sexta-feira, 1 de junho de 2007

Avandia: as teorias conspiratórias

Abaixo, a descrição de teorias conspiratórias sobre o caso Avandia retiradas do heartwire.
Rosiglitazone meta-analysis continues to drive controversy in second week May 30, 2007Lisa Nainggolan New York, NY - The fallout continues from the publication in the New England Journal of Medicine (NEJM) last week of a meta-analysis of rosiglitazone (Avandia, GlaxoSmithKline [GSK]), which suggested it increases the risk of MI and cardiovascular death. As reported by heartwire, many experts have said the data were far from perfect and have expressed concern about the manner in which they were released. But new reports go one step further—suggesting that FDA whistleblowers coordinated with politicians critical of the agency and the study authors to get damaging data into the public arena before the FDA could issue a safety statement on rosiglitazone. And damage has certainly been done in the form of a battering of the stock of GlaxoSmithKline, as Avandia was until now a $3-billion-a-year drug. Shares of the company were today at their lowest level in two years, following the sixth drop in seven trading days. Prescriptions for Avandia have also plummeted, with its slice of new oral diabetes prescriptions dropping from 10% to almost zero in the two days following the NEJM report. As part of the company's response to the controversy, chief medical officer of GSK, Dr Ronald L Krall, has written a letter, published online in the Lancet today In support of the cardiovascular safety of rosiglitazone, he cites, among other things, the decision by the independent data safety monitoring board to continue the ongoing Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) study, which is specifically designed to look at cardiovascular outcomes with rosiglitazone. However Krall told the New York Times last week that the RECORD study could be under threat because some of the patients have dropped out of the trial due to safety concerns following last week's events Conspiracy theories An in-depth feature in a biotechnology weekly newsletter relates the tale of who knew what and when with regard to the rosiglitazone saga. US politicians have "portrayed Avandia as the quintessential. . . . Washington scandal, complete with maverick outsider who exposes wrongdoers and alerts congressional guardians of the public health," writes Steve Usdin in BioCentury But according to an editorial by former FDA deputy commissioner Scott Gottlieb, published May 29, 2007 in the Wall Street Journal, the truth is that the study authors, the NEJM, and politicians with their own motives tried to upstage the FDA in an attempt to influence public debate.According to Gottlieb, lead author Dr Steve Nissen (Cleveland Clinic, OH) submitted his manuscript to the NEJM on May 1 and did not inform either the FDA or GSK. The journal expedited the review of the paper and commissioned a commentary from two well-known critics of FDA's drug safety record, Drs Curt Furberg (University of Washington, Seattle) and Bruce Psaty (Wake Forest University, Winston-Salem, NC). The paper and commentary were published online by the NEJM on May 21, a move Gottlieb says was "timed to get ahead of the FDA's more careful evaluation of the same issues." The FDA had planned to issue a safety statement about Avandia around May 23, according to an unnamed drug safety official cited in the article by Usdin. Following publication of the NEJM paper, the FDA issued a statement on May 21 saying that its analyses were ongoing and that it would convene an advisory committee on the issues as soon as possible. Gottlieb says the NEJM claims to have made the decision to publish quickly because of the medical importance of the research but, if that were the case, he wonders why it did not inform the FDA about its publication or the findings. "When it comes to the issue du jour, drug safety, no description of medical research in a medical journal comes close to the detail level or scrutiny imposed by the FDA on study results before approval. Yet NEJM and other journals have tried on other occasions to upstage FDA investigations through well-timed but much less complete publications," he asserts. He adds that there was no mention in the NEJM paper or editorial of rosiglitazone's benefits or of how doctors should advise patients. Steven Galson (director of the FDA's Center for Drug Evaluation and Research) told Usdin: "Medical journals have to take their job seriously. They have a responsibility to patients and physicians to publish information in a responsible and balanced manner. I'm not sure that responsibility was adequately executed in this instance." But NEJM editor Dr Gregory Curfman told BioCentury that his journal is not responsible for the media reactions to the rosiglitazone paper and commentary: "We are a scholarly journal, not a news outlet. What happens in the media is beyond our control

quinta-feira, 31 de maio de 2007

Avandia: resposta da Glaxo Smith Kline

Estou em Belo Horizonte, em reunião do Estudo Longitudinal de Saúde do Adulto, com restrição de acesso. Leiam a resposta da Glaxo sobre o Avandia em carta ao The Lancet.

