Aids não se associa com guerras civis na África.

Mesmo cientistas e pesquisadores não gostam de ser contrariados nas suas crenças adquiridas e disseminadas por eles mesmo sem qualquer base empírica. Abaixo, um exemplo que é contra-intuivo: Paulo B Spiegel e colegas avaliaram todos os artigos sobre incidência de aids e prevalência de soropositivos para o HIV em populações que passaram por guerras civis na África e, não encontraram associação direta. O texto citado publicado no The Lancet é de acesso gratuito para quem se cadastrar no site. Abaixo, o resumo

Prevalence of HIV infection in conflict-affected and displaced people in seven sub-Saharan African countries: a systematic review. Dr Paul B Spiegel e colaboradores.
Background Violence and rape are believed to fuel the HIV epidemic in countries affected by conflict. We compared HIV prevalence in populations directly affected by conflict with that in those not directly affected and in refugees versus the nearest surrounding host communities in sub-Saharan African countries. Methods Seven countries affected by conflict (Democratic Republic of Congo, southern Sudan, Rwanda, Uganda, Sierra Leone, Somalia, and Burundi) were chosen since HIV prevalence surveys within the past 5 years had been done and data, including original antenatal-care sentinel surveillance data, were available. We did a systematic and comprehensive literature search using Medline and Embase. Only articles and reports that contained original data for prevalence of HIV infection were included. All survey reports were independently evaluated by two epidemiologists to assess internationally accepted guidelines for HIV sentinel surveillance and population-based surveys. Whenever possible, data from the nearest antenatal care and host country sentinel site of the neighbouring countries were presented. 95% CIs were provided when available. Findings Of the 295 articles that met our search criteria, 88 had original prevalence data and 65 had data from the seven selected countries. Data from these countries did not show an increase in prevalence of HIV infection during periods of conflict, irrespective of prevalence when conflict began. Prevalence in urban areas affected by conflict decreased in Burundi, Rwanda, and Uganda at similar rates to urban areas unaffected by conflict in their respective countries. Prevalence in conflict-affected rural areas remained low and fairly stable in these countries. Of the 12 sets of refugee camps, nine had a lower prevalence of HIV infection, two a similar prevalence, and one a higher prevalence than their respective host communities. Despite wide-scale rape in many countries, there are no data to show that rape increased prevalence of HIV infection at the population level. Interpretation We have shown that there is a need for mechanisms to provide time-sensitive information on the effect of conflict on incidence of HIV infection, since we found insufficient data to support the assertions that conflict, forced displacement, and wide-scale rape increase prevalence or that refugees spread HIV infection in host communities

Brasileiras obesas nos Estados Unidos.

O jornal eletrônico Pesquisa Fapesp traz artigo do professor Antônio Bianco sobre o impacto da obesidade sobre as brasileiras que vivem nos Estados Unidos, na região de Boston, Estados Unidos. Não há novidade: brasileiras estão mais gordas e as mulheres de Boston muito mais obesas do que a média das brasileiras. O que há de novo é também muito antigo no Brasil, mas relativamente desconhecido nos Estados Unidos e, introduzido lá por nossos compatriotas: o uso de hormônio tireoideano e outros medicamentos para reduzir o peso corpóreo. A globalização traz novos desafios, um deles, a assistência médica e farmacêutica, ainda regulada dentro dos limites dos Estados-nação. Abaixo, trecho do artigo de Bianco.

Tireóide, Brasil e obesidade. Qualquer uma dessas palavras chama a minha atenção, mas as três juntas, na mesma sentença, me fizeram parar o que estava fazendo e prestar atenção. No meu laboratório, por um motivo ou outro, um rádio está sempre ligado, invariavelmente na National Public Radio (NPR), uma estação sem fins lucrativos que fornece notícias e talk shows sem comerciais para cerca de 26 milhões de pessoas, por semana. Ao escutar a seqüência de palavras-chave, interrompi a conversa com o colega John Harney e sintonizei mentalmente na matéria que estava sendo noticiada por Alan Coukell, um repórter de ciência e saúde da NPR. Coukell estava contando que muitos residentes de Massachusetts estão usando pílulas brasileiras para emagrecer, para perder os quilinhos a mais que ganharam durante o inverno. Essas pílulas, manipuladas no Brasil, são desconhecidas das autoridades locais, portanto ilegais, e potencialmente fatais

A volta de Hong Kong à China e, mais uma vez a droga....

Dez anos após a volta de Hong Kong à China, uma notícia da Reuters reproduzida abaixo mostra o consumo de drogas no sul da China aumenta e, pelo preço mais baixo do que o cobrado na ex-colônia inglesa. A droga - no caso o ópio - faz parte da história da China e Inglaterra (clique aqui) e, parece que permanecerá ainda por um bom tempo.

Hong Kong drug addicts head to China to pop pills
Fri Jun 29, 2007 9:35am ET By Tan Ee Lyn
HONG KONG (Reuters) - The ease of travel to the China mainland since Hong Kong's handover in 1997 has drawn the city's young people to a cheap and convenient playground just across the border in Shenzhen city. Every weekend, young people pour into Shenzhen in China's southern Guangdong province to devour cheap food, entertainment -- and illicit party drugs. Street drugs of all types -- cocaine, ecstasy, heroin, ketamine and methamphetamine -- are more easily available and cheaper in discotheques in southern China than in Hong Kong. "At first I didn't like Shenzhen because it seemed foreign and dangerous, but after a while it was very nice, a new place with new faces and we didn't get raided there," said Siu Bak, a former addict of nine years who kicked the habit in 2005. "It's far easier to get drugs in China. Any staff can get it for you. The security guards will just turn a blind eye or they will tell you to take them in the toilet," said Siu Bak, 24. Ketamine is one of the most popular party drugs now in Hong Kong and it is proving to be a disastrous health hazard. In a report published last week, a group of Hong Kong doctors detailed cases of bladder and kidney dysfunction in 10 ketamine addicts. Their mean age was 25, with the youngest only 18.

Google se organiza na área da saúde.

O texto abaixo foi liberado pela empresa Google informando que estabeleceu um conselho consultivo para assuntos referentes a saúde, devido a procura de informações sobre o tema cada vez mais frequente.

6/27/2007 09:50:00 AM Posted by Missy Krasner, Product Marketing ManagerEvery day, people use Google to learn more about an illness, drug, or treatment, or simply to research a condition or diagnosis. We want to help users make more empowered and informed healthcare decisions, and have been steadily developing our ability to make our search results more medically relevant and more helpful to users. Although we have some talented people here with extensive backgrounds in health policy and technology, this is an especially complex area. We often seek expertise from outside the company, and health is no exception. We have formed an advisory council, made up of healthcare experts from provider organizations, consumer and disease-based groups, physician organizations, research institutions, policy foundations, and other fields. The mission of the Google Health Advisory Council is broadly to help us better understand the problems consumers and providers face every day and offer feedback on product ideas and development. It's a great privilege for us to work with this esteemed group

Psiquiatras premiados pelo excesso de diagnóstico e prescrição.

Uma revelação assustadora publicada no The New York Times (27/06/07): psiquiatras americanos são os especialistas que mais ganham presentes da indústria farmacêutica, em parte pela prescrição de medicamentos para crianças. Esses dados são do Estado de Vermont, um dos que exigem a declaração de ganhos por parte dos médicos. Quando morava nos Estados Unidos no final dos anos 90 fiquei estarrecido com o excesso de diagnóstico de hiperatividade em crianças. Não via qualquer motivo para esse diagnóstico, mas tome-lhe Ritalin (metilfenidato).

