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CURRENT PROJECTS: Diseases | Medicine | Nutrition | Obesity | Pandemic Flu PAST PROJECTS: Safety & Health |
The Keystone National Policy Dialogue on Establishment of Studies to Optimize Medical Management of HIV Infection, Final Report One outcome of this effort was the creation of the forum for collaborative HIV research which focuses on identifying and researching critical unanswered questions surrounding new HIV drug therapies. Representatives from 40 public and private organizations who participated in the dialogue presented their recommendations to Vice President Gore.
Keystone National Policy Dialogue on Expanded Access to Promising Therapeutic Drugs for HIV Infection and AIDS with Implications for Other Life Threatening Diseases Final Report This report summarizes the discussions which took place in the Keystone Policy Dialogue on Expanded Access to Promising Therapeutic Drugs for HIV Infection and AIDS with Implications for Other Life-Threatening Diseases. The report and recommendations contained within are important not only for their substance, but because of the varied perspectives and opinions that converged to develop them. The AIDS crisis has raised a number of challenging scientific, ethical and public policy questions, including issues associated with early or expanded access to potentially therapeutic drugs. The crisis has created a conflict between society’s obligation to make promising therapeutics for people with HIV infection and AIDS available as soon as possible, especially in situations where alternatives are limited or do not exist. Traditionally, the primary driving force of regulation has been to protect the desperately sick from false hope and potential harm. The AIDS crisis has highlighted the emotional and financial costs of withholding approval until an extensive understanding of the clinical benefit of a therapy has been reached. Acknowledgment of these costs has sparked action for exploring the need for shifting the risk-benefit ratio used by regulatory process surrounding promising therapies for AIDS. This shift does not mean abandoning efforts to ensure that marketed drugs are safe and effective, but rather recognizing the need for addressing the significant costs of delaying access to those without adequate alternatives.
Keystone AIDS Vaccine Liability Project Final Report The Keystone Center convened this Dialogue group because of concerns that our product liability system is serving as an impediment to the development of a vaccine effective against AIDS. The goal of the group was to consider the validity of the problems and to seek a consensus on a solution. The Dialogue group believes this document is an important one for those concerned with this issue, both due to the substance of its discussions and recommendations and, perhaps most importantly, because of the diverse composition of the group which formulated it.
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