In his neatly appointed office with its volumes of medical references in the West Wing of the UVA Medical Center, Dr. Jonathan Moreno, director of the Center for Biomedical Ethics, speaks softly while his hands remain folded in his lap. With his slight stature, firmly pressed shirt and perfectly trimmed beard, he sits as an unlikely portrait of one of the few people to say “No” to the Bush Administration. But one month ago, on January 4, that’s exactly what he did.
Moreno had served on the Federal committee that advises on matters of medical research involving human subjects. He was first appointed by Bill Clinton in 2000. On January 3, Tommy Thompson, Bush’s Secretary of Health and Human Services, released the names of the new 11-member committee. When, without his consent, Moreno’s name showed up among them, he refused membership, making headlines across the country. It was a drastic about-face for someone who has made it his life’s work to explore questions of research protocols and their ethical implications. But the Secretary’s Advisory Committee on Human Research Protection, as the committee is now known, would have to carry on without Moreno. His own sense of protocol had been violated.
It wasn’t just that he’d been thrown onto the committee without being asked to re-enlist. Moreno had grave doubts about the panel’s newly rewritten charter, which explicitly includes embryos and fetuses among those who merit government protection. The Administration, which has repeatedly come under fire for rearranging its scientific committees to advance conservative goals, had changed the focus of the human research protection group. Moreno saw an opportunity to score his own political point, and he grabbed it.
“There are those who think I objected too much, but I’ve found I can get a lot more attention this way,” says Moreno. “I had the opportunity to make a public point.”
The urge to speak out likely had been brewing for a while. After the new Administration came into office in 2001, Moreno watched his advisory committee deteriorate. In contrast to Clinton’s team, no one from Bush’s Health and Human Services office attended any meetings of the Committee on Human Research Protection. Additionally, morale plummeted as members turned in reports on such matters as informed consent and the ethical issues surrounding research on children with nary a word of feedback in return. Thompson allowed the committee’s charter to expire last year, leveling the final blow (the move seemed calculated to restock the renamed committee, which had been originally known as the National Human Research Protections Advisory Committee, with Bush sympathizers). Speaking to The Washington Post at the time he announced his resignation, Moreno was blunt.
“This Administration cares about finding any way they can to advance their platform on the protection of embryos, in general, and on stem cell research, in particular,” Moreno said. “They’re clearly more interested in making ideological points than in increasing human research protections.”
With the flush of media attention behind him for now, 50-year-old Moreno remains at UVA directing the masters program in biomedical ethics and teaching the foundations of bioethics to students from all backgrounds from law to medicine to nursing. And while the calls from The New York Times have dwindled, he gets daily reminders of the stance he took last month. Plenty of colleagues stop by his quiet office to pat him on the back.
T he goal of the original Clinton panel, created in 2000, was to advise the small Federal agency overseeing scientific research that used human subjects. Moreno was appointed to it after several patients had been seriously harmed in medical experiments. The committee’s former chair, Mary Faith Marshall, suggested him for appointment to then HHS Director Donna Shalala.
“We were looking for someone who was a social scientist, a scholar in his field,” says Marshall, “and Jonathan spearheaded issues like the informed consent rules.” Informed consent covers the gray area of how ethically to involve, say, Alzheimer’s patients, in medical experiments when the patients are unable to give the consent. The joker in the deck, as Moreno sees it, lies in the fact that those patients in dire condition are just the ones sorely needed in the research. Given his stance on the issue, Marshall figured, Moreno would be a solid and thoughtful presence on the advisory committee.
Of the committee’s original 11 members, three were expert patient advocates. The others included specialists from such areas as the National Organization for Rare Disorders, the Academy of Medicine, the Dean of Research from Emory University and the founder of Citizens for Responsible Care and Research. As advisors, they had a broad mandate. The original charter said, “…it’s the duty of the SACHRP to counsel [the Administration] on matters pertaining to the continuance and improvement of functions within the authority of Health and Human Services directed towards protections for human subjects in research.”
The Clinton panel accomplished more than that. They hammered out statements clarifying rules to protect children and those who can’t give consent. They drew up protocol guidelines for behavioral and social studies in genetics.
Moreno and others on the panel, including Marshall, now a professor of medicine in bioethics at Kansas University, say that their work was abruptly aborted when the committee’s charter was allowed to expire by the Bush Administration. Disappointed, the panel felt the time and work they invested may have been, in the end, ill-used.
