Vioxx, Merck faz acordo de quase US 5 bilhões

A Merck americana, aqui Merck Sharp & Dohme concordou em pagar até 4,8 bilhões de dólares a quem teve infarto do miocárdio ou acidente vascular cerebral isquêmico na vigência do uso de Vioxx. Isso não significa que há culpa no caso, pela legislação americana. Há uma imensidão de processos em todos os estados americanos. Esse caso teve de tudo, como fraude científica , informação distorcida, o lançamento de um me-too da concorrência (depois proibido em São Paulo e Brasil). A história original está contada em texto publicado em Diagnóstico & Tratamento. Agora, está se chegando ao seu quase final, afinal as ações da companhia subiram 2% com essa decisão. Uma lembrança: quando as primeiras publicações mostraram risco no uso do Vioxx, dois reumatologistas ´paulistas rapidamente foram acionados para defender a empresa e, desqualificar a pesquisa original. Onde estão eles agora? A declaração de hoje da empresa pode ser lida no The Wall Street Journal.

Uma verdadeira "mudança de paradigma" no controle da hipertensão.

A proposta de uma "vacina" para hipertensão existe há mais de duas décadas. Houve somente insucessos. Agora, na reunião da American Heart Association foram divulgados resultados auspiciosos sobre a administração intramuscular de medicamento que mantém a pressão arterial controlada por quatro meses. Se não houver sucesso nas novas fases de experimentação, haverá mudança radical no panorama do controle de hipertensão em todo o mundo. Vamos torcer.

Hypertension vaccine safe, well-tolerated in phase 2a study
November 6, 2007From Medscape Medical News—a professional news service of WebMD
Orlando, FL - Results of a phase 2 study suggest that an investigational vaccine against angiotensin II was safe and well tolerated in patients with mild to moderate hypertension. The vaccine produced a long-lived antibody response with a half-life of about four months. "Treatment with the high dose produced a significant reduction of daytime ambulatory blood pressure and a marked reduction in the early morning hours, when most adverse cardiovascular events occur," study author Dr Jürg Nussberger (Centre Hospitalier Université Vaudois, Lausanne, Switzerland) told attendees here at the American Heart Association 2007 Scientific Sessions. "Future studies will apply state-of-the-art formulations and treatment regimens to explore the full potential of this approach," he said. Good control of hypertension has been undermined by problems of patient compliance with antihypertensive medications. Although many effective drugs are available, only about 25% of patients are optimally controlled, Nussberger said. "This has probably something to do with the fact that these drugs have to be taken daily and lifelong." However, many of these drugs have a half-life of less than 24 hours, so if patients take them in the morning, the medications are at a trough in the early-morning hours, he said, just as the normal rise in BP takes place and when most cardiovascular events occur. "With a vaccine against angiotensin II, where there is a long-lasting effect with antibodies, you may not have this problem of peak-trough, and the patient has to come to the doctor maybe only two or three times a year," Nussberger said.
Previous work by Morris J. Brown and colleagues at the University of Cambridge, United Kingdom, had tested a vaccine against angiotensin I and shown some reduction of aldosterone, but no BP-lowering effect.
The current study explored the safety and tolerability of CYT006-AngQb, a viruslike particle-based conjugate vaccine that targets angiotensin II in a placebo-controlled phase 2a sequential two-dose comparison trial. The study enrolled 72 patients with mild to moderate hypertension, defined as a systolic pressure of 140 to 179 mm Hg and a diastolic pressure of 90 to 109 mm Hg; five patients dropped out for reasons unrelated to the study, he noted. The study was done over four months; patients were given 100 µg or 300 µg of the antigen or placebo at time zero, then at one month and three months, after which they were followed for eight months for safety. End points were safety and tolerability, with an "exploratory" look at efficacy with ambulatory BP measurements and plasma renin concentrations.
Adverse events occurred in all patients in both groups, a finding that was not unexpected, since even placebo patients received an injection of aluminum hydroxide emulsion and so reported pain, erythema, or edema at the injection site. Headache was also more frequent in the vaccination group, but all of these effects occurred over the first one or two days and were reversible

Para quem os sinos não batem.......

