Obama ou McCain: palpite do The Lancet

The Lancet analisa as possíveis mudanças no "sistema" de saúde americano, com Obama ou McCain vencendo a eleição em novembro. No entanto, há dois pontos importantes: a questão econômica será mais importante do que o Iraque e, também da saúde. Fato impensável há um ano; o poder legistlativo controla o orçamento e, os democratas já está há 18 meses com maioria nas duas casas.

With John McCain long the last man standing among the Republican candidates, and Hillary Clinton having just stepped aside for Barack Obama, the long drawn out campaign for the US presidential nomination now takes a new path. The electorate can turn its attention to the issues, and not just the personalities, at hand. For many Americans, especially the large number of uninsured and underinsured, the most pressing domestic concern is health care. So where do the presumptive nominees stand on this issue? The first fault line between them is predictable: in traditional Republican style, McCain believes in market-based solutions to health-care reform. He would not dismantle the employer-based insurance system, but would provide tax credits to make it more affordable. McCain claims that he would promote competition among insurance companies by allowing the selling of policies across state lines; whether this step would be enough to create real competition is doubtful. Obama's plan is also predictably Democratic, although it is not as radical as the single-payer plan favoured by the most liberal wing of the party. His plan instead is a compromise of sorts: universal coverage would be achieved through retention of private insurance along with the expansion of existing public programmes, such as Medicaid, the federal insurance scheme for low-income Americans, and SCHIP, the State Children's Health Insurance Program, which is jointly funded by the federal government and the states, and through the creation of a new public plan. Neither candidate mandates coverage for all Americans. Obama would require only children to have health insurance, presumably paid for through the expansion of SCHIP. Perhaps the most innovative Obama proposal is a National Health Insurance Exchange, which would provide a range of insurance choices through a pooling scheme, specifically for those people who are not eligible for existing public programmes and who do not have employer-based insurance coverage. The National Health Insurance Exchange would also benefit small businesses that cannot afford to provide their employees with insurance—the group that has often proved most problematic in debates about mandated coverage. Both candidates therefore aim, commendably, to expand coverage. But just being able to afford insurance does not solve one of the biggest problems that exists in most private plans, that is, the power of insurers to deny coverage, or to charge extraordinary premiums, on the basis of applicants' pre-existing conditions. McCain says he will work with the states to create a plan that would, with the support of the federal government, guarantee coverage to people with pre-existing conditions and limit the cost of their insurance premiums, with financial aid for those who do not meet income minimums. Obama's plan would require insurers in his newly created pool to offer guaranteed coverage, and to charge a fair premium that is not dependent on the applicant's health status. We endorse both candidates' intention to remove the inequity and capriciousness of denial of coverage, though a plan that depends, as does McCain's, on the cooperation and financial support of all of the states, is certainly less likely to succeed than a federal programme. Any programme put forth by either candidate must be funded from the outset. Unfunded mandates pose obstacles in even the most trivial legislation; an issue as important as health coverage cannot be relegated to a state-by-state scramble to find the money to pay for it, or, as is most often the case, robbing one of Peter's state plans to pay for Paul's federal mandate. The issues relevant to health are not, of course, limited to insurance, as important as insurance ranks for Americans. Both candidates pledge to invest in cost-containment and quality-improvement measures. McCain wants legislation that will curb frivolous malpractice claims and protect against excessive damage payments. He wants to promote guidelines-based practice, invest in prevention and chronic-disease management programmes, and use telemedicine in remote areas. Many of Obama's proposals are similar, though he also wants to invest US$50 billion in health information technology, and plans to address the health disparities that exist across the country. That the candidates have many similar goals in the non-insurance arena comes as no surprise, since being against these improvements would be akin to opposing motherhood and apple pie. What is needed now, in the long hot days before the conventions at which the respective party platforms will be adopted, is more nuanced debate on these issues, further specifics, and increased boldness. Let the real campaign begin.

A seqüência do caso dos psiquiatras de Harvard

Interessante verificar o seguimento da questão dos psiquiatras infantis que receberam quantia vultosa da Big Pharma, sem considerar e declarar "conflito de interesse". Aqui, encontra-se a posição do Mass Gen Hosp e, uma crítica ferica do Carlat blog. Aliás, recomendo, o Carlat Psychiatric Report.

Corrigindo o besteirol "Made in UK" ou pelo fim dos "o fim de...."

Desde o famoso texto sobre o "fim da história", passou a ser um modismo decreta o fim de alguma coisa. Agora, a aids. Há dez anos houve a "barriga" história de Gina Kolata no The New York Times, graças ao pouco sério J.Watson, quando eles decretaram o fim do câncer. Eu não tinha lido o original, somente a repercussão no Brasil, com comentários sem qualquer base na realidade. Agora, o desmentido oficial e, a origem do besteirol: The Independent.