Psychiatrists Top List in Drug Maker Gifts
By GARDINER HARRIS
Published: June 27, 2007
WASHINGTON, June 26 — As states begin to require that drug companies disclose their payments to doctors for lectures and other services, a pattern has emerged: psychiatrists earn more money from drug makers than doctors in any other specialty. How this money may be influencing psychiatrists and other doctors has become one of the most contentious issues in health care. For instance, the more psychiatrists have earned from drug makers, the more they have prescribed a new class of powerful medicines known as atypical antipsychotics to children, for whom the drugs are especially risky and mostly unapproved. Vermont officials disclosed Tuesday that drug company payments to psychiatrists in the state more than doubled last year, to an average of $45,692 each from $20,835 in 2005. Antipsychotic medicines are among the largest expenses for the state’s Medicaid program. Over all last year, drug makers spent $2.25 million on marketing payments, fees and travel expenses to Vermont doctors, hospitals and universities, a 2.3 percent increase over the prior year, the state said. The number most likely represents a small fraction of drug makers’ total marketing expenditures to doctors since it does not include the costs of free drug samples or the salaries of sales representatives and their staff members. According to their income statements, drug makers generally spend twice as much to market drugs as they do to research them. “For the fourth year in a row, our analysis shows that there is a great deal of money being spent in our small state on marketing pharmaceutical products,” said William H. Sorrell, the Vermont attorney general. Endocrinologists received the second largest amount, according to the Vermont analysis, earning an average of $33,730. Since the state identified the specialties of only the top 100 earners, these averages represent the money earned by only some of the state’s specialists. There were 11 psychiatrists and 5 endocrinologists in that top group of 100. Still, a similar pattern was evident in a Minnesota database that was the subject of a series of articles in The New York Times this year. As in Vermont, psychiatrists earned on aggregate the most in Minnesota, with payments ranging from $51 to $689,000. The Times found that psychiatrists who took the most money from makers of antipsychotic drugs tended to prescribe the drugs to children the most often. These and other stories have helped to fuel a growing interest among state and federal officials to document and restrict payments to doctors from drug makers. At a gathering last month at Columbia Law School in New York, state attorneys general from across the country discussed ways to get similar data for their states. And today, the Senate Special Committee on Aging, which is led by Senator Herb Kohl, Democrat of Wisconsin, will hold the first of a series of hearings on the issue, which could lead to legislative proposals to restrict and require disclosure of payments and gifts to doctors from drug companies nationwide.
Several lawmakers on Capitol Hill have expressed interest in such legislation, including Senator Charles E. Grassley, Republican of Iowa. “A federal law requiring public disclosure of payments to doctors could be very effective if it was carefully monitored and consistently applied,” Mr. Grassley said.
Efforts to require disclosure of payments to doctors began almost by happenstance in 1993, when The Minnesota Legislature passed a law that restricts drug companies from giving doctors gifts valued at more than $100 in any given year. The legislation also required companies to report and make public any consulting fees paid to doctors.
Lee Greenfield, a former state representative in Minnesota and one of the law’s authors, said it passed with little fanfare or debate after legislators heard stories about doctors accepting gifts of great value from drug makers.
“Why do we want them bribing doctors to use what may not be the best or most cost-effective drug for the patient purely to get some hand-held TV, we all asked,” Mr. Greenfield said.

A indústria alimentícia se adapta, mas....

A Gazeta Mercantil (27/06/07) destaca que empresas como Nestlé, McDonald´s, Kellogg e Hellman´s (Unilever) estão se adequando à "busca do consumidor por uma vida mais saudável". Trata-se de iniciativa que pode ter impacto em indicadores de saúde pública, como obesidade, diabetes e doença cardiovascular. A sintonia das empresas alimentícias com o conhecimento epidemiológico é bem vinda. No entanto, o problema está no que é estado da arte na epidemiologia nutricional porque há aspectos importantes: (1) o conhecimento ainda insuficiente para permitir ações coletivas; (2) extrapolação indevida de resultados obtidos em populações muito específicas; (3) equívocos conceituais, como o de considerar somente a qualidade dietética e, desconsiderar a importância do consumo calórico total.

Harvard na varguarda....

Segue abaixo reportagem do The Boston Globe, do dia 19 de junho de 2007, mas somente "postado" aqui, por ser o momento certo. Notem que os eventos ocorreram em Harvard em 2001 antes do 11 de setembro foram depois repetidos em Vermont, Purdue e California. . Interessante, não?

Protesters' hunger strikes stir worry on campuses
By Marcella Bombardieri, Globe Staff June 19, 2007
At Harvard, they consumed only Gatorade and water for nine days. At the University of Vermont, they subsisted for five days on orange juice, herbal tea, and sea salt. At the University of California, some lived off a potion of lemon juice, maple syrup, and cayenne pepper.
This is not the latest dieting craze, but a controversial trend in student activism: hunger strikes.
Students on at least five campuses went on hunger strikes this year, most of them protesting what they saw as their university's involvement in unfair treatment of workers. At Purdue University in Indiana, a strike last winter lasted 26 days.
In most of the protests, the hunger strikers claimed to have won concessions. But they have also alarmed university leaders and, on some campuses, triggered a backlash from fellow students.
Hunger strikes demonstrate the depth of passion many students feel about the fight against economic inequality. They also represent a certain desperation, according to some students and labor historians, as universities become less tolerant of public disruptions, such as a high-profile sit-in at Harvard in 2001. While most protests are nonviolent, activists believe that a cultural shift since the Sept. 11, 2001 terrorist attacks has encouraged administrators to crack down on civil disobedience on campus.

Students know they can be arrested or expelled for taking over the president's office -- a time-tested way to get noticed on campus -- but they cannot really be punished for forsaking their meal plans.
In society at large, "people are more afraid of dissent than they should be," said Kelly Lee , who just graduated from Harvard and took part in a hunger strike there last month. "The tactics have to fit the time and the audience."
Hunger strikes have a long tradition, from Mahatma Gandhi to Bobby Sands , the IRA member who starved himself to death in prison in 1981. But they have not been a dominant form of campus protest in the past.
Some of the recent student hunger strikes have clearly been inspired by those on other campuses. Janitors in a few places have also gone on hunger strikes, but labor leaders say there were no coordinated efforts to enlist students.
Hunger strikes -- on campus and off -- are a relatively new phenomenon in the labor movement, said Eve Weinbaum , a professor of labor studies at the University of Massachusetts at Amherst. Workers today have less ability to influence their employers, she said, because they are so often part-time employees who are not in unions and, in many cases, are in the country without proper immigration documents.
In the spring of 2001, Harvard students occupied the main administration building for three weeks, demanding the university pay workers a "living wage." The school eventually agreed; some of the 30 protesters were briefly put on probation, a punishment seen as mild.

