Panel: Government Must Work Harder to Prevent Mental Illness in Young People

Abstract

evidence creates new challenges. Calabrese noted that many physicians are not familiar with PML and how to identify it and that those who do choose to use these drugs must learn how to monitor their patients for signs of PML. According to the NINDS, such symptoms may include clumsiness and progressive weakness, as well as changes in vision, speech, and, sometimes, personality. In addition, Smith noted that PML can be particularly difficult to diagnose in patients with multiple sclerosis or some other neurological diseases because physicians may attribute the symptoms to a worsening of the patient’s existing illness. The potential risk of PML also profoundly changes the risk-benefit analysis for these drugs, Calabrese said. But it can be difficult for severely ill patients to objectively weigh the risks of a treatment that they hope will help them, noted Smith, who dissented with the FDA panel’s decision to allow marketing of natalizumab for Crohn disease. She explained that even though these disorders may be devastating to the individuals affected by them, it is important to question whether the benefit that a patient might derive from the drug is worth the risk of PML, which results in death for the majority of patients, often within months. It is not yet clear which patients may be at greater risk of developing PML when taking these drugs, although Calabrese and colleagues suspect patients with systemic lupus erythematosus may be particularly vulnerable. Treatment primarily involves immuneboosting therapies. In patients with HIV, such treatment consists of highly active antiretroviral therapies; however, only about 50% survive. The prognosis for patients without HIV is even worse: 80% die within 6 months, while survivors may have severe neurological problems.