quarta-feira, 30 de maio de 2007

Mais um perigo nos ares: Tuberculose

Talvez a informação abaixo do The New York Times seja de utilidade para quem viajou nos vôos abaixo. Mas, não é a primeira vez que tais fatos são identificados. Há seis meses, o Hospital Universitário internou com meningite meningocócica paciente com dupla nacionalidade brasileira e italiana que morava na Itália com sintomas já no vôo para São Paulo. Ele permaneceu 12 horas infectado em um avião de carreira. As autoridades sanitárias italianas foram avisadas à época, mas não houve contágio descrito.
TB Patient Is Isolated After Taking Two Flights By LAWRENCE K. ALTMAN Published: May 30, 2007 Federal and international officials are tracking down passengers and crew members on two trans-Atlantic flights earlier this month who may have been exposed to a man infected with an exceptionally dangerous form of tuberculosis.The male passenger flew to Paris from his home in Atlanta on May 12 on Air France 385 and arrived in Paris on May 13. He returned to the United States on May 24 after taking Czech Air 104 to Montreal from Prague. The man drove into the United States that day and entered a hospital in New York City on May 25.The man is now in an Atlanta hospital under federally enforced isolation after he was flown there from New York City on Monday in a plane owned by the Centers for Disease Control and Prevention in Atlanta.Dr. Martin S. Cetron , an agency official, said he reached the man on his cellphone while he was in Italy to inform him that tests performed before he left for Europe showed that he had a form of tuberculosis that was extremely resistant to standard antibiotics. Dr. Cetron said that he advised the man not to take commercial flights home from Europe and that a United States Embassy would provide assistance, including examination by a tuberculosis expert.While the agency began to explore ways to bring the man home, he flew to Montreal and drove into the United States. Then, after agency officials made contact with him, he followed their instructions to drive safely into New York without risk to the public.The New York City health department said the man spent 72 hours in a hospital in isolation and did not interact with anyone other than trained medical workers.The disease control agency said that because it was the first airline contact investigation for extremely drug resistant tuberculosis, it was not sure that current recommendations were adequate to determine the possible range and risk of transmission on infection.Dr. Julie L. Gerberding, director of the C.D.C., said her agency was advising passengers on the commercial flights to be tested for tuberculosis even though they are believed to have a low risk of infection.That appraisal was based on tests showing that the number of tuberculosis bacteria in the man’s sputum were too low to be detected but still enough to infect others. Dr. Gerberding said her agency was erring on the side of caution because the form of tuberculosis, known as XDR TB, was often fatal and a growing public health threat in many countries.The advisory applies only to the crew members on the man’s flight and to his fellow passengers, particularly those who were seated next to him and in the two rows behind him and the two rows in front of him.“We’re not concerned about a generic threat to travelers,” Dr. Gerberding said.Drug-susceptible, or regular, TB and XDR TB are thought to be spread the same way. The TB bacteria become aerosols when a person coughs, sneezes, speaks or sings. The bacteria can float in the air for several hours, depending on the environment. People who breathe air containing these bacteria can become infected.The risk of acquiring any type of TB appears to depend on several factors, such as the extent of disease in the person who is the source of the bacteria, the duration of exposure and ventilation.People who become infected have usually been exposed for several hours or days in poorly ventilated or crowded environments. An important way to prevent the spread and transmission is by limiting an infectious person’s contact with other people. People who have a confirmed diagnosis of TB or XDR TB are placed on treatment and kept isolated until they are no longer infectious. Contact passengers will be advised to undergo a medical evaluation and testing and then have follow-up tests 8 to 10 weeks later.Dr. Gerberding said doctors had not determined the source of the man’s infection. Molecular fingerprints used to distinguish among bacterial strains so far do not match that of any other known case, she said. People who think they may have been exposed to TB or XDR TB can call (800) CDC-INFO for more information.

