A woman experienced deep sorrow when her husband passed away shortly after participating in a drug trial. Malcolm Williams received a diagnosis of transitional cell bladder cancer in January 2024, but due to existing health conditions, surgery was not a viable option for him.
Facing an uncertain future, Malcolm was offered a lifeline through a new immunotherapy trial that was touted as a potential cure or a means to extend his life by five years. However, two weeks into the treatment, he became severely ill and required hospitalization at the Royal Preston Hospital.
Doctors, unaware that Malcolm was part of the trial, treated him for what they believed was an infection by administering antibiotics. Tragically, Malcolm, a beloved father of four, was diagnosed with immunotherapy-related myocarditis, a rare complication of the drug he was testing. Despite efforts to halt his immune system from attacking his heart muscle with high doses of steroids, Malcolm passed away at the age of 76.
In the course of the drug trial, Lauren and Malcolm were not informed of the specific immunotherapy drug being used. Nevertheless, the trial involved combining pembrolizumab with chemotherapy and radiotherapy, targeting patients ineligible for surgical procedures.
Previous studies indicated that pembrolizumab significantly improved survival rates for advanced bladder cancer patients. During an inquest held in July, Dr. Omi Parikh, a consultant oncologist, disclosed that the drug Malcolm received was pending NHS funding approval when he enrolled in the trial in March 2024. The estimated cost of treatment with this drug is £84,000 according to the National Institute for Health and Care Excellence (NICE).
Lauren, Malcolm’s wife, has been actively seeking answers regarding her husband’s death for the past 14 months. She revealed that she only learned about the specific drug after Malcolm’s passing and expressed regret over not knowing that he was only the second person in Preston to receive it.
Pembrolizumab, the drug in question, is produced by Merck Sharp & Dohme (MSD). Following the inquest, an MSD spokesperson emphasized their commitment to patient safety and adherence to established clinical trial standards, expressing condolences to the family of the deceased patient.
The company stated that they cannot disclose individual patient details for privacy reasons but reassured the cancer community of their dedication to maintaining high pharmacovigilance standards.