All Posts Tagged With: "drug safety"
Promoting HIV Prevention as We Seek a Vaccine
Ambassador Mark Dybul, Former U.S. Global AIDS Coordinator
Co-director, O’Neill Institute for National and Global Health Law, Georgetown University
Today, on HIV Vaccine Awareness Day , we pay tribute to all those contributing to the pursuit of a safe, effective and affordable vaccine against HIV. Much progress has been made globally to advance prevention, treatment and care because of the leadership, commitment and talent of leaders from all sectors in-country at the national, community and individual levels. However, with support from the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) , the Global Fund to Fight AIDS, Tuberculosis and Malaria and the UN family though the co-sponsors that make up UNAIDS , we have only just begun. We cannot reach the ultimate goal – an HIV Free Generation – without a safe and effective vaccine.
The U.S. is the global leader in HIV vaccine development. Biomedical researchers in our nation’s world-class laboratories are funded by the pharmaceutical and biotech industries, the U.S. Government (which provided approximately 80 percent of public expenditures for HIV vaccines), and foundations, most notably the Bill & Melinda Gates Foundation . In addition to basic research, clinical research physicians are leading HIV vaccine studies, volunteers are enrolling in clinical trials, and the community voices are advocating for funding and partnerships to reach the goal of an AIDS vaccine. All deserve our recognition and appreciation.
Twenty-five years ago, the U.S. Health and Human Services Secretary predicted an AIDS vaccine would be in ready for testing in two years. Another 20 years and numerous promising HIV vaccine candidates have come and gone. The past year was a difficult one, but that is the natural arc of scientific advance. We have learned much, and from that learning we continue the movement and momentum to find a vaccine. Now is not the time to back away because we do not have a vaccine – now is the time to redouble our efforts because we do not have a vaccine.
But without an unanticipated technological breakthrough, realistically, it will be years – 5, 10, or maybe another 20 – before we have an HIV vaccine. Meanwhile, we are still facing over 7,000 new HIV infections every day around the world. We know how HIV is transmitted and despite difficulties in measuring the success of specific programs, we know that HIV prevalence rates can drop dramatically. Recently, Namibia reported a nearly 50 percent decline in HIV rates among 15-24-year-old persons, following previous reports of 30 percent reductions in Kenya, 23 percent in Zimbabwe, and an overall reduction in Africa.
So we don’t need to wait for a vaccine to prevent HIV infections –there are proven strategies and evidence-based approaches that can dramatically reduce the transmission of HIV today. Education and behavior change including delaying sexual debut, partner reduction – both casual and multiple concurrent - and use of condoms, counseling and testing, prevention of mother-to-child transmission, male circumcision, post-exposure prophylaxis and the rapid expansion of treatment that contributes to decreased transmission, need to be financed and championed for scale-up, penetration and coverage. And we are hopeful that pre-exposure prophylaxis will contribute to the prevention arsenal in the near future.
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Is Drug Safety in the U.S. Moving in the Right Direction?
Protecting the public’s health is an important part of the part of the U.S. Food and Drug Administration (FDA) job. And on May 7, the FDA proposed several measures that would allow the agency to better regulate the safety of Americans’ food and medical products. The FDA request for the President’s fiscal year 2010 budget asks for $3.2 billion to protect and promote public health. This figure, which is a 19 percent increase from the current FDA fiscal year budget, is a significant step towards the direction of a safer pharmaceutical supply chain.
If approved, the budget would be directed towards two major pharmaceutical protection goals –Safer Medical Products and Follow-on Biologics & Drug Importation. The Safer Medical Products proposal will allocate $166.4 million towards safeguarding human and animal drugs, medical devices, vaccines, blood, and other medical products. This proposal will also establish fees to reinspect medical product facilities, so they will meet safety standards, and also instate a review for generic drugs.
An additional $5 million will be distributed to the Follow-on Biologics & Drug Importation proposal, which would give the FDA authority to follow biologics through a regulatory path. While all significant strides, a part of this money will be allocated towards developing policies for Americans to import drugs from foreign countries.
Read the rest of this article on drug safety here.