O blog do GAT

World Health Assembly Passes Breakthrough Resolution

MSF Hails Move as ‘Crucial First Step’ toward Global R&D Framework That Meets Health Needs

Geneva, Saturday May 27th 2006 - The medical humanitarian organisation Médecins Sans Frontières (MSF) welcomes the breakthrough agreement on essential health research and development (R&D) reached today by the World Health Assembly. With a resolution passed by the annual meeting of health ministers, governments today agreed to start talks to establish a global plan of action to tackle the current crisis in R&D and to implement the recommendations of the report of the Commission on Intellectual property, Innovation and Public Health (CIPIH).

“The current system that is based on patents and high drug prices as the way to finance R&D leaves huge health needs unmet, particularly in developing countries, and it leaves millions without access to the drugs they need,” said Ellen ‘t Hoen, Director of Policy and Advocacy at MSF’s Campaign for Access to Essential Medicines. “Without political leadership, the gaping holes in essential R&D and the lack of access to innovations will never be adequately addressed. This week, we have seen health ministers take the lead, and show that they want to set the priorities, they want to find new ways of financing the development of new products, and they want to assure access to innovations for all,” she added.

By passing the resolution that was based on an initial proposal by Kenya and Brazil, countries are agreeing to work towards “…securing an enhanced and sustainable basis for needs-driven, essential health R&D.” This will ensure that patients’ needs – and not simply profits – drive medical innovation.

“For the first time, we’re starting to see action that begins to mirror the magnitude of the problems and needs that we witness everyday in our field programmes,” said Dr. Tido von Schoen-Angerer, Director of R&D at MSF’s Campaign for Access to Essential Medicines. “This is a crucial first step that will help put in place new ways of stimulating R&D for health problems that so far industry has ignored,” he added.

Published in April 2006, the CIPIH report added to the growing body of evidence showing that the system is fundamentally flawed because it steers investment towards areas of highest profitability, and thus fails to find a balance between global medical needs and resource allocation.

40,333,274 and ticking...

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International Airfare Solidarity Contribution (IASC) – Supporting Treatment of HIV/AIDS, Tuberculosis and Malaria through the Global Fund - NGO Statement, May 2006

As representatives of a number of NGOs working to combat HIV/AIDS, tuberculosis and malaria, we support the implementation of international solidarity contributions (IASC) levied on airplane tickets and their dedication to treatments through an International Drug Purchase Facility (IDPF).

On April 20-21, in Geneva, the leading Group of countries that support this initiative issued from the Paris Conference, met to define the utilization and the implementation modalities of the levy on airplane tickets.

In response to these ongoing discussions, we strongly reaffirm the importance of the following principles:

- Any funding raised from solidarity contributions should be truly additional in nature. These new resources should not reduce existing government budgets for international development – nor be counted as part of government commitments to spend 0.7 percent (or other percentages) of GNI/GDP on overseas development assistance.

- Given that funding from the IASC is likely to be stable, predictable, and long-term, the resources available should be used for support and development of the long-term treatment of HIV/AIDS, tuberculosis and malaria.

- There should be a clear commitment from all countries implementing airline ticket contribution schemes to dedicate the new resources for treatment, wholly or partly to the Global Fund to Fight AIDS, TB and Malaria. The GFATM has proven the world to be the most efficient vehicle for treating people. Let’s not weaken this institution by using other pathways through which the air ticket levy money would flow.

We are united in our support for this lifesaving linkage of the IASC and GFTAM.
May 22, 2006
GAT

A few days before his death, Dr Lee explained his vision of "universal access" to staff in his office as he worked on his speech to the World Health Assembly.

He said: "There can be no 'comfort level' in the fight against HIV. We must keep up the pressure to get prevention, treatment and care linked and working. A key outcome of "3 by 5" was the commitment to universal access to treatment by 2010. But what does universal access mean? To me, this means that no one should die because they can't get drugs. It means that no one will miss being tested, diagnosed, treated and cared for because there aren't clinics."

Aidsportugal 16.05.06

De AIDSinfo
4 de Maio de 2006

As Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents foram revistas e incluem as seguintes alterações:

Recomendação para os testes de resistências

- Recomenda-se executar um teste de resistência genotípica antes de se iniciar terapêutica anti-retroviral em doentes com infecção aguda ou crónica pelo VIH1. (BIII)
- Anteriormente recomendava-se os testes de resistências nos doentes crónicos. Os dados recentes referem mais de 16% de prevalência de resistência aos anti-retrovirais em doentes não tratados. Alguns dados sugerem que o início de terapêutica com fármacos para os quais o doente seja resistente pode resultar numa supressão viral sub-óptima. O uso de testes genotípicos permite uma selecção terapêutica com melhor custo/benefício.
- Os testes de resistências podem ser considerados em doentes que estão a ser avaliados mas que não necessitam ainda de terapêutica. (CIII)
- Na Tabela 3 faz-se uma revisão que reflectem as recomendações acima referidas.

Recomendações a interrupção terapêutica

Esta secção foi revista no sentido de incluir

1. recomendações para tratamentos anti-retrovirais de curta duração planeadas e não planeadas, tal como quando os doentes são submetidos a cirurgias ou têm reacções adversas aos fármacos graves; e

2. discussões sobre os riscos e benefícios de interrupções planeadas de longa duração em doentes infectados cronicamente com supressão viral. Os dados recentes resultantes de dois estudos prospectivos mostraram uma maior incidência de progressão para SIDA e morte em doentes que descontinuaram o tratamento com os seus Cd4+ passaram para 350 células/mm3 e que o retomaram quando os CD4+ caíram abaixo dos 250/mm3. O painel enfatizou a necessidade de mais controles clínicos, usando outras estratégias, no sentido de avaliar os riscos e benefícios da interrupção terapêutica. O painel recomendou precaução a doentes e médicos em relação à interrupção terapêutica a qual só deverá ser feita com controle clínico apertado.

Co-infecção B/VIH

Esta secção foi revista e actualizada sobre o manuseamento de doentes co-infectados com VIH e HBV.

As seguintes tabelas foram actualizadas
- Tabela 3: Esta tabela foi actualizada e reflecte as Recomendações para testes de resistências.
- Tabela 7 e 13: Estas tabelas foram actualizadas no sentido de incluírem informação tendo em vista a nova formulação do Kaletra em comprimidos de lopinavir/ritonavir 200/50mg.
- Tabelas 20-22b: As tabelas sobre interacções de fármacos foram actualizadas.

Para aceder às Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents em PDF, fazer click aqui.

Aidsportugal 16.05.06

Apesar da incidência casos de SIDA em Espanha ter diminuído 11,5 por cento de 2004 para 2005, este país continua a apresentar uma das taxas mais elevadas de infecção de toda a Europa. Cerca de 48 por cento dos novos diagnósticos de SIDA contraíram a infecção através da partilha de agulhas infectadas, enquanto que 46 por cento dos casos ocorreram por via sexual.

Entre os infectados sexualmente, cerca de 55 por cento souberam que estavam infectados quando lhes foi diagnosticada SIDA. Cerca de 77 por cento dos novos casos de SIDA são homens, com uma idade média de 40 anos. Daqueles infectados por via sexual, 31 por cento são heterossexuais e 15 por cento são homossexuais. Mais de 52 por cento das novas infecções em heterossexuais atingem mulheres.

Aidsportugal 21.05.06

Na conclusão de uma cimeira em Abuja, Nigéria, na Quinta-Feira, os líderes africanos reafirmaram o seu compromisso em fornecer aos doentes do continente acesso universal a drogas paa combater o HIV/SIDA, TB e Malária.

“Nós concordámos que teríamos acesso universal”, disse Olusengun Obasanjo, presidente Nigeriano. “Acesso Universal não é falar de 80%, nem de 90%. É falar de 100% de acesso a serviços preventivos e de tratamento”.

A União Africana patrocinou a conferência. O presidente da UA Dennis Sassou-Nguesso, presidente do Congo, disse que as nações africanas estão a ser convocadas para decretar e utilizar legislações apropriadas e regulamentos e flexibilidades de comércio internacional de modo a garantir a disponibilidade de medicamentos e comodidades a preços suportáveis” e de edificar liderança “a níveis nacionais, regionais e continentais” para mobilizar as sociedades a combater o HIV/AIDS, a TB e a Malária.

Os dirigentes também se comprometeram a regulamentar recursos locais; negociar o cancelamento das dívidas; e procurar concessões visando as três doenças . Para além disto, a cimeira concordou numa posição Africana comum para a Sessão Especial Sobre SIDA da Assembleia Geral das Nações Unidas dos próximos meses e em coordenar as abordagens dos membros aos direitos dos Africanos infectados com HIV.

Agence France Presse (05.05.06)

A WHO report finds system fails the poor

By Elisabeth Rosenthal
International Herald Tribune

SUNDAY, MAY 21, 2006

World Health Organization delegates meeting in Geneva this week will be discussing a new report that will dramatically increase pressure on pharmaceutical companies, governments and even on the organization itself to do far more to develop and provide medicines for the world's poor countries.

Commissioned by the WHO General Assembly in 2003 and released quietly last month, the expert panel report offers a stinging condemnation of the current patent-based global system for new drug development, marketing and pricing.

The current system of "research and development has not yet produced the results hoped for, or even expected, for the people of developing countries," the report of the Commission on Intellectual Property Rights, Innovation and Public Health says. While in richer nations the system "broadly works to provide the health care required by their inhabitants, this is far from being the case in developing countries."

The pharmaceutical industry and many developed countries insist that the current system of granting lucrative patents for new drugs is crucial for encouraging and financing the invention of much-needed medicines, which are almost always produced in the private sector.

But the commission, led by former President Ruth Dreifuss of Switzerland, said that this path to innovation was inadequate, because people in the developing world often cannot afford to pay for high-priced new drugs, and because they sometimes need treatments that offer little profit for drug companies.

Governments should therefore develop and finance an alternate system for drug development and distribution in the developing world, the report concluded. More controversially, it suggested that drug companies should not seek patents in poor countries.

The report marks the first time the organization has positioned itself to become so directly involved in this contentious issue, which drug companies and global health charities have argued over increasingly in recent years.

"This is a very strong call for governments and the WHO to take leadership in an area where it has not shown a lot of leadership before," said Ellen't Hoen, director of advocacy at the Médecins Sans Frontières Campaign for Access to Essential Medicines. "It is the first time the WHO has dealt comprehensively with the link between access to medicines and intellectual property rights."

