terça-feira, 31 de julho de 2007

Isto é SamPa

A foto ao lado de José Patrício da Agência Estado foi feita em São Paulo, hoje, para ilustrar o frio. Como o objetivo foi flagrar a compra de roupas, ele captou nessa amostra da população paulistana, um caleidoscópio racial e de cor de pele. Essa realidade é difícil de ser aceita pelos scholars americanos e os adeptos brasileiros que estão impondo o racialismo como política de estado. O falecido grupo Premeditando o Breque, já tinha cantado que a "japonesa loura, nordestina moura, só em São Paulo"

Quanto gastar em saúde?

Quanto um país deve gastar em saúde? Diz a lenda que a Organização Mundial de Saúde considera que 5% é um valor ideal. Mínimo ou máximo? Nessa semana no Health Affairs há uma discussão muito boa de William Savendof sobre o tema.

Quanto gastar em saúde?

Um questão antiga relaciona-se ao quanto gastar em saúde em um determinado país. Diz a lenda que um dia a Organização Mundial de Saúde estipulou em 5%. Valor mínimo ou maximo do Produto Nacional Bruto? Afinal, não depende da realidade demográfica e epidemiológica de cada país? Simplificando para a economia doméstica: um casal jovem com filhos irá ter gasto em educação e saúde diferente de seus pais já idosos e sem filhos em casa. Em Health Affairs , William Savedoff faz uma análise simples e elegante da questão do financiamento em saúde.

segunda-feira, 30 de julho de 2007

FDA: comissão considera que Avandia deve continuar no mercado.

20 x 3 foi o resultado. Leia no The New York Times. Interessante, o maior problema do diabetes é aumentar o risco de doença cardiovascular, mas o Avandia, não aumenta, nem reduz o risco de doença coronariana, diz o FDA. Então, por que prescrevê-lo?

A migração do médico da "rica" África para o "pobre" Canadá

A saída de pessoal médico da África para Europa, Estados Unidos e Canadá é motivo de preocupação cada vez maior. Há duas publicações recentes analisando o tema.
Ronald Labonte, Corinne Packer, Nathan Klassen, Arminee Kazanjian, Lars Apland, Justina Adalikwu,Jonathan Crush, Tom McIntosh,Ted Schrecker, Joelle Walker, David ZakusSeries Editor: Prof. Jonathan CrushAfrican Migration and Development Series No. 2, 2006Southern African Migration Project (SAMP) ISBN 1-920118-38-1 Produced by Idasa PublishingAva ilable online PDF [92p.]
Significant numbers of African-trained health workers migrate every year to developed countries developed countries including Canada. They leave severely crippled health systems in a region where life expectancy is only 50 years of age, 16 per cent of children die before their fifth birthday and the HIV/AIDS crisis continues to burgeon.1 The population of Sub-Saharan Africa (SSA) totals over 660 million, with a ratio of fewer than 13 physicians per 100,000.2 SSA has seen a resurgence of various diseases that were thought to be receding, while public health systems remain inadequately staffed.
Migration and Developmente in Africa: an overview
Richard Black, Jonathan Crush, Sally Peberdy with Savina Ammassari, Lyndsay McLean Hilker, Shannon Mouillesseaux, Claire Pooley, Radha Rajkotia African Migration and Development Series No. 1, 2006PDF [169p.] at:
"....The aim of this study is to synthesise existing research on migration in Africa, and its relationship to development policy. The report focuses on the relationship between migration, poverty and pro-poor development policy. Propoor policy is taken here to mean policies that are context-specific, listen and react to poor people’s voices, and/or seek to assist poor people to become less vulnerable and build up their income and assets. Government health and education policies might not be considered intrinsically pro-poor, but become so where they are targeted at widening access to health and education services, and especially basic health and education services (e.g. primary care, vaccination campaigns, primary schooling), or at responding to the specific needs of the poor. ..."

Dica de livro: Globalization and Health

Um livro que merece tradução é Globalization and Health de Ichiro Kawachi e Sarah Wamala, da Oxford University Press. Ele apresenta uma visão diferenciada da saúde pública abordando temas relevantes pouco discutidos como a dominação do automóvel nos dias atuais.
O grande pecado desse livro, para variar, é considerar a globalização como um fenômeno atual, contemporâneo. Essa é a grande negação da história que muitos pesquisadores - involuntariamente - cometem.
Eu particularmente aprecio muito a visão de Charles M. Boxer, expressa na obra O Império Marítimo Português - 1415 - 1825, edição da Companhia das Letras. Ele apontou que a expansão portuguesa e holandesa se chocaram naquilo que ele descreveu como sendo a Primeira Guerra Mundial que envolveu Pernambuco, Angola e a Indonésia. Em outros termos, a globalização se inicia muito antes com impacto no desenvolvimento da humanidade, vide a transferência de ouro, a migração de alimentos e de doenças entre os continentes.

domingo, 29 de julho de 2007

NYT: uma análise da aids na Líbia

The New York Times (ver abaixo) apresenta uma análise da situação da aids na Líbia, após a libertação das enfermeiras búlgaras e do médico palestino. Revela que racismo, predomínio dos clãs na região de Bengazi e, o total descontrole sobre a hemoterapia estão na base do ocorrido. A Organização Mundial da Sáude considera os dados oficiais sobre a doença como "subnotificados". Foram-se os injustiçados profissionais da saúde, ficaram as vítimas de um sistema infame, cruel e incompetente.
THE safe landing of five Bulgarian nurses and a Palestinian doctor in Sofia last week, freed of a death sentence after eight years in Libyan prisons, was an apparent victory of diplomacy at long last.
But the drawn-out drama over Libyan accusations that the medical workers had infected children with
H.I.V. also reflects how difficult Libya’s own internal politics made it to reach an obvious solution far earlier, experts in the case said. And it calls attention to a sad epilogue that will play out in Libya: an AIDS epidemic that has never been fully acknowledged and that continues to spread, even as the 426 children who figured in this case depend on treatment in a system ill prepared for the task. Officially, two visits to Libya by Cécilia Sarkozy, the wife of the president of France, Nicolas Sarkozy, precipitated the release of the medical workers, who had been found guilty — not once, but twice — of infecting the children as part of a purported plot by the Israeli secret service. But hers were only the latest in countless series of pilgrimages by diplomats and scientists to plead with Libya’s leader, Col. Muammar el-Qaddafi. “It was completely clear scientifically since 2002 that they were not guilty,” said Vittorio Colizzi, an AIDS expert whom the Qaddafi family invited in 2000 to study the hospital in Benghazi where the infections took place. “But the nurses suffered for years from the incapacity of diplomacy and politics to free them in a timely manner.” He and another expert, Dr. Luc Montagnier, concluded that the AIDS virus was present in the hospital before the nurses arrived, probably carried to Libya by guest workers from countries in sub-Saharan Africa. In many of those nations more than 10 percent of the adult population is infected. Mr. Colizzi concluded that the virus had been spread by the infusion of unscreened blood and blood products, as well as by unsterilized equipment, pervasive problems that have only been partly solved. A home-grown AIDS outbreak caused by lax practices at a government hospital was not an explanation the government could acknowledge, medical and other experts say, especially when there were convenient foreign scapegoats. Bulgarians have long provided medical care in Libyan hospitals, and “are very unpopular because of racism,” said George Joffe, an expert on Libya at Cambridge University’s Center of International Studies. Palestinians are unpopular, too, he said, “so this group provided an obvious target.” Once the doctor and nurses had been blamed, the families of the children had to be placated, which took time. Colonel Qaddafi is unpopular in Benghazi, which is Libya’s second-largest city and was the home of Libya’s former regime, Dr. Joffe said. Also, Benghazi is a city of extended clans, so each sick child could be related to many residents, if distantly. “Qaddafi needed to pacify the community there, while satisfying the international community,” Dr. Joffe said. “Of course, he exploited the issue for political and economic gain internationally. But basically, a domestic issue delayed international resolution.” (....) Libya reported 10,450 cases of H.I.V./AIDS to the World Health Organization by the end of 2006, but outside experts consider that figure low. “There may be a lot out there that’s not detected or reported, as is true in many countries in the region,” said Gabriele Riedner, regional adviser to the World Health Organization in Cairo.
“There is evidence of increasing H.I.V. infections in Libya, especially among the younger age groups,” with many cases, if not most, among users of injection drugs, the W.H.O.’s annual report says. Early on, European negotiators recognized that winning over the families would be crucial in freeing the doctor and nurses.
Once the death sentences had been handed down, the negotiators felt the best hope for the jailed medical workers would be to invoke Islamic law and custom, under which injured parties accept compensation and express forgiveness, allowing the sentences to be reduced or overturned. “We were constantly working around two axes: to give signs of attention to the families to show them the world cared, vis-à-vis things like equipping hospitals and providing medical care,” the E.U. diplomat said. “And to see how far we could go in helping with compensation. But in many ways this was less important.” In the end, the families received $1 million apiece, almost all of that paid by the Libyan state, Dr. Joffe said, and agreed to the death sentences’ being dropped. The
European Union and its member states have sent tens if not hundreds of million of dollars in aid to Libya, to create “a positive psychological and political environment” for the families. Furthermore, the children have been treated in hospitals in Italy, France and Britain. Still, said Dr. Colizzi, who has seen the children during visits to Benghazi and in Europe, some are “really sick” and are not getting good treatment at home. More than 50 have died. “The tragedy for the nurses is finished; now starts the tragedy for the children,” he said.

