Saturday, June 27, 2020
It is remarkable that a series of events taking place over the past 3 months produced a unified message about hydroxychloroquine, and produced similar policies about the drug in the US, Canada, Australia, NZ and western Europe. The message is that generic, inexpensive hydroxychloroquine is dangerous and should not be used to treat a potentially fatal disease, Covid-19, for which there are no (other) reliable treatments.
Hydroxychloroquine had been used safely for 65 years in millions of patients. And so the message was crafted that the drug is safe for its other uses, but dangerous when used for Covid-19. It doesn’t make sense, but it seems to have worked.
Were these acts carefully orchestrated? You decide.
Might these events have been planned to keep the pandemic going? To sell expensive drugs and vaccines to a captive population? Could these acts result in prolonged economic and social hardship, eventually transferring wealth from the middle class to the very rich? Are these events evidence of a conspiracy?
Here is a list of what happened, in no special order. Please help add to this list if you know of other actions I should include. This will be a living document. I have penned this as if it is the “to do” list of items to be carried out by those who pull the strings. The items on the list have already been carried out. One wonders what else might be on their list, yet to be carried out, for this pandemic.
1. You stop doctors from using the drug in ways it is most likely to be effective (in outpatients at onset of illness). You prohibit use outside of situations you can control.
Situations that were controlled to show no benefit included 3 large, randomized, multi-center clinical trials (Recovery, Solidarity and REMAP-Covid), the kind of trials that are generally believed to yield the most reliable evidence. However, each of them used excessive hydroxychloroquine doses that were known to be toxic and may have been fatal in some cases; see my previous articles here and here.
2. You prevent or limit use in outpatients by controlling the supply of the drug, using different methods in different countries and states. In NY state, by order of the governor, hydroxychloroquine could only be prescribed for hospitalized patients. France has issued a series of different regulations to limit prescribers from using it. France also changed the drugs’ status from over-the-counter to a drug requiring a prescription.
3. You play up the danger of the drug, emphasizing side effects that are very rare when the drug is used correctly. You make sure everyone has heard about the man who died after consuming hydroxychloroquine in the form of fish tank cleaner.
4. You limit clinical trials to hospitalized patients, instead of testing the drug in outpatients, early in the illness, when it is predicted to be most effective.
5. You design clinical trials to give much too high a dose, ensuring the drug will cause harm in some subjects, sufficient to mask any possible beneficial effect. You make sure that dozens of trials in dozens of countries around the world use these dangerous doses.
6. You design clinical trials to collect almost no safety data, so any cause of death due to drug toxicity will be attributed to the disease instead of the drug.
7. You issue rules for use of the drug based on the results of the unethical, overdosing Recovery study. (Of course their results showed more deaths in the hydroxychloroquine arm, since they gave patients 2.4 g in the first 24 hrs.)
8. You publish, in the world’s most-read medical journal, the Lancet, an observational study from a huge worldwide database that says use of chloroquine drugs caused significantly increased mortality. You make sure that all major media report on this result. Then 3 European countries announce they will not allow doctors to prescribe the drug.
And then Sanofi announced it would no longer supply the drug for use with Covid, and would halt its two hydroxychloroquine clinical trials, based on the fabricated Lancet study. One of the cancelled Sanofi trials was expected to test 210 outpatients early in the course of disease. The trial remains suspended, long after the Lancet paper was exposed as fraudulent. You surely don’t want a trial of hydroxychloroquine treatment early in the disease, since it might show an excellent effect.
9. Even after hundreds of people renounce the Lancet’s observational study due to easily identified fabrications–which, as James Todaro, MD, wrote was a “study out of thin air“–the Lancet held firm for two weeks, serving to muddy the waters about the trial, until finally 3 of its 4 coauthors (but not the journal) retracted the study. You make sure very few media report that the data were fabricated and the “study” was fraudulent. You let people believe the original story: that hydroxychloroquine routinely kills.
10. You ensure federal agencies like FDA and CDC hew to your desired policies. For example, FDA advised use only in hospitalized patients (too late) or in clinical trials (which are limited, are difficult to enroll in, or may use excessive doses). As of mid June, FDA advises patients and doctors to only give the drug to patients if they are in a clinical trial where, presumably, the results can be controlled.
Another example: you have FDA make unsubstantiated and false claims, such as: “Hospitalized patients were likely to have greater prospect of benefit (compared to ambulatory patients with mild illness)“ and claim the chloroquine drugs have a slow onset of action. If that were really true, they would not be used for acute attacks of malaria or in critically ill patients with Covid. (Disclosure: I once dosed myself with chloroquine for an acute attack of P. vivax malaria, and it worked very fast.). Providing no other treatment advice, CDC refers clinicians to the NIH guidelines, discussed below.
