sexta-feira, junho 30, 2006
Boehringer avisa sobre efeito adverso do tipranavir
This AE has not been correlated to TPV (according to BI) as the incidence of this side effect is normally 0,4% per year in treatment while in the TPV trial was of 0,2% (14 patients on 6000).
Nevertheless BI decided to inform pharmacovigilane in US and a first Dear Dr. letter was edited recently in Canada. More Dear Dr. letters are planned in Europe and US.
(ver Dear Dr. letter aqui)
BI has updated its package insert with the following Black Box warning:
APTIVUS CO-ADMINISTERED WITH 200 MG RITONAVIR HAS BEEN
ASSOCIATED WITH REPORTS OF BOTH FATAL AND NON-FATAL
INTRACRANIAL HEMORRHAGE. (SEE WARNINGS)
From the Warning section of the package insert:
APTIVUS, co-administered with 200 mg of ritonavir, has been associated with reports of both
fatal and non-fatal intracranial hemorrhage (ICH). Many of these patients had other medical
conditions or were receiving concomitant medications that may have caused or contributed to
these events. No pattern of abnormal coagulation parameters has been observed in patients in
general, or preceding the development of ICH. Therefore, routine measurement of coagulation
parameters is not currently indicated in the management of patients on APTIVUS.
quinta-feira, junho 29, 2006
Gates Foundation sobre Warren Buffet
Date: Wed, 28 Jun 2006 17:32:04 -0700
Subject: Thoughts and Plans
As you probably know, Warren Buffett made a momentous and humbling announcement this week: He will give away the bulk of his wealth for charitable activities, including a substantial portion to the Bill & Melinda Gates Foundation. Because you are one of our crucial partners, I wanted to share a few thoughts with you about the gift and what it means to us.
Warren pledged to donate stock he holds in Berkshire Hathaway Inc. to the Gates Foundation and four foundations related to his family. He earmarked ten million Class B shares for the benefit of the Gates Foundation. Five percent of the balance of these shares will be delivered each year, and starting in 2009, the Gates Foundation must spend the value of this annual gift in addition to spending 5 percent of its own endowment. The total value of the pledge will depend on the price of Berkshire Hathaway stock, but we expect that as a result of these contributions our annual grantmaking will roughly double, starting in 2009. You can read more about all of Warren’s pledges in the July 10 issue of Fortune magazine, or online at http://www.fortune.com/.
I can not put into words how much this amazing commitment by Warren means to me, to Bill and Melinda Gates, and to the entire team at the foundation. It is a historic statement, not just about the power of philanthropy, but about the importance of our shared responsibility to serve those most in need. There are no words of thanks that will suffice.
While this is a breathtaking announcement, it also presents us with a huge challenge: How do we make the most of Warren's amazing commitment? In the coming months, we have to do a lot of planning, and a lot of listening. Through it all, we’ll remain absolutely committed to Bill and Melinda Gates’ goal of reducing inequality in the United States and around the world. We will be guided in this process by a few key principles:
· Our first priority will be to go deeper into our current strategies, accelerating the work we are already supporting. As Warren wrote in his pledge letter, we are focused on a few important but critically underfunded issues, and we will keep it that way for the time being.
· We reorganized earlier this year into three grantmaking groups, each run by a president—U.S. Programs (run by Allan Golston), Global Development (Sylvia Mathews), and Global Health (Tachi Yamada)—and an operations group run by Chief Operating Officer Cheryl Scott. That reorganization was also designed to give leaders at all levels of the foundation more authority and allow us to move faster, which will be critical to managing the growth we’re about to experience.
· As large as our annual grantmaking will become, it will always be dwarfed by the money governments and markets can bring to the table. They will continue to be the key to solving these problems, and we will partner with them rather than replace them.
· We must continue and increase the priority we place on the collaboration and learning we do with other foundations, governments, or non-governmental organizations. That’s the only way to make sure our combined resources have the greatest possible impact.
· We also have to share the results of our grantmaking, good or bad. On www.gatesfoundation.org you can read our 2005 annual report as well as a series of case studies, to which we will be adding in the coming months and years. We still have a long way to go, but this is a major goal for our foundation, and we are deeply committed to it.
I’ll conclude by asking you to do something for us. As we grow, truth-tellers will become ever more important to us. So please: Let us know when things are going well, and even more importantly, when they aren’t. Everyone at the foundation understands that we need to learn from bad news as well as from good, but we can only do that if you help us.
Thank you for being such a committed partner. All of us at the Gates Foundation are honored to work alongside you.
Chief Executive Officer
quarta-feira, junho 28, 2006
Problemas de acesso a medicamentos aprovados para doentes em falência terapêutica
14 nações irão adoptar uma taxa aérea para subsidiar medicamentos para a SIDA
Na sexta-feira, na reunião de elevada importância sobre SIDA em Nova Iorque, 14 nações, representados pela França, anunciaram uma nova taxa nos bilhetes de avião que se espera vir a aumentar anualmente em mais do que $258.3 milhões o contributo para medicamentos contra a SIDA nas nações subdesenvolvidas.
O Brasil, o Chile, o Chipre, o Congo, a França, o Gabão, a Costa do Marfim, a Jordânia, o Luxemburgo, o Madagáscar, as Maurícias, a Noruega e o Reino Unido implementarão a taxa, cujos lucros serão orientados para a compra de grandes quantidades de medicamentos para a SIDA, de modo a ajudar a reduzir os preços e fornecer incentivos às companhias farmacêuticas para criarem mais fórmulas antiretrovirais pediátricas.
A França, a partir de dia 1 de Julho, irá impor uma taxa na classe económica equivalente a $1.30 dólares americanos para voos dentro da Europa e equivalente a $5.12 dólares americanos para voos internacionais. Nas classes de primeira e executiva a taxa irá ser equivalente a $12.80 dólares americanos para os voos na Europa e equivalente a $51.23 dólares americanos para voos exteriores à Europa.
Erik Solheim, ministro para o Desenvolvimento Internacional da Noruega, afirmou “Cada pessoa no mundo que tem dinheiro para comprar um bilhete de avião pode suportar esta taxa de valor mínimo”. Os Estados Unidos da América opuseram-se à taxa.
Los Angeles Times (06.03.06) Maggie Farley
Aprovado novo IP para uso em doentes com TARV prévia
Em 23 de Junho a Food and Drug Administration (FDA) anunciou a rápida aprovação do darunavir, formerly known as TMC114, um novo Inibidor das Proteases Não Péptideo (IP); o fármaco debe ser comercializado com o nome de Prezista.
O Darunavir foi aprovado para ser usado em adultos com tratamentos prévios que não respondam aos regimens terapêuticos anti-retrovirais actuais. Para alcançar concentrações adequadas no organismo a darunavir deve ser administrado em simultâneo com ritonavir (Norvir). A dose recomendada é de 600 mg darunavir (dois comprimidos de 300 mg) com 100 mg de ritonavir duas vezes por dia com a refeição.
"Uma dos grandes desafios no tratamento do VIH é encontrar terapêuticas para os doentes que já fizeram outros tratamentos," disse Michael Saag, Médico e director da University do Alabama no Birmingham's Center for AIDS Research. "Esta é uma nova opção para milhares de pessoas com VIH dos EUA que são resistentes a mais do que um Inibidor das Proteases." A aprovação foi baseada num estudo de fase Iib que durou 24 semanas que mostrou superioridade na supressão viral e melhor recuperação dos CD4+ comparado com ouras associações de IP’s. O estudo POWER 1 (que teve lugar na Europe, Austrália, Brasil e Canadá) e o POWER 2 (nos Estados Unidos da América) incluiu cerca de 600 participantes. Os resultados a longo prazo vão requerer a aprovação mais tradicional mais completa.
Na 13ª Conference on Retroviruses and Opportunistic Infections que teve lugar em Fevereiro os investigadores referiram que nos dois estudos 70% dos doentes com grande expriência em medicação anterior e evidência de mutações que causavam resistências aos IP’s apresentaram reduções de 1 log (90%) de redução na carga viral após tomarem darunavir durante 24 semanas, comparado com 21% dos doentes que ficaram a tomar outros esquemas com IP’s. Além disso 45% dos doentes a tomar darunavir tiveram cargas virais abaixo das 50 cópias/ml comparados com os 12% dos que tomaram outros IP’s.; A contagem de CD4 aumentou 92 células/mm3 versus 17 células/mm3, respectivamente. Os estudos mostraram também que o darunavir é bastante activo quando combinado com o T-20 (enfuvirtide, Fuzeon). Num estudo adicional não-randomizado e aberto (POWER 3), 65% dos doentes tiveram pelo menos uma redução de 1 log de carga viral e 40% tiveram carga viral indetectável após 24 semanas.
Os efeitos colaterais mais frequentes observados em doentes que tomavam darunavir foram cefaleias, diarreia, dor abdominal, obestipação e vómitos (todos referidos em cerca de 5% dos casos). Por outro lado 7% tiveram rash cutâneo de gravidade variável incluindo alguns casos de eritema multiforme e sindrome de Stevens-Johnson; as pessoas com alergias às sulfamidas não devem tomar darunavir. Alguns doentes tiveram elevação dos enzimas hepáticos. É muito cedo para saber se o darunavir causará alguma alteração a a longo prazo e causar alterações metabólicas (p.e elevação dos lípidos, alterações da morfologia corporal, diabetes) que se vêm em pessoas que tomam outros IP’s.
O Darunavir não deve ser usado com uma variedade de outras medicações (incluindo certos anti-histamínicos, anti-convulsivantes, sedatives, estatinas e a erva de St. John's) e deve ser adimistrado com precaução com outros inibidores/indutores do citocromo CYP3A devido a potenciais interacções entre os fármacos.