sábado, 28 de julho de 2007

Ron Laporte, um cidadão do mundo e, o Supercourse

Ron Laporte é daquelas pessoas que são classificadas como as "essenciais". Sem elas, a humanidade fica muito inferior. Ele dirige há anos o esforço do Supercourse, uma série imensa de aulas para todos os estilos na epidemiologia, estatística e medicina. Ele pertence ao Departamento de Epidemiologia da Universidade de Pittsburgh onde é pesquisador na área de diabetes. Eu o conheci discutindo a epidemiologia dessa doença há 12 anos. Nessa época ele já antevia o futuro com a a internet e a massificação do conhecimento e, a quase inutilização das revistas impressas. Abaixo transcrevo, a newsletter que recebi hoje, dele mostrando a visão e disposição de criar um mundo melhor. Depois da leitura, recomendo um passeio pelas aulas do Supercourse.
Legacy
In the past few weeks two of the giants of epidemiology, died. Ralph Paffenbarger’s research helped start the exercise boom, and George Comstock was one of the major forces in the prevention of tuberculosis in the US and world. Sadly, neither left a legacy lecture for future generations of students. We hope that you as one of global leaders of science might consider “saving a lecture” for the students of your students, and the students of the world. Sadly we were not able to obtain a lecture from these two Giants. It would have been wonderful for my students to learn the natural history of exercise epidemiology from its father. What will your legacy be for the students and faculty who come after you. Perhaps the greatest gift to future generation is your knowledge. Assistant professors and all educators should “stand on the shoulders of giants”, you.
Please consider your legacy.
Improving the Training of the World
Over the past few weeks we have been taking stock of where we are. There is little question that we are serving as a transforming agent for higher education, and it is very exciting. We have shown how to e-recruit globally from 174 countries. We have collected over 3300 lectures, and we have established the first multinational system for sharing curricula. Not bad!!
A basic problem is crossing the digital divide. The backbone of our work is the Internet. However in developing countries such as India, less than 5% of the population have access to the Internet. How do we improve teaching say in the rural areas of India, Pakistan and China? We have thus have the network the lectures and the Internet, but it is not enough.
We need to deliver the lectures to the schools across the digital divide, and the teachers have to have the means to present these to the students. Last year we thought of a simple approach (that did not work). This was where say a teacher in rural Pakistan would call Lahore, and type in say “67” and the lecture “the epidemiology of Type 1 diabetes” would drop into the cell phone. Then one would go off line and a yellow plugged video would connect into a TV for presentation. The concept was good, but it did not work as there is so much variability across telephone, also in Pakistan less than ½ of the schools had TVs…back to the drawing board.
We have a new idea, and would appreciate your comments. Suppose say 1000 lectures could be put onto a DVD. In addition free books would be put on the DVD from Google books. The problem then is getting the DVDs to the schools, why couldn’t the Post Office deliver these? The cost for the DVDs would be less than a dollar each, and delivery would be very inexpensive. This is similar to a model used used in the US called NetFlix. Why couldn’t a DVD player with a screen be made available a shared among several schools. A cheap one may be onle $50.00. For the schools that had electricity and a TV, the lectures could be played through TVs. For those with no electricity, the DVD could be battery operated. If the class was small enough the lecture could be presented on the .25 meter screen. If it were a large screen the teacher could use the materials from the lectures and present this on a chalk board. The educators would have over a 1000 lectures to chose from. In addition, every year the DVD could be recycled with new materials.
Using this method, we use the power of what we are created, but move beyond the Internet to bring the best possible materials to students, even where there is no electricity. We are convinced that to improve global education it has to be a multiple channel approach from high speed internet, to low speed mules carrying DVDs.
Please let us know if something like this could be used in the schools in your country. Please write to
ronlaporte@aol.com

sexta-feira, 27 de julho de 2007

A doação de vacinas pelo G-8

The Lancet apresenta opinião de Donald Light sobre a doação de vacinas a países pobres. A discussão da benemerência merece ser revista à luz de novos fatos como os narrados no textos abaixo. A questão da vacinação para pneumococos entrará em breve em discussão em vários países.
Is G8 putting profits before the world's poorest children? Donald W Light
Several affluent countries have announced donations totalling US$1·5 billion to buy new vaccines that will help eradicate pneumococcal diseases in the world's poorest children. Donations from the UK, Italy, Canada, Russia, and Norway launch what many hope will be a new era to ease the burdens of disease and foster economic growth. Yet only a quarter of the money will be spent on covering the costs of vaccines—three-quarters will go towards extra profits for vaccines that are already profitable.
The Advanced Market Commitment (AMC), to which the G8 leaders and the Bill & Melinda Gates Foundation have committed, is the difficulty. An AMC is a heavily promoted but untried idea for inducing major drug companies to invest in research to discover vaccines for neglected diseases by promising to match the revenues that companies earn from developing a product for affluent markets.
By committing to buy a large volume of vaccine at a high price, an AMC creates a whole market in one stroke. However, no money is spent until a good product is fully developed.
In reality, revenue from an AMC depends on whether a new vaccine can be successfully developed, whether there is a second or third competitor, and whether recipient poor countries sign up.
These factors undermine not only the revenue-matching basis of the AMC but also a company's ability to predict how much it will earn. There are also several legal and contractual difficulties, none of which are discussed in either the Tremonti report5 or the briefing document prepared for G8 leaders.6 If we exclude these design flaws, however, the idea of an AMC has apparent appeal—the ingenuity of commercial research teams is mobilised by the creation of a market for a neglected disease.
For pneumococcal vaccines, the AMC rationale does not apply: vaccines have already been discovered by Wyeth and GlaxoSmithKline and their clinical trials are already funded because they will generate large revenues and profits in affluent markets. Thus the so-called G8 AMC pilot is really a large long-term procurement and not an AMC or a pilot of one. Yet leaders of the AMC project talk as if it is both.
If G8 leaders and the GAVI Alliance use an AMC approach, there will be three unfortunate consequences. First, I estimate that the new pneumococcal vaccines can be manufactured for a sustainable average cost of $1·25 a dose, including the capital costs of manufacturing capacity. At that price, a long-term procurement contract would justify enlarging capacity and lasting commitments by governments to immunise their children.
Thus the $1·5 billion donation could buy 1·2 billion doses of vaccine. The AMC model, however, has set the price at $5 or more (in an appendix it is $7·53), so that only 300 million or fewer children will be inoculated, and 80% of the donations will go towards profits.
Second, because AMCs were designed to match corporate revenues and profits in affluent markets,
they transform the humanitarian movement from the eradication of diseases of poor people into a for-profit market that is worldwide. Will donors and poor countries stand for the G8 and GAVI Alliance paying four times the average sustainable cost of these vaccines that are already profitable simply because they are connected to an irrelevant purchasing model?
Third, by commercialising vaccines for poor people, the AMC approach is making the culture of the GAVI Alliance more commercially oriented than it previously was, and it is shifting the Alliance towards becoming the vehicle for making vaccines for poor individuals into the next main market for the drug industry. In a review of five immunisation initiatives, Hardon and Blume
concluded that the GAVI Alliance is more corporate-led, less transparent, not really accountable outside of itself, and more oriented to paying profitable prices than were previous initiatives. This worrisome outcome is covered up by the Alliance's dubious claim that the AMC will prevent 5·4 million child deaths—89% of which are projected to take place after the donors' money has been spent.
Political leaders and the Gates Foundation need to press for reaching the maximum number of children whose lives can be changed by being inoculated—ie, 1·2 billion children, not 300 million. Even better than this aim would be to press companies for licences so that manufacturers in developing countries could compete for the long-term contracts. The donated money would then boost the economies of low-income countries, rather than the economies of affluent countries. The lower cost structure in developing countries might get the price down to $1 a dose, so that 300 million more children could be saved. This alternate strategy could be called the Advance Maximum Benefit Commitment (AMBC). G8 leaders should consider replacing the AMC with an AMBC.

quinta-feira, 26 de julho de 2007

FDA avaliará Avandia na próxima semana.

Voltando ao caso Avandia. Na próxima, semana o FDA irá avaliar se o medicamento aumenta ou não o risco cardiovascular. Porém, será desconsiderado o artigo publicado no The New England Journal of Medicine porque:
We should note that while Dr. Nissen’s meta-analysis … engendered considerable public notice and concern … this metaanalysis, performed out of necessity on study level data, will not be a focus of this Advisory Committee meeting. … This is because we believe the results of the analysis performed by GSK and subsequently by the FDA on the more granular individual datasets do not greatly differ from that of Dr. Nissen … Importantly, though, we believe that the FDA analysis of the data, including patient level data, is more robust than would be possible for an analysis utilizing study-level data alone.
O texto imenso com quase 500 páginas está disponível clicando aqui. Se for por motivo processual, com implicação jurídica, talvez tenha o mínimo de nexo. Porém, como não considerar estudo que até agora, apesar do imenso esforço não houve invalidação científica do método e resultado.

quarta-feira, 25 de julho de 2007

A triangulação do mercado de trabalho médico

A agência Reuters publica relato de americanos formados em medicina em Cuba. Eles são oito, mas há mais oitenta e oito em formação. Há um compromisso de trabalhar nos EUA em áreas pobres e carentes. A situação do mercado de trabalho médico pode ser resumido, no seguinte quadro: (1) redução de médicos dedicados à atenção primária nos EUA e Inglaterra(vide os posts anteriores sobre o mercado de trabalho nesses países); (2) insistência em Cuba em criar o “genérico de médico” como forma de amealhar divisas (vide Angola e Venezuela); (3) o fato de que Índia, Paquistão, Gana e Filipinas formam médicos de qualidade, mas não os retém por falta de recursos, aliado ao fato de que os cursos médicos são ministrados em inglês nesses países.
A conseqüência poderá ser: (1) migração cada vez maior de médicos de países com formação boa para ocupar posições nos EUA e Europa; (2) venda de mão de obra médica por parte de Cuba para vários países, inclusive para os Estados Unidos, em áreas carentes. Essa situação já existe em Gana.
Bem, e nós como ficamos? A confusão é tamanha nessa área, que somente chamando a “Denise do charuto”, “o brigadeiro da Infraero” sob a coordenação do ex-ministro Waldir Pires para organizar a formação médica no Brasil.
P.S. as entrevistadas pela Reuters em nenhum momento questionam o exame de qualificação para recertificação do diploma obtido em Cuba a que serão submetidas nos EUA.

