Editorial: 鈥�Beyond the call of duty鈥�
SIXTY-FIVE years ago in Nuremberg, Germany, American prosecutors confronted the Nazi physicians who had subjected Jews and others to a murderous regime of medical research. The 鈥渄octors鈥� trial鈥� was the first of the war crimes trials; one of its outcomes was the famous .
The first tenet of the code is very clear: 鈥淭he voluntary consent of the human subject is absolutely essential.鈥�
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Today, the Nuremberg Code is the most important influence on US law governing human medical research. Even so, marginalised groups have frequently been coerced into studies that violate their right to consent. A recent review of the bioethics of human research in the US offers little prospect for change.
鈥淢arginalised groups have frequently been coerced into studies that violate their right to consent鈥�
My book documents many cases. In 1994, for example, the Medical University of South Carolina in Charleston was accused of without their knowledge. The next year in Los Angeles, an was tested on children, mostly black and Hispanic, without their parents鈥� consent. In 1994 and 1995, New York City law enforcement officials helped researchers coerce black parents into enrolling their boys into a that sought to establish a genetic propensity for violence, again without their consent. And in 2001, the Kennedy Krieger Institute in Baltimore was of encouraging black families to move into lead-contaminated housing as part of a study on lead levels in children (the verdict was later overturned).
This scourge has spread beyond racial minorities, as detailed in my new book .
Since the 1980s, around 20 US research projects have won legal waivers allowing them to bypass any form of consent. From 1990 until 2005, for example, the Department of Defense obtained a waiver that allowed it to force 8.9 million ground troops to accept inoculation with experimental anthrax vaccines.
Civilians鈥� rights are violated too. In 1996, on the pretext that they are unconscious and unable to give their consent.
Private companies, for whom time is money when seeking approval to sell their products from the US Food and Drug Administration (FDA), were quick to see the advantages in enrolling subjects who could not refuse. In 2003, biotechnology company Northfield Laboratories set up a nationwide trial of its blood substitute PolyHeme. The substance was randomly administered by ambulance crews to unconscious victims of car accidents, shootings and cardiac arrests.
The law required the researchers to offer a means for opting out. Northfield鈥檚 answer was to provide plastic bracelets inscribed with the words 鈥淚 decline the PolyHeme study鈥�. Crucially, to opt out, one first had to know the study existed 鈥� a challenge, because the obligatory community notification tended to be desultory. Ross McKinney Jr, vice-dean for research at Duke University School of Medicine in Durham, North Carolina, estimated that consultation in his area reached about 450 out of a possible 267,000 people.
In 2009 the FDA reviewed the trial. It concluded that there were more heart attacks and deaths in subjects who had received PolyHeme than those who had not, and . The company went into later that year.
A larger number of non-consensual studies is still ongoing. The $50 million aims to recruit around 21,000 subjects to test the safety and effectiveness of various emergency treatments for severe injury and cardiac arrest. ROC is being conducted at 11 trauma centres in the US and Canada. As in the PolyHeme study, subjects are enrolled at random and no consent is sought.
One ROC experiment infused concentrated saline into trauma victims鈥� blood vessels to test its effect on traumatic brain injuries. Doctors are well aware of the dangers of administering such a highly concentrated solution and these concerns proved well founded in August 2008 when the study was over concerns about patient safety.
Once news coverage alerted some residents of targeted areas to the study, the researchers were overwhelmed by demands for opt-out bracelets. One study continued even after high demand made the bracelets unavailable.
Prospects for progress appear minimal. Late last year the Presidential Bioethics Commission issued a . Called Moral Science, it made much of the US鈥檚 鈥渞obust鈥� protections 鈥� the very rules that permit and legitimise breaches of informed consent.
The failure to elicit consent is not confined to the US. One in every three US corporate medical studies is now carried out abroad, usually in places where trials can be conducted more cheaply than in the US. Subjects are often unaware that the treatments are experimental.
In 2011, drug giant Pfizer to settle claims that children in Kano state, Nigeria, were injured or killed by non-consensual administration of its experimental meningitis drug Trovan. Just as US physicians demanded justice at Nuremberg, Nigerian parents stormed courts in Kano and Manhattan to demand that we live up to our stated ideals. Sixty-five years on, it is high time we did.
