From Vol. 33, No. 6, 2005

Special Issue Featuring: "Treating Children with HIV: The Role of Faith-Based Investors"

"Children with AIDS are being left to die," Dr. Essajee says in a classic British accent. We are sitting in a small Indian restaurant on the East Side, Dr. Shaffiq Essajee and I. It is almost a year since I journeyed to Kenya, Botswana, and South Africa and saw for myself the immense challenge of treating pediatric AIDS. Yet I am still trying to come to grips with the enormity of the challenge. Dr. Essajee, who spends more time in Mombassa then Manhattan, treats children at the AIDS Research and Family Care Clinic in Kenya. He is funded by the American charity Keep A Child Alive.

The Scope of The Pediatric AIDS Crisis (source: UNAIDS)

Each Day: 1,900 children are infected with HIV.
1,350 children with HIV die.
Each Year: 630,000 children become infected with HIV (the vast majority during birth or through breast-feeding).
490,000 children die from HIV. Half of all children with AIDS die before they reach two years old.

The Cost of Treating Kids (source: Medecins Sans Frontieres)

Pediatric First Line: Three oral syrups of d4T, 3TC, & NVP
Pediatric Annual Cost: $284 per year
Adult First Line: One tablet containing d4T/3TC/NVP
Adult Annual Cost: $244 per year
Pediatric Second Line: Three oral syrups of ZDV, ddl, & NFV
Pediatric Annual Cost: $3150 per year
Adult Second Line: Three tablets of ZDV, ddl, & NFV
Adult Annual Cost: $1096 per year

He continues, "Apart from Thailand and Brazil, fewer than 15000 kids worldwide are currently on treatment, and yet HIV-positive children are the most vulnerable group of patients in Africa. Without treatment, mortality approaches 60% in the first 2 years of life, whereas children who get ARVs can lead healthy lives." That means, in plainer English, that over half of kids with AIDS are dead by age two, unless they get ARVs. ARVs are antiretroviral medicines, live-saving therapies which should be a birthright of every child born with HIV.

HIV and AIDS strikes down people in the most vibrant years of their lives, when they are working, raising children, and laying the foundation for the next generation of their - and our - societies. But the cruel calculus of HIV means that women are infected, often by their husbands, and give birth before they are AIDS-sick and aware that they have the virus.

The result is a rising wave of children living with HIV. While many become infected through sexual abuse or sexual activity, the vast majority of children with HIV are infected at birth or shortly after.

Often these children lose their HIV-positive parents as well, and become doubly scarred by the virus: both AIDS orphans, and AIDS patients.

During my ICCR-sponsored research trip to Botswana, Kenya, and South Africa, I met the doctors, nurses, lay missioners, women religious, aunts, and grandmothers who daily care for these children. Many kids owe their lives to faith-based or non-governmental organizations. I remember vividly the pride with which one elderly priest informed me none of his charges died in the past year.

Members of the Interfaith Center on Corporate Responsibility are supporting their colleagues in AIDS-impacted regions with a massive effort to encourage new policies at Abbott Laboratories, Bristol-Myers Squibb, GlaxoSmithKline, Merck, Johnson & Johnson, Pfizer, and the biotechnology company Gilead Sciences to increase access to life-saving medicines.

Sister Vicki Bergkamp of the Sisters Adorers of the Blood of Christ, and Chair of the HIV/AIDS Caucus at ICCR, explains "ICCR Members see the ravages of HIV and AIDS in their daily work in Africa, India, and China. Our experience on the ground in these regions has convinced us that leading pharmaceutical companies can - and must - do more to make their life-saving products accessible to the people who desperately need them."

Abbott, Merck, and their competitors make anti-retroviral drugs (ARVs) which dramatically slow the onset of AIDS in HIV-positive patients, allowing them to lead normal and productive lives, often for many years. Generic competition has dropped the price of these medicines by astounding amounts. For example, a first line treatment regime costing over $1,000 in 2001 now costs $400. Generic versions of ARV medicines - which are often combined into a single pill - cost under $200 per patient per year.

But children with HIV are largely cut out of this price competition because they have little purchasing power. 2.1 million children live with HIV , but they can not finance their own care. Generic drug makers rely on economies of scale to make their thin profit margins. Without a large market, they can not compete.

