- 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.
A Community Town Hall on HIV Cure Research in Washington D.C.
On Tuesday, October 14th, 2014, Please join us at an educational community town hall for HIV-positive individuals, advocates, providers and policymakers in the DC area interested in learning about the current status of research into curing HIV infection.
Two New Activist Guides on Delamanid and Linezolid
September 23, 2014 – Delamanid (also called Deltyba), the newest drug to fight tuberculosis (TB) was approved in Europe and Japan in 2014. An Activist’s Guide to Delamanid explains what we know about the drug’s efficacy and safety. Linezolid, an older drug important for treating some cases of drug-resistant TB, is being used more and more, and An Activist’s Guide to Linezolid summarizes the information we have on linezolid’s safety and efficacy in TB treatment. Both guides describe what activists—including people with TB, researchers, and doctors who treat TB—can do to help ensure access, fair pricing, and further research.
Research Toward a Cure
September 10, 2014 – A listing of clinical trials and observational studies related to the research effort to cure HIV infection.
Advocacy Groups Report to UN on U.S. Failures to Address the HIV Epidemic in Communities of Color
August 14, 2014 – A national coalition of HIV/AIDS advocacy organizations has submitted a report to the United Nations in Geneva detailing the disparate impact of HIV/AIDS on communities of color, and identifying the lack of U.S. action on social drivers of the epidemic in those communities as a human rights violation. The report was produced by AIDS Foundation of Chicago (AFC), Center for HIV Law and Policy (CHLP), Counter Narrative Project, HIV Prevention Justice Alliance (HIV PJA), National Working Positive Coalition (NWPC), Positive Women’s Network of the United States of America (PWN-USA), Sero Project, Treatment Action Group (TAG), and Women with a Vision.
- Press release from the AIDS Foundation of Chicago.
- Complete report: HIV Criminalization, Poverty, and Health care Access – United States’ Violations of the International Convention on the Elimination of All Forms of Racial Discrimination.
Activists Hold Die-In to Protest High Price of Gilead’s Hepatitis C Drug
MELBOURNE, AUSTRALIA, July 24, 2014 – Treatment activists at the 20th International AIDS Conference held a die-in to protest the exorbitant pricing of Sovaldi (sofosbuvir), Gilead’s new hepatitis C virus (HCV) drug. As Gregg Alton, Gilead’s Executive Vice President of Corporate and Medical Affairs, spoke, activists brought him a liver on a silver platter while chanting “Pills Cost Pennies, Greed Costs Lives,” “Shame, Shame, Shame,” and “Pharma Greed Kills.” Their signs said, “Wanted: Crimes Against Access,” “Hep C Criminal,” and “Gilead Kills” as the O’Jay’s “For the Love of Money” blared in the background.
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.
July 17, 2014 – TAG's staff and Board of Directors are at a loss for words following today's tragic downing of Malaysia Airlines Flight 17, made all the more horrific by the reported loss of several HIV/AIDS researchers, civil society staffers, and other community leaders en route to the International AIDS Conference in Melbourne. Our thoughts are with the families, friends, and colleagues of all 298 passengers and crew who perished.
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 threefold: 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.
Treatment Action Group Commends Governor Cuomo for Launching Historic New York State Plan to End AIDS
TAG Calls on Governor to Expeditiously Appoint a High-Level Task Force to Develop Blueprint to End AIDS Deaths and Halt New HIV Infections
June 29, 2014, New York, New York – Treatment Action Group (TAG) applauds Governor Andrew M. Cuomo for his full support of a historic community-developed plan to end the AIDS epidemic in New York State by 2020, as announced this morning by the Governor’s office and reported in today’s edition of the New York Times (“Cuomo Plan Seeks to End New York’s AIDS Epidemic,” Anemona Hartocollis, page A18). With this bold initiative, New York State—long the epicenter of the nation’s HIV epidemic—becomes the first jurisdiction anywhere in the world to publicly declare a goal of ending AIDS as an epidemic with the launch of a comprehensive effort to end AIDS deaths and halt new infections by employing state-of-the-art testing, preventive technologies, treatment, and supportive services.