Delegates meeting at the World Health Assembly in Geneva this week will take up the report Thursday or Friday, said Daniella Bagozzi, a spokeswoman for the organization in Geneva, although she said it was too early to know if its recommendations would be adopted. "In the past, research and development of medicines wasn't seen as a primary part of access, but this report says we should be working on both," she said." If the member states say this is part of WHO's mandate, then we'll take it on," Bagozzi said.

The issue gained particular urgency a decade ago, with the advent of new lifesaving AIDS drugs costing $10,000 a year, far too expensive for residents of African nations being decimated by the condition.

But it is much broader than that.

Last week, for example, the U.S. Food and Drug Administration recommended approval of the first vaccine to prevent cervical cancer, the leading cause of death from cancer among women in poor countries, which harbor 80 percent of the world's cases. In the developed world, routine tests usually detect the disease in its treatable, precancerous stages.

With that announcement, Merck, the manufacturer, announced the price: $500 for the series of three shots - making it unaffordable where it is needed most.

In the past, such cost problems have been partly remedied by a number of mechanisms: Manufacturers cut deals with poorer countries, one at a time, for discounted rates. Manufacturers of generic drugs in countries like India invoke special provisions of trade law to produce low-cost versions of patented drugs - although drug companies condemn and sometimes block the practice. And foundations and international projects, like the Gates Foundation and the Global Fund to Fight AIDS, Tuberculosis and Malaria, have managed to purchase and distribute costly drugs in pilot projects.

But these initiatives fall far short of meeting the global need, treating only a small fraction of poor patients. Although the Clinton Foundation purchases drugs for children with AIDS in central China, for example, it provides hundreds of treatment courses - not the thousands that are needed. That means that where an older brother might get the lifesaving drugs, his younger siblings would have to suffer the disease.

"The response till now has been, we have private-public partnerships and then there is Bill Gates," said 't Hoen of Médecins Sans Frontières. "What the report says is that this should not be just a matter of charity - it is a global responsibility and that political action is needed.

"Some of the loopholes that have allowed cheaper generic drugs into the developing world have been closing in recent years. A thriving generic-drug industry in India has helped bring the cost of the standard three-drug treatment for HIV, the virus that causes AIDS, down to about $150 a year. That was possible because for many years India did not have pharmaceutical patents, and poor countries invoked World Trade Organization exceptions allowing them to bypass patent laws and import such generics in the event of a national emergency.

But since January of last year, India has begun enforcing medicine patents to be fully compliant with WTO rules. Pharmaceutical manufacturers are now applying for patents for newer AIDS drugs in India, which makes generic production impossible. Newer AIDS drugs that many patients require are unavailable or prohibitively expensive in the developing world.

The WHO report concludes, "Governments have the major responsibility to mobilize funds and promote new financing and incentive mechanisms to meet our shared goals." Brazil and Kenya, two countries with serious HIV problems, have proposed that the organization's General Assembly use the report as the basis for creating some sort of global program for developing essential drugs. Both countries have come under fire from drug manufacturers and the nations where they are based for violating patents, and have even been threatened with trade sanctions.

But many health advocates worry that the organization will not heed the recommendations in the report that it solicited on intellectual property, noting that the topic was not accorded prime position on the World Health Assembly agenda this week. Dreifuss, who heads the committee that produced the report, has not been invited to address the meeting, for example, although she has spoken at seminars organized by outside groups.

Ver post em baixo:

"...António Correia de Campos considera o acesso à terapêutica um assunto global, uma vez que o nosso país consome 5% dos gastos públicos em anti-retrovíricos, pelo que apelou aos clínicos para se responsabilizarem por protocolos com despesas aceitáveis e ao mesmo tempo esforçarem-se em garantir a igualdade de acesso. ..."

Um amigo nosso fez os cálculos:

gastos totais do estado - OGE de 2006 (a): 89.771.081.901,00

gastos do MS - OGE 2006 (b): 7.780.392.479,00 (8,67%)

5% dos gastos públicos (a): 4.488.554.095,05

5% dos gastos do MS (b): 389.019.623,95

pessoas em tratamento: 12.000

custos unitários dos ARV/ano:
(a) 374.046,17
(b) 32.418,30

custo "normal": de 8 a 10 mil euros/ano

Demagogia inocente ou alguém quer cortar nos ARVs?

CNSIDA Newsletter 22.05.06

Quase vinte e cinco anos depois do aparecimento da infecção VIH/sida em Portugal, o acesso aos medicamentos anti-retrovíricos no nosso país é uma realidade muito diferente dos restantes países lusófonos que compõem a CPLP. As assimentrias são visíveis, mas Correia de Campos, ministro da saúde de Portugal assume que a cooperação com estes países deverá ser feita sem paternalismos e com participação visível das nações ajudadas. "Só com responsabilidades repartidas e rigor há sucesso", afirmou no discurso que proferiu no âmbito da visita dos dirigentes para a área da sida dos países da CPLP que estiveram em Portugal num seminário sobre saúde e desenvolvimento nos dias 18 e 19 de Maio em Lisboa.

António Correia de Campos considera o acesso à terapêutica um assunto global, uma vez que o nosso país consome 5% dos gastos públicos em anti-retrovíricos, pelo que apelou aos clínicos para se responsabilizarem por protocolos com despesas aceitáveis e ao mesmo tempo esforçarem-se em garantir a igualdade de acesso.

Atendendo às condições orçamentais, a colaboração com os países africanos terá de ser um contributo reduzido, mas António Correia de Campos mostrou-se disponível para o envio de recursos humanos para esses países, sem que isso signifique um grande peso no erário público.

Em Portugal o acesso a estes medicamentos é universal, mas existem barreiras sociológicas e até mesmo práticas a esse acesso. Por um lado nem sempre a adesão ao tratamento é efectiva, o que implica o insucesso da terapêutica, por outro lado a distância média entre o local de residência e os hospitais centrais que promovem a terapêutica é, segundo Henrique Barros, de 130KM. Contudo, há que contar com a deslocação voluntária de quem prefere receber a terapêutica num local mais distante, com o objectivo de manter maior privacidade do seu estado serológico.

Francisco George, director-geral de saúde, enumerou ainda outras limitações, de índole prática, como o facto dos tratamentos apenas estarem disponíveis em hospitais, impedindo os centros de saúde de promoverem campanhas de adesão ao tratamento, assim como a impossibilidade dos médicos privados tratarem doentes infectados e poderem prescrever terapêuticas. Isto acontece, segundo Francisco George, "por causa de uma exigência forte na formação dos profissionais de saúde que acompanham os tratamentos e também por razões de contenção orçamental, já que todos os encargos com os tratamentos são suportados pelo Serviço Nacional de Saúde".

De acordo com Henrique Barros, Coordenador Nacional para a Infecção VIH/sida, há actualmente cerca de 10 mil pessoas em tratamento em Portugal. Henrique Barros lamenta ainda a sub-notificação exageradamente elevada em Portugal, apelando assim não só aos clínicos para a notificação dos casos diagnosticados, como também à população em geral para a realização do teste de diagnóstico da infecção.

"If I'd have known 20 years ago that in 2006 I'd be watching a whole new generation facing this tragedy, I don't think I would have had the strength to continue."

Cleve Jones, creator of the AIDS Memorial Quilt, commenting on the commemoration of 25 years of AIDS (Newsweek, May 15, 2006).

Novo Boletim Infarmed Notícias (Número 20/IISérie . Maio 2006)

Secretário-Geral nomeia Jorge Sampaio, antigo Presidente da República de Portugal, primeiro Enviado Especial para a iniciativa “Acabar com a Tuberculose”

O Secretário-Geral da ONU, Kofi Annan, nomeou o antigo Presidente da República de Portugal, Jorge Sampaio, seu primeiro Enviado Especial para a iniciativa “ Acabar com a Tuberculose”. Jorge Sampaio, cuja nomeação se torna efectiva hoje, terá como principal missão sensibilizar o público para esta doença, uma das principais causas de morte do nosso tempo. A sua tarefa imediata é incentivar os dirigentes de todo o mundo a reforçarem o seu empenhamento no controlo da tuberculose e a esforçarem-se por alcançar o Objectivo de Desenvolvimento do Milénio que consiste em pôr fim à propagação da doença, até 2015, e começar a inverter a tendência actual.

Cerca de 5 000 pessoas morrem diariamente de tuberculose e mais de 8 milhões de novos casos são detectados todos os anos. Jorge Sampaio irá dirigir uma campanha que visa que os países financiem e ponham plenamente em prática o plano mundial “ Acabar com a Tuberculose 2006-2015”, lançado no início do ano pela Organização Mundial de Saúde (OMS). Este plano apresenta as acções necessárias para tratar 50 milhões de doentes e salvar 14 milhões de vidas. Para levar a bom termo esta missão essencial a favor da saúde, Jorge Sampaio trabalhará em estreita colaboração com a Parceria “ Acabar com a Tuberculose” e a OMS.

Jorge Sampaio, que teve uma ilustre carreira, traz uma vasta e rica experiência para as suas novas funções. Tomou posse como Presidente da República de Portugal em Março de 1996, tendo sido reeleito para um segundo mandato de cinco anos, em Janeiro de 2001. Ao longo desse período, Jorge Sampaio contribuiu para várias causas internacionais, nomeadamente a luta contra o VIH/SIDA, os direitos humanos ou ainda a independência de Timor Leste.
...
(Fonte: Comunicado de Imprensa SG/A/1004 - BIO/3769 de 15/05/2006).

New York, 22 May 2006. Mark Harrington, Executive Director of Treatment Action Group, a US-based research and treatment activist organization, issued this statement today.

People living with HIV/AIDS (PLWHA) around the world should take a moment and recognize the pivotal contributions to their lives made by Dr. LEE Jong-Wook, the Director General of the World Health Organization from 2003 until his death this morning. TAG expresses its solidarity with all those who are mourning the loss of this transformative leader in the world’s struggle against AIDS.

Unusually among global leaders, Dr. Lee made transforming the world’s response to HIV/AIDS one of his leading priorities. Until he took over, WHO’s efforts to respond strongly and comprehensively to the HIV/AIDS pandemic had been in abeyance for over a decade, since the years when Jonathan Mann ran the Global Programme on AIDS (GPA) until the mid-90s.

Under his watch, and with his whole support, WHO – for the first time in the pandemic’s relentless and devastating twenty-five year eruption and global spread – took a leading role in guiding the response to the pandemic.

The signature initiative of Dr. Lee’s brief tenure at WHO was the ‘3x5' initiative, which sought to provide countries with technical assistance, resources, motivation, and guidance to treat three million of the estimated six million HIV-infected persons in developing countries who needed antiretroviral therapy by the end of 2005.

Time was short when Lee came into office, but he deliberately endorsed this ambitious scale-up target as he believed the pandemic required an emergency response in keeping with its explosive, uncontrolled, and fatal nature.