Mudando de Avandia para Actos

The Wall Street Journal (assinante clique aqui) que médicos americanos evitam Avandia e, ao mesmo tempo prescrevem mais Actos (pioglitazone). Há uma grande chance que a maioria dos pacientes, ao invés da prescrição de um desses dois medicamentos se beneficiaria mais de outras condutas com redução radical de peso, aumento da atividade física, redução dos níveis de pressão arterial e de colesterol. Por isso, talvez não seja mudança adequada, somente conveniente a quem prescreve. Abaixo parte do texto.
U.S. Doctors Shun Glaxo MedicineIn Wake of Study LONDON -- Doctors in the U.S. have shunned GlaxoSmithKline PLC's diabetes drug Avandia since a study was published last week linking the drug to greater heart-attack risk, according to early prescription data. Market-intelligence group Impact RX said Avandia's share of the market for newly prescribed oral antidiabetics fell to around zero from around 10% in the two days after the article was published in the New England Journal of Medicine on May 21. At the same time, the rate of patients switching from one drug to another was three times the usual level. Takeda Pharmaceutical Co.'s rival drug, Actos, saw its share of the new-prescription market increased to 22% from 10%. The U.K. company played down the data, saying, "Two days of data is not enough to reach sensible conclusions on the trend for Avandia new prescriptions."

terça-feira, 29 de maio de 2007

Avandia: FDA strikes back The New England

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

Avandia: rumo ao precipício?

Do sempre bem informado blogueiro do WSJ.
Avandia Dips: Pothole or Cliff? Posted by Jacob Goldstein New prescriptions of GlaxoSmithKline’s Avandia dipped sharply last week after the New England Journal of Medicine published a study suggesting the diabetes drug raised the risk of heart attacks, according to pharma research shop ImpactRx. In a note to investors this morning, Deutsche Bank cited ImpactRx data showing that Avandia’s market share of newly prescribed diabetes pills fell from about 10% before the NEJM paper to roughly zero in the two days after the paper was published. The situation “is far worse than we had anticipated and suggests that there could be as much as 22% downside risk to GSK’s near term earnings,” the note said. But the data don’t support such a far-reaching prediction, ImpactRx CEO Richard Altus argued in an interview with the Health Blog. “It’s premature to draw any conclusions from our data with respect to the future script writing of Avandia,” he said, adding that he was “shocked” at Deutsche Bank’s interpretation of his company’s figures. GlaxoSmithKline and Deutsche Bank have both been clients of ImpactRx, but Altus said he was not acting at GSK’s request. The Health Blog couldn’t reach the London-based authors of the note Tuesday afternoon for comment.

China: condenado a morte por corrupção

O blogueiro do WSJ destacou a condenação a morte do ex-diretor do equivalente à ANVISA chinesa. Denuncio aqui a sentença de morte e gostaria de conhecer o nome das oito companhias que participaram da "mutreta".
Death Sentence for China’s Former Top Drug Regulator Posted by Jacob Goldstein Zheng Xiaoyu, the first chief of China’s State Food and Drug Administration, was sentenced to death today for taking $850,000 in bribes from eight unnamed drug companies, reports.The sentence comes as China struggles with a series of domestic and international incidents arising from food and medicines — ranging from pet chow to toothpaste to antibiotics. Zheng (pictured, left) ran China’s FDA from its founding in 1998 until 2005, the New York Times reports He was detained in February along with two other top regulators. Officials are now reviewing over 170,000 licenses issued by the agency over the past decade, according to the Times. The death sentence, handed down by Beijing Municipal No. 1 Intermediate People’s Court, said that Zheng’s acts “endangered public life and health and had a very negative social impact,” according to China’s Xinhua news service

Trasylol: risco mantido de insuficiência renal

O caso “Trasylol” (aprotinina) já foi aqui discutido duas vezes. Trata-se de medicamento utilizado em cirurgia cardíaca com riscos maiores do que os descritos pela empresa inicialmente. Ela foi também acusada pelo FDA de não incluir 65 mil participante no estudo de segurança. Hoje, Circulation (clique aqui para ler o resumo) publica metanálise com resultados um pouco diferentes, à favor da segurança da aprotinina, mas revelando que doses altas se associam a risco de insuficiência renal. No entanto, o custo do medicamento não justifica seu uso comparado aos demais concorrentes

Um pouco de feijão com arroz e menos Avandia.

