Warning About Global Efforts to Provide Drug Therapies in Developing World

Johns Hopkins infectious disease specialists who have spent more than two decades leading efforts to combat HIV and AIDS worldwide are warning that limited international relief supplies of antiretroviral therapies currently being distributed in Africa, Asia, and the Caribbean will not get to those who can least afford to pay for them.

In an article appearing in the American Journal of Public Health online June 28, infectious disease specialist Jonathan Zenilman, MD, a professor at The Johns Hopkins University School of Medicine, reports that poorer people have been left out in the past due to insufficient local planning, and that donors and developing countries should learn from these mistakes as the number of people requiring therapy continues to grow.

Local health officials are faced with the unenviable and difficult task of having to decide who will get therapy and live, and who will have to do without and possibly die, he says. But this dilemma is unavoidable because supply will fall far short of demand, despite the generous nature and growing scope of aid efforts.

While President Bushs 2003 Emergency Plan for AIDS Relief is spending more than $600 million on antiretroviral therapies for 2 million people, demand in the developing world is even greater and steadily growing, with at least 6.5 million people in need of drug therapy and only 15 percent receiving any. And, Zenilman notes, treatment for HIV is a lifelong need for infected people.

Even if the presidents plan was successful and included with the Global Fund to Fight AIDS, Tuberculosis and Malaria, which calls for providing treatment to 3 million people by 2005, these efforts would only reach half of those in need, says Zenilman, senior author of the journal article.

Though more people in developing countries are receiving therapy, growing from 400,000 in June 2004 to 700,000 in December 2004, it still amounts to only 4 percent of infected people in India, 5 percent in Ethiopia, and 7 percent in South Africa, he writes.

Internationally, Zenilman has led clinical studies to determine how best to prevent the spread of sexually transmitted diseases in the Americas, Africa, Asia and, in particular, the Middle East.

In the new article, the Hopkins researchers argue that the history of medicine is packed with examples of immediate demand for new therapies outstripping supply. They also point out that rationing of supplies was necessary in all cases, but that public distrust and outrage arose when patient selection methods conflicted with local principles.

Led by Hopkins medical historian Laura McGough, PhD, the team reviewed four major developments in medicine that shared the issues confronting distribution of antiretroviral therapies.

The first two pivotal events were advances to treat if not cure then-fatal diseases: the discovery of insulin for diabetes in 1922 and the mass distribution of the antibiotic penicillin in 1943.

In the case of diabetes, insulins availability turned a once-fatal disease into a chronic, manageable, lifelong one, like antiretroviral therapy has done for HIV. However, the researchers point out that what ensued was a mess. In a completely haphazard fashion, medication went to family members of prominent politicians, private clinics or friends of the physician discoverers, who were caught off guard and almost instantly flooded with requests from the public.

More controversial was the penicillin case, in which two government-appointed committees, one military and the other civilian, decided who received medications. While the civilian committee allocated drugs to the most seriously ill, its decisions were viewed as cold-hearted and distant in letters to committee members and in press headlines. Further inflaming public sentiments was the militarys allocation of supplies to soldiers with non-life-threatening sexually transmitted diseases. Eager to return soldiers to active duty, wartime needs outweighed civilian concerns, but this did not sway public opinion that the military was wasting its share of medication.

While the lack of a plan is the worst-case scenario, even a plan with no public input can backfire if it fails to win local support, says McGough, a research fellow at Hopkins Institute of the History of Medicine. It is as important to make sure that the decision-making body is politically legitimate and accountable to the public as it is to agree on the criteria for patient selection to begin with.

The other two precedents are the introduction of hemodialysis for end-stage kidney disease in the 1960s and allocation of livers for transplant in the 1980s and early 1990s.

Like HIV infection, these conditions require expensive, lifelong follow up. Indeed, people who benefit most from hemodialysis are the ones who strictly follow their physicians advice and their dialysis schedule. Initially, however, who would most likely adhere to hemodialysis therapy was determined by using social-worth criteria that favored members of the middle class, from whose ranks came the majority of patient selection committee members. Married people with high salaries were favored over singles, working men over stay-at-home moms, churchgoers over non-believers, and parents over children. The public outcry led Life magazine to feature on its cover a picture of a child rejected for treatment, prompting the committee to attempt to change its criteria toward a psychological assessment.

With liver transplants, patient selection was plagued by different interpretations of who medically benefited most from a transplant and by a scoring system that favored patients most likely to survive their surgery over those most likely to die. In this system, the patients getting a liver transplant were often the most likely to benefit from it, but not always in greatest medical need of surgery. Due to public pressure, the allocation system was revised to put first the most urgent cases, not those who stood the chance of living the longest. Similarly, previous studies have recommended that the most severely affected AIDS patients be first in line for therapy.

According to McGough, medical criteria are never completely neutral, and they have to be balanced against the society being served, so the patient-selection criteria need to be developed locally and to incorporate local values about priorities, adherence and such issues as whether or not children should be treated first.

If current global efforts to prevent the spread of HIV/AIDS are to work in the long term, they must avoid public suspicions of being unfair, and they must build public trust for the future, she adds.

HIV-positive people in each country affected must be involved in deciding how limited therapies are rationed, and these decisions cannot be made for them by self-appointed experts. We do not want this opportunity to become another case where only a few privileged people receive therapy. What international authorities can do is help these countries plan for rationing, so that the medical and ethical mistakes of the past are not repeated.

Source: Johns Hopkins