Tomislav VurušićLux Vitae

Pula, Croatia

HIV treatment activism –

bridge that connects

History of AIDS

1981: First AIDS cases reported

1980ies: Community-based treatment research

1984: HIV described

1987: first AIDS-treatment approved (azidothymidine, AZT)

1991: didanosine (ddI) & zalcitabine (ddC) approved

2012: 26 antiretroviral drugs (ARVs)

The Denver Principles (1983)

People with AIDS (PWAs) meet in Denver for the conference “Health Pioneering in the Eighties”

“We condemn attempts to label us as "victims," a term which implies defeat, and we are only occasionally "patients," a term which implies passivity, helplessness, and dependence upon the care of others. We are "People With AIDS."

"Nothing about Us, Without Us“

HIV treatment history

All known antibacterial or antiviral treatments were ineffective

No governmental agency or pharmaceutical company made any efforts in therapeutical research

Only some basic biological research was fundedGovernment-sponsored research into treatment

options started in the U.S.A. only after gay men had demonstrated for the administration‘s support for treatment research

Community organized small clinical trials on some experimental compounds

E.g. a trial including ribavirin and isoprinosine

With the support from volunteering physicians and scientists, community-based organizations had undertaken some of the first treatment trials in the AIDS field

1987 approval of AZT as first AIDS treatment Anti-cancer compound in 1960 never developped Today known as zidovudine – ZDV (Retrovir)

Project Inform – San Francisco

1985: Project Inform created by Martin Delaney & others

1989: a parallel track program for ddI annouced by Project Inform and U.S. National Institute of Allergy and Infectious Diseases

included much more patients and had less restrictive entry criteria

Early 1990s: Project Inform instrumental in introducing accelerated approval & expanded access programmes

“Who should decide which risks are acceptable, the bureaucracy in Washington or the patient whose life is on the line?”

Delaney, “Acceptable Risks” (Poseidon Press, 1992)

Act Up – New York

1987: Act Up created by Larry Kramer, playwright & author (GMHC founder)

use of placebos in clinical trials has been one of the most controversial issues in clinical AIDS research and other disease areas

1989: ACT UP New York demanded an end to placebo-controlled trials that required "body counts" or a „death toll“ to prove efficacy

AIDS activism in Europe

In 1989, 1990, the European situation differed from the US

Drug companies would initiate clinical trials in Europe only after they had obtained positive results from trials in the US

delay in access to treatments in Europe

early 1992: AIDS activists from 10 European countries met in Berlin to found an organization which aimed to overcome these difficulties and accelerate access to experimental treatments in Europe

European AIDS Treatment Group (EATG) was founded One of first initiative was EU-wide EAP (expanded access program)

EATG in 1992

Scope: To achieve effective treatment & access to experimental therapies

for as many PLWHA as possible & as soon as possible. To enable people with HIV to have maximum control over the

treatment and research agenda.

Focus on: Research priorities and ethics Access to information Access to medical services Access to experimental drugs Pan-European communication

EATG today

>90 members, majority PLWHA, cca. 35 countries, WHO Europe

Working Groups: ECAB, PWG, DMAGEuropean Community Advisory Board:

Scientific research, drug development, research networks, EMA - under confidentiality

Policy Working Group: Policy & advocacy work – Commission, Parliament, multilateral organisations

Development and Membership Advisory Group: Development, governance

Challenges of HIV treatment activism

Continuous funding for HIV/AIDS treatment and care

Access to treatments in underserved communities and/or regions

Establishing a standard of care

End to discrimination to PLWHA

Involvement and active participation in research and trials

Access to information

Tratment interruptions

Case of South Eastern Europe

Registration of drugs very late (e.g. Croatia) Abacavir: FDA (1998), EMA (1999), Croatia (2005) Efavirenz: FDA (1998), EMA (1999), Croatia (2004) TDF/FTC: FDA (2004), EMA (2005), Croatia (2009)

Registration of a drug doesn’t mean immediately availability for people in need

Health insurance drug list and price of a drug

Donation by pharmaceutical company of needed drug

Emergency guidance on ART forced treatment interruptions due to drug unavailability (forced stock-outs) for people living with HIV and their care providers in Europe and Central Asia

Issued by the European AIDS Treatment Group, October 2011

Treatment activism organisations in region

EATG (European AIDS Treatment Group)

NeLP (Network of low-prevalence countries in Central and South-East Europe)

Central and South East Europe

Budapest Declaration (NeLP)

Key areas: Treatment and care Prevention Key populations Policies and legislations

The Website www.nelp-hiv.org

• Country profiles• Epidemiological fact sheets• Prevention• Treatment and care (ARV – prices)• Institutional background: health services, financing of

services• Legislation

• Budapest declaration• News

Who are activists?

http://www.youtube.com/watch?v=d1-j0hLgPEQ

Song from a movie “And The Band Played On (1993)

Thank you!!!

"Care for us and accept us - we are all human beings. We are normal. We have hands. We have feet. We can walk, we can talk, we have needs just like everyone else - don't be afraid of us - we are all the same!“

Nkosi Johnson (February 4, 1989 – June 1, 2001)

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