A falta de médicos de atenção primária em Boston.

Pensar, propor, aprovar e financiar um novo modelo assistencial, sem formar o profissional que será a base desse modelo implica em problemas sérios como os vividos no Estados de Massachusetts. Ele foi o primeiro estado a instituir o seguro obrigatório de saúde nos Estados Unidos. Como consequência da ausência de política de fixação do profissional, faltam médicos em Boston, a cidade com o maior número de escolas médicas por habitante daquele país.
The Boston Globe publica hoje artigo de Debra Geihsler, da Harvard Vanguard, uma medicina de grupo, sobre a dificuldade de manter um sistema centrado na atenção primária sem que haja a remuneração compensatória. A proposta de extensão da cobertura assistencial à população do Estado de Massachusetts está comprometida pela falta de médicos na atenção primária. Hoje, o The Wall Street Journal (texto completo para assinantes) publica mais dados sobre o problema como a diferença salarial, o excesso de trabalho dos médicos dedicados à atenção primária. Houve redução em 6% de novos médicos de família nos Estados Unidos e queda substancial do número de residentes de terceiro ano de clínica médica que se dirigiam à atenção primária. Como resultado, uma primeira consulta está demorando sete semanas.

terça-feira, 24 de julho de 2007

Vitória desse blogue: Enfermeiras búlgaras e médico palestino estão livres.

Permito-me a exercer minha onipotência e narcisismo de forma explícita: nunca ninguém nesse país tinha denunciado a prisão absurda na Líbia das enfermeiras búlgaras e do médico palestino, antes desse blogue. Com exceção do Estadão, nenhum outro órgão da imprensa seguiu o tema e, claro, as ONGs da aids ficaram à distância. Abaixo, a notícia do fim do caso.
Enfermeiras acusadas de contaminar crianças chegam à Bulgária
Líbia concedeu prisão perpétua aos profissionais por disseminação do vírus da aids em crianças
'Sei que sou livre, sei que estou na Bulgária, mas ainda não acredito', disse enfermeira
SÓFIA - As cinco enfermeiras búlgaras e o médico palestino, detidos por oito anos e meio na Líbia sob acusação de infectar crianças com o vírus da aids, chegaram a Sófia, capital da Bulgária, nesta terça-feira, 23. Ao descerem do avião, foram abraçados por parentes e receberam buquês de flores. O primeiro-ministro e o presidente da Bulgária saudaram as enfermeiras e a primeira-dama da França, Cecilia Sarkozy, que fez parte da delegação que negociou o retorno do grupo.
"Quero recuperar minha vida como era há 10 anos", declarou à imprensa a enfermeira Kristiana Valcheva, principal acusada no julgamento pela suposta contaminação com aids de mais de 400 crianças líbias. Ela denunciou ter sido torturada para confessar sua culpa.
"Sei que sou livre, sei que estou na Bulgária, mas ainda não acredito", disse Kristiana.
Os seis profissionais de saúde tomaram esta manhã um avião oficial francês junto com a delegação francesa. Além da primeira-dama francesa, a delegação, que chegou a Tripoli no domingo para negociar a libertação, incluía o representante da União Européia para assuntos estrangeiros, Benita Ferrero-Waldner, e o secretário-geral do Palácio do Eliseu, Claude Gueant.
Aliviado com a libertação, o presidente da Bulgária, Georgi Parvanov, assinou um decreto de indulto às cinco enfermeiras e ao médico. O ministro de Relações Exteriores búlgaro, Ivailo Kalfin, anunciou o indulto presidencial num breve ato no aeroporto de Sófia, 45 minutos depois de aterrissar o avião com o grupo.

segunda-feira, 23 de julho de 2007

A falta de médicos nos Estados Unidos

The Washington Post noticia o problema da falta de médicos nas áreas rurais pobres dos Estados Unidos. Uma solução era a contratação de médico estrangeiros, principalmente da Índia e Filipinas. Mas, depois do “11 de setembro” aumentaram as restrições e, agora com o episódio dos médicos árabes na Inglaterra acusados de planejarem atentados, a situação se agravou. Calcula-se que o déficit atual seja de 16 mil médicos no país e, em 2020 seja de 24 mil.
Volto ao tema porque considero que ele não foi devidamente apreendido pelos educadores e lideranças médicas brasileiras o significado da falta de enfermeiros e médicos nos Estados Unidos.

domingo, 22 de julho de 2007

Industriais ingleses reclamam de consulta médica no horário do trabalho

The Guardian publica estudo da Confederação Britânica da Indústria, a FIEESP local, (clique aqui) mostrando que há perda de um bilhão de libras por ano devido a consultas médicas no horário comercial. Reclamam do não atendimento nos fins de semana pelos médicos de família. Obviamente, os empresários não querem aumento de imposto para financiar o atendimento nos fins de semana. Abaixo, trecho da matéria.
£1bn cost of waiting to see a GPJo Revill, Whitehall editorSunday July 22, 2007The Observer
Business leaders are to deliver a tough warning to the government that employees are spending millions of hours a year sitting in doctors' waiting rooms during office hours because of the lack of weekend GP clinics.
Three and a half million working days were lost last year because employees had to see a doctor during working hours, according to the Confederation of British Industry. This was more than four times the number of days lost to industrial action in 2006.

sábado, 21 de julho de 2007

Steven Nissen, novamente no holofote

Se você não aguenta mais o caso Avandia descrito aqui em detalhes, passe adiante, mas se quiser recapitular clique aqui. Abaixo, mais um capítulo centrado na figura de Steven Nissen.
The New York Times descreve nesse domingo (artigo completo para registrados no site) as atividades de Steven Nissen, o pesquisador que mostrou os problemas de segurança com o Avandia. Muitos dizem que ele tem como objetivo dirigir o FDA. Apesar do rigor do artigo publicado no The New England of Journal , Nissen cometeu deslizes como afirmar que Avandia mataria mais gente do que o 11 de setembro. Questiona-se também o fato de que Nissen procura ativamente financiamento da indústria, mas sempre afirma que o dinheiro é distribuído para instituições de caridade. Nas quais se incluem entre outras, American College of Cardiology e o Cleveland Museum of Art, onde trabalha sua mulher.
Tudo isso é perfumaria e bobagem perto da afirmação que após ter sido o responsável principal pela derrubada do Vioxx, Nissen está trabalhando em ensaio clínico com o Celebrex, também um inibidor da COX-2, do mesmo grupo farmacológico do Vioxx.

quinta-feira, 19 de julho de 2007

Triste ironia: a "falida saúde pública" ajuda a "dinâmica empresa aérea"

Esse blogueiro não sabe como um avião levanta vôo, nem como túneis de metro são contruídos. E, detesta exploração de cadáver.
Durante esses dois dias observou no Hospital das Clínicas o drama vivido pelos familiares da tragédia do avião da TAM que esperam notícias em frente ao Instituto Médico Legal que fica do outro lado da rua, em frente ao Instituto da Criança. Soube que os familiares estão no auditório do Instituto da Criança e, recebem apoio do Serviço Social do Hospital das Clínicas.
Fantástico, esse mundo de Deus!!! Congonhas e Santos Dumont drenaram uma grana tremenda em obras suntuosas. Gol e TAM receberam inúmeras vantagens governamentais. Por outro lado, o Ministério do Planejamento boicotou e, continua boicotando emenda constitucional que aumenta o orçamento do SUS.
Triste ironia, o HC faz o serviço da TAM. Como dirigente hospitalar, solicitarei que o presidente da TAM designe algumas mocinhas para ajudar na recepção do pronto-socorro nas segundas-feiras.
Gostaria também que os famosos colunistas econômicos, aqueles que louvavam a TAM ( por acaso, algum desconto na tarifa? upgrade em viagem ao exterior??) e que decretam a todo momento a "falência da saúde pública", assistissem as cenas em frente ao IML de São Paulo.

Propaganda de alimentos para crianças: limitação também nos EUA

A proposta da ANVISA em restringir propaganda de alimento às crianças já foi interpretada como um subterfúgio do Governo Lula para a submissão econômica da Rede Globo. Mas, tudo começou na gestão do pefelista César Maia no controle das cantinas e, agora avança para limitar a propaganda de "junk food' para crianças. Abaixo, a proposta das "organizações socialistas" Coca, Pepsi e General Foods sobre o assunto, tal como divulgado na agência Reuters cujo texto integral pode ser lido aqui.
U.S. food companies promise to limit ads for kids
Wed Jul 18, 2007 5:02pm ET
NEW YORK (Reuters) - Some of America's largest food and drink companies, including McDonald's, Coca-Cola, PepsiCo and General Mills, promised on Wednesday to put stricter controls on advertising aimed at children under 12. The voluntary steps varied among the 11 companies and were announced as the Federal Trade Commission held a forum to spotlight the need for more responsible food marketing to help address childhood obesity. McDonald's Corp. said 100 percent of its advertising primarily directed to children under 12 would further the goal of healthy dietary choices. The Coca-Cola Company said it would not directly market any of its beverages to children under 12, although it said it had a number of drinks including water, juice, dairy and fortified beverages that would qualify for children. PepsiCo Inc., which makes Frito-Lay snacks, Quaker Foods breakfast cereals and drinks such as Pepsi and Gatorade, will advertise only two of its products to children -- Baked Cheetos Cheese Flavored Snacks and Gatorade energy drinks --and said the ads will emphasize active lifestyles.
PepsiCo said it is taking the additional step of stopping advertising its products in elementary and middle schools. General Mills Inc., whose products include Trix cereal and Progresso soups, said it will stop advertising foods containing more than 12 grams of sugar per serving to kids under 12. The company said it will also add nutrition highlights to its cereal packaging.
"We want to be part of the solution," said Chris Shea, a senior vice president of General Mills. "We believe that companies like ours can make a difference and can play an important role in providing lower calorie, higher nutrient products to parents and their children."

quarta-feira, 18 de julho de 2007

George W Comstock (1915-2007): um exemplo de cientista, professor e cidadão do mundo.

