Ethical Questions

[Allan Frey]

The following was published this month. Comments are invited.

Allan

Environmental Health Perspectives, Volume 106, Number 7, July 1998

Ethical Questions on the Use of Magnetic Field Reports=20

Results from National Toxicology Program draft reports on carcinogenesis
and promotion of 60-Hz magnetic fields (1,2) are a mixed bag of apparent
effects in some cases and no effects in other cases. The studies were
carried out, apparently, with the intent to provide information that can
be used in making health policy for humans. I contend that these studies
cannot be used for this purpose because of two implicit assumptions that
were made when the studies were being designed.=20

First, it was assumed that the relevant magnetic field parameter for
inducing biological effects is a pure 60-Hz sine-wave, and such was
used. But the public is exposed to something very different, as the
authors admit (1):=20

"While power line magnetic field exposures are predominantly sine-wave
fields, residential and occupational exposures may include square waves,
sawtooth waves, and other wave forms. Harmonics (120 Hz, 180 Hz, etc.)
may also be found. Further, as appliances are switched on and off,
spikes or transients in fields may occur. It is not feasible to evaluate
all possible variables in large animal studies Therefore, this study
used linearly polarized, pure sine-wave exposures at 60 Hz, with the
fields turned on when the sine wave was at zero amplitude and gradually
increased over seven to nine cycles (between 0.11 and 0.15 seconds) to
full intensity, and similarly gradually decreased to avoid transients.
The NIEHS studies evaluate the predominant component (60-Hz sine-wave
magnetic fields) without all the complexities of the exposures that
occur in residential and occupational settings."

Biological theory, as well as substantial published data, indicates that
the field characteristics which people are actually exposed to, and
which the authors eliminated from their experiments, are the effective
agents (3). Thus, if one wants to use the results of these studies in
setting health policy for people exposed to power line fields, one must
first prove that a pure sine-wave field is the relevant parameter for
inducing biological effects.=20

The second implicit assumption made by the authors was that magnetic
fields are an alien substance, such as arsenic, etc. Thus, they set up
the experiments using a toxicology model--in a dose-response format. In
fact, electrical and magnetic fields are not alien substances; rather,
they are fundamental in the functioning of living organisms. I have
addressed this matter in detail in several publications (3,4). Thus, if
one wants to use the results of these studies in setting health policy
for people exposed to power line fields, one must first prove that a
toxicology model is appropriate.=20

Although the technology in these experiments may be fine, it would not
be ethical to use the results in the formulation of health policy for
the human population without first proving that the implicit assumptions
that were made are true. These comments also apply to other recent
studies, such as the study by Mandeville et al. (5).=20

Allan H. Frey=20
Randomline, Inc.=20
Potomac, Maryland=20
af...@uu.net

References and Notes=20

1. NTP. Toxicology and Carcinogenesis Studies of 60-Hz Magnetic Fields
in F344/N Rats and B6C3F1 Mice (Whole-Body Exposure Studies)-Draft.
Research Triangle Park, NC:National Toxicology Program, 1998.
http://ehis.niehs.nih.gov/ntp/docs/tr488/488full.pdf [cited February
1998].=20

2. NTP. Studies of Magnetic Field Promotion (DMBA Initiation) in
Sprague-Dawley Rats (Gavage/Whole-Body Exposure Studies)-Draft. Research
Triangle Park, NC:National Toxicology Program, 1998.
http://ehis.niehs.nih.gov/ntp/docs/tr489/489full.pdf [cited February
1998].

3. Frey AH, ed. On the Nature of Electromagnetic Field Interactions with
Biological Systems. Austin, TX:R.G. Landes Co., 1994.=20

4. Frey AH. Is a toxicology model appropriate as a guide for biological
research with electromagnetic fields? J Bioelectr 9 (2):233-234(1990).=20

5. Mandeville R, Franco E, Sidrac-Ghali S, Paris-Nadon L, Rocheleau N,
Mercier G, D=E9sy M, Gaboury L. Evaluation of the potential
carcinogenicity of 60 Hz linear sinusoidal continuous-wave magnetic
fields in Fischer F344 rats. FASEB J 11:1127-1136 (1997).=20

--=20
Allan H. Frey Email: af...@uu.net
11049 Seven Hill Lane Voice: 301.299.5181
Potomac, MD 20854, USA

[Paul Heroux]

I agree with you, Allan.

15 years ago, while I was doing research for an electrical utility
(Hydro-Quebec), I promoted the idea that an arbitrary waveform generator
should be purchased, and fitted to an exposure system for biological
experiments in vitro.
In-depth and numerous biological experiments would need to be done over
years, if not decades, to assess EMFs completely.
As part of this admittedly expensive exercise, primarily aimed at assessing
EMF safety, I promoted that engineering should contribute to medicine by
clarifying the parameters of the most efficient EMF signals for various types
of tissue regeneration.
Engineers do not seem inclined to support the long-term work that leads to
scientific progress. Scientific progress is always a long-term exercise
because scientists deal with the unknown. Engineeers are used to dealing with
prepared, applied knowledge.
Thus, electrical utilities went for the "short fix" on EMFs, with work
primarily aimed at "proving" that EMFs are inoccuous, mostly using old
toxicological methods, expected to yield no effects. Another tactic has been
to manipulate public opinion by inciting public declarations from various
professional groups, some of which have been so discredited by attempting to
pontificate outside their own areas of expertise.