This year, activists declared that Harvard security guards, who are employed by an outside contractor, were not being offered a decent contract. Marches and rallies had produced no result, and time was running short before summer vacation.
But another sit-in like in 2001 seemed out of the question. Lee and three other students had been arrested in April for heckling the director of the FBI, which students and officials believe are the first arrests of protesters on campus in decades.
Lee, of Springfield, Ore., said campus police told the detained students that Harvard had a new policy to discourage disruptive protests. So they were worried about taking action that could get them suspended, expelled, or dragged out by police. A hunger strike seemed like the answer.
Before they started fasting, the protesters met with a university health services doctor to learn how to stay as healthy as possible. After five days on their Gatorade diet, they visited the health center for blood tests.
Late that night, Javier Castro received a call from the health center: His sodium levels were dangerously low. Castro learned he had taken in too much water, putting him at risk of seizure or coma even though he felt fine.
What topics are worth protesting, and what protesting method is most effective?
He was admitted to Mount Auburn Hospital at 2 a.m. but insisted on fasting for nearly another two days. "It was not the best thing a pre-med like myself could do," Castro, 19, of Irvine, Calif., said last week. Still, "I definitely think it was worth it."
However, most of the hunger strike participants have made it clear that they would not be willing to fast to death. At some schools, the protesters weighed themselves daily or had student EMTs take their blood pressure.
"I want to be effective, not dead," Lee wrote on a blog kept by the Harvard activists.
Fasting was not that uncomfortable, said students who have taken part in hunger strikes. Several described the first few days as most difficult, due to headaches, stomach cramps, and nausea.
But they kept enough energy to go to classes and study for finals. Several described feeling a high or a sense of clarity and well-being on the third or fourth day.
"Basically, your body adjusts," said Zack Pesavento , who went on a juice-and-salt-only hunger strike at Georgetown two years ago. "On day three or four I felt a sense of peace. I remember on the seventh day thinking, 'How is it possible that I'm walking around and talking to people?' "
Although the hunger strikers managed to avoid punishment, in some cases they also acknowledged that the results were not all they desired.
The Harvard protesters broke their fast when negotiators appeared to be making progress. The guards and the company reached a deal a few weeks later, but only after labor leaders had threatened to disrupt commencement.
Most university officials are loath to comment on the tactics of student protesters. A Harvard spokesman would only refer to official statements expressing concern for the students' well-being and commitment to the university's wage guidelines.
Enrique Corredera , a spokesman for the University of Vermont, readily credited the "strong and very passionate" student activism that started long before the hunger strike in April for the university's decision to reexamine salaries and benefits for its low-wage workers. But he refused to credit the hunger strike , saying it had only added stress and anxiety to students and administrators, without changing the results.
Some students who believe universities should treat workers better see hunger strikes as a distraction. Jessica Coggins , a senior at Harvard, said she agreed with the protesters' goals but said hunger strikes are "a very alienating tactic" that put lives at risk and discourage more moderate students from attending rallies.
The hunger strikers counter that they needed an extreme form of protest to break though the indifference to their concerns.
Marcella Bombardieri can be reached at bombardieri@globe.com.

Ah, esse monstro de olhos verdes..

Heartwire, o boletim do InfoHeart apresenta os problemas do foco na pessoa de Steven Nissen e, não no FDA e na Glaxo-Smith Kline no caso Avandia. O título acima é uma tradução tosca de Otello de Shakespeare, que os americanos popularizam como The Irish eyes of envy. Sim, a inveja é a aquilo que os caminhoneiros escrevem nos para-choques.

The media, the man, and his message: Nissen seeks to refocus scrutiny on rosiglitazone June 21, 2007Shelley Wood
New York, NY - The first act appears to be over in the rosiglitazone (Avandia, GlaxoSmithKline) drama, but the media have not yet loosened their grip on the man who first sounded the alarm about the diabetes drug: Dr Steven Nissen (Cleveland Clinic, OH). Nissen's meta-analysis, published in the New England Journal of Medicine (NEJM) and reported by heartwire, propelled rosiglitazone into the spotlight, culminating in a congressional hearing earlier this month and an FDA hearing on July 30. Despite Nissen's repeated insistence that the focus should be on patient safety, not his methods or motives, newspapers and their editorialists—as well as alternative media—continue to take disparate views on the man in the middle of the maelstrom.
Dr Steven Nissen
An editorial in the Cleveland Plain Dealer insists Nissen is being victimized for championing the public good . "Nissen, and clinicians like him around the country, aren't sifting drug performance data so they can add to their scrapbooks of news clippings. They're doing it so they can add to the store of knowledge in the medical community, which can then improve care for patients," the Dealer asserts. "As it now stands, public-spirited doctors like Nissen, who are trying to save patients grief, can be accused of poking their noses where they don't belong. That's ludicrous."
Other media outlets have profiled Nissen, emphasizing his lifelong activism in different spheres. A glowing portrait of Nissen on MedPageToday.com points out that he was a part of the college antiwar movement during the 1960s at the University of Michigan. "His years as a campus activist left him with an entrenched commitment to righting wrongs and a willingness to challenge the status quo, attributes that he has integrated into his medical career," Peggy Peck writes for MedPageToday. "And he never forgot the power of the press."
Altruism not universally accepted
Indeed, the mainstream media loves a whistleblower, but not all of the coverage of Nissen's role has accepted the notion of him as altruist. Earlier this week, the Wall Street Journal (WSJ) ran an editorial questioning the "larger political context" in which the rosiglitazone concerns were raised, noting that "Dr Nissen has a reputation as an adversary of the pharmaceutical industry" and that he "admitted that he consulted with several congressional committees" prior to the publication of his rosiglitazone meta-analysis. "Ostensibly serious medical research isn't supposed to be peer-reviewed by the Democratic majority," the WSJ editorial gibes.
Nissen, for his part, has repeatedly rejected claims that politics had anything to do with it. "That's just not what happened," he told heartwire. "The scientific process proceeded in the usual way: the journal had the article reviewed by peer scientists, it was a very careful review, it was revised based upon those reviews, and it has absolutely nothing to do with politics, it was about patients. . . . If the reviewers had not recommended publication, I'm sure that the NEJM would not have published it."
Other news coverage has implied that Nissen had a different, more personal, political agenda. On June 5, Boston Globe staff reporter Diedtra Henderson quotes critics who claim Nissen's motives stem from a desire to run the FDA, a charge Nissen flatly rejects. "I'm not running for anything," Nissen is quoted in the Globe. "I've got a great job here [at the Cleveland Clinic], and I'm not going anywhere."
Nissen reiterated this point to heartwire: "Speculation about the FDA is a very common topic. I am very happy as the chair of CV medicine at the Cleveland Clinic: I have no interest in going anywhere else; I have my hands full. I'm certainly not interested in running for an office like the FDA commissioner, I don't know where that comes from, it certainly doesn't come from me."
Headline news
A sticking point for the media mania around Nissen has been his apparent eagerness to make headlines. That was also the charge levied by California Republican Rep Darrell Issa during the congressional hearing, where he accused Nissen of caring more for making a "public splash" in the media than informing the FDA directly of his concerns about rosiglitazone. Even earlier, a Bloomberg news report posted online when his meta-analysis was first published notes that Nissen "put the Cleveland Clinic's in-house television studio to good use this week, appearing on a dozen broadcasts across the world."
Nissen agrees that his paper "had more than the usual amount of media attention," but, he insists, "We published this because of the science. It was certainly not about politics, it's certainly not about media. . . . Ninety-nine percent of the coverage of the rosiglitazone story has been very good and very responsible. It's a very tiny group that's making an effort here to make this about the messenger, not the message."
Nontraditional media have their say
The bulk of that negative press has come from independent bloggers and other nontraditional media, many with major conflicts of their own. One of the more novel was a video podcast on the popular video-sharing website, YouTube, that opens with the question, "What do you think about a doctor … who compares a diabetes drug to 9/11?" a reference to a comment Nissen made during an interview that aired on ABC's Nightline website. The one and a half minute video features Dr Michael Weber (SUNY, Brooklyn, NY) expressing his misgivings about how Nissen described rosiglitazone's risks in the media. But the YouTube video was funded by the Center for Medicine in the Public Interest (CMPI), a "research" organization funded by the pharmaceutical industry, and Weber's own ties to industry have been scrutinized in the past.
Contacted by heartwire, Weber said he did not even know what YouTube was. He stated that he is a member of an external, unpaid advisory group of directors for the CMPI and that the CMPI approached him to do "a video," not the other way around. He also emphasized that his comments were not about the scientific validity of the study, but about how they were disseminated. "As far as I'm concerned, the full story about Avandia still isn't known, and the concerns that were raised by Dr Nissen may be something we need to find out about," Weber said. "I'm not criticizing or disputing the scientific data, and in fact the whole reason I agreed to be videoed was because I did get very upset when I saw that Steve had said that the Avandia situation was worse than what happened on 9/11. I found that to be the sort of hyperbole that is really unacceptable in discussing these sorts of issues, and as a New Yorker, the statement was particularly unacceptable."
But Weber rejected any suggestions that he himself was conflicted in this particular circumstance. "I do consult for industry, and I have done research projects and been a part of research activities that have been funded by industry, and I've always fully disclosed or acknowledged those. In this case, there is really not an industry connection, because I have not in any way defended Avandia or defended the way the company that manufactures Avandia has managed the situation."
Nissen says he hasn't seen the video and doesn't want to. "What can I say? We publish scientific work, we did this analysis not to address the YouTube audience but because we believe that providers and patients have a right to know that there are significant safety issues with rosiglitazone," he told heartwire. "If it in fact stimulates people to create YouTube videos, I can't do anything about that, but that's not the audience."
Blogs and missed potential
Other blogs, associated with online editions of newspapers and magazines, have also debated Nissen's role. Ivan Oransky, blogger for The Scientist online, pointed out that Nissen has twice in the past year been wrong about drugs that he thought "held promise": torcetrapib (Pfizer), and now rimonabant (Sanofi-Aventis), the latter unanimously panned by the FDA's advisory panel last week. Oransky's observations were subsequently picked up in the WSJ health blog by veteran reporter Scott Hensley, who observed that Nissen, "a frequent and outspoken critic of the drug industry," has an "imperfect crystal ball."
Oransky, quoted by Hensley, writes: "I think it's worth noting the record of someone whose pronouncements on drugs are so often held up by drug industry critics and that make media headlines."
This is not like handicapping horse races; it's about doing good scientific studies and reporting the results in a faithful and accurate fashion.
Nissen calls this a "straw-man" argument. "I'm always enthusiastic about drugs that we're studying, but when results come in, we tell it the way it is," he told heartwire. "I don't predict the success of drugs, I study the effects of drugs. . . . I have no vested interest, personally, one way or another in whether a drug works or not. It's my job to report scientific results in a neutral fashion, and I never predicted that torcetrapib would be successful. I thought it had great potential, and that was a potential that didn't pan out."
In the case of rimonabant, investigators, including Nissen, did not have data on psychiatric side effects of the drug. "I'm glad that those data were reviewed; I hope that it can be overcome, because I do think [rimonabant] has potential. But this is not like handicapping horse races; it's about doing good scientific studies and reporting the results in a faithful and accurate fashion."
Biting the hand that leads
For health reporters, Nissen is a rare gem in the parched, baked earth that is the medical/pharmaceutical beat. In a sphere where wooden interviews, cautious opinions, and technical jargon are the norm, Nissen speaks his mind and is deliciously quotable. At the major cardiology meetings when he's spoken at a press conference, Nissen will glide through the pressroom like he's hosting a garden party, offering opinions, warmly greeting reporters by name.
Asked whether the proximity he's always enjoyed, even nurtured, with the press has come back to bite him, Nissen cordially steers the conversation back to where he insists it should remain. "The last thing in the world I want is for this to be about me. It has to be about the science. If there are criticisms of the manuscript, let them be directed at the science, not at the messenger."
Yet even as the hue and cry dies down, many journalists following the rosiglitazone saga are left wondering if Nissen—always so frank with and accessible to the media—may, this time, have gotten more attention than he wanted. Which just goes to prove the adage: Be careful what you wish for, you just might get it.