Under Lee’s leadership, the WHO HIV Department was revitalized and enlarged and associated with the tuberculosis (TB) and malaria departments in an HIV, TB, and Malaria (HTM) cluster, which enabled the responses to the three diseases to be better coordinated within WHO and with outside agencies such as the Global Fund to Fight AIDS, TB, and Malaria.

Many donor countries and many developing countries did not appreciate WHO suddenly taking a leading role in demanding that the global response to HIV/AIDS include a strong commitment to scaling up access to antiretroviral treatment (ART). Some countries such as the US opposed the setting of global targets, while other countries such as South Africa claimed the right to set their own targets for scale-up, though when 3x5 was launched in early 2003, not one South African was yet receiving ART through the public sector.

Catalytic activism on the ground led by grassroots advocacy groups such as the Treatment Action Campaign (TAC), substantial donor funds from GFATM and the US-led President’s Emergency Program for AIDS Relief, and technical assistance by the WHO 3x5 team led to an astonishing 800% increase in access to ART in sub-Saharan Africa between early 2003 and December 2005.

While the 3x5 target of 3 million people on ART by December 2005 was not met, the global numbers of individuals on ART went up by 400% between 2003-2005, and twice that rate in sub-Saharan Africa.

Significant problems remain. Access to treatment is not always equitably distributed between men and women, or between urban and rural areas. Children lag behind in access to ART. Comprehensive services providing prevention, care, and treatment, are not yet available in most places. Weak health systems, inadequate human resources for health, and problems with expensive drugs and inadequate procurement and supply chain management systems have impeded the rate and scope of ART scale-up. Much work remains to be done as the emergency 3x5 response is transformed into a sustainable build-up towards the goal of as close as possible to universal access to HIV/AIDS prevention, care, and treatment by the end of 2010. On Wednesday the International Treatment Preparedness Coalition (ITPC) will release its report on Missing the Target – Off Target for 2010: How to Avoid Breaking the Promise of Universal Access (http://www.aidstreatmentaccess.org/), which will lay out what donors, countries, and technical agencies need to do to more successfully sustain the ART scale-up process.

WHO’s HIV work remains desperately underfunded. Less than 25% of the funds it needs to support countries in scaling up HIV prevention, care, and treatment in 2006-2007 are on hand. Donors repeatedly refuse to support WHO’s most important efforts, while simultaneously criticizing it for over-ambitious targets. This must change. Without much greater support, WHO cannot help countries build up their health systems to improve treatment and care for HIV, TB, malaria, and other diseases of the poor.

None of these hurdles and obstacles however – which had been used as excuses by global leaders and health bureaucrats for two decades to avoid responding fully to HIV/AIDS in developing countries – takes away the historical accomplishment in ART scale-up and delivery which has occurred in the past three years, with substantial credit due to the World Health Organization (WHO) for its catalytic role in supporting 3x5.

Many share the credit for this work, including Drs. Bernhard Schwartländer, Paulo Teixeira, and Jim Kim, who led the WHO HIV Department in the years from 2002-2005, but it was Dr. Lee’s commitment that made the entire organization change its response to HIV/AIDS from an indolent and inadequate one to the truly comprehensive global emergency response the pandemic required.

For this reason, PLWHAs, activists, and people around the world who support universal access to HIV care and treatment – including antiretroviral treatment – should remember Dr. Lee’s contribution as they fight for ambitious scale-up targets to be included in next month’s United Nations General Assembly meeting to review and update the UNGASS political declaration of 2001.

Sérgio Vitorino - Panteras Rosa:

Como suspeitávamos, apesar do anúncio por parte do Instituto Português do Sangue de que as normas relativas à doação estarão prestes a ser alteradas para deixar de excluir os dadores homossexuais, a discriminação continua a ser actualmente praticada com os mais discriminatórios dos argumentos que têm sido utilizados por este organismo.

Recentemente, várias Panteras da cidade do Porto testaram a possibilidade de doação no Hospital de Stº Antº, para verem recusada a sua doação após preenchimento do inquérito. Argumentos utilizados pela médica responsável:

- "os bancos de sangue recusam a doação por parte de homossexuais porque a Lei a proíbe".
- "o sexo anal é muito mais duro e comporta mais riscos de contaminação" - como todos sabemos, heterossexuais não fazem dessas coisas
- "os homossexuais são considerados mais promíscuos e sujeitos a infecção".

Continuamos confiantemente à espera de que as regras mudem por si, como prometido? Não, parece-nos que não!...

Veremos se o Prof Miguel Pereira do Alto Comissariado apoiará a resolução na próxima semana em Genebra.

Governments Must Move Forward with Global R&D Framework at World Health Assembly

Geneva, 19 May 2006 – As health ministers meet in Geneva at the WorldHealth Assembly (WHA) next week, the medical humanitarian organisationMédecins Sans Frontières (MSF) is calling on governments to overhaul theway medical research and development (R&D) is prioritised and financed, andsupport a resolution proposed by Kenya and Brazil for a “global frameworkon essential health R&D.” Despite gathering increasing support from manygovernments, this resolution has faced consistent obstruction on the partof the WHO Secretariat.

The proposed resolution is boosted by the analysis and recommendationsreached by the report of the independent Commission on IntellectualProperty, Innovation and Public Health (CIPIH), which was set up by the WHAin 2003. The report confirms that the current system, which relies onpatents to stimulate innovation, does not foster the necessary research toaddress the needs of billions of people in developing countries.

Tuberculosis is a perfect example of how the system is broken. “Despitemassive needs and close to two million deaths a year, we are still forcedto use a test that only detects half of all cases, and use long, cumbersomeand increasingly inefficient treatment,” said Dr. Tido von Schoen-Angerer,Director for R&D at MSF’s Campaign for Access to Essential Medicines.

This is because the R&D system provides greater rewards for developingdrugs that sell well, rather than drugs that meet unaddressed health needs.Pharmaceutical companies therefore largely ignore the needs of patients indeveloping countries, while gearing their research towards wealthy markets.A new analysis by MSF shows that only 1% of the drugs reaching the marketin the three decades between 1974 and 2004 address neglected diseases suchas kala azar, sleeping sickness, or tuberculosis.

“The CIPIH report is a strong call for action by governments and WHO,” saidEllen ‘t Hoen, Director for Policy and Advocacy at MSF’s Access Campaign.“It’s been a long uphill struggle to get WHO interested in this question,and if you look at the enormous health needs out there, you think, how onearth is this the case?” she added.

“Governments need to commit to changing the rules of the game, or peoplewill continue to die because the diseases they suffer from don’t provideprofits,” said Dr. Rowan Gillies, International President of MSF, speakingat a press conference in Geneva. “If this WHA doesn’t come out with astrong initiative, paving the way for a new needs-driven R&D framework andsecuring its public financing, WHO and governments will have again missed avital opportunity to tackle urgent health needs,” he added.

Although product development is not a traditional activity for a medicalhumanitarian organisation, MSF increasingly has no choice but to act inthis field. After having been a co-founder of the Drugs for NeglectedDiseases Initiative (DNDi) three years ago, the organisation is nowcollaborating with the Diagnostics Development Unit at CambridgeUniversity, which is developing a much-needed simple, cheap and rapid HIVviral load test for use in resource-poor settings, called SAMBA (Simple AMplification BAsed nucleic acid test).

Right now, the difficulty of diagnosing HIV in small children inresource-poor settings is an obstacle to putting them on life-prolongingtreatment, so a simple and affordable test is an urgent priority. Ifsuccessfully developed, the SAMBA test will help diagnose HIV in infantsand improve treatment monitoring in adults.

“We are aiming to simplify current technologies so that children withHIV/AIDS can be diagnosed and virological failure can be detected on thespot, without the need for specialised facilities, highly trained personneland expensive equipment,” said Dr. Helen Lee, the researcher leading theproject at Cambridge University.

“We feel compelled to support the development of vital health tools,because industry is failing to address the needs of the most vulnerable,and governments and the WHO are not taking responsibility either,” said Dr.von Schoen-Angerer. “What we are doing is just a stopgap measure. Preciselythis kind of R&D is what needs to happen on a much wider scale, and needsto be supported through a global framework,” he added.

WHO 19.05.06

The World Health Organization announces new standards for registration of all human medical research

19 MAY 2006 BRUSSELS/GENEVA --

The World Health Organization (WHO) is urging research institutions and companies to register all medical studies that test treatments on human beings, including the earliest studies, whether they involve patients or healthy volunteers. As part of the International Clinical Trials Registry Platform, a major initiative aimed at standardizing the way information on medical studies is made available to the public through a process called registration, WHO is also recommending that 20 key details be disclosed at the time studies are begun.

The initiative seeks to respond to growing public demands for transparency regarding all studies applying interventions to human participants, known as clinical trials. Before making the recommendations announced today, the Registry Platform initiative consulted with all concerned stakeholders, including representatives from the pharmaceutical, biotechnology and device industries, patient and consumer groups, governments, medical journal editors, ethics committees, and academia over a period of nearly two years.

"Registration of all clinical trials and full disclosure of key information at the time of registration are fundamental to ensuring transparency in medical research and fulfilling ethical responsibilities to patients and study participants," said Dr Timothy Evans, Assistant Director-General of the World Health Organization.

Although registration is voluntary, there is a groundswell of policies aimed at spurring registration of all clinical trials. In July 2005, for example, the International Committee of Medical Journal Editors, a group representing 11 prestigious medical journals, instituted a policy whereby a scientific paper on clinical trial results cannot be published unless the trial had been recorded in a publicly-accessible registry at its outset.

Some groups have raised concerns that these new requirements could jeopardize academic or commercial competitive advantage if they apply to preliminary trials of new interventions. Similar concerns have been voiced about the requirement to disclose certain items--such as the scientific title of the study, the name of the treatment being tested and the outcomes expected from the study--at the time of registration.

"Our aim is to make clinical research transparent and enhance public trust in science, but we are engaged in a fair and open process with all stakeholders. We look forward to continued dialogue about trial registration and results reporting as we move forward with the Registry Platform," said Dr Ida Sim, Associate Director for Medical Informatics at the University of California, San Francisco and coordinator of the Registry Platform initiative.

The planned Registry Platform will not be a register itself, but rather will provide a set of standards for all registers. It has not only standardized what must be reported to register a trial but is creating a global trial identification system that will confer a unique reference number on every qualified trial.

Currently, there are several hundred registers of clinical trials around the world but little coordination among them. The Registry Platform seeks to bring participating registers together in a global network to provide a single point of access to the information stored in them.

