sexta-feira, 18 de abril de 2008

Malária: repercussão do anúncio da FIOCRUZ

Brazil Details Single-Dose Drug Combination for Malaria Associated PressApril 17, 2008 10:57 p.m. RIO DE JANEIRO -- Brazil announced a new malaria treatment Thursday that scientists say offers a potentially cheap and effective way to attack a disease that largely afflicts the world's poor. The treatment, developed by the Brazilian government in conjunction with the Drugs for Neglected Diseases Initiative, combines existing malaria drugs artesunate and mefloquine into a single, fixed-dose tablet and reduces the cost of treatment. A key benefit is that it reduces the number of tablets patients must remember to swallow. "Now they only need take one to two tablets a day for three days," said Bernard Pecoul, executive director of the Drugs for Neglected Diseases Initiative, an international alliance of seven health organizations. "The fixed dose combination will probably mean greater adherence to the treatment program," said Keith Carter, regional adviser on malaria at the Pan American Health Organization, who was not involved with the treatment's development. Mr. Carter said he had not seen the result of the Brazilian study and could not comment on it. But he noted that the World Health Organization has recommended similar combination treatments for several years and said development of a single, fixed-dose medication should make treatment easier and more effective. Another single-dose combination is available to fight malaria, but Mr. Pecoul said this combination was more effective. Mr. Pecoul said developers would not try to patent the new treatment because they are trying to reduce the cost of attacking a disease that mainly affects the poor. The Brazilian government will distribute the medication, known as ASMQ, free of charge and will transfer the technology to India for production and distribution in Southeast Asia, where a full course of treatment should cost around $2.50. A field study involving 17,000 patients in Brazil's Amazon state of Acre showed that the incidence of malaria dropped by 70% over a year, Mr. Pecoul said. A similar study in the Peruvian Amazon where the two drugs were used in separate doses only showed a drop of 50%. Carlos Morel, one of the drug's developers and director of Brazil's Center for Developing Medical Technology at Fiocruz/Farmanginhos, said the number of patients hospitalized with malaria in the Brazilian region dropped from 2,500 to only 500 over the course of the year. Copyright © 2008 Associated Press

terça-feira, 15 de abril de 2008

Uma baixaria comprovada: a falsa autoria de ensaios clínicos por acadêmicos

JAMA publica artigo que será motivo de muita discussão e, com certeza será um marco na luta contra degeneração da profissão médica e da universidade provocada pelos "vendilhões do templo". A autoria de ensaios clínicos produzidos pela indústria eram oferecidos a professores universitários que se tornavam autores sem participar do estudo. Com isso a empresa ganhava credibilidade acadêmica. Há exemplos em todos os lugares do mundo, no Brasil onde há speakers e também ventríloquos da Big Pharma há artigos obviamente feitos na indústria com falsos autores com filiação em universidades.
Tudo isso foi possível porque os processos constra Merck no casos Vioxx permitiram cruzar os dados da empresa com os disponíveis nos banco de dados médicos como o PubMed.
Guest Authorship and Ghostwriting in Publications Related to Rofecoxib. A Case Study of Industry Documents From Rofecoxib Litigation Joseph S. Ross, MD, MHS; Kevin P. Hill, MD, MHS; David S. Egilman, MD, MPH; Harlan M. Krumholz, MD, SM JAMA. 2008;299(15):1800-12. Context Authorship in biomedical publication provides recognition and establishes accountability and responsibility. Recent litigation related to rofecoxib provided a unique opportunity to examine guest authorship and ghostwriting, practices that have been suspected in biomedical publication but for which there is little documentation. Objective To characterize different types and the extent of guest authorship and ghostwriting in 1 case study. Data Sources Court documents originally obtained during litigation related to rofecoxib against Merck & Co Inc. Documents were created predominantly between 1996 and 2004. In addition, publicly available articles related to rofecoxib identified via MEDLINE. Data Extraction All documents were reviewed by one author, with selected review by coauthors, using an iterative process of review, discussion, and rereview of documents to identify information related to guest authorship or ghostwriting. Data Synthesis Approximately 250 documents were relevant to our review. For the publication of clinical trials, documents were found describing Merck employees working either independently or in collaboration with medical publishing companies to prepare manuscripts and subsequently recruiting external, academically affiliated investigators to be authors. Recruited authors were frequently placed in the first and second positions of the authorship list. For the publication of scientific review papers, documents were found describing Merck marketing employees developing plans for manuscripts, contracting with medical publishing companies to ghostwrite manuscripts, and recruiting external, academically affiliated investigators to be authors. Recruited authors were commonly the sole author on the manuscript and offered honoraria for their participation. Among 96 relevant published articles, we found that 92% (22 of 24) of clinical trial articles published a disclosure of Merck's financial support, but only 50% (36 of 72) of review articles published either a disclosure of Merck sponsorship or a disclosure of whether the author had received any financial compensation from the company. Conclusions This case-study review of industry documents demonstrates that clinical trial manuscripts related to rofecoxib were authored by sponsor employees but often attributed first authorship to academically affiliated investigators who did not always disclose industry financial support. Review manuscripts were often prepared by unacknowledged authors and subsequently attributed authorship to academically affiliated investigators who often did not disclose industry financial support.

Speakers: fora de moda nos EUA...

