Alternative medicine: Raising new dilemmas
Use complicates admission into clinical trials
Fifteen years after receiving a one-year prognosis for surviving ovarian cancer, a 58-year-old patient decided to fight back. She volunteered for an experimental drug trial and began taking a combination of herbal medicines at the urging of friends and family.
Her story is not unique. Increasingly, Americans are taking disease treatment into their own hands, turning to acupuncture, massage therapy, and a dizzying choice of herbal and non-FDA-approved treatments to battle bleak diagnoses. But this alternative or "complementary" medicine is raising serious ethical questions.
Studies have shown that most patients use alternative treatments in conjunction with conventional medical treatments. Now experts are wondering how to address this growing movement toward patient autonomy and where it fits within conventional medicine. Should patients taking complementary substances be denied participation in clinical trials? Do these complementary methods compromise the validity of a drug trial or harm other patients in the trial? Should loved ones who know a patient is using complementary treatments tell the doctor if they fear the patient may be harmed? What responsibility do physicians have to ask about complementary treatments their patients may be taking along with conventional treatments?
"The ethical problems arise from the fact that the majority of these patients do not tell their doctor, or a research trial investigator, about using alternative or complementary methods," says Wayne Jonas, MD, director of the Office of Alternative Medicine at the National Institutes of Health (NIH)in Bethesda, MD. When patients enroll in a clinical trial, they sign an informed consent agreement that also discloses any other medications or treatments they may be taking, he says. Patients sometimes must defer the use of one treatment to participate in a clinical trial of another experimental treatment. Otherwise, they are excluded from the trial.
Open communication forms the very heart of the doctor/patient relationship. "People have to feel that you will do something to help them," says John J. Lynch, MD, associate director of the Cancer Institute at the Washington (DC) Hospital Center. "If you talk to the patient in a pejorative way about these ideas, then you all but assure that they will not tell you whether they are using [alternative treatments]," he says.
Doctors must do a better job of communicating with their patients, experts say; the "doctor knows best" attitude is becoming a quaint relic. "We have to acknowledge to patients that we don’t have all the answers but also gently steer them away from any treatment that might be harmful," Lynch says. "One of the worst mistakes a doctor makes is to say, There is nothing more I can do for you.’"
Gaining approval
Unwilling to give up when conventional treatments offer little hope and given no alternatives by their physicians, patients are turning to methods that do not have U.S. government approval. But as evidence of the groundswell of popularity these complementary treatments enjoy, a growing number of insurance plans are covering them, and the American Medical Association has endorsed some of them. In several states, insurance plans such as Pacific Health and Life in Oregon and Kaiser in Northern California are offering subscribers access to everything from acupuncture and hypnosis to herbs and therapeutic touch.
The federal government is taking the growing use of alternative treatments seriously. The Office of Alternative Medicine (OAM) opened its doors in 1992 under a Congressional mandate. The office fields more than 1,000 calls per month on average, more than three-quarters from cancer patients, Jonas says. It serves as a clearinghouse for public information and coordinates research training programs in alternative medicine.
Will alternatives become standard?
Jonas, who has traveled around the world reviewing alternative therapies, says their use is even more common in Europe and other countries. His office recently funded 30 grant programs of $30,000 each to explore the use of alternative medicines in this country. The pilot projects will be conducted at major university medical centers.
The movement toward complementary medicine has led some states to examine the issue. In 1993, the Maryland legislature created the Maryland Commission on Complementary Medical Methods. "The legislature believed that individuals should have the right and freedom to choose what they believed to be the most appropriate course of treatment for their medical conditions," reads an executive summary written by commission members in December 1995.
The summary defined complementary medical methods as "those forms of treatment which are not widely used by conventional health care professionals and the skills of which are not taught as part of the curriculum of conventional medical and paramedical health care courses."
The commission made these four recommendations regarding complementary medicine:
1. State medical schools and continuing education for practicing physicians should include complementary medicine information.
2. Guidelines for health insurance in the state should be evaluated and expanded to include coverage of cost-effective complementary medical methods.
3. Peer review of physicians using complementary medical methods in the state should include the expertise of professionals knowledgeable of complementary medicine, such as the OAM.
4. Exploration of complementary medicine methods should be conducted by a funded state commission.
Regardless of whether complementary medicine is recognized in your state, patients are using these alternative treatments, and doctors must begin communicating with patients about them, says Evan G. DeRenzo, PhD, senior staff fellow in the office of bioethics at the NIH.
The question all caregivers should be asking, he says, is "whether we set a climate for patients to be dishonest." DeRenzo suggests that doctors discuss alternative methods with patients to find out if they are using them. An open discussion at least will allow patients to make informed decisions about more traditional treatments.
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