Clinical research in Latin America - Controversies in Boliva and Guatemala

Hello Everyone,  

Here are follow up materials on the Surfaxin in Bolivia case study that Joe Millum presented at yesterday's class session on ethics in biomedical research.

This chapter posted by Public Citizen "Ethical Issues in International Biomedical Research: A Casebook" describes the Surfaxin issue in detail and addresses through commentary the three seminal issues important for the ethical conduct of research:  respect for persons, beneficence, and justice.  I think you will find the commentaries both compelling and instructive.   

You may have heard about the apology issued in 2010 by Secretary of State Hillary Clinton and Health and Human Services Secretary Kathleen Sebelius for the conduct of a US Public Health

NY Times news clipping, 1947

Service researcher who, 64 years earlier, in the 1940s, infected thousands of Guatemalans with syphilis bacteria without informing them of the risks. The researchers apparently knew they were breaching research ethics rules, but proceeded anyway. This news clipping from the NY Times seems to indicate that the motivation for this was to get results quickly.  Clearly, the "ends justified the means," in the mind of these researchers. 

Qs: Is this surprising to you?  Does the risk of unethical research persist in the 21st century?  Can researchers be held accountable to the principles of ethical research, regardless of their country of citizenship? 

 Best, Jim

Data

Hi Everyone,

I'm showing my age when I say I'm a fan of Data.  Actually, I like data, too.  Seriously, in follow up to Sudha's lecture on determinants of health, I wanted to provide a few additional resources for you. 

For example, CDC offers the free software program Epi Info version 7, an essential tool for public health practice. There is also OpenEpi, which is a free, online, multilingual, and open source software for epidemiologic statistics entry and calculation that is compatible with smartphones. 

But if you want to know the basics of how to use these tools, the CDC EXCITE program has a nice description of epidemiology fundamentals and a step-by-step process for conducting an outbreak investigation as a disease detective.

A WWII sign admonishing US soldiers to take their antimalarial medicine

If you like mysteries and want to get some page turning epidemiological investigative texts, a must read classic in this genre is Berton Roueche's "The Medical Detectives."  A couple of more recent true tales are described by Richard Preston in his 1994 book "The Hot Zone," about a hemorrhagic virus incident in Reston, VA, and his 2002 book "The Demon in the Freezer," about the biological weapon agents smallpox and anthrax.  Also, here is a recent story from the BBC about current day detectives of exotic diseases.

Lastly, here are links to two papers I published from my dissertation where I used the cross-sectional survey method for assessing the US population's risk perceptions regarding ticks and Lyme disease and mosquito bites and viral encephalitis.  I observed, among other things, that the majority of Americans (the survey sample size was representative of the US population) have misperceptions and inadequate knowledge regarding the safety and efficacy of DEET-containing insect repellents, despite a nearly 40 year history of the product's positive safety record.

In terms of theory to guide the development of surveys, the theoretical basis I used was the Precaution Adoption Process, developed by Neil Weinstein et al, Rutgers University, which, simply stated, suggests that people decide to adopt a protective behavior based on the individual's perceived susceptibility to and severity of a hazard.  The greater the perceived susceptibility and severity, the greater likelihood a precaution will be adopted by the individual.  The lower the perceived susceptibility and severity, the less likelihood a precaution will be adopted by the individual. Maybe the skulls and Atabrine sign above is an attempt to change malaria prophylaxis behavior, i.e., you are susceptible and the severity is death?

For example, a hazard with low perceived susceptibility and severity is radon gas.  It is odorless, tasteless, invisible, and produces a serious hazard, lung cancer, that may not be experienced for decades.  Thus, taking a precaution to mitigate one's house against naturally occurring radon gas from underlying soil, by sealing cracks, installing a special ventilation system, etc., will usually be low, in a surveyed population.

What are other examples where you think the Precaution Adoption Process could be relevant in understanding health behavior or not applicable?

See you soon,

Jim



 

Welcome to Intro to Global Health Course

Hi Everyone, This is Jim.  Welcome again to the Intro to Global Health Course, Spring 2014 semester.
This blog is offered to those of you who would like additional interaction and information outside the textbooks, readings, and class discussion.  I will typically revisit an issue discussed in class, and then pose a series of questions (Qs).  Have fun!   Jim

Female anopheles mosquito taking a blood meal

THE DEFINTION OF GLOBAL HEALTH: During the first class I stressed that one major difference between "international health" and "global health" is that the latter "emphasizes transnational health issues, determinants, and solutions [and] involves many disciplines within and beyond the health sciences and promotes interdisciplinary collaboration," as described in the Koplan et al paper.  When you think of interdisciplinary collaboration, who are we talking about?  

Photo Source: Media NPR

One example is the issue of substandard, falsified, fake, and counterfeit (SFFC) antimalarials.  A former student of mine, Gaurvika Nayyar, researched the literature a couple of years ago in order to understand the extent of this problem.  In the paper published in Lancet, she reported that over 1/3 of the antimalarials tested (N=1,437 Southeast Asia; N=2,634 in sub-Saharan Africa) failed packaging and/or chemical analysis. The ability of the counterfeiters to copy the real thing is remarkable.  Check out these photos of fake and real holograms.  

So, to combat the issue of SFFC antimalarials, these interdisciplinary teams may benefit from the skills of pharmacologists (who know drugs), forensic scientists (can see real vs fake in an analysis), chemists (to test the suspect compounds), law enforcement (to trace the smugglers' routes from source to point-of-sale, and economists (to tally up the costs). 

Qs: Who else should be on the team, and why?  What are other corollaries to this problem and what can we learn from them, e.g., tobacco smuggling?   If you were in charge, how would you tackle this problem?  Who should lead point, among the team members?  What would be the desired outcome you would want?