Aeroportos e Reposição Hormonal:mais uma vez nas manchetes

Estou em viagem de negócios aos EUA em dois congressos e muitos contatos de colaboração. Isso obriga o uso de avião e aeroporto. A situação aqui está se aproximando da brasileira, com excesso de passageiros, e congestionamenos nas pistas, além de espera no próprio avião. Hoje, estarei com minha ex-chefe, JoAnn Manson, autora do artigo publicado essa semana no The New England Journal of Medicine sobre o impacto da reposição hormonal na calcificação coronária. Houve proteção na faixa etária entre 50-59 anos, mas isso não altera em nada a conduta atual de não indicar a reposição para prevenção primária de doença cardiovascular. No entanto, toda as rádios, TVs e jornais estão interpretando erroneamente os resultados.

How deal with Airport mess...

Esse é o título da US World News and Report (na tradução tosca, Como conviver com a bagunça nos aeroportos) que leio no aeroporto de Boston rumo a Atlanta para atividades relacionadas ao Estudo Longitudinal de Saúde do Adulto e participação em eventos científicos nessas cidades. O vôo está atrasado mais de uma hora, a bagunça começa no front desk. Motivo: mau tempo em Atlanta. Abro a internet e, leio a notícia sobre o fechamento do Galeão e de outros aeroportos por motivos não explicados. Ao contrário dos comentários que minimizam a crise aérea por não afetar os "pobres e despossuídos", acho que há motivo mais do que suficiente para ser por fim à bagunça existente no setor em todo o mundo, principalmente no Brasil. O transporte aéreo é fundamental para o funcionamento da economia mundial e, poderá restringir ainda mais a participação brasileira na divisão do "bolo" da riqueza mundial.

Aproveitando o momento "minhas férias", impressões de Boston.

1. a cidade se renova ano a ano, o que eram docas e armazéns são agora hotéis, restaurantes e um bom centro de convenções.

2. a região de Cambridge - onde estive hoje visitando o laboratório de genética da Harvard - está cada vez mais pujante devido a biotecnologia.

3. Boston era uma região com menos obesos do que o restante dos EUA, mas já é visível o número maior de obesas e obesos nas ruas.

4. apesar de todo o ciência produzida na cidade, a prefeitura local não consegue sinalizar decentemente as ruas e, principalmente não consegue fazer marcas para cruzamentos à esquerda.

5. o Brazilian Barbeque está cada vez mais presente na cidade, mas ainda perde das taquerías.

6. a situação dos brasileiros está piorando ano a ano com as restrições federais e, isso preocupa municípios com grande proporção de brasileiros porque são vitais para a economia local. Segundo, um banqueiro há 250 mil compatriotas na região e movimentam um valor muito considerável de recursos.

Respondendo How deal: somente posso saudar o inventor da Internet, do Skype e do YouTube porque nossa vida fica bem melhor, afinal posso ler notícias, atualizar-me, falar em casa, ouvir música e, enviar mensagens para a quase centena de leitores que prestigiam esse blogue. Ah, a bateria está acabando e o atraso aumentou para mais uma hora......

A crise da assistência médica nos EUA: o caso de Houston, Texas.

Abaixo, reproduzo matéria do USA Today, um jornal cheio de gráficos e cores e pouco conteúdo. Por isso, a descrição do que ocorre em Houston merece destaque. O estado do Texas tem a maior proporção de cidadõs sem cobertura de assistência médica: 23%, o dobro da média nacioanal. Incrível, como a maior economia do mundo não consegue resolve esse problema. O debate encontra-se em todas as páginas de op-ed. Ontem, havia uma comparação do sistema suíço com o proposto no Estado de Massachusetts no The Boston Globe.