George W. Comstock, 92, Dies; Leader in Fight Against TB
By
LAWRENCE K. ALTMAN Published: July 18, 2007
Dr. George W. Comstock, an epidemiologist who made major contributions to the treatment and prevention of
tuberculosis and was regarded by many peers as the world’s foremost expert on the disease, died Sunday at his home in Smithsburg, Md. He was 92 and had worked until last week. The cause was cancer of the prostate, said the Johns Hopkins Bloomberg School of Public Health in Baltimore, where Dr. Comstock taught for more than 40 years. Two sets of studies by Dr. Comstock in the 1940s and ’50s had a critical impact on the federal government’s response to tuberculosis. One set led public health officials to reject the tuberculosis vaccine known as BCG, which had been under consideration for routine use among American children.The second series of studies led the health profession to adopt the use of the drug isoniazid (INH) as a mainstay in treating tuberculosis, which mainly affects the lungs and remains a leading killer in the world today. Many BCG vaccines are used throughout the world. By the late 1940s, one such vaccine had been found effective in two trials in the United States. But the government wanted further research and dispatched a team led by Dr. Comstock to conduct studies among schoolchildren in Georgia and Alabama from 1947 to 1950. The studies found that the vaccine was largely ineffective. Public health officials then decided against routinely vaccinating children in the United States with BCG.
On receiving an award from the National Foundation for Infectious Diseases for his work, Dr. Comstock said he suspected he was the first person to be so honored for persuading people not to use a vaccine. Dr. Comstock attributed the discrepancies among the trials to variations in different strains of the BCG vaccine and a lack of standard manufacturing techniques. Later,
genetics studies documented that there was no uniformity among BCG vaccines, said Dr. Richard E. Chaisson, a tuberculosis researcher at Johns Hopkins. In 1957, the United States Public Health Service sought a doctor to study tuberculosis patterns in Alaska, where one of every 30 natives was in a tuberculosis hospital. Dr. Comstock volunteered, saying he saw an opportunity to study preventive treatment. He conducted a controlled trial in 29 villages near Bethel, Alaska, where tuberculosis was rampant. Members of each household were given the drug INH or a placebo for a year, Dr. Chaisson said. The study showed the effectiveness of INH in preventing tuberculosis: after a year, INH produced a 70 percent decline in cases of the disease; a follow-up study five years later showed the drug’s benefit had been sustained.
In the trial, Dr. Comstock and his family took INH themselves to convince the participants of his belief in the therapy’s safety, Dr. Chaisson said. After the trial, Dr. Comstock returned and gave INH to those who had received the placebo.
The federal
Centers for Disease Control and Prevention’s latest guidelines on INH therapy use Dr. Comstock’s data to this day. George Wills Comstock was born in Niagara Falls, N.Y., on Jan. 7, 1915, the son of George Frederick Comstock, a metallurgical engineer, and Ella Gardner Wills Comstock. He entered Antioch College planning to become a metallurgist. While working eventually on the vitamin deficiency disease pellagra, for the pharmaceutical company Eli Lilly, he developed an interest in nutritional diseases. He went on to earn a medical degree from Harvard Medical School in 1941 and a master’s degree and a doctorate in public health from the University of Michigan and Johns Hopkins, respectively. In medical school, Dr. Comstock, a thin, considerate man who stood about 6 feet 6 inches, rejected his parents’ wish that he study piano and instead bought a recorder, using money he had made by selling his blood for transfusions, a customary means of income for medical students in those days. Later, he took up the bassoon and played in symphony orchestras. He interned with the Public Health Service and later became chief of its tuberculosis epidemiologic studies. After he retired from the agency in 1962, he moved to Johns Hopkins. He was editor of the American Journal of Epidemiology from 1979 to 1988.
Dr. Comstock founded the Johns Hopkins Training Center for Public Health Research and Prevention in Hagerstown, Md., where for 30 years he oversaw community-based research studies on cancer,
heart disease and an eye disease known as histoplasmosis. The center was renamed for Dr. Comstock in 2005. He was a lifelong advocate of public health efforts and expressed disappointment in later years that more doctors were not devoting their services to it. In an interview in 2003, Dr. Comstock said that members of medical school faculties had little contact with public health departments. Dr. Comstock was preceded in death by his first wife, of 60 years, Margaret Karr Comstock, and his sister, Ruth Comstock Dunlap. He is survived by his wife, the former Emma Lou Davis; two sons, Dr. Gordon Frederick Comstock of Arcade, N.Y., and Dr. Lloyd Karr Comstock of Chapel Hill, N.C.; a daughter, Martha Wills Comstock Williams of Marietta, Ga.; five grandchildren; one great-granddaughter; two stepchildren, Jonathan Davis and Anna Davis; and two step-grandchildren

terça-feira, 17 de julho de 2007

Carta aos adoradores da Big Pharma

Reproduzo abaixo, texto de José Aristodemo Pinotti publicado hoje, na Folha de S.Paulo denominado Bravata ou patriotismo? Em negrito, destaco as informações que são desconhecidas por muitos e escondidas por poucos.
As discussões sobre quebra de patentes não foram ainda aprofundadas de forma suficiente e fugiram do noticiário. Retomo o assunto. O ministro da Saúde, José Gomes Temporão, em artigo nesta mesma seção ("Tendências/Debates", dia 27/5), mostra a dimensão dessa afirmação, ao dizer: "As indústrias [farmacêuticas nacionais] perderam competitividade internacional ao longo da década de 90". Mas o mercado farmacêutico, que, no começo dessa década, movimentava R$ 4 bilhões, hoje movimenta R$ 22 bilhões, gerando lucros e empregos, predominantemente, para as indústrias sediadas fora do país. Voltemos a 1996 (nada é mais distante que o passado recente). Vemos um Congresso Nacional desinformado e submisso às pressões para aprovar a lei das patentes com três salvaguardas que teriam prevenido não só o atual licenciamento compulsório como também a derrocada da indústria farmoquímica brasileira. Naquela ocasião, tínhamos cerca de 50 fábricas. Hoje, restam menos de 20. A Índia, de quem vamos comprar o Efavirenz, tem mais de mil. As salvaguardas -discutidas, combinadas e depois derrubadas no plenário- eram: 1) "interregno", ou seja, aprovada a lei, teríamos cinco anos para ela entrar em vigor, o que valia dizer: indústria farmoquímica brasileira, aprimore-se e se prepare para a concorrência internacional; 2) "fabricação local" -reconheceríamos as patentes dos medicamentos fabricados aqui, ou seja, estaríamos atendendo o apelo da "propriedade intelectual industrial" e o fim da "pirataria" (se é que ela existia), mas importando ciência e tecnologia abertas, democratizando-as, dando empregos e desenvolvendo o país; 3) "permissão especial aos laboratórios públicos", como a Furp (Fundação para o Remédio Popular) e outras, para fabricarem, sem as proibições patentárias, por um período de dez anos, os medicamentos que seriam distribuídos gratuitamente pelo sistema público de saúde, com economia de recursos e impacto sobre a saúde pública. As duas primeiras salvaguardas eram, inclusive, recomendadas pelo Trips (Trade-Related Aspects of Intellectual Property Rights), que regula internacionalmente o direito de propriedade intelectual. Faltou coragem, patriotismo, seriedade e independência ao Congresso Nacional, e lembro-me de que, no dia seguinte à aprovação da lei (sem as salvaguardas), o então presidente dos Estados Unidos, Bill Clinton, festejou a criação de 60 mil novos empregos no seu país. Onze anos depois, o que vemos por aqui: aumento contínuo no preço dos medicamentos, falência da indústria farmoquímica e a necessidade de agir no varejo, ameaçando uma patente ali, quebrando outra aqui. O Congresso Nacional tem todas as condições e o poder para se redimir, revendo a lei das patentes, o que seria, aí sim, uma manifestação de coragem e patriotismo. Existem lá dois projetos de lei (nº 230 e nº 303, de 2003) de minha autoria. É só fazê-los andar -foram bloqueados pelos mesmos interesses anteriores. Para mostrar que é possível quando existe vontade política, é bom lembrar o que aconteceu com os "genéricos". Depois de conseguirmos desengavetar e colocar o projeto, em caráter de urgência, para ser votado, o então ministro da Saúde, José Serra, com suporte do presidente à época, Fernando Henrique Cardoso, fez dele uma realidade que resultou em menor custo dos medicamentos, geração de empregos e riqueza para o país. Aí está a diferença entre uma bravata, convenhamos, necessária, e uma medida patriótica que desenvolve o país sem afetar a globalização, o capitalismo ou como quiserem nominar esse conjunto de interesses que dominam o mundo contemporâneo. Na verdade, sem fugir muito das regras, é possível proteger o país, como o ex-presidente Clinton fez para os Estados Unidos, em detrimento do nosso. Para isso existem Congresso, governo e democracia

segunda-feira, 16 de julho de 2007

Revolucionário é ser conservador no tratamento do diabetes.

Revolucionário na medicina é o conservador que recusa modismos e a obrigatoriedade de solicitar exames inúteis. E, também prescrever remédios caros, menos efetivos e, muitas vezes com maior risco. O tratamento do diabetes tipo 2 foi alvo de novos tipos de medicamentos para substituir as sulfonilureias e a metformina. O Annals of Internal Medicine publicou on line, revisão sistemática (acesso livre) onde mostra que o tratamento tradicional com esses dois grupos de medicamentos não foi superado pelos novos e caros fármacos.

