Sunday, May 16, 2021

FDA's last word on the safety of hydroxychloroquine and chloroquine was issued last year/ FDA

FDA managed to find 385 adverse event reports for either HCQ or CQ in its FDA adverse event reporting system database, as justification for withdrawing its EUA for the chloroquine drugs.

But there wa something strange about these reports.  Only 102 of the 385 reports, or 26%, came from the United States.  Why would foreigners be submitting reports of adverse events associated with a chloroquine drug to the FDA, instead of to their own pharmacovigilance system?

According to FDA, "FAERS is a database that contains information on adverse event and medication error reports submitted to FDA."  It is not an international database.

Might FDA have requested that foreign entities submit reports?  Might some of those foreign entities have been sites where the HCQ overdose trials were conducted?  The big three multicenter overdose trials were Recovery, Solidarity and REMAP-Covid. Page 8 of the FDA report does indicate that some of those patients, for whom adverse event reports were filed, had received excessive HCQ doses.  Of a total of 256 reports for which FDA had dosing data, depending where you place the excessive dose cut-off, between 23 and 95 had received high doses.

FDA did a number of different things to suppress the use of hydroxychloroquine.  This just happens to be one thing I had not previously reported on.

What else is interesting is that this report was compiled in May 2020.  It is attached to a website dated July 2020, ten months ago.

In the intervening 10 months, well over 100 papers have been published on HCQ's use in Covid. FDA claims, "The FDA’s job is to carefully evaluate the scientific data on a drug to be sure that it is both safe and effective for a particular use..." Yet FDA has ignored this massive amount of accumulating literature on hydroxychloroquine, during which 400,000 Americans died of/with Covid.  Why? Willful misconduct?

Here is FDA's Drug Safety Priorities 2020, pages 8-9

Hydroxychloroquine sulfate and chloroquine phosphate 
Early in the pandemic, preliminary research data showed that the antimalarial drugs chloroquine and hydroxychloroquine may be effective in treating COVID–19, however, the data had significant limitations. MARCH 28 | Based on the scientific information available at the time, FDA issued an EUA for hydroxychloroquine and chloroquine to be used to treat certain hospitalized patients with COVID–19 when a clinical trial was not available or feasible. FDA continued to urge the conduct of clinical trials to determine whether the benefits of the medications outweighed any potential risks to patients of this new use. APRIL 24 | FDA issued a Drug Safety Communication cautioning against the use of hydroxychloroquine or chloroquine for COVID–19 outside of a hospital setting or clinical trial due to risk of serious heart-rhythm problems. JUNE 15 | FDA revoked the EUA for chloroquine and hydroxychloroquine. Based on continued review of the scientific evidence available — including results from a large, randomized clinical trial in hospitalized patients that found that these medications showed no benefit [the Recovery trial that poisoned patients with excessive doses--Nass]— the Agency determined that chloroquine and hydroxychloroquine were unlikely to be effective in treating COVID–19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of these medications no longer outweighed the known and potential risks for the authorized use. 

The fact is that the serious cariac risk was only when you used poisonous doses. And subsequent to last June, FDA has wilfully ignored massive accumulated evidence of the safety and effectiveness of these drugs for eacly stage Covid.  It would appear that FDA knowingly recommended this drug only in settings in which it was likely to show benefit:  late in teh course of illness.

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