Technological diseases -1 (Sonograms)

[Guest guest]

In search of various causes for the diseases which his patients bring

to him, an ayurvedist can stumble on anything least imagined.

 

We had discussions on this list regarding modern drug caused

diseases. Chemicals also have been discussed. Discussion may now move

on to technology caused diseases. Modern medical science could

impress the patients with technology, and pinpointing the location of

abnormality on a photograph by using X-rays, ultrasounds or CT, MRI

scans. Nobody thinks of damage on living tissues when undergoing

these tests. All are high energy waves or radiations, and in our

traditional mind, radiations are tightly linked to nuclear ones.

Light, sound, magnetism we take it for granted since everything we

have handled since child hood! However, it needs to be noted that

before sending an astronaut to Moon, NASA studied the effects of zero

gravity and intense electromagnetic radiations on working of the mind

of an astronaut. It was found that vision distorts in intense

magnetic fields and headache, halunciations can come.

 

Today we are able to communicate across the globe free, due to

communication satellites. When a rocket takes these satellites to

space, the control of firing is from a room about half a mile away,

located deep underground. Deafening noise is the reason. The

satellites themselves are tested to go through this acoustic noise

(approx. 130 dB) in a special facility, and scientists stay in a

control room well insulated. Failures of solar cells by microcracking

and delicate optics are frequent during these tests. However, we do

not even bat an eyelid when we subject our babies in the womb to

similar noise for obtaining sonogram.

 

Ultrasound is being used in medicine practice since 1955. In 1935 it

was said that "antenatal work without the routine use of X-rays is no

more justifiable than would be the treatment of fractures" [1]. In

1978: "It can be stated without qualification that modern obstetrics

and gynecology cannot be practiced without the use of diagnostic

ultrasound" [2]. Two years later, it was said that "ultrasound is now

no longer a diagnostic test applied to a few pregnancies regarded on

clinical grounds as being at risk. It can now be used to screen all

pregnancies and should be regarded as an integral part of antenatal

care" [3]. On neither of these dates did evidence qualify the

speakers to make these assertions.

 

In many countries, the commercial application of ultrasound scanning

during pregnancy is widespread, offering "baby look" and "fun

ultrasound" in order to "meet your baby" with photographs and home

videos. Like many things, the safety of ultrasound depends on the

level of exposure. Studies of the lower exposures common in the 1970s

and 1980s are fairly reassuring. But since 1993, allowable exposure

levels have risen dramatically, and little research has been done on

the effects of these higher doses.

 

The extent to which medical practitioners nevertheless followed such

scientifically unjustified advice, and the degree to which this

technology proliferated, can be illustrated by recent data from three

countries. In France, in one year three million ultrasound

examinations were done on 700,000 pregnant women-an average of more

than four scans per pregnancy.

 

These examinations cost French taxpayers more than all other

therapeutic and diagnostic procedures done on these pregnant women.

In Australia, where the health service pays for four routine scans,

in one recent year billing for obstetrical ultrasound was $60 million

in Australian dollars. A 1993 editorial in U.S.A. Today makes the

following statement: "Baby's first picture-a $200 sonogram shot in

the womb-is a nice addition to any family album. But are sonograms

medically worth $1 billion of the nation's scarce health-care

dollars? That's the question raised by a United States study released

this week. It found the sonograms that doctors routinely perform on

healthy pregnant women don't make any difference to the health of

their babies."

 

Meanwhile the use of prenatal ultrasound continues to expand in what

one consumer advocate calls "the biggest uncontrolled experiment in

history." [4] In 2000, approximately 2.7 million women in the United

States received prenatal sonograms—some 67 percent of pregnant women

[5]

 

Ultrasounds are certainly emotionally very rewarding to have! Thus

ectopic pregnancy, miscarriage, multiple pregnancies, fetal

abnormalities, dating the pregnancy, estimation of fetal position and

weight, placental problems can be decided early so that actions can

be planned. However, they are greatly overused in society, raising

the costs of healthcare significantly. This is money that could be

spent better elsewhere. Therefore, ultrasound overuse is a matter of

important public health debate. Kmom [6] urges all pregnant women to

thoroughly research any test before deciding whether to use it or

not. Do NOT accept blindly what your doctor tells you

 

When ultrasounds provide useful medical information, such as due date

or indications of malformations, most doctors consider the risks

acceptable. After a medical ultrasound exam, parents typically take

home a simple 2D printout showing their fetus, and such pictures have

become a virtual ritual of pregnancy in many industrialized countries.

After a technology has spread widely in clinical practice, the next

step is for health policy makers to accept it as standard care

financed by the official health sector.

 

Several European countries now have official policy for one or more

routine ultrasound scans during pregnancy. For example, in 1980 the

Maternity Care Guidelines in West Germany stated the right of each

pregnant woman to be offered at least two ultrasound scans during

pregnancy. Austria quickly followed suit, approving two routine

scans. Do the scientific data justify such widespread use and great

cost of ultrasound scanning?