This system is broken'
The growth of the nation's uninsured population has stretched hospital emergency departments to the breaking point.
Nationally, ER visits rose from 93 million to 110 million from 1994 to 2004, an 18% jump, according to the Centers for Disease Control and Prevention. Texas experienced a 33% increase; in the Houston area, it was more than 50%, according to the Texas Hospital Association. The number of hospital emergency departments dropped by more than 12% in the USA in the same period.
Emergency rooms here are routinely overcrowded. "When I came in this morning, there were people waiting from yesterday," says Kellie Manger, a triage nurse at Ben Taub, on a recent weekday.
About half of the people going to emergency rooms here just need primary care, a percentage that's similar elsewhere. "We see lots of patients here who haven't seen a doctor in years," says Katherine King-Casas, an emergency room physician at Ben Taub.
Packed emergency rooms also are caused by overcrowded hospitals in general. At Ben Taub, Mattox gets calls from area business leaders and politicians seeking to "sneak in the back door a maid, a nanny." Doctors, frustrated by long delays for surgeries, try getting patients admitted to the hospital to move them ahead in line.
"Safety-net facilities were never designed to handle one-third of a population," says George Masi, Ben Taub's chief operating officer. "I don't think this is unique to Texas. Something's got to be done. This system is broken."
Crowding leads hospitals to send patients elsewhere.
In the Houston area, hospitals divert patients about 20% of the time, says Charles Begley of the University of Texas School of Public Health. Ambulances pile up outside emergency rooms, often waiting an hour or two to get their patients in for treatment. David Persse, the Houston Fire Department's medical director, says the area record is six hours. The situation is so bad that patients have called 911 from one ER to get to another.
Doctors here cite horror stories, such as the patient who died after being diverted by helicopter from a Houston hospital to one in Austin. "Diversion kills you," Clifton says.
Long waits, packed corridors
The greatest demand for health care isn't in emergency rooms. It's at the clinics and health centers designed to relieve them.
Maria Gutierrez came to Ben Taub's orthopedics clinic one day last month to have her ankle checked after surgery and to fill some prescriptions. The visit took 8½ hours. A week later she was back, in a corridor where as many as 350 people with specialty clinic appointments wait for hours. "Sometimes you don't want to be in the hospital all day," she says.
Bartolome Martinez arrived at the Strawberry Health Center in Pasadena, just outside Houston, at 4 one recent morning to be first in line for the few walk-in slots allotted. The 70-year-old native of Cuba waited outside until the center opened at 7:30 and was still waiting inside at 9 to have the pain in his side analyzed. Still, he says, that was better than waiting three months for an appointment.
Joyce Heifner, 54, discovered the San Jose Clinic, the nation's oldest charity care clinic, five years ago after struggling for about 15 years with the effects of polio she contracted as a child. The clinic, booked like all the others, is a 70-mile drive for her from Livingston, Texas, which has no public hospitals or clinics for the uninsured.
San Jose tries to fill the gap between primary and hospital care with its own specialists, but the wait can take months. "We have one rheumatologist who comes here," says Rosanne Popp, a primary care physician. "There's not an appointment until next year."
For the working poor, waiting for treatment means less time on the job. Angel Martinez, 20, broke his ankle last month and was taken to a private hospital, which put on a cast and billed him $4,500. "That's money that I don't have," he says. He had surgery at Ben Taub and is eager to get his stitches out so he can go back to work as a driver. "This is the foot I use for the gas and the brakes," he says.
The large numbers of uninsured and overburdened health care system have consequences: Studies done during the past 25 years indicate that being uninsured is hazardous to your health.
The uninsured are more likely to have high infant mortality rates. They are more likely to develop high blood pressure and hypertension. They are less likely to get treatment for trauma. They are less likely to receive timely cancer diagnoses. They are more likely to die from heart attacks.
'They die sooner'
Among the states, Texas has the highest percentage of uninsured adults — 27.6% — who say they are in poor or fair health, rather than good or excellent health, the American Hospital Association says.
Even when the uninsured see doctors, they often can't afford drugs. "You prescribe, you send them home, they don't get well," says Efrain Garcia, a cardiologist who volunteers at San Jose. "They die sooner. They have more complications. They are more disabled."
Cora Sylvester, 50, of La Porte, about 25 miles east of Houston, waited about a year after noticing a lump on her breast because she was poor, uninsured — and busy. Eventually she came to The Rose, a women's diagnostic center. She has since had chemotherapy, surgery and radiation, but her long-term prognosis is questionable.
"It's always an issue to not have any type of insurance," she says. "You feel like you just fell in a hole."
Faced with the onslaught of uninsured patients, Texas is taking steps to rework some of its policies.
Late last month, the Legislature changed its rules to add more than 127,000 children to the 300,000 now covered by the Children's Health Insurance Program. Asset tests were eased, enrollment periods extended and waiting periods eliminated for many clients. The Legislature also paved the way for a new program that will subsidize insurance for 200,000 adults.
'We make a little dent'
Still, there is nothing being proposed on the scale of Massachusetts' fledgling program to insure all residents. "There is not going to be a Massachusetts-mandate, one-size-fits-all solution for Texas. We're just too big," Belcher says. To do that here, says Camille Miller, president of the Texas Health Institute, would cost $6 billion.
In the meantime, Houston's health care system is doing what it can. The Harris County Hospital District is educating patients about when to use clinics, not emergency rooms. The Harris County health care Alliance is trying to develop less costly insurance products, especially for small employers.
"Gateway to Care" navigators help uninsured people find primary or specialty care at area clinics. "We're touching thousands of people, but there are a million people without insurance," says Sandy Steigerwald, patient care coordination manager for Gateway to Care.
An "Ask Your Nurse" program offers phone advice to ease the burden on emergency rooms. "We make a little dent," says the nursing program's Titiana Grossley-Brown.
For all their efforts, Houston-area health officials have been unable to reduce the numbers of uninsured.
"Our problems are horrible and embarrassing, but everybody's aware of them," Begley says. "What we're struggling with is what can we do about them."

Fora do Ar

Uma viagem internacional ou nacional tem as suas peripecias. Eu ainda estava com baixa incidencia de problemas, mas os tenho suficiente para ter ficado fora do ar durante 3 dias e, talvez no proximo. Estou nos Estados Unidos em atividades das mais interessantes. Conto na volta.

Nissen não é mágico

O blogueiro de The Scientist não perdou a incapacidade de Steven Nissen - autor da metanálise sobre o Avandia - em prever o futuro. O colega do The Wall Street Journal reproduziu o ocorrido cujo texto segue abaixo.
Cleveland Clinic Cardiologist’s Crystal Ball Imperfect Posted by Scott Hensley
The FDA advisory panel that just dissed Acomplia, Sanofi-Aventis’s weight-loss drug, dealt an indirect blow to a frequent and outspoken critic of the drug industry. The thumbs-down for Acomplia marks at least the second time in a year that Cleveland Clinic cardiologist Steven Nissen “has been wrong about the promise of new drugs,” writes Ivan Oransky on the blog of The Scientist today. Last October, Nissen (pictured, upper left) was part of a panel discussion that Oransky moderated at a meeting of health-care journalists in Cleveland. In preparation for the talk, Oransky asked the speakers to come with two ideas that the audience of reporters and editors might be interested in as potential stories. “Nissen brought two: Acomplia, which he said was a clever scientific idea and held real promise, and CETP inhibitors such as Pfizer’s torcetrapib,” he writes. “He was quite excited about both drugs, and was involved in trials of both at the time, which he disclosed.” The panel discussion took place on Friday, Oct. 27. Three days later, Pfizer disclosed information that heightened concerns about torcetrapib’s tendency to raise blood pressure in patients taking it. Afterwards, Nissen acknowledged the findings raised the hurdle for approval of the medicine. But Pfizer halted development of torcetrapib in early December after excess deaths were found in a 15,000-patient study of the medicine. The FDA advisors who voted down Acomplia yesterday dimmed the prospects for the drug being approved in the U.S. anytime soon. Plenty of people besides Nissen were hopeful about both Acomplia and torcetrapib. And nobody can know for sure about the hypothesized benefits and risks of an experimental medicine until the clinical data are in. Still, Oransky concludes: “I think it’s worth noting the record of someone whose pronouncements on drugs are so often held up by drug industry critics and that make media headlines.” The Health Blog called Nissen, who declined to comment.

O Yin e o Yang da regulação de medicamentos.

O The New York Times publicou um artigo com questionamento já abordado nesse blogue e, defendido por muitos pesquisadores e diretores clínicos da Big Pharma: não é possível liberar um medicamento novo com a velocidade exigida e que seja, ao mesmo tempo, seguro. Ponto final. Defendo também a Big Pharma na questão tempo de patente: o ideal é a contagem de tempo após a publicação de estudos de segurança e , não do registro do medicamento.

Outro problema decorrente dessa pressa é que medicamento com grande utilidade - mas, com prescrição mais restrita - foram "queimados" pelo risco apresentado em indicações de certa forma indevida.