Later this year, the WHO Registry Platform will launch a web-based search portal where scientists, patients, doctors and anyone else who is interested can search among participating registers for clinical trials taking place or completed throughout the world.

The Economist 26.04.06

Marijuana is medically useful, whether politicians like it or not

IF CANNABIS were unknown, and bioprospectors were suddenly to find it in some remote mountain crevice, its discovery would no doubt be hailed as a medical breakthrough. Scientists would praise its potential for treating everything from pain to cancer, and marvel at its rich pharmacopoeia-many of whose chemicals mimic vital molecules in the human body. In reality, cannabis has been with humanity for thousands of years and is considered by many governments (notably America's) to be a dangerous drug without utility. Any suggestion that the plant might be medically useful is politically controversial, whatever the science says. It is in this context that, on April 20th, America's Food and Drug Administration (FDA) issued a statement saying that smoked marijuana has no accepted medical use in treatment in the United States.

The statement is curious in a number of ways. For one thing, it overlooks a report made in 1999 by the Institute of Medicine (IOM), part of the National Academy of Sciences, which came to a different conclusion. John Benson, a professor of medicine at the University of Nebraska who co-chaired the committee that drew up the report, found some sound scientific information that supports the medical use of marijuana for certain patients for short periods - even for smoked marijuana.

This is important, because one of the objections to marijuana is that, when burned, its smoke contains many of the harmful things found in tobacco smoke, such as carcinogenic tar, cyanide and carbon monoxide. Yet the IOM report supports what some patients suffering from multiple sclerosis, AIDS and cancer -and their doctors- have known for a long time. This is that the drug gives them medicinal benefits over and above the medications they are already receiving, and despite the fact that the smoke has risks. That is probably why several studies show that many doctors recommend smoking cannabis to their patients, even though they are unable to prescribe it. Patients then turn to the black market for their supply.

Another reason the FDA statement is odd is that it seems to lack common sense. Cannabis has been used as a medicinal plant for millennia. In fact, the American government actually supplied cannabis as a medicine for sometime, before the scheme was shut down in the early 1990s. Today, cannabis is used all over the world, despite its illegality, to relieve pain and anxiety, to aid sleep, and to prevent seizures and muscle spasms. For example, two of its long-advocated benefits are that it suppresses vomiting and enhances appetite -qualities that AIDS patients and those on anti-cancer chemotherapy find useful. So useful, in fact, that the FDA has licensed a drug called Marinol, a synthetic version of one of the active ingredients of marijuana-delta-9-tetrahydrocannabinol (THC). Unfortunately, many users of Marinol complain that it gets them high (which isn't what they actually want) and is not nearly as effective, nor cheap, as the real weed itself.

This may be because Marinol is ingested into the stomach, meaning that it is metabolised before being absorbed. Or it may be because the medicinal benefits of cannabis come from the synergistic effect of the multiplicity of chemicals it contains.

Just what have you been smoking?
THC is the best known active ingredient of cannabis, but by no means the only one. At the last count, marijuana was known to contain nearly 70 different cannabinoids, as THC and its cousins are collectively known. These chemicals activate receptor molecules in the human body, particularly the cannabinoid receptors on the surfaces of some nerve cells in the brain, and stimulate changes in biochemical activity. But the details often remain vague -in particular, the details of which molecules are having which clinical effects.

More clinical research would help. In particular, the breeding of different varieties of cannabis, with different mixtures of cannabinoids, would enable researchers to find out whether one variety works better for, say, multiple sclerosis-related spasticity while another works for AIDS-related nerve pain. However, in the United States, this kind of work has been inhibited by marijuana's illegality and the unwillingness of the Drug Enforcement Administration (DEA) to license researchers to grow it for research.

Since 2001, for example, Lyle Craker, a researcher at the University of Massachusetts, has been trying to obtain a licence from the DEA to grow annabis for use in clinical research. After years of prevarication, and pressure on the DEA to make a decision, Dr Craker's application was turned down in 2004. Today, the saga continues and a DEA judge (who presides over a quasi-judicial process within the agency) is hearing an appeal, which could come to a close this summer. Dr Craker says that his situation is like that described in Joseph Heller's novel, "Catch 22". "We can say that this has no medical benefit because no tests have been done, and then we refuse to let you do any tests. The US has gotten into a bind, it has made cannabis out to be such a villain that people blindly say 'no'."

Anjuli Verma, the advocacy director of the American Civil Liberties Union(ACLU), a group helping Dr Craker fight his appeal, says that even if the DEA judge rules in their favour, the agency's chief administrator can still decide whether to allow the application. And, as she points out, the DEA is a political organisation charged with enforcing the drug laws. So, she says, the ACLU is in this for the long haul, and is already prepared for another appeal -one that would be heard in a federal court in the normal judicial system.

Ms Verma's view of the FDA's statement is that other arms of government are putting pressure on the agency to make a public pronouncement that conforms with drug ideology as promulgated by the White House, the DEA and a number of vocal anti-cannabis congressmen. In particular, the federal government has been rattled in recent years by the fact that eleven states have passed laws allowing the medical use of marijuana. In this context it is notable that the FDA's statement emphasises that it is smoked marijuana which has not gone through the process necessary to make it a prescription drug. (Nor would it be likely to, with all of the harmful things in the smoke.) The statement's emphasis on smoked marijuana is important because it leaves the door open for the agency to approve other methods of delivery.

High hopes
Donald Abrams, a professor of clinical medicine at the University of California, San Francisco, has been working on one such option. He is allowed by the National Institute on Drug Abuse (the only legal supplier of cannabis in the United States) to do research on a German nebuliser that heats cannabis to the point of vaporisation, where it releases its cannabinoids without any of the smoke of a spliff, and with fewer carcinogens.

That is encouraging. But it does not address the wider question of which cannabinoids are doing what. For that, researchers need to be able to do their own plant-breeding programmes.

In America, this is impossible. But it is happening in other countries. In 1997, for example, the British government asked Geoffrey Guy, the executive chairman and founder of GW Pharmaceuticals, to come up with a programme to develop cannabis into a pharmaceutical product.

In the intervening years, GW has assembled a "library" of more than 300 varieties of cannabis, and obtained plant-breeder's rights on between 30 and 40 of these. It has found the genes that control cannabinoid production and can specify within strict limits the seven or eight cannabinoids it is most interested in. And it knows how to cross breed its strains to get the mixtures it wants.

Nor is this knowledge merely academic. Last year, GW gained approval in Canada for the use of its first drug, Sativex, which is an extract of cannabis sprayed under the tongue that is designed for the relief of neuropathic pain in multiple sclerosis. Sativex is also available to a more limited degree in Spain and Britain, and is in clinical trials for other uses, such as relieving the pain of rheumatoid arthritis.

At the start of this year, the company made the first step towards gaining regulatory approval for Sativex in America when the FDA accepted it as a legitimate candidate for clinical trials. But there is still a long way to go.

And that delay raises an important point. Once available, a well-formulated and scientifically tested drug should knock a herbal medicine into a cocked hat. No one would argue for chewing willow bark when aspirin is available. But, in the meantime, there is unmet medical need that, as the IOM report pointed out, could easily and cheaply be met -if the American government cared more about suffering and less about posturing.

DN 10.05.06

"Já há informação suficiente para agir. " A frase é de Henrique Barros, coordenador nacional da luta contra o HIV-Sida, mas foi repetida pela maioria dos especialistas internacionais no combate às doenças infecto-contagiosas em meio prisional que estiveram presentes no primeiro dia de um colóquio em Lisboa sobre "drogas e saúde nas prisões". Um colóquio em que os responsáveis pelas prisões portuguesas primaram pela ausência, enquanto seus homólogos da Espanha e Suíça apresentaram as respectivas experiências de troca de seringas e tratamentos de substituição.

Membro do grupo de trabalho interministerial que deverá apresentar em Junho um Plano de Acção para Combate à Propagação das Doenças Infecciosas em Meio Prisional, Henrique Barros lembrou que "tem havido na última década muitas comissões que fazem estudos e propõem muita coisa e não se vai além disso", acrescentando: "Espero que desta vez isso não suceda".

Defensor, como João Goulão, presidente do Instituto da Droga e da Toxicodependência (e também membro do referido grupo de trabalho), da criação de projectos-piloto de troca de seringas no meio prisional português, Barros considera que a medida é necessária mas já não tão fundamental como há 10 ou 15 anos, "quando, por se estar no auge do consumo de heroína injectável, podia ter feito uma grande diferença. Infelizmente, vem tarde...".

Prometida na fase final do governo de António Guterres como parte da estratégia de redução de danos, a troca de seringas nas prisões tem sido objecto de um braço de ferro entre os responsáveis da saúde e da justiça. A não participação da Direcção Geral dos Serviços Prisionais (DGSP) no colóquio organizado no Instituto de Higiene e Medicina Tropical pela SOMA (associação portuguesa anti-proibicionista) parece ser mais um episódio.

A justificação oficial é de que essa participação poderia ser entendida como "pressão ou ingerência no funcionamento" do grupo de trabalho inter-ministerial. Do qual a presidente é a directora dos Serviços da Saúde da DGSP, Graça Poças, que, apesar de estar mencionada no programa do colóquio como integrante de uma das mesas, garante nunca ter dado o seu assentimento para tal. "Nunca confirmei a minha presença e considero isso um abuso de confiança." Quanto à essência da questão - a aplicação ou não de novas medidas de redução de danos do consumo de drogas nas prisões -, a responsável admite que o grupo de trabalho "vai sugerir troca de seringas em alguns estabelecimentos".

DN 07.05.06

Estima-se que 40% dos casos de sida em Portugal afectem indivíduos com mais de 50 anos, existindo uma tendência crescente que se vem avolumando desde 1998. Só em 2003 houve mais casos notificados em pessoas com mais de 65 anos heterossexuais do que entre 1983 e 1993.

A revelação foi feita por Ana Campos Reis, da Santa Casa da Misericórdia de Lisboa - que participou ontem, em Évora, num simpósio sobre a sexualidade na terceira idade -, tendo sido fundamentada com a experiência desta especialista, que trabalha actualmente com 3000 infectados com HIV, sendo que cerca de 1200 se situam entre os 50 e os 87 anos.

A mesma responsável lamentou que Portugal não esteja a saber lidar com esta situação, garantindo que têm faltado respostas do serviço de saúde, dos lares e da própria escola, indo ao ponto de alertar que não vale a pena trazer muitos dados estatísticos à liça por estar convicta de que os casos de sida notificados em Portugal (entre 28 a 30 mil) estão "muito abaixo" do valor real. Por isso, diz, "será necessário multiplicar por dez" para se conseguir chegar mais próximo da realidade nacional.