Acompanhei a repercussão do LearJet que matou a família Fernandes na Casa Verde. E, hoje, massacre em escola na Finlândia. Os seres humanos que se foram valem menos do que aqueles que morreram na obra do metro, em Congonhas e na Virgínia Tech. Por que? Foram mortes que não puderam ser capitalizadas politicamente, por aqueles que desejam instalar uma tirania,onde somente suas vozes são ouvidas.

Sinceramente, estou farto do militantismo e do jornalismo engajado. Os urubus ficam voando atrás da carniça que os satisfaz, compaixão e solidariedade é coisa de .....

For Whom the Bell Tolls?

Como se esgotaram os cantores pop que fazem apologia do crime, a Folha de S.Paulo (clique aqui) ressuscitou a Bell Curve e suas conclusões para lá de enviesadas. Para economia de tempo dos leitores do blogue recomendo ler a página do wikipedia com os argumentos contra o famoso livro. A entrevista de Murray, hoje, mostra a forma pouco séria como expõe sua argumentação. Confunde o tempo todo o componente génetico e o adquirido. Ele erra ao criticar a ação afirmativa na sua origem. Hoje, a avaliação poderá ser outra, mas representou fator importante de inclusão dos negros na sociedade americana à época da implantação.

Para quem não sabe o título é do romance autobiográfico de Ernst Hemingway passado na Guerra Civil Espanhola, por sua sua originado de "Meditation XVII" de John Donne.

Médicos e indústria farmacêutica: pontos positivos

Recebi uma provocação sobre o post sobre a indústria farmacêutica - a Big Pharma - e relacionamento com os médicos. Os pontos negativos já foram tão ressaltados, que prefiro lembrar em outro momento. O ponto positivo foi a introdução das pesquisas clínicas na fase III ao mesmo tempo que em outros países. Para mim, representou o começo de um rigor inexistente nas pesquisas com seres humanos realizadas até então e, uma obsessão com a documentação da informação. Essa foi a contribuição principal que adquirimos em mais de dez anos de participação em pesquisas patrocinadas pela Big Pharma.

