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http://www.nytimes.com/2002/07/02/science/02CONV.html

Weighing Medical Ethics for Many Years to Come

By HOWARD MARKEL

r. Harold T. Shapiro, the economist and former university president, tackled some of the most contentious ethical issues in medicine, including stem cell research and the cloning of human cells, while heading the National Bioethics Advisory Commission from 1996 to 2001.

Then, last summer, President Bush proposed a ban on all cloning experiments, including work on discarded embryos directed toward developing medical therapies. At the same time, Mr. Bush appointed Dr. Leon R. Kass as chairman of a new bioethics commission with the express purpose of readdressing these controversial questions.

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Last July, the House of Representatives approved a ban on all cloning experiments for reproductive and therapeutic purposes. But when the bill reached the Senate in June, a deadlock was created, killing any hope of a solution this year.

Dr. Shapiro, who headed Princeton and the University of Michigan, recently discussed the ethical questions. "None of these issues are likely to be resolved soon," he said.

Q. As chairman of the national bioethics commission, you presided over 100 public hearings. What impressed you most?
A. In addition to the experts' testimonies, a critical component was the opportunity for citizens to express opinions about the topics under discussion. What impressed me was that the comments of the majority of these people were largely about their fears about a particular scientific technology or medical practice. My view is that when a lot of people have fears, you must try to understand them. We all need to get used to the fact that we are going to be confronted by complex moral challenges all of the time as a result of scientific progress.
Q. What are your views on reproductive cloning?
A. There is so much unjustified hysteria about reproductive cloning, but I think it is much ado about nothing. There are no new ethical issues raised by reproductive cloning that are not raised by the use of genetic engineering and other reproductive technologies. Ethically, it is a subset of these broader problems.

But putting aside issues such as safety or reliability, which will be resolved someday, cloning is a bad solution to just about any problem you can think of in reproduction. What can you gain from it? For normal people who want to have children, this is the worst possible way to do it. Some worry about others who may want to clone themselves or particularly gifted people, but in my view this will never become a widespread social practice.
Q. How should we approach the current debate over stem cell research?
A. The isolation of embryonic human stem cells and the production of stem cell lines from them are enormous accomplishments. I continue to believe that the federal government ought to fund research both to derive stem cells from embryos, provided that their source is limited to embryos created as part of a reproductive project and that appropriate consents were obtained, and from existing or future stem cell lines.

What I think is ethically problematic is the attempt to distinguish the derivation from the use of these cell lines or public versus private sponsorship of these activities.

If one believes that the destruction of an embryo to isolate these cells is the moral equivalent of homicide, then why do we distinguish between public and private sponsorship of these activities? With the policy that exists now, stem cell research will obviously continue, but it will do so in the private sector, where no one can see it. I think we have gotten ourselves into the worst possible situation. There's no oversight, we don't know what's going on and it is hidden from the public eye.
Q. Do you have concerns about the close relationship between university-based scientists and for-profit biotechnology companies?
A. I don't think there has ever been a time in the history of modern scientific research when such a large proportion of those engaged in academic biological research are so involved with for-profit biotechnology companies. Now there are a lot of benefits to these activities, such as technology transfer. On the other hand, it is hard to find scientists who are not potentially conflicted by their financial interests in these companies.

Full disclosure solves a lot of these issues, but when you think of the erosion of the confidence the public may have in what scientists say, these conflicts, real or perceived, become very important.
Q. What are your views on experiments with humans?
A. We must accept that medical research is an enormously ethical activity. But to use human beings in medical research is a special privilege that carries special responsibilities. Every participant needs to be covered by two principles: independent review and voluntary informed consent based upon respect for the autonomy and rights of the individual participant.

The medical institutional review boards that supervise these activities are overburdened and tend to focus on properly filling out forms rather than substantive protection. We need to increase the public accountability of these boards, to include members of the outside community, to compel them to produce annual reports of what they approved, disapproved and why, and to require an annual system of auditing on a random basis of a certain percentage of those studies.

We also need to look at how we obtain informed consent from human subjects. This should be seen as a continuing process throughout the experiment rather than a moment that ends with the participant's signature on the dotted line.

While there is a uniform set of requirements enforced for F.D.A.- and N.I.H.-funded studies, these regulations do not apply to those investigators conducting privately funded or privately conducted research. We need a set of universal regulations and a certification process for everyone who conducts research on human subjects. Finally, we must consider participants in these studies to be heroes, nothing less.
Q. While many areas of scientific advancement raise compelling ethical issues, something that gets less attention is access to health care, especially for the nation's poorest children. How do we strike a balance?
A. We have done a horrible job of prioritizing our health care expenditures and have allowed the market to determine too much. Now, I am an economist, and I believe in the market a lot, how it mobilizes resources and generates creativity, but it doesn't do everything and it is often wrong. That's one of the reasons we need governments, because the market often generates inappropriate solutions. It is a scandal that we spend so much on very expensive medical products or procedures when we have these basic needs that are completely unattended to for a very large number of children and that we can fix for a far smaller investment.

Reproductive cloning is little more than a dot on the wall compared with these problems. Taking care of tuberculosis or immunizing children may not be nearly as energizing to the public as the possibility that science fiction might come true, but we must change that orientation.

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