A segurança e eficácia do darunavir como fármaco de primeira linha ainda não foi determinada. Como condição da aprovação a Tibotec deve conduzir estudos post-marketing no sentido de avaliar se o fármaco é útil para as crianças e pessoas com alterações a nível do fígado, bem como interacções com outros fármacos.
O Darunavir é o primeiro anti-retroviral desenvolvido pela Tibotec Pharmaceuticals, uma companhia Escocesa adquirida pela Johnson & Johnson em 2002 e agora uma sucursal da Ortho Biotech Products. A companhia também faz investigação num Inibidor Não Nucleosídeo da Transcriptase Reversa o etravirine (TMC125) já numa fase avançada de ensaios clínicos.
"Esta aprvação oferece nova esperança para os doentes com HIVpara os quais seja urgente uma nova terapêutica que possa manter a sua saúde," disse a Acting Commissioner of Food and Drugs, Doutora Andrew von Eschenbach. "Este fármaco não é uma cura mas quando combinado com outros tratamentos representa uma nova etapa no nosso esforço de ajudar a conseguir combater os efeitos da doença.”
Food and Drug Administration. FDA Approves New HIV Treatment for Patients Who Do Not Respond to Existing Drugs. Press release. June 23, 2006.
Tibotec Pharmaceuticals. Prezista Receives U.S. FDA Approval as Part of HIV Combination Therapy. Press release. June 23, 2006.
Por Liz Highleyman
A new initiative on the part of the international community
- launched by Brazil, Chile, Norway and France, supported by about 40 other countries and many partners: international organisations, non-governmental organisations, private foundations;
- based on a new idea: the international air-ticket solidarity levy, a long-term, guaranteed and predictable resource with solid perspectives for growth. Initiated by Brazilian President Luiz Inacio Lula da Silva and French President Jacques Chirac and adopted at the Paris Conference on Innovative Financing for Development on 28 February and 1 March 2006, this levy is set to be implemented in 14 countries (Brazil, Chile, Congo, Cyprus, Gabon, Ivory Coast, France, Jordan, Luxembourg, Madagascar, Mauritius, Nicaragua, Norway and the United Kingdom) and will be supported by multi-year budgetary assistance from other countries.
This funding mechanism should better respond to the specific needs of the developing countries in terms of production volume, price level and drug suitability. It is also designed to reassure the national authorities of these countries with regard to the long-term ability of the international community to provide sustainable financing for health care programmes and thereby to launch large-scale programmes aimed, in the case of AIDS in particular, at approaching the goal of universal access in 2010, as endorsed by the United Nations Millennium + 5 Summit in September 2005.
- complementarity of action on the part of international organisations or existing instruments, such as the WHO, UNAIDS, UNICEF and the Global Fund to Fight Aids, Malaria and Tuberculosis, UNITAID/IDPF does not intend to replace any of the existing organisations that help facilitate developing country access to drugs. To deploy its activities without setting up a new bureaucracy, while reducing the risk of duplication, UNITAID/IDPF plans to forge partnerships with existing bodies and initiatives.
The governance and operation of UNITAID/IDPF will be defined following broad consultations with the players concerned as well as NGOs and civil society.
A new instrument for development
- to fight the three major diseases (HIV/AIDS, malaria and tuberculosis)
- to provide a stable and continuous source of financing to boost public health systems in developing countries
- to facilitate poor people’s access to drugs
A socially-minded approach:
By supporting UNITAID, I am helping fight disease everywhere in the world and especially helping the poorest children.
UNITAID united to treat those in need!
terça-feira, junho 27, 2006
Coordenação Nacional e IDT assinam protocolo
O Dia Internacional de Luta Contra a Droga e Toxicodependência foi o momento escolhido para a formalização do protocolo de colaboração entre a Coordenação Nacional para a Infecção VIH/sida e o Instituto da Droga e Toxicodependência (IDT), no sentido dos Centros de Apoio a Toxicodependentes (CAT) serem locais de despistagem para a Infecção VIH/sida, através do teste rápido.
O programa Klotho, projecto de detecção precoce da infecção VIH/sida em utilizadores de drogas, que já contou com uma iniciativa piloto no CAT de Gondomar, alarga-se agora para para pelo menos um CAT por Sub-Região de Saúde, tendo o projecto como objectivos para o final de 2007 a cobertura de 100% da rede pública de CATs, bem como a existência de 2 unidades móveis e 10 estruturas de redução de danos.
Segundo Henrique Barros, Coordenador Nacional para a Infecção VIH/sida, a colaboração de IDT para a prosecussão deste projecto reveste-se da maior importância, atendendo a que além de se conseguir melhor informação epidemiológica em relação à incidência da infecção em utiizadores de drogas, consegue-se mais precocemente encaminhar os VIH positivos para estruturas de saúde, a fim de efectuarem tratamento adequado e dirigido mais cedo, propiciando-lhes uma melhor qualidade e esperança de vida.
As comemorações do Dia Mundial da Droga e Toxicodependência decorreram em Matosinhos, com a inauguração das novas instalações do CAT da cidade e da terceira comunidade terapêutica do país, na Ponte da Pedra. António Correia de Campos, Ministro da Saúde, também presente nas comemorações, evidenciou o facto da luta contra a droga ter sido de há uns tempos para cá esquecida pelos media, mas de em termos de orçamento de estado ser uma área que, pela sua importância, não merece contenção orçamental.
TESTES AO HIV/SIDA PARA TODOS OS CONSUMIDORES EM TRATAMENTO
Diário de Notícias, 26-06-2006
MAIS CAMAS CONTRA DROGA
Correio da Manhã, 26-06-2006
Folheto sobre VIH/sida nas farmácias
Os jovens que se dirigirem às farmácias para comprar preservativos ou contraceptivos orais (tradicionais ou de emergência) terão a partir de agora mais informação sobre a infecção VIH/sida.
Um folheto desenvolvido pela Coordenação Nacional para a Infecção VIH/sida e pela Associação Nacional de Farmácias estará dentro em breve disponível nas farmácias aderentes e visa realçar a importância do diagnóstico à infecção depois de um comportamento de risco.
A iniciativa insere-se no ciclo de folhetos de 'informação saúde' da Associação Nacional de Farmácias' e será uma importante forma de melhorar a informação dos jovens em relação à infecção VIH/sida e à vulnerabilidade de todos perante comportamentos de risco.
O folheto começará a ser distribuído nas farmácias já este mês.
segunda-feira, junho 26, 2006
Médicos e activistas americanos aplaudam preço do TMC114
The Fair Pricing Coalition, an ad hoc coalition of hundreds of community AIDS organizations, medical facilities and concerned individuals, today applauded the pricing of Tibotec Therapeutics new protease inhibitor for the treatment of people with advance AIDS and resistant virus. The Food and Drug Administration announced approval of the drug, called Prezista, late on Friday, June 23, 2006. A spokesperson for the Coalition, Martin Delaney of Project Inform (a nationally known HIV treatment information and advocacy organization), said “We are very pleased with this drug for two reasons. First, it is a very important addition to the arsenal of drugs for treating HIV, perhaps the most potent drug yet for people who have developed resistance to other therapies. But just as importantly, we are pleased that Tibotec Therapeutics has reversed a years-long trend toward ever higher prices by the pharmaceutical industry. The last three drugs approved for HIV each set new and dramatically higher pricing thresholds, making it more and more difficult for public and private payers to keep up with the demands for care. After lengthy discussions, Tibotec finally priced their drug within pennies of the cost of the least expensive of the other new drugs and far below the most expensive. It has finally reversed the juggernaut of higher pricing and acted as a responsible corporate citizen.”
The Fair Pricing Coalition, which organized a series of meetings between the company and representatives of community organizations to discuss pricing, still emphasized that prices should be lower still, even as Tibotec has taken a major step in the right direction. Mark Milano, another Coalition member, stressed "There is plenty of room for profit and for additional research at even lower price levels. Now that Tibotec has reversed the awful trend of ever-increasing prices, their action needs to be the standard for other new drugs. Each new drug should further step back from the obscene prices that have been reached in recent years."
Lynda Dee, of AIDS Action Baltimore and the AIDS Treatment Activists Coalition (ATAC) said, “This successful outcome proves that it is worth making our needs known to pharmaceutical companies. Had we not made the effort and gotten so many people involved and speaking out, I don’t doubt we’d be seeing another jump in prices today. Instead, we’re celebrating what we hope will be the end of an era of escalating prices.” Martin Delaney added, “We have to share the credit with the leadership at Tibotec Therapeutics. Without their support and their understanding of the problems that drug prices have been causing, we would not have seen this reversal. I hope they are rewarded with quick approval on all the major formularies.”
National Patient Advocate Coalition Commends Pricing of New HIV/AIDS Drug
New York, New York, June 25, 2006 – The Drug Development Committee (DDC) of the AIDS Treatment Activist Coalition (ATAC) today applauded the general direction on pricing announced today for the new protease inhibitor Prezista from Tibotec Therapeutics. Prezista received accelerated FDA approval on June 23, 2006. Company spokespeople announced that the price would be well under the prices of two other recently approved HIV drugs and virtually the same as a third.
The new drug, a member of the class of anti-retroviral drugs known as protease inhibitors, is an important addition to this drug class since it works in people who have resistance to previous dugs of this type. ATAC Steering Committee Chair Rey Candelaria commended Tibotec for its decision to stop the continuing escalation of drug prices. “This is the first time we can remember an HIV drug company pricing a new drug lower than the last FDA approved anti-HIV medication. This pricing decision is especially necessary in light of the lack of political will and misplaced spending priorities in Washington.”
The price of prescription drugs has gone up radically over the last ten years. In 1996, when the first highly effective anti-HIV combination therapy became available, treatment for a single individual cost at least $12-15,000 a year per person for a typical 3-drug cocktail. Today, a single drug can cost this much or even twice this amount.
