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.