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Case 1: Cosmetic Treatment or Damaging Experiment?

How would you feel if you discovered that your surgeon had chosen your face as the site of an experiment?

That happened to twenty women and one man who paid to have facelifts at the Manhattan Eye, Ear and Throat Hospital in 1992 and 1993. The doctors were trying to figure out which of two standard procedures-deep surgery or superficial surgery-was most effective. So, for each of the 21 patients, one group of surgeons "lifted" the left side of the face one way while a second group "lifted" the right side differently. The doctors never asked the patients if the surgical duet-or possibly tug-of-war-would be okay with them.

The surgeons published a paper in a medical journal in 1996. They described the study and noted that, after one year, the two surgeries seemed to have produced similar results. They did not follow the progress of the patients longer than that.

Some time later, the story surfaced when, according to an article in the New York Times, someone alerted the division of the federal government that monitors experiments on humans.

"Dear Sir, I am writing (anonymously) to inform you of this unauthorized medical study on unknowing human clinic patients. These people had two different doctors and operations (on each side of face) and were never told! The chairman (Aston) conducted the study without institutional approval. We are not guinea pigs. Thank you."

The letter sparked an official investigation into the operations and the ways in which the surgeons went about doing them.

Every experimental study that involves people in the United States is supposed to be evaluated by an Institutional Review Board (IRB) at the hospital, clinic, university, or research center where the experiment-known as a clinical trial-will take place. The IRB includes physicians, other medical personnel, ethicists, clergy, lawyers, and people from the community. The IRB members read the plan of the experiment-called the protocol-and decide whether the experiment is reasonable, whether its benefits to the participants outweigh its risks, and whether it is worth doing.

Next, all people who are considering being in the study are asked to read a document called an "informed consent" form that explains all aspects of the experiment. When potential subjects are sure that they understand the experiment, what they have to gain or lose by being in it, and what other options they have, and after they have asked all the questions they need answered, they decide whether or not to participate. Only if they want to take part and after they sign the consent form can the clinical trial proceed.

The surgeons in the facelift study sidestepped the IRB at their hospital. They claimed that, because both procedures were standard, they were not doing anything 'experimental.' But, clearly, comparing two different procedures on the face of one person is an experiment, one that might leave some patients, the unlucky ones, with lop-sided faces.

Included References

  1. New York Times, June 21, 1998, 25-26, Hilts.

Additional Resources

  1. Plastic and Reconstructive Surgery, Dec 1996, 98(7):1134-1143. Ivy, E.J., Lorenc, Z.P., Aston, S.J.
  2. Plastic and Reconstructive Surgery, Dec 1996, 98(7):1144-1147. Hamra, S.T.
  3. The Autobiography of a Face, Lucy Grealy, HarperPerennial Library, 1995.
  4. Website: http://clinicalstudies.info.nih.gov
  5. Website: http://www.humansubjects.com
  6. Website: http://www.med.umich.edu/irbmed/ethics/belmont/
    BELMONTR.HTM

Aims

Students should understand the following:
  • Terms: clinical trial, protocol, research subject (or subject volunteer), informed consent, experiment, standard of care, Institutional Review Board (IRB)
  • Responsibilities of doctors, patients, subjects, researchers, IRBs, insurance companies, journal editors and reviewers, the media, and other "players" in medical research
  • Experiment versus treatment
  • Procedures preceding clinical trials
  • Importance of communication between all players in clinical trials
  • Significance of clinical trials in advancing medical knowledge and treatments
  • Rights of patients
  • Professional responsibilities of doctors, researchers, other health professionals, and medical institutions
  • Responsibilities and importance of IRBs
  • Cultural perspectives on beauty
  • Surgical procedures and risks of cosmetic surgery
  • Necessary versus elective procedures
  • Vulnerability of research subjects and patients
  • Responsibilities of care givers

