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

Avandia: resposta da Glaxo Smith Kline

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

Mais um perigo nos ares: Tuberculose

Talvez a informação abaixo do The New York Times seja de utilidade para quem viajou nos vôos abaixo. Mas, não é a primeira vez que tais fatos são identificados. Há seis meses, o Hospital Universitário internou com meningite meningocócica paciente com dupla nacionalidade brasileira e italiana que morava na Itália com sintomas já no vôo para São Paulo. Ele permaneceu 12 horas infectado em um avião de carreira. As autoridades sanitárias italianas foram avisadas à época, mas não houve contágio descrito.

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

Mudando de Avandia para Actos

The Wall Street Journal (assinante clique aqui) que médicos americanos evitam Avandia e, ao mesmo tempo prescrevem mais Actos (pioglitazone). Há uma grande chance que a maioria dos pacientes, ao invés da prescrição de um desses dois medicamentos se beneficiaria mais de outras condutas com redução radical de peso, aumento da atividade física, redução dos níveis de pressão arterial e de colesterol. Por isso, talvez não seja mudança adequada, somente conveniente a quem prescreve. Abaixo parte do texto.

U.S. Doctors Shun Glaxo MedicineIn Wake of Study LONDON -- Doctors in the U.S. have shunned GlaxoSmithKline PLC's diabetes drug Avandia since a study was published last week linking the drug to greater heart-attack risk, according to early prescription data. Market-intelligence group Impact RX said Avandia's share of the market for newly prescribed oral antidiabetics fell to around zero from around 10% in the two days after the article was published in the New England Journal of Medicine on May 21. At the same time, the rate of patients switching from one drug to another was three times the usual level. Takeda Pharmaceutical Co.'s rival drug, Actos, saw its share of the new-prescription market increased to 22% from 10%. The U.K. company played down the data, saying, "Two days of data is not enough to reach sensible conclusions on the trend for Avandia new prescriptions."

Avandia: FDA strikes back The New England

Abaixo, transcrevo parte do texto acessível a assinantes de Scott Gottlieb publicado no The Wall Street Journal . Ele foi vice diretor do FDA no período 2005-07 e está criticando o The New England Journal of Medicine porque considera que houve "manipulação política". Em outras palavras, houve interesse em minar a atual política do FDA, da qual ele foi um dos praticantes. Segundo ele, as revistas são favoráveis a uma política mais restritiva de liberação de novos medicamentos. Gottlieb em outro texto com acesso livre há sete anos criticava a dissseminação da informação como sendo perigosa. Eu concordo com ele, a informação é perigosa. Depende sempre para quem. O aqui já citado (sem nome para não sujar essas páginas), tesoureiro pivo do mensalão não está só na sua conclusão: "transparência demais é burrice". Gottlieb faz alusão a vazamento da informação a um deputado democrata, mas a própria Glaxo foi informada, tanto que já tinha uma resposta pronta que foi publicada logo após a publicação. Ah, Gottlieb acusa a tendência esquerdista da atual direção da revista. Ironia, porque quando Marcia Angell - a editora anterior - foi substituída por Jeff Drazen dizia-se a boca pequena - leia-se The Boston Globe - que Drazen seria um representante da Big Pharma que neutralizaria a política de Marcia, uma feroz opositora da indústria farmacêutica. Ela é autora do excelente "The Truth About the Drug Companies" e há um ano deu uma entrevista `a Globo News muito didática.

Journalistic Malpractice By SCOTT GOTTLIEBMay 29, 2007; Page A15 As medical information is exploding and becoming more accessible, all of us, particularly physicians, need objective sources to interpret data and present a balanced view. Unfortunately, major medical journals that should be filling this role often put more weight on pushing political agendas. Their editorial prejudice has left a troubling void for rigorous and unbiased arbiters of medical evidence who can guide sound medical practice decisions. The behavior of the New England Journal of Medicine (NEJM) is a case in point, when it rushed onto its Web site a limited and flawed analysis of safety concerns around the diabetes drug Avandia. The publication was timed to get ahead of the Food and Drug Administration's more careful evaluation of the same issues. The journal seemed bent on beating the FDA to the punch. The goal? Painting the FDA as impotent, in order to argue for legislation winding through Congress that would increase regulatory hurdles for drug approvals. The journal's motives were made bare by its own editorial on the matter.

NEJM said it rushed to post the study on the Web because of its medical importance, but the FDA, which would need to act on any safety issues, wasn't even given a heads up about the study's publication or its findings. Rep. Henry Waxman (D., Calif.), however, seems to have known in advance that it was coming because he issued a substantive press release immediately after the study was posted online. He was even ready with the date and location of oversight hearings aimed at probing the FDA's "handling" of the drug safety issues. Mr. Waxman is trying to add new restrictions to the FDA's drug approvals. The study's primary author, Cleveland Clinic Cardiologist Steve Nissen, admitted to The Wall Street Journal that he was in touch with Congress while preparing his analysis. Three days after the study was submitted to NEJM, and before it was published, the FDA commissioner received a letter about Avandia from members of the House Energy and Commerce Committee that seemed to reference the NEJM study. At what cost do political machinations of the medical journals come? NEJM editors have long favored more drug regulation. But medical journals have also historically played a special role in helping to define medical practice standards. Even decisions they make on how prominently to place a study, let alone how they editorialize about it, are seen as strong signals to clinicians on how doctors should weigh the evidence. So when editors pursue a political agenda, it's public health that pays a price. Degrading an institution that doctors depend on for balanced analysis and fair-minded editorial judgments isn't good for anyone. (.....) There is a problem when some journals let antipathy for business interests and left-leaning views interfere with the medical decisions that they make, bending standards or stepping outside their mandate, using their prestige and influence in ways that distort medical facts in the aim of influencing political outcomes. Prestigious biomedical journals are important public health tools, provided they stick to their core business of weighing medical evidence and informing physicians of important practice advances. When they use shortcuts and shoddy analysis to fabricate criticism and doubt of drug regulation, they're no better than some politicians they increasingly comport with. Dr. Gottlieb, a physician, is resident fellow at the American Enterprise Institute and was Deputy Commissioner of the FDA from 2005 to 2007.