An open letter from Eric Topol to Dr.Stephen Hahn details a number of glaring mistakes at the FDA which threaten its credibility and its mission.
Here’s the link: Dear Commissioner Hahn: Tell the Truth or Resign
The letter points to three high profile, politically-fraught decisions at the FDA:
- Authorization of hydroxychloroquine
- “Immediately after President Trump widely and aggressively promoted hydroxychloroquine as a “miracle drug,” on March 30, 2020, you granted an Emergency Use Authorization (EUA) for this drug without any sufficient or meaningful supportive evidence”
- Authorization of convalescent plasma
- “This is a major advance…[A]nd a 35% improvement in survival is a pretty substantial clinical benefit. What that means is — and if the data continue to pan out — [of] 100 people who are sick with COVID-19, 35 would have been saved because of the admission of plasma.” Every part of that statement is incorrect and a blatant misrepresentation of the data. “
- Authorizaton of remdesevir
- The third breach of evidence-based data was your EUA issued August 28, 2020 broadening the remdesivir approval to include any patient hospitalized with moderate COVID-19. There are insufficient data to support this approval, as it is based on small, open-label studies with subjective endpoints.
Dr. Topol worries that Dr. Hahn will further erode confidence in the FDA by approval of a SARS-CoV-2 vaccine prematurely. “Any shortcuts will not only jeopardize the vaccine programs but betray the public trust, which is already fragile about vaccines, and has been made more so by your lack of autonomy from the Trump administration and its overt politicization of the FDA.”
S Xanthakos et al. Clin Gastroenterol Hepatol 2020; 18: 1070-81. Full Text: Nutritional Risks in Adolescents After Bariatric Surgery
This was a multicenter prospective cohort study with 226 adolescents (mean age 16.5 years, mean BMI of 52.7) who had either Roux-en-Y bypass (RYGB, n=161) or vertical sleeve gastrectomy (VSG, n=67).
- At 5 years, 59% of RYGB and 27% of VSG had ≥2 nutritional deficiencies
- The most prevalent abnormality we observed was hypoferritinemia, which affected nearly twice as many RYGB recipients by Year 5 compared with VSG.
- Vitamin B12 status likewise worsened disproportionately after RYGB, despite similar trajectories of weight loss after VSG
- Image below shows the prevalence of abnormal values for vitamins over time
My take: This study shows that adolescents undergoing VSG had fewer nutritional deficiencies than RYGB and provides data supporting nutritional monitoring after bariatric surgery.
B Koletzko et al. JPGN 2020 70: 702-10. Full Text: Prevention of Childhood Obesity: A Position Paper of the Global Federation of International Societies of Paediatric Gastroenterology, Hepatology, and Nutrition (FISPGHAN)
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