ACT UP to Tom Frieden: You’re MIA on HIV
New Infections on the Rise in Key Subpopulations, Despite Options for Prevention
June 9, 2014 – Members of ACT UP/NY, along with Treatment Action Group (TAG) and Atlanta allies, will meet with the Centers for Disease Control and Prevention's (CDC's) HIV prevention personnel in Atlanta, Georgia. ACT UP will call upon the CDC to meet its commitment of keeping all Americans healthy and to act now upon the promise of TasP, PrEP, and PEP, address social and structural barriers to lifesaving prevention options, and reduce the transmission of HIV in those groups where the incidence is rising.
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.
New Hepatitis Resolution Is Passed at World Health Assembly; Challenges World Health Organization and Member States to Act
Geneva, Switzerland, May 22, 2014 —Today, four years after introducing its first viral hepatitis resolution, the World Health Assembly (WHA)—the decision-making body of the World Health Organization (WHO)—passed the Hepatitis Resolution, which commits the WHO and United Nations (UN) member states to urgent action to address the global hepatitis pandemic, including that of hepatitis C virus (HCV).
Defuse Hepatitis C, the Viral Time Bomb: Test and Treat Hepatitis C
Position Paper for the 67th World Health Assembly, May 19–24, 2014
We, people living with HCV, HIV/AIDS, people who use drugs, and our advocates, urge United Nations (UN) Member States to act with urgency to end the hepatitis C epidemic; it is possible!
- 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.
Pharma Refuses to Ensure Access to Lifesaving Hepatitis C Treatment at Global Meeting
February 28, 2014, Bangkok, Thailand – Thirty-eight activists from 22 countries joined forces at the first-ever Hepatitis C Virus (HCV) World Community Advisory Board (CAB) to demand equitable access to treatment for hepatitis C virus (HCV) from six multinational pharmaceutical companies. Yet AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Merck, and Roche refused to provide a plan for equitable access to treatment for HCV, a curable infection that kills over 350,000 people each year.
Letter to Governor Cuomo on Ending AIDS in New York State
February 18, 2014, New York, New York – We write to follow-up on our January 14, 2014 letter regarding the development of a plan to end AIDS in New York State. In addition to creating a Task Force to End AIDS in New York to promptly develop a strategic blueprint and plan in collaboration with the community and the DOH AIDS Institute, we urge you to include the following items in your 30-day amendments to the 2014-2015 Executive Budget:
- $10 million in new funding for the AIDS Institute to implement the plan developed by the above noted task force;
- Article 7 language to eliminate the use of condoms as evidence of prostitution by police and prosecutors; and
- Article 7 language to legalize the possession of syringes.
Treatment Action Group mourns the death of TAG’s founding treasurer Marvin Shulman (May 17, 1932–January 15, 2014), who died Wednesday in Miami Beach, Florida. A beloved, compassionate, generous, and tireless AIDS activist, Marvin Shulman first joined the AIDS Coalition to Unleash Power (ACT UP)/New York at the time of its Wall Street II action on March 28, 1988, where he was arrested as a member of the ACT UP affinity group known as Wave 3. Marvin quickly became an active member of ACT UP/NY’s leadership, serving as ACT UP’s treasurer for several years.
2013 TAG Update
TAG’S PROGRESS ON THE FIGHT TO END HIV/AIDS, VIRAL HEPATITIS, AND TUBERCULOSIS
In this issue:
- Letter from Tom Duane
- Message from Board President Barbara Hughes
- TAG’s Progress Toward Revitalizing the National HIV/AIDS Strategy
- Working to Improve TB Care and Treatment among the Tibetan Community in Dharamsala, India
- Reports from the Front
- Politics Is a Major Hurdle in HIV Treatment
- Q & A with TB/HIV Project Officer Mike Frick
- Q & A with HIV Prevention Research & Policy Coordinator Jeremiah Johnson
- Q & A with Board Member Earl L. Plante
- Q & A with Board Member Frank Bua
CRAG, TAG Welcome Sanofi U.S. Commitment to Reduce the Price of Tuberculosis Drug Rifapentine
December 12, 2013 – The Community Research Advisors Group (CRAG) and Treatment Action Group (TAG) welcome the Sanofi U.S. decision to lower the price of the tuberculosis (TB) drug rifapentine to $32 per 32-tablet blister pack. The company indicates that the new price will become effective in January 2014 under 340(b) Public Health Service pricing.