Avandia: julgadores em conflito

A agência Bloomberg que informa que a comissão que analisará o caso Avandia para o FDA é composta seis médicos com conflito de interesse em relação ao medicamento, conforme o texto da agência. O mesmo problema ocorreu na análise do Vioxx e Bextra pelo FDA.
July 16 (Bloomberg) -- Six doctors with financial ties to the pharmaceutical industry, including stock holdings or speaking fees, will be among members of a U.S. advisory panel on the use of a GlaxoSmithKline Plc diabetes medicine linked to heart risks.
The doctors will discuss the safety of the drug, Avandia, and similar treatments at a July 30 meeting convened by the Food and Drug Administration. As many as four of the six doctors with conflicts may vote on recommendations to the FDA, according to financial disclosure documents released by the agency. The agency wouldn't say how many members the committee will have. The FDA lets too many doctors with financial conflicts serve as advisers, lawmakers and consumer advocates say. Panelists with industry ties have backed drugs including Vioxx, the Merck & Co. painkiller that was withdrawn in 2004 after being linked to heart attacks and strokes. Legislation approved by the House last week would permit only one person with a financial conflict to vote on drug recommendations. ``They shouldn't appoint people with conflicts of interest,'' said Merrill Goozner, director of the Integrity in Science project at the Washington-based Center for Science in Public Interest, in an interview. ``The public perception of the evenhandedness of the process will be immeasurably enhanced if they appoint only people who do not have conflicts.'' To allow the doctors to participate in the Avandia review, the FDA is waiving rules that bar panelists with financial conflicts. Regulators, who routinely issue the waivers, say researchers often consult for drugmakers or have other ties and aren't swayed by those connections.

Gravidez indesejada e crime em São Paulo

O Estado de S.Paulo publicou hoje o texto "Estudo liga gravidez indesejada a crimes violentos em cidades de SP" baseado no estudo do economista Gabriel Hartung da Fundação Getúlio Vargas no Rio de Janeiro. Até aí, poderia ser algo do mais alto interesse, mas há uma informação terrível" esta é a conclusão de um trabalho ..., em etapa final de elaboração". Ora, como há conclusão de algo ainda não terminado? Como avaliar um trabalho acadêmico ainda não publicado? Qual revista irá aceitar um trabalho que já ganhou as manchetes?
A precipitação em divulgar um trabalho ainda na fase final poderá trazer prejuízo ao autor e seu orientador. Mas, pior porque poderá "queimar" uma boa pergunta. Trata-se da formulada por Steven Levitt no livro Freaknomics onde ele mostra que a queda da mortalidade nos EUA seria explicada pela liberação do aborto duas décadas antes. Essa tese é de grande importância e, não pode ser perdida pelo afobamento.
Espero que o trabalho original, com o devido rigor, seja publicado para que possa ser analisado de forma criteriosa. As implicações práticas serão evidentes, mas altamente polêmicas.

domingo, 15 de julho de 2007

A realpolitik da Big Pharma e do Governo Lula

O termo realpolitik aqui utilizado foi cunhado há mais de um século para mostrar a diferença entre decisões práticas daquelas movidas pela ideologia. Os ideólogos de esquerda e, principalmente os de direita gastaram muita tinta discutindo uma questão simples: a da quebra de patente do efavirenz. Já afirmei aqui, que esse fato ocorreu pelo desdém da filial brasileira da Merck com o governo brasileiro do que por motivação ideológica. A Abbott foi mais esperta e, rapidamente se acertou com o Ministério da Saúde. Afirmei aqui e, em entrevista a uma revista semanal, que o prejuízo para o país no caso efavirenz seria zero.
A Big Pharma e o Governo brasileiro não são pouca coisa no cenário mundial. A primeira controla quase todos os medicamentos, o segundo é um dos seus maiores compradores - pagador pontual e correto - porque a responsabilidade na política de assistência farmacêutica no Brasil - principalmente aquela de alto custo - é maior do que na maioria dos países renda equivalente ou superior à nossa.

Leste europeu pagará resgate à Líbia

A solução para o absurdo caso das cinco enfermeiras búlguras e do médico palestino está próxima, conforme notícia no The Washington Post. Países do Leste Europeu perdoariam dívidas com a Líbia no valor de 400 milhões de dólares. Esse valor iria para o fundo de apoio às crianças que foram contaminadas pelo HIV. Já falei demais sobre o assunto. O governo líbio não merece mais qualquer qualificativo, ao utilizar profissionais de saúde como reféns. Mas, volto a perguntar: onde esteve a militância da aids?
AIDS Case Deal May Forgive Libyan Debt
By KHALED EL-DEEBThe Associated PressSaturday, July 14, 2007; 8:58 PM
TRIPOLI, Libya -- Several eastern European countries would forgive Libyan debt dating back to the Cold War under a proposal to compensate families whose children were allegedly infected with the AIDS virus by five Bulgarian nurses and a Palestinian doctor, a victims' advocate said Saturday. The six foreign medics have been sentenced to death in the case, and Libyan officials have said a settlement could pave the way for their release.

sábado, 14 de julho de 2007

Enfermagem: não quebrem a espinha dorsal do sistema.

Leigos em administração hospitalar, incluindo nessa lista uma quantidade imensa de ministros e secretários de saúde e de educação, acreditam piamente que o médico é o profissional mais importante em um hospital. Leigos com verniz acadêmico, como sanitaristas, afirmam em tom demagógico que a "equipe multiprofissional" é decisiva.
Eu não tenho problema algum em afirmar que se por um lado todos são importantes na organização hospitalar, por outro lado, a "cara" do hospital é o corpo de enfermagem. Por que não o médico? Médicos (fisioterapeutas, odontólogos, fonoaudiólogos não deixam de ser médicos ao dominar o binômio "diagnóstico-tratamento" ) são clientes do hospital, pois podem trabalhar ou encaminhar paciente a mais de uma instituição. Imaginem a situação de um médico estacionando um carro em um hospital na região da avenida Paulista. Ele poderá visitar quatro pacientes seus, em quatro hospitais. Mas, a enfermagem será específica de cada um desses hospitais. O médico passa uma visita de meia hora, no momento que melhor se aprouver. A enfermagem rende guarda (tempo dependente) por plantão e controla espaços, situação restrita somente aos médicos de pronto-socorro.
Outro aspecto ignorado, agora pelos economistas e planejadores de saúde, é que o aporte de equipamentos novos, não reduz pessoal, mas ao contrário, aumenta a necessidade de equipe de enfermagem. Exemplo, aparelhos de tomografia e ressonância magnética implicam em equipe de enfermagem específica.
O assunto é longo e apaixonante. Voltarei em breve com mais dados, mas abaixo reproduzo a situação americana retratada pela blogueira do The Wall Street Journal. A frase final vai de encontro ao que expus: Enfermagem é a espinha dorsal do sistema.
Nursing Crisis: NY Legislator Suggests Solutions
Posted by Heather Won Tesoriero
Amid the doomsday scenarios for future of nursing, it’s refreshing to find a bright spot. The Health Blog learned that Clinique, a division of cosmetics giant Estee Lauder, established the Clinique Nursing Scholarship Program this year to encourage people to become RNs. Next week, the company will honor five nursing students and scholarship recipients at a luncheon in New York. The keynote speaker is New York State Assemblywoman and RN
Aileen Gunther (pictured), who is supporting the creation of a federal Office of the National Nurse to raise awareness about health issues and to keep nurses in the health care dialogue.
The Health Blog spoke to Gunther, a Bronx native, with 29 years’ experience in health care, working in everything from obstetrics and emergency room care to infection control. She’s an advocate for RNs, particularly in New York, which has roughly 239,000 nurses, though nearly 70,000 no longer work in the field. The number of nurses on the sidelines is “because of the working conditions,” Gunther told us. “Do you think those people would leave if they had better working conditions? We as a government have to look and listen to those people in the trenches.”
This year, the New York Assembly passed a bill, which is now in the state Senate, that would ban mandatory overtime for nurses. Eleven other states have such laws, Gunther said. When she was a nurse, she was often forced to work back-to-back eight-hour shifts, she tells the Health Blog. Such double-time demands are the kinds of things that drive people, particularly those with families, out of the profession, she said. “I loved being a nurse, and I loved the people I worked with,” Gunther said. “
But as far as quality of life, it’s very, very difficult.”
Gunther thinks the state should also provide supplemental funds to nursing school teaching salaries, too. She said there are waiting lists at the nursing schools in her district because there aren’t enough teachers. For nurses to go into teaching, “they’d take a $20,000 decrease in pay,” she said. “Why not invest in opening up more classrooms? Nurses are the backbone of health care.”

