Saturday, September 12, 2020

WHO trials overdosed HCQ patients, MD says

WHO and UK trials use potentially lethal hydroxychloroquine dose--according to WHO consultant | Anthrax Vaccine blog - Meryl Nass, M.D.

June 14, 2020 - "The Solidarity Trial is a WHO-led conglomeration of many national trials of treatments for Covid-19.... The hydroxychloroquine arm of the Solidarity trials restarted enrolling patients June 3, after being halted May 25 by WHO Director-General Dr. Tedros Adhanom Ghebreyesus and the Executive Group of the Solidarity Trial... after publication of the Lancet Surgisphere study, which claimed that patients who received chloroquine or hydroxychloroquine had 35% higher death rates, but the Lancet study was retracted 13 days after publication.... The HCQ Solidarity trials are currently ongoing.... The doses were not specified on WHO's list of the drugs to be trialed, nor were they specified, surprisingly, in WHO's April 8 four-person 'consultation on chloroquine (CQ) dosing'....

"Last week, I was alerted to the fact that India's ICMR, its official medical research agency, had written to the WHO, telling WHO that the hydroxychloroquine doses being used in the Solidarity trial were 4 times higher than the doses being used in India.  Then I learned that Singapore had been hesitant to participate in the WHO trial due to the hydroxychloroquine dose....  

"The Solidarity trial is registered but the registration fails to specify dosages. The registration of the Canadian portion of the Solidarity trial informs us of its HCQ dose: ten 200 mg tablets during the first 24 hours (800 mg initial dose, 800 mg 12 hours later then 400 mg every 12 hours for 9 more days).  This is 2.0 grams during the first 24 hours, and a cumulative dose of 8.8 grams over 10 days.... The Norwegian Solidarity trial uses dosing identical to Canada....

"How is the drug hydroxychloroquine normally used?  For chronic daily use in systemic lupus erythematosus, rheumatoid arthritis or Lyme disease, patients receive between 200 and 400 mg daily....  In acute Q fever, 600 mg daily may be given at the start of treatment. For acute attacks of malaria, 1,500-2,000 mg may be given over 3 days. Professor Didier Raoult's group in Marseille used 600 mg daily for up to ten days in 1061 Covid-19 patients, and reported 8 deaths, a mortality rate of 0.75%, all over 74 years of age....

"What is a toxic dose?  All experts agree on this: '... chloroquine has a small toxic to therapeutic margin,' according to Goldfrank's Toxicologic Emergencies.  The drug is very safe when used correctly, but not a lot more can potentially kill.  Prof. Nicholas White, a Wellcome Trust Principal Research Fellow and expert in malaria treatment, who attended both WHO consultations on the chloroquines, has confirmed this.... The WHO hired a consultant to explore the toxicity of chloroquine in 1979. The consultant, H. Weniger, looked at 335 episodes of adult poisoning by chloroquine drugs. Weniger on page 5 notes that a single dose of 1.5-2 grams of chloroquine base 'may be fatal.' According to Browning and Goldfrank, the pharmacokinetics and potency of chloroquine and hydroxychloroquine are almost identical.... 

"The [independent UK] Recovery trial used 1.86 grams hydroxychloroquine base (equal to 2400 mg of hydroxychloroquine) in the first 24 hours for treatment of already very ill, hospitalized Covid-19 patients.  The Canadian and Norwegian Solidarity trials used 2,000 mg of HCQ, or 1.55 grams of HCQ base in the first 24 hours. Each trial gave patients a cumulative dose during the first 24 hours that, when given as a single dose, has been documented to be lethal. (The drug's half-life is about a month, so the cumulative amount is important.)  The doses used in these trials are not recommended for therapy of any medical condition, which I confirmed with Goodman and Gilman's Pharmacology textbook, the drug's US label, and the online subscription medical encyclopedia UptoDate.... 

"Excessive dosing makes it impossible to assess therapeutic benefit, if any, of HCQ. Furthermore, because there are over 400 trial sites, and relatively few subjects in each, unexpectedly high trends in mortality are likely to be missed at individual trial sites. Finally, testing the drug only in hospitalized patients means that the window of time during which HCQ would be expected to provide the most benefit, early in the illness when viral titers are rising, has passed....

"To sum up: 

  1. In the UK Recovery trial, and in WHO Solidarity trials, HCQ is used in a non-therapeutic, toxic and potentially lethal dose.
  2. HCQ is furthermore being given, in clinical trials, too late in the disease course to determine its value against SARS-CoV-2.
  3. Collection of limited safety data in the Solidarity trials serves to protect trial investigators and sponsors from disclosures of expected adverse drug effects, including death.
  4. It appears that WHO has tried to hide information on the hydroxychloroquine doses used in its Solidarity trial.  Fortunately, the information is discoverable from registries of its national trials....

"Update June 18:  I sent a tweet to WHO Director General Tedros informing him of these findings 3 days ago.  I also emailed WHO's Dr. Restrepo, inquiring about the doses used in the Solidarity trial.  I am very pleased to report that WHO stopped this deadly trial yesterday, with no fanfare ... on the basis of the Recovery trial result ... as well as WHO data. I like to think my investigation has helped save some lives."

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