Joint Note for the media WHO/UNAIDS11 June 2008 Correction to AIDS story in Independent article 8 June 2008 We wish to clarify misinterpretations concerning WHO and UNAIDS positions on the status of the AIDS epidemic in recent media articles. The story in the Independent on Sunday titled: "Threat of world AIDS pandemic among heterosexuals is over, report admits" contained a few seriously misleading statements that have led to inferences and conclusions that bear no relation to the highly complex realities of the HIV epidemic. First and foremost, the global HIV epidemic is by no means over. At the end of 2007, an estimated 33.2 million people were living with HIV. Some 2.5 million people became newly infected that year, and 2.1 million died of AIDS. AIDS remains the leading cause of death in Africa. Worldwide, HIV is still largely driven by heterosexual transmission. The majority of new infections in Sub-Saharan Africa occur through heterosexual transmission. We have also seen a number of generalized epidemics outside of Africa, such as in Haiti and Papua New Guinea. Heterosexual transmission continues to drive the epidemic among sex workers, their clients, and their clients' partners. In addition, prisoners, injecting drug users, as well as men who have sex with men, may also engage in heterosexual relationships. In sub-Saharan Africa almost 60% of adults living with HIV were women: 48% in the Caribbean. HIV prevention and treatment efforts are showing results. Building on these successes will require improved outreach to populations most at risk with evidence-informed approaches based on local HIV epidemiology - an approach we call "knowing your epidemic." In all settings, a supportive environment is required, free from stigma and discrimination, legal barriers or other obstacles that prevent access to services. AIDS awareness campaigns and school-based efforts are essential to promote sexual and reproductive health, ensuring young people have the knowledge and ability to protect themselves against sexually transmitted diseases, and teenage pregnancy. UNAIDS and WHO remain focused on strengthening monitoring of the epidemic to refine responses further and to recognize changes in transmission patterns should they occur. To recap: AIDS remains the leading infectious disease challenge in global health. To suggest otherwise is irresponsible and misleading. Dr Kevin M. De Cock,Director,Department of HIV/AIDS,WHO, World Health Organization

Situação dos PS...americanos

Para quem adora falar na "vala comum do SUS" ou na "falência da saúde pública", nada melhor do ler o Emergency Department - Pulse Report 2008 onde se apresenta um perfil dos pronto-socorros americanos. O relatório discute muito o tempo de espera e de permanência. Maior do que os observados em pronto-socorros paulistas, com certeza. Aliás, essa foi experiência minha como paciente nas unidades de emergência de Boston há dez anos. Abaixo, uma ação de hospital da Dakota do Sul para reduzir espera no pronto-socorro.

Triage: The hospital condensed the questions that triage nurses ask, made the route patients travel within the department more direct, and started requiring triage nurses to assign patients to their next nurse — rather than waiting for somebody else to do it at the next stop. The Next Step: After triage, patients see a nurse and doctor simultaneously, rather than the old method of nurse first, doctor second. If the nurse isn’t ready, the doctor can go ahead and treat the patient without waiting. For common ailments, there are set protocols folks in the hospital can follow if a doctor is delayed. For instance, patients with likely fractures can get X-rays while they wait. “Universal” Rooms: These are equipped with bedside supplies that allow the hospital to care for 85% of problems patients arrive with at the ER. Other supplies can be rolled to patients on carts. The idea is to keep patients from having to move around and employees from stepping on each others’ toes as they walk around to gather supplies. Paperwork: Registration functions such as getting patients’ addresses and payment information take place at the bedside, after care has been started. Who Goes Where: The hospital did a deep dive into its data to figure out where patients typically end up after going through the ER. Each department is expected to prepare daily to admit the number of patients it tends to get, so that it can pull them out of the ER quickly.

Um livro grátis para quem gosta de mudar as coisas

From news to everyday use - The difficult art of implementation. A literature review by Karin Guldbrandsson. Swedish National Institute of Public Health, 2008

Esse livro é de acesso livre sobre a dificil arte de implementar inovações na área da saúde pública. Entre outros exemplos, a demora em administrar suco de cítricos aos marinheiros para evitar o escorbuto. Entre a primeira evidência e a ação foram 200 anos e milhares de vidas...

Não consegui ler todos os textos, mas há dicas muito interessantes, principalmente para quem não tem muita paciência com os elocubradores próprios da saúde pública.

Conflito de interesse: psiquiatras de Harvard

Por falar em conflito de interesse.......

Researchers Fail to Reveal Full Drug Pay By GARDINER HARRIS and BENEDICT CAREY Published: June 8, 2008 A world-renowned Harvard child psychiatrist whose work has helped fuel an explosion in the use of powerful antipsychotic medicines in children earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but for years did not report much of this income to university officials, according to information given Congressional investigators. Senator Charles E. Grassley pushed three experts in child psychiatry at Harvard to expose their income from consulting fees. Dr. Joseph Biederman belatedly reported at least $1.6 million in consulting fees. By failing to report income, the psychiatrist, Dr. Joseph Biederman, and a colleague in the psychiatry department at Harvard Medical School, Dr. Timothy E. Wilens, may have violated federal and university research rules designed to police potential conflicts of interest, according to Senator Charles E. Grassley, Republican of Iowa. Some of their research is financed by government grants. Like Dr. Biederman, Dr. Wilens belatedly reported earning at least $1.6 million from 2000 to 2007, and another Harvard colleague, Dr. Thomas Spencer, reported earning at least $1 million after being pressed by Mr. Grassley’s investigators. But even these amended disclosures may understate the researchers’ outside income because some entries contradict payment information from drug makers, Mr. Grassley found. In one example, Dr. Biederman reported no income from Johnson & Johnson for 2001 in a disclosure report filed with the university. When asked to check again, he said he received $3,500. But Johnson & Johnson told Mr. Grassley that it paid him $58,169 in 2001, Mr. Grassley found. The Harvard group’s consulting arrangements with drug makers were already controversial because of the researchers’ advocacy of unapproved uses of psychiatric medicines in children.

