In the trials, Recovery and Solidarity, it is not excluded that patients have died because of an overdose therapeutic hydroxychloroquine. Decidedly hydroxychloroquine has not yet finished talking about it. Clinical trials in the courts, 27 brazilian researchers who find themselves on the bench of the accused for an overdose which resulted in the death of 11 patients in Manaus (capital of the State of Amazonas in Brazil). The warning of toxicity of the test brazilian date of 17 April 2020.
In previous articles, we wrote that the Pr Horby and Pr Landray investigator of the trial british Recovery surely would have to be accountable to the court, both the loading dose (2.4 g over 24 hours) and the successive doses combined (800 mg/day) of hydroxychloroquine oral appeared excessive in view of the toxicity-limiting established for this drug.
This same day the primary endpoint of the study, Recovery has been changed from “death in hospital ” to “death to 28 days.. ” in the context likely to confuse the interpretation of the measurement, thus preparing the non-disclosure of the average time elapsed before death.
In addition to the April 18, 2020 to be 2 days after the final publication of the brazilian study, the Pr Horby and Landray have also amended the list of frequently asked questions (FAQ) to remove the part on the dosage be excessive. They have also removed the pharmacokinetic analysis of the descriptive sheet of hydroxychloroquine in order to hide the mistakes made. To complete the information on this arm of the study had not been published 20 days after the announcement.
Some patients will have suffered the dramatic consequences of this experience of inhuman conduct by the Pr Horby and Landray, who have not only continued to prescribe high doses in spite of the warning of the Brazilians, but tried awkwardly to hide their mistakes.
As was the case of brazilian justice, we believe that a criminal investigation should be opened in the United Kingdom.
How do I explain the dosages very abnormal test Recovery ?
The WHO document referred to in the document of justification of the treatment doses administered in the trial Recovery indicates that the lethal dose of chloroquine, delivered in a single oral intake, is from 50 mg/kg (as base) that is to say around 65 mg/kg as phosphate (oral route) a dose between 3 and 5 g according to the weight of an adult is between (50 and 80kg). We note that, for children, overdose fatal is 1 g or less !
It should be noted that hydroxychloroquine, a derivative that is very close to chloroquine, is used in its place for decades because of a lower retinal toxicity. But, even if there are much less data on toxicity, rate-limiting, it is accepted that the lethal dose for the hydoxychloroquine is in the same range as that of chloroquine (i.e., around 4 g of a dose for an adult). In this respect, as we have described in a document of investigation published on the test Recovery to the statements of the Pr Landray, who considered that the overdose fatal hydroxychloroquine was 10 or 20 times the above doses administered in the trial, Recovery (), left breathless !
Even more alarming, an article describing a case of fatal intoxication subsequent to a suicide attempt at the hydroxychloroquine states that : “In sum, intoxication hydroxychloroquine is rare, but potentially fatal, and should be suspected in cases of hypopotassemia grave associated with the shock, ventricular arrhythmias or arrest, cardio-pulmonary of uncertain origin. “
The icing on the cake : the WHO document on the therapeutic use of chloroquine indicates that the overdose of this drug leads to a difficulty in breathing due to pulmonary edema !
One can thus consider, rightly, that the toxicity of hydroxychloroquine is exacerbated by lung damage, and fragile cardiovascular in-patient unit at a stage already serious disease with an increased risk of the rush to a respiratory failure acute. Mechanically, the exacerbation of toxicity may induce events more frequently and at lower doses than those considered as potentially life-threatening. This effect is well known to all clinicians. In addition, this has the result of seriously complicate the attribution of the deaths to treatment in the case of the COVID-19, so that a mathematical analysis is needed to assess correctly the disastrous consequences of the overdose of the HCQ in Recovery. The Pr Horby and Landray are visibly on it to drown the fish.
The timing of Recovery parallel to that of the brazilian study allows to notice the ominous behavior of the Pr Horby and Landray that if it was proven that they acted in all conscience to deserve criminal prosecution for medical malpractice been proven.
For Recovery, on the 7th of April is the day or the 3rd amendment to the protocol was made. It is also the date of registration of the document of the brazilian study in which the toxicity of hydroxychloroquine with a high dosage. The same day Recovery has been a significant change in the primary endpoint of the study : “death in hospital” to ” death under 28 days of randomization in the trial “
Calendar Recovery vs Study brazilian – FranceSoir
For the test Recovery the 22 April the frequently asked questions contained the question on the dosing of HCQ : “We are aware that there are issues on the high dosage of hydroxychloroquine. However, after consideration precautionnée, the dose of the load will remain the same. No dose modification.”
Recovery FAQ Dosage – question missing – FranceSoir
This question and its answer have simply been removed from version 5 of the April 24, 2020. This is the only change in the document and corresponds to the dates of the warning of the test the brazilian on the toxicity of hydroxychloroquine. Clare Brittain, who is responsible for the document on hydroxychloroquine and has written under the direction of Pr Horby and Pr Landray, was unavailable to answer our questions.
The investigators have worked to erase the evidence of their failures by removing the pharmacokinetic analysis between the version 2 and version 3 on April 18, the day after the announcement of the Brazilians, and changing in the wake of the FAQ, thus continuing the clinical trial, while minimizing their potential liabilities. This analysis is the one that allows you to determine the dosage and is the subject of a previous article.
Between April 18 and June 4, the Pr Horby and Landray will, therefore, continued to overdosing consciously hydroxychloroquine to patients of this arm of the study so that we think that they knew that there were very large risks.
The regulation agency of health English MHRA under the influx of reports of serious adverse events (Serious Adverse Events) has certainly raised a number of deaths too important 1 patient out of 4. Pr Horby and Landray had to produce an interim analysis at the request of the MHRA, which has avoided momentarily to acknowledge their faults.
We can only say that their announcement on the pseudo-success of the arm déxaméthasone looks like powder in the eyes in order to cover their shortcomings.
The mesuresà take
To verify the conclusions of this analysis are difficult to dismiss, only the reports of the events adverse serious (SAE) will be able to understand the details of what happened to the patients in Recovery who have received an overdose of hydroxychloroquine.
In the clinical trial Recovery, it is dramatic to note that the patients were considered as guinea pigs in a laboratory for reasons completely unrelated to medical ethics.
In addition, the law on the protection of the patients considers that it is not ethical to enter patients into a clinical trial, placebo-controlled trial (Huriet-sérusclat law of 1988, as supplemented by the law Jardé n° 2012-300 of 5 march 2012 regarding research involving human person).
Author(s): The Citizens ‘ group for FranceSoir