May 1 2020
Q: Hi, Dr. Why! Thanks for your time! What are your thoughts please in the findings below done at this large hospital in France treating Corvid-19 patients. Maybe I have it completely wrong but I feel it does look good!? If you don’t have time to read it all please scroll down to the last 2/3 paragraphs to see their conclusions.
I would be very interested to hear your thoughts. There have not been many clinical trails like this done properly. Thank you so much for your time! Hope to meet up in London when you are here next.
A: Of course! The study quoted has the following issues:
It is ORSERVATIONAL, e.g. both doctor and the patient knew what is being used for treatment. The GOLD standard is a DOUBLE-BLIND study when neither doctor no patient knows what is being used: drug or placebo;
It is a COHORT study. Cohort is a group of people who share a defining characteristic, typically those who experienced a common event in a selected period, such as a particular disease. The GOLD standard is CONTROLLED study, e.g. a study where there is a treatment group and control group (no treatment, or different treatment);
It is not a RANDOMIZED study. The randomized study requires RANDOM decision who gets treatment vs. placebo or one treatment vs. another;
The CONCLUSION of the study DOES NOT even include mentioning of drugs efficacy. Instead, it concludes that combination of Hydroxychloroquine and Azithromycin is “THEORETICALLY SAFE”:
“According to these data, the combination of hydroxychloroquine and azithromycin appears to have a theoretical safe profile with few clinically relevant drug-drug interactions. The main side-effects related to hydroxychloroquine are gastrointestinal symptoms and mainly nausea, vomiting and diarrhea. The main risk of the drug combination remains the risk of cardiac toxicity which can be prevented by respecting the contraindications of each drug and monitoring through systematic electrocardiogram and ionogram during the association. Our current observations and practices illustrate the efficacy of risk management. Data about safety of alternative dose regimen of this protocol, ongoing in clinical trials with COVID-19 patients are needed”;
Last, but not least, it is not PEER-REVIEWED and it is published in on the web site of the Mediterranee Infection Institute, Marseille. This is the same, if I publish something I did on my website instead of submitting formal publication to a peer-reviewed journal.
Importantly, there was a RANDOMIZED study published recently which did not result in clearing the virus, even if it improved symptoms somewhat, while adverse events increased significantly. See my blog post Hydroxychloroquine - No Wonder...
Also, the recent study by American Veterans Medical Centers concluded that hydroxychloroquine use was associated with higher risk of death. When hydroxychloroquine was used, patients were 2.61 times more likely to die from any cause. Interestingly, azithromycin compensated for some negative effects of hydroxychloroquine but combination was worse that azithromycin alone. Check out my blog: One More Nail
Here are other blog posts I did on (hydroxy)chloroquine:
Hydroxychloroquine for COVID-19 Study Did Not Meet 'Expected Standard' "Anectodal" Hydroxychloroquine
The bottom line: sounds good, but far from being proven and, most likely, wishful thinking!
Please let me know, if you have any questions! I like to be challenged!