A Fundação Getúlio Vargas divulgou ontem (Valor Econômico) que o consumo de arroz com feijão foi de 085% do orçamento familiar, mas que o gasto com cigarros representou 1,25%. A questão do tabagismo além do dano à saúde para os mais pobres é um problema econômico sério. Agora que a Big Pharma também está com bons produtos na área, é o caso de avançarmos ainda mais nas políticas corporativas e locais de controle do tabagismo. Para os adeptos da "falência da saúde pública", lembrem o que era uma viagem aérea há dez anos.
Recomendo o programa do Hospital Universitário da USP com exemplo de atividade de qualidade nessa área.

Desfecho: a palavra-chave no caso Avandia e outros.

Hoje, o The New York Times (texto completo para registrados) aborda a questão "Avandia" verificando os critérios utilizados para concluir se um medicamento é útil ou não. Essa é uma das aulas básicas nos curso de epidemiologia:"ensaio clínico". Há tratamentos que nunca foram e nunca foram testados, como por exemplo o uso de penicilina para tratar pneumonia, porque a sua eficácia e efetividade foram tão evidentes que dispensou qualquer ensaio comparativo do antibiótico com um placebo. No entanto, quando entramos nas era das doenças crônicas com duração prolongada, a capacidade de observar se houve melhora ou não somente pela observação médica se reduziu. Surgiram então os ensaios clínicos que testam um medicamento versus placebo ou um medicamento contra outro com critérios rigorosos independente do médico. E, nesse caso há um desfecho (outcome) a ser alcançado. Aí, na definição do desfecho que surgem os problemas. Como foi abordado por Nissen no artigo mais discutido, mas não tão lido - da última semana: é um erro aprovar medicamento para diabetes somente com o desfecho "redução da glicemia". Afinal, o objetivo principal é reduzir a carga de doença cardiovascular no diabético e, não a diminuição "cosmética" da glicemia. Um exemplo com mais de 30 anos: um medicamento foi lançado por reduzia o colesterol, diminuia o número de infartos do miocárdio e , da mesma forma a mortalidade cardiovascular.Ótimo, não? Não, porque aumentou a mortalidade por outras causas, por isso não vingou. Ou seja não adianta verificar se o medicamento afetou parte do mecanismo fisiopatológico, mas sim se houve um ganho efetivo para quem dele se utiliza. Abaixo, parte do texto do NYT com outros exemplos e também o custo da extensão dos ensaios clínicos dos surrogate outcomes para os hard outcomes.
By DENISE GRADY Published: May 29, 2007 People with diabetes have too much sugar in their blood, so a drug that lowers blood sugar ought to be a good treatment, right? Maybe not. Consider the diabetes drug Avandia, or rosiglitazone, which was approved in 1999. It lowers blood sugar, and about a million people in the United States have been taking it for Type 2 diabetes, the most common form of the disease. But last week, doctors reported that Avandia might increase the risk of heart attacks. ...... Avandia was approved because it lowered blood sugar, and seemed safe in clinical trials. But the real test of whether a drug is any good is, How are the patients? Not their blood tests or X-rays or EKGs, but the people themselves, and not after just six months, but after years, especially if they have a chronic disease and will be taking medicine for the rest of their lives. Are those taking the drug more or less likely than people not taking it to have heart attacks, die or develop heart disease or other illnesses? The problem is, it can take a long time and a lot of patients — and, therefore, a lot of money — to get a real picture of health and survival. That is especially true for something like heart disease, which develops slowly and is so common that it may be hard to detect a small increase in risk. Studies might have to go on for years instead of months, and include far more than the few thousand patients in whom drugs are typically tested before they get approved. So instead of waiting to see if people die or have heart attacks, drug companies have looked for other traits that seem to correlate with health and survival and that could stand in as a yardstick — objective measures like blood pressure, cholesterol levels, blood sugar or tests of heart function. Researchers call these measurements “surrogate endpoints,” and the F.D.A. has encouraged companies to find surrogates that could reliably predict how patients would fare. These kinds of tests are seen as a way to streamline the drug approval process. But reliable surrogates are hard to find. There are plenty of endpoints that in theory should do the job, but do not. Tumor size, for instance: there are drugs that can shrink tumors without prolonging a patient’s life. Bone density is another example. Fluoride can increase it in people whose skeletons have thinned from osteoporosis, so fluoride should prevent fractures. But it doesn’t. In fact, it makes fractures more likely, because it turns bones brittle. Heart rhythm can also be deceptive. Certain medicines can stabilize dangerous, abnormal heartbeats in people who have had heart attacks — and yet have been found to increase their odds of dying. Cholesterol levels do not always tell the whole story, either. Hormone treatment in women after menopause can raise HDL, the so-called good cholesterol, and so was expected to prevent heart disease — but does not. Similarly, researchers had high hopes for an experimental drug that raises HDL, but instead of preventing heart attacks the drug wound up increasing the risk. Part of the problem is that surrogate endpoints do not always reflect what’s happening to the whole patient. The disease being treated may be too complicated to gauge with just one tool, and the drug in question may have many more effects than the one being measured. ......