“Tibotec’s decision to do the right thing is a good first step that must be copied by other drug companies. Price escalation had to stop somewhere. We’ve drawn a line in the sand and there’s no turning back,” said Lynda Dee, long-time DDC member. “Tibotec has tried very hard to work in partnership with the patient community. We’re elated they have taken our suggestion and reversed the upward spiral of unconscionable new life-saving drug prices. While ATAC would still prefer even lower drug prices as the price point achieved here is still far from inexpensive, we believe this represents real progress.”
About ATAC: ATAC (www.atac-usa.org) is a national coalition of AIDS activists, many living with HIV/AIDS, working together to end the AIDS epidemic by advancing research on HIV/AIDS. The Drug Development Committee (DDC) of ATAC works with government, academia and the pharmaceutical industry to provide a community perspective in the development of new HIV drugs and access to HIV therapies.
MEDICAL PROVIDERS HIGHLY ENCOURAGED BY PRICING DIRECTION
TAKEN BY TIBOTEC THERAPEUTICS FOR NEW PROTEASE INHIBITOR
WASHINGTON, DC – Today, the American Academy of HIV Medicine (AAHIVM) commended Tibotec Therapeutics for pricing their newly-approved protease inhibitor, TMC-114 (darunavir), at a price near to that of one of its older, key competitors and far less than other antiretrovirals more recently approved by the Food and Drug Administration.
“AAHIVM commends Tibotec, Inc., a subsidiary of Johnson & Johnson, for its pricing restraint during this critical time,” said Tony Mills, MD, a physician in private practice and treasurer of AAHIVM’s Board of Directors. “According to Dr. Mills, HIV care providers have been fighting a “war of escalation” with spikes in health care costs -- particularly with prescription drugs. “HIV care providers and their patients, faced with increasing uncertainty and fixed programming budgets, have been stretched beyond capacity for years now,” said Dr. Mills. “Funding for the Ryan White CARE Act, which houses the AIDS Drug Assistance Program, was largely flat funded or cut over the last few years. Some recent entries into the antiretroviral market are priced higher than the public payers can afford.”
The Ryan White CARE Act is currently up for reauthorization before Congress; if current legislative language passes as is through Congress, authorization levels for funding the program over the next five years would be set with only limited increases, and only for certain sections.
Outside of the Ryan White CARE Act, other public payers are also struggling as the Deficit Reduction Act aims to limit Medicaid costs, and the states themselves face rising program costs. Even in the private insurance market, where increasing numbers of individuals are under-insured, patients are no longer shielded from the skyrocketing price of medicines.
“The pricing of darunavir, while not as low as we had hoped or asked for, is still a giant step in the right direction,” said AAHIVM Executive Director Dr. Howard Grossman. “We know companies have an obligation to their shareholders, but the pricing decisions need to be made with more criteria than just what the health care ‘market can bear.’”
According to Dr. Grossman, that health care market – including HIV/AIDS care -- does not exist in a vacuum, and advocates are realizing the level of responsibility that everyone shares in containing costs. “Darunavir looks like a highly effective drug that fulfills a need for people with HIV,” said Dr. Grossman. “It should be a significant new addition to the antiretroviral armamentarium. We’re sure there will be a great demand for it, but with no inherent controls on price, companies have to be self-policing – and it is refreshing to see someone buck the trend. We congratulate Tibotec on a pricing decision that we think demonstrates true leadership. Hopefully, others will follow.”
About The American Academy of HIV Medicine
The American Academy of HIV Medicine is an independent organization of HIV Specialists and others dedicated to promoting excellence in HIV/AIDS care. Through advocacy and education, the Academy is committed to supporting health care providers in HIV medicine and to ensuring better care for those living with AIDS and HIV disease. AAHIVM members provide direct care to more than 340,000 HIV patients. This is more than two thirds of the patients in active treatment for HIV disease. Nearly 50 percent of the Academy’s members receive Ryan White CARE Act funding, with 18 percent of the Academy’s members practicing in community clinics.
TMC114 (Prezista) aprovado pela FDA
WASHINGTON (Reuters) - U.S. health officials on Friday approved the use of a new HIV drug, made by Johnson & Johnson, in combination with related therapies to help treat patients who do not first improve with other treatment.
The drug, Prezista, is a protease inhibitor designed to treat resistant strains of HIV, the virus that causes AIDS. The approval marks the New Jersey-based drugmaker's first entry into the $1.5 billion U.S. market for protease inhibitors, a class of drugs designed to suppress the virus and prevent it from replicating.
Also known as TMC114, the drug is given with a low dose of an older protease inhibitor called ritonavir, which slows the breakdown of Prezista in the body, increasing its concentration in a patient's system, the Food and Drug Administration said.
The human immunodeficiency virus that causes AIDS infects close to 40 million people worldwide, with more than 1 million in the United States. The U.S. Centers for Disease Control and Prevention estimates that 40,000 Americans become infected with HIV each year. While many HIV therapies are now available, AIDS specialists and activists have said resistance to them is becoming a problem because the virus can quickly mutate and current drugs can become ineffective.
JP Morgan analyst Michael Weinstein, in a note to clients on Wednesday, forecast Prezista sales of $65 million in the second half of 2006 and peak sales of $800 million to $900 million."I really expect it to be used quite widely even with the indication that it has," Dr. Tim Wilkin of Weil-Cornell Medical College, New York, who helped conduct one of the Prezista clinical trials, said in an interview before the approval.
J&J said it will charge $6.25 per tablet, which must be taken four times daily (which is $25 per day, total, 24 cents over Reyataz).
Still, other doctors sounded a more cautious note. Dr. Steven Deeks, an associate professor of medicine at the Universityof California, San Francisco, said he plans to delay prescribing the J&J drug for patients who are highly resistant until he can combine it with a second compound. "These drugs typically don't work well alone. They need to be partnered with another effective drug. For many patients with truly highly resistant HIV, there is no drug yet to partner with it," Deeks said in an interview on Friday.
The FDA said it approved Prezista based on two clinical trials that found 70 percent of patients who had tried other therapies improved with Prezista and ritonavir after 24 weeks compared with 21 percent in those who took ritonavir with other protease inhibitors.
Side effects can include diarrhea, nausea and headache as well as mild to serious skin rashes. The risks for patients who have not undergone other treatments first is unknown, the agency said. J&J must also conduct post-marketing studies, it said.
Prezista is the first of three advanced compounds in J&J's HIV franchise, which aims to combat HIV drug resistance. Prezista will be followed by TMC125, a non-nucleoside reverse transcriptase inhibitor typically used in combination with other drugs expected to be launched in late 2008. That will be followed by TMC278, a second non-nucleoside reverse transcriptase inhibitor. J&J also is also studying Prezista in comparison to currently approved protease inhibitors.
Shares in the company were up 66 cents, or 1 percent, at $61.98 in after-hours trade on the Inet exchange after earlier closing up 14 cents at $61.32 on the New York Stock Exchange.
International Drug Purchase Facility
The International Drug Purchase Facility
Position Paper on the establishment of the IDPF
The members of our network have supported the initiative of taxing aeroplane tickets as part of an experimental approach to promoting the concept of international taxation to finance development. They are aware of the necessity of obtaining guarantees about how the resources collected would be allocated, of the importance of ensuring stable and predictable funding and the fact that this must be additional to existing public expenditure on development.
Since the Paris Conference that took place in February 2006, Norway, Chile, Brazil and France have come to a consensus around the idea of dedicating revenues from the taxation of plane tickets to an International Drug Purchase Facility (IDPF). Funding the IDPF with this proposed new form of taxation would guarantee it a secure and sustainable funding stream.
In Geneva, on 20th and 21st April 2006, the main supporters of the IDPF proposed that this new plan would provide affordable drugs on a regular and sustainable basis, to affected people in the poorest countries. The IDPF should pursue a pro-active policy to reduce prices and encourage the diversification of quality controlled drugs.
The members of our network have also highlighted the importance of a flexible and straightforward system of allocating IDPF funds, the involvement of civil society, read-across with national public health strategies and integration with other international strategies for dealing with pandemics. They have also argued that the proposal should not be simply superimposed onto existing mechanisms, thereby complicating decision-making processes and increasing bureaucracy.
Access to drugs in developing countries
17 million people die every year from infectious and contagious diseases because they are unable to access proper treatment. 95% of them live in developing countries. Out of the 40 million people living with AIDS in the world, 6 million are currently in urgent need of antiretroviral drug treatment. Only 7-12% of them have access to the necessary treatment. Moreover, the number of people who have to switch drugs as their virus becomes resistant to the first-line treatment increases steadily. A 2nd line antiretroviral treatment generally costs between US$1,200 and 2,000 per patient per year. The more recent these treatments have been developed, the more expensive they are. This is as much the case for drugs designed to combat opportunistic infection and other pathologies as it is for antiretrovirals. More than 4.5 thousand million people live on annual incomings between $200 and $1,200. Most affected people in developing countries are therefore completely unable to afford the treatment they need.
The extent of the AIDS epidemic and the need to improve access to antiretrovirals has opened the debate on the price of drugs and the need for competition by generics. Since 1997, government laboratories (in Brazil and Thailand) or private companies (in India) have been working to produce generic versions of antiretrovirals. By breaking the monopoly, these generics have had a huge impact on the price of drugs. In early 2000, the Indian company Cipla developed a generic tritherapy at the cost of $800 per patient, per year; less than 10% of the price charged by multinationals. Between 2000 and 2004, Cipla and other Indian companies (Hetero, Aurobindo, Ranbaxy) increased the availability of generics and prices plummeted as a consequence. Today, the lowest cost for a tritherapy is around $150.
The introduction of generic antiretrovirals has resulted in a reduction of more than 95% in the cost of first-line tritherapies. In many African treatment access programmes, the Indian generic products now represent between 50 and 75% of the drugs taken. The impact of generic antiretrovirals has highlighted a well-known fact: the greater the number of producers, the closer a product’s price gets to the cost of producing it. Intellectual property rights are still a threat to affected people. However, despite the 2001 Doha declaration and the commitments made by the members of the World Trade Organisation (WTO), the protection of intellectual property rights is still threatening competition in the sale of generic drugs in developing countries.
