April 16

InfoMail for April 16, 2002



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News Stories on Human ResearchProtection and
Commentary by Vera Hassner Sharav

April 16, 2002

Do Risk Factors NecessarilyLead to Disease?


Dr. Peter Gotzsche, who touched off a firestorm when hechallenged the assumption that early detection of a tumor by a mammogram iscritical for saving lives, has written a provocative article in TheBritish Medical Journal, challenging the unproven suppositions about avariety of cancer screening tests:

"Senior scientists argue that this debate should notbe taking place in public. This misguided paternalism makes us wonder why healthprofessionals are so eager to intervene in healthy people’s lives and aboutthose people’s own perspectives on risks."

Dr. Gotzsche argues against the underlying belief thatrisk factors are a reliable barometer for the presence of disease:"Precursors to cancer can be seen in most healthy people above middle age,and the potential for screening to cause harm and lead to a diagnosis of"pseudo-disease" is frightening. Whether risk factors should be turnedinto diseases also needs careful reflection…"

Similarly, we note with ever growing concern about effortsnow underway to reinterpret federal regulatory protections in order toaccommodate the need for pediatric research subjects. The mandate to protectchildren is giving way to facilitate the interests of academic research centers.Those eager to recruit children for research argue that healthy children maynevertheless be "at risk" for the condition being studied.
BMJ 2002;324:886-891 ( 13 April 2002)
Commentary: "Medicalisation of risk factors"
Peter C Gøtzsche, Director,
Nordic Cochrane Centre, Rigshospitalet
2100 Copenhagen ÿ, Denmark

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