MIAMI — In an exclusive interview with AMG, Infectious Disease specialist at the University of Miami’s School of Medicine, Dr. Hector Bolivar, retreated from statements previously attributed to him in the Miami Herald which appeared to question the ethics of an HIV study in Cuba.
The study was conducted by researchers at the Catholic University of Leuven in Belgium with the help of the Institute for Tropical Medicine in Havana, following concerns raised by Cuban clinicians about the speed of the disease’s progression in CRF19-infected patients.
To arrive at the study’s conclusions, the researchers examined and compared blood samples from 95 Cubans at various stages of HIV infection. None of the patients had received anti-retroviral treatment in the years prior to the study, and all remained off treatment at some point into the study’s duration.
Ethical questions: Untreated HIV leads to AIDS when the body’s immune defenses are too compromised to fight other diseases and infections. The extent to which researchers were aware of the patients’ deteriorating immune function during the study period is unclear, but the Miami Herald seemed to imply that Bolivar – who was not directly involved with the project – deemed that patients were intentionally left untreated for the sake of the study.
Quoted in the Herald, Bolivar was said to have commented: “It would be difficult for researchers in the United States, or many places where there are treatments for HIV, to replicate [these] findings in the long term, because it is unethical to wait until someone progresses until they can no longer benefit from treatment.”
And while Bolivar reiterated some of his criticisms of the study to AMG during the interview, he suggested that there was, in fact, no reason to believe that the researchers involved in the study conducted themselves unethically, or endangered any of the patients involved, based on the information currently available.
He further explained that the researchers behind the study have announced that they will soon release more details on their methodology, which may assuage some of the ethical concerns that have been raised.
The Geography of Ethics?
Anti-retroviral therapy (ART) drugs have been available in Cuba since 2001. The caveat, however, is that ART is initiated in Cuba later than in other countries. For example, Cuban guidelines state that ART is indicated at CD4 counts of 200-350 cells/mm³, just above the World Health Organisation’s clinical definition of AIDS (less than 200 cells/mm³).
Researchers were able to continue studying patients until their CD4 levels fell to this threshold, whereas in another country, treatment would have had to be initiated earlier.
By contrast, in Barbados, treatment is initiated at CD4 counts of 350 cells/mm³, while in New York City, ART is offered whenever HIV infection is identified, regardless of CD4 count.
— AMG Health Desk
Bolivar said that the uneasiness expressed over the circumstances of the study stem from fairly recent developments in HIV/AIDS research and treatment.
He pointed specifically to new World Health Organisation (WHO) guidelines¹, and cheaper, well-tolerated HIV drugs, which have helped to improve access to HIV treatment in recent years.
And as to why some knowingly HIV-positive Cubans might not have sought this treatment in the years prior to the start of the study, Bolivar proposed that access to HIV treatment for patients in countries like Cuba was more tenuous prior to the start of the 2007 study, than it is today.
Risks of border crossing: In contrast to how his views had been portrayed in the Miami Herald article, Dr. Bolivar was dismissive of the possibility of an epidemic-level threat from the CRF19 strain to populations within and outside of Cuba.
He pointed out that the study failed to establish the aggressiveness the strain’s transmission, and he claimed that the Cuban sample size was simply too small to jump to conclusions².
“It is not sensible”, Bolivar said, to extrapolate that it [the new strain] could threaten Florida.”
¹The WHO’s clinical definition changed in 2007. Clinical staging details are available here
² Cuba has one of the lowest HIV prevalence rates in the world – although HIV incidence rates are increasing among some groups, such as men who have sex with men
Cover image: Flickr/dadakim. CC BY-NC-SA 2.0.