Since 3rd January 2005, all the developing countries in the WTO, with the exception of a few Least Developed Countries (LDCs), have been obliged to respect the trade-related aspects of intellectual property rights (TRIPS) agreement which sets a minimum standard on the protection of intellectual property. In practice, this means that these countries must now grant a patent of at least 20 years to drugs and not use generics during this 20 year period.
- This creates a strong barrier to the production and sale of cheap generic versions of patented drugs. This will have a rapid impact on the expansion of antiretroviral access programmes and on the availability of second and third line drugs and paediatric treatment.
Before this agreement came into force, producers of generics in India and Thailand were able to produce fixed-dose combination treatments- tritherapy in one tablet. Because they are easier to use and cheaper, these products play a key role in the widening of access to antiretrovirals. Today, however, the future of generics production and commercialisation is uncertain. It is even more doubtful whether similar products will be made available in the future.
The introduction of WTO standards in a growing number of countries is increasingly limiting the production of generic versions of recent products. This has had a direct impact on prices and constitutes a major obstacle to the development of adapted treatments and to the widening of access to drugs. As a result, 2nd line antiretrovirals are between two and 12 times more expensive than first-line treatments. Governments’ budgets for the purchase of 2nd and 3rd line treatments is becoming an increasing percentage of their total budget for drugs. In Brazil, for example, 70% of the antriretroviral budget is used to buy four patented products (lopinavir/ritonavir, tenofovir, efavirenz et nelfinavir).
Generally speaking, the monopolies created by patenting prevents affected people in developing countries from accessing the latest treatments. It is estimated that the new legislation on intellectual property in India could lead to an increase of around 200% in the price of new drugs. This will, of course, also impact on the countries which depend on Indian generics.
- It is therefore clear that the IDPF will only be able to make a significant contribution to the widening of access to drugs in developing countries if it works towards the establishment of mandatory licences in affected countries.
The IDPF should therefore address both the solvency and longevity of markets and the legal issues concerning production, exporting and importing.
- Promote the development, production and sale of drugs, while focusing on those products which are necessary for improving the treatment of people in developing countries.
The IDPF should therefore promote the sale of the new generation of first-line generic drugs at low prices, treatments for therapeutic failure; the development of generic paediatric treatments and the availability of cheap challenge agents.
Widening the range of first-line therapies. Many developing countries have started programs providing access to antiretroviral drugs for a small number of people living with AIDS. The generic treatments prescribed in these countries are mainly tritherapies based on stavudine or zidovudine and nevirapine (Triomune, for example, or Duovir-N). These tritherapies are effective and cheap, but their daily intake produces significant undesirable side-effects in a large number of patients. These can compromise adherence to the treatment over the long term. For several years now, patients and doctors in the North have been using recently-developed medicines that are just as effective and have a much more favourable tolerance profile. The main ones are tenofovir, emtricitabine, a fixed-dose combination of these two medicines, plus certain protease inhibitors. It must be admitted that none of these recent medicines is currently available on a large scale in developing countries, and the main reason for this is their cost (given the absence of generic versions of these products).
Addressing treatment failure. Patients using antiretroviral drugs need new therapeutic options when first-line therapies are no longer effective. But access to medicines to address treatment failure remains extremely difficult and costly in developing countries. The main reasons for this unavailability are comparable to what is happening in the case of new first-line medicines: the absence of competition from generics, resulting in costs that remain too high despite pharmaceutical laboratories’ tiered pricing policies. We should note in this context that no generic protease inhibitor (the ARV class used in 2nd or 3rd line treatment) is included on WHO’s prequalification list.
Paediatric formulations. Generic laboratories have brought about innovation in the treatment of HIV/AIDS. They have developed fixed-dose combinations (several active ingredients in a single tablet) leading to the commercialisation of several tritherapies consisting of a single tablet, taken twice a day. On the other hand, generic laboratories have not moved forward in terms of developing a combined form of syrup or powder for children living with AIDS. Similarly only a very few generic, WHO-prequalified ARV paediatric formulations exist.
Reagents. The cost of reagents for patient monitoring can represent 70 to 80% of the total cost that patients need to pay for their care. Thus in order to make this treatment truly accessible it is essential to allow research, development, production and commercialisation of generic reagents.
Given the long-term nature of its resources, and provided it concentrates on the niches that have been identified, IDPF can provide security in the market for products considered to be strategic and thus lead to the production and commercialisation of new generic medicines or reagents. But in order to be effective, IDPF must also be an influential tool for implementing the TRIPS agreements on intellectual property.
- Support the establishment of mandatory licences in developing countries.
There currently exists no sufficiently well-coordinated assistance to help countries seeking to require mandatory licences for trademark medicines.
The obstacles are well-known: they relate on the one hand to the WHO prequalification of generics and technical capacity in the countries concerned, and on the other hand to political and economic hurdles related to constraints imposed in the context of bilateral negotiations. So far as the technical aspects are concerned, IDPF can have an impact in moving the current situation forward.
Strengthen WHO’s capacity for generics pre-qualification. The human resources currently available to the WHO prequalification department do not enable it to fulfil its mission. Dozens of prequalification files are pending at present, thereby delaying the production and distribution to patients of the corresponding generic medicines. Prequalification of production sites requires WHO inspection and approval of the manufacturing line. These procedures require a very considerable commitment of human resources, which WHO does not have. IDPF could make available to the WHO prequalification department the technical assistance required to carry out its job and increase the range of quality generics available for the fight against the pandemic, thereby contributing to the desired price reductions.
Strengthen technical skills in the countries concerned. In many cases, the countries concerned do not have the full range of skills necessary for implementing a strategy of developing mandatory licences. IDPF could propose short-term technical assistance to countries wishing to develop these licences, thereby facilitating and assisting their initiative.
Finance an independent monitor for the implementation of TRIPS agreements. The implementation of TRIPS agreements is often substantially compromised by constraints imposed in the context of bilateral negotiations and by the main medicine producers. These constraints are unfortunately only very rarely made public and at present it is particularly difficult to judge and to understand the real obstacles. By supporting an independent monitoring body whose principal aim would be to make these difficulties public, IDPF could contribute to re-energising the implementation of these agreements, which is an essential condition for its success.
Intervention and governance modalities
Making therapies available must necessarily be done in the context of global strategies for which treatment is necessary, but never sufficient. Too often, the responses provided have been only very classical ones in a public health context, boiling down to a sterile confrontation between prevention and treatment or between the public and community sectors. The Global Fund for fighting the three pandemics, created in 2002, proposes an approach which in many respects is new: support for strategies really originating in the countries concerned; the promotion of global approaches involving associations in the field; a transparent and independent decision-making and evaluation system; and finally, management participation by civil society.
- Build on programs supported by the Global Fund.
IDPF should therefore build on these programs and reinforce strategies that have been endorsed and will be evaluated in the Global Fund context. Treatment quality, and also the coherence of the struggle overall, depend on this happening.
Avoid creating new centres of decision-making. The multiplication of decision-making centres already constitutes an undeniable hindrance to those involved in the struggle against HIV/AIDS. IDPF must under no circumstances create further procedures and decision-making cycles. In this sense, support for programs that have been approved in an independent and transparent context would considerably limit the risk of duplication. IDPF’s choices could then concentrate on its own area of competency (stimulating the production and commercialisation of selected products) with appropriate guarantees concerning acceptable use of the products that it will have enabled to be purchased.
Build on existing evaluation processes. The evaluation mechanisms developed by the Global Fund, although still by no means perfect, are beginning to provide objective analyses of system breakdowns. Gradually they will lead to changes in various practices. It would be logical for IDPF to support and strengthen this dynamic.
- Support programs that really involve civil society.
Universal access to treatment for these three illnesses, which is a commitment entered into by the G8 at Gleneagles in 2005, will not happen without a very strong involvement by civil society in developing countries, which has been a pioneer in global treatment practices. Much remains to be done. Decision-making bodies are insufficiently open to community involvement and thus deprive themselves of expertise that has been developing over at least the last 10 years. IDPF could, through the choices it makes within the different programs supported by the Global Fund, contribute to promoting programs in which participation by civil society is the most satisfactory.
IDPF must work on the basis of the most innovative governance processes.
- Allow for participation by representatives of civil society.
IDPF must allow full participation of civil society representatives, from donor and beneficiary countries, in its governing body.
In any case, IDPF must come under the jurisdiction of a decision-making body involving equally its donors, representatives of beneficiary countries, civil society in both the North and the South and also the private sector.
 Coordination SUD : NGOs’ views on new mechanisms to fund development.
sexta-feira, junho 23, 2006
Problemas de acesso a medicamentos aprovados para doentes em falência terapêutica
O GAT foi alertado para o facto de, no Hospital de Egas Moniz, o acesso a terapêuticas com medicamentos novos e/ou experimentais – Tipranavir, T20 e TMC 114 – por parte de pessoas sem qualquer outra alternativa terapêutica e para quem estes medicamentos foram prescritos pelos seus médicos assistentes e têm clara e inequívoca indicação clínica, está a ser bloqueado.
O GAT já contactou a CNSIDA acerca deste assunto mas não sabemos quantas pessoas estão em risco de vida por causa desta situação, nem se o mesmo se passa noutros hospitais. Essa informação é indispensável para podermos pressionar uma solução urgente.