Ana Campos Reis acha que o país procura "esconder a doença", dando como exemplos casos dos próprios médicos que, para protegerem os seus pacientes, não os notificam. É a forma de evitarem a sua marginalização social, não faltando exemplos de idosos a quem só é diagnosticado o vírus HIV quando algumas patologias, como a tuberculose, não cedem aos medicamentos. Verifica-se depois que a contaminação remonta há 15 ou mesmo 20 anos."

O problema é que quando um idoso surge num lar com sida tentam que ele saia, pelo que enquanto houver pessoas estigmatizadas pelo HIV há médicos que se calam e nunca teremos dados nem frontalidade para tratar a doença. Temos que mudar de mentalidade, porque se um pediatra disser que um menino está infectado com sida, esse menino também não entra na escola", disse, recordando como há uns anos Portugal só tinha notificados os casos que existiam no Hospital de Santa Maria, como se eles fossem toda a realidade nacional. Mais recentemente, na Madeira, a notificação não passava de cinco ou seis casos, apesar de num congresso uma médica ter dito que tinha cem infectados na sua consulta.

Para minimizar este flagelo, Ana Campos Reis sugere que sejam dados passos em matéria de Educação Sexual, adjectivando-a de "tão importante" como o Português ou a Matemática. "É um problema grave de saúde pública e é isso que os nossos governantes têm de perceber."

Aids Portugal 21.04.06

“Como melhorar a cobertura jornalística da epidemia do HIV/SIDA nos países lusófonos africanos” é o tema de um workshop que decorre em Namaacha, de 24 a 27 de Abril, organizado por PlusNews-Português.

Participam no workshop jornalistas de Angola, Guiné-Bissau e Moçambique, além da brasileira Roseli Tardelli, fundadora e directora da Agência de Noticias AIDS, sediada em São Paulo, Brasil.

“Por causa da língua e da história, estes países são marginalizados do fluxo pan-africano de informação sobre HIV/SIDA, e PlusNews preenche este vazio em quantidade e qualidade,” disse o coordenador global do PlusNews, Obinna Anyadike.

O PlusNews informa sobre as actividades dos governos, sociedade civil e doadores, com dados epidemiológicos, análises de peritos e o contexto da crise humanitária, política, económica e cultural do HIV/SIDA.

Os artigos do PlusNews-Português são regularmente reproduzidos, na internet, pelo Programa Nacional de DST e AIDS do Brasil, Agência Aids do Brasil, Aids Portugal e o portal SIDA de Moçambique. Em Angola, os artigos são usados pelo semanário Cruzeiro e a Rádio Nacional de Angola; e em Moçambique pelos semanários Savana e Meia-noite.

A inovação “CoraçãoAberto”, um blog que arrancou com a emocionante história da seropositiva moçambicana Ana Maria Muhai, é uma das atracções de momento. Colaboram no workshop o UNICEF, Médicos do Mundo, Conselho Nacional de Combate a SIDA de Moçambique e a Embaixada do Brasil em Maputo.

Por causa do workshop, a página do PlusNews-Português voltará a ser actualizada no dia 2 de Maio.

COLÓQUIO INTERNACIONAL

Recomendações, Experiências e Práticas
www.soma-apa.pt

Dias 9 e 10 de Maio de 2006

Instituto de Higiene e Medicina Tropical (IHMT), UNL

Auditório, Rua da Junqueira nº 96

Lisboa, Portugal

9 de Maio 2006 (SESSÃO PLENÁRIA) (com interpretação simultânea)

9.15/ 9.30 ABERTURA

•Dr. António Almeida Santos, ex-Presidente da Assembleia da República
•João de Menezes Ferreira Cons. Direc. SOMA (Presid.)
•Patrocinadores: IDT e CNsida (M. S.), DGSP (M.J.), IHMT, Fundação Calouste Gulbenkian

9.30 / 11.15 TEMA I ENQUADRAMENTO INTERNACIONAL

Pres./moder. Mª José Campos (SOMA)

Comunicações

•Lars Moller/Martin Donoghoe WHO/OMS (Org. Mundial Saúde) Project Manager Health in Prisons Project and Illicit Drugs

•Ralf Jürgens Law Degree (McGuill Univ., Montréal), Law Doctorate (Munich Univ.), Former Executive Director 1998-2004 (Canada HIV/AIDS Legal Network)
•Dagmar Hedrich Project Manager redução de riscos Chloe Charpentier, Project Manager Prisões EMCDDA/OEDT (Observatório Europeu)

Intervenções da sala/debate

EATG (European Aids Treatment Group) Mauro Guarinieri,

CEEHRN (Central and Eastern Europe Harm Reduction Network) Raminta Stuikyte

Coffeebreak

11.30 / 13.00 TEMA II SITUAÇÃO NACIONAL

Pres./moder. Luís Andrade (SOMA)

Comunicações

•Dr. Nascimento Rodrigues Provedor de Justiça

•Doutora Anália Cardoso Torres, ISCTE «Toxicodependência nas prisões: um diagnóstico»

•Dr.ª Graça Poças, Directora dos Serviços de Saúde, DGSP
Intervenções da sala/debate

reclusos, FORUM PRISÕES, ACED, etc.

Almoço

14.30 / 16.00 TEMA III BOAS PRÁTICAS ESTRANGEIRAS

Pres./moder. Luís Mendão (SOMA)

Comunicações

•Alemanha Prof. Heino Stöver, Universidade de BremenDirector, Archive and Documentation Center for Drugs

•Espanha Dr. Julián S. Sanz Director dos Serviços Prisionais de Adição

•Suiça Dr. Heinz Stutz Direcção da prisão Oberschöngrün, «10 anos - da repressão à prescrição de heroína»

Intervenções da sala/debate

Jorge Alves, Sindicato Nacional Corpo Guardas Prisionais,

Pedro Silvério Marques, GAT

16.00 / 17.30 TEMA IV BALANÇO E PERSPECTIVAS

Pres./moder. Eurico Figueiredo

Pres. Cons. Científico SOMA

Comunicações

•Prof. Ambros Uchtenhagen, Universidade de Zürich Chairman, Research Institute for Public Health Addiction

•Prof. Henrique Barros Coordenados CNsida

Intervenções da sala/debate

deputados nacionais (líderes juventudes partidárias), deputados ao Parlamento Europeu (Sérgio Sousa Pinto, Assunção Esteves, Miguel Portas, etc.)

Coffee break

17.45 / 18.30 ENCERRAMENTO

Pres./mod. Conselho Directivo e Conselho Científico SOMA

•Conclusões relator: João de Menezes Ferreira (SOMA)

•Intervenção final Dr. João Goulão Presidente IDT

10 de Maio 2006 (SESSÃO GRUPOS DE TRABALHO)

9.30 / 10.00 APRESENTAÇÃO DOS GRUPOS DE TRABALHO

(com interpretação simultânea)

Pres./moderador Mike Trace (RAPT - Rehabilitation for Addicted Prisoners Trust) Chief Executive (BECKLEY FOUNDATION) e Coordenadores:

Peter Wiessner (EATG)

Cinzia Brentari ENDIPP (European Network on Drugs and Infections Prevention in Prison) Project Manager for Europe

Lars Möller (WHO/OMS)

10.00 / 11.30 GRUPOS DE TRABALHO

•Grupo 1 Intervenção das ONGs e das Organizações de Base nas Prisões

•Grupo 2 Questões práticas dos profissionais dos serviços prisionais (experiências, alemã, espanhola, Suiça, portuguesa, etc.) (com interpretação simultânea)

•Grupo 3 Propostas de boas práticas e linhas de orientação para as prisões na Europa

coffee break

12.00 / 13.30

Discussão e Apresentação das Conclusões dos Grupos de Trabalho (materiais para Recomendações de Lisboa sobre «Drogas, Saúde Pública e Prisões»)

Mike Trace e Coordenadores (com interpretação simultânea)

x-x-x-x-x-x-x-x-x-x-x-x-x-x-x-x-x-x-x-x-x-x-x-x-x-x-x-x-x-x-

Destinatários preferenciais do Colóquio: pessoal (funcionários e contratados) dos CATs do IDT e dos Serviços de Saúde das Prisões (DGSP): guardas prisionais, médicos, enfermeiros, assistentes sociais, etc. Reclusos.

Inscrições : 50 € (Redução para estudantes e membros de ONGs)

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Organização: SOMA–Associação Portuguesa Antiproibicionista

Patrocínios Oficiais em Portugal: IDT e CNSida (MS), DGSP (MJ), Fundação Calouste Gulbenkian

Apoios internacionais: EATG, IHRD

A 7° Edição do International Workshop on Clinical Pharmacology on HIV infection, realizado em Lisboa de 20 a 22 de Abril de 2006, permitiu uma actualização compreensiva de diversos temas como interacções farmacológicas recentemente estudadas, modelos e simulações farmacocinéticas, toxicidade induzida por fármacos e farmacogenética, farmacocinética de fármacos em desenvolvimento, e farmacovigilância pós-comercialização. No Workshop foi apresentado o estado actual da Monitorização Sérica da Terapêutica (TDM) e a sua inclusão em guidelines clínicas.

As apresentações e posters, permitem antever um ambiente competitivo no mercado do tratamento anti-retroviral, com muitos novos fármacos a completar classes terapêuticas existentes ou inaugurar novas classes e novos mecanismos de acção farmacológica.

Outro assunto de destaque foi a discussão da uniformização conceptual e estrutural da informação a incluir nos Summary of Product Caracteristics (SPCs) dos Estados Unidos (correspondentes aos RCMs na Europa), particularmente em relação aos dados pré-clínicos e de farmacocinética clínica/interacções farmacológicas, na presença de representantes da FDA. É de esperar uma preocupação comparável das autoridades regulamentares europeias.

Lusa 21.04.06

A Associação Portuguesa de Medicamentos Genéricos (APOGEN) comprometeu-se hoje a apoiar a introdução em Portugal dos genéricos produzidos nos países de língua portuguesa, ao mesmo tempo que pretende implantar-se nesses países.

"Quando Angola, Cabo Verde e Moçambique fabricarem bons medicamentos devemos abrir-nos a esse mercado", defendeu Jorge Ruas da Silva, em declarações à margem do primeiro simpósio Luso-Brasileiro e Africano de Medicamentos Genéricos, que se realizou hoje em Lisboa.

Segundo o Presidente da APOGEN, aquela associação "vai intervir junto das autoridades portuguesas, cabo-verdianas, brasileiras, angolanas e moçambicanas, a solicitar que dêem às empresas idêntico tratamento".