segunda-feira, 28 de maio de 2007

Avandia: editorial do NYT (25/05/07)

Começando a semana, com o tema da semana passada: Avandia. Abaixo, reproduzo o editorial do The New York Times da última sexta-feira que passou despercebido.. Ele faz a síntese desse episódio. A Glaxo e o FDA estão com a palavra para responder aos fatos do artigo publicado no The New England Journal of Medicine e das declarações confusas da empresa e da própria agência.. Vamos ver o que ocorrerá na semana que entra. Infelizmente não poderei acompanhar porque estarei fora para reunião do Estudo Longitudinal de Saúde do Adulto que ocorrerá em Belo Horizonte, quinta e sexta-feiras e, preparando participação em evento no exterior na próxima semana. Mas, novamente citando o beisebolista americano Yogi Berra (um Vicente Matheus local) It's like déjà vu all over again. Editorial Ignoring the Warnings, Again? The latest findings on Avandia, a top-selling diabetes drug, raise concerns both about its safety and about the way the manufacturer and the Food and Drug Administration have responded to signs of danger. It would be rash to make definitive judgments until the F.D.A. completes a detailed analysis. But the handling of this case bears disturbing resemblances to the Vioxx debacle, in which early warning signs were ignored by its manufacturer until the evidence of serious harm became inescapable and the drug was pulled from the market. Avandia was approved for sale in 1999 based on studies showing that it could lower blood glucose levels in patients suffering from Type 2 diabetes, also known as adult-onset diabetes. The assumption was that the drug could alleviate some of the most damaging effects of the disease, such as heart attacks and other cardiovascular ailments. But a paper just published in The New England Journal of Medicine suggests that Avandia may instead increase the risk of a heart attack by 43 percent and perhaps the risk of cardiovascular deaths as well. The study — an analysis of the combined results of 42 previous studies that compared people who took the drug with people who did not — is not definitive, and the absolute risk to any given patient is small. But the study points to a risk that could potentially harm thousands of patients a year. Its lead author was Steven Nissen, a cardiologist at the Cleveland Clinic, who blew the whistle on the cardiovascular risks of Vioxx, which adds to the sense of déjà vu.What’s most troubling is the possibility that early warning signs were not adequately heeded.Seven years ago a leading diabetes doctor warned the F.D.A. of “a worrisome trend in cardiovascular deaths,” two years later a safety monitoring group within the agency expressed concern over cases of heart failure in patients taking the drug. In late 2005 and again in August 2006 the drug’s manufacturer — GlaxoSmithKline — informed the F.D.A. that its own combined analysis of various studies showed a 31 percent increase in adverse cardiovascular events. But the company also cited studies that it said showed no evidence of harm, and the F.D.A. concluded the findings were too mixed to take immediate regulatory action.Now, prodded by Dr. Nissen’s article, the agency has issued a safety alert, is completing its own safety analysis and will convene a panel of experts to review the data. The best hope for a definitive answer may lie in a clinical trial that won’t finish monitoring all enrolled patients until late next year. If the verdict goes against Avandia, the F.D.A. and Glaxo will have a lot to explain. Congress will need to probe hard to determine what risks the agency and the manufacturer were aware of and what they did — or didn’t do — to mitigate them.

