The FDA has approved a new biologic treatment for psoriasis even though there were reported cases of completed suicides in clinical trials. Siliq (brodalumab), is designed for patients who are candidates for systemic therapy (treatment using substances that travel through the bloodstream, after being taken by mouth or injected) or phototherapy (ultraviolet light treatment) and have failed to respond. There was not enough evidence in the trials to establish a casual relationship between Siliq and suicidal behavior. An FDA press releases notes that the approval comes with a Risk Evaluation and Mitigation Strategy (REMS) due to the risk of suicidal ideation and behavior. This mean that only certain providers can write prescriptions for it and only certain pharmacies may dispense it. Posted February 15, 2017. Via FDA.
Doctors are more likely to prescribe an antibiotic if they believe a patient is expecting it, even if the clinician doesn’t believe there is a bacterial infection present. A study conducted among 400 doctors in the United Kingdom involved 2 experiments. Each presented different situations where they had to decide if they would prescribe antibiotics. Physicians were more likely to prescribe one if patients had expectation of receiving it, according to research published in Health Psychology Doctors were more likely to do so if patients had high expectations of receiving antibiotics. The findings are concerning since overuse of antibiotic contributes to antibiotic resistance. Posted February 17, 2017. Via HealthDay.
Human trials for drugs should only be permitted if there is evidence the drug is effective in preclinical animal studies. Researchers at McGill University in Montreal, Canada say that many Phase I clinical trials – the first stage that involve human subjects – are often “launched on the basis of flimsy, under-scrutinized evidence). If even patients aren’t harmed in these early-stage trials, because money is wasted on research resources and patients and healthy control volunteers may miss out on being involved in the development of more promising medications. The researchers also argue that pharmaceutical companies includes negative results from animal studies to regulatory authorities. Posted January 30, 2017. Via McGill University.