Os responsáveis da área farmacêutica pretendem introduzir em Portugal e na Europa os bons medicamentos brasileiros e levar os medicamentos portugueses de boa qualidade à América do Sul, Brasil, Angola, Cabo Verde e Moçambique.

A acessibilidade da população aos medicamentos é uma preocupação das autoridades de Cabo Verde, Moçambique e Brasil, como foi expresso no encontro de hoje.

Foi exactamente para permitir uma maior acessibilidade aos medicamentos que Cabo Verde adoptou em 1976 a política dos genéricos, afirmou Judith Lima, presidente do Conselho de Administração da INPHARMA, que se dedica à produção nacional de medicamentos.

"Em Cabo Verde, o mercado é totalmente de genéricos (...) o médico é obrigado a prescrever sob o nome genérico e mesmo quando o prescreve com o nome comercial o medicamento vendido na farmácia é um genérico", explicou, sublinhando que isto permitiu baixar em 30 a 40 por cento o preço dos medicamentos.

Também em Moçambique há um mercado de genéricos desde 1977, segundo Renato Ronda, Presidente do Conselho de Administração da MEDIMOC, Medicamentos de Moçambique.
"O primeiro formulário nacional de medicamentos editado em Moçambique já mencionava o medicamento na sua designação comum internacional, ou genérico", salientou, frisando que no sector público (hospitais do Estado) 100 por cento dos medicamentos prescritos são genéricos.
O sector privado (clínicas privadas) prescreve apenas cerca de 10 por cento do total de medicamentos.

"Foi definido pelo Governo que os medicamentos, para entrarem em Moçambique devem ser acessíveis e de boa qualidade, portanto têm que ter um preço bom para que a maioria da população possam adquiri-los", frisou.

A título de exemplo referiu os antiretrovirais, medicamentos para a SIDA, que em Moçambique são todos genéricos, e que o país compra ao melhor preço seguindo as recomendações da Organização Mundial de Saúde (OMS).

No Brasil, que ocupa o 10º lugar no mercado de medicamentos do mundo (10 mil milhões de dólares), há actualmente 1.847 registos de medicamentos genéricos, 310 substâncias activas, 91 classes terapêuticas, e 66 laboratórios, segundo Dirceu Raposo Mello, presidente da Agencia Nacional de Vigilância Sanitária (ANVISA).

O sistema de saúde é universal - todo o cidadão, brasileiro ou não, em território brasileiro tem direito a atendimento médico gratuito, adiantou.

Apesar disso, o acesso aos medicamentos reflecte a qualidade de vida dos brasileiros: 15 por cento da população (os mais abastados) consome 48 por cento dos medicamentos, 34 por cento consume 36 por cento e 51 por cento (os mais pobres) 16 por cento.

Actualmente em Portugal os genéricos representam 14 por cento do mercado de medicamentos, mas segundo Ruas da Silva esta quota poderá ainda aumentar. Neste contexto lembrou que a produção de genéricos portugueses para o mercado externo aumentou quatro vezes entre 2004 e 2005.
(...)

Lusa 27.04.06

Especialistas e activistas reunidos durante quatro dias na Cidade do Cabo defenderam a necessidade de desenvolver um microbicida de aplicação local para reforçar a prevenção contra o HIV/SIDA.

No último dia da conferência "Microbicidas 2006, uma epidemiologista insistiu na necessidade de ser aperfeiçoado um microbicida eficaz contra o HIV, mas alertou que um tal produto deve ser comercializado de forma atractiva para mulheres e homens para que não tenha a mesma carga de preconceitos associados aos preservativos.

Sarah Whitehead recorreu a vários estudos - conduzidos nomeadamente na Tailândia e na África do Sul - para defender que os microbicidas não deverão ser rotulados como "preventores de doenças", mas sim como lubrificantes do acto sexual, estimuladores sexuais ou contraceptivos para que se tornem mais atractivos para os utilizadores.

Em discussão esteve também o nível de partilha entre homens e mulheres na utilização de um tal mecanismo de prevenção.

Usando um teste clínico efectuado na Tailândia com um microbicida em forma de gel, aquela especialista salientou que metade dos homens envolvidos no estudo declararam que o gel provocou um aumento do prazer sexual e que 41 por cento deles auxiliaram as suas parceiras na colocação do gel antes do acto sexual.

Definido como "um importante auxiliar na luta contra o HIV/SIDA", particularmente porque dá às mulheres a capacidade de se protegerem mesmo em situações e ambientes culturais adversos, o microbicida em gel foi defendido pela conferência e o seu pleno desenvolvimento e comercialização incentivados.

Apesar dos benefícios óbvios e dos testes clínicos já realizados e em curso, a conferência concluiu que a colocação no mercado de um produto deste género não deverá ocorrer antes de 2010.

"Tendo em consideração que demorámos 25 anos a encarar a luta contra a SIDA de uma forma séria, 2008 (ano em que se esperam os resultados dos primeiros testes conclusivos do microbicida) não me parece muito distante", desabafou Gita Ramjee, do Conselho Sul-Africano de Pesquisa Médica e co-presidente da Conferência.

"Precisamos de um microbicida já", exortou Graça Machel, mulher do ex-presidente da África do Sul Nelson Mandela, na abertura da conferência, no domingo passado, perante uma salva de palmas dos cerca de mil delegados presentes.

Lembrando que em África 76 por cento dos seropositivos no grupo etário dos 15 aos 24 anos são mulheres, Graça Machel salientou a necessidade de o mundo aumentar o financiamento na pesquisa de um microbicida eficaz contra as células portadoras de HIV para os 280 milhões de dólares/ano de forma a tornar este projecto uma realidade acessível às mulheres.

Será preciso investir esta soma nos próximos cinco anos e convencer as multinacionais farmacêuticas de que quaisquer riscos que corram neste projecto poderão ser cobertos por vendas nos países em desenvolvimento, onde o produto é uma necessidade premente, disse Machel.

Segundo esta activista, um microbicida com um grau de eficiência de apenas 06 por cento poderá ajudar a prevenir 3,7 milhões de novas infecções em três anos se for utilizado por mulheres incapazes de exigir aos seus parceiros sexuais a utilização de preservativos, concluiu Graça Machel na abertura da conferência.

BMJ 2006;332:1050 (6 May), doi:10.1136/bmj.332.7549.1050-a

Watchdog gives spoof awards for aggressive marketing of drugs

London Owen Dyer

The lobbying group of the US drug industry, Pharmaceutical Research and Manufacturers of America (PhRMA), last week won two spoof awards from a watchdog that tracks aggressive and misleading marketing by the industry.

PhRMA led the field in the second annual Bitter Pill awards, winning prizes in two categories from the Prescription Access Litigation Project, a national umbrella organisation of 118 consumer health advocacy groups.Aggressive marketing is driving up health costs and encouraging patients to take drugs they do not need, argued Jerry Avorn, a professor at Harvard Medical School and one of the organisers of the awards. "As a physician I have seen how the avalanche of direct to consumer drug advertising infects the doctor-patient relationship," he said.

The first of the two awards was for the organisation's guidelines on direct to consumer advertising, which the consumer pressure group claimed were ineffective, not least because they had no enforcement mechanism. It was called the "Fox Guarding the Hen House" award.

PhRMA received even less flattering recognition with the "Truth is Stranger than Fiction" award, for "commissioning a hackneyed thriller to scare Americans about Canadian drugs."

In an effort to discourage drug purchasing across the border the PhRMA consultant Mark Barondess last year persuaded the industry group to spend $100 000 (£54 600; EURO79 300) underwriting a thriller in which Islamic terrorists put poison in Canadian generic drugs to kill American consumers (BMJ 2005;331:1103). After seeing the manuscript Mr Barondess tried to cancel the project, but the authors went ahead with publication despite legal threats.
The Karasik Conspiracy was published in December but with a new plot wrinkle: in addition to the terrorists, a fictional US drug company plans its own attack to scare consumers away from Canadian drugs.

The Bitter Pill "counter awards" were timed to coincide with the industry's own national awards for the most effective direct to consumer drug advertisements.Direct to consumer campaigns featured in three of this year's Bitter Pill awards, with the dubious honours shared among five of the country's best selling drugs.

The "Got Cholesterol?" award, given for "overpromoting expensive brand name statins," was presented to Pfizer's atorvastatin (Lipitor) and AstraZeneca's rosuvastatin (Crestor).
Rosuvastatin was the subject of a Food and Drug Administration enforcement letter last year, over a television advertisement claiming that the drug was more effective than other statins.

The Driven to Distraction Award, "for hawking an attention deficit drug by distracting consumers with ADHD [attention-deficit/hyperactivity disorder]," went to Eli Lilly, for a televised advertisement for its drug atomoxotine (Strattera). This advertisement showed daily life as a video game, in which a person lost points for being distracted or disorganised. Messages describing these penalties flashed on the screen as the drug's side effects were being shown.

In a letter of complaint the FDA charged that the graphics worked to "undermine the consumer's ability to pay attention to and comprehend risk information." But by the time the letter was issued the campaign was over. Last September the atomoxotine campaign was a winner at the Pharmaceutical Advertising and Marketing Awards.

The "While You were Sleeping" award, given for "overmarketing insomnia medications to anyone who's ever had a bad night's sleep," was shared between zolpidem (Ambien and Ambien CR, made by Sanofi-Aventis), and eszopiclone (Lunesta, made by Sepracor).

The Bitter Pill organisers described Ambien CR as a successor drug, designed primarily to stave off generic competition when the original Ambien's patent expires in 2007. Eszopiclone's advertising campaign cost Sepracor $215m last year-more than the company's average quarterly revenue. Sepracor is now reporting net profits for the first time, largely on the strength of sales of eszopiclone.

None of the drug companies named in the awards had returned calls from the BMJ requesting comments as the journal went to press.

But PhRMA last month set up a new panel to "review trends in direct to consumer (DTC) advertising as they relate to PhRMA's voluntary Guiding Principles." Professor Lawrence Brown of the University of Tennessee, who chairs the new panel, said: "DTC advertising can play a valuable role in educating patients and health care providers about health issues and options. However, over the years, there have been concerns that DTC may oversell benefits and undersell risks or lead to inappropriate prescribing practices." He said he hoped the new panel would "help DTC advertising and the PhRMA Guiding Principles live up to their potential."

May 4, 2006

DSMB Recommends That all clinical studies in maraviroc phase 3 development program continue without change

Studies fully enrolled with patient volunteers


Pfizer reported that the independent Data Safety Monitoring Board (DSMB) for maraviroc, Pfizer’s CCR5 antagonist in development for the treatment of HIV, met in April 2006 as part of their scheduled review of the phase 2b/3 development program. The maraviroc DSMB is an independent group that includes experts who specialize in the treatment of patients with HIV/AIDS. The ongoing review of data by the DSMB helps to ensure the safety of patients participating in the studies.

