Informed Consent Clouded by Technology,

Marketing Pressures

WESTPORT, CT (Reuters Health) Oct 25 - The importance of informed consent is being obscured by the pressures of the marketplace and issues that exist only as a result of recent technological advances. A series of articles in the Fall issue of the Journal of the American Medical Women's Association reviews how the standards of informed consent, in the context of women's health, can be met in the rapidly changing medical environment.

Nancy Neveloff Dubler, of the Albert Einstein College of Medicine,

Cites breast augmentation surgery as a situation in which informed consent as conventionally presented fails to protect patients.

In May of this year, the Food and Drug administration approved saline implants for breast augmentation. (See Reuters Health report, May 12, 2000.) However, the FDA stressed that the surgical procedure is associated with relatively high complication and failure rates.

"Here you have culturally determined, market-created, advertising-supported demand," Dubler told Reuters Health. She emphasized that sophisticated advertising of skills and products to increase patient desire impedes physicians' ability to present risks as clearly as they do benefits.

To counteract the enticement of sophisticated advertising, she suggests, "Warnings should be presented as cleverly and professionally as the advertisements." Statements of adverse outcomes should be placed within the advertisements, Dubler said, "in bold face type!"

"I would extend this rule to any medical procedure or product that is market driven, where there are advertisements from physicians that help to create the demand," Dubler added.

In another article, Dr. Dena S. Davis, of Cleveland State University, in Ohio, reveals how convoluted informed consent can become when politics and morality are involved, as is the case in the disposition of human embryos created for the purpose of in vitro fertilization. She suggests that for most individuals the embryo occupies a middle ground "between full personhood and mere tissue."

Three organizations, the American Association for the Advancement of Science, the National Institutes of Health, and the National Bioethics Advisory Commission, have each issued policy statements regarding when, how, by whom, and to whom requests for embryo donation for stem cell research should be made.

Dr. Gail Geller, of Johns Hopkins University, and colleagues expand the notion of informed consent to include process rather than a single event, especially when children are involved. The investigators use as an example the benefits and risks of participating in genetic susceptibility research.