11. You make sure to avoid funding/encouraging clinical trials that test drug combinations like hydroxychloroquine with zinc, with azithromycin, or with both, although there is ample clinical evidence that such combinations provide a cumulative benefit to patients.
12. You have federal and UN agencies make false, illogical claims based on models rather than human data. For example, you have the FDA state on June 15 that the dose required to treat Covid is so high it is toxic, after the Recovery and Solidarity trials have been exposed for toxic dosing. This scientific double-speak gives some legal cover to the clinical trials that overdosed their patients. According to Denise Hinton, RN, the FDA’s Chief Scientist, or a clumsy FDA wordsmith:
“Under the assumption that in vivo cellular accumulation is similar to that from the in vitro cell-based assays, the calculated free lung concentrations that would result from the EUA suggested dosing regimens are well below the in vitro EC50/EC90 values, making the antiviral effect against SARS-CoV-2 not likely achievable with the dosing regimens recommended in the EUA. The substantial increase in dosing that would be needed to increase the likelihood of an antiviral effect would not be acceptable due to toxicity concerns.”
You have a WHO report claim toxic doses are needed. This of course is nonsense since a) CDC researchers showed strong effects against SARS-1 at safely achievable concentrations, b) the drug at normal doses is being tested in over 30 different medical conditions (see clinicaltrials.gov), and c) reports from many different countries say that the drug is effective for Covid-19 at normal doses, while d) a high dose chloroquine treatment trial was halted in Brazil and a preprint of the study was posted April 11, after finding the toxic effects were causing ventricular arrhythmias and deaths, after only 3 days of treatment. But the Solidarity, Recovery and REMAP-Covid trials continued overdoing patients until June, despite Brazil’s evidence of deaths by overdose.
13. You create an NIH Guidelines committee for Covid treatment recommendations, in which 16 members have or had financial entanglements with Gilead, maker of Remdesivir. The members were appointed by the Co-Chairs. Two of the three Co-Chairs are themselves financially entangled with Gilead. Are you surprised that their guidelines recommend specifically against the use of hydroxychloroquine and in favor of Remdesivir, and that they deem this the new “standard of care”?
14. You frighten doctors so they don’t prescribe hydroxychloroquine, if prescribing it is even allowed in their jurisdiction, because prescribing outside the new NIH “standard of care” leaves them open to malpractice lawsuits. You further tell them (through the FDA) they need to monitor a variety of lab parameters and patient EKGs when using the drug, although this was never advised before, which makes it very difficult to use the drug in outpatients. You have the European Medicines Agency issue similar warnings.
15. You manage to control the conduct of most trials around the world by badly designing the WHO-managed Solidarity trials, currently conducted in 35 countries. WHO halted hydroxychloroquine clinical trials around the world, twice. The first time, May 25, WHO claimed it was in response to the (fraudulent) Lancet study. The second time, June 17, WHO claimed the stop was in response to the Recovery trial results. Recovery used highly toxic doses of hydroxychloroquine in over 1500 patients, of whom 396 died. You stop the trial before the data safety monitoring board has looked at your data, a move that is unlikely to be consistent with trial protocol. WHO’s trial in over 400 hospitals overdosed patients with 2.0 g hydroxychloroquine in the first 24 hours. The trial was halted days after the toxic doses were exposed (by me).
16. You have the WHO pressure governments to stop doctors prescribing hydroxychloroquine.
17. You have the WHO pressure professional societies to stop doctors prescribing hydroxychloroquine.
18. You make sure that the most-consulted US medical encyclopedia, UptoDate, provides bad guidance to physicians, advising them to restrict hydroxychloroquine to only patients in clinical trials, citing the above sources of information.
19. You have the head of the Coronavirus Task Force, Dr. Tony Fauci, insist the drug cannot be used in the absence of strong evidence…while he insisted exactly the opposite in the case of the MERS coronavirus outbreak several years ago, when he recommended an untested drug combination for use…which had been developed for that purpose by his agency. And while he was bemoaning the lack of evidence, he was refusing to pay for trials to study hydroxychloroquine. And he was changing the goalposts on the Remdesivir trial, not once but twice, to make Remdesivir show just a tiny bit of benefit, but no mortality benefit. And don’t forget, Fauci was thrilled to sponsor a trial of a Covid vaccine in humans before there were any data from animal trials. So much for requiring high quality evidence before risking use of drugs and vaccines in humans!
20. You convince the population that the crisis will be long-lasting. You have the 2nd richest man in the world, and biggest funder of the WHO, Bill Gates, keep repeating to the media megaphone that we cannot go back to normal until everyone has been vaccinated or there is a perfect drug. (The Gates Foundation helped design the WHO clinical trials, and Gates is heavily invested in pharmaceuticals and vaccines.)
21. Fauci and Robert Redfield (CDC Director) wrote in the New England Journal on Feb.28
Posted by Meryl Nass, M.D. at 10:18 PM