domingo, 27 de maio de 2007

A atualidade de Yogi Berra

" When you come to a fork in the road....Take it "
expressão de Yogi Berra, filósofo popular americano de décadas atrás, mas com atualidade cruel nos dias de hoje. Mais, visite o site

Avandia: a prova da revolução da Internet

Não poderia deixar o domingo sem falar do caso "Avandia". Esperei para as revistas semanais para ler os comentários dos especialistas. Nada que fugisse do bom senso. Bom, o ZecaPagodinho quesito diabetes, está sem vencedor por falta de candidatos aptos. Mas, nos EUA, "the Irish eyes of envy", não pouparam Steven Nissen, o autor do artigo. Os comentários nos blogues por pesquisadores e médicos americanos mostram o quanto Shakespeare é eterno...... Mas, gostaria de discutir a internet.
Não há como negar como a internet - criada pelo "imperialismo ianque" ou "neoliberalismo" , mas proibida no "socialismo real" - é uma revolução. Imaginem, o tema tratado da forma tradicional.
O "New England" publicaria o texto na forma impressa. Haveria repercussão na imprensa americana e, a maioria do mundo receberia somente os despachos da Reuters e AP. Enquanto isso, a empresa colocaria toda a "força de venda" para desqualificar o autor, o método e a qualidade do artigo, o qual ninguém ainda tinha tido acesso ao texto integral. Isso ocorreu no passado com o Adalat e de certa forma com o Vioxx. Agora, a coisa foi diferente: o New England publicou no site, permitiu que o mundo todo lesse e concluísse. Enquanto isso, a versões da da empresa, FDA, EMEAS, sociedades de especialistas circularam igualmente. E, permitiram que os blogueiros pudessem opinar à vontade, questionando os dados e, principalmente o comportamento dos poderosos. Não coincidentemente esse blogue bateu o recorde de acesso.
Dedico esse post ao professor Eduardo Chaves da UNICAMP que há mais de dez anos afirmava que a internet significaria tanto para a humanidade quanto representou a criação da imprensa. Exemplificava ele (se a memória não me trai): "não haveria Lutero, sem Gutemberg. Sem a possibilidade de imprimir a Bíblia,não seria possível a Reforma Protestante e, consequentemente tudo aquilo que ela influenciou". Algúem, consegue imaginar as revoluções americana, francesa e russa sem a palavra escrita?

"Unimed Paulistana vira caso de polícia": uma pena

O Estadão divulga com essa manchete problemas na Unimed Paulistana. É uma pena, mas trata-se de problemas que os cooperativados precisam resolver comparecendo às assembléias deliberativas e exigindo balancetes periódicos compreensíveis. Nunca fui cooperativado, mas considero o sistema Unimed (a Unimed Paulistana é independente das demais) ser um dos grandes pilares da asssistência médica no Brasil, principalmente no interior de São Paulo e, cidades como Vitória, ES (27% da população). Espero que os problemas da Unimed da capital sejam solucionados pelos seus cooperativados. A atuação da UNIMED é fundamental para parcela considerável da cidade de São Paulo onde há mais de um milhão de asssociados

A importância econômica do setor saúde.