Se não tem alternativas terapêuticas, o seu médico lhe recitou alguma combinação que inclui estes medicamentos e está sem fazer terapêutica porque o seu hospital não fornece os medicamentos necessários – contacte-nos para firstname.lastname@example.org
O seu contacto será sempre tratado confidencialmente. Toda a informação recebida, respeitando os princípios da protecção dos dados pessoais, será sempre tratada de forma anónima e os casos concretos nunca serão divulgados.
quinta-feira, junho 22, 2006
As language shapes beliefs and may influence behaviours, considered use of appropriate language has the power to strengthen the response to AIDS. UNAIDS is now pleased to make these Notes freely available to all. We want the Notes to be a living, evolving document. Comments and suggestions sent to Alistair Craik (email@example.com) will be gratefully received and will be considered for future updates.
-- Dr. Kent A. Sepkowitz, infectious disease specialist at Memorial Sloan-Kettering Cancer Center, on society's refusal to confront the realities of a disease that is mostly spread sexually. (The New England Journal of Medicine, June 8, 2006)
Médicos não devem quebrar confidencialidade
BHIVA issues draft briefing paper on UK law and HIV transmission
The British HIV Association (BHIVA) has published a briefing paper providing information and guidance regarding the responsibilities and duties of healthcare staff in the light of recent United Kingdom prosecutions of HIV-positive people for the transmission of HIV. The briefing paper, which can be downloaded from the BHIVA website is open for consultation until Friday 21 July 2006.
There have now been nine criminal convictions for the reckless transmission of HIV in the UK: one in Scotland, and eight in England and Wales. The most recent case was reported on aidsmap.com yesterday.
The briefing paper addresses the complex questions that clinicians may have about their patients' rights, and their own responsibilities and legal obligations to disclose information about their patients' HIV status to others.
The paper's authors include legal expert, James Chalmers, representatives from two patient advocacy organisations - Terrence Higgins Trust (THT) and the African HIV Policy Network (AHPN) - and members of both BHIVA and the British Association of Sexual Health and HIV (BASHH).
"For an effective therapeutic relationship to be established and maintained, people living with HIV and their clinical carers must be able to discuss any relevant matter openly," they write in their introduction. "An underlying principle in the provision of clinical care for people with HIV is the need for a secure and confidential environment in which extremely sensitive matters can be frankly and fully discussed.
"The importance of ensuring that full trust is maintained by people with HIV in their clinical services in the light of the introduction of the criminal law into the HIV arena is fundamental, not only for the health of people living with HIV but also for people who may wish to seek information or testing and thus for the wider public health."
In day-to-day clinical practice, the paper suggests that healthcare professionals:
- advise patients with HIV appropriately about HIV infection and the implications for themselves and others
- support patients with HIV appropriately
- ensure confidentiality of medical information in line with GMC guidance
HIV transmission, the law and disclosure
The authors argue that whilst "disclosure of HIV status is neither necessary nor sufficient to ensure that safer sex is consistently practiced...lack of disclosure associated with onward transmission has been an important determinant in the successful convictions for reckless transmission."
Although the authors do not agree with current law regarding the criminalisation of HIV transmission, they say that it is clear that "people living with HIV in the UK must be aware of the risk of legal action if they do not disclose their status to sexual partners and there is onward transmission of HIV."
They add that the use of condoms without disclosure "may possibly provide a successful defence against the charge of reckless transmission," although this point of law has not yet been clarified.
Duties for healthcare professionals: proper advice
A healthcare worker must properly advise a patient on ways of protecting their sexual partners from infection. A failure to do this may give rise to legal liability if the patient's sexual partner becomes infected as a result. Liability may also arise where a healthcare worker negligently fails to diagnose the patient as having the infection.
The paper lists the General Medical Council's (GMC) crucial requirements for healthcare workers to properly advise their patients on serious communicable diseases, including HIV. This includes "ways of protecting others from infection." It also includes a discussion of the clinician's liability in the "extremely rare" case of someone being infected by an undiagnosed patient suing the clinician for negligence.
Duties for health care professionals: confidentiality and disclosure
A healthcare worker must maintain the confidentiality of patient information unless the patient has consented to disclosure or disclosure is necessary in the public interest. A failure to maintain confidentiality may give rise to legal liability.
The paper discusses in great detail the duty of health care workers to keep information confidential - as addressed in the GMC's guidance - and where this may sometimes be outweighed by the public interest, which is ultimately decided by the courts.
Differences between the power to disclose and the legal duty to disclose
One of the most vexing moral and legal dilemmas facing clinicians today - and one that worries many patients - is whether a healthcare worker is legally required to breach confidentiality and disclose a patient's HIV status to close contacts, if the healthcare worker is aware that their patient is putting this close contact at risk of HIV infection.
The paper discusses this in great detail, and suggests that when the close contact is also a patient, nondisclosure may "be a breach of duty owed to the close contact." However, if the close contact is not a patient, although disclosure would be lawful due to the public interest, it is not necessarily unlawful not to disclose. "In other words," the paper's authors write, "it is thought that there is a power to disclose, but no legal obligation to do so."
However, the current law covering GUM clinic confidentiality (NHS Venereal Disease Regulations 1974) conflicts with the GMC's guidance and creates some doubt as to whether disclosure to close contacts is ever permissible, leaving the above guidance in some doubt. The Department of Health is due to issue an imminent consultation on whether the 1974 Regulations should be changed.
Disclosing information to the police and in court
The paper strongly suggests that only the HIV-positive individual and "NOT the health care provider" should decide to make a complaint to the police if they believe they were infected through the 'recklessness' of another.
"Doctors have no duty to report criminal acts which have already taken place,' the authors write, and confirm that healthcare professionals "have no duty to answer questions that the police ask about their patients unless the request is sanctioned by a court order." The paper's authors say that this applies both HIV healthcare workers and to GPs.
Nevertheless, they write, "although medical evidence is confidential, it is not legally privileged" and that if a healthcare professional is required to testify in court, "all information must be disclosed."
Apresentação em Lisboa do filme GISBERTA LIBERDADE
O filme, de carácter documental, foi realizado em reacção ao brutal assassínio da transsexual Gisberta Salce Júnior no passado mês de Fevereiro na cidade do Porto, e aborda não apenas este crime em particular mas as vivências transexuais em Portugal. À exibição seguir-se-á um debate público.
A entrada é livre, o bar do ESPAÇOKARNART estará aberto e à disposição dos espectadores. Sejam bem-vind@s.
KARNART - Criação e Produção de Objectos Artísticos, Associação
Rua da Escola de Medicina Veterinária, 21,
Tel. 213 152 192 Fax. 213 152 192
Glosario del VIH/SIDA
AIDSinfo is pleased to announce a new edition of the Glosario del VIH/SIDA, the Spanish translation of AIDSinfo’s popular Glossary of HIV/AIDS-Related Terms. The Glosario is designed to help health care providers, caseworkers, community-based organizations, and people living with HIV/AIDS and their families and friends understand the complex web of HIV/AIDS terminology—en Español! This edition of the Glosario del VIH/SIDA features an expanded “Additional Resources” section as well as new and updated HIV/AIDS-related terms and definitions. You can download the Glosario or use it on the Web. Printed copies of the glossary in Spanish will be available later this summer.
Also new to this edition of the Glosario is the Guía de Traducciones (Translation Guide), a comprehensive list of HIV/AIDS-related terms translated from English into Spanish. This guide can help you communicate important HIV/AIDS-related concepts across a language barrier and can also help organizations create a standardized vocabulary of Spanish HIV/AIDS terms.
segunda-feira, junho 19, 2006
Tod@s aos bancos de sangue
TODOS/AS AOS BANCOS DE SANGUE!
O EMPURRÃO QUE FALTA
PARA ACABAR DE VEZ
COM A DISCRIMINAÇÃO
Panteras Rosa www.panterasrosa.blogspot.com
O Instituto Português do Sangue anunciou há tempos a alteração das regras que há décadas discriminam os dadores homossexuais masculinos sem outro critério que não o do preconceito. O tempo passa, porém, e o processo arrasta-se, tal como nada mudou nas práticas do centros de recolha de sangue.
Face à lentidão e às contradições do processo de eliminação da discriminação de homossexuais nas regras de doação de sangue, as Panteras Rosa propõem, na semana em que se celebra o 28 de Junho - Dia Mundial da Libertação LGBT - em quase todo o mundo, que toda a comunidade LGBT portuguesa e simpatizantes se dirija aos centros de recolha de sangue mais próximos para tentar fazer valer o direito à doação.
As Panteras Rosa apelam a toda a população Lésbica, Gay, Bissexual, Transsexual e heterossexuais que tenham tido relações com parceir@s LGBT nas várias zonas do país que tentem fazer uma doação, não escondendo no preenchimento do questionário as práticas homossexuais ou práticas com parceiros LGBT;
a) em caso de recusa da doação, solicitando e deixando registo no livro amarelo (de reclamações);
b) se recolhido sangue, exigindo uma notificação escrita sobre o destino final do sangue doado;
c) e dando em qualquer caso conhecimento da tentativa e do seu resultado ao nosso movimento através do e-mail firstname.lastname@example.org.
Com os dados recolhidos, pretendemos divulgar informação pública sobre a disparidade e o preconceito das práticas hoje assumidas pelos centros de recolha de sangue a nível nacional face à população LGBT e pressionar decisivamente o IPS e os responsáveis políticos para a eliminação desta discriminação inaceitável, que constitui aliás um problema de saúde pública para a população em geral, transmite mensagens de prevenção erradas e prejudica o stock de sangue disponível nos hospitais ao excluir muitos milhares de potenciais dadores.
quinta-feira, junho 15, 2006
A Coordenação errou...
A Infecção VIH/sida tem um peso de 5% nos gastos do Estado com medicamentos e não no orçamento geral.
A Coordenação Nacional para a Infecção VIH/sida corrige assim a notícia enviada na última newsletter que enfatizava a percentagem nos gastos totais do Estado.
Na verdade, a infecção VIH/sida representa 5% dos gastos públicos em medicamentos, estando assim na linha da frente, juntamente com o cancro.
