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TAGline Fall 2014: hello generics

  • A Drug by Any Other Name
    The basics of generic medications, bioequivalence, and the push for good manufacturing practices
    Securing access to generic drugs to treat HIV, hepatitis C virus (HCV), and tuberculosis (TB) is now one of the most prominent strategies of global health care and treatment activism.
     
  • The Road to Treatment Access
    Generic drug registration, licensing, and a trip to Gilead’s islands
    Access to essential medicines is part of the human right to health. But several steps are needed to create access to generics, including registration and licensing. Understanding these steps is critical for effective advocacy.
     
  • Safeguarding against Stock-Outs
    The time has come for U.S. tuberculosis programs to have full access to the Stop TB Partnership’s Global Drug Facility procurement and stockpile safety nets

    In the United States, where low-prevalence diseases like tuberculosis (TB) are at the mercy of limited market competition among generic drug makers, which can result in drug shortages when manufacturing or distribution problems arise.
     
  • Generics vs. the Giant
    For people with drug-resistant tuberculosis (DR-TB), generic linezolid may be a lifesaver. But only if quality-assured versions are available and affordable
    As new drugs bedaquiline and delamanid offer renewed hope of treating DR-TB, doctors and programs are faced with the challenge of finding companion drugs to create regimens to which patients’ TB is still susceptible. For this reason, interest in procuring linezolid has been increasing.

An Activist’s Guide to Delamanid
September 23, 2014 – Delamanid (also called Deltyba), the newest drug to fight tuberculosis (TB) was approved in Europe and Japan in 2014. This guide explains what we know about the drug’s efficacy and safety. The guide describe what activists—including people with TB, researchers, and doctors who treat TB—can do to help ensure access, fair pricing, and further research.

An Activist’s Guide to Linezolid
September 23, 2014 – Linezolid, an older drug important for treating some cases of drug-resistant TB, is being used more and more, and this guide summarizes the information we have on linezolid’s safety and efficacy in TB treatment. The guide describe what activists—including people with TB, researchers, and doctors who treat TB—can do to help ensure access, fair pricing, and further research.

2014 Pipeline Report
July 20, 2014 – HIV, HCV, and TB Drugs, Diagnostics, Vaccines, Preventive Technologies, Research Toward a Cure, and Immune-Based and Gene Therapies in Development.
Visit www.PipelineReport.org to read the report online.

1st Hepatitis C Virus World Community Advisory Board Report
July 14, 2014 — The hepatitis C virus (HCV) World Community Advisory Board (CAB) grew from an international AIDS activist movement. The objectives of the meeting were three-fold: 1. To provide a forum for leading activists to learn about developments in HCV treatment and access barriers; 2. To find common advocacy strategies; and 3. To meet with pharmaceutical companies about their plans for low- and middle-income countries (LMICs).

2013 Annual Report
July 11, 2014 — Progress in the Fight Against HIV, HCV, and TB.

An Activist's Guide to Tuberculosis Drugs
May 29, 2014 - TB treatment must be shorter, simpler, less toxic, and more tolerable and affordable. Activists can contribute to the development and uptake of improved TB treatment by calling attention to research, quality of medications, and access priorities. This guide provides a brief summary of safety and efficacy data for those drugs currently in use for TB (many of which have been approved for other diseases but are used off-label for TB), and suggests advocacy points for activists.

TAGline Spring 2014: The April Fools' Issue

  • Fool Us Once…
    By Tim Horn
    We’re being duped by our government agencies. We’re being hoodwinked by the Affordable Care Act (ACA). We’re being bamboozled by pharmaceutical companies and research networks. In this April Fools’ issue of TAGline, we highlight several missteps in research and policy that have required some degree of advocacy to remedy and ensure that the jokes don’t remain on us.
     
  • Forgotten Negatives: The Limits of Treatment as Prevention
    The CDC’s High-Impact Prevention strategy takes aim at the stubborn HIV incidence rate in the United States. The only problem: it doesn’t include an ambitious plan for those at risk for the virus
    By Jeremiah Johnson
     
  • The White House’s Fuzzy Math
    An Office of National AIDS Policy progress report obscures the state of the domestic U.S. HIV/AIDS response

    By Mark Harrington
     
  • Marketplace Menaces: Discriminatory Practices by the ACA’s Qualified Health Plans
    Advocates scramble to stay ahead of coverage rejections, formulary concerns, and exorbitant out-of-pocket expenses facing people living with HIV

    By Kenyon Farrow
     
  • Better Late Than Never: Efavirenz Dose Optimization
    After a study suggests that we’ve been using too high a dose of efavirenz for a decade and a half, the move toward scaling up a lower and more cost-effective one faces some hurdles

    By Tim Horn and Polly Clayden
     
  • Punked by Pharma: Public Funds for Private Products
    Tax dollars are making it easier for the drug and diagnostics industry to develop and market essential TB products. Is the public getting a fair return on its investment?

    By Lindsay McKenna
     
  • Fool’s Errand: The Sloppy Science of the MDR-TB STREAM Trial
    Confirming the efficacy and safety of bedaquiline-inclusive regimens is a priority. Comparing them to unvalidated MDR-TB drug combinations in the planned STREAM study is not the way to go about it

    By Mike Frick


Falling Funding for Tuberculosis Research Threatens to Derail TB Elimination Efforts in the United States
Research Dollars Drop Just as Old Disease Grows More Difficult to Treat

March 24, 2014, Washington, D.C. – The goal of eliminating tuberculosis (TB) as a public health threat in the United States is under threat, a new policy brief released today by Treatment Action Group (TAG) shows. Analysis conducted by TAG reveals that spending on TB research and development (R&D) among U.S. government agencies declined from 2009 to 2012 in the face of budget instability, sequestration, and the rising costs of biomedical research.

