The Daily Dose: FDA opens an investigation into itself; Chinese scientists in another bioethics controversy.

After a very loud public outcry by many pharmaceutical industry watchersabout Biogen’s Alzheimer’s Drug, the Food and Drug Administration in the U.S. has opened an investigation into itself over the approval process.According to STAT, “In a letter posted Friday, acting Commissioner Janet Woodcock asked the independent Office of Inspector General to investigate how agency staff interacted with Biogen in the run-up to the June 7 approval of Aduhelm. The agency cited STAT’s reporting that FDA officials worked hand in hand with Biogen executives to get the drug on the market, including an off-the-books meeting and an unprecedented decision to approve Aduhelm through a regulatory shortcut.” https://bit.ly/2UAtydJ


Since the early days of the COVID-19 pandemic, why some people get severe COVID-19 while others do not has been an enduring mystery. Now, researchers believe they have identified genetic markers associated with severe disease onset. Per Nature, “The authors identified 13 loci that were associated with SARS-CoV-2 infection and disease severity (Fig. 1), including 6 loci not reported in previous human genomics studies of COVID-194,5. Four loci affect general susceptibility to SARS-CoV-2, whereas nine were associated with disease severity. Two of the previously unassociated loci were discovered only when individuals with East Asian ancestry were included in the analysis, highlighting the value of including diverse populations in human genomics studies.” Anytime genetics is involved, the possibility for gene therapy always seems possible. https://go.nature.com/3APPS3k


Myocarditis caused by the mRNA COVID-19 vaccine has been a concern, particularly among adolescents and young adults. Reuters reports, “Europe’s drug regulator has found a possible link between very rare heart inflammation and COVID-19 vaccines from Pfizer-BioNTech (PFE.N), (22UAy.DE) and Moderna (MRNA.O), it said on Friday, stressing that the benefits of the shots outweighed any risks. The conditions, myocarditis and pericarditis, must be listed as side-effects of the two mRNA vaccines, the safety committee of the European Medicines Agency (EMA) said, adding that such cases primarily occurred within 14 days of inoculation.” https://reut.rs/3hXzkhi


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Chinese scientists are embroiled in YY another bioethical controversy. Per Nature, “An experiment to impregnate male rats stitched to female rats, by researchers at the Naval Medical University in Shanghai, has stirred debate in China and beyond about the ethics of the work. Researchers say the experiment was highly contrived and unnecessarily distressing to the animals, and that it offers few insights into the possibility of pregnancy in people assigned male at birth — if anything, the poor success rate suggests that such a goal is a long way off. But other scientists say the rat model could eventually be used to gradually tease apart what might be required to maintain pregnancy in people of any sex who wish to bear children. The study was detailed in a bioRxiv preprint posted online on 10 June.” Honestly though, not a good look. https://go.nature.com/3hw4YDS

Thanks for reading, Let’s be careful out there.


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