Stem cell therapies: Know your limits now

Bedside not the place for crisis of conscience 

Accepted clinical therapies developed from embryonic stem cell research may be years away, but now is the time for health care providers to ask themselves where they stand on the use of treatments derived from human embryos.

"When we talk about embryonic stem cell research right now, it’s just research," says Nancy Berlinger, PhD, MDiv, deputy director and associate for religious studies at the Garrison, NY-based The Hastings Center, an independent, nonpartisan, nonprofit bioethics research institute.

"But let’s say the promise delivers," she offers. "It will have application to many different specialties, and the time to think about how you feel about it is now, not at the bedside."

MDs can decide for themselves

As with procedures such as abortion and in vitro fertilization (IVF), commonly addressed in so-called "conscience clauses," physicians have a choice whether they agree with embryonic stem cell therapies and their use.

In June 2003, the American Medical Association (AMA) approved recommendations by its Council on Ethical and Judicial Affairs (CEJA) that cloning for biomedical research is consistent with medical ethics, according to AMA spokesman Robert J. Mills.

"The CEJA report that was a source of these recommendations also recognizes that physicians are free to decide whether to participate in this type of research or to use the products that result from this research," he says. "The recommendations also note the critical importance of appropriate oversight of this research and safeguards for subjects participating in this type of research."

How a physician feels about the research end of stem cell medicine will have a big impact on how she or he feels about the use of any resulting therapies, says Berlinger.

But then, she adds, people can change their minds.

"Sherlock Holmes says in all his novels something like, It’s a mistake to make judgment in advance of the facts,’" Berlinger points out. "There is only so much we can do right now or know right now, but when we see the fruits of stem cell research, our feelings might change, or they might stay the same."

Medical minds have changed with each wave of progress. The advent of modern anesthesia in the 19th century was met by many in the medical community with great reservation and, in some cases, outright fear. New families of pharmaceuticals often meet with reluctant acceptance at first.

"Chiefs of departments can usually think of many examples that have come up during their careers," Berlinger suggests. "They can say, I can think of when X was considered totally unnatural.’"

In its ethical opinion on cloning for biomedical research (AMA ethics opinion E-2.146), CEJA acknowledges that while the welfare of the patient is paramount, physicians must reach personal decisions about stem cell research and therapies: "The conflict [around stem cell use] centers on the moral status of embryos, a question that divides ethical opinion and that cannot be resolved by medical science."

Start getting used to the idea

Clinicians — including physicians, nurses, anesthesiologists, pharmacists, and residents — in all specialties are likely at some point to encounter the products of embryonic stem cell research, Berlinger says, and should start examining their beliefs about it now.

"You need to ask yourself lots of questions and, if the moment comes that you realize you would absolutely not be able to participate in using a procedure or therapy that is derived from embryonic stem cells, your obligation is to make that known to your colleagues well in advance of ever becoming involved in a procedure," she urges.

One place to start is to learn about embryonic stem cell research, and apply personal beliefs to the science.

"You also should ask yourself how you feel about IVF," Berlinger suggests. "IVF leads to the discarding of a lot of embryos, so if you’re against embryonic stem cell research, what’s your theory about IVF?"

These questions are especially important for residents to consider, she says, because they are quite likely to be presented with the opportunity to use stem cell therapies with their patients.

"Residents might be thinking of this, as their career is evolving, because it could affect their career choices," she says. "They have to engage the ethical dimensions of it, or at least to understand why people feel about this subject the way that they do."

Even though stem cell therapies are not yet available outside research programs, they should be receiving attention at hospital and practice inservice training and even in grand rounds, Berlinger suggests.

"We need to make sure physicians understand the nature of research and where a therapy came from," she says. "If it came from embryonic research, they should know that, because people have very strong beliefs about this.

"We rarely think about the drug on our shelves and the research where it began. But this raises strong moral and personal beliefs, so hospitals should engage it well, well before the bedside, because it’s not fair to the patients to compromise their care at that point.

"Even if someone else drops out — a nurse, pharmacist, anesthesiologist — that’s a problem for the health care team. Say it’s an appropriate procedure — safe and effective — then the clinician is responsible for making sure it’s delivered appropriately, and if you drop out at the last minute, then it’s not being delivered appropriately and quality is compromised."

Berlinger suggests making stem cell topics part of continuing education and ethics education, including role-playing centered on a hypothetical safe, important therapy that is the fruit of embryonic stem cell research.

"What do you do when a member of your team says, I object to that.’? What do you do when you feel you object to it? Will it change the way people feel about stem cell research?" she asks.