 

Now, manufacturers are pushing hard to win acceptance for a much more

extensive new ritual: a 4D (full motion 3D) movie of the unborn

infant, provided by "fetal portrait" studios in shopping malls. These

movies are captured on DVD using state-of-the-art ultrasound

equipment such as the Voluson 730 made by General Electric.

A recent General Electric TV ad bypasses doctors to promote these

videos directly to parents, saying, "When you see your baby for the

first time on the new GE 4D ultrasound system, it really is a

miracle." [7].

 

General Electric's website provides links to commercial facilities

where the new technology is available. With names like "Womb with a

View" and "Peek-a-Boo," these businesses advertise heavily in

parents' magazines and on the Internet, offering a variety of

packages, ranging from a basic 2D ultrasound video ($75) to a deluxe

package that includes a 20-minute 4D video set to music and stored on

DVD, a set of wallet photographs, and a set of larger photographs

suitable for framing ($285).

 

And the videos are in hot demand. Seeing their unborn baby thrills

and comforts many parents. Writes British doctor Stuart

Campbell, "Both maternal and paternal reaction to the moving 3D image

is something we have not previously encountered. I have seen fathers

kiss the screen or, more appropriately, their partner's abdomen in an

ecstasy of recognition and pleasure."[8]

 

In assessing the effectiveness of ultrasound in pregnancy, it is

essential to make the distinction between its selective use for

specific indications and its routine use as a screening procedure.

Essentially, ultrasound has proven valuable in a handful of specific

situations in which the diagnosis "remains uncertain after clinical

history has been ascertained and a physical examination has been

performed." Yet, considering whether the benefits outweigh the costs

of using ultrasound routinely, systematic medical research has not

supported routine use.

 

One of the most common justifications given today for routine

ultrasound scanning is to detect intrauterine growth retardation

(IUGR). Many clinicians insist that ultrasound is the best method for

the identification of this condition. In 1986, a professional review

of 83 scientific articles on ultrasound showed that "for intrauterine

growth retardation detection, ultrasound should be performed only in

a high-risk population." In other words, the hands of an experienced

midwife or doctor feeling a pregnant woman's abdomen are as accurate

as the ultrasound machine for detecting IUGR. The same conclusion was

reached by a study in Sweden comparing repeated measurement of the

size of the uterus by a midwife with repeated ultrasonic measurements

of the head size of the fetus in 581 pregnancies. The report

concludes: "Measurements of uterus size are more effective than

ultrasonic measurements for the antenatal diagnosis of intrauterine

growth retardation."

 

If doctors continue to try to detect IUGR with ultrasound, the result

will be high false-positive rates. Studies show that even under ideal

conditions, such as do not exist in most settings, it is likely that

over half of the time a positive IUGR screening test using ultrasound

is returned, the test is false, and the pregnancy is in fact normal.

The implications of this are great for producing anxiety in the woman

and the likelihood of further unnecessary interventions.

 

There is another problem in screening for IUGR. One of the basic

principles of screening is to screen only for conditions for which

you can do something. At present, there is no treatment for IUGR, no

way to slow up or stop the process of too-slow growth of the fetus

and return it to normal. So it is hard to see how screening for IUGR

could be expected to improve pregnancy outcome.

 

We are left with the conclusion that, with IUGR, we can only prevent

a small amount of it using social interventions (nutrition and

substance abuse programs), are very inaccurate at diagnosing it, and

have no treatment for it. If this is the present state of the art,

there is no justification for clinicians using routine ultrasound

during pregnancy for the management of IUGR. Its use should be

limited to research on IUGR.

 

That ultrasound during pregnancy cannot be simply assumed to be

harmless is suggested by good scientific work in Norway. By following

up on children at age eight or nine born of mothers who had taken

part in two controlled trials of routine ultrasound in pregnancy,

they were able to show that routine ultra-sonography was associated

with a symptom of possible neurological problems.

 

With regard to the active scientific pursuit of safety, an editorial

in Lancet, a British medical journal, says: "There have been no

randomized controlled trials of adequate size to assess whether there

are adverse effects on growth and development of children exposed in

utero to ultrasound. Indeed, the necessary studies to ascertain

safety may never be done, because of lack of interest in such

research."

 

The safety issue is made more complicated by the problem of exposure

conditions. Clearly, any bio-effects that might occur as a result of

ultrasound would depend on the dose of ultrasound received by the

fetus or woman. But there are no national or international standards

for the output characteristics of ultrasound equipment. The result is

the shocking situation described in a commentary in the British

Journal of Obstetrics and Gynaecology, in which ultrasound machines

in use on pregnant women range in output power from extremely high to

extremely low, all with equal effect. The commentary reads, "If the

machines with the lowest powers have been shown to be diagnostically

adequate, how can one possibly justify exposing the patient to a dose

5,000 times greater?" It goes on to urge government guidelines on the

output of ultrasound equipment and for legislation making it

mandatory for equipment manufacturers to state the output

characteristics. As far as is known, this has not yet been done in

any country.