O texto do NYT começa dessa forma:

Potentially Incompatible Goals at F.D.A. By GARDINER HARRISPublished: June 11, 2007
Safety and speed are the yin and yang of drug regulation. Patients want immediate access to breakthrough medicines but also want to believe the drugs are safe. These goals can be incompatible. Race a drug to market and much is likely to remain unknown when patients take it. Test a drug thoroughly to assess all possible risks and its release may be delayed by years.A series of drug-safety scandals has led many on Capitol Hill to question whether the Food and Drug Administration has failed to strike the right balance between speed and safety. A clear sign of this imbalance, these critics say, is the increasing number of F.D.A. drug-safety officers who say they have been punished or ignored after uncovering dangers of popular medicines.

Aqui se apresenta as origens da crise atual:

In the 1980s, the F.D.A. took nearly three years to approve most drugs. The AIDS crisis demonstrated that such long delays could condemn to death patients who might have been helped by recent scientific breakthroughs. F.D.A. managers said they did not have enough people to assess reviews more quickly. So in 1992, Congress helped the F.D.A. and the drug industry reach a deal. Companies agreed to pay millions of dollars in fees, and the F.D.A. guaranteed that drug reviews would be completed within a year or as little as six months for a life-saving medicine. At the time, it seemed a good solution. But the deal’s fine print soon came to haunt the agency. Drug makers refused to let their money pay for the routine monitoring of drugs’ safety once they were on the market. As the agency began to depend more and more on industry fees, those parts of the agency slowly withered.

O impacto da ideologização da ciência

O gráfico ao lado mostra o aumento da razão masculino/feminino de nascimento na Armênia, após a sua independência. A explicação é a seguinte: por ter forte apoio externo devido à diáspora armênia, houve entrada de muitos recursos e doações como aparelhos de ultra-som. Com o aborto permitido, houve um feminicídio em proporção maior que a chinesa. Tudo isso em um país com grau elevado de cultura, mas pertencente a um conjunto de países - a União Soviética - onde prevaleceu a ideologia sobre a ciência. Apesar do Sputinik. Esse é um pequeno exemplo de um artigo excelente publicado no International Journal of Epidemiology Cochrane on Communism: the influence of ideology on the search for evidenceMartin McKee. Acessível somente a assinantes ou aqueles com permissão da base CAPES de periódico. Abaixo, dois pequenos trecho do artigo.

In his seminal work Effectiveness and Efficiency,1 Archie Cochrane asked why, despite their enormous potential, randomized trials were much less widely used that they should be. At the time that he was writing, their geographical distribution was very uneven. He wrote ‘If some such index as the number of RCTs per 1,000 doctors per year for all the countries of the world were worked out, and a map of the world shaded according to the level of the index, one would see the UK in black, and scattered black patches in Scandinavia, the USA, and a few other countries. The rest would be nearly white. It appears in general that it is Catholicism, Communism, and underdevelopment that appear to be against RCTs. In underdeveloped countries this can be understood but what have Catholicism and Communism against RCTs?’

An example can be seen in Armenia. Shortly after gaining independence, Armenian physicians acquired large numbers of ultrasound machines, often benefiting from assistance from the extensive Armenian Diaspora. This was associated with a rapid rise in the male:female sex ratio to a level that now exceeds that in China. There are, however, many other examples. A recent study of obstetric care in a region near Moscow found that many of the obstetric interventions were ineffective, such as physical therapies based on light, electricity or magnetism, administered at some stage during pregnancy. Other treatments were unnecessarily unpleasant, such as the near universal practice of administering intra-muscular injections of vitamins. Yet, others were potentially harmful, such as the administration of diethylstilbestrol, even though it has been known since the 1960s that it causes vaginal cancer in those exposed in utero. Many of the drugs used, including a diverse range of infusions administered almost universally to pregnant women, have never been subject to rigorous evaluation.

Avandia: tentativa de encerramento

Tentarei encerrar o caso Avandia porque já cansou. O próximo passo será a retirada do mercado ou a saída à francesa, visto que as prescrições se reduziram nos EUA em 15-20%. (ver reportagem do The Wall Street Journal) Os artigos publicados na semana passada no The New England Journal of Medicine ampliaram a crítica ao medicamento, ao contrário do esperado pela empresa ao liberar a análise preliminar do estudo Record cujo desfecho foi doença cardiovascular e, não normalização da glicemia. O estudo Record apresentado pela empresa como prova de que não há risco com o uso de Avandia, torna a sua prescrição como desnecessária. Afinal, se não não há redução do risco cardiovascular, qual a vantagem de se prescrever medicamento tão caro? Há problemas metodológicos que aumentam a limitação do estudo. Pior, Psaty e Furberg (em editorial no mesmo dia) adicionaram os dados publicados à metanálise original de Nissen (que originou o problema) e, mesmo assim há risco aumentado de infarto do miocárdio. Por último, não há qualquer lógica em corrigir a glicemia com medicamento que aumenta o risco (comprovado também no Record) de insuficiência cardíaca.

Senhor Yamada (ou equivalente) para Ministro da Saúde.

The Economist (edição de 09 a 15 de junho) apresenta reportagem sobre o que eles chamam de ataque à patentes da indústria farmacêutica. O artigo é bem ponderado com vários pontos de vistas, exceto a do governo brasileiro, visto que o foco é mais na Tailândia e na Índia. Porém, há uma frase de personagem já aqui citado, o senhor Tadataka Yamada, hoje diretor da Fundação Melinda e Bill Gates: “Brazil is not Rwanda, which cannot afford to pay”. Interessante, muito interessante, as análises vindas dessa Fundação. Quando convém aos interesses da Fundação, o Brasil é um país rural onde campeia parasitores sendo imposta a vacina jeca tatu para ancilostomíase. Em outro momento, onde a defesa dos interesses da Big Pharma é mais importante, o discurso muda o estágio de desenvolvimento do país é outro. Já discorri mais de uma vez sobre a vacina da ancilostomíase e o papel da Fundação Melinda e Bill Gates. (clique aqui) Discordo que os Institutos Rene Rachou (MG) e Butantan (SP) gastem tempo com essa proposta. Melhor seria se preocupar com o vírus sincicial respiratório cuja contaminação aflige milhões de crianças e aumentam consideravelmente a morbidade nessa época do ano.

Ou o Ministério da Saúde, Secretarias de Saúde e acadêmicos de uma forma geral estabelecem qual a agenda de prioridades de ações em saúde ou estaremos sendo dirigidos por pessoas como o senhor Yamada, ora na Glaxo Smith-Kline ora na Fundação Gates.

Avandia: em breve nos tablóides

Ainda não consegui ler os textos do NEJM sobre o Avandia, talvez no vôo de retorno a São Paulo se a a bateria permitir. Mas, conseguir ler o NYT reportagem sobre a ameaça o professor americano pelo senhor Yamada, hoje na fundação Bill Gates. O caso Avandia começou no The New England, foi para os jornais e em breve chegará aos tablóides.A má educação e arrogância de executivos de empresas que são contrariadas por acadêmicos é indescritível. Quem assistiu a um evento no Centro de Convenções Rebouças há uns dois anos pode se lembrar da grosseria e impertinência à crítica. Recentemente, recebi de dois anônimos uma resposta a um post de novembro que falava da Merck Sharp e Dhome, onde eu fazia um relato de reportagem de revista. Leiam o post e a resposta e o texto abaixo do The New York Times.