sexta-feira, 13 de julho de 2007

Mais força para o FDA com a maioria democrata na Câmara dos Deputados dos EUA

A vitória do Partido Democrata em 2006 provocará aumento do controle pelo FDA do processo regulatório e, maior preocupação com a segurança dos medicamentos em uso. Mas, um ponto importante será a regulação do marketing direto com o consumidor.
Há um ponto duvidoso: a aprovação de genéricos de produtos biotecnológicos, um assunto polêmico sem uma conclusão clara e contundente, como a favorável aos genéricos da "química fina". Abaixo, reportagem do The Wall Street Journal.
House Acts to Boost FDA Powers; Biotech Fight Looms
By ANNA WILDE MATHEWSJuly 12, 2007; Page A2
WASHINGTON -- The House passed legislation that would bolster the powers of the Food and Drug Administration, but the vote sets up a confrontation with the Senate over whether to create a pathway for generic versions of biotechnology drugs.
The House FDA bill, approved 403-16, mostly parallels a bill that passed the Senate in May. Both versions would devote more money to monitoring the safety of marketed drugs and increase the agency's authority over medications that raise safety concerns. The agency would have the clear ability to order follow-up studies, restrict distribution and enforce changes to the medications' labels. The bills don't grant the FDA the power to force a moratorium on direct-to-consumer advertising, a tough restriction that was discussed earlier, though the agency would be able to levy fines for false and misleading promotions. A compromise version of the two measures is expected to be completed in the next few months -- perhaps before the August recess -- because the legislation renews industry fees that fund much of the FDA's work. Both the House and Senate versions would also force drug companies to make public information from many clinical trials. But there is a key divide between the Senate and House bills: the Senate will include language that creates a pathway for the FDA to approve copycat versions of biotech drugs, and the House bill doesn't address the issue. The Senate provisions reflect an agreement among a group of key senators including Democrat Edward Kennedy of Massachusetts and Republican Michael Enzi of Wyoming, the health-committee leaders. Mr. Kennedy has said he will introduce that compromise, which was reached after the Senate passed its FDA bill, as part of the proceedings of the bicameral conference committee that will resolve differences between the House and Senate proposals. A key question is whether House leaders, including Energy and Commerce Committee Chairman John Dingell, a Michigan Democrat, will be willing to accept the move. Different House members have introduced divergent bills, but the Energy and Commerce Committee hasn't moved forward with any of them.
In an interview yesterday, Mr. Dingell signaled that he will oppose inclusion of the copycat biotech-drug language in a final bill. He said he supports a pathway for such drugs, but has safety concerns as well as questions about whether science is advanced enough to verify a copy's similarity to the original medication. "There's really no record to justify that kind of action" in the House, which hasn't yet fully debated a bill, he said. The issue is extremely important for the generics and biotech industries, and it has been the focus of extensive lobbying. Currently, the FDA doesn't have the power to approve generic versions of most biotech drugs, which have become some of the most important, and expensive, treatments. Generics makers will prod for inclusion of the Senate generic-biotech language. Biotech makers, though, are expected to push for the House to consider its own bill, which could stall the change.A spokesman for the Biotechnology Industry Organization said "it's a complex issue, and it deserves full and deliberate consideration."A spokeswoman for the Generic Pharmaceutical Association said in an email that the group is "cautiously optimistic" that the copycat-biotech provisions will be in the final FDA legislation.

quinta-feira, 12 de julho de 2007

Líbia: enfermeiras e médico condenados à morte


O Estado de S. Paulo publica despacho da agência EFE sobre a condenação à morte na Líbia de cinco enfermeiras búlgaras e um médico palestino preso há quase 9 anos. Eles foram acusados de contaminar de propósito 4oo crianças. Esse blogue iniciou a solitária denúncia contra esse absurdo (clique aqui) há vários meses. A União Européia e os Estados Unidos pressionam o governo líbio pela liberação. Uma saída será a comutação da pena e, o acordo de extradição com a Bulgária, permitirá a transferência das enfermeiras. Mas, e o médico palestino? Ainda, não entendi porque a militância da aids, tão ativa e tão opinativa em tantos terrenos, não se manifestou até o momento.




Finalmente, apoio à mulher...

As mulheres são vítimas de religiosos, ONGs, sociedades de especialistas e governantes que sempre as consideram ignorantes e despreparadas para a vida reprodutiva. Programas de Planejamento Familiar (segundo alguns, isso significa para a maioria da população: planejamento econômico-financeiro) nunca conseguiram ser executados. Mas, gastaram tempo e dinheiro em treinamentos, cursos e aperfeiçoamentos. Enquanto, o poder público instruído por acadêmicos e ONGs viravam as costas, os balconistas de farmácia, médicos descolados da academia/sociedades, comadres e outros faziam a orientação reprodutiva, mesmo com desvio grave como a "laque-cesárea". Agora, com a distribuição ampla de contraceptivos, vamos chegar a uma solução mais efetiva que respeita a mulher.

quarta-feira, 11 de julho de 2007

A China continua a mesma......

Médico que revelou a magnitude da pneumonia asiática na China foi proibido de deixar o país para aceitar prêmio. Não destaquei ontem, mas no mesmo país, o responsável pelo órgão regulador, o equivalente à nossa Anvisa, foi condenado à morte por corrupção. Abaixo, despacho da Associated Press.
China Bans Doctor's Leave to Accept Award ASSOCIATED PRESSJuly 12, 2007
BEIJING -- A Chinese military surgeon who broke government secrecy to reveal the true scale of Beijing's SARS outbreak in 2003 has been banned from leaving China to accept a human-rights award, a rights watchdog said yesterday. Jiang Yanyong, 76 years old, was praised as an "honest doctor" by Chinese media after he wrote a letter to reporters saying that Beijing had more than 100 unreported cases of severe acute respiratory syndrome, or SARS. The revelation was followed by embarrassing official admissions and the firing of a cabinet minister. Mr. Jiang has been awarded the Heinz R. Pagels Human Rights of Scientists Award by the New York Academy of Sciences, but his work unit banned him from leaving China to accept the prize in September, the Hong Kong-based Information Center for Human Rights and Democracy said in a faxed statement. In rejecting Mr. Jiang's request, officials with People's Liberation Army Hospital 301 said the ceremony coincides with the 17th Party Congress, a politically sensitive time, the Hong Kong group's statement said. A man surnamed Sheng who works in the president's office of Hospital 301 said he wasn't aware of the case. A message seeking comment was left at Mr. Jiang's home number. An email seeking comment was sent to the New York Academy of Sciences before U.S. business hours yesterday. Copyright © 2007 Associated Press

A Big Pharma joga melhor que seus defensores tupiniquins.

A GlaxoSmithKline disponibilizará quimioterápico para câncer de incidiência rara. Muito bom. Mais interessante foi ligação dessa decisão com o atitude do Ministério da Saúde do Brasil (e, também da Tailândia) em relação à aids feita pela blogueira do The Wall Street Journal. Os críticos da atitude brasileira da quebra da patente do efavirenz prognosticaram o caos, mas a realidade da relação entre a governos independentes e soberanos com responsabilidade com a sua população e a Big Pharma estão no patamar da realpolitik e, não da ideologia.
Glaxo Readies Drug for Rare Cancer at Modest Price. Posted by Sarah Rubenstein
Drug makers have come under fire recently from countries such as Thailand and Brazil for the high prices of their products. But GlaxoSmithKline is taking a step in Europe that may burnish its image.
Later this year the company expects to launch a drug for a rare cancer at a modest price — with no chance of generating a profit, the Financial Times
reports.The drug, called Atriance, will be offered to the fewer than 500 patients across the European Union annually. It’s indicated for people who haven’t responded to other chemotherapies that target T-cell acute lymphoblastic leukemia and lymphoblastic lymphoma, rare blood diseases that predominantly affect children, the FT says.Andrew Witty, president of Glaxo’s European pharmaceuticals division explained the rationale to the FT. “The economics [for Atriance] are very unlikely to work, but we have never seen this as a commercial opportunity,” he said. “This is part of our commitment to ensure the right balance between the company and society.” Asked whether Glaxo considered abandoning the drug, Witty said there was a “debate inside the company,” but the “overwhelming” view was that the drug worked and should be brought to market. Still, a moderately priced cancer drug can still carry a big sticker. Atriance will cost about $5,000 for a 21-day cycle of treatment, the FT reports. The newspaper says that’s far less than most other “orphan drugs,” which are for diseases that affect small groups of people. This 2005 page-one article from the WSJ details the experience of Carol Lees, a patient with an orphan disease who was racking up bills of $1,400 a day for treatment with a drug from Genzyme.Meanwhile, Tykerb, Glaxo’s new drug for metastatic breast cancer, costs about $2,900 a month. See this interactive feature from WSJ for more about drugs for advance breast cancer.

terça-feira, 10 de julho de 2007

Mais um vexame da Administração Bush

Nos Estad0s Unidos, o cargo de Surgeon General é uma referência técnica e moral na assistência médica. Não é o Ministro da Saúde, mas é mais respeitado que o Secretário de Saúde. Agora, ex Surgeon General denuncia que foi "editado" pela equipe Bush.
Former Surgeon General Says White House Edited Speeches
By LAURA MECKLERJuly 10, 2007 8:22 p.m.
WASHINGTON -- The most recent U.S. surgeon general told Congress the Bush administration routinely blocked him from speaking out on controversial issues, including stem-cell research, emergency contraception and sexual abstinence, and pressured him to support an "ideological, theological" agenda.
Dr. Richard Carmona, surgeon general from 2002 until 2006, said that his speeches were edited to remove material about controversial issues and that he was encouraged to attend internal "political pep rallies." He said he was prevented from releasing a report on global health because he wouldn't make it a "political document" touting actions by the U.S. The report has yet to be released.
"The reality is that the 'nation's doctor' has been marginalized and relegated to a position with no independent budget and with supervisors who are political appointees with partisan agendas," he told the House Oversight and Government Reform Committee yesterday. "Anything that doesn't fit into the political appointees' ideological, theological or political agenda is often ignored, marginalized or simply buried."
The Bush administration denied that it tried to muzzle the former surgeon general. "This administration gave Dr. Carmona ample opportunity to communicate his views to the American people, and he routinely did so," the Department of Health and Human Services said in a statement.
The surgeon general's post has little formal power but can be a megaphone on public-health issues. Dr. C. Everett Koop used the post most notably to detail the dangers of smoking and to talk about AIDS. Dr. David Satcher, Dr. Carmona's immediate predecessor, issued a landmark report on mental health. Both men joined Dr. Carmona at the hearing yesterday and recounted their own challenges melding public health with politics of their administrations. But Dr. Carmona said the pressures he faced were more intense.
A trauma surgeon and onetime high-school dropout, Dr. Carmona got a lot of attention for his colorful past -- he once rappelled from a helicopter to rescue a victim. But he kept a low profile after taking office. He left in August when his term expired. A Senate committee plans to hold a hearing tomorrow on James Holsinger Jr., a Kentucky cardiologist who has been nominated to be the next surgeon general. He is likely to be questioned about what critics say are antigay views.
Dr. Carmona told the committee that, as surgeon general, he hadn't been permitted to talk about the importance of comprehensive sex education or emergency contraception. He said he wasn't permitted to discuss the science of embryonic-stem-cell research. Under the Bush administration, there are strict limits on federal funding for such research. "I was blocked at every turn," he said. "I was told the decision had already been made -- stand down, don't talk about it," he said.
He also said he was prevented from attending a Special Olympics event to talk about health and disabilities. "I was told I would be helping a politically prominent family, [and] why would I want to help those people?" Dr. Carmona said. The Special Olympics were founded by Eunice Kennedy Shriver, sister of Sen. Edward Kennedy (D., Mass.).
He said his speeches were regularly vetted to ensure they weren't controversial. Speeches were edited to add references to Mr. Bush -- he was told there should be at least three per page. "The vetting was done by political appointees who were specifically there to spin my words to ideologically preconceived notions," he said.

segunda-feira, 9 de julho de 2007

Tarso Genro é candidato a Rudy Giuliani?