The clinical development program evaluating maraviroc for HIV/AIDS has enrolled more than 2000 patients representing more than 750 patient years of follow up observation that began in December 2004. The studies have been fully recruited and are closed to further enrollment.

Based on their April 2006 meeting the DSMB recommended that the four Phase 2b/3 clinical studies for the investigational drug continue as currently designed. The DSMB further reported that they continue to see no evidence of maraviroc associated hepatotoxicity, including those patients receiving concomitant tipranavir. Their review of HIV-associated malignancies such as Non-Hodgkin's Lymphoma and Kaposi's Sarcoma, observed within the maraviroc Phase 2b/3 development program, found the incidence to be consistent with known rates of these malignancies in similar HIV-infected populations.

For more information about maraviroc clinical trials, please visit www.clinicaltrials.gov.

By Gregg Gonsalves

Rage Against the Machine: Anti-Politics and the AIDS Epidemic


By ‘political’ I mean having to do with power: who’s got it, who wants it, how it operates; in a word, who’s allowed to do what to whom, who gets what from whom, who gets away with it and how.
Margaret Atwood “Second Words”


We're so busy putting out fires right now, that we don't have the time to talk to each other and strategize and plan for the next wave, and the next day, and next month and the next week and the next year. And, we're going to have to find the time to do that in the next few months. And, we have to commit ourselves to doing that. And then, after we kick the shit out of this disease, we're all going to be alive to kick the shit out of this system, so that this never happens again.
Vito Russo “Why We Fight”


I told a few friends the other day that I was worried that I was turning into a shrieking harpy. There is no doubt that I have been horribly angry for the past 15 years. I have watched the AIDS epidemic flourish, mow down friends, family and colleagues and despite the vast sums of money and hives of activity devoted to combating the disease, new infections erupt in the millions and millions more die horrible, painful deaths each year.

I do blame my government, other governments, drug companies, conservative religious institutions, and a rogue’s gallery of other villains, but, lately, I can’t help but think of my own role, our community’s role in perpetuating the epidemic. I’ve written about this phenomenon twice now, once in a piece for the International AIDS Conference in Bangkok, called “How to Lose the War on AIDS,” and then again for a meeting convened by the Lawyers’ Collective in Mumbai last year, in a paper called “It Ain’t What You Do, but the Way That You Do It: Ten Points on International AIDS Treatment Activism.” I am still stuck thinking about this, largely because despite my attempts to provoke a conversation about how we do this work, nothing seems to change very much in our modus operandi.

The AIDS epidemic has everything, in Margaret Atwood’s words, “to do with power: who’s got it, who wants it, how it operates; in a word, who’s allowed to do what to whom, who gets what from whom, who gets away with it and how.” We knew this once, the rallying cry of ACT UP was that AIDS is a political crisis; we know this is still true particularly in places where the fight is conceived as an essentially political one: by South Africa’s Treatment Action Campaign, by Russia’s Front AIDS, by Thailand’s Thai Drug Users’ Network, by Costa Rica’s Agua Buena Human Rights Association.

Don’t get me wrong, I do believe that AIDS is recognized as a political crisis by many, many people. Think of the dozens of sign-on letters we write and circulate, the meetings we attend to pound on the table, the reports, the press releases we put out demanding this, demanding that. However, I have the sickening feeling that there has been a tremendous domestication of our political resistance--we trade on the legacy of our activist past or the reputation of our fiercest living champions, but as a movement, we have become a paper tiger.

Let’s take the upcoming United Nations General Assembly Special Session on HIV/AIDS in New York in May 2006 where governments will come to boldly lie about their records in fighting AIDS and make hundreds of new, empty promises. UNAIDS has staged a series of consultations leading up to this gathering to develop a framework to achieve universal access to HIV prevention, care and treatment by 2010. Activists were hand-picked by UNAIDS to attend most of these consultations, where UN and government officials listened to the needs of people living with HIV/AIDS, of sex workers, drug users, women, men-who-have-sex with men and other “vulnerable” populations, wrote them up in reports and issued the findings in glossy newsletters put together just for the occasion. The UNGASS meeting will culminate in yet another political declaration on HIV/AIDS, based in part on these consultations and more centrally on negotiations with the governments that compose the UN’s membership on what they can agree to support. Tremendous amounts of energy, money and time have been invested in these processes over the past six months. I was part of the “Global Steering Committee” on Universal Access and attended three meetings and helped to develop pages and pages of input for UNAIDS, hundreds of my colleagues are now busy finalizing “shadow reports,” deciding who will go to New York City in May, who will be selected to speak at the UN, organizing satellite events to highlight important issues. Will anyone listen to us? Does anyone care what we have to say?

Has anyone asked why the hell we’re devoting millions of dollars and hours to this process, when the previous UNGASS in 2001 resulted in a “Declaration of Commitment,” which was honored neither in word nor deed? What are the opportunity costs for activists that are now hip deep in this bullshit? What work hasn’t been done or could have been done with this time, this money? The UN system is a system made for and by governments. Why are we engaging with a system in which we are not represented and is beholden not to us but to its member states? Yes, “the international community must do more about HIV.” But the international community doesn’t exist as an institution, there are countries and countries have leaders. Imagine if all these resources expended by the community alone for this May meeting in New York City had been devoted to national campaigns demanding that governments honor what they promised 5 years ago? Or towards building real infrastructures for national, regional and international advocacy on HIV/AIDS? Or training each other on how to push for political change?

I can hear Zackie Achmat’s voice in my head calling me an ultraleftist for refusing to deal with institutions to affect change. Well, Zackie and TAC engage with their government on a daily basis and have created a national infrastructure to press for political change. I am not suggesting that there is no use in the UNGASS meeting in May, particularly when it is part of a comprehensive political response to the AIDS crisis. However, for many people, the UNGASS meeting in May has a role that is isolated from any other kind of political activity and has taken on a significance that it doesn’t deserve. For me, the frenzy around the UNGASS meeting represents an anti-political moment. The UNGASS’s role, its real contribution, to paraphrase Arundhati Roy, is to defuse political anger and blunt the edges of political resistance.

How did we get here? Well, not to over-simplify, but I think that we’ve seen an NGO-ization of HIV/AIDS that has weakened or destroyed our ability to build a social movement to fight for our right to health, to be free of discrimination and violence, to the other services we need to stay alive and free from HIV infection. We’ve also seen people living with HIV/AIDS, sex workers, women, men-who-have-sex-with-men, ethnic minorities, young people, drug users who are also working in the field become essential monsters: that is they think and act as if the greater involvement of people with AIDS (GIPA) or their “vulnerable” group has a value in and of itself, as if they have some special purchase on knowledge or rights simply because of who they are instead of linking those rights to a responsibility to engage politically in a feminist, anti-racist, anti-homophobic, pro-sex, pro-harm reduction, and pro-poor struggle that links us in solidarity, in commonality with each other, with millions of other people for whom other struggles perhaps matter more than our own.

What would I love to see? Well, it would be great if we could have the chat that Vito Russo asked for in 1988. I’d like us to ask if the institutions and organizations we’ve built up are really working towards achieving political change or are actually stymieing it. How accountable are our NGOs to people living with HIV/AIDS and communities affected by the epidemic at the district level, the province, the country, the region, the planet? Are we creating institutions that seek to justify their own existence, their own organizational survival and expansion at the expense of challenging the powers-that-be: governments, UN agencies, drug companies, etc? Who is setting the agendas for our work? Are these agendas in the service of achieving specific, local political accountability or are they making calls for a more diffuse, generalized, international responsibility? Are we becoming carpetbaggers, itinerant technocrats, damn missionaries, toting our expertise around the globe trying to help people in other countries to solve their own problems or are we trying to promote local solutions to local problems by local people? Are we just talking about change, rather than mobilizing for it, trying to make it happen? Are we just managing change, trying to turn resistance into “a well-mannered, reasonable, salaried, 9-to-5 job,” channeling the struggle into a three-day media event in New York City in May, a weeklong international AIDS conference in Toronto in August, and endless series of meetings, reports, conference calls and email exchanges?

I also want to stop talking about GIPA-the greater involvement of people living with HIV/AIDS. I am sick of GIPA and will not promote it any longer. Roy Cohn, the vicious, nasty, conservative asshole had AIDS and he was gay to boot. Roy Cohn sent Julius and Ethel Rosenberg to the electric chair and sat at the right hand of Senator Joseph McCarthy in the 1950s when he persecuted hundreds of decent Americans for communist sympathies, whether or not they had then or ever been members of the Communist Party. He was not part of my community. Do women want to claim Margaret Thatcher as one of their own? Do gay men want to claim Ernst Rohm, commander of the Nazi storm troopers as a fellow fag? Do Africans want to claim Idi Amin or Hendrik Verwoerd among their kin? If your own sense of your history or politics is based on biology, serostatus, country of origin, gender, sexuality, well, get ready to get in bed with all of the folks mentioned above. This kind of identity politics excuses everything and accepts no political responsibility.

It’s time we start asking each other: what are you doing to promote the reproductive and sexual rights of women; to fight rape and violence against women; to promote access to HIV/AIDS prevention, care and treatment, to education, to safe and affordable housing and other basic services regardless of gender, sexuality, ethnic origin, regardless of ability to pay? What are you doing to legalize methadone, buprenorphine, syringe exchange and reform drug and narcotics regulation, protect sex workers from harassment, ensure they have working conditions that don’t endanger their health or well-being? What are you doing to ensure that young people get comprehensive information about sexuality, STIs and HIV/AIDS? Let’s base our personal commitment to the fight against HIV/AIDS not on who we are, but what we do for others and not just for those who are like us, but those who are different in whichever way each of us chooses to categorize it. If we hold our organizations accountable, we have to hold ourselves accountable too.

So, I am one pissed off sister. I am angry at the epidemic, but angry about a machine we’ve created that drains the politics out what is happening around us, that, in fact, fosters both an institutional and personal anti-politics that fuels the fires of HIV/AIDS. I don’t know when we’ll all get the chance to talk, but we need to have a conversation about where we’re going and how we’re going to get there. Otherwise, we’ll see each other at the next UNGASS in another 5 years’ time and realize we’ve been driving around in circles all this time, never recognizing we’ve seen this all before, our journey hasn’t even started and the car is, sadly, out of gas.