 

Safety is also clearly related to the skill of the ultrasound

operator. At present, there is no known training or certification for

medical users of ultrasound apparatus in any country. In other words,

the birth machine has no license test for its drivers.

On their websites, providers offer sweeping assurances that using

ultrasound to view unborn infants is devoid of any risk. One

confidently states, "Extensive studies over 30 years have found that

ultrasound has not been shown to cause any harm to mother or

baby."[9]. Another says flatly, "There has never been a harmful

effect shown by the use of ultrasound. Many women have multiple

ultrasounds during pregnancy with no negative effect on the

baby."[10] Yet another: "Thousands of studies have been conducted.

Nothing has surfaced yet that indicates any harmful effects in the

use of ultrasound on animals or on humans."[11]

 

Yet even as business interests strive to reassure their customers,

government health officials and professional medical associations

issue warnings.

 

In 1999, the American Institute of Ultrasound in Medicine (AIUM)

released the following statement:

 

The AIUM strongly discourages the non-medical use of ultrasound for

psychosocial or entertainment purposes. The use of either two-

dimensional (2D) or three-dimensional (3D) ultrasound to only view

the fetus, obtain a picture of the fetus, or determine the fetal

gender without a medical indication is inappropriate and contrary to

responsible medical practice.[12]

 

In February 2004, the American Food and Drug Administration (FDA)

issued the following statement:

 

Persons who promote, sell or lease ultrasound equipment for

making "keepsake" fetal videos should know that FDA views this as an

unapproved use of a medical device. In addition, those who subject

individuals to ultrasound exposure using a diagnostic ultrasound

device (a prescription device) without a physician's order may be in

violation of state or local laws or regulations regarding use of a

prescription medical device.[13]

 

Which is right, the statements that fetal ultrasound is perfectly

safe or the cautions against it? Why the concern over a technology

that has been in everyday use in doctors' offices for decades?

In a continuing post tomorrow, we will examine the tissue damage and

brain damage issues, as a result of exposure to high power ultrasound.

 

Dr Bhate

 

1. Reece, L. (1935). The estimation of fetal maturity by a new method

of x-ray cephalometry: its bearing on clinical midwifery. Proc Royal

Soc Med 18.

2. Hassani, S. (1978). Ultrasound in Gynecology and Obstetrics. New

York: Springer Verlag.

3. Campbell, S. & Little, D. (1980). Clinical potential of real-time

ultrasound. In M. Bennett & S. Campbell (Eds), Real-time Ultrasound

in Obstetrics. Oxford: Blackwell Scientific Publications

4. 1993 statement attributed to UK consumer activist Beverly Beech in

Sarah Buckley, "Ultrasound Scans: Cause for Concern," Nexus, Vol. 9,

No. 6, Oct.-Nov. 2002.

5. Figures are for the year 2000. Source: National Center of Health

Statistics of the Centers for Disease Control and Prevention, "Live

births to mothers with selected obstetric procedures," National Vital

Statistics Reports, Vol. 50, No. 5, Feb. 12, 2002, Table 36.

6. .http://www.plus-size-pregnancy.org/Prenatal%

20Testing/prenataltest-ultrasoundsafety.htm#Ultrasound Summary

7. www.gehealthcare.com/usen/ultrasound/4d/commercial.html

<http://www.gehealthcare.com/usen/ultrasound/4d/commercial.html>

8. Stuart Campbell, "4D, or not 4D: that is the question," Ultrasound

in Obstetrics and Gynecology, Vol. 19, No. 1, Dec. 12, 2002, 1-4.

9. www.firstlooksonogram.com/qa.htm

<http://www.firstlooksonogram.com/qa.htm>

10. www.littlesproutimaging.com/faq.htm

<http://www.littlesproutimaging.com/faq.htm>

11. www.geddeskeepsake.com/factsheet.html

<http://www.geddeskeepsake.com/factsheet.html>

12. www.aium.org <http://www.aium.org>

13. Carol Rados, "FDA cautions against ultrasound `keepsake' images,"

FDA Consumer, Jan.-Feb., 2004. at

www.fda.gov/fdac/features/2004/104_images.html

<http://www.fda.gov/fdac/features/2004/104_images.html>

[Guest guest]

Dr. Bhate,

There is another issue with the "recreational" ultrasound: what

happens if parents stumble on some visible, horrible defect in the

fetus? I don't think these types of ultrasound are justified, ever.

The overuse of medical ultrasound is another issue and another thing

driving our healthcare costs up and up.

Darla Wells