Esse blogue fará uma pequena incursão na política, com o risco inerente ao terreno. Mas, vamos tentar. Antes disso, recomendo ao leitor, os post anteriores sobre homicídio, um tema recorrente aqui.
(1) os homicídios nas regiões metropolitanas estão aumentando, com exceção de São Paulo e, quem diria, Rio de Janeiro. A queda em São Paulo foi de quase 50% em cinco anos. A tendência declinante será seguida nas demais regiões metropolitanas. Programas específicos vão decidir a desacelaração dessa queda. Até o momento não há uma explicação plausível para essa queda em São Paulo, bem como nas demais cidades do mundo que passaram pelo pico de violência, seguido de declínio.
(2) Há mais de uma década, Nova Iorque tinha taxas elevadas de homicídio. Rudolph Giuliani, ex-promotor foi eleito prefeito com o mote de combater a violência (nos EUA, a segurança pública é municipal e, não estadual). No seu período de mandato (1994-2001) a queda das taxas foi de 50%. Ele credita isso a sua política de tolerância zero. Na verdade, a política era "no broken window" para as escolas públicas e, ele se apropriou dessa idéia.
(3) Provavelmente, nesse momento, o candidato à presidência dos Estados Unidos - Rudy Giuliani - está fazendo um discurso em algum canto daquele país, falando dos resultados de sua política. Um gaiato na platéia perguntará porque em Boston -com prefeito democrata que se elegeu 4 vezes seguidas -, sem "tolerância zero", a redução foi maior e, a violência policial muito menor do que na "Big Apple". Giuliani irá desqualificar o inquisidor insinuando ser o oponente mais um "democrata de Massachusetts", ou seja "um lugar estranho onde gays podem casar".
(4) Hoje, 09/07/07, Lula aprovou o Programa Nacional de Segurança Pública com Cidadania que investirá R$ 4,8 bilhões na integração de políticas de segurança pública com ações sociais nas 11 regiões mais violentas do país. Para 2007 estão previstos R$ 483 milhões. O" presidente aprovou o Programa e pediu que fosse feita uma reunião com os ministros cujas ações têm interface”, disse Tarso Genro aos jornalistas. Segundo a nota oficial do Ministério da Justiça: "Composto por 72 ações, o Pronasci tem como eixo principal a integração de ações de segurança pública e políticas sociais para o enfrentamento da criminalidade. O objetivo do programa é enfrentar as causas sociais e culturais do crime, por meio de ações de prevenção, controle e repressão da violência. Inicialmente, o Pronasci será implantado nas onze regiões metropolitanas do país com maiores índices de criminalidade. Seu desenvolvimento se dará por meio da articulação contínua entre União, estados e municípios."
(5) Daqui há três anos, as taxas de homicídio estarão em baixa nessas onze regiões metropolitanas e, Tarso Genro creditará o fato ao Pronasci, inclusive em São Paulo. Será o nosso Giuliani, aquele que assume créditos indevidos com interesse eleitoral óbvio.

A voz do dono: entrevista com o CEO da GlaxoSmithKline

Abaixo, segue entrevista com o CEO da GlaxoSmithKline publicada hoje no The Wall Street Journal. Destaquei algumas opiniões como de que o risco da Avandia já era conhecido pela empresa - obviamente, em magnitude menor - e que há países que preferem comprar metralhadoras a vacinas.
Glaxo's GarnierIs Taking the Heat
Defending Safety of Avandia Preoccupies,But Doesn't Consume, Drug Company's CEO
By JEANNE WHALENJuly 9, 2007; Page B1
Jean-Pierre Garnier, chief executive of
GlaxoSmithKline PLC, has been in the hot seat since May, when an article in the New England Journal of Medicine raised concerns about the safety of the diabetes treatment Avandia, his company's second-biggest selling drug.
In the article, cardiologist Steven Nissen analyzed 42 past clinical trials of Avandia -- an approach known as a meta-analysis -- and concluded that patients taking the drug may be at a higher risk for heart attacks than patients taking other drugs. Since then, Avandia prescriptions have fallen sharply, and Glaxo's stock price has plummeted.
Dr. Garnier is now trying to fight research with research. He says Glaxo performed its own meta-analysis of Avandia before Dr. Nissen's -- and also found a risk of heart attack. But the risk was very slight, and was outweighed by other evidence showing that Avandia is as safe for the heart as other diabetes drugs, Dr. Garnier says. The Food and Drug Administration is now carrying out its own meta-analysis and will convene a panel of medical advisers on July 30 to weigh the evidence.
Dr. Garnier has faced safety crises before. In 2004, medical experts raised concerns that Glaxo's Paxil and other antidepressants could induce suicidal thinking and behavior in children, leading the FDA to add strong warnings to the drugs.
In an interview in Glaxo's Philadelphia office, Dr. Garnier discussed such topics as managing the Avandia crisis, the pricing of HIV drugs, serving poor communities and what he wants to accomplish before stepping down as CEO in May 2008. Excerpts follow.
WSJ: Has Glaxo done everything it could to study Avandia and communicate its risks to the public?
Dr. Garnier:
We're not perfect, I'm sure. With 20-20 hindsight we could have done more. But I have to say in the case of Avandia, you see that we were diligent from the day of the launch to start to study the drug in some depth in [clinical] studies and then we did the meta-analysis a year ahead of Dr. Nissen. As soon as we found out that there was at least a question raised by the meta-analysis, we immediately did the epidemiology study with 30,000 patients that came out absolutely squeaky clean and supportive of Avandia. So you look at the totality, Avandia is by far the most studied diabetic agent on the market today. So sure, maybe we could do more, but frankly the record is very good. Not only have we studied this drug right, left and center, but also we have been transparent, informed everybody.
WSJ: What feedback are you getting from doctors about Avandia?
Dr. Garnier: Doctors are worried about being sued for putting patients on Avandia and things like this. But overall, they are staying behind Avandia. Very few patients actually are switching off their medication. But some have.
WSJ: Are doctors more concerned about liability risk when putting new patients on the drug?
Dr. Garnier: Physicians are naturally gun-shy about putting new patients on. The reality is, and we have the data, they're putting fewer new patients on it. We've just run a big survey of physicians, and they're playing back again the two key points: "Most of my patients have not switched, and I have no intention of switching them. However, as far as putting new patients on Avandia, I'm putting far fewer than before, and I'm waiting to see what the FDA has to say."
WSJ: Does the safety flap take up your entire day?
Dr. Garnier: Pretty much, 24-7. This is a very unpleasant event. But on the other hand this is not my first one. I've been there before. My job is to manage the company through the crisis.
WSJ: How do you do that?
Dr. Garnier: We have crisis-management phone calls every day. These things don't get done without a lot of coordination.
WSJ: Glaxo recently donated 50 million pandemic flu vaccines to the World Heath Organization. What's the story?
Dr. Garnier: It's probably the largest vaccine donation ever. The company could have sold possibly those 50 million units. They [Glaxo] decided to set them aside because frankly those countries are not going to buy any pandemic vaccine. Some of them have no commitment to health care.
Let's call a cat a cat. They'll buy a lot of other things including Kalashnikovs before they allocate enough money for health care in their own countries. [Some] are committed to better health care but [pandemic flu] never makes their top 10 list because they have humongous problems. They have HIV, and they have this and that. So putting resources aside for a maybe problem doesn't work out to their top priority.
WSJ: How has Glaxo changed its HIV-drug pricing in the developing world since you started running the company?
Dr. Garnier: I always wanted to have access as part of the DNA of the company. I don't look at those things as philanthropic undertakings. Even Tykerb -- we just introduced this breast-cancer treatment in the U.S. It's a very expensive product for the average person. We provide funding and subsidies for people up to an income level of $100,000 per family. It's intertwined with the purely commercial pricing. I wanted that. I
never wanted to just close my eyes to the fact that 80% of the population won't be able to afford the drugs. Because that's the truth -- 80% of the market for pharmaceuticals comes from 20% of the world-wide population. I'm not going to be CEO of a company that just works for rich countries. And even within rich countries, by the way, you have holes in the safety net that are part of the equation.
WSJ: What has that meant in HIV?
Dr. Garnier: To me, it became very obvious that we had to go much further than to give discounts [on drugs]. We had to make basically a philosophical statement that for the very poor countries of this world, we were going to sell our drugs without making a profit, completely not for profit. And overnight we did this. And that allowed the consumption of HIV drugs in Africa to increase dramatically, exponentially. Overnight we went from very little to hundreds and hundreds of millions of tablets. Then we went one step further and said, why don't we give licenses to generic companies [to make our drugs], particularly local companies. Maybe they can make it even cheaper.
WSJ: What are the main things Glaxo has done to provide better access [to HIV drugs] and what's been the effect?
Dr. Garnier: What we sell at this not-for-profit price corresponds to roughly a million patients being treated, mostly in Africa. We dropped the price, helped with access -- that is, we have a number of community support programs. Because treating people who have HIV is not a simple thing.
WSJ: What are you doing? Opening clinics? Hiring doctors?
Dr. Garnier: No, we don't own the infrastructure but we've supported clinics. Not just with money -- with advice, sending doctors.
WSJ: Do you do much licensing for production of your drugs in middle-income countries like Thailand?
Dr. Garnier: No, no, no. Middle-income countries should pay a fair price for our drugs. They certainly can use some of their resources to pay a fair price, which is clearly an intermediate price between the lowest and the highest -- we try to price according to standard of living.
WSJ: You're retiring next year. What more do you want to do?
Dr. Garnier: No. 1 is deliver the pipeline. We have a very exciting, high-quality, deep, dense, innovative pipeline of late-stage drugs. So let's make sure we deliver, and those drugs pass the last hurdle and get launched.

