RESUMO
The ouster of Professor Peter Gotzsche who headed the Nordic Cochrane Centre, from Cochrane, a respected international research organisation, has provoked a crisis of confidence in the organisation's future. Disputant and bystander reactions on this issue are presented, as well as concerns regarding conflicts of interest and the reliability of Cochrane reviews. Cochrane's crisis mirrors the larger crisis of confidence that pervades the entire enterprise of medical research. We note that within weeks after Gotzsche was expelled from Cochrane, the HPV vaccine (whose Cochrane review he had publicly criticised for conflicts of interest and poor science) received a license expansion in the United States that might be worth billions of dollars to the manufacturer. Finally, we suggest a variety of new approaches that could strengthen the value of Cochrane analyses, broaden Cochrane's approach to include additional methodologies, and enhance its independence from financial interests.
Assuntos
Pesquisa Biomédica/ética , Conflito de Interesses , Dissidências e Disputas , Indústria Farmacêutica , Organizações , Projetos de Pesquisa , Revisões Sistemáticas como Assunto , Conflito de Interesses/economia , Indústria Farmacêutica/economia , Ética em Pesquisa , Humanos , Infecções por Papillomavirus/prevenção & controle , Vacinas contra Papillomavirus , Reprodutibilidade dos Testes , Apoio à Pesquisa como Assunto , Revelação da Verdade , Vacinação/éticaRESUMO
The anthrax vaccine was never proved to be safe and effective. It is one cause of Gulf War illnesses, and recent vaccinees report symptoms resembling Gulf War illnesses. The vaccine's production has been substandard. Without adequate evaluation, the Food and Drug Administration recently approved (retrospectively) significant changes made to the vaccine's composition since 1990. The vaccine's mandatory use for inhalation anthrax is "off-label." A skewed review of the vaccine literature by the Centers for Disease Control and Prevention (CDC) led to remunerative collaborative research with the army, involving civilian volunteers. Despite acknowledging possible fetal harm, the CDC offered the vaccine to children and pregnant women. New trends could weaken prelicensure efficacy and safety review of medical products intended for biodefense and avoid manufacturer liability for their use.