Doctor Says He Was Assailed for Challenging Drug’s Safety
By STEPHANIE SAUL
Published: June 7, 2007
WASHINGTON, June 6 — The business of developing and selling new drugs is fraught with peril and setbacks. Billions of dollars are at stake. Nerves are on edge. Tempers flare. Just ask Dr. John B. Buse, a medical researcher who testified at a House hearing on Wednesday about the safety of the popular diabetes drug, Avandia.Dr. Buse described name-calling and what he said was the veiled threat of a lawsuit by a high-ranking drug company executive in 1999 after he had criticized Avandia at a medical meeting. He said the executive called him a “liar” and “scoundrel” in criticizing him to his supervisor at the University of North Carolina medical school, where Dr. Buse was an associate professor and has since become the chief of endocrinology.Dr. Buse did not name the executive, but he was later identified at the hearing by another company official as Dr. Tadataka Yamada. In 1999 Dr. Yamada was the chief of research and development for Avandia’s maker, SmithKline Beecham, which is now called GlaxoSmithKline. Dr. Yamada is a well-known scientist who left GlaxoSmithKline in June 2006 to become director of global health programs for the Bill and Melinda Gates Foundation. A spokesman for the Gates Foundation, Joe Cerrell, said that Dr. Yamada was not reachable for comment. The committee released a letter Dr. Buse wrote in 1999 to Dr. Yamada in which he expressed anger and frustration. “Please call off the dogs,” Dr. Buse wrote. “I cannot remain civilized much longer under this kind of heat.” Some members of the Congressional panel, the House Committee on Oversight and Government Reform, said the company’s behavior toward Dr. Buse was inappropriate and unacceptable. “We cannot have a post-regulatory environment where manufacturers intimidate scientists,” said Representative John Yarmuth, Democrat of Kentucky. In documents and in a prepared statement, he said his problems with the company began in 1999, the same year Avandia was approved by the Food and Drug Administration, during a presentation at a meeting of the American Diabetes Association. Dr. Buse recalled trying to squeeze two hours of scientific data into a 25-minute speech to the group, in which he said the data suggested Avandia raised the risk of chest pain and heart attacks by 50 percent. “In the week that ensued,” Dr. Buse said in his prepared statement, “there were a number of phone calls from SmithKline Beecham. During these calls, it was mentioned on two occasions that there were some in the company who felt my actions were scurrilous enough to attempt to hold me liable for a loss in market capitalization.” He was referring to a decline in the company’s stock price.
The company also contacted the chairman of medicine at the University of North Carolina, Dr. Fred Sparling. In his letter to Dr. Yamada, Dr. Buse wrote, “I was not upset when my chairman called me into his office to tell me that some in your company perceive me as being ‘for sale,’ as he knows me well enough to doubt it.”
In testimony yesterday, GlaxoSmithKline’s current chief of research and development, Moncef Slaoui, who succeeded Dr. Yamada in that job, said that Dr. Buse made an error in the presentation he gave in 1999.
Dr. Buse said he ultimately signed a statement clarifying his position about Avandia that the company could present to financial analysts. But in his letter to Dr. Yamada, he said: “I cannot change my opinions in the absence of new data or understanding, in large part because I am not for sale.”
After the hearing, Senator Max Baucus, the Montana Democrat who is chairman of the Senate Finance Committee, and Senator Charles E. Grassley of Iowa, the ranking Republican on the committee, asked that GlaxoSmithKline and the University of North Carolina supply additional information about any retaliation against Dr. Buse

Conflito de interesse: mais um episódio

A questão do conflito de interesse está cada vez mais presente e, agora com os mecanismos de controle originados pela internet, a verificação de conflito fica muito mais fácil. Pesquisar o nome do pesquisador no google, p.ex, já é uma forma muito fácil de verificar situações como palestras e conferências para a indústria. Abaixo, a descrição da política do Journal Watch, a partir de um caso referente a depressão na gravidez publicada na edição de hoje do The Wall Street Journal.

Research Digest to Ease Access To Author Disclosures
By DAVID ARMSTRONGJune 8, 2007
A popular online research digest will make it easier for readers to discover its authors' potential conflicts of interest, after criticism of its handling of a commentary defending the use of antidepressants in pregnancy.
The system adopted by the Web site Journal Watch was the latest move to toughen disclosure after a series of cases in which authors' ties to the pharmaceuticals industry weren't disclosed. Journal Watch is owned by the Massachusetts Medical Society, publisher of the New England Journal of Medicine. Under Journal Watch's new system, to be adopted later this month, online readers will be able to click on an author's name and instantly see disclosures about his or her financial ties to drug makers and other sources of support. The site, aimed at doctors, summarizes significant articles on recent medical journals.The change comes after a dust-up over an April 26 article by psychiatrist Claudio N. Soares arguing that despite cautions from regulators and medical societies, considerable data support antidepressant use by pregnant women. Dr. Soares, a professor at McMaster University in Hamilton, Ontario, has been a researcher, consultant or speaker for several antidepressant makers, including Forest Laboratories Inc., GlaxoSmithKline PLC, Wyeth and Eli Lilly & Co. After a query by a reader, information about Dr. Soares's financial relationships was appended to the article on May 31. The article also triggered a rebuke from Adam Urato, a perinatologist at New England Medical Center in Boston, who said the piece minimized dangers posed by some antidepressants and should have noted Dr. Soares's financial relationships. Dr. Soares didn't reply to messages seeking comment.Brown University professor Sandra Carson, editor of the section of Journal Watch that published the piece by Dr. Soares, says the financial disclosures of authors was available on the Web site on April 26. To find the information, a reader was required to go to the main page of the Women's Health section and find a link in small type entitled "More about Journal Watch Women's Health and its board." There, Dr. Soares is listed as an associate editor. The reader then needed to click on another link, "about Dr. Soares," to get to a page listing his biography. On that page, clicking the "disclosure" link produces a list of his financial relationships. Most major medical journals include any financial disclosure information related to authors on the first or last page of the article.Last year, the Journal of the American Medical Association toughened its disclosure demands for writers after a series of cases. In one case, the journal issued a correction on a study it published in February 2006 that reported pregnant women who stopped taking antidepressant medication were more likely to suffer a relapse of depression than those who continued taking medication. The correction said seven of the 13 authors had relationships with drug makers that weren't disclosed.

Explicando a queda da mortalidade cardiovascular nos EUA

The New England Journal of Medicine apresenta estudo do CDC mostrando que a queda da mortalildade nos EUA entre 1980 e 2000 foi decorrente tanto da redução dos fatores de risco como do tratamento. O texto integral pode ser lido clicando aqui e, o resumo dos resultados encontra-se abaixo.

Results From 1980 through 2000, the age-adjusted death rate for coronary heart disease fell from 542.9 to 266.8 deaths per 100,000 population among men and from 263.3 to 134.4 deaths per 100,000 population among women, resulting in 341,745 fewer deaths from coronary heart disease in 2000. Approximately 47% of this decrease was attributed to treatments, including secondary preventive therapies after myocardial infarction or revascularization (11%), initial treatments for acute myocardial infarction or unstable angina (10%), treatments for heart failure (9%), revascularization for chronic angina (5%), and other therapies (12%). Approximately 44% was attributed to changes in risk factors, including reductions in total cholesterol (24%), systolic blood pressure (20%), smoking prevalence (12%), and physical inactivity (5%), although these reductions were partially offset by increases in the body-mass index and the prevalence of diabetes, which accounted for an increased number of deaths (8% and 10%, respectively).

Feriadão em Londres

Estou em Londres a convite da Wellcome Trust participando de workshop sobre prevenção secundária da doença cardiovascular com participantes de quase todos países. Discute-se muito a poli-pílula para prevenção, ou seja o uso de diurético, beta-bloqueador, inibidor da enzima de conversão, aspirina, estatina e ácido fólico. Continuarei em breve falando sobre esse tema, mas ainda não li os textos do NEJM sobre Avandia.

Avandia, o Legislativo americano assume uma posição.

Estou ainda sem possibilidade de avaliar os textos do NEJM publicados ontem, mas estou publicando abaixo, o despacho da Reuters.

