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Uselessness of Whole Body Scanning Using Computed Tomography (CT)



I thought this was an interesting piece that I received through another list

server.



-- John 

John Jacobus, MS

Certified Health Physicist 

3050 Traymore Lane

Bowie, MD  20715-2024



E-mail:  jenday1@email.msn.com (H)      



-----Original Message-----

From: Grissom, Mike [mailto:mikeg@slac.stanford.edu]

Sent: Friday, April 26, 2002 1:49 PM

To: 'Medhp-Sec (E-mail)'

Subject: MEDHP-SEC: US FDA Web Site Update: Whole Body Scanning Using

Computed Tomogr aphy (CT)



The following was recently provided on the Food and

Drug Administration's Web site:





----------

April 26, 2002



	Whole Body Scanning Using Computed Tomography

	(CT)



	http://www.fda.gov/cdrh/ct/



Extract:



"Currently some medical imaging facilities are promoting

 a new use of computed tomography (CT), also called

 computerized axial tomography (CAT) scanning. This use

 is referred to as whole-body CT scanning or whole-body

 CT screening, and it is marketed as a preventive or

 proactive healthcare measure to healthy individuals who

 have no symptoms or suspicion of disease. At this time

 the FDA knows of no data demonstrating that whole-body

 CT screening is effective in detecting any particular

 disease early enough for the disease to be managed,

 treated, or cured and advantageously spare a person at

 least some of the detriment associated with serious

 illness or premature death. Any such presumed benefit

 of whole-body CT screening is currently uncertain, and

 such benefit may not be great enough to offset the

 potential harms such screening could cause. Public

 health agencies and national medical societies-the

 American College of Radiology, the American College of

 Cardiology, and the American Heart Association-do not

 recommend CT screening.



 CT is a diagnostic imaging procedure that uses x rays

 to obtain cross-sectional images of the body. Since its

 introduction and rapid adoption into medicine in the

 mid-1970s, CT has become recognized as a valuable

 medical tool for the diagnosis of disease, trauma, or

 abnormality and for planning, guiding, and monitoring

 therapy.



 Important information regarding whole-body CT screening:



  o	Such screening provides uncertain benefit with

	potential for some risk - The most likely outcomes

	of CT screening of a healthy person with no

	symptoms of illness are:



	  1.	Normal findings or

	  2.	Suspicious findings requiring follow-up

		tests



	Normal findings carry the possibility of

	inaccuracy and false reassurance. For suspicious

	findings, follow-up may involve simple,

	non-invasive testing. It may also involve invasive

	procedures associated with surgical risks of

	anesthesia, bleeding, infection, scarring, or it

	may entail additional radiological exams,

	associated with radiation risk and the potential

	risk of allergic reaction to injected contrast

	material. In any case, it is unlikely that CT

	screening will benefit an individual lacking signs

	or symptoms of disease by detecting a serious

	disease early enough to treat it and alter the

	outcome significantly.



  o	Radiation Dose - CT screening subjects the

	individual screened to radiation exposure from

	x rays. The dose a patient receives during a

	typical CT procedure is generally much larger than

	the radiation doses associated with most

	conventional x-ray imaging procedures. The

	principal risk associated with the radiation dose

	resulting to a person from a CT procedure is the

	small possibility of developing a

	radiation-induced cancer some time later in that

	person's life. For a patient with a medical need,

	the benefit of a diagnostic or therapeutic CT

	procedure recommended by a physician normally far

	exceeds the small cancer risk associated with a

	CT procedure. For a person without symptoms, CT

	screening is unlikely to discover serious disease,

	and the potential harm to the individual may be

	greater than the presumed benefit.



  o	Scientific Studies - There are no data

	demonstrating that whole-body CT screening of

	individuals without symptoms provides a greater

	probability of benefit than harm. Nor is there any

	scientific study known to be underway to develop

	such data. Although there are several ongoing

	investigational studies of the effectiveness of

	using CT to screen people, the studies are focused

	on high-risk groups for specific diseases (e.g.,

	cigarette smokers for lung cancer). In such

	studies only a limited portion of the body is

	irradiated, not the whole body, and only screening

	for a specific type of disease is being evaluated,

	rather than screening for just anything that might

	be found anywhere in the body.



  o	No Food and Drug Administration (FDA) Approval of

	CT for Screening - Statements by CT imaging

	facilities that imply FDA "approval," "clearance,"

	or "certification" of CT for screening procedures

	misrepresent the actual situation. FDA has never

	approved or cleared or certified any CT system

	specifically for use in screening (i.e., of

	individuals without symptoms), because no

	manufacturer has ever demonstrated to the FDA that

	their CT scanner is effective for screening for

	any disease or condition."





----------

The above may be viewed on the FDA Web site at URL:



  http://www.fda.gov/cdrh/newpg.html

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