Cinco anos da "débâcle" da Terapia de Reposição Hormonal

Há cinco anos, feriado em São Paulo, abri o site do The Boston Globe e, vi com surpresa relativa o anúncio da suspensão do Women´s Health Iniative, o ensaio mais caro já realizado para testar a hipótese de que a terapia hormonal seria uma forma de prevenir a doença cardiovascular em mulheres. Vários ensaios clínicos estavam indo no sentido oposto aos estudos epidemiológicos que mostravam redução importante do risco cardiovascular. Hoje, no The Wall Street Journal publica reportagem tentando "corrigir a rota" depois do 9 de julho. Eu continuo defendendo que a reposição hormonal está indicada por curto período para tratamento de sintomas. Não há nada convicente que justifique seu uso na prevenção cardiovascular.
How NIH Misread Hormone Study in 2002
By TARA PARKER-POPEJuly 9, 2007; Page B1
On July 9, 2002, federal government health officials announced that they had halted a major study of menopause hormones, saying the drugs increased a woman's risk of heart attack by 29%. But in the five years since, it's become clear that some aspects of what was initially reported from the $725 million Women's Health Initiative study were either misleading or just wrong. Although the government initially said the findings applied to all women, regardless of age or health status, additional data published in recent months show that the age of a woman and the timing of hormone use dramatically changes the risk and benefits. WHI data published in April in the Journal of the American Medical Association showed that women in their 50s who took a combination of estrogen and progestin or estrogen alone had a 30% lower risk of dying than women who didn't take hormones. Last month, the New England Journal of Medicine reported that 50-59-year-old women in the WHI who regularly used estrogen alone showed a 60% lower risk for severe coronary artery calcium, an important risk factor for heart attack. How could the heart risks of menopause hormones for this crucial cohort change so dramatically in just five years? Officials from the National Institutes of Health, which directed the study of more than 27,000 women, say the interpretation of the WHI has simply evolved as researchers have used different methods to analyze the voluminous body of data.
The average age of women in the study was 63. While older women in the study did show a heart risk, researchers eventually focused on women in their 50s who were closer to menopause, finding that hormones were more likely to protect those women's hearts than harm them. But critics including some of the WHI's own investigators, speaking out for the first time, say that NIH officials initially overgeneralized in large part because they excluded many of the study's own investigators and physicians from the first review. As a result, key questions that could have clarified the data far sooner weren't asked. Just 11 days before the public announcement in July 2002, the WHI's 40 investigators met in Chicago, where they were told the study had been stopped early. Several people who attended the meeting say several WHI researchers were stunned and angry when they were given final page proofs of the study report for the Journal of the American Medical Association. Although some researchers expressed concern that the results were too broadly interpreted, it was too late to make meaningful changes to the JAMA article. Many investigators who had spent nearly a decade working on the WHI had no input in the final and most important paper. "I think that had the initial report been written by a broader group, as almost all of our later papers have been, it would have been framed differently," says Robert D. Langer, the former principal investigator for the WHI's clinical center at University of California, San Diego, who was among those who protested at the time. He has since served as an expert witness for hormone maker
Wyeth. Dr. Langer says he remains concerned that the interpretation of the WHI has unnecessarily scared a generation of women from the treatment. Jacques Rossouw, a physician with the National Heart Lung and Blood Institute who has overseen the WHI since its inception, confirms that some investigators were upset that they weren't included in writing the first WHI report. "That was an NIH decision supported by the WHI executive committee to keep it to a small group because we realized it was a sensitive paper," he says.
Still, he defends the government's handling of the study results "based on what we knew at the time," and says that study officials wanted to make a dramatic statement. "Our main job at the time was to turn around the prevailing notion that hormones would be useful for long-term prevention of heart disease," he says. "That was our objective. That was a worthy objective which we achieved."
But many in the medical community disagree, saying key questions about long-term use still aren't answered. Although the WHI data clearly show that starting hormones at an older age is risky, what's not clear is whether the heart protection women get starting at a younger age will continue with long-term use. That was the question that the WHI was supposed to answer when it was launched in 1991 after data from an ongoing trial of nurses showed that women who used menopause hormones have as much as a 50% lower risk of heart attack. But the WHI designers didn't take into account that the timing of hormone use might affect the results and recruited mostly older, symptom-free women. Some of the study participants were already 20 years past menopause when the WHI began. Since mostly older women were recruited, there weren't enough recently menopausal women under 60 to generate conclusive data in some of the findings. But the trends were provocative. Among recently menopausal women who used estrogen and progestin, heart attack risk fell 11%. By comparison, women who started taking hormones 10 or more years past menopause had a 22% to 71% higher risk of heart problems.
In a second part of the study, in which women who had undergone hysterectomy took estrogen without progestin, women who started hormones after the age of 70 had an 11% higher risk of heart problems. But women below 60 in the estrogen-only study had a 37% lower heart risk. In a bid to draw a more definitive conclusion, the WHI in April 2007 published a report in JAMA combining the data from both hormone trials. That paper showed that the timing of hormone use matters: Younger women appear to receive heart protection, while older women are at risk. "We now have a refined understanding of the benefits and risks of hormone therapy, and there has been so much reassuring evidence for younger women over the last few years," says Harvard professor and WHI investigator JoAnn Manson, who has no ties to drug firms. Despite the recent data, questions about long-term use of hormones are far from resolved. While most people now agree that hormones are a reasonable option for women to treat menopause symptoms like hot flashes, the bigger question is whether hormones should be considered in the armamentarium of drugs used for heart protection, along with blood pressure medications and cholesterol-lowering drugs called statins. The National Heart, Lung and Blood Institute, which oversaw the WHI, firmly believes that menopause hormones shouldn't be used to prevent heart disease because of potential risk of blood clot, stroke and breast cancer. Indeed, the WHI showed that hormones have a range of risks and benefits. On the plus side, they may protect younger women's hearts, they definitely protect against hip fractures, they lower the risk for diabetes and may lower the risk for colon cancer. On the other hand, menopause hormones do increase the risk for blood clots and stroke. Women in the WHI who used both estrogen and progestin were at 24% higher risk for breast cancer. But women who regularly use estrogen without progestin had a 33% lower risk of breast cancer. "Hormone therapy long term has these other adverse events hanging around. It doesn't fit the paradigm of what you are looking for in a viable long-term prevention strategy," says Dr. Rossouw. "If you're going to use something to prevent atherosclerosis, your choice is statins, not hormones." The data on women who use statins are mixed, but suggest that they lower a woman's heart risk by 15% to 20%. Statins carry their own risks, including liver effects, muscle pain, memory problems and in rare cases a life-threatening muscle disease call rhabdomyolysis. There are no studies showing the risks and benefits of long-term use of statins. Many doctors now believe that for younger women without a uterus, estrogen should be an option for long-term prevention of heart disease. (The progestin is added to protect against uterine cancer.) "If this is preventing heart disease and saving lives, I think it's really wrong not to consider it," says Yale associate professor Hugh Taylor, a principal investigator for the Kronos Early Estrogen and Prevention Study, a study of estrogen and heart disease funded by Arizona billionaire John Sperling, an education entrepreneur who was upset with the way the WHI study was initially interpreted. "Some of the other drugs we use for cardiovascular disease don't have the evidence that we have for hormone therapy." Two important ongoing studies will further illuminate the role estrogen plays in heart disease. The KEEPS study is recruiting 720 women, ages 42 to 58, to study the effects of oral or transdermal estrogen as well as progesterone on the coronary arteries of healthy women. An NIH-funded Early Versus Late Intervention Trial will study 500 women and the effects of hormone therapy given within six years of menopause compared to treatment given 10 or more years after menopause. Both studies will also test whether using natural progesterone, instead of the synthetic progestin used in the WHI, lowers or eliminates the risk of breast cancer associated with combination therapy. Even though the long-term heart issue is unresolved, some critics say the NIH's handling of the WHI data scared away younger women who might want to use hormones for menopause symptoms. "We've gone to considerable efforts to reassure women and gynecologists that it's okay [to use hormones] in the short term," to treat the symptoms of menopause, Dr. Rossouw says. Still, since the WHI results were announced in 2002, hormone sales have plummeted 30% to $1.9 billion, according to IMS Health, a health-care information company. "I don't think it's fair to extrapolate from the data that women should be put on this as a preventative treatment for heart disease," says Michael E. Mendelsohn, a Tufts University professor who recently wrote an NEJM editorial about estrogen and heart disease. "What the data do support is that women who use hormones to treat menopause symptoms can feel reassured that they are not increasing their cardiovascular risk and may be providing some long-term benefit."