Diabetes: o complexo médico industrial midiático não dorme no ponto

Eu, também, porque estou no aeroporto de Natal nessa madrugada para retornar a São Paulo. Mas, como os coleguinhas são rápidos no gatilho! Ativados pela imprensa, que com certeza foi fornida pela assessoria de imprensa da empresa, não tiveram dúvidas em apoiar os resultados do Advance em contraposição ao Accord. O acesso aos artigos foi possível somente quando The New England Journal of Medicine liberou ontem, às 18 hs de Brasília, os dois estudos, mais três editorais. Mas, os coleguinhas já tinham opinião e as matérias já estavam prontas. para serem lidas nesse sábado.Já tratei desse assunto aqui. Os textos iniciais estão na seção "Clínica & Epidemiologia" desse blogue.

Depois disso, meu amigo, presidente da Sociedade fica bravo comigo quando ressalto o conflito de interesse dentro da corporação médica.Em breve, atualizarei "Clínica & Epidemiologia" com os estudos completos e os editoriais.

Abuso de crianças pelos capacetes azuis no Haiti

The Lancet comenta o relato do Save the Children UK onde há relatos de abuso por funcionários de ONGs e dos capacetes azuis da ONU no Sudão, Costa do Marfim e....Haiti. Hum, são tropas brasileiras? O que haverá de mais substancioso nesse relato?

The exploitation of children is nothing new. For example, as we have previously reported, roughly 1·2 million children are traded as commodities (trafficked) every year. So it is rather surprising that a report published last week by Save the Children UK managed to cut through the usual apathetic response given to this uncomfortable subject and cause shockwaves. The report focuses on the sexual exploitation of children by UN peacekeepers and non-governmental-organisation (NGO) workers in three countries—Côte d'Ivoire, Haiti, and Sudan. The researchers organised focus groups in the three countries and conducted in-depth interviews with individuals. The result is a collection of moving accounts from children about the abuse they have experienced or witnessed by UN peacekeepers and NGO workers. The feeling of helplessness evoked by the striking imbalance of power between the children and their supposed saviours leaps off the page. Children are often afraid to report sexual abuse, but in this context, the threat that the rewards of trading sexual favours, such as food and safety, might be withdrawn if they speak out, makes the behaviour of the all-powerful peacekeepers even more appalling. With perverse irony, the Save the Children report coincides with the 60-year anniversary celebrations of UN peacekeepers worldwide. As part of the celebrations, the Under-Secretary-General of Peacekeeping Operations, Jean-Marie Guéhenno, paid tribute to the sacrifice and dedication of the men and women in the peacekeeping forces who are prepared to risk their lives in the pursuit of the noble goals of the UN. Currently, almost 130000 military, police, and civilian personnel are serving in 20 UN peace operations throughout the world. It is unfortunate that the actions of a few should tarnish the reputation of the whole peacekeeping force. There is no doubt about the commitment from those at the top to tackle sexual exploitation and abuse. Last week at the Wilton Park Conference entitled Women targeted or affected by armed conflict: what role for military peacekeepers? UN Director-General, Ban Ki-Moon, said that the UN is committed to a zero-tolerance policy against sexual exploitation or abuse, and also that there is a zero-complacency policy to investigate such allegations. The UN and the NGO community have been aware of the exploitative behaviour of some peacekeepers and NGO staff for several years and have developed many initiatives to try and stamp out such despicable practices. These initiatives include the development of interagency bodies and task forces to tackle the problem. Standards of conduct and guidance have been specifically developed for aid workers and peacekeepers. UN and NGO staff have been trained and appointed to work on the ground to help tackle sexual exploitation and abuse and more female peacekeepers have been deployed. The Save the Children report recommends the formation of an effective local complaints mechanism for reporting abuse and a new global watchdog to monitor and report efforts to tackle abuse and exploitation. This watchdog would sit within the UN system but would be developed and owned by the international community. All this activity has merit and will undoubtedly have some effect. But without tackling the root causes of sexual exploitation and also re-examining the role, responsibility, and accountability of the UN, such measures will never fulfil their potential. The UN does not have the authority to discipline peacekeepers found to have abused their power. The member states where the peacekeepers are from—currently 118 countries—have this responsibility. In some of these countries it is not illegal to have sex with minors and child abuse might also be acceptable behaviour. Yet despite the fact that all but two states—Somalia and the USA—have ratified the UN Convention on the Rights of the Child, these children have been horrifically violated. 60 years ago battered and bruised by World War II, the world looked with optimism to a future where the life of every man, woman, boy, and girl would be equal. This hope was enshrined in the UN Declaration of Human Rights. However, as featured in the annual report from Amnesty International published last week, this utopia is a long way off. Injustice, inequality, and impunity are the hallmarks of today's world. Amnesty International has challenged world leaders to apologise for six decades of human rights failure and to recommit themselves to deliver concrete improvements. Unless every member state is prepared to take human rights seriously, egregious acts, such as the sexual exploitation of children by peacekeepers, will continue to go unpunished despite the UN's best efforts

Determinantes de vendas de medicamentos

Uma análise da vendas da indústria farmacêutica entre países foi publicada por pesquisadores da Universidade Erasmus, de Roterdam, Holanda. (texto completo aqui) Destaca-se a questão do marketing direto, com sendo um incentivador de vendas. O Brasil ainda não caiu nesse conto, apesar de tentativas disfarçadas de divulgação de medicamentos tanto na publicidade como no "publijornalismo". Que assim se mantenha.

