It\u2019s 1946. On one side of the Atlantic, American lawyers are prosecuting Nazi doctors at Nuremberg for crimes against humanity \u2013 so-called \u201cresearch\u201d carried out on concentration camp prisoners. On the other side of the Atlantic, in Guatemala, the United States Public Health Service (PHS) is deliberately infecting prisoners and mental patients with syphilis in another \u201cexperiment\u201d aimed at replacing the ineffective drugs used by soldiers during the war that had just ended.<\/p>\n
It sounds too perverse to be true. Yet a special commission appointed by President Barack Obama has just confirmed that the Guatemalan experiments really did take place. Obama has also issued an apology to the people of Guatemala. But why did it take so long to get to this point?<\/p>\n
Sixty-three years after the Guatemalan experiments, an American historian, Susan Reverby, was rummaging through archived medical papers from the 1940\u2019s. Reverby was completing a final task in her two decades of studying the PHS\u2019s detestable Tuskegee experiments, in which hundreds of African-American men with late-stage syphilis were observed but not treated, even after penicillin was developed. She was examining the papers of Thomas Parran, US surgeon-general from 1936-1948, when the Tuskegee research was already in full swing. So, too, she found, was the previously unknown Guatemalan experiment.<\/p>\n
For years, Tuskegee has been a byword for ethical abuses in scientific research \u2013 to the extent that President Bill Clinton apologized to its surviving \u201csubjects.\u201d Hard as it may be to believe, as Reverby was to discover, the abuse in Guatemala was even more egregious.<\/p>\n
As Reverby put it, \u201cI\u2019d spent nearly two decades explaining that there had been no inoculation at Tuskegee, that while the PHS had used deplorable ethics, they had never infected anyone with syphilis.\u201d That was not true in Guatemala. There, \u201cthe US government\u2019s health service had deliberately infected 427 Guatemalan men and women, prisoners and mental patients, with syphilis.\u201d<\/p>\n
The US prosecutors at Nuremberg didn\u2019t know about the Guatemala experiments, so there\u2019s no allegation of deliberate hypocrisy. But the case is no less troubling for that. How could the public-health authorities override medicine\u2019s basic ethical rule \u2013 \u201cFirst do no harm\u201d? Why was informed consent from the research \u201csubjects\u201d considered unnecessary? Could such a thing happen again?<\/p>\n
Most experts believe that the answer to the last question is no \u2013 at least not in the same form. In fact, one should view the Guatemalan study, with its incontrovertible horrors, as an extreme example of the biggest ethical problems in research today. Now, as then, richer developed countries are able to put pressure on weaker, poorer ones.<\/p>\n
A report in 2010 revealed that foreign citizens made up more than three-quarters of all the subjects in clinical trials conducted by US firms and researchers. The US Food and Drug Administration inspected only 45 of these sites, about 0.7%. There is no suggestion that Third World patients are deliberately being made ill when research is outsourced \u2013 unlike in the Guatemalan case \u2013 but that does not attenuate the inherent vulnerability of populations lacking basic medical care or experiencing epidemics.<\/p>\n
During a major meningitis epidemic in northern Nigeria in 1996, the drug company Pfizer supplied doctors with the oral antibiotic Trovan, which the firm wanted to test against the most effective known drug, Ceftriaxone, as a \u201ccontrol.\u201d This procedure is consistent with the general consensus in research ethics that the control group must receive the best-known treatment for comparison.<\/p>\n
The Trovan trial nonetheless caused a storm of controversy, for two reasons. First, even if the trials proved favorable, Trovan was never intended for sale in Africa, but rather for the US and European markets. Second, the sparsely staffed clinical teams were already facing measles and cholera epidemics as well.<\/p>\n
As Jean Herv\u00e9 Bradol, who was president of M\u00e9decins sans Fronti\u00e8res <\/em>at the time and led its African teams, put it: \u201cIt was not a time for a drug trial at all. They were panicking in the hospital, overrun by cases on the verge of dying. The team were shocked that Pfizer continued the so-called scientific work in the middle of hell.\u201d<\/p>\n Nowadays, another major controversy has erupted in several Indian states, owing to a research project to vaccinate girls against cervical cancer \u2013 an issue that has now entered the US presidential campaign, because Texas\u2019s governor, Rick Perry, now seeking the Republican presidential nomination, backed a similar mandatory program. While preventing cervical cancer might seem a genuine benefit, critics charge that the program seems to be mainly about meeting targets, rather than serving the health-care needs of disadvantaged groups.<\/p>\n Apart from one recommendation \u2013 to create a government compensation program for Third World nationals harmed by trials intended to benefit First World subjects \u2013 US Presidential Commission for the Study of Bioethical Issues, chaired by Dr. Amy Gutmann, the president of the University of Pennsylvania, did not get much beyond vague notions of community engagement and transparency. But, with 70% of all drug trials now conducted by private companies, such concepts won\u2019t go very far towards tougher regulation.<\/p>\n And why should government should pay the costs anyway? Because private companies reap the benefits of the trials that do succeed, they should also shoulder the risks.<\/p>\n ________________________<\/p>\n Donna Dickenson, Emeritus Professor of Medical Ethics and Humanities at the University of London, was the 2006 winner of the International Spinoza Lens Award for contributions to public debate on ethics. Her latest book is <\/em>Body Shopping: The Economy Fuelled by Flesh and Blood.<\/p>\n