Suggested Questions for Discussion

  1. Analyze the positions of the surgeons and of their critics. Whose position do you find has the most merit and why?
  2. What does it mean to be a subject in an experiment? What guidelines protect subjects in clinical studies? (Note: subjects are sometimes called "subject-volunteers" or just "volunteers" to emphasize the voluntary nature of participation in clinical trials.)
  3. Some argue that all surgery and all medical treatments are experimental, because every patient is unique physiologically. How would you decide what is experimental and what is a standard procedure? Where do distinctions between experiments and standard procedures blur?
  4. Were the facelifts experiments or standard treatments? What evidence supports your conclusion?
  5. What recourse do the facelift patients have now in this case? What would you consider fair compensation for the patients? What punitive actions, if any, could or should be taken against the doctors?
  6. What is informed consent? What is a consent form? What rights does a consent form preserve?
  7. What does a subject need to know before signing a consent form? What does a researcher need to know about a patient before asking the patient to sign the form?
  8. List reasons why subjects and patients would be willing to sign consent forms? Why would doctors or hospitals want them to sign?
  9. What responsibilities do medical journals have to "flag" unethical research in papers that are submitted to them for publication?
  10. In clinical trials, what obligations do doctors and researchers have for longterm follow-up with their patients?
  11. What does the term "standard of care" mean?
  12. What kinds of medical procedures and experiments are you willing to have your insurance company cover? Should the insurance companies cover vanity operations, such as facelifts?
  13. How are beauty and youth glorified in our society today? To what extent would you be willing to endure cosmetic surgery to change your face? How does cultural relativism figure in concepts of beauty?

Topics for Discussion/Written Assessment

  1. Sometimes doctors and patients have difficulty understanding one another. Doctors frequently use medical terms that are not clear to their patients. Suggest ways to resolve the language barrier between doctors and patients.
  2. Imagine being on an IRB. What sorts of questions would you ask about an experiment if you were a) a social worker, b) a lawyer, c) a citizen with no medical background, d) a doctor not involved with the experiment, e) a nurse, f) a chaplain.
  3. Financial resources for healthcare in the United States are not limitless, so insurance companies must choose which treatments and procedures to pay for. Often they choose not to pay for experimental treatments until the treatments have been shown to be effective. How should decisions be made about spending money? What considerations should the insurance companies include when deciding whether to provide coverage for a particular procedure?
  4. When ill patients are subjected to experimental treatments that carry risks, a reasonable expectation is that the benefits of such treatments outweigh the risks. What factors contribute to the risk-benefit equation for clinical trials involving cosmetic surgery?
  5. An organization called Doctors Without Borders sends doctors around the world to disaster zones to provide medical treatment to victims. Often, the doctors do cosmetic surgery to repair disfiguring wounds. Does this type of "plastic" surgery differ from facelifts? What are the differences?
  6. Doctors working for Doctors Without Borders sometimes speak out against unjust conditions that led to the medical casualties that they are treating. How do their humanitarian efforts reflect some of the values that are fundamental to medical care?
  7. Would you feel differently about this case if the surgery had been done on some part of the body other than the face? For example, if patients were having surgery on their hands for carpal tunnel syndrome and the doctors tried two different procedures on their two hands, would that have raised an ethical issue the way face surgery did?
  8. How much do research subjects really want to know about every possible complication that can occur in an experiment? If every clinical trial included the statement that one complication might be death, would anyone ever participate in a trial?

Extension Questions for Additional Research

  1. Find additional examples of situations in which patients were unaware that they were participating in medical experiments. What actions did the subjects take, what compensations did they receive, and were punitive actions taken against the researchers?
  2. When and why did IRBs come into existence?
  3. Each state decides how to use its Medicaid money. Oregon was a pioneer in setting priority lists for which medical procedures the money should support. Research the Oregon plan and the plans of other states. Which plans would fund cosmetic surgery? In which ones would such surgery be paid for through a "quality of life" rating?
  4. Find out how subjects volunteer or are selected to participate in clinical trials. How do researchers and institutions build their participant lists? What selection processes do you feel are the most valid and fair?
  5. Research cultures-current and past-that value(d) or appreciate(d) beauty in ways that differ from the way our society's "popular culture" defines beauty today.
  6. How symmetrical is the human face? Some computer programs allow you to take one half of your face and make a mirror image of it for the other side. Find out what your face would look like if you did this.

Topics for Teacher Preparation

  • Clinical trials
  • Protocols
  • Informed consent and the legal implications
  • Experiment versus standard of care
  • Institutional Review Boards: origin, procedures
  • Office of Protection from Research Risks (agency with oversight for clinical trials)
  • Cultural relativism
  • Insurance coverage for experimental procedures
  • Elective versus nonelective surgery
  • Risks of plastic surgery
  • Physicians' responsibilities to patients with respect to information and caring
  • Patients' rights in both normal care and experimental situations
  • Human metabolism: how individuals differ

 
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