terça-feira, 29 de maio de 2007

Avandia: FDA strikes back The New England

Abaixo, transcrevo parte do texto acessível a assinantes de Scott Gottlieb publicado no The Wall Street Journal . Ele foi vice diretor do FDA no período 2005-07 e está criticando o The New England Journal of Medicine porque considera que houve "manipulação política". Em outras palavras, houve interesse em minar a atual política do FDA, da qual ele foi um dos praticantes. Segundo ele, as revistas são favoráveis a uma política mais restritiva de liberação de novos medicamentos. Gottlieb em outro texto com acesso livre há sete anos criticava a dissseminação da informação como sendo perigosa. Eu concordo com ele, a informação é perigosa. Depende sempre para quem. O aqui já citado (sem nome para não sujar essas páginas), tesoureiro pivo do mensalão não está só na sua conclusão: "transparência demais é burrice". Gottlieb faz alusão a vazamento da informação a um deputado democrata, mas a própria Glaxo foi informada, tanto que já tinha uma resposta pronta que foi publicada logo após a publicação. Ah, Gottlieb acusa a tendência esquerdista da atual direção da revista. Ironia, porque quando Marcia Angell - a editora anterior - foi substituída por Jeff Drazen dizia-se a boca pequena - leia-se The Boston Globe - que Drazen seria um representante da Big Pharma que neutralizaria a política de Marcia, uma feroz opositora da indústria farmacêutica. Ela é autora do excelente "The Truth About the Drug Companies" e há um ano deu uma entrevista `a Globo News muito didática.
Journalistic Malpractice
By SCOTT GOTTLIEBMay 29, 2007; Page A15
As medical information is exploding and becoming more accessible, all of us, particularly physicians, need objective sources to interpret data and present a balanced view. Unfortunately, major medical journals that should be filling this role often put more weight on pushing political agendas. Their editorial prejudice has left a troubling void for rigorous and unbiased arbiters of medical evidence who can guide sound medical practice decisions. The behavior of the New England Journal of Medicine (NEJM) is a case in point, when it rushed onto its Web site a limited and flawed analysis of safety concerns around the diabetes drug Avandia. The publication was timed to get ahead of the Food and Drug Administration's more careful evaluation of the same issues. The journal seemed bent on beating the FDA to the punch. The goal? Painting the FDA as impotent, in order to argue for legislation winding through Congress that would increase regulatory hurdles for drug approvals. The journal's motives were made bare by its own editorial on the matter.
NEJM said it rushed to post the study on the Web because of its medical importance, but the FDA, which would need to act on any safety issues, wasn't even given a heads up about the study's publication or its findings. Rep. Henry Waxman (D., Calif.), however, seems to have known in advance that it was coming because he issued a substantive press release immediately after the study was posted online. He was even ready with the date and location of oversight hearings aimed at probing the FDA's "handling" of the drug safety issues. Mr. Waxman is trying to add new restrictions to the FDA's drug approvals. The study's primary author, Cleveland Clinic Cardiologist Steve Nissen, admitted to The Wall Street Journal that he was in touch with Congress while preparing his analysis. Three days after the study was submitted to NEJM, and before it was published, the FDA commissioner received a letter about Avandia from members of the House Energy and Commerce Committee that seemed to reference the NEJM study.
At what cost do political machinations of the medical journals come? NEJM editors have long favored more drug regulation. But medical journals have also historically played a special role in helping to define medical practice standards. Even decisions they make on how prominently to place a study, let alone how they editorialize about it, are seen as strong signals to clinicians on how doctors should weigh the evidence. So when editors pursue a political agenda, it's public health that pays a price. Degrading an institution that doctors depend on for balanced analysis and fair-minded editorial judgments isn't good for anyone. (.....)
There is a problem when some journals let antipathy for business interests and left-leaning views interfere with the medical decisions that they make, bending standards or stepping outside their mandate, using their prestige and influence in ways that distort medical facts in the aim of influencing political outcomes. Prestigious biomedical journals are important public health tools, provided they stick to their core business of weighing medical evidence and informing physicians of important practice advances. When they use shortcuts and shoddy analysis to fabricate criticism and doubt of drug regulation, they're no better than some politicians they increasingly comport with.
Dr. Gottlieb, a physician, is resident fellow at the American Enterprise Institute and was Deputy Commissioner of the FDA from 2005 to 2007.

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