sábado, 7 de junho de 2008

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abuse, but in this context, the threat that the rewards of trading sexual favours, such as food and safety, might be withdrawn if they speak out, makes the behaviour of the all-powerful peacekeepers even more appalling.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

quarta-feira, 4 de junho de 2008

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….”

terça-feira, 3 de junho de 2008

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."