By Jeremiah Norris – Senior Fellow, Hudson Institute
In December 2010, UNAIDS issued a Report on the Global AIDS Epidemic. A key finding after four decades of the epidemic: “the world has turned a corner—it has halted and begun to reverse the spread of HIV.”
Other significant findings:
- Since 1999, the year in which the epidemic peaked, the number of new infections has fallen by 19%;
- of the estimated 15 million people living with HIV in low and middle income countries in need of treatment, 5.2 million have access;
- in 2009 alone, 1.2 million people received HIV antiretroviral therapy for the first time—an increase of 30% in a single year;
- increased access to treatment has contributed to a 19% decline in deaths between 2004 – 2009;
- in 33 countries, HIV incidence rates have fallen by more than 25% between 2001 – 2009, and of these, 22 are in Sub-Sahara Africa;
- in countries with the biggest share of HIV—South Africa, Nigeria, Zambia, Ethiopia and Zimbabwe — rates have either stabilized or are showing signs of decline;
- however, in Eastern Europe and Central Asia, HIV incidence rates increased by more than 25% between 2001 – 2009;
- in 2009, an estimated 370,000 children contracted HIV, down from 500,000 in 2001;
- among young people in 15 of the most severely affected countries, HIV prevalence has fallen by more than 25%;
- and, domestic expenditure is the largest source of HIV financing globally today, accounting for 52% of total resources in low and middle-income countries.
The UNAIDS Report focused almost exclusively on public health outcomes, such as the numbers of HIV patients being treated from one period to the next. It is difficult to find any clinical information on patients’ outcomes. Although we are now ending the fourth decade of treatment, UNAIDS is unable to inform us if ARV ‘x’ has a higher viral suppression level than ARV ‘y’, or if patients initiating treatment on one or the other regimens remain longer on first line therapies before proceeding to the more expensive 2nd line therapies.
Most importantly, UNAIDS is not reporting on the levels of drug resistance being experienced with 5.2 million patients.
In July of 2010, the Center for Global Development found that “about 22 percent of AIDS patients switch to second-line therapies after an average of 20 months on first line therapy”. In June 2010, PEPFAR reported to the Congress that total costs for first line therapy was $754 per patient per year. It increased to $1,745 per patient per year for 2nd line therapy. The economic considerations for 2nd line AIDS treatment is fast closing in on the costs for all other AIDS patients. There is no faster way to migrate patients from first to 2nd line therapies than to treat them with non-approved ARVs, otherwise known as sub-standard therapies.
In 2009, the Global Fund approved a revised Quality Assurance Policy for Pharmaceutical Products. It has two Options:
1) Prequalified by WHO or authorized for use by a Stringent Regulatory Authority;
2) Recommended for use by an Expert Review Panel (ERP). Subsequently, WHO was delegated as the ERP.
In the first Option, WHO—a membership organization, is equated with a stringent regulatory authority—an apple and brick comparison. In the second Option, WHO’s central requirement is its own issuance of a GMP (Good Manufacturing Practices) Certificate to a Member State. This is a manufacturing standard, attesting to clean and sterile production facilities, etc. It isn’t a product standard certifying the quality, safety and efficacy of the products manufactured. In all editions of WHO’s Prequalification Programme since 2003, it issues a public disclaimer, stating: not warranted for safety and/or efficacy if used in the treatment of HIV/AIDS.
Since many of WHO’s Member States follow its recommendations, as does UNITAID, the World Bank and UNICEF, the continuing use of non-approved ARV therapies in the absence of reports on patients’ clinical outcomes can accelerate the spread of drug resistance and undo all the good that is being done in the global HIV/AIDS fight.