Pfizer Recalls Sickle Cell Treatment

Facts

• Pharmaceutical company Pfizer announced Wednesday a global recall of its sickle cell anemia drug Oxbryta, citing an 'imbalance' of deaths and health complications in patients.^[1]
• Oxbryta, which is meant to help hemoglobin attract oxygen and prevent the damaging of red blood cells, was approved by US regulators in 2019 through a fast-tracked method based only on preliminary data.^[1][2]
• Pfizer said that studies had found links to deaths and vaso-occlusive crisis — the blocking of blood flow — in patients. One study of 236 patients resulted in eight deaths among those who took Oxbryta, compared to two from the placebo group.^[3]
• A day later, the European Medicines Agency suspended its approval of the drug amid an ongoing investigation into 16 deaths potentially linked to the drug.^[1]
• Pfizer, whose stock price dropped to $28.97 on Thursday, bought Oxbryta and its developer, Global Blood Therapeutics, for $5.4B in 2022, making an estimated $395M from the sickle cell drug in 2024.^[4]

Sources: ^[1]BNN Bloomberg, ^[2]Business Wire, ^[3]Reuters and ^[4]Investors.

Narratives

• Narrative A, as provided by European Medicines Agency (EMA). The data has shown too strong of a link between Oxbryta and patient deaths to keep this drug on the market. While drugs are supposed to make sickle cell patients better, this one has led to additional health issues, including arthritis, kidney failure, and stroke.
• Narrative B, as provided by Sickle Cell Society. While it's understandable for a company to prioritize patient safety, this recall is devastating to the many sickle cell patients who have virtually no treatment for their disease. Between this recall and that of Crizanlizumab earlier this year, 20 years of research have gone out the window.