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.”

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.

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.

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.

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.

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."

Excesso de chumbo aumenta violência.

Não se trata de brincadeira de mal gosto, mas sim a repercussão de estudo publicado nesse domingo no The Washington Post. O estudo tenta induzir que a violência urbana é determinada em grande parte pela intoxicação por chumbo. A maior fonte de chumbo vem da gasolina em todos os países e, naqueles com casas de madeira da tinta utilizada nas paredes, mas que foi proibida há mais de uma década.

Para epidemiologistas essa associação insere-se em mais um de viés de confusão porque há outros fatores que dirigem tanto a redução do chumbo na gasolina como as causas da violência. Mas, trata-se de uma hipótese que se não for verdadeira, ao menos estimula a redução da poluição ambiental.

Research Links Lead Exposure, Criminal Activity Data May Undermine Giuliani's Claims By Shankar Vedantam Washington Post Staff Writer Sunday, July 8, 2007; Page A02 Rudy Giuliani never misses an opportunity to remind people about his track record in fighting crime as mayor of New York City from 1994 to 2001. "I began with the city that was the crime capital of America," Giuliani, now a candidate for president, recently told Fox's Chris Wallace. "When I left, it was the safest large city in America. I reduced homicides by 67 percent. I reduced overall crime by 57 percent." Although crime did fall dramatically in New York during Giuliani's tenure, a broad range of scientific research has emerged in recent years to show that the mayor deserves only a fraction of the credit that he claims. The most compelling information has come from an economist in Fairfax who has argued in a series of little-noticed papers that the "New York miracle" was caused by local and federal efforts decades earlier to reduce lead poisoning. The theory offered by the economist, Rick Nevin, is that lead poisoning accounts for much of the variation in violent crime in the United States. It offers a unifying new neurochemical theory for fluctuations in the crime rate, and it is based on studies linking children's exposure to lead with violent behavior later in their lives. What makes Nevin's work persuasive is that he has shown an identical, decades-long association between lead poisoning and crime rates in nine countries. "It is stunning how strong the association is," Nevin said in an interview. "Sixty-five to ninety percent or more of the substantial variation in violent crime in all these countries was explained by lead." Through much of the 20th century, lead in U.S. paint and gasoline fumes poisoned toddlers as they put contaminated hands in their mouths. The consequences on crime, Nevin found, occurred when poisoning victims became adolescents. Nevin does not say that lead is the only factor behind crime, but he says it is the biggest factor. Giuliani's presidential campaign declined to address Nevin's contention that the mayor merely was at the right place at the right time. But William Bratton, who served as Giuliani's police commissioner and who initiated many of the policing techniques credited with reducing the crime rate, dismissed Nevin's theory as absurd. Bratton and Giuliani instituted harsh measures against quality-of-life offenses, based on the "broken windows" theory of addressing minor offenses to head off more serious crimes. Many other theories have emerged to try to explain the crime decline. In the 2005 book "Freakonomics," Steven D. Levitt and Stephen J. Dubner said the legalization of abortion in 1973 had eliminated "unwanted babies" who would have become violent criminals. Other experts credited lengthy prison terms for violent offenders, or demographic changes, socioeconomic factors, and the fall of drug epidemics. New theories have emerged as crime rates have inched up in recent years. Most of the theories have been long on intuition and short on evidence. Nevin says his data not only explain the decline in crime in the 1990s, but the rise in crime in the 1980s and other fluctuations going back a century. His data from multiple countries, which have different abortion rates, police strategies, demographics and economic conditions, indicate that lead is the only explanation that can account for international trends. Because the countries phased out lead at different points, they provide a rigorous test: In each instance, the violent crime rate tracks lead poisoning levels two decades earlier. "It is startling how much mileage has been given to the theory that abortion in the early 1970s was responsible for the decline in crime" in the 1990s, Nevin said. "But they legalized abortion in Britain, and the violent crime in Britain soared in the 1990s. The difference is our gasoline lead levels peaked in the early '70s and started falling in the late '70s, and fell very sharply through the early 1980s and was virtually eliminated by 1986 or '87. In Britain and most of Europe, they did not have meaningful constraints [on leaded gasoline] until the mid-1980s and even early 1990s," he said. "This is the reason you are seeing the crime rate soar in Mexico and Latin America, but [it] has fallen in the United States." Lead levels plummeted in New York in the early 1970s, driven by federal policies to eliminate lead from gasoline and local policies to reduce lead emissions from municipal incinerators. Between 1970 and 1974, the number of New York children heavily poisoned by lead fell by more than 80 percent, according to data from the New York City Department of Health. Lead levels in New York have continued to fall. One analysis in the late 1990s found that children in New York had lower lead exposure than children in many other big U.S. cities, possibly because of a 1960 policy to replace old windows. That policy, meant to reduce deaths from falls, had an unforeseen benefit -- old windows are a source of lead poisoning, said Dave Jacobs of the National Center for Healthy Housing, an advocacy group that is publicizing Nevin's work. Nevin's research was not funded by the group. The later drop in violent crime was dramatic. In 1990, 31 New Yorkers out of every 100,000 were murdered. In 2004, the rate was 7 per 100,000 -- lower than in most big cities. The lead theory also may explain why crime fell broadly across the United States in the 1990s, not just in New York. The centerpiece of Nevin's research is an analysis of crime rates and lead poisoning levels across a century. The United States has had two spikes of lead poisoning: one at the turn of the 20th century, linked to lead in household paint, and one after World War II, when the use of leaded gasoline increased sharply. Both times, the violent crime rate went up and down in concert, with the violent crime peaks coming two decades after the lead poisoning peaks. Other evidence has accumulated in recent years that lead is a neurotoxin that causes impulsivity and aggression, but these studies have also drawn little attention. In 2001, sociologist Paul B. Stretesky and criminologist Michael Lynch showed that U.S. counties with high lead levels had four times the murder rate of counties with low lead levels, after controlling for multiple environmental and socioeconomic factors. In 2002, Herbert Needleman, a psychiatrist at the University of Pittsburgh, compared lead levels of 194 adolescents arrested in Pittsburgh with lead levels of 146 high school adolescents: The arrested youths had lead levels that were four times higher. "Impulsivity means you ignore the consequences of what you do," said Needleman, one of the country's foremost experts on lead poisoning, explaining why Nevin's theory is plausible. Lead decreases the ability to tell yourself, "If I do this, I will go to jail." Nevin's work has been published mainly in the peer-reviewed journal Environmental Research. Within the field of neurotoxicology, Nevin's findings are unsurprising, said Ellen Silbergeld, professor of environmental health sciences at Johns Hopkins University and the editor of Environmental Research. "There is a strong literature on lead and sociopathic behavior among adolescents and young adults with a previous history of lead exposure," she said.