O Ministro da Saúde ocupa a página 3 da Folha de S.Paulo para descrever vários aspectos do setor saúde. Ele parte para o ataque contra a visão estúpida das equipes econômicas - desse governo e passados e, de todas as esferas de governo - que somente lamentam os gastos do setor saúde, embora seus membros adorem uma mordomia nos hospitais públicos para si, familiares e amigos. Destaca o desaparelhamento da indústria, já citado nesse blogue como sendo o grande problema da atualidade no setor saúde. Acrescentaria a esse texto, a não desprezível atividade econômica do "turismo da saúde" com a ocupação de hotéis, por familiares, por exemplo que se dirigem a centros de excelência. Abaixo, parte do texto de José Gomes Temporão e Carlos Grabois Gadelha.
O entendimento dessas atividades como ônus ao orçamento público é cego. O segmento contribui para cidadania, investimentos, inovações, renda, emprego e receitas ao Estado. A cadeia produtiva representa entre 7% e 8% do PIB (R$ 160 bilhões). Emprega, com trabalho formal, 10% da população e é a área em que os investimentos públicos com pesquisa e desenvolvimento são os mais expressivos no país. O mercado farmacêutico brasileiro movimenta R$ 22 bilhões, equipamentos médico-hospitalares, R$ 6 bilhões, e vacinas, reagentes e hemoderivados, R$ 3 bilhões. São indústrias que geram 300 mil empregos diretos. Na prestação de serviços, 77 mil estabelecimentos de saúde empregam 1,6 milhão de pessoas (mais da metade com nível superior e alta qualificação). Por ano, o SUS realiza 2,8 mil transplantes renais, 215 mil cirurgias cardíacas e 9 milhões de procedimentos de rádio e quimioterapia, refletindo capacitação do sistema que se destaca entre países com grau semelhante de desenvolvimento. Há, porém, enorme fragilidade econômica e tecnológica. As indústrias perderam competitividade internacional ao longo da década de 90. O déficit acumulado cresceu de US$ 700 milhões ao ano, no final dos anos 80, para US$ 4 bilhões, sendo 60% concentrados na área farmacêutica. Um país desenvolvido requer base produtiva forte para atender a inclusão social e atenuar as desigualdades. O Brasil apresenta grande possibilidade de superação dessa vulnerabilidade. Nossa base produtiva, ciência, recursos humanos qualificados e sistema de saúde universal conferem ao Estado elevado poder de compra de bens industriais, com financiamento de longo prazo pelo BNDES. Fatores singulares na realidade latino-americana. Significa que a saúde é frente de expansão e janela de oportunidades ao padrão de desenvolvimento humanizado, equânime e solidário. (restante da matéria para assinantes da Folha)

A tecnologia insuperável: a observação humana.

A Folha de S.Paulo publicou uma matéria excelente de Marcelo Coelho questionando a propalada biodiversidade amazônica e, a importância estratégica para a indústria farmacêutica. O Centro Biotecnológica da Amazônia é um fracasso. Ponto final. Os novos medicamentos virão muito mais da beira do leito, dos consultórios e pronto-socorros associados aos laboratórios de pesquisadores básicos localizados em grandes centros urbanos. A base para as novas descobertas será a tecnologia mais desenvolvida até o momento: a observação humana. Como dizia, um filósofo popular americano - equivalente ao nosso Vicente Matheus - o jogador de beisebol Yogi Berra: "you can see a lot of things watching".
Uma consulta à página na internet do Centro de Biotecnologia da Amazônia, em Manaus, revela que os 12 mil metros quadrados da instalação contêm espaço para 25 laboratórios, mas abrigam só nove doutores e, ao todo, menos de cem funcionários. Se a Amazônia fosse de fato o Celeiro de Genes do mundo, o Pulmão Molecular do planeta, seu Eldorado Tecnobiológico, como explicar que permaneça vazio o elefante branco no Distrito Industrial da Zona Franca de Manaus?Há muitas explicações, decerto, a começar pela carência de recursos humanos qualificados na região. No passado, em 2000, também fracassou um acordo entre a iniciativa BioAmazônia e a empresa Novartis, firmado à revelia do governo federal e por ele anulado. Havia sido moldado em acordo similar firmado uma década antes, e dado como paradigma da bioprospecção, entre a empresa Merck e o INBio, do governo da Costa Rica, pela quantia de 2,8 milhões de dólares, do qual hoje ninguém mais fala.Do acordo brasileiro se pode dizer que naufragou por impróprio e por força da saudável reação social aos seus termos e condições. Mas o que dizer dos parcos resultados colhidos pelo INBio e, provavelmente, do futuro acanhado do CBA?Com certeza, que a bioprospecção não tem rendido nem uma fração do que prometia em 1992. Naquele ano se negociou no Rio de Janeiro a versão final da Convenção-Quadro das Nações Unidas sobre Diversidade Biológica, consagrando o generoso princípio da repartição de benefícios pelo uso de saberes tradicionais. O objetivo, aqui, é precisamente este: questionar a idéia feita de que a Amazônia represente uma espécie de Paraíso Genético, imagem fadada a se desfazer, assim como se desfizeram as do Pulmão Verde do mundo e do Celeiro de Alimentos. (assinante da Folha clique aqui).