The FDA announced a trial hold after two participants with sickle cell disease (SCD) in the LentiGlobin gene therapy trials developed AML and MDS. According to bluebird bio, the manufacturer of LentiGlobin products, the company was unable to find any cancer cells in the patient’s bone marrow and has asked the FDA for permission to resume clinical trials.

In this Original Investigation from JAMA Oncology, the authors seek to discover the characteristics that define modern randomized clinical trials (RCTs) in oncology and whether they differ from characteristics of RCTs from the preceding decades, as concerns have emerged regarding the use of putative surrogate end points, such as progression-free survival (PFS) and marginal effect sizes.

According to research presented at the virtual ASCO GI Cancers Symposium from the phase 3 ALTER0703 trial, anlotinib was beneficial in Chinese patients with refractory metastatic colorectal cancer (CRC), with particular overall survival (OS) improvement – the primary endpoint – among patients with RAS/KRAS/BRAF-wildtype.

The data, concluded in a report posted to the preprint server medRxiv, support prioritization of cancer patients for an early (21-day) second dose of the BNT162b2 vaccine, as barely one-quarter of patients with cancer obtained protection (28% immune efficacy rate, including 13% in patients with blood cancers) against COVID-19 after one dose of the Pfizer/BioNTech vaccine.

According to a recent study published in Clinical Toxicology, the authors examined the makeup of 17 brands of OTC supplements in the US, purchased online, that were labeled to include banned and unapproved stimulants, including deterenol, a beta-agonist that has never been approved for use in the US and which the FDA banned from supplements in 2004.

In this podcast/article from KevinMD, the story of Dr. Hasan Gokal is examined, a Houston physician who was fired from his public health job and was subsequently faced with criminal charges for stealing a vial of the vaccine. His case was also brought to the Texas Medical Board. In a sea of regulations and protocols, were his actions well-intentioned and in the best interest of patient care and safety?