LAUSR

Recently, two facts brought to the spotlight the limits of physicians’ autonomy to prescribe medicines and the Brazilian Federal Council of Medicine (CFM). The first fact was a conflict between the CFM and the Brazilian Health Regulatory Agency (Anvisa) regarding the agency’s decision to remove amphetamine weight-loss medicines from the market 1. The second was the widespread prescription of ineffective and potentially harmful medicines during the COVID-19 pandemic. In both cases, CFM stated that professional autonomy – a central tenet of medical practice – ensures physicians the right to prescribe whatever they think is the most beneficial therapy for their patients. When the results of the Sibutramine Cardiovascular Outcomes (SCOUT) study emerged in 2010, suggesting that the cardiovascular risks of sibutramine outweighed its potential benefits in the treatment of obesity and overweight, the agency’s Technical Chamber of Medicines (CATEME) recommended Anvisa to withdraw it as well as three other amphetamine-like anorectics from the market 1. CATEME’s recommendation was debated with CFM and other stakeholders and, in 2011, the Anvisa’s board of directors decided to ban three anorectics (fenproporex, mazindol, and diethylpropion) and keep sibutramine on the market under stricter control rules for dispensation. Despite the agency’s reasonable decision, CFM and some medical associations continued to pursue the goal of bringing the three amphetamine medicines back to the drugstores shelves. In 2017, a strong advocacy campaign promoted by CFM and some medical associations for the return of amphetamine-like anorectics succeeded when the Brazilian National Congress, overlapping Anvisa’s regulatory jurisdiction over the pharmaceutical market, approved a law (Federal Law n. 13,454/2017) that authorized the production, sale, and consumption of these drugs. In October 2021, however, the Brazilian Supreme Federal Court (STF) considered the amphetamine anorectics law unconstitutional, bringing the regulatory affairs back on track. The CFM campaign reiterated many times that, by removing amphetamine-like drugs from the market, the Anvisa would be jeopardizing physicians’ professional autonomy to prescribe the drugs they think are the most suitable to meet their patients’ clinical needs. The news posted on the CFM website as well as a letter from CFM president to the congressman Rodrigo Maia, then President-inOffice of the Chamber of Deputies, showed their point of view. The letter emphasized that the provisions of the amphetamine anorectics bill to be enacted “respect the autonomy of physicians and patients to choose recognized and valid therapeutic procedures” and that Anvisa’s decision to prohibit them “would represent a direct interference with this process” 2. 1 Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz, Rio de Janeiro, Brasil.