2016 Pipeline Report
July 15, 2016 – HIV and TB Drugs, Diagnostics, Vaccines, Preventive Technologies, Research Toward a Cure, and Immune-Based and Gene Therapies in Development
Breathing Life into Flatlined U.S. Government Funding for Tuberculosis Research: FY 2017–2020 Allocations and Recommendations
June 2016 – This policy brief provides an overview of investments made by the U.S. government and explains how increasing TB R&D funding can catalyze the development of better vaccines, diagnostics, and treatments for TB. It is built upon resource tracking and reporting done by Treatment Action Group (TAG), and it recommends areas in which investments will not only fill research gaps but also provide clarity in the vision proposed by the National Action Plan and prevent the rising threat of multidrug-resistant TB (MDR-TB).
New and Updated HCV Treatment Fact Sheets Now Online
May 31, 2016 – A new fact sheet on Zepatier, and updated fact sheets on Solvaldi, Harvoni, Viekira Pak, and Daklinza now available for download.
TAGline Spring 2016
NEWS ON THE FIGHT TO END HIV/AIDS, VIRAL HEPATITIS, AND TUBERCULOSIS
- Fair Pricing: Reclaiming Drugs for the Common Good
By Tim Horn
- Greed and the Necessity for Regulation
The story of U.S. drug pricing run amok isn’t just about corporate arrogance and avarice—it is also about government permissiveness and inaction
By Tim Horn, Erica Lessem, and Kenyon Farrow
- PrEP Pricing Problems
A number of barriers to pre-exposure prophylaxis (PrEP) uptake, use, and adherence have been identified—cost shouldn’t be one of them
By James Krellenstein and Jeremiah Johnson
- The Low Cost of Universal Access
Generic treatments for HIV, viral hepatitis, and cancer can be affordably—and profitably—mass-produced for broad, unobstructed availability
By Tracy Swan
TAG’S PROGRESS ON THE FIGHT TO END HIV/AIDS, VIRAL HEPATITIS, AND TUBERCULOSIS
December 13, 2015
- Letter from Kenyon Farrow, TAG's U.S. & Global Health Policy Director
- Message from Board President Barbara Hughes
- Ending the Epidemic Update
- HCV Report from the Front
An Activist’s Guide to Regulatory Issues: Ensuring Fair Evaluation of and Access to Tuberculosis Treatment
December 2015 – This guide explains different regulatory processes and terms and offers examples of how to use a variety of regulatory mechanisms to improve access to treatment. The guide also encourages activists to advocate for effective, efficient, transparent regulatory systems.
2015 Report on Tuberculosis Research Funding Trends, 2005–2014: A Decade of Data
November 30, 2015 – Ten years of data collected by Treatment Action Group (TAG) show that funding shortfalls for TB research and development (R&D) are serious and chronic.
2015 Pipeline Report
July 17, 2015 – HIV, HCV, and TB Drugs, Diagnostics, Vaccines, Preventive Technologies, Research Toward a Cure, and Immune-Based and Gene Therapies in Development.
TAGline Fall 2015
- In Defense of Stringency
In response to growing public concern with health risks posed by approved drugs, a 2006 landmark report by the Institute of Medicine (IOM) argued that the U.S. Food and Drug Administration (FDA) lacks the unambiguous authority necessary to ensure the safety and efficacy of the country’s medicinal products. The IOM emphatically recommended that Congress enact any legislation necessary to buttress the agency’s enforcement powers so that it may apply the strengths of the pre-approval process, including stringent data review, to postapproval monitoring and regulation. Nine years later, Congress and federal courts have followed a markedly different course. Instead of ensuring agency leadership and resources, they have continued assaults on the FDA’s regulatory powers—eroding not only its postapproval oversight, but also the safety and efficacy requirements for its approval of drugs and medical devices.
- The 21st Century Cures Act’s “Pathway to Crisis” in Drug Safety
Federal legislation promises a substantial increase in NIH funding—at the expense of a significantly weakened FDA
- The FDA’s Concession Conundrum
Can regulatory incentives promote responsible TB drug development?
- The Challenge of Defining HIV Remission
Supportive regulatory guidance for cure research requires a clear understanding of all possible outcomes, including remission
- Improving Regulatory Systems to Address Global TB Drug Access Failures
Worldwide inefficiencies in drug approval processes are proving disastrous for people living with TB and other diseases
- PrEP: The Pathway to Global Access
Regulatory filing and review delays keep Truvada as pre-exposure prophylaxis out of reach of those who need it most
Toward Comprehensive HIV Prevention Service Delivery in the United States: An Action Plan
June 24, 2015 – An objective of the National HIV/AIDS Strategy (NHAS), released by the White House in July 2010, is to lower the annual number of new infections in the United States by 25 percent by the end of 2015. Yet it is unclear if we will succeed in meeting this arguably unambitious target: 36,400 estimated new infections in 2015, compared with the 48,600 new infections estimated for the baseline year of 2006.
Activist Strategies for Increasing Access to HCV Treatment in Low- and Middle-Income Countries
February 2, 2015 – This report presents a number of key strategies through real-world case studies and shows how strategies used to combat the AIDS epidemic can be—and have been—adapted to increase HCV treatment access. These strategies are introduced in three sections: Laying the groundwork through community organizing; overcoming the cost barriers to HCV treatment access; and collaborating with researchers to build your case for HCV treatment access.
December 15, 2014 – TAG’S PROGRESS ON THE FIGHT TO END HIV/AIDS, VIRAL HEPATITIS, AND TUBERCULOSIS
- Letter from TAG Board Member Alby Maccarone
- Message from Board President Barbara Hughes
- TAG Catalyzes New York State’s Plan to End AIDS
- Reports from the Front
- Q&A with Kenyon Farrow, U.S. and Global Health Policy Director
- Q&A with Board Member Jim Aquino
HIV Cure Research Fact Sheet
December 2014 – Combination antiretroviral therapy (ART) is a highly effective treatment for HIV infection, preventing progression of the disease in the vast majority of recipients. When ART is accessible and started early in the course of infection, the lifespan of HIV-positive people is typically very close to that of comparable HIV-negative people. But ART can have toxicities, is often costly, and requires strict daily pill taking that can lessen quality of life. Because of the limitations of ART, a cure for HIV infection remains a vital goal for research.
2014 Report on Tuberculosis Research Funding Trends, 2005–2013
October 22, 2014 – Reader beware: funding data presented in this report may be less encouraging than they appear. A quick glance at Treatment Action Group’s ninth annual Report on Tuberculosis Research Funding Trends would suggest good news: funding for tuberculosis research and development (TB R&D) increased by US$37.9 million over 2012 to reach a total of $676.7 million in 2013. The foundation of the TB research enterprise, however, is shakier than at any other time since Treatment Action Group (TAG) began tracking funding levels in 2005.
- 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.
- 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.