Treatment Action Group Remembers Nelson Mandela
December 8, 2013 – Treatment Action Group salutes the achievements, life, legacy, and memory of Nelson R. Mandela, freedom fighter, prisoner at Robben Island, president of the African National Congress (ANC), from 1994 to 1999 South Africa’s first freely-elected President, and the man whose plea to his colleagues led to the establishment of South Africa’s public-sector HIV treatment program, now the world’s largest.
TAG Applauds $12 Billion Replenishment of Global Fund to Fight AIDS, Tuberculosis and Malaria, and Calls for Greater Flexibility to Support Middle-Income Countries Coping with Large HIV or TB Epidemics
December 3, 2013, New York, New York – Treatment Action Group applauds the donors who have helped make it possible to save more lives by raising a record-breaking $12 billion for the Global Fund to Fight AIDS, Tuberculosis and Malaria over the next three years. TAG also commends the Obama administration for its generous match of one dollar for every two dollars contributed by other donors, which helped to drive up funding commitments in the current replenishment round.
167 Organizations and 513 Individuals Sign on to Letter to Secretary Sebelius on the Allowance of Co-pay Assistance in the ACA Health Plans
December 2, 2013 – We, the undersigned organizations and individuals, are writing to urge that the HHS issue clear guidance on the allowance of drug industry–provided co-payment, co-insurance, or other out-of-pocket discount cards and coupons in the Affordable Care Act’s (ACA) Health Insurance Marketplaces. As people living with, and organizations serving people with, HIV, HCV, and other life-threatening and chronic health conditions, we are alarmed by the possibility of the prohibition of these critical financial lifelines in the ACA, just as affordable health insurance for people with preexisting conditions is finally becoming a reality in the United States, thanks to the ACA.
amfAR and Treatment Action Group Call for a Strategic Research Agenda Needed to End HIV/AIDS in the United States
December 1, 2013, New York, New York – Today, on World AIDS Day, amfAR, The Foundation for AIDS Research, and Treatment Action Group (TAG) called for a deliberate and expedited research agenda designed to begin to end the AIDS epidemic in the United States. Both organizations noted that in order to achieve this goal, Congress must end sequestration and work to ensure the full implementation of the Affordable Care Act (ACA). AmfAR and TAG’s new report, Filling the Gaps in the U.S. HIV Treatment Cascade: Developing a Community-Driven Research Agenda, outlines several recommendations for the Obama administration.
Treatment Action Group Applauds European Approval of New Drug to Fight Tuberculosis, Demands Expanded Access and Affordable Pricing
— Approval of and access to delamanid are crucial while further research is pending —
November 22, 2013, New York, New York – Treatment Action Group (TAG) congratulates the Committee for Medicinal Products for Human Use (CHMP) for its recommendation to the European Medicines Agency (EMA) to grant marketing approval to delamanid, a new drug for multidrug-resistant tuberculosis (MDR-TB) now in phase III clinical trials. MDR-TB treatment options that do not include new drugs are long, toxic, difficult to tolerate, and often ineffective.
October 30, 2013 – Activists stormed the stage at the World Health Organization (WHO) sponsored Stop TB Symposium during the 44th Union World Conference on Lung Health. TAG's TB Project Director Colleen Daniels called for global action and a new global attitude in the fight against TB.
A Double Blow: Private-Sector Funding for TB Research Drops Sharply Amid Severe Public-Sector Budget Cuts
—As threat of drug-resistance grows, big Pharma decreases investments in TB research by 22 percent—
October 29, 2013, Paris, France – The 2013 Report on Tuberculosis Research Funding Trends, 2005–2012 finds that funding for tuberculosis research and development (TB R&D) dropped by US$30.4 million compared with 2011—the first time funding has fallen since TAG began tracking investments in 2005. Funding declined for diagnostic, drug, vaccine, and operational research, increasing the likelihood that new tools to fight TB will remain out of reach for the 8.7 million people who develop TB each year.
135 Organizations Send Letter Urging UNITAID to Prioritize HIV/HCV Coinfection
October 10, 2013 – We commend UNITAID for addressing viral hepatitis in its 2013–2016 Strategic Objectives. We are writing to underscore the need for a swift response from UNITAID to hepatitis C virus (HCV) coinfection; delays will cost lives and impede scale-up when more effective and tolerable therapies are available.