For the 1,900 children newly infected with HIV today, big-name American companies are their only hope. Shareholders in those firms have a moral obligation to change management policies to fulfill the promise of life-saving medicines.

"HIV treatment for adults is slowly becoming easier," explains Dr. Koen Frederix, a pediatrician working in Malawi with the charity Medecins Sans Frontieres, "with increasing availability in developing countries of a three-drug cocktail in one tablet. But children who need treatment still have to drink large amounts of foul tasting syrup or swallow large tablets - that's if they can actually access treatment at all. Children with HIV are generally not interesting to pharmaceutical companies."

Treating children is not easy. The cost is high, diagnosis is challenging, and ensuring adherence (taking pills consistently and correctly, which is important to prevent viral mutations) is complicated. The stigma attached to HIV casts a shadow over the whole process.

Dr. Essajee explains, "While there are many issues that contribute to this tragic situation, one of the key problems is the lack of access to drugs. Pediatric formulations are many times the cost of adult meds - whether generic or branded - and the supply chain - especially from US manufacturers is woefully inadequate to support the numbers of kids who need treatment."

But treatment is possible, given the resources. In Sao Paulo - which has the largest number of pediatric AIDS cases in Brazil - median survival time is over seven years, a hopeful contrast to the half of children with AIDS who die before age two.

Adherence challenges can also be met. In Thailand, forty-four children at Prachomklao Hospital in Petchburi achieved a 95% adherence rate. Doctors found "continuous support for adherence was the main challenge for treatment success." Only five children died, all of tuberculosis, and none due to poor adherence.

Adding to these treatment burdens is the high cost of treating children. In Thailand, pediatric cases cost the health care provider 18,600 Baht ($475) per child, with families absorbing 6,231 Baht ($160). In Brazil, two sites providing care to HIV-positive children spent 62% and 78%, respectively, of their cost total on ARV drugs, despite an aggressive program by the Brazilian government to negotiate lower prices from Western drug companies.

When leading medical providers were asked to identify the greatest barrier to treating children, the consensus was clear: money. Dr. Aziz O. Abdallah, the Director of HIV Care Services at Liverpool VCT and Care Center in Kenya, sent a terse email from Nairobi: "The unavailability of affordable pediatric ARV formulations." He recommended drug companies simply "reduce the cost" of the drugs his patients need.

Recently, ICCR members developed a menu of policy options for the Boards of Directors of major pharmaceutical companies. Sister Doris Gormley, a corporate responsibility consultant to the Society of Jesus, explained why: "While many companies have taken some positive action in the past, it is clear to us that no pharmaceutical company is taking advantage of the range of policy options available to them to increase access to medicines. Shareholders want to see strategic leadership from the Board of Directors to this crisis, not just ad hoc responses."

This menu, also printed in this issue of the Corporate Examiner, covered both adult and pediatric AIDS-drug access issues. But for children, we focused on three core areas: Reduce, Research, and Register.

First, drug companies should commit to holding pediatric prices at adult levels.

Second, they should direct research energies to developing pediatric formulations which work in the real world settings of resource poor countries. That means chewable tablets, fixed-dose combination syrups, smaller pills, and more research in dosing. As children grow, dosing is a constant problem for caregivers.

Finally, all ARV drugs in all formulations should be registered in all countries. Too often, companies do not navigate the bureaucratic hurdles in the local equivalents of our Food and Drug Administration. Ideally, of course, those bureaucratic hurdles would be slight. But patients must be not be punished for the inefficiencies of their governments. They need companies to aggressively bring all formulations to market.

With this advocacy, faith-based investors are completing the circle begun by the faith community in Africa and Asia, who have embraced children with AIDS as the most vulnerable of patients. I am pleased to report that ICCR shareholders are leading the way. The question now is, will management follow?

Recommendations for Pharmaceutical Companies
Reduce: Reduce the price of pediatric formulations to adult levels.
Research: Develop fixed dose combination syrups, chewable tablets, and other child-friendly medicines.
Register: Ensure all pediatric formulations are registered in all markets.

To read more, just order the full special issue online here.

Article written by By Daniel Rosan, Program Director, ICCR's Access to Healthcare Working Group