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The Changing Moral Focus of Newborn Screening: An Ethical Analysis by the President's Council on Bioethics

Letter of Transmittal

The President’s Council on Bioethics
1425 New York Avenue, NW, Suite C100
Washington, D.C. 20005
December 2008

The President
The White House
Washington, D.C.

Dear Mr. President:

With this letter, I am transmitting a white paper entitled The Changing Moral Focus of Newborn Screening: An Ethical Inquiry by the President's Council on Bioethics.

Nearly four million newborns undergo genetic screening every year in the United States . Yet, the process of genetic screening and its ethical implications are not well understood by their parents. Public discussion and education about recent changes in public policy and screening techniques is insufficient for parents to make informed choices. One aim of this white paper is to provide the background information every parent needs in order to understand the issues and to make informed choices.

Most states have mandatory genetic screening programs for newborn babies. Until recently such screening was limited to diseases that were well understood and for which effective treatments were available. Now, however, most mandatory screening programs also test for diseases that are not well understood and for which there is no available treatment. Some believe this change is ethically justifiable because much knowledge of little understood diseases could be gained and lead eventually to treatment and cure.

This white paper describes how the change in policy to include screening for untreatable as well as treatable diseases came about. To this end, it provides basic information about the techniques of screening, the practical and ethical choices parents must face, and the public policies behind those choices.

The Council concludes that the potential benefits of mandatory, population-wide newborn screening for diseases for which there is no current treatment are outweighed by the potential harms. These harms will be accentuated once new DNA technologies make it possible to expand screening to target additional diseases and to detect disease susceptibility as well. But the Council also acknowledges that the gains in biomedical knowledge from expanded screening programs should not be ignored.

Therefore, the Council recommends that the states mandate newborn screening only for diseases that meet traditional criteria, including the availability of an effective treatment. But the states are encouraged to implement pilot studies for newborn screening of conditions that do not meet the traditional criteria. Participation in these pilot studies should require the voluntary, informed consent of the infant's parents.

In this way, the present benefits of newborn screening can be optimized in an ethical way, and the future benefits of new techniques to expand our knowledge of untreatable diseases will be facilitated in an ethically sensitive way.


Sincerely yours,

Edmund D. Pellegrino, M.D. Chairman

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