The Lancet doubled down on its previous smear of Hydroxychloroquine (Mehra et al.), the main component of the effective COVID-19 treatments. On July 9, it published
Retraction and republication: cardiac toxicity of hydroxychloroquine in COVID-19
Christian Funck-Brentano, Lee S Nguyen, Joe-Elie Salem
Notice that two of the three authors (Funck-Brentano and Salem) were also authors of the op-ed or comment to Mehra et al., published on the same day, which was also retracted.
This latest article re-uses the debunked Magagnoli et al., Rosenberg et al., and the tragicomic RECOVERY trial. In addition, it relies on an earlier fraudulent paper from the same authors Nguyen et al. (with additional co-authors).
Nguyen et al. , May 22
Lee S. Nguyen, Charles Dolladille, Milou-Daniel Drici, Charlotte Fenioux, Joachim Alexandre, Jean-Paul Mira, Javid J. Moslehi, Dan M. Roden, Christian Funck-Brentano, and Joe-Elie Salem
It is another example of “database studies”. It uses fake methodology, described in gibberish. This is an excerpt (self-references are omitted):
Association between hydroxychloroquine, azithromycin, and their combination with CV-ADR was assessed using reporting-odds-ratio (ROR) and information component (IC), an indicator value for disproportionate Bayesian reporting that compares observed and expected values to find associations between drugs and ADR. The lower end of the IC’s 95% credibility interval is IC025. It is considered significant when above 0.
ROR and IC are BS. The authors made up these quantities. The data is extracted from WHO’s VigiBase, using VigiAccess interface (its description can be found in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5051262/). Similarly to FDA’s FAERS, WHO’s VigiBase (Vigi- comes from vigilance)contains mostly unverified reports of adverse effects, possibly linked to the drug. In addition, it contains complaints about drugs’ effectiveness and even administration procedures. The number of records has little relation to the drug safety. On July 13:
Paracetamol: 151, 575
These are numbers of reports, not adjudicated cases. For HCQ, the largest group category is General disorders and administration site conditions (10422); the largest subcategory is Drug ineffective (6182).
The authors claim that they have found “76,822 ADR cases associated with hydroxychloroquine alone” – more cases than non-duplicate records. In less than 500 of these cases, HCQ was suspected in cardiovascular adverse reactions. Hydroxychloroquine with Azithromycin were suspected in 9 (nine) cases.
This paper contains no abstract and no subsection. Its only coherent conclusion “Hydroxychloroquine was also associated with potentially lethal HF [heart failure] when exposure was prolonged over several months” is neither relevant for a 5-day treatment for COVID-19 nor in agreement with other literature on the subject. Another oddity of this paper: it has only five references, three of which are self-references (i.e., references to papers including at least one of the authors).
As expected, the authors have hidden a conflict of interest. Christian Funck-Brentano is a Scientific Advisor to Banook Group (http://www.banookgroup.com/ap/webinar/). The Banook Group (formerly Cardiabase) offers services in the field of cardiac safety (https://www.banookgroup.com/for-all/solutions/cardiac-safety/).
A huge clinical trial RECOVERY, conducted in the Britain, would be comical if it were not tragic. The clinical researchers confused HCQ with another drug and gave their patients 6x higher dose than normal one (2,400 instead of 400 mg/day). It was tolerated well, but, on the balance, did not improve odds.
CQ/HCQ Cardiac Safety
In 2017, WHO investigated suspicions of cardiotoxicity of various anti-malarial drugs. It found CQ and HCQ to be exceptionally safe. In hundreds of millions of doses, only 11 deaths were reportedly associated with CQ or HCQ, four of which were clearly shown to be overdoses.
Exposure to chloroquine and hydroxychloroquine was reported in six and five cases of sudden death, respectively. In four of these cases, overdose was listed as the indication. Hydroxychloroquine was used to treat rheumatoid arthritis, systemic lupus erythematosus and small cell lung carcinoma in one case each.
Despite hundreds of millions of doses administered in the treatment of malaria, there have been no reports of sudden unexplained death associated with quinine, chloroquine or amodiaquine, although each drug causes QT/QTc interval prolongation.
via Science Defies Politics
July 13, 2020 at 10:51PM