Prevenção e Terapêutica na luta contra a sida
A prevenção e a terapêutica são alguns dos pontos em que a nova Coordenação Nacional para a Infecção VIH/sida irá fazer uma grande aposta no próximo plano estratégico, com o objectivo primordial de diminuir a incidência da infecção em Portugal e a mortalidade relacionada com VIH/sida.
Henrique Barros, Coordenador Nacional, focou durante o curso para jornalistas "O que há de novo para comunicar sobre a infecção VIH/sida" a ideia dos esforços terem de ser conjuntos entre os diferentes sectores da sociedade, tendo a Coordenação Nacional como prioridade dar maior enfoque à área do Ministério da Saúde. "Não podemos pedir ao ministério da Educação, ou do trabalho que se unam por esta causa se não temos a casa arrumada dentro do ministério da saúde". Apesar disso Henrique Barros evidenciou os esforços que estão a ser feitos no campo da justiça, nomedamente no que respeita às condições de saúde nas prisões.
A elaboração do novo plano estratégio de actuação da nova Coordenação Nacional para a Infecção VIH/sida que deverá vigorar entre 2007 e 2010 tem sido discutido com diversos grupos da sociedade, tendo sido esta semana a vez dos profissionais da comunicação social.
Depois das associações não-governamentais, das administrações regionais de saúde, das comissões distritais de luta contra a sida, os jornalistas reuniram-se no Porto para um curso de formação sobre VIH/sida que conciliou a disponibilização de informações mais específicas sobre a matéria com espaços de debate, críticas e reflexões.
Portugal fez-se representar na Assembleia das Nações Unidas sobre VIH/sida
Portugal vai estar presente na Assembleia-Geral extraordinária das Nações Unidas sobre os progressos no cumprimento das metas definidas na declaração de compromisso sobre VIH/sida que decorre em Nova Iorque entre 31 de Maio e 2 de Junho.
Além da delegação governamental Portuguesa, irão estar presentes também nesta reunião de alto nível três representantes da sociedade civil com intervenção exclusiva na área do VIH, de acordo com o apelo feito pela Organização das Nações Unidas.
Os critérios de selecção basearam-se nas organizações que têm estado envolvidas de forma activa na preparação do relatório nacional a apresentar na reunião - GAT, Abraço, Fundação Portuguesa A Comunidade Contra A Sida, Liga Portuguesa Contra a Sida e OpusGay.
Tendo apenas manifestado interesse em estar presente em Nova Iorque dentro do prazo estabelecido a associação Abraço, a Fundação Portuguesa a Comunidade Contra a Sida e o Grupo de Activistas para o Tratamento, a comitiva representante da sociedade civil portuguesa para a área da infecção VIH/sida será constituída por Nuno Viegas, Machado Caetano e Luís Mendão, respectivamente.
As restantes organizações que trabalham exclusivamente com a área do VIH/sida - Positivo, AJPAS, MAPS, SOL e ILGA não colaboraram na resposta ao questionário sobre a implementação da declaração de compromisso, tendo por isso sido de imediato afastadas do processo de selecção.
A Comitiva será chefiada pela Secretária de Estado Adjunta e da Saúde, Dra. Carmen Pignatelli.
quarta-feira, junho 14, 2006
Parlamento Europeu aprova legislação para medicamentos pediátricos
O Parlamento Europeu votou favoravelmente a proposta de regulamentação europeia para medicamentos pediátricos, num processo iniciado pela Comissão Europeia em Abril de 2006.
Esta votação reúne um consenso entre o Conselho Europeu, a Comissão Europeia e o próprio Parlamento e conclui o processo de consulta aos Deputados Europeus.
Esta regulamentação tem sido solicitada desde há muito tempo pela Indústria Farmacêutica e os familiares dos doentes, tendo-se dado hoje um passo decisivo para a sua efectivação.
A proposta votada visa melhorar a saúde nas crianças europeias através da introdução de medidas científicas e regulamentares que facilitem a investigação, o desenvolvimento e a autorização de medicamentos para uso pediátrico.
Para além da criação de uma infra-estrutura de I&D europeia prevêem-se, ainda, medidas de incentivo à investigação pediátrica, quer para os novos medicamentos, quer para os antigos.
Cabe agora ao Conselho assumir a votação parlamentar e dar por terminado o processo legislativo. A Regulamentação entrará depois em vigor no trigésimo dia após publicação no Jornal Oficial, que se dá poucas semanas após a adopção.
terça-feira, junho 13, 2006
Boehringer pára estudos com tipranavir em naives
PARIS, June 13 (APM) - Boehringer Ingelheim announced on Tuesday on its website that it was closing a clinical trial of HIV drug Aptivus (tipranavir) in treatment-naïve patients due to insufficient effectiveness at 60 weeks.
Aptivus is an HIV protease inhibitor which received European marketing approval in October 2005. It is currently only indicated in combination with Abbott's Norvir (ritonavir) in treatment-experienced patients who are resistant to several protease inhibitors, on the basis of trials RESIST-1 and RESIST-2, which included about 1,400 patients.
Boehringer Ingelheim was also carrying out a trial called 1182.33 in 558 treatment-naïve patients in 15 countries including France, Germany and the UK.
This was a non-inferiority trial against Abbott's Kaletra (lopinavir/ritonavir), whose primary endpoint was the proportion of patients with an undetectable viral load (< 50 copies/mL).
Patients in both Aptivus arms received 500 mg Aptivus twice daily. Only the Norvir dose varied, at 200 mg or 100 mg twice daily.
For both doses of Norvir, Aptivus' non-inferiority was proved at 48 weeks.
Following this, the 200 mg Norvir arm was closed due to an asymptomatic elevation of liver enzyme levels. This phenomenon had already been observed in the RESIST trials.
The following analysis, carried out at 60 weeks, showed that the effect of Aptivus/Norvir (500 mg/100 mg twice daily) had declined and that this therapy was now inferior to Kaletra in terms of virologic success.
The press release does not specify the proportion of patients with undetectable viral loads, but says that there was a 15.03% difference between the Kaletra and Aptivus arms, 0.3% above the limit fixed in the trial protocol.
Boehringer Ingelheim decided at this point to halt the whole trial, specifying that this "does not change the positive benefit-risk profile of Aptivus/ritonavir (500 mg/200 mg) for the highly treatment-experienced patient population for which it is currently indicated."
Mais sobre 25 anos de SIDA
Perspective: What 25 years of AIDS Has Taught Me
By Eric Sawyer, published by CommonDreams.org
10 June 2006
I have been living with symptoms of HIV/AIDS for 25 years, and I am glad to have survived to see this week's marking of the 25th anniversary of the first recognition of the disease. For these many years I have been able to manage my symptoms and contribute to society by educating others about the disease and advocating for stronger public and private action to end the epidemic.
That's why it troubles me so much to see that many of the lessons of the last 25 years of AIDS are being ignored by policymakers and government officials. While my own medical fight against HIV infection is being won, on a global level, the fight is still being lost.
Over 11,000 people are infected with HIV for the first time every day, despite clear evidence that, when people understand HIV and have the tools to prevent it, infections can be greatly reduced. Over 8,000 people are dying needless deaths every day, despite the fact that we now have the medications to keep them alive.
Why is this happening? The central problem is that a key lesson of the past 25 years - the need to keep ourselves honest in this fight by setting clear timetables for reaching basic goals - is being ignored by world leaders.
Last week's United Nations General Assembly Special Session on HIV/AIDS, which I attended, is a case in point. From the outside, this event seemed to represent more progress in the fight against AIDS. Important statements were made, for instance, about the need to end the violence against women that underlies the epidemic in much of the world. But, the meeting failed to produce the clear road map we need to really confront AIDS, in sharp contrast to the UN plan issued in 2001 on the same issue, which included specific milestones.
As an American, it was especially appalling to witness the role of US diplomats at this meeting. I had to watch as they fought to prevent the UN from including the specific, time-bound goals that African governments and civic groups had called for just one month ago at a summit in Nigeria. One of these was to deliver AIDS treatment to 80% of the people who need it in Africa by 2010. While US Secretary of State Condoleezza Rice has said the US approach to AIDS is "rooted in partnership with Africa," the US insisted this clear target be left out of the UN plan.
Another instance of accountability-avoidance struck me as bordering on nonsensical. The American public does not want to see the US shoulder the whole burden of the fight against AIDS. Since the US is already providing a significant share of the resources needed, it would make sense to include a clear global funding commitment in the UN declaration. Then, that promise could be used to help persuade Japan, Canada, countries in Europe, and others, to increase their contributions.
Yet, oddly, the US government refused to go along with setting such a funding commitment. So, while First Lady Laura Bush told the UN session that "The United States looks forward to working with you, and to finally winning the fight against AIDS," just down the hall US diplomats were insisting the UN statement avoid any commitment to provide the funding needed to actually do this. She also spoke in her address of the benefits of the US contribution to the Global Fund to Fight AIDS, TB and Malaria, while, back in Washington, President Bush has proposed cutting this contribution by 45%.
Platitudes and vague promises will not win the fight against AIDS. AIDS could kill 31 million people in India and 18 million in China by 2025, according to projections by the UN. In Africa, the toll could reach 100 million.
To prevent this nightmare from unfolding, we have to admit that the problem today is not primarily technological or medical. It's that we are still not bringing to this fight the level of seriousness and resolve needed to overcome the problem.
We as people who care about the millions suffering and dying have to go beyond more candlelight memorials for those who have died. Instead, let's declare the next 25 years a zone of zero-tolerance for empty rhetoric and insist on results.
Eric Sawyer is the co-founder of ACT-UP New York, an AIDS activist group, and co-founder of Housing Works, the largest provider of housing for people with AIDS in the U.S. Mr. Sawyer has been HIV-positive since 1981.