Sales Growth of New Pharmaceuticals Across the Globe: The Role of Regulatory Regimes

Stefan Stremersch and Aurélie LemmensErasmus Research Institute of Management (ERIM) – May 2008RSM Erasmus University / Erasmus School of Economics - Erasmus Universiteit Rotterdam

“…..Prior marketing literature has overlooked the role of regulatory regimes in explaining international sales growth of new products. This paper addresses this gap in the context of new pharmaceuticals (15 new molecules in 34 countries) and sheds light on the effect regulatory regimesni have on new drug sales across the globe. Based on a time-varying coefficient model, we find that differences in regulation substantially contribute to cross-country variation in sales. One of the regulatory constraints investigated, i.e. manufacturer price controls, has a positive effect on drug sales. The other forms of regulation such as restrictions of physician prescription budgets and the prohibition of direct-to-consumer advertising tend to hurt sales. The effect of manufacturer price controls is similar for newly launched and mature drugs. In contrast, regulations on physician prescription budget and direct-to-consumer advertising have a differential effect for newly launched and mature drugs. While the former hurts mature drugs more, the latter has a larger effect on newly launched drugs. In addition to these regulatory effects, we find that national culture, economic wealth, introduction timing, lagged sales and competition, also affect drug sales. Our findings may be used as input by managers for international launch and sales decisions. They may also be used by public policy administrators to compare drug sales in their country to other countries and to assess the role of regulatory regimes therein….”

Como jornalistas cobrem a área médica

Esse blogue não é um media watcher. Ao contrário, serve como orientação de pauta de inúmeros artigos que tem sido publicados. Essa é sua função, orientar sem "mostrar a cara". Apesar de algumas bobagens publicadas deixarem-me "muito nervoso", relevo. Agora, surgiu uma forma mais científica de avaliação de reportagens cujos tópicos apresento abaixo. Clique aqui para ver o artigo do Plos Medicine.

HealthNewsReview.org Ratings Criteria and Explanation 1. Adequately discusses costs. We believe that, in an era when health care spending represents 16% of the US gross domestic product, a story is incomplete if it does not address the costs of an approach, and a comparison with existing alternatives. We also think journalists should explore whether insurers are likely to pay for it. 2. Quantifies benefits. Stories should give some sense of the size of the potential benefits of the approach being discussed. Stories (and studies, for that matter) should also explain the benefits in absolute, not just relative, terms. 3. Adequately explains and quantifies potential harms. Stories should give a complete picture of potential harms of an approach, and quantify those potential harms in absolute terms. 4. Compares the new idea with existing alternatives. We expect that a story would put the new approach being discussed into the context of existing alternatives, with some discussion of the possible advantages or disadvantages of the new approach compared with existing alternatives. 5. Seeks out independent sources and discloses potential conflicts of interest. We expect, just as the Association of Health Care Journalists does, that journalists should “recognize that most stories involve a degree of nuance and complexity that no single source could provide. To reflect only one perspective of only one source is not wise; [journalists should] be vigilant in selecting sources, asking about, weighing and disclosing relevant financial, advocacy, personal or other interests of those [they] interview as a routine part of story research and interviews”[4]. 6. Avoids disease mongering. This criterion is an attempt to help journalists avoid promulgating the medicalization of normal states of or variations in health (e.g., baldness, menstruation, short stature, etc.). We also try to educate journalists about surrogate endpoints and about how risk factors are not diseases. With this criterion, we also remind them not to exaggerate the prevalence or incidence of a condition. 7. Reviews the study methodology or the quality of the evidence. The story should reflect an understanding that not all studies are equal. If a story does not point out some of the limitations of an observational study and does not caution about interpreting uncontrolled data, for example, we will judge it unsatisfactory. 8. Establishes the true novelty of the idea Many “new” products or procedures are not really novel. The product reported may be the sixth new member of a well-established class of drugs. It may be a device that has only been judged to be substantially equivalent to other devices already on the market. Journalists should accurately reflect the novelty (or lack thereof) of “new” products or procedures. 9. Establishes the availability of the product or procedure. Many stories report on products or procedures that are still in clinical trials. We expect journalists to explain whether something is only available via limited access in clinical trials, whether something is FDA approved, whether insurability limits availability, etc. Many news stories seem to treat FDA approval of an investigational drug as a fait accompli, making predictions about how the drug “could be” or “should be” approved and on the market within a given time frame. Such stories would be rated as unsatisfactory. 10. Appears not to rely solely or largely on a news release. We expect, just as the Association of Health Care Journalists does, that journalists should “Preserve journalistic independence by avoiding the use of video news releases or the use of quotes from printed news releases; label and credit the source whenever a portion of a video or printed news release is used” [4]. We expect a journalist to use a news release for background information only, and to then seek independent experts to comment on a development.

Participação em ensaios clínicos: leia os exemplos em negrito

Abaixo, na íntegra texto publicado essa semana no The New England Journal of Medicine. Preocupa-me no Brasil, o aparecimento do profissional de testes de bioequivalência para teste de genéricos.