Their suspicions have been confirmed by the make-up of the new SACHRP. Stacked with compliance officers and industry sympathizers, the SACHRP lacks any patient advocates now. The Administration quickly ramped up a defense of its choices. On January 5, Health and Human Services spokesman Bill Pierce was quoted in The Washington Post saying, “The committee’s charter does not require that patient advocates be appointed. As you know there have been troubles in this business, and this is our attempt to aggressively address these issues.”
Indeed, the Bush Administration’s aggressive redress includes a new charter for a new committee: “Specifically, the committee will provide advice relating to the responsible conduct of research involving human subjects with particular emphasis on special populations, such as neonates and children, prisoners and the decisional impaired; pregnant women, embryos and fetuses; individuals and populations in international studies; populations in which there are individually identifiable samples, data or information; and investigator conflicts of interest.”
The important difference for Bush’s advisory committee is the addition of the words “embryos and fetuses” to the charter.
Moreno, who identifies himself as anti-abortion and pro-choice, still sees a big change implicit in a few small words. “I began to see a pattern of rules and regulations being developed around the protection of the fetus,” he says. “The very language of the fetus and the embryo has never appeared in the wording of who should and shouldn’t be protected before, and doesn’t belong there now.”
Born in Poughkeepsie, New York in 1952, Moreno graduated from Hofstra with highest honors in philosophy and psychology. He was a University Fellow at Washington University in St. Louis, earning his doctorate there in philosophy. In 1988, he received a Doctorate of Humane Letters from Hofstra.
In 1998, after establishing and directing a medical bioethics division at the State University of New York at Brooklyn, Moreno relocated to Charlottesville. When Marshall tagged him for the Clinton advisory committee, Moreno was already somewhat experienced in politics. For two years in the mid-1990s, he was a senior policy and research analyst for the Federal advisory committee on human radiation experiments. He also consulted for the departments of energy and education, the National Institutes of Health and the Institute of Medicine.
Many of Moreno’s colleagues regard him as highly knowledgeable and bold for refusing a presidential committee. There are others, though, who see a man who should have remained on the committee as the alternative voice.
“I’ve had several people tell me it’s unheard of to resign from a committee,” says Moreno, “but when I was appointed without my knowing it, I felt as if I was immediately being introduced into a political agenda.”
Interestingly, Moreno does not lay blame at the feet of Secretary Thompson, whose conservative credentials were secured with his overhaul of the welfare system when he was governor of Wisconsin. He sources it right at the top of the Bush Administration.
“Their political agenda is to get people talking about embryos,” he says. “ If they can do that, then they can open the wedge for their constituency.”
Jim Childress, the UVA John Allen Hollingsworth Professor of Ethics and the director of the Institute for Practical Ethics, says the new language in the SACHRP charter has made good work go bad and only produced a stalemate.
“When the Clinton-appointed charter expired and was replaced with an entirely new committee, all the work the SACHRP had done for human subjects was virtually abandoned,” says Childress. “And now, there’s a new panel with a newly worded charter. That was a mistake.”
A mistake, perhaps, but not an accident, the way Marshall sees it. She contends that “embryos and fetuses” are a concession to a leading right-wing pro-life think tank.
“I am certain the Family Research Council played a role in the new appointments and the new charter languaging,” she says.
Known to oppose abortion and stem cell research, the FRC states on its home page, “In Roe v. Wade, the Supreme Court ruled that a mother’s right to privacy outweighs her unborn child’s right to life. What nonsense! One’s right to life should take precedence over another’s right to privacy.”
Ideologies aside and the political realities of committee appointments notwithstanding, Moreno is most concerned about the severe clamp the new committee could put on stem-cell research.
“Not only would government-funded research be out of the question, but privately funded research wouldn’t be allowed either,” says Moreno. “One could make it impossible to use embryos for stem cell research.”
Britain, Israel, Sweden and China are among the countries already researching the benefits of stem cells. “The United States, were it not to participate in stem cell research,” says Moreno, “would lose an edge in an area of medical research that we don’t want to lose.”
Along with the brain drain of smart young people interested in the field, Moreno says the research cannot proceed as quickly if the Federal wallet isn’t backing it. But the Administration refuses to give the ground-breaking research the green light. Bioethicists are not the only ones worried over the delay. Physicians are also uneasy.