Lawmakers to grill Glaxo, FDA on diabetes drug
By Lisa Richwine and Susan Heavey
WASHINGTON (Reuters) - U.S. health officials and drugmaker GlaxoSmithKline Plc are likely to face tough questioning from lawmakers on Wednesday over their handling of data suggesting a heart risk with the widely used diabetes pill Avandia. A furor erupted last month when a Cleveland Clinic analysis linked Avandia to a 43 percent higher chance of having a heart attack. The Food and Drug Administration and Glaxo say other data provided conflicting evidence. Glaxo has said it gave regulators information in August 2006 that estimated a 30 percent higher heart-attack risk with Avandia. Some critics question why neither the FDA nor Glaxo alerted patients sooner. "The American people deserve to know why eight years after FDA approved Avandia, it's still unclear whether the drug is harmful or helpful," Rep. Henry Waxman, a California Democrat and chairman of the House Oversight and Government Reform Committee, said in a statement. Millions of patients take Avandia, known generically as rosiglitazone, and sales topped $3 billion last year. But analysts this week said prescriptions have fallen 16 percent since the Cleveland Clinic report as doctors switch patients to Takeda Pharmaceutical Co. Ltd.'s rival drug Actos. Glaxo released early findings on Tuesday from an ongoing company-funded study that was unable to show a link to heart attacks. It also defended itself and reassured patients in full-page advertisements in at least a dozen U.S. newspapers. "Patients and physicians should find these data reassuring," said a statement by Moncef Slaoui, London-based Glaxo's research and development chairman. Still, several experts said the new evidence still suggests a greater risk of heart attack. Waxman's panel is set to question Slaoui, FDA Commissioner Andrew von Eschenbach; cardiologist Steve Nissen, who wrote the Cleveland Clinic analysis, and others.
CRITICISM OF FDA
Concerns over Avandia have sparked an outcry from members of Congress who have blasted the FDA in recent years as being slow to respond to problems with other medicines, including Merck & Co Inc.'s withdrawn arthritis drug Vioxx. The controversy comes as Congress considers legislation meant to bolster the FDA's oversight of drug side effects. Some critics are seeking to use the Avandia case to push for tougher safeguards. Waxman said the House hearing would focus on whether the FDA is properly safeguarding the public and whether changes in the agency's authority, resources or leadership might be needed. The FDA is finishing its own Avandia analysis to better assess the heart risk but has not said when it will be completed.
FDA officials have defended their actions, saying they had to weigh warning the public against concerns that diabetic patients could stop taking their medication altogether. "I believe we did it right with regard to Avandia," von Eschenbach told reporters last week. The agency has scheduled a July 30 public meeting to discuss the

Avandia, a saga continua.

Hoje, The New England Journal of Medicine publicou os dados parciais do RECORD realizado em tempo recorde. Além desse artigo original, mais três editoriais. Ainda não consegui lê-los pela correria de estar em três cidades diferente em menos de 72 horas. Talvez, não consiga nos próximos dias. Os textos estão em http://www.nejm.org.

Valor Econômico: ANVISA prepara ataque a produto pouco nutritivo

Em manchete Valor Econômico (assinante clique aqui) anuncia que a ANVISA regulamentará a propaganda de alimentos, principalmente a dirigido a crianças. Um bola dentro. Simples, não há porque anuncia comida. Ou temos em quantidade necessária, ou então precisamos de políticas de segurança alimentar. O problemas dessas ações são os equívocos técnicos e, não políticos. A questão toda não é atuar em um componente da dieta, como a gordura saturada, mas sim no consumo total. A grande questão é o aumento da obesidade. Obesidade se faz com balanço positivo calórico e, não interessa de onde vem a caloria, se proveniente da gordura, do carbohidrato ou da proteína. Para aqueles com dieta balanceada, aí sim há diferenças nos tipos de componente da dieta ingerido.

Folha de S. Paulo: Saúde privada cresce 30%

A Folha (assinante clique aqui) traz reportagem sobre os dados da Agência Nacional de Saúde Suplementar (ANS) com destaque para o fato que entre 2003 e 2006 houve um acréscimo de 8,6 milhões que tiveram a ter algum plano de saúde. Confesso minha surpresa. A informação vinda da ANS era de expulsão e redução de cobertura da população em magnitude semelhante (falava-se em 9 milhões). Uma explicação para essa contradiçao. seria que as faixas econômica atingidas seriam diferentes. Em outros termos, a classe A e B teria perdido ou sido ejetada dos planos de saúde mais caros e, migrado para os planos mais baixos, associado a uma nova clientela das classes C e D que passaram a ter recursos para adquirir ou então conseguiram empregos com planos de saúde coletivos.

Um dado importante é sobre a cobertura da saúde suplementar (em porcentagem): Brasil: 23,9; Norte:9,0; Nordeste; 11,9; Centro-Oeste: 14,9; Sul: 21,2 e Sudeste: 37,5.

Barack Obama sai do muro: cobertura universal à saúde.

O pré-candidato democrata à Presidência da República dos Estados Unidos, Senador Barack Obama saiu do muro e, agora defende a cobertura universal à saúde. Já dediquei vários textos a esse tema que considero com um dos mais importantes, não somente para os americanos, como também para os demais países. Os EUA é o último bastião da idéia que assistência médica é um problema individual. A cobertura universal significará novas tecnologias na área, principalmente na responsabilidade fiscal. Abaixo, a introdução de análise sobre o financiamento do atendimento a todos no The Wall Street Journal disponível somente a assinantes.

Health Care: Time for Universal Coverage?
By NICK TIMIRAOSJune 2, 2007; Page A9

Sen. Barack Obama became the latest presidential candidate to call for universal health coverage this past week. It's been 13 years since First Lady Hillary Clinton's effort at creating universal health care helped cause Democrats to lose control of Congress. Nevertheless, Democratic presidential hopefuls are once again embracing the proposition, following the lead of some Republican governors. Earlier this year, California Gov. Arnold Schwarzenegger unveiled a plan to cover all of the state's uninsured and Massachusetts next month implements the nation's first comprehensive coverage plan, requiring residents to buy health insurance or face tax penalties. That plan was signed into law by then-Gov. Mitt Romney, now a Republican candidate for president.

Pesquisa clínica e comportamento de médicos e hospitais.

The New York Times (03/06/07) apresenta reportagem extensa (texto completo para leitores cadastrados) sobre o relacionamento de médicos com empresas farmacêuticas para realização de pesquisa com medicamentos. O tema específico é o pagamento por recrutamento de pacientes para ensaios clínicos. E, há fraudes que prejudicam diretamente o sujeito da pesquisa, mas também a médio e longo prazo a própria empresa contratante. Aqui, no Brasil os estudos estão concentrados em hospitais e faculdades de medicina, o que de certa forma reduz esse comportamento. O Board (equivalente ao nosso Conselho Regional de Medicina) de Minnesota já condenou um médico por comportamento considerado fraudulento no recrutamento de pacientes para estudo com medicamentos.
Esse tema – a pesquisa clínica – merece vários comentários, mas a questão básica é que o problema é muito mais de quem é contratado do que é o contratante. Se, médicos, hospitais e faculdades de medicina abandonam sua missão de acolher o doente e formar recursos humanos, o problema é muito mais de profissionais e instituições do que das empresas que por sua vez também são lesadas. O texto do NYT enfatiza que
Payments by drug companies to doctors, whether or not the doctors have been disciplined, are a matter of much debate. Drug makers and doctors say the money finances vital research and helps educate doctors about helpful medicines. But others in the medical profession say the payments are thinly disguised incentives for doctors to prescribe more, and more expensive, drugs.
Isso mostra também que o destino do recurso obtido de pesquisa – quando feita de forma honesta e correta – é o que mais interessa nesse debate. Para isso, nada melhor que a transparência. Relato aqui que recurso obtido no estudo Clarity foram aplicados em grande parte para criar e organizar o Estudo Longitudinal de Saúde do Adulto, hoje uma realidade com financiamento dos Ministérios da Saúde e da Ciência & Tecnologia.

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