Medical ethicist Ezekiel Emanuel explored the ethical implications of three hypothetical medical situations in an open discussion with students, faculty and other audience members in the Rockefeller Center on Friday. Emanuel also explained his own personal views on the medical ethics of the cases and challenged audience members to defend their reasoning for their ethical opinions.
"The hope [of the talk] is to give you a sense of the kinds of things that need to be grappled with in the real world," Emanuel said.
In order to frame his discussion on medical ethics, Emanuel first presented a case that did not pose extreme ethical questions.
He asked the audience whether they would approve a research grant to test the DNA of Pygmies in the Central African Republic. In the experiment, researchers would give Pygmies toothbrushes to withdraw oral samples of their DNA. The researchers would then analyze those samples to determine if any Pygmies were carriers of a specific gene mutation associated with a protein deficiency disease. If any genes were identified with high frequency, researchers would potentially return to the Pygmies to develop a cure for the disease.
The researchers would compensate the Pygmies by giving them the toothbrushes and funds to build a school.
Most of the ethical questions raised by the audience about this case revolved around the Pygmies' lack of a written language and their ability to give informed consent to the testing. In the case text, however, Emanuel had given instructions as to how he would explain the experiment to government and tribal leaders before testing. This, he said, would allow the Pygmies to give informed consent without being able to read a contract.
"We have a fetish in the United States for signed, written consent," Emanuel said. "We don't believe any other agreement holds. We're obsessed with signatures."
Other questioners asked whether the test would infringe on the Pygmy culture.
Emanuel said that simply giving a toothbrush and building a school are not cultural infringements, but instead would benefit the Pygmies.
At the end of the first case discussion, Emanuel laid out his principles for ethical practice in medicine and showed how the Pygmy case met most of the criteria. In Emanuel's opinion, the research must be of social value, have scientific validity and be subject to independent review. He added his view that the research subjects must also be fairly selected, have their medical information protected and not be subject to risks that outweigh the testing's benefits.
The experiment posed in the first case was ethical because it posed zero risk to the Pygmies and could lead to treatment for the disease, according to Emanuel.
The second case revolved around the testing of a drug designed to treat Respiratory Distress Syndrome, which can kill infants born prematurely.
In the case, a drug company sought to test a new RDS drug in Bolivia, even though the Food and Drug Administration had already approved four drugs that have reduced RDS deaths by about 34 percent in the United States. In the experiment model, researchers would give half the participants in the study the drug and the other half a placebo, with all infants in the test being put on ventilators and other life-support equipment.
Some audience members objected to the study because some infants would receive a placebo instead of treatment.
"Clearly it's unethical," one audience member said. "You can't use a placebo once you know that 34 percent of the babies would have survived with the [drug]. The ethical thing is to save the babies."
Emanuel argued that there is a need for multiple drugs to treat a single disease because of potential side-effect and treatment problems with only one available treatment, but he admitted that four already existing drugs may have been enough.
"I think this is a really tough study," he said. "I don't think this is obviously ethical or obviously unethical."
Emanuel discussed his uncertainty, explaining that the infants receiving the placebo were still more likely to survive because they were provided with ventilators. He added that the test might violate informed consent rules.
"Are [parents of premature infants] really giving consent in an extreme moment like that?" he asked. "It's hard to make a critical evaluation if they are worried."
The drug trial's location in Bolivia also raised some questions for Emanuel, especially since the FDA would not approve the trial in America. People's concerns rose from their belief that everyone should be entitled to the same health care that is available in the United States, he said.
"How does global justice intersect with this trial? What are [the Bolivians] entitled to if they aren't entitled to the best care that the developed world has?" he asked. "I don't think that's an easy question, and I don't think there's a good systematic answer."
The third case Emanuel presented asked the audience to decide to give a liver to one of three people in need of a liver transplant. One patient was two years old, another was 20 years old and the third was 70 years old. Emanuel and the audience discussed criteria they would use in making the decision and eventually decided on four key values to employ.
According to Emanuel, equality is important when making difficult medical decisions such as the allocation of scarce organs. He said he would be willing to consider a lottery for organ donation because it was a perfectly equal system and "very hard to corrupt." Emanuel criticized the current system of first-come, first-served organ waiting lists because they reward the rich.
"The are lots of ways if you are well-off and well-connected, and can find ways to grease the system first-come, first served benefits you," Emanuel said. "This is a flawed principle and ought to be eliminated."
The second of the four criteria stressed making medical decisions to help the worst-off, according to Emanuel. He criticized this policy, however, by explaining that the sickest people often have a poor post-transplant prognosis. He added that this method of selection creates a "perverse incentive" to be sick in order to get a transplant.
"It's kind of a really stupid way to do things," Emanuel said. "You want someone to keep someone as healthy as possible going into a transplant, not to make them look as sick as possible."
The third value Emanuel highlighted was the importance of utility and saving the most lives possible. He also included "life-years," or the amount of years in a person's life saved by a potential transplant, in his definition of utility.
"This seems to emphasize saving younger rather than older people," Emanuel said.
The final value to consider in transplant decisions is the principle of social value, according to Emanuel. During a flu outbreak, for example, it would be important to first give treatment to medical workers who can then save other people.
Backward looking considerations, which give preferences to groups the government seeks to reward like veterans over groups the government seeks to discourage like alcoholics would only be applicable in situations when the patients are equal measured by other criteria, according to Emanuel.
Emanuel said no single principle was sufficient to make the liver transplant decision, but that all the different values and principles had to be carefully balanced.
"You get a principle that emphasizes younger, but not necessarily the absolute youngest, and how long they are going to live," he said.
The Dartmouth College Hillel, the Dickey Center for International Understanding, the Nelson A. Rockefeller Center and the Tucker Foundation co-sponsored the event.
Emanuel serves as the chair of the Clinical Center Department of Bioethics at the National Institutes of Health and as a special advisor on health policy to the director of the Office of Management and Budget.