Exploiting a Research Underclass in Phase 1 Clinical Trials. Carl Elliott, M.D., Ph.D., and Roberto Abadie, Ph.D. In November 1996, the Wall Street Journal reported that Eli Lilly was paying homeless alcoholics from a local shelter to participate in safety testing of new drugs at its trial site in Indianapolis. "These individuals want to help society," asserted Lilly's director of clinical pharmacology. The subjects, however, said they took part for easy money and free room and board. Although Lilly reportedly offered the lowest per diem in the business, it managed to attract poor subjects from all over the country. The medical director of the local Homeless Initiative Program said Lilly had created a "shadow economy" of paid human subjects. Today, the Lilly episode seems like an early warning about an emerging set of ethical problems. Over the past decade, clinical trials have moved from universities to private testing sites, the pressure to recruit subjects quickly has intensified, and ethical oversight has been outsourced to for-profit institutional review boards (IRBs). Payment to subjects has escalated, creating "shadow economies" in cities throughout North America and elsewhere. In 2005, Bloomberg Markets reported that SFBC International, a contract research organization, was paying immigrants to participate in drug trials under ethically questionable conditions in a dilapidated Miami motel. A few months later, nine apparently previously healthy subjects at an SFBC subsidiary in Montreal contracted latent tuberculosis during a trial of an immunosuppressant. In 2006, six healthy subjects required intensive care in a phase 1 trial of a monoclonal antibody at a London facility run by the contract research organization Parexel. For all the ethical debate over these cases, however, few commentators have addressed the most troubling question: Is it ethically problematic to pay poor people to test the safety of new drugs? Paying study subjects is not a new practice, but neither is it uncontroversial. According to regulators, payment should not be so high as to become an "undue inducement," lest subjects enroll in risky, unpleasant, or degrading trials against their better judgment. But this standard gives IRBs little practical guidance: a sum of money that the wealthy can easily resist may be very tempting for poorer people. Keeping payments low, however, seems unfair to the poor, who submit to trials precisely because they need the money. And whether or not such people are being unduly induced, the larger question is whether they are being exploited. To exploit people is to take unfair advantage of them, but there is no consensus that current trial arrangements are unfair. Defenders of the status quo argue that people who enroll in trials have agreed to their conditions, that they get paid enough to make it worth their while, and that they are made better off by the arrangement. Nevertheless, there are good reasons to believe that poor subjects are being exploited. First, poor people are less likely than wealthier ones to get access to the drugs in question, if and when they are approved. Volunteers are unlikely to have full-time employment or, therefore, to have health insurance. Placing the burden of safety testing on the poor appears to contravene article 19 of the Declaration of Helsinki, which states that medical research is ethically justified only if there is a reasonable chance that the population in which it is conducted will benefit from the results. Second, the U.S. oversight system is not well equipped to monitor a highly competitive, market-based, multinational research industry. The Office for Human Research Protections has no jurisdiction over privately sponsored studies, and the Food and Drug Administration inspects only about 1% of clinical trials. IRBs, the most important bodies charged with protecting subjects, were designed primarily to review trial design, risk–benefit ratios, and informed-consent documents. Recent research scandals — which have been uncovered largely by investigative reporters rather than regulators — have concerned a very different set of issues: fraud, conflicts of interest, unfair payment practices, and unsafe or degrading trial conditions. Such problems are magnified still further when studies are conducted at private testing sites and reviewed by for-profit IRBs that are financially dependent on research sponsors. Third, even though the purpose of phase 1 trials is to test whether new drugs are safe, most sponsors apparently do not provide free care or treatment for subjects who are injured in these trials. In fact, no agency is even tracking injuries in phase 1 trials, much less the long-term health of people who volunteer for many trials over a period of years. A recent study commissioned by the Department of Health and Human Services showed that only 16% of academic health centers provide injured subjects with free care. None compensate injured subjects for pain and suffering or lost wages. Although no comparable data are available for private research sponsors, there is little reason to believe that private sponsors are much more generous; indeed, many include disclaimers in their consent forms indicating that subjects retain responsibility for their own medical care. Most of these problems can be seen as consequences of the transformation of clinical research into a business. Many subjects in phase 1 trials today see their participation as a job. They must pay taxes on their trial income, and sponsors often require them to sign a form acknowledging their status as "independent contractors." The payment has become high enough to make participating in trials more lucrative than holding a minimum-wage job, even if subjects abide by the requirement that they wait 30 days between trials. Yet subjects get none of the rights or benefits that come with a good job, such as workers' compensation, the right to unionize, disability benefits, or health insurance. Subjects whose livelihoods depend on trial income are often reluctant to drop out of trials that turn out to be risky or unpleasant, especially if they have traveled some distance to the trial site and have invested a substantial amount of money in accommodations while waiting to enter the trial. Subjects have little incentive to be truthful about their medical history or health status because known medical problems may preclude their participation in a study. Nor do they have anyone to go to with complaints. Many say they are reluctant to complain to sponsors about poor conditions for fear of being excluded from future trials. For similar reasons, they are reluctant to go to a lawyer, even if a trial goes seriously wrong. Without actually intending to do so, policymakers have allowed participation in clinical trials to become something very close to a job. Sponsors call subjects' payments "compensation" to suggest that they are merely reimbursing participants for expenses and inconvenience, even as they fill studies with unemployed people who depend on trial income to make ends meet. They refer to paid subjects as "volunteers," implying that participation is a freely chosen act of altruism, whereas most subjects indicate that they take part in trials for the money. Regulators allow sponsors to use money to attract subjects but do not require them to provide the kinds of benefits that subjects would demand if they had more power. The result is what one Philadelphia trial subject describes as "a mild torture economy." "You are not being paid to do something," he explains. "You are being paid to endure."

Uma semana fora e, um assassino preso e outro solto.

Estive em várias atividades e compromissos na semana que se encerra. Dois eventos quase ao mesmo tempo em Brasília, mostrando que o Ministério da Saúde assume cada vez mais a direção da pesquisa e da educação na área.