Far-reaching applications foreseen

Researchers predict the potential application for human stem cells is as varied as the number of illnesses and injuries. While some types of stem cell therapy already are commonplace — bone marrow transplants, for example — applications involving cells derived from human embryos are the most controversial.

Called "a renewable source" for replacement cells and tissues, embryonic stem cells are seen as the source of future therapies for Parkinson’s and Alzheimer’s diseases, spinal cord injury, stroke, burns, heart disease, diabetes, osteoarthritis, and rheumatoid arthritis, among others.

The Clarksburg, MD-based Stem Cell Research Foundation predicts that half of all Americans with presently incurable diseases, injuries, or birth defects could benefit from stem cell research. Therefore, experts say, in addition to evaluating their own feelings about embryonic cell therapy, physicians should ready themselves to educate their patients.

Mills says the AMA’s CEJA insists potential recipients of stem cells derived from cloned embryos should be afforded the same informed consent process as participants in clinical trials, with disclosures about the source of the stem cells.

Furthermore, because there could be unforeseen contamination by infectious agents and DNA damage during growth of new tissues and organs after stem cell transplantation, the CEJA states that stem cell therapies could raise ethical concerns similar to those surrounding xenotransplantation (animal to human transplantation), so the informed consent process for stem cell transplantation should conform to that of xenotransplantation.

Conscience clause might apply

Most states have conscience clauses in their statutes that protect physicians who have conscientious objections to performing certain procedures, most commonly surgical abortion. But those conscience clauses might be applicable to physicians who object to embryonic stem cell procedures, Berlinger says, depending on how broadly the states define the laws.

"The term conscientious objection’ generally refers to surgical abortions when it is applied to health care, but the term can be used in other contexts and with other procedures," she says. "If it says physicians,’ does it cover pharmacists and nurses, too, and does it cover procedures other than abortion?

"And if the law covers abortion, and you think a procedure is like abortion [as when embryos are destroyed during the research process], then are you covered?"

The right of the health care provider to raise his or her objections — and when those objections should be raised — is a subject ripe for discussion at inservice training or ethics training, Berlinger notes.

"What is the right of the health care provider to say he or she personally will not participate, and what is the effect of that to the health care team and the patient? There are also legal procedures to consider," she says.

While patient care is paramount, and no patient should learn just before undergoing a treatment that his or her physician has suddenly recognized a moral opposition to the procedure, patients are equally within their rights to refuse a treatment they are conscientiously opposed to.

"That’s another question: You have a patient, and you have a safe, legal treatment that is standard of care — what do you do?" she asks. "And it happens all the time. [For example], patients reject blood transfusions and other standards of care."

Sometimes, she says, it just takes time for society to adjust to a new idea.

"In the 1800s, there was a real question as to whether or not women should use anesthesia in childbirth, because the Bible said that women would deliver their children in pain," Berlinger points out. "But then, Queen Victoria used anesthesia when she had her 10 children, and suddenly it was OK."

Having well-known advocates for a cause can have a big effect on public opinion, she says.

Actor Michael J. Fox (Parkinson’s disease), the late Christopher Reeve (spinal cord injuries), and presidential son Ron Reagan (Alzheimer’s disease) have been vocal in support of embryonic and nonembryonic stem cell research. But on the other side of the coin, actor Mel Gibson, President Bush, and both the late Pope John Paul II and Pope Benedict XVI have denounced research using embryos.

"When you have a visible person, it does galvanize public thinking," Berlinger says. Understanding, even if not agreeing with, patients’ views on stem cell therapies is part of delivering good care, she adds.

"It’s not all black and white; lots happen in that messy middle ground," she says. "We’re all just people trying to sort things out. So thinking about them well in advance so you’re ready to reason them out when they come along in a form that maybe you haven’t thought about will help you work through it."

Resources

  • Stem Cell Research Foundation, 22512 Gateway Center Drive, Clarksburg, MD 20871. Phone: (877) 842-3442. Web: www.stemcellresearchfoundation.org.
  • National Institutes for Health, U.S. Department of Health and Human Services, Stem Cell Information Center, One Center Drive, MSC 0188, Bethesda, MD 20892. Web: stemcells.nih.gov.

Sources

  • Nancy Berlinger, PhD, MDiv, Deputy Director, Associate for Religious Studies, The Hastings Center, Garrison, NY. E-mail: berlingern@thehastingscenter.org.
  • Robert J. Mills, Senior Public Information Officer, American Medical Association, 515 N. State St., Chicago, IL 60610. Phone: (312) 464-5970.