“As an individual, it is my opinion that we have an obligation to use fetal tissue,” says James Q. Miller, UVA professor of neurology and chair of the Ethics Committee. “In fact, it would be immoral not to use it.”
Scientists like Miller and Moreno contend that stem cell research can help lead to breakthroughs in the treatment of virtually any disease that involves the destruction of tissue—cancer, Parkinson’s, strokes, Alzheimer’s—nearly all diseases, period. That’s because, in theory, fetal stem cells, created in a laboratory setting, haven’t had time to become true tissues. In other words, they’re still pluripotent and when added into an organ, the fetal stem cells take on the characteristics of that organ. Be it a liver, a kidney, brain cells or heart muscles, the messenging, the absorption by the cells of healthy information from the organs, works—although it’s not fully understood.
“It seems to be a real error in judgement to have a rule or an authority figure say we cannot use fetal tissue,” Miller says. “For me, I think if it might save someone who’s already suffering, then we have an obligation to use it—to do otherwise, would be immoral.”
But might stem cell research save someone’s life? Moreno says that the claims remain theoretical at this point. “It’s a legitimate area, and promising, but like gene therapy, it’s been hyped and for now there’s more talk than action. The promise of the benefits is there, but we may not see them for 20 years.”
The debate rages on, sometimes exceeding the discussion of fetuses to include questions of cloning, too—casting the creation of laboratory embryos as a variation on that questionable practice. Recently in the pages of The New York Times, Leon R. Kass, writing on January 24, said, “Supporters of cloning for research have often tried to confuse the issue by euphemistic distortion—claiming that the production of cloned embryos is not really cloning, that the embryos are not really embryos at all. Were this danger better understood, opposition to the practice would mount.”
But without a green light for the research, most scientists will be unable to gain a solid idea of the true benefits or even the line that must never be crossed.
Long before the human research advisory committee got mired in debates over embryos and fetuses, it was trying to address real problems in medical research. More than a dozen leading research institutions, including Johns Hopkins, Duke University and the University of Pennsylvania’s gene therapy program, had been under fire since 1998 for violations dating back much further. Lawsuits against everyone involved from the hospitals to the doctors, corporations and even states were popping up everywhere, including the case of breast cancer patient Kathryn Hamilton.
A 48-year-old health care administrator from Spokane, Washington, Hamilton was a breast cancer patient who died in 1992 during her participation in a controversial clinical trial. She turned to the stem cell transplant experiment at the Fred Hutchinson Cancer Research Center when her breast cancer returned for a second time.
While part of the experimental process involved high doses of chemotherapy, with which Hamilton had bad experiences before, the doctors at “Hutch,” as the medical facility is known, told her that if she threw up the pills intended to reverse fatal side-effects going along with the chemo, they’d give her the drugs intravenously. It turned out that Hutch’s supply of the drug in intravenous form had been cut off two months earlier. Hamilton, indeed, repeatedly threw up the pills, and died from the effects of high chemotherapy only 44 days later. Doctors had previously given her one to two more years to live.
Just one example of severe experimental mistreatment, this is exactly the kind of case that drove Moreno to be on the panel in the first place. He believes that under even the most extreme circumstances (national security issues, say), the Federal government must have a process in place and means to protect the 19 million people who participate as research subjects every year.
Moreno has questioned the role of government, committees and patients rights before.
In his book, Undue Risk: Secret State Experiments on Humans, published more than two years ago, Moreno looks at the history of the U.S. use of human subjects in biological, atomic and chemical warfare experiments from World War II to the present. Undue Risk, hailed by some as going where no researcher has gone before, is a litany of secret government documents revealing experiments involving LSD and mescaline and injecting substances like plutonium into unwilling hospital patients. He even details Federal efforts to recruit Nazi medical scientists shortly after World War II.
It’s fodder for conspiracy theorists, and it demonstrates that Moreno’s advocacy on behalf of human subjects is not a newfound political stance.
His views may have a newish wrinkle, namely the case for stem cell research, but he doesn’t regret his decision to reject the President’s appointment, he says.
“Science is an exercise in democracy,” he says. “Without it, it cannot function properly.
“Science must be held accountable. If we could just build a zone between politics and science.”