No entanto, o motivo desse post é fazer eco com aqueles que querem punições severas aos crimes de trânsito. Além da lamentável morte de Rodrigo, o episódio provocou suspensão de cirurgias no Hospital, danos materiais a outro motorista etc etc. Um criminoso foi preso, mas outro está à solta à espreita para um novo assasinato...... A grande imprensa paulista não deu a mínima para o ocorrido

Meus cumprimentos às equipes de resgate, da PM e, obviamente a equipe do pronto-socorro do HU. Jovem é preso por morte de analista durante racha Plantão Publicada em 31/05/2008 às 10h24mAiuri Rebello, Diário de S. Paulo SÃO PAULO - O autônomo Thiago da Matta Rossi Faria, de 25 anos, foi preso em flagrante quando estava em observação no pronto-socorro do Hospital Albert Einstein, na zona oeste de São Paulo, na tarde de quarta-feira, após se envolver em um acidente de trânsito que resultou na morte do analista de sistemas Rodrigo Neves de Melo, de 25 anos, naquela manhã. Faria é acusado de ter causado o acidente durante um racha. A defesa do rapaz nega. Por volta das 6h30 de quarta, Faria guiava um Subaru Impreza prateado em alta velocidade, na contramão da Rua Dr. Luiz Migliano, no Morumbi, na zona sul. De acordo com quatro testemunhas que estavam no local, ele vinha em alta velocidade (acima dos 120 quilômetros por hora) e apostava racha com um Audi preto. A via é estreita e de mão dupla. O limite de velocidade no local é de 30 km/h. Por cerca de 700 metros, os dois carros teriam ficado várias vezes emparelhados, em uma disputa acirrada. Na altura da esquina com a Rua Dr. José de Andrade Figueira, em um trecho de ladeira, o Audi bateu na traseira no Subaru (que o havia fechado), perdeu o controle e se chocou violentamente de lado em um Palio que subia a rua, guiado por Rodrigo Neves de Melo. Com o impacto, o Palio foi prensado contra um furgão que vinha atrás dele. O Subaru ainda rodopiou e se chocou contra um muro em frente ao local, destruindo-o. O motorista do Audi fugiu. Nenhuma testemunha anotou a placa. O analista de sistemas foi levado pelo helicóptero Águia, da Polícia Militar, para o Hospital Universitário da USP, na zona oeste. Ele morreu horas depois, por volta das 11h30, de politraumatismo. Melo estava indo para o trabalho. De acordo com a vigilante Michele dos Santos, de 23 anos, que trabalha próximo ao local do acidente, chamava a atenção o ronco dos motores dos dois carros importados. Ela ficou com medo até que eles perdessem o controle dos veículos e batessem na cabine onde ela estava. Os carros estariam "rachando" de forma evidente. Faria foi levado pelo Serviço Atendimento Móvel de Urgência (Samu) para o hospital particular Albert Einstein. Baseado nos depoimentos das testemunhas, o delegado Walter Ferrari foi ao hospital e prendeu em flagrante por homicídio doloso (com intenção). Além disso, no veículo do jovem foi encontrada uma pequena quantidade de maconha. - Quando a pessoa assume riscos, como tirar racha, e coloca a vida dos outros em perigo conscientemente, pode ser presa e acusada de ter praticado o crime de propósito - disse o delegado-assistente do 89º Distrito Policial (Portal do Morumbi), Celso Lahoz Garcia. Faria está preso no Centro de Detenção Provisória de Osasco, em cela comum. O advogado Maurício Ozi, que defende Faria, diz que seu cliente não participava de racha. Segundo ele, o jovem estaria sendo perseguido pelo Audi preto, daí a alta velocidade. De acordo com o advogado, Faria foi abordado pelo carona do Audi em um semáforo, um quarteirões antes do local do acidente. Esse outro motorista carregaria um revólver na mão e teria anunciado o assalto, de dentro do carro. - A rua é de mão dupla, estreita e cheia de lombadas. Se fosse um racha, não seria num local tão inadequado - argumenta Ozi. Sobre a droga, o defensor diz que seu cliente não sabe como o material foi parar no carro, e que alguém deve ter colocado o entorpecente ali. Faria estaria voltando para casa, após passar a noite em seu escritório.

Uma "doença" que se esvai....a síndrome metabólica

In today's Lancet, Naveed Sattar and co-workers put yet another nail in the coffin of the metabolic syndrome. (VER POST ANTERIOR) Their analysis of longitudinal data from two independent population-based cohorts, which document the incidence of cardiovascular events or diabetes in elderly patients, shows that a fasting plasma glucose test is as good as or potentially better than a diagnosis of the metabolic syndrome for predicting diabetes. They also show that a diagnosis of the metabolic syndrome has negligible association with risk of cardiovascular disease; and that the whole is not greater than the sum of the parts. Thus diagnosis of the metabolic syndrome has no apparent clinical value. In the joint statement from the American Diabetes Association and the European Association for the Study of Diabetes on the metabolic syndrome, eight major concerns were identified. Since then, other commentaries support the concept of the metabolic syndrome or, conversely, provide additional perspectives that concerns raised in the statement were justified.Panel. Summary of concerns about the metabolic syndrome2 • Criteria are ambiguous or incomplete; rationale for thresholds is ill-defined • Value of including diabetes in definition is questionable • Insulin resistance as unifying cause is uncertain • No clear basis for including or excluding other cardiovascular risk factors • Cardiovascular risk value is variable and dependent on specific risk factors present • Cardiovascular risk associated with the syndrome seems to be no greater than sum of its parts • Treatment of syndrome is no different from treatment for each of its components • Medical value of diagnosing the syndrome is unclear