You may post this answer on the bionet if you wish.
--
Paul Heroux
McGill Medicine

[Kenneth R. Foster]

Frey's letter, repeated below, is posted on the Environmental Health
Perspectives website at

http://ehpnet1.niehs.nih.gov/docs/1998/106-7/toc.html

But readers should also note the (in my mind very effective) reply by
Boorman that follows Frey's letter.

Clearly, an infinite number of rocks can still be turned over in this
already well-studied field. If Frey thinks that there is something
important remaining to be discovered, he should develop testable (and
falsifiable) hypotheses -- not shift the burden of justifying research
choices onto other people.

>References and Notes=20
>
>1. NTP. Toxicology and Carcinogenesis Studies of 60-Hz Magnetic Fields
>in F344/N Rats and B6C3F1 Mice (Whole-Body Exposure Studies)-Draft.
>Research Triangle Park, NC:National Toxicology Program, 1998.
>http://ehis.niehs.nih.gov/ntp/docs/tr488/488full.pdf [cited February
>1998].=20
>
>2. NTP. Studies of Magnetic Field Promotion (DMBA Initiation) in
>Sprague-Dawley Rats (Gavage/Whole-Body Exposure Studies)-Draft. Research
>Triangle Park, NC:National Toxicology Program, 1998.
>http://ehis.niehs.nih.gov/ntp/docs/tr489/489full.pdf [cited February
>1998].
>
>3. Frey AH, ed. On the Nature of Electromagnetic Field Interactions with
>Biological Systems. Austin, TX:R.G. Landes Co., 1994.=20
>
>4. Frey AH. Is a toxicology model appropriate as a guide for biological
>research with electromagnetic fields? J Bioelectr 9 (2):233-234(1990).=20
>
>5. Mandeville R, Franco E, Sidrac-Ghali S, Paris-Nadon L, Rocheleau N,
>Mercier G, D=E9sy M, Gaboury L. Evaluation of the potential
>carcinogenicity of 60 Hz linear sinusoidal continuous-wave magnetic
>fields in Fischer F344 rats. FASEB J 11:1127-1136 (1997).=20
>
>
>--=20
>Allan H. Frey Email: af...@uu.net
>11049 Seven Hill Lane Voice: 301.299.5181
>Potomac, MD 20854, USA
>

Kenneth R Foster
Department of Bioengineering
University of Pennsylvania
220 S. 33rd St.
Philadelphia PA 19104-6392
215-898-8534
fax 215-573-2071
President IEEE Society on Social Implications of Technology 1997-8
Chair, EMBS Committee on Man and Radiation 1997-
*****************************************************************************
SSIT Website: http://www4.ncsu.edu/unity/users/j/jherkert/
COMAR website http://homepage.seas.upenn.edu/~kfoster/comar.htm
Blurb for latest book http://homepage.seas.upenn.edu/~kfoster/book.htm
Recent Papers http://homepage.seas.upenn.edu/~kfoster/papers.htm

[Allan Frey]

Foster states
>he (Frey) should =85 not shift the burden of justifying research
>choices onto other people.

If the research is to be used to make Public Health decisions, then the
burden is on those who use it to show that it is appropriate for such
use. Is it appropriate to base public health decisions on one treatment
when we know that the public is exposed to another treatment?

For example, suppose workers in a factory are exposed to 120 degree
temperatures and 95 percent humidity. I want to get data to make public
health decisions. I can conveniently set up an experiment in which I
have 65 degree temperatures and 95 percent humidity. I run the
experiment and no one gets ill or dies. Is it ethical for public health
decision-makers to apply the results in the 120 temperature and 95
percent humidity factory situation?=20

I thank Foster for also giving me an opportunity to comment on Boorman's
reply to my published commentary. Boorman says many words trying to
justify the choice of signal that was made; mostly that it was on the
basis of opinions of "experts". But he admits my point; he refers to the
60 Hz sine wave signal that was used as a " candidate exposure
parameter". He thus acknowledges that we don't know if it is the
relevant signal among the various signals to which people are exposed.=20

Physicians do not have a full understanding of cancer genesis and
promotion. So we have one set of unknowns. And then we have another set
of unknowns. We lack measurements of individual residences in the years
before the diagnosis of cancer when the cancer started. We don't know
how well a single current measurement characterizes present exposure,
much less emf exposure years earlier when the cancer presumably started.
We don't know what is the best indicator of emf exposure years ago when
the cancer started or was promoted: is it wiring configuration,
measurement of distance from source, direct measurement of fields, etc.
We don't even know what characteristics of the fields, those many years
ago, were important. Thus, most in vitro studies that have been done may
not be relevant because of the assumptions that were made in designing
those studies. =20

Thus, my question still stands. Is it ethical to use such data as the
basis for Public Health decisions?=20

Allan=20