be recalled as a classic medical parable of the pandemic. It was a drug that seemed so promising that physicians were desperate to use it, and researchers were equally driven to see if it actually delivered the hoped-for results. In the end, the enthusiasm of the first camp most likely slowed the speed with which the second could study the drug — only to find that the enthusiasm was never really justified in the first place.

In mid-March, Steven Libutti, director of the Rutgers Cancer Institute of New Jersey, read about a small hydroxychloroquine trial in France that was generating attention, having found that the anti-malarial might be effective in the treatment of Covid-19. “It looked interesting, exciting, promising, but it looked very far from convincing,” Libutti said. Although his specialty is cancer, he wanted to bring his extensive research knowledge to bear on the pressing question of the drug’s effectiveness. He wrote a proposal for a randomized, controlled trial that would measure the effectiveness of hydroxychloroquine on a patient’s viral load. (He was comparing the effect of the drug alone with placebo, as well as with the drug when administered with another drug called azithromycin.)

The story of hydroxychloroquine will most likely be recalled as a classic medical parable of the pandemic. It was a drug that seemed so promising that physicians were desperate to use it, and researchers were equally driven to see if it actually delivered the hoped-for results. In the end, the enthusiasm of the first camp most likely slowed the speed with which the second could study the drug — only to find that the enthusiasm was never really justified in the first place.

In mid-March, Steven Libutti, director of the Rutgers Cancer Institute of New Jersey, read about a small hydroxychloroquine trial in France that was generating attention, having found that the anti-malarial might be effective in the treatment of Covid-19. “It looked interesting, exciting, promising, but it looked very far from convincing,” Libutti said. Although his specialty is cancer, he wanted to bring his extensive research knowledge to bear on the pressing question of the drug’s effectiveness. He wrote a proposal for a randomized, controlled trial that would measure the effectiveness of hydroxychloroquine on a patient’s viral load. (He was comparing the effect of the drug alone with placebo, as well as with the drug when administered with another drug called azithromycin.)

Thousands of patients were pouring through those six New Jersey hospitals, but Libutti waited, for weeks, with great frustration as only a handful of patients were enrolled in his trial each day. Typically, in clinical trials, after a patient is admitted to the hospital, a doctor or nurse, often affiliated with the research, talks to the patient about the possibility of enrolling in a clinical trial. But Libutti’s team was finding that by the time a nurse could begin the conversation with the patient, that person had already been administered hydroxychloroquine — which meant the researchers could not get a baseline reading of that patient’s viral load. Patient after patient was disqualified from the study. They had “been handed hydroxychloroquine along with their toothbrush and slippers when they got to the emergency room,” Libutti told me. “They were giving it out like dinner mints.” The researcher said he “was shocked by the number of folks whom I thought were incredibly well-read, knowledgeable physicians but were just panic-prescribing hydroxychloroquine. I’ve never seen anything like it. It just shows how lost in the storm folks were.” (Michael Steinberg, who helps oversee trials as well as clinical care at Robert Wood Johnson University Hospital, which was involved in Libutti’s trial, said that although physicians use their clinical judgment to make decisions about treatment, they strongly encourage doctors to use evidence-based criteria.)

Other doctors shared Libutti’s experience. Arthur Caplan, a bioethicist at New York University’s medical school, said he is aware of three medical centers where researchers trying to study hydroxychloroquine felt that the early ardor for the drug among doctors and patients made it difficult for them to recruit subjects — to determine, essentially, whether the embrace of the drug was at all justified. Caplan and a colleague argued, in an article published online in April in The Journal of Clinical Investigation, that “panicked rhetoric about right-to-try must be aggressively discouraged in order for scientists to learn what regimens or vaccines actually work.” Communicating directly with doctors at various hospitals who were making the drug part of the official protocol, he used more plain language: “This is nuts!”

The Montefiore Health System in New York was one of the many that included hydroxychloroquine as an option in its treatment protocol, starting in late March. Michelle Ng Gong, the director of critical-care research, did not actively fight to have the drug removed from the protocol. But when she was working in her capacity as a critical-care doctor, she does not recall ever prescribing the medication, and she sometimes took patients who had received it in the emergency room off it. “When so many people are dying, you want to do something,” she said. But very sick patients are more susceptible to adverse events. “The problem is that we know from critical-care literature, as well as trials in the past, that we can always do more harm.”

In the end, the biggest randomized, controlled trial on hydroxychloroquine came out of Britain in June, and preliminary results found that the drug was not an effective treatment for Covid-19. In contrast to American doctors whose access to the use of the drug, even outside trials, had been eased by a federal agency, British physicians were given the opposite message. On April 1, the highest medical officials in England, Wales, Northern Ireland and Scotland each sent a letter to every hospital in their respective countries, urging doctors not to prescribe medications off-label outside trials. Instead they encouraged doctors to enroll their patients in large, multicenter, randomized, controlled trials, like a study run by the University of Oxford called Recovery, which looked at the efficacy of hydroxychloroquine, tocilizumab, convalescent plasma, dexamethasone and two other treatments. At some hospitals in Britain, as many as about 60 percent of patients were enrolled in Recovery trials; even the Northwell system, which is committed to research, was able to enroll, at its most trial-driven hospital, North Shore University Hospital, around only 20 percent of its patients in clinical trials.

A flood of patients all with the same illness presents logistical challenges to trials, but also the perfect conditions for them; that the American medical system could not harness more of those patients into randomized, controlled trials, said Peter Horby, one of the two chief investigators for Oxford’s Recovery trials, represents a lost opportunity. Whether or not convalescent plasma actually helps patients, for example, has not yet been resolved by a randomized, controlled trial despite the tens of thousands of doses that American patients have received, numbers that dwarf those in Britain. Given those numbers, American researchers “could have nailed it by now,” said Horby, whose own trial on convalescent plasma is still underway.

Caplan, the N.Y.U. bioethicist, acknowledges that doctors in the United States did manage to enroll more patients in trials more quickly than ever. But even still, he believes that the commitment to long-shot efforts to rescue patients was stronger than the commitment to science, which slowed results and possibly cost more lives. “We did a lot,” he said. “But we could have gone faster and resolved questions sooner.”

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