Declaração da Arrábida (VIH/SIDA nas Escolas e Prisões)
Sua Excelência o Presidente da Républica, Prof. Aníbal Cavaco Silva
Sua Excelência o Primeiro Ministro, Eng. José Sócrates
Exmo. Senhor Minsitro da Justiça, Dr. Alberto Costa
Exmo. Senhor Minsitro da Saúde, Dr. António Correia de Campos
Exmo. Senhora Minsitra da Educação, Dra. Maria de Lurdes Reis Rodrigues
Exmo. Senhor Presidente da Assembleia da República, Dr. Jaime Gama
Exmo. Senhor Coordenador da CNSIDA, Prof. Henrique de Barros
Exmo. Senhor Alto-Comissário para a Saúde, Prof. Pereira Miguel
Exmo. Senhora Coordenadora do Grupo de Trabalho sobre Saúde em Meio Prisional, Dra. Graça Poças
Lisboa, 9 de Junho de 2006
ASSUNTO: VIH/SIDA Escolas e Prisões
“O futuro Plano Estratégico Nacional de resposta ao VIH/SIDA nas escolas e prisões”
Os participantes e organizações aderentes, abaixo indicados, no I Encontro da Arrábida, promovido pela Coordenação Nacional para a Infecção VIH/SIDA consideram que,
face à evolução da situação epidemiológica da infecção pelo VIH em Portugal nos últimos 25 anos, quer na população geral, quer na população prisional, para ser possível planear, implementar, monitorizar e avaliar acções eficazes de Informação, Educação e Comunicação para a redução da incidência do VIH e outras doenças transmissíveis é imprescindível garantir, à partida:
- O acesso universal à educação sexual no sistema de ensino;
- O acesso ao Sistema Nacional de Saúde no sistema prisional.
Esta urgente decisão política deverá fazer-se acompanhar de medidas ao nível do executivo, capazes de promover e garantir o acesso efectivo da população escolar e prisional aos meios de prevenção concretos das ISTs/VIH/SIDA, por exemplo:
- A distribuição de preservativos em meio escolar e
- O acesso a material de injecção estéril, vacinação e tratamentos continuados (VIH/TB/Hepatites/Drogas), nas prisões.
Sem estarem garantidas as decisões acima referidas, consideram os subscritores que qualquer estratégia de Informação, Educação e Comunicação que pretenda contribuir para a redução da infecção pelo VIH, está condenada a falhar.
Este documento foi discutido durante o encontro “ Ouvir a Sociedade Civil para incorporar a sua voz na elaboração do futuro Plano Estratégico Nacional de resposta ao VIH/sida. “, realizado no Convento da Arrábida.
Com os melhores cumprimentos.
Ricardo Fernandes, Associação Positivo
Associação Cidadãos do Mundo
AJPAS – Associação de Jovens Promotores da Amadora Saudável
Fundação Eng. Nuno Xavier
Fundação Portuguesa “A Comunidade Contra a Sida”
GADS - Grupo de Apoio e Desafio à SIDA
GAT - Grupo Português de Activistas sobre Tratamentos de VIH/SIDA Pedro Santos
Grupo de Trabalho para a Prevenção do VIH/Sida e outras ISTs da Associação ILGA Portugal
Liga Portuguesa Contra a SIDA
MAPS – Movimento de Apoio à Problemática da SIDA
Obra Social das Irmãs Oblatas do Santíssimo Redentor
E-mail para onde indivíduos e organizações possam continuar a subscrever: email@example.com
segunda-feira, junho 12, 2006
Fórum online da CNSIDA promove discussão entre a sociedade civil
O Fórum Online da Coordenação Nacional para a Infecção VIH/sida reserva a partir de agora um espaço para o debate de ideias entre Organizações Não-Governamentais do nosso país relacionadas com a infecção VIH/sida.
Pretende-se que as Instituições que desenvolvem projectos na área do VIH/sida comuniquem online, partilhando assim experiências positivas e negativas. Além disso, potencia-se ainda a partilha de ideias dos diferentes projectos em desenvolvimento, o que poderá permitir até que se abram caminhos para parcerias inter-institucionais. O fórum tem ainda como objectivo o debate do que deve ser uma boa estratégia na resposta à infecção VIH/sida.
Para utilizar o fórum, é necessária uma inscrição online, podendo-se logo de seguida entrar no espaço de discussão.
Ir para o Fórum
O preço do 114
Consensus Statement on the Pricing of TMC114 /Darunavir
June 09, 2006
TMC114/darunavir will soon become Tibotec’s first licensed drug for the treatment of HIV disease. It is likely to be the first of several important anti-HIV drugs from Tibotec. To date, the HIV/AIDS community’s relations with Tibotec have been exemplary as the company has shown an exceptional willingness to invite and listen to input from people affected by HIV disease. Based on everything we know now, the licensure of TMC-114/darunavir will be a worthy addition to our anti-HIV armamentarium, especially for people who have developed resistance to the existing protease inhibitors.
This good news, however, does not exist in a vacuum. Instead, it will be played out against a background of growing national and international crises in the cost of health care. The cost of a typical anti-HIV regimen in United States has risen to $15,000 or more for initial therapy, while the cost of salvage therapy can easily reach three times that amount. This is just for cost of the drugs. These costs plus the cost of associated medical care must be supported for decades to come for every single person with HIV disease. Better drugs, like TMC114/darunavir, result in longer lives and thus even longer times on therapy. If the average duration of therapy is limited to no more than 50 years per person, the costs of HIV drugs over this period will easily exceed a trillion dollars in the US alone, not even counting future price increases. Add in a reasonable cost for the vast numbers needing therapy in developing nations and the overall cost of drug for treating HIV disease worldwide could easily equal the current US national debt. Clearly, the path we are on is not sustainable, at least not for anyone other than the pharmaceutical industry.
At a time when evidence of responsible citizenship is needed from the pharmaceutical industry, we have instead been treated to ever increasing prices with each new drug. Two recently approved protease inhibitors, Reyataz and Aptivus, leapfrogged each other in setting new pricing thresholds, quickly reaching a price nearly three times that charged for Crixivan when it offered the first real breakthrough in AIDS treatment in 1996. TMC114/darunavir is the next drug in line and all eyes will be on it the day its price is announced. Its net price must include the cost of a booster drug, Norvir from Abbott Labs, whose price was recently increased by 400% in another demonstration of reckless civic behavior by a pharmaceutical company. While Tibotec isn’t responsible for the price increases taken by others, it is responsible for the decision to use the Norvir booster. Tibotec now has two choices. It can either follow in the footsteps its predecessors, defying the needs of patients and taxpayers, or it can make a bold statement that shows that the industry will do its part to restrain the cost of healthcare. Make the wrong choice and all of the company’s efforts to maintain strong relationships with the government and the community will have been for naught. The cycle of ever increasing costs, and ever higher profits, will once again be validated. Is this the legacy that Tibotec wishes to create?
Since it was formed in 1998, the Fair Pricing Coalition has sought drug pricing that is cost neutral. We seek to avoid having each new drug push the cost of treatment upward. In the case of TMC114/darunavir, this leads to a very specific demand: we ask that the price charged for TMC114/darunavir should be less than or equal to the current price of Kaletra, which is presently the best selling protease inhibitor and the drug that TMC114/darunavir is most likely to replace in clinical practice. Since Tibotec has chosen to use a ritonavir booster to improve the bioavailability of TMC114/darunavir, the price must include its cost, just as the ritonavir booster is already included in the price of Kaletra.
We also expect substantial discounts over and above the minimum required by law for the AIDS Drug Assistance Program and other government payers. We trust that separate negotiations are underway with the appropriate representatives of those programs, but we hope to establish the baseline for those discussions with the pricing principles laid out here.
We urge the leadership of Tibotec Research, Tibotec Therapeutics, and parent companies Ortho and Johnson & Johnson to give this proposal the most serious possible consideration. We believe that the company will benefit greatly from agreeing to this request. It will establish the company both as a scientific leader and also as a civic leader. It will stand as evidence to the taxpayer and to the Congress that the pharmaceutical industry is capable of more than simply seeking the greatest possible profits without regard for the impact on society. Perhaps most importantly, it will be welcomed and appreciated by the people with HIV and the medical professionals who treat them. It will almost certainly generate positive press about a “new, more responsible attitude” by industry. And, we believe, it will encourage the fastest possible uptake of the drug into clinical practice. Tibotec is aware, no doubt, that recent Medicare Part D formulary guidance issued by the Centers for Medicaid and Medicare services, has changed the mechanism for adding newly FDA approved drugs in the six protected classes, including anti-retrovirals, as of April 17, 2006. Any drug approved by the FDA after April 17 must be approved for inclusion in the individual plan formulary by that plan's Pharmacy and Therapeutics (P & T) committee. Drugs included in a protected class will have a expedited approval time that can take up to 90 days or three months, but there is no guidance suggesting that newly approved drugs in the protected classes must automatically be added to the plan formulary. Each state will likely take price into account along with therapeutic value. Additionally the P& T committees will make decisions as to how to tier new drugs for co-payment amounts. Because of their price, most of the newer anti-retrovirals are tiered in the highest tiers making them unaffordable for many. Therefore, if Tibotec hopes to see a rapid inclusion in formularies, they must price it aggressively. How state authorities and the HIV affected public feel about the pricing of new drugs will contribute to the speed of this process. At the state level, price will almost certainly be a key consideration. Meeting the goal described here will make it possible for the activist community to support the fastest possible acceptance on the formularies.
