Guinea Pigs.

• Author: WEED, WILLIAM SPEED

When doctors experiment on their patients

AS THE NAZI DOCTORS KNEW WELL, there's a seductive inverse relationship in human experiments: the less you protect the particular humans you study, more you can learn about humans in general. Systematic near-freezing of Jews in concentration camps taught the German Luftwaffe a lot about staving off hypothermia, which was crucial for their pilots when they had to ditch in the North Sea. But the Nazis weren't the only ones to understand this perverse dichotomy. Fifty years ago the U.S. government allowed black men with syphilis in Alabama to go untreated as part of the notorious Tuskegee experiments.

Even today, there are troublesome cases that keep regulators, doctors and ethicists up all night. A two-year old gift died recently when doctors forwent a known surgical cure for her bladder cancer and gave her an experimental drug instead. We still have lapses. And we still have the pull of experiment's inverse relationship. In all but the rarest of cases, we don't have mad scientists bent on discovery at the expense of human welfare anymore. So when little girls die in research, or when mentally ill patients are subjected to experimental harm, or when pregnant women don't know they are in studies, it is a systemic problem: one that points out inherent flaws both in the way the government is organized to protect citizens, and in the very nature of having some human beings poke, prod, cut and drug the rest of us.

In 1995, President Clinton wrote an executive order creating a National Bioethics Advisory Commission (NBAC), composed of doctors, lawyers, and ethicists from around the country. In renewing its mandate in 1997, he said that, "Science must respect the dignity of every American. We must never allow our citizens to be unwitting guinea pigs in scientific experiments." NBAC resolved that the president's goal would be met if every subject in a medical trial enjoyed two protections: informed consent and independent review of research. Informed consent means that patients know everything they need to know about what is going to happen to them, and that they willingly agree to submit to the research. Independent review means that researchers open their studies to outside observers (usually a committee of doctors and community members) so that a disinterested party can assess their ethics.

But commission members say the president's goal has not been met; Americans are not as safe as they could be. Federal protections do not cover all research. And the research the government does oversee is on shaky ground. Informing patients to get consent is difficult because average patients and average doctors speak very different languages. And independent review is compromised by mounting pressures for institutions to make money through medical discovery: A culture of "approve it now, ask questions later" pervades the research community. It may not be long before Americans lack up-front guarantees that what doctors do to them is needed, ethical, and benign. Earlier this year, the commission put it this way in a memo to the president, "The U.S. Government cannot know how many Americans currently are subjects in experiments, cannot influence how they have been recruited, cannot ensure that research subjects know and understand the risks they are undertaking, and cannot ascertain whether they have been harmed."

Why? First there is the problem of jurisdiction. As the law stands, the federal government oversees research it funds (the lion's share is an annual $12 billion in grants from the National Institutes of Health), and regulates research that will lead to products sold in interstate commerce (FDA trials). Some states, such as California, have laws about the ethical...