2013 TAGupdate
TAG’S PROGRESS ON THE FIGHT TO END HIV/AIDS, VIRAL HEPATITIS, AND TUBERCULOSIS
December 2013
In this issue:


Filling the Gaps in the U.S. HIV Treatment Cascade: Developing a Community-Driven Research Agenda
December 1, 2013 – TAG and amfAR sponsored a workshop in Washington, D.C., on June 18–19, 2013, to develop a community-based agenda to improve implementation of effective service-delivery approaches and identify research priorities for improved management of HIV treatment and prevention, with a particular focus on filling the gaps in the United States HIV continuum of care (or treatment cascade). This document represents the outcomes from that meeting, attended by representatives from government, academia, and health care systems, along with community-based advocates and service providers.

TRAINING MANUAL FOR TREATMENT ADVOCATES: Hepatitis C Virus and Coinfection with HIV
November 2013 – The information here is written by and for people who are not medical specialists. We are treatment activists who learned about hepatitis C because it was a problem for people in our communities. We designed it to help you understand basic information about hepatitis C and coinfection with HIV: how it is transmitted, how to prevent hepatitis C, how a person can find out if he or she has hepatitis C, what happens to both HIV-negative and HIV-positive people who have hepatitis C, information used for making treatment decisions, and treatment options.

2013 Report on Tuberculosis Research Funding Trends, 2005–2012
November 2013 – Over the last eight years, Treatment Action Group (TAG) has tracked annual spending on tuberculosis research and development (TB R&D) and compared investments in six areas of research with the corresponding annual funding targets called for by the Stop TB Partnership’s 2011–2015 Global Plan to Stop TB (2011–2015 Global Plan). For the first seven years, TAG observed slow and unsteady increases in funding signaling slow progress toward the new tools needed to end the global TB epidemic. This year, for the first time, TB R&D investors reported a drop in spending that threatens to undermine the tenuous gains made since 2005.

TAGline Fall 2013: The Domestic Issue

  • Rising to the Domestic Challenge
    The past decade has brought astonishing developments in HIV disease management...Yet the U.S. epidemic continues unabated. We are at a stalemate.
     
  • U.S. TB Control: From Confidence to Crisis
    Funding cuts and shifting budgetary priorities threaten tuberculosis gains
    The United States is losing ground in its fight against the tuberculosis (TB) epidemic within its own borders.
     
  • An Obligatory Overhaul to Address Domestic TB Drug Shortages
    Bold strategies are required to remedy frequent stock-outs and supply interruptions

    Drug shortages, especially of tuberculosis (TB) drugs, have become increasingly common in the United States.
     
  • A Commitment to the HIV Continuum of Care
    President Obama orders multiagency cooperation to achieve National HIV/AIDS Strategy goals, but without required funding commitment

    If the United States is to effectively move toward the 2015 goals outlined in the National HIV/AIDS Strategy (NHAS), tighter collaboration between various federal agencies will be required.
     
  • Engagement in Care: A Final Frontier of HIV Medicine
    Getting more HIV-positive people linked to and retained in care requires innovation and research

    Far too many people living with HIV aren’t accessing the care they need to benefit from the personal and public health benefits of antiretroviral therapy.
     
  • Toward a Plan to End AIDS in New York State
    A coalition of community groups push to end AIDS at the epicenter of the U.S. epidemic
    A series of discussions to reenvision the state’s HIV/AIDS response to encourage the government to develop a New York State plan to end AIDS have begun.
     
  • HIV Prevention Is the Surest Way to Fight AIDS
    ACT UP/NY demands Department of Health accountability at the epicenter of the U.S. epidemic and commits to reinvigorate the national prevention agenda
    New York’s Mayor Michael Bloomberg has put his personal stamp on campaigns against guns, cigarettes, and big soft drinks. But HIV prevention has been neglected for years.
     
  • TAG’s Commitment to HIV Prevention
    Though the number of new HIV infections in the United States is down from its peak in the 1980s, incidence has refused to budge below its decade-long average.
     
  • Emerging Regulatory Issues in HIV Cure Research
    The science of discovery comes with ethical challenges in human clinical trials

    To prove their worth, potential curative strategies—whether based on a single approach or a combination—will need to be evaluated in human trials.


amfAR/TAG Issue Brief: The Cost of Flat Funding for Biomedical Research
August 12, 2013 – “The Costs of Flat Funding for Biomedical Research,” prepared by the Foundation for AIDS Research (amfAR) in collaboration with TAG, examines the declining purchasing value of public funding for health research at the National Institutes of Health (NIH) and the impact this has on public health, scientific progress, US productivity, and US science leadership.

The Immune System, HIV, and Aging
June 3, 2013 – Little more than a decade ago, it was almost inconceivable that the issue of aging with HIV infection would emerge as an important concern. But it has now become clear that combination antiretroviral therapy (ART) can suppress virus replication for many years—likely for life—in most people who can access the drugs, and the opportunistic infections that were once the primary causes of illness have largely evanesced everywhere treatment is available. Morbidity and mortality from HIV infection has plummeted, and the survival of HIV-positive individuals is edging ever closer to that of comparable HIV-negative people. With the specter of AIDS having finally been chased from the near horizon, attention has turned to health problems that may lie further down the road.

Pipeline Report
June 30, 2013 - HIV, Hepatitis C Virus (HCV), and Tuberculosis (TB) Drugs, Diagnostics, Vaccines, and Preventive Technologies in Development.