Importantly, critics of the metabolic syndrome do not question or doubt the evidence that many risk factors of cardiovascular disease are found more often in combination than chance would dictate. Thus identification of one risk factor for cardiovascular disease in a patient should prompt the search for others—even those not in the syndrome's construct. Moreover, there is no argument that results from many studies show that metabolic syndrome factors by themselves, or in any combination, portend cardiovascular disease and many other adverse outcomes. It is well known that elevated blood glucose, obesity, increased blood pressure, or dyslipidaemia are serious. Substantial evidence also shows that insulin resistance plays an important part in risk-factor clustering, and probably contributes in some way to many of the untoward outcomes attributed to the metabolic syndrome. Indeed, nearly everyone agrees that lifestyle modification is a helpful intervention for those who have one or any combination of the syndrome's components and other risk factors for cardiovascular disease or diabetes (eg, raised LDL cholesterol, smoking). On the other hand, sceptics of the usefulness of the metabolic syndrome's construct would like evidence that diagnosis of an individual with the syndrome somehow focuses attention on the need for lifestyle therapy that would otherwise be ignored or missed. They would also like evidence that such a diagnosis informs clinicians that cardiovascular disease is a multiple risk-factor model of a form they would otherwise not know, or that the diagnosis conveys the seriousness of obesity in a way not currently appreciated. They would also like evidence that the diagnosis inspires patients to take action and be more adherent to therapy than if they were diagnosed with one or more risk factors, but not the metabolic syndrome. And that the diagnosis results in a treatment that would otherwise not be recommended for modifiable risk factors, and that the construct is a valuable risk-assessment method to identify patients at increased risk of cardiovascular disease or diabetes. More than a decade since its formal introduction and thousands of papers later, these six propositions—promulgated by the proponents of the syndrome—remain no more than intriguing thoughts. However, the last argument—ie, metabolic syndrome is valuable for risk assessment and therefore its identification will improve patients' outcomes—is often considered as the syndrome's greatest strength. That people with metabolic syndrome are at increased risk of cardiovascular disease events or diabetes does not mean that the construct is useful for risk prediction in itself or compared with other approaches. First, as reviewed by Pepe and colleagues, odds ratios or relative risks regarded as giving strong associations in observational studies (eg, odds ratios of 1·2–2·5) are inadequate to distinguish between people who do (will) or do not (will not) have the outcome of interest. Much stronger associations are needed (eg, ≥4·0). Second, many reports compare metabolic syndrome with much simpler risk-assessment tests for cardiovascular disease, and those risk-assessment tests are significantly better. and Additionally, a simple fasting plasma glucose measurement is a much better predictor of future diabetes than the expense and inconvenience necessary to diagnose the syndrome.] What seems to make most sense is for clinicians to focus on global risk assessment that takes into account all the well-established cardiometabolic risk factors (and then to treat each abnormality appropriately. Also, more research is needed to understand the cause of risk-factor clustering and the pathogenesis of insulin resistance. Both actions would better serve the health of those at risk of diabetes and cardiovascular disease than seeking a diagnosis of the metabolic syndrome.

Diabetes e Sindrome Metabólica

Na edição do The Lancet dessa semana, http://www.thelancet.com para quem se inscrever e, com acesso livre para assinantes do Science Direct vários artigos de folego sobre diabetes e a tal da síndrome metabólica.Vale o passeio nesse final de feriado.

Can metabolic syndrome usefully predict cardiovascular disease and diabetes? Outcome data from two prospective studies Background: Clinical use of criteria for metabolic syndrome to simultaneously predict risk of cardiovascular disease and diabetes remains uncertain. We investigated to what extent metabolic syndrome and its individual components were related to risk for these two diseases in elderly populations. Methods We related metabolic syndrome (defined on the basis of criteria from the Third Report of the National Cholesterol Education Program) and its five individual components to the risk of events of incident cardiovascular disease and type 2 diabetes in 4812 non-diabetic individuals aged 70–82 years from the Prospective Study of Pravastatin in the Elderly at Risk (PROSPER). We corroborated these data in a second prospective study (the British Regional Heart Study [BRHS]) of 2737 non-diabetic men aged 60–79 years. Findings :In PROSPER, 772 cases of incident cardiovascular disease and 287 of diabetes occurred over 3·2 years. Metabolic syndrome was not associated with increased risk of cardiovascular disease in those without baseline disease (hazard ratio 1·07 [95% CI 0·86–1·32]) but was associated with increased risk of diabetes (4·41 [3·33–5·84]) as was each of its components, particularly fasting glucose (18·4 [13·9–24·5]). Results were similar in participants with existing cardiovascular disease. In BRHS, 440 cases of incident cardiovascular disease and 105 of diabetes occurred over 7 years. Metabolic syndrome was modestly associated with incident cardiovascular disease (relative risk 1·27 [1·04–1·56]) despite strong association with diabetes (7·47 [4·90–11·46]). In both studies, body-mass index or waist circumference, triglyceride, and glucose cutoff points were not associated with risk of cardiovascular disease, but all five components were associated with risk of new-onset diabetes. Interpretation: Metabolic syndrome and its components are associated with type 2 diabetes but have weak or no association with vascular risk in elderly populations, suggesting that attempts to define criteria that simultaneously predict risk for both cardiovascular disease and diabetes are unhelpful. Clinical focus should remain on establishing optimum risk algorithms for each disease

Doenças negligenciadas: Big Pharma não se dá tão mal quanto seus defensores brasileiros alegam

Em tradução livre: pântano ou mina de ouro? Aquilo que seria custoso e sem sentido para os interesses da Big Pharma pode ser uma fonte rentável: o mercado de países como Brasil, China e Índia, por exemplo, mesmo com quebra de patentes. Pela importância, reproduzo na íntegra o texto do The Economist.