Agência Aids 01.05.06

Tenzin Gyatso, o dalai-lama, em seu último dia de visita ao Brasil, defendeu o uso da camisinha. Durante entrevista publicada na edição deste domingo, 30, na Folha de S.Paulo, ele disse que considera o preservativo “o melhor método para o controle da natalidade. Controle populacional é necessário. O mundo já tem 6 bilhões de habitantes. Há uma enorme diferença de renda entre famílias pobres e ricas. Essa lacuna não é só moralmente errada mas também um problema social.”
...

Agência Aids 29.04.06

A Organização dos Estados do Caribe Oriental (OECS, sigla em inglês) se beneficiará de um suprimento de medicamentos anti-retrovirais fornecido pelo Brasil, nos próximos cinco anos, informou um comunicado do Mercado Comum e Comunidade do Caribe (CARICOM).

O relações públicas do escritório da CARICOM, Calvin Brown, declarou esta semana que os preços dos medicamentos ainda serão estabelecidos. Mas ele disse que eles serão inferiores aos atuais preços de mercado. Brown informou que os anti-retrovirais estavam sendo fornecidos sob um acordo especial e estavam sendo financiados pelo governo brasileiro.
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Agência Aids 29.04.06

As autoridades de saúde dos EUA iniciaram uma investigação sobre denúncias de transplantes realizados com tecidos infectados com vírus como o HIV, os da hepatite B e C e o da sífilis. Fontes médicas disseram hoje que a Administração de Drogas e Alimentos (FDA) alertou médicos, hospitais e laboratórios para a suposta existência de tecidos infectados.

A denúncia envolve a empresa Biomedical Tissue Services (BTS), que não teria cumprido as normas estabelecidas. Seus tecidos poderiam conter vírus. A BTS rejeitou as acusações. A denúncia foi apresentada por pacientes que apresentaram resultado positivo nos exames para detectar a presença dos microorganismos, disseram fontes judiciais.

As fontes informaram que até agora dois homens, um em Nebraska e o outro em Ohio, abriram processos contra a empresa. Equipes de advogados estão investigando as outras denúncias.

Nos Estados Unidos, são feitos aproximadamente 1 milhão de intervenções cirúrgicas envolvendo o transplante de tecidos extraídos de cadáveres. A retirada do material tem que ser aprovada pelo doador, antes de morrer, ou pela sua família.

As normas da FDA exigem uma análise exaustiva do doador, uma avaliação física e outros testes para confirmar que não existem doenças perigosas nos tecidos. Assim, segundo o órgão, são mínimas as possibilidades de transmissão de doenças através dos tecidos oferecidos pela BTS. No entanto, os advogados de mais de 100 pessoas que disseram ter recebido implantes de tecidos da BTS desafiaram as afirmações.

Segundo uma das denúncias, Steve Fogle se submeteu a uma operação de fusão espinhal em agosto de 2005. Cinco meses depois, ele recebeu uma carta de seu médico, dizendo que o tecido implantado poderia ter sido infectado. No entanto, garantia que o material tinha sido esterilizado e que o risco de infecção era muito baixo. Dois meses depois, os exames revelaram que ele sofria de hepatite C.

No caso de Ned Jackson, em Nebraska, os documentos judiciais informam que em agosto de 2003 ele se submeteu a um implante na parte inferior das costas. Dois anos depois, os exames determinaram que ele tinha contraído hepatite B e C.

Arjun Srinivasan, epidemiólogo dos Centros para o Controle e Prevenção de Doenças (CDC) afirmou que está investigando as denúncias. No entanto, "será muito difícil determinar com certeza se existe alguma relação entre a infecção no tecido do receptor e a do tecido do doador", disse.

Lusa 24.04.06

Representantes de 20 países começaram a analisar hoje, em Maputo, a Iniciativa de Emergência do Presidente norte-americano contra a Sida (PEPFAR), um programa polémico por incidir na fidelidade e abstinência, em detrimento do uso do preservativo.

O PEPFAR foi lançado em 2003 por George W. Bush e coloca uma verba de cerca de 12 mil milhões de euros à disposição de países pobres afectados pela Sida, incluindo Moçambique.

O programa impõe, no entanto, como condição da ajuda que esta seja prioritariamente utilizada na promoção da abstinência e fidelidade e só, secundariamente, na promoção do preservativo, como decorre do próprio nome dado pelos norte-americanos à estratégia - "abordagem ABC" (Abstinence, Be faithful, use Condom).

Na semana passada, o mais conhecido jornal de medicina do mundo, o britânico The Lancet, criticou aquela estratégia, acusando-a de incapacidade para evitar a morte de crianças por HIV/SIDA.

Segundo o jornal, a "abordagem ABC" condiciona a distribuição de fundos, dos quais um terço é destinado a promoções para a abstinência e fidelidade, provocando o corte financeiro de campanhas como a da prevenção da transmissão da doença de mãe para filho.

Como exemplo, The Lancet aponta mesmo o caso de Moçambique, onde o programa de prevenção de transmissão vertical (de mãe para filho) carece de mais fundos do que os disponibilizados.

No âmbito da iniciativa do Presidente Bush contra a Sida, Moçambique vai receber este ano 76 milhões de euros, o que representa um aumento de cerca de 28 milhões de euros em relação ao apoio prestado no ano passado.

Moçambique é um dos países mais afectados pelo HIV/SIDA no mundo, com uma taxa de incidência de 16,2 por cento dos cerca de 19 milhões de habitantes.

Lusa 21.04.06

O Centro de Aconselhamento e Detecção Precoce do VIH/SIDA do Porto vai oferecer, a partir de segunda-feira, exame e diagnóstico gratuitos para esta doença, anunciou hoje, no Porto, fonte da Administração Regional de Saúde do Norte.

A fonte referiu que não é necessária qualquer marcação, sendo a consulta gratuita para os cidadãos, nacionais ou estrangeiros, na sede daquele organismo, na Rua da Constituição, nº 1.656.

O atendimento é garantido por um psicólogo e um enfermeiro, que estão aptos a dar toda a informação e aconselhamento ao doente.

A partir de segunda-feira, será efectuado o teste rápido, pelo que o utente ficará a saber o resultado na mesma consulta.

Caso seja positivo, a equipa de atendimento proporcionará ao doente todo o aconselhamento necessário, encaminhando-o para os serviços especializados de tratamento, nomeadamente os serviços de Infecciologia dos hospitais.

Finalmente começam a mudar...

Lusa 27.04.06

A utilização do preservativo como forma de evitar a propagação da Sida, no seio do casal, foi hoje admitida como podendo ser encarada como um "mal menor" pelo vice-presidente da Conferência Episcopal Portuguesa (CEP), D. António Montes.

Comentando a anunciada divulgação, em breve, de um documento do Vaticano revendo a posição da Igreja quanto ao recurso ao preservativo para evitar a propagação da Sida, D. António Montes defendeu que a Igreja tem como missão, também, "apresentar a finalidade da sexualidade", num tempo em que se fala "do uso do preservativo de forma desgovernada".

"A vivência da sexualidade de uma forma anárquica, pode ter como consequência que o preservativo seja visto como panaceia universal", disse o vice-presidente da CEP, esclarecendo que "o exercício da sexualidade só tem uma verdadeira dimensão humana e cristã se for um veículo de amor, só se realiza num matrimónio heterossexual e monogâmico".

"Se no contexto desse matrimónio, algum ou os dois estão infectados, aí a utilização do preservativo é o chamado caso do mal menor", admitiu, durante a conferência de imprensa final da Assembleia Plenária da CEP, que hoje terminou em Fátima.
...

Lusa 28.04.06

O príncipe Harry de Inglaterra fundou no Lesoto uma organização de beneficência para crianças órfãs por causa da Sida, seguindo o trabalho da mãe, a falecida princesa Diana, informou o gabinete do pai, o Príncipe de Gales.
(...)
O Lesoto é um dos países mais pobres do mundo, com um Produto Interno Bruto (PIB) por habitante que não ultrapassa, em média, 451 dólares por ano.
Cerca de 31 por cento dos seus 1,8 milhões de habitantes estão infectados pelo vírus do HIV-SIDA, uma das taxas mais altas do mundo, e a pandemia foi declarada "emergência nacional".

New HCV Drugs- Protease Inhibitors & Polymerase inhibitors and Drug Resistance

from Jules Levin
EASL, May 1, 2006,
Vienna, Austria

As I leave Vienna today & return to NYC a very important message is the potential development and risk associated with newly developed HCV protease inhibitors. You should recall 10 years ago the impact of HIV drug resistance, particularly drug resistance associated with HIV protease inhibitors & NNRTIs. Emerging out of the 41st EASL conference in Vienna this year 2006 is a message from regarding HCV protease inhibitors.

Early during the meeting Vertex Pharmacueticals reported results from drug resistance research conducted in accordance with the 14-day monotherapy study of their new HCV protease inhibitor VX-950. They used an assay they reported detected drug resistant mutation variants present at about 5% of frequency. They reported single and double drug resistance mutations emerged during therapy and later double mutation changes emerged, and IC50s increased. After VX-950 therapy stopped at the 14-day mark HCV viral load increased and resitance mutations started to not be detected and wild-type virus started to emerge. By the time of 3-7 months later wild-type virus was about 65% for the patient group who had viral "breakthrough" on therapy, about 90% for the patient group who had viral "plateau" on therapy and for the patients who had vira; "continuing decline" on therapy. The presentation by Vertex was called elegant research by a number of researchers & doctors in the audience.

These findings suggest that like in HIV, HCV drug resistance is a concern, certainly at this point in time. That until we see longer term clinical study results we need to pay attention to this issue. also during the EASL meeting Vertex reported the results from the small 14-day study which included some patients receiving VX-950 plus Pegasys and after 14-days it appeared that the combination fully suppressed the patients HCV viral load and Vertex reported that after VX-950 was stopped due to study protocol and patients remained on Pegasys/RBV all patients remained with undetectable HCV RNA.

So, as with HIV it appears combination therapy in HCV may be crucial to full suppression of HCV. Of note, Schering Plough reported the results of their HCV protease inhibitor 14-day study. They reported only 1 patient had 1 HCV drug mutation. I went to the microphone after the presentation and asked why they only reported this 1 mutation finding after Vertex had such an elegant presentation. The presenter said to me and the entire audience that they used an assay which was not sensitive and the Schering PI SCH 503034 was not potent enough for resistance to emerge. For several days numerous people came up to me to discuss my question & the response and this was a hot topic at the meeting.

The important point here is that HCV drug resistance is an important point to be concerned about, that combination therapy appears to be important in suppressing HCV & in preventing cross-resistance to drugs in the same class, and that exposing oneself to a new oral antiviral HCV drug until we better understand the impact of drug resistance for HCV drugs can put one at risk for drug resistance unless full suppression is achieved.