Doenças negligenciadas ganham revista com acesso livre

A figura ilustra a primeira edição do PLoS Neglected Tropical Diseases. Abaixo, o editorial de lançamento.
The neglected tropical diseases (NTDs) are a group of tropical infections, such as river blindness, hookworm, lymphatic filariasis, leishmaniasis, and trachoma, which represent some of humankind's most ancient scourges and possibly our greatest global health disparities. Largely confined to the unseen rural areas of the developing world, the NTDs were for centuries the forgotten diseases of forgotten people [1]. They are chronic, disabling, and often stigmatizing conditions, and their poverty-promoting features provide a genuine reason why parts of Africa, Asia, and the tropical regions of the Americas cannot escape their low-income status.
Although these diseases have been overshadowed by better-known conditions, especially the “big three”—HIV/AIDS, malaria, and tuberculosis—evidence collected in the past few years has revealed some astonishing facts about the NTDs. They are among the most common infections of the poor—an estimated 1.1 billion of the world's 2.7 billion people living on less than US$2 per day are infected with one or more NTDs. When we combine the global disease burden of the most prevalent NTDs, the disability they cause rivals that of any of the big three. Moreover, the NTDs exert an equally important adverse impact on child development and education, worker productivity, and ultimately economic development. Chronic hookworm infection in childhood dramatically reduces future wage-earning capacity, and lymphatic filariasis erodes a significant component of India's gross national product. The NTDs may also exacerbate and promote susceptibility to HIV/AIDS and malaria.
All hope is not lost. Through the provision of a package of preventive chemotherapy, we have a unique opportunity to reduce the health and economic costs of the NTDs, a strategy that cannot be applied to most other disease entities in the developing world. Such a package may also help to tackle the big three diseases. These drug packages are being administered by a group of NTD partnerships that are working together through the Global Network for NTD Control (http://gnntdc.sabin.org/), while new product development partnerships have been established that will someday produce a revolutionary generation of additional drugs, diagnostics, and vaccines. Taking on the NTDs represents one of the most efficient and cost-effective means of achieving the Millennium Development Goals in the areas of child and maternal health, infectious diseases, poverty reduction, and building global partnerships, and is a step forward in achieving international human rights.
PLoS Neglected Tropical Diseases is an important new ally for global efforts to control and eliminate the world's most burdensome NTDs. We believe that our new journal, dedicated to publishing research that can help reduce disease and despair, is a modest yet important contribution to relieving suffering and building research and disease control capacity in developing countries. With unprecedented representation from women and developing countries on our Editorial Board, together with a magazine section devoted to policy, analysis, and debate, we hope that PLoS Neglected Tropical Diseases will promote a collective voice for the world's poorest people. And by adopting an open-access model—all articles are freely available worldwide and can be copied, distributed, translated, and built upon provided authors are credited and the source is cited—we hope to reach an audience of 6 billion.
PLoS Neglected Tropical Diseases was not launched in a vacuum. From its very beginning, the Public Library of Science's founders—Harold Varmus, Pat Brown, and Mike Eisen—grasped the power of open access for the developing world. Subsequently, the Bill and Melinda Gates Foundation recognized the potential of PLoS Neglected Tropical Diseases for building research and public health capacity in developing countries and awarded the journal a grant to cover its launch phase. The announcement of the journal was greeted with tremendous support by the popular press and by other scholarly journals. The Lancet, for example, in an editorial praising our launch, wrote: “We welcome this initiative. Any investment in scaling up communication about global health is to be warmly applauded”. With all of this support comes a responsibility. We aspire to make PLoS Neglected Tropical Diseases an international resource, one that truly benefits the scientific, medical, and public health communities. This means that we need our readers to tell us how we can be helpful. We exist solely for the benefit of our constituents: the thousands of dedicated scientists, health care professionals, and public health experts, and the poor communities worldwide that you serve every day. This is a journal “run by and for the community,” and we look forward to receiving your best work

Relação indústria farmacêutica e médicos

The New England Journal of Medicine (acesso gratuito) publica artigo sobre a relação indústria farmacêutica e médicos. Na figura há

apresentação dos relacionamentos mais descritos como amostras grátis, presentes etc etc.

O texto apresenta duas considerações bem válidas do lado positivo e negativo:

Clearly, relationships between physicians and industry can have some positive effects on patient care. Many, if not all, of the drugs currently on the market simply wouldn't exist if it weren't for relationships whereby physicians enroll patients in manufacturers' clinical trials and provide companies with advice on drug development. And even a relationship in the form of attendance at an industry-sponsored luncheon or dinner may lead physicians to recommend beneficial drugs that are being underprescribed — though there is no reason why an educational activity needs to be accompanied by an expensive meal or a trip to a tropical resort.
But physician–industry relationships can also have serious negative effects. For example, doctors with ties to industry may be more inclined than their colleagues to prescribe a brand-name drug despite the availability of a cheaper generic version. The provision of free samples may reinforce this behavior and perhaps stimulate off-label use of medications, which can pose risks for some patients. Industry relationships may stimulate the premature adoption of novel treatments, which could lead to serious health problems for patients. Industry inducements may reduce physician adherence to evidence-based practice guidelines in favor of company medications or interventions that are not recommended in independently developed guidelines. Finally, the financial rewards from industry relationships may reinforce a culture of entitlement among physicians, which could limit their ability to honestly acknowledge and manage the potential negative effects of these relationships. In general, physicians vehemently deny that their industry relationships have any of these negative effects — but they are less convinced that the same is true of their physician colleagues.