PS: destaco a volta do senhor Yamada, agora na Gates Foundation, já motivo de comentários nesse blogue.

Quagmire to goldmine? May 15th 2008 NEW YORK From The Economist print edition The rapid growth in developing countries prompts a rethink by drugs companies Illustration by David Simonds BRAZIL has long been a thorn in the side of the global drugs companies. The country's vibrant generics industry has often trampled over their patents. As recently as last year, its government threatened to invoke compulsory licensing (a legal mechanism that, in effect, legitimises such trampling) to browbeat a foreign drugs firm into offering huge discounts. And Brazil's state-funded researchers have devised some impressive drugs, including a new therapy for malaria (see article). Small wonder, then, that big drugs firms have remained leery of this market. Indeed, they have been cautious about developing countries in general, which they have regarded as the source of many headaches and few profits. A decade ago Britain's GlaxoSmithKline (GSK) got a bloody nose in South Africa when it tried too vigorously to defend patents on an HIV drug. More recently Novartis, a Swiss firm, lost a bitter battle in India over patent protection for Gleevec, a profitable cancer drug. In Thailand the government has invoked compulsory licensing for some drugs. And next week the industry can expect another drubbing over patents harming “innovation for the poor” at the World Health Organisation's annual assembly. But consider the story of Moksha8, a new drugs firm launched last month with money from Texas Pacific Group, a private-equity outfit. It aims to capitalise on Big Pharma's neglect of many emerging economies by striking licensing deals for branded drugs which it, in turn, intends to market to affluent customers in those countries. It already has some two dozen drugs under licence for Brazil from Roche and Pfizer. Fernando Reinach of Votorantim, a Brazilian firm that also invested in Moksha8, expects its annual sales to top $1 billion within a year or two. All of which suggests that the situation is ripe for change. For much of its history, the industry has focused chiefly on the diseases that afflict people in rich countries, while largely neglecting research into diseases of the poor. But as growth slows in developed markets, and the twin threats of generic drugs and price controls advance even in pharma-friendly America, drugs companies are thinking again. That is not simply because governments in developing countries are wielding the big stick of busting patents: their expanding middle classes also provide a tantalising carrot. McKinsey, a consultancy, estimates that the value of the Indian drugs market will grow from $6.3 billion in 2005 to $20 billion in 2015. China's market is expected to soar even more spectacularly. Given such prospects for growth, says Mark Feinburg of Merck, an American drugs giant, “you've got to be in these markets—it's a great opportunity.” G.V. Prasad, vice-chairman of Dr Reddy's, a successful Indian drugs firm that is evolving from copycat to innovator, is convinced that the thinking at Western firms is changing, and cites a recent reorganisation at GSK as evidence. Andrew Witty, who takes over as the firm's chief executive on May 22nd, wants to combine all its little divisions that deal with developing countries into one emerging-markets group, to be run by Abbas Hussain, whom he has just poached from Eli Lilly, a rival American firm. Serving these markets will mean building up local expertise and research efforts. Where drugs firms have set up shop in developing markets, it has generally been to cut costs, rather than to cater to the needs of locals. But that is changing. Novartis has opened a research centre in Shanghai and has another outpost in Singapore focused on tropical diseases. Merck has struck several deals with firms in emerging markets to do early-stage research. The drugs giants argue that this new approach allows them to tap a global network of innovation, and also provides insights into local markets. Paul Herrling of Novartis points out that virally induced cancers are rare in Europe but common in China. Terry Hisey of Deloitte, a consultancy, notes that Asians and Europeans can respond differently to anaesthesia. “We see China and India as research-and-development partners, and partnerships can help us learn how to do business there,” says Robert Court of GSK. New thinking is also needed when deciding how to sell drugs in developing countries. In the past Western firms either ignored such countries or saw them as charity cases. But now, says Tachi Yamada of the Gates Foundation, who was at GSK when the firm faced the South African backlash over HIV drugs, “pharma companies can't possibly survive without recognising their responsibilities to the poor.” Some firms have adopted “differential pricing” schemes that use formulas, based on average income per head, to set lower prices in poor countries. Merck, for example, recently launched Januvia, a blockbuster diabetes drug, in India for a fraction of the price it charges in America. But in future, says Prashant Yadav of the Massachusetts Institute of Technology, firms must “price differentially not between OECD and developing-country markets, but within each developing-country market.” In other words, middle-class Indian patients will pay more than the rural poor. Both Novartis and GSK say they are thinking along these lines. But is there not a danger that cheap drugs intended for the poorest will be pilfered and sold at a profit to the urban middle classes, or shipped overseas to rich countries? This has been the standard argument against differential pricing from the drugs companies. Once again attitudes are shifting. Some diversion will happen, but firms that have tried tiered pricing have found ways to reduce it. Just changing the colour of a pill can help. So too can after-market checks on distributors and pharmacists by drugs companies: those selling looted products may be cut off from future distribution. Nan Wang of Sinovac Biotech, a Chinese vaccine firm, says her company has long sold the same vaccine at lower prices in poor parts of China than in rich cities; the two versions have different packaging. But not everyone is convinced. “In the absence of competition, differential pricing is a hoax,” scoffs Yusuf Hamied, chairman of Cipla, an Indian generics firm. In his view, only generics-makers like his firm provide genuine competition to Big Pharma, which he insists should have no patent rights in poor countries. Even if the drugs giants really have changed their approach to the developing world, the arguments over their rights and responsibilities will continue to rage.