The payers, Congress, patients and providers are greatly frustrated with the pricing practices of the pharmaceutical industry. While patients and payers are struggling year after year to raise the money needed to obtain access for a growing patient population, the pharmaceutical industry has shown virtually no restraint in its quest for profits and shareholder benefits. Its profitability ranks among the highest of all industries while the percentage of revenues devoted to research and development are at best average. The pharmaceutical industry speaks proudly of the need for a “free market economy” and the benefits of competition, but in fact it behaves more like a group of monopolies. It accepts little or no pressure on prices as a result of competition, the cornerstone of a market driven economy. In the US, the industry funds massive political lobbying to prevent government from negotiating prices for the largest national payers. Unlike other industries, in which high profits are usually the result of the consumers’ selection of outstanding products, the “buyers” of pharmaceutical products have little choice in the selection of products and product quality bears no relationship to the price charged. This coercive relationship between buyer and seller can no longer be tolerated. It must be challenged, whether through consumer protest, eventual price controls, or payer product selection, none of which are very attractive to industry. Make the right choice now and none of these approaches will be necessary.
We will follow-up this letter with continued discussions and one or more face to face meetings with Tibotec. The list of signers supporting this position will be updated weekly.
Carta ao Presidente da AG das Nações Unidas
President of the General Assembly
New York, NY
Dear Mr. President,
On behalf of the Civil Society Task Force for the 2006 High Level Meeting on AIDS, the Civil Society Coalition and many more civil society participants present at the recent meeting in New York, we would like to express our gratitude for the unique inclusion and the organisation of the Civil Society Hearing: “Keeping the Promise; The People Speak” on May 31.
This was a landmark UN Meeting on AIDS, not only for its demonstration of the level of political engagement in the issue, but also for the level of inclusion of civil society viewpoints. By inviting this level of representation from civil society, you have reaffirmed the role of agencies and groups outside of government in informing and energising the response to the epidemic. This process furthered civil society gaining the political literacy required to provide a counterpoint to international political processes, and strengthened our ability to engage at national, regional and global level with renewed confidence and commitment.
You have set an extremely important example by your own strong personal and professional commitment to the greater participation of people living with HIV and AIDS. The presence and prominence given to civil society and people living with HIV was unprecedented. For your part in this, too, you have our thanks. However, we also need to work together to overcome unjust immigration restrictions for positive people in the US and wherever else they exist, be stronger advocates for the participation of positive people on national delegations, in civil society as a whole and continue to promote and expand the application of the GIPA principle.
The Civil Society Hearing allowed the diversity, energy, passion and sense of urgency that we bring to the global response to be visible to and influential upon member states. We thank you for providing the platform for civil society to be heard. In future meetings on AIDS within the General Assembly, we look forward to working with the UN to ensure that the inputs from civil society can be even more meaningfully included.
Now that the meeting in New York is over, our work continues at the country level. Despite our disappointment in some aspects of the Declaration, we will seek to ensure that the political statement articulated in the High Level Meeting will be translated into a reality with measurable targets. This political statement will provide a crucial reference for groups to measure the performance of their own national leaders. None of the points it contains will go forgotten as we work to hold AIDS policymakers accountable. We look forward to reconvening in the General Assembly for the next High Level Review Meeting on AIDS, and once again offering our perspectives on the progress being made to overcome this global pandemic.
Civil Society Task Force for the 2006 High Level Meeting on AIDS
subscrita pelo GAT
Coordenação Nacional prepara formação em aconselhamento psicológico
O aconselhamento psicológico pré e pós teste de diagnóstico à infecção VIH/sida é uma das componentes tomadas em grande linha de conta pela Coordenação Nacional para a Infecção VIH/sida no âmbito do programa Klotho, que prevê o diagnóstico aos utilizadores de drogas nos centros de apoio a toxicodependentes (CAT).
A Formação dos técnicos dos CAT será iniciada em Setembro e tem como principais destinatários enfermeiros, psicólogos, psiquiatras e técnicos de serviço social.
Depois de terminada a experiência piloto de diagnóstico à infecção VIH/sida nos utentes do CAT de Gondomar, será iniciada a segunda fase do projecto, que além da formação prevé a extensão do programa a um CAT por cada sub-região de saúde.
Até ao fim de 2007, o projecto que tem como principal objectivo promover aos utilizadores de drogas o conhecimento do seu estado serológico, deverá estar alargado a todos os CATs do país e a dez estruturas de redução de danos.
VIH teve origem em chimpanzés selvagens dos Camarões
Há muito tempo que se suspeita que o VIH/sida passou para os humanos através de populações selvagens de chimpanzés. Mas uma equipa de cientistas dos Estados Unidos, Europa e Camarões confirmam agora isso mesmo na revista Science. Até agora só se encontrava o vírus em chimpanzés de cativeiro, mas depois de uma investigação de nove anos e da recolha de 1300 amostras de fezes de chimpanzés provam que o vírus teve origem nos chimpanzés selvagens dos Camarões.
O primeiro ser humano conhecido infectado por VIH era um homem de Kinshasa, no Kongo, tendo o seu sangue sido guardado em 1959, muito antes dos cientistas saberem da existência da sida.
Alguém nos Camarões foi mordido por um chimpanzé provavelmente ou então cortou-se enquanto o esquartejava e infectou-se passando depois a alguém.
A investigadora principal do estudo, Beatrice Hahn da Universidade do Alabama em Birmingham afirma que "eventualmente o vírus acabou numa área urbana e foi aí que se espalhou". Segundo os cientistas o vírus tornou-se mais mortal nos humanos do que nos chimpanzés.
Anti-retrovirais a baixos preços para países em desenvolvimento
O preço dos medicamentos anti-retrovirais poderá deixar de ser um dos maiores entraves no combate à infecção VIH/sida nos países em desenvolvimento. A ONU lança hoje, no âmbito da reunião da alto nível para a área da sida que decorre em Nova Iorque, uma central de compras de anti-retrovirais a preços baixos, com o principal objectivo de ajudar os países mais pobres a responderem às ameaças da infecção.
Além de medicamentos para combater a infecção VIH/sida, a mesma central de compras, que resulta de uma parceria entre a Noruega, França, Brasil e Chile, negociará o preço também de medicamentos para o paludismo e tuberculose.
Os fundos para este sistema será proveniente de 43 países, sendo que o contributo da França resultará de uma taxa cobrada nos aeroportos do país. Os passageiros que voarem em França pagarão sobre cada bilhete entre 1 e 4 euros na classe económica, taxa que pode ir até aos 40 euros em primeira classe.
A central de compras será gerida pela Organização Mundial de Saúde e pelo Banco Mundial e beneficiará ainda de uma parceria com a Federação Internacional de Futebol (FIFA).
Concurso CNSIDA: Spot para prevenir a Infecção VIH/sida
Com o propósito dos trabalhos contribuírem para informar os cidadãos em geral no que respeita à infecção VIH/sida, a Coordenação Nacional desafia os estudantes a fazerem projectos de spots publicitários em formato audiovisual com o máximo de 20 segundos.
Os trabalhos vencedores destinam-se a serem exibidos nos meios de comunicação social audiovisuais como publicidade institucional (televisão, internet, cinemas,...).
Condições de concurso
Os concorrentes podem apresentar uma ou mais propostas para quaisquer das seguintes opções.
§ Spot que promova a realização do teste VIH/sida, recorrendo à utilização da mensagem “Só há uma maneira de saber” e do respectivo logotipo disponível em ficheiro no site http://www.sida.pt
§ Promoção da realização do teste VIH/sida durante a gravidez – consoante normas da Direcção Geral de Saúde.
§ Promoção da utilização consistente do preservativo nas relações sexuais.
O estilo a utilizar para os spots é livre e todos deverão utilizar em algum momento o logótipo da Coordenação Nacional para a Infecção VIH/sida bem como os logótipos do Alto Comissariado da Saúde e do Ministério da Saúde, disponíveis em ficheiro no site http://www.sida.pt
quarta-feira, junho 07, 2006
Activistas expulsos da ONU
Dois membros do GAT fizeram parte desta acção.
Outraged AIDS Protesters Evicted From UN Headquarters, New York
published: 02 Jun 2006 — 9:48
June 1st, 2006
In the final hours of negotiations of the UN High-Level meeting on HIV/AIDS in New York this week, more than 100 civil society organizations worldwide staged an unprecedented protest shouting “The Declaration must include: treatment, targets, women and girls, harm reduction and vulnerable groups”. As they were herded out from the hall by security guards they chanted “Silence is Death”.
They were rejecting a draft political declaration that fell far short of expectations at a time when 8000 people a day die of AIDS globally. Governments failed to make commitments in five areas critical to ending the global AIDS epidemic.
According to the civil society coalition monitoring the UN drafting process the following concrete pledges are missing from the draft Declaration:
- targets for universal access to prevention, treatment, and care, such as ensuring access to treatment for 80% of all people living with HIV worldwide by 2010;
- comprehensive prevention strategies for all vulnerable populations;
- substitution therapy for intravenous drug users, and
- women’s reproductive and sexual health and rights.
The document further fails to identify highly vulnerable and marginalized groups, such as men who have sex with men, sex workers, injecting drug users, prisoners, migrants, and people in conflict situations.
“We came here because in the last five years many new issues have emerged that were not anticipated when the 2001 Declaration of Commitment was signed. This new draft declaration is simply not bold enough. It does not address the changing realities of the AIDS epidemic,” said one of the protesters.
“Today, for example, we can afford to treat people with antiretroviral therapy – which we couldn’t do five years ago because drug prices were still so high. But in the room right now, governments have refused to set a target for treatment because they are afraid that this will be used to hold them accountable.”
Since 2001 the AIDS epidemic has shifted. In Eastern Europe, for example, there is an explosion of new infections among intravenous drug users, who need immediate access to clean needles and substitution therapy to avoid infection. In sub-Saharan Africa, there has been a feminization of the epidemic. Women now make up the majority of those infected. Yet commitments to providing substitution therapy and to promoting women’s rights were rejected by conservative governments.
Many of the goals left out of today’s draft declaration would have represented a significant advancement to the 2001 Declaration of Commitment. According to another protester, “We demand a political commitment from governments that moves our struggle against AIDS forward rather than back.”