Excelente reportagem do The New York Times mostrando que várias lideranças médicas abandonaram o papel de speakers da indústria. Um bom começo.
With little fanfare, a small number of prominent academic scientists have made a decision that was until recently all but unheard of. They decided to stop accepting payments from food, drug and medical device companies. No longer will they be paid for speaking at meetings or for sitting on advisory boards. They may still work with companies. It is important, they say, for knowledgeable scientists to help companies draw up and interpret studies. But the work will be pro bono. The scientists say their decisions were private and made with mixed emotions. In at least one case, the choice resulted in significant financial sacrifice. While the investigators say they do not want to appear superior to their colleagues, they also express relief. At last, they say, when they offer a heartfelt and scientifically reasoned opinion, no one will silently put an asterisk next to their name. They are part of a group responding to accusations of ethical conflicts inherent in these arrangements, and their decisions repudiate decades of industry influence, says Dr. Jerome P. Kassirer, a professor at the Tufts School of Medicine, who has written a book on conflicts of interest. Five years ago, “nobody paid any attention to taking money from industry,” he said, adding: “They just took it. In some instances, I think people thought they were suckers if they didn’t.”

segunda-feira, 14 de abril de 2008

Extirpação de órgãos em Kosovo?

O comércio de órgãos, principalmente dos rins, tem sido abordado aqui em vários posts. (clique aqui). Hoje, no blog do Alon há menção a extirpação à força de órgãos por guerrilheiros kosovares. A história parece fantasiosa. Porém, a autora - Carla del Ponte - e, o jornal que divulgou a denúncia - El País merecem crédito. O livro sobre o ocorrido foi publicado em italiano em co-autoria com o ex-correspondente do The New York Times.
Abaixo, trecho da reportagem que pode ser lida na íntegra (clique aqui):
En el verano de 1999, entre 100 y 300 prisioneros serbios en manos de la guerrilla del Ejército de Liberación de Kosovo (UÇK, en sus siglas albanesas) fueron llevados en camiones a una casa de Burrel (Albania), con la complicidad del actual primer ministro kosovar y ex líder guerrillero Hashim Thaçi. Una vez allí, se les extirpaban diversos órganos para ser utilizados en el tráfico internacional, hasta que los prisioneros perdían la vida. Tales aseveraciones forman parte del libro La caza. Yo y los criminales de guerra, publicado en italiano por Carla del Ponte, ex fiscal del Tribunal Internacional Penal para la ex Yugoslavia, constituido por el Consejo de Seguridad de la ONU para juzgar los crímenes de aquella guerra. La obra, escrita en colaboración con Chuck Sudetic, ex corresponsal en la zona de The New York Times, se ha publicado esta semana en Milán y ha suscitado inmediatamente la polémica. Del Ponte cuenta en el libro que la oficina dirigida por ella en el Tribunal para Yugoslavia "comenzó a recibir informaciones a lo largo del verano de 1999 sobre unas 300 personas que habrían sido transportadas en camiones cruzando la frontera hacia el norte de Albania (...) A los prisioneros más jóvenes, sanos, fuertes y mejor alimentados se les evitaban los golpes. Eran atendidos por personal médico y posteriormente transferidos a otras estructuras de detención en Burrel. Allí eran alojados en una casa amarilla utilizada como quirófano clandestino donde les extirpaban órganos".

Prescrição mais cara nos Estados Unidos

The New York Times apresenta os novos problemas da assistência farmacêutica nos Estados Unidos, onde as companhias de seguro estão repassando parte do custo aos segurados. Esse problema não existe no Brasil, onde o Sistema Único de Saúde cobre todos esses medicamentos, mesmo prescritos por médicos de convênios, seguradoras ou particulares.
E, ainda há "cara de pau" na imprensa, universidades, associações médicas, empresas farmacêutica criticando o SUS... Abaixo trecho da reportagem (clique aqui para conteúdo completo):
Health insurance companies are rapidly adopting a new pricing system for very expensive drugs, asking patients to pay hundreds and even thousands of dollars for prescriptions for medications that may save their lives or slow the progress of serious diseases. With the new pricing system, insurers abandoned the traditional arrangement that has patients pay a fixed amount, like $10, $20 or $30 for a prescription, no matter what the drug’s actual cost. Instead, they are charging patients a percentage of the cost of certain high-priced drugs, usually 20 to 33 percent, which can amount to thousands of dollars a month. The system means that the burden of expensive health care can now affect insured people, too. No one knows how many patients are affected, but hundreds of drugs are priced this new way. They are used to treat diseases that may be fairly common, including multiple sclerosis, rheumatoid arthritis, hemophilia, hepatitis C and some cancers. There are no cheaper equivalents for these drugs, so patients are forced to pay the price or do without. Insurers say the new system keeps everyone’s premiums down at a time when some of the most innovative and promising new treatments for conditions like cancer and rheumatoid arthritis and multiple sclerosis can cost $100,000 and more a year

domingo, 13 de abril de 2008

Dica de leitura no Estadão: a balela da osteopenia

Nesse domingo, O Estado de S.Paulo reproduz artigo publicado originalmente no The Washington Post de Shannon Brownlee, autora de Overtreated: Why Too Much Medicine Is Making Us Sicker and Poorer. O artigo é uma delícia. A autora ridiculariza os alardes dos especialistas, denuncia mentiras deslavadas e repetidas como "o câncer de mama é o que mais mata mulheres" (são as doenças cardíacas) e, traz um exemplo de "não-doença": a osteopenia. Uma entidade clínica inexistente, mas cuja exploração econômica é das mais rentáveis pela Big Pharma. Claro, que não poderia faltar o "pré-diabetes" e a "pré-hipertensão". Eu incluiria também a "síndrome metabólica".