*This REMAP-Covid study, Meryl explains, is an outgrowth of "a multicenter study of community-* *acquired pneumonia begun in 2016." She wonders how it is that those running/operating these* *dubious trials have apparently "lost the ability to think for themselves. How can this be? Overwork?* *Certainly ambition. Medicine is very hierarchical, so why even consider raising questions?" *
*MCM * Even worse than 'Recovery,' potentially lethal hydroxychloroquine study in > patients near death > <https://anthraxvaccine.blogspot.com/2020/06/even-worse-than-recovery-potentially.html> > * by Meryl Nass, MD* https://anthraxvaccine.blogspot.com/2020/06/even-worse-than-recovery-potentially.html > What could be worse than giving potentially lethal doses of > hydroxychloroquine to Hospitalized Covid-19 patients? > > The REMAP-Covid study is using the same HCQ dose as the Recovery trial for > 6 days. But it is even worse for the following reasons: > > > 1. You have to be close to death, either on a ventilator or in shock, > on pressor medications, to be included in the trial > <https://clinicaltrials.gov/ct2/show/record/NCT02735707> > 2. You may receive HCQ alone, or HCQ in combination with 2 more drugs, > lopinavir/ritonavir. Yet lopinavir/ritonavir predisposes to QT > prolongation, as does HCQ, and the drug label states, "Avoid use in > combination with QTc- or PR-interval prolonging drugs." > 3. Patients who are in shock or on a ventilator may be unable to give > their consent to enroll in a clinical trial. But the trial investigators > have deemed that consent may not be required: *"**For patients who > are not competent to consent, either prospective agreement or entry via > waiver of consent or some form of deferred consent can be applied, as > required by an appropriate ethical review body."* > 4. For patients too sick to swallow a pill, the drug will be > administered via a feeding tube. This could entail an extra procedure for > patients > > > From the Covid protocol > <https://static1.squarespace.com/static/5cde3c7d9a69340001d79ffe/t/5ea3fd83f222897b8d528195/1587805583231/REMAP-CAP+-+COVID-19+Antiviral+Domain-Specific+Appendix+V2.0+-+01+April+2020_WM.pdf> > page > 23: > > *Dosing will be hydroxychloroquine administered by the enteral route. A > loading dose is important because of the large volume of distribution. The > loading dose will be 800 mg, administered 6-hourly, until 2 doses have been > administered. Subsequently, starting 12 hours after the first loading dose, > the dose will be 400 mg administered 12-hourly for 12 doses. The preferred > method of administration is tablets swallowed whole but, if a patient is > unable to swallow, crushed tablets dispersed in water can be administered > via an enteral tube (a large bore gastric tube is preferred). No dose > adjustment is required when hydroxychloroquine is administered via a > gastric tube. No dose adjustment is necessary for renal dysfunction or > concomitant use of renal replacement therapy. Clinicians should consider a > dose adjustment in the presence of liver failure, however no dose > adjustment is necessary for abnormal liver function tests in the absence of > liver failure.* > > This is 2400 mg hydroxychloroquine in the first 24 hrs, over 1.86 g of the > "base," then 800 mg/day for 5 more days or until discharge from the ICU, or > 6.4 g total. WHO's consultant Weniger reported in 1979 that a single dose > of 1.5-2 g of chloroquine "base" *"may be fatal."* A detailed discussion > of therapeutic and toxic doses of chloroquine and hydroxychloroquine can be > found in my article > <http://anthraxvaccine.blogspot.com/2020/06/who-trial-using-potentially-fatal.html> > of > June 14. > > The study protocol acknowledges that the combination of > lopinavir/ritonavir and hydroxychloroquine increases the risk of > ventricular arrhythmia, but states that the risk is mitigated because > patients this sick will be on cardiac monitors, with QTc monitoring. > However, it fails to say that the most likely arrhythmia in this setting is > *torsade > de points, *which is very difficult to treat. Patients who are already > critically ill are unlikely to survive if it occurs. So why use such an > excessive hydroxychloroquine dose? That is not explained. > > The REMAP clinical trial is ongoing in 200 sites in 14 countries > <https://www.remapcap.org/participating-sites>. > > All their online protocols have been stamped "Not for IRB (Institutional > Review Board) submission," which makes one wonder what was changed when the > trial arms were put before IRBs for approval. > > Five UK chief medical officers wrote a "Dear Colleague" letter > <https://static1.squarespace.com/static/5cde3c7d9a69340001d79ffe/t/5e8d413e713b2d6cd799e143/1586315583723/CEM_CMO_2020_012.pdf>, > begging physicians to enroll their Covid patients in clinical trials, > including 'Recovery' and REMAP, and discouraging "off-label" treatments for > Covid outside of trials. Did they know they were asking treating > physicians to significantly up the risk of death for their patients? Are > they aware that as of today, June 19, the UK has had more deaths > <https://www.newscientist.com/article/2237475-covid-19-news-uk-coronavirus-alert-level-lowered-from-four-to-three/> > from > Covid-19 than any country in the world outside the US and Brazil, with 5 > and 3 times the UK population, respectively. > > Why is public health being turned on its head? > -- If you appreciate News From Underground, please consider making a donation — either a one-time gift or a monthly subscription: http://markcrispinmiller.com/support/ Thank you for your support. Ways to unsubscribe: 1) send a blank email to [email protected] PLEASE NOTE: you must unsubscribe using the SAME email with which you subscribed 2) go to http://groups.google.com/group/newsfromunderground and click on the "Unsubscribe or change membership" link in the yellow bar at the top of the page, then click the "Unsubscribe" button on the next page. 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