Ethics of military drug testing questioned

Degree of 'voluntary' participation raises concerns

By David R. Sands (Contact) | Sunday, June 22, 2008

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Colombian and Indonesian troops have been drafted to test new anti-malaria drugs. South African researchers used Tanzanian soldiers to study the effectiveness of an unorthodox treatment for HIV/AIDS.

And a trial conducted on some 2,000 Nepalese soldiers for a new hepatitis-E vaccine by a major U.S. drug company sparked public protests and complaints that the Nepalese troops were being used as human guinea pigs.

An investigation by The Washington Times and ABC News, which on Tuesday reported a troubled U.S. government program using military veterans to test potentially dangerous drugs, has focused new attention on what medical ethicists say is an especially difficult problem. The U.S. military is not the only one that has had to deal with the consequences.

Military personnel and veterans represent two particularly tempting populations for medical study, researchers say. A large sample of participants, complete with detailed medical histories and personal data, can be quickly assembled. Their behavior, travel and personal habits are far easier to control during the study period.

But that high level of control also makes military medical testing a moral minefield, ethicists say. Just how much freedom does a soldier, sailor, airman or Marine in the ranks have to refuse to participate in a medical trial when asked by a superior officer?

"Considering that the majority of defense-related research is 'non-therapeutic' and ... is typically carried out on healthy volunteers, the standard of legal consent is high," according to recent study of military medical issues by lawyer Ashley R. Melson.

Earlier this year, Britain's Ministry of Defense paid out more than $5.9 million to settle claims from 369 veterans subjected to tests at the government's Porton Down chemical-warfare center. The veterans claimed in a lawsuit that they had been exposed to nerve gas and mustard gas in trials there, leading to a wide variety of health problems.

Porton Down, believed to be the oldest chemical-warfare research site in the world, has tested some 25,000 British servicemen since its establishment in 1916.

In Nepal in the mid-1990s, an institute of the Walter Reed Army Institute of Research set up a field station to test a new hepatitis vaccine licensed to pharmaceutical giant GlaxoSmithKline.

After popular protests forced the cancellation of plans to test the vaccine on Nepalese citizens, researchers in 2001 turned to 2,000 Royal Nepalese Army soldiers at a military hospital in Katmandu.

The U.S. Embassy strongly defended the tests, saying the Nepalese soldiers had volunteered for the trial and denying a link between the research and U.S. military aid to the poor Asian nation. The U.S. government had given tens of millions of dollars to the government as it battled a Maoist insurgency.

But critics said the Nepalese military was unlikely to refuse a request from its biggest patron to provide recruits for the medical study.

The money, training and equipment supplied by the U.S. military to Nepal's army "threatened the voluntary nature of the institutional and individual participation in the trial," medical researcher Jason Andrews wrote in the American Journal of Bioethics.

cRita Tiwari contributed to this report.

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