[ RadSafe ] Human Radiation Experiments --was: Re: Five men and a bomb DRAFT 909 FRI
Stewart Farber
SAFarber at optonline.net
Fri Jul 20 21:28:32 CDT 2012
Hello,
Regarding the preceding comments Rob Gunter about protocols for human rad
experiments, and claims made by some about "rogue scientists", the
following history may be of interest. In some human rad experiments there
were clearly unethical behavior by later standards, but someone approved the
research with an objective of learning something -even if poorly conceived.
I think the following history of consideration in the recent past [if 1995
forward can be considered recent] of human rad experiments may be
informative to many, in part due to the specific rad treatment discussed
having been judged by the government panel tasked with reviewing human rad
experiments to have the highest cancer risk of any human experiment
--greater than the Pu injections, greater than experiments involving
prisoners having their testicles x-rayed [voluntarily to gain some extra
prison "privileges" ], or the overall average excess cancer risk of the
Atomic Veterans. Plus NRI was the only radiation experimental treatment
which exceed the threshold for medical notice, and follow-up. Plus after
WWII the rad treatment involved exploded into common use as a "standard
medical practice".
Excuse the length of the following, which grew longer as I started thinking
again about an issue I had largely put behind me. My Facebook profile has
among my basic information: "Don't get me started [you'll be sorry --I can
be totally insufferable". ] How true.
My apology. If not interested in this subject, please pass it by, or simply
delete. Please don't spend your time criticizing me if you consider it too
long, or irrelevant. I began to write this up not just as a note to Radsafe,
but hope to use the info below as a review for other audiences.
The radium rad treatment reviewed here was ultimately used not just in human
experiments, but in a very ill-conceived standard medical treatment on no
fewer than 500,000 US children from post-WWII through 1961 per an estimate
from a published CDC estimate when they were forced into considering the
issue by Senator Lieberman [D-CT] after a US Senate hearing he organized on
Nasal Radium Irradiation [ NRI ] in 1994. The practice continued in use far
beyond 1961 in some locations based on about 1,000 people, mostly from the
Baltimore area, who contacted me after the Advisory Committee Committee on
Human Radiation Experiments [ACHRE ] report was issued. [See info below
about the ACHRE committee]
This radiation treatment, initially experimental, was called Nasal Radium
Irradiation -NRI. A commercially manufactured sealed Ra-226 source [50 mg
Ra-226, encapsulated in a 0.3 mm monel metal tube] was inserted through the
nostrils [bilaterally]. After the 6" rod with Ra-226 sealed source at the
tip was guided through the nasopharynx, the tip was positioned at the
opening of the Eustachian tube. A typical "course" of treatment being 3 or
4, ten to 12 minute treatment, with the goal of shrinking the adenoids to
promote pressure equalization between the middle ear and nasopharynx. The
0.3 mm monel encapsulated source [rather than 0.5 mm Au or Ag as typically
used in cancer therapy] was used to maximize penetration of the more
energetic betas --resulted in contact doses of about 20 Gy in a standard
course of treatment.
In Jan. 1994 President Clinton established, via Executive Order, "The
Advisory Committee on Human Radiation Experiments" [ACHRE].
ACHRE included 14 supposed experts in various aspect of human rad
experiments, a committee headed a bioethicist, with members including a
radiologist, statistician, dosimetrist, and 10 others. This group had a
well-funded Staff and ended up spending about $14 million and reviewed about
4,000 "human rad experiments" initially funded by the US Government. ACHRE's
task was to identify experimental groups which may have suffered harm from
the experiments, which the Committee decided up front would be defined as a
1 in 1000 chance of dying of excess cancer from having received the rad
exposure. Other potential health effect from the rad exposure were ignored.
In Aug. 1995 ACHRE issued a 500 or so page "Final Report on Human Radiation
Experiments" to President Clinton in a ceremony in the White House Rose
Garden. Unfortunately, the ceremony and report received little attention on
the day it was presented, because the presentation was on the day of the OJ
Simpson verdict which was obviously much more important to the media than
the risk and ethics of exposing US citizens in 4,000 Government sponsored
experiments. A day or two after the OJ verdict, the ACHRE report was old
news to most in the media.
I had frequent dealings with ACHRE starting in 1994 - 1996 as an outside
private public health scientist concerning both Army Air Force [AAF]
crewmembers and Navy Submariners who were members of two human experiments
performed under US Government funding, and one experiment performed on
children.
To me, the important issue at the time was not to simply criticize past
practices in human rad experiments as being unethical [because in the
military rad treatments were done as part of a WWII wartime need] and
dangerous, but what should be done in the present by the Navy, Air Force,
VA, DoD, and CDC to provide proper identification and medical surveillance
for individuals who were at risk based on current knowledge about potential
harm. And there was as of 1994 good epidemiological data that these test
subjects were part of a "special population at risk" with significantly
elevated risk of brain tumors, various cancers of the head and neck, and
other non-malignant conditions such as a RR for Thyrotoxicosis of 8.8 [due
apparently to irradiation of the pituitary, and the pituitary releasing an
excess of Thyroid Stimulating Hormone -TSH]. I had published a
letter-to-the Editor of The New England Journal of Medicine [ titled "Radium
Exposure in US military personnel Vol. 326 [1]: p. 71-72; Jan. 2. 1992 ]
before the intensive review of Human Rad Experiments was initiated 2 years
later by the ACHRE.
In my NEJM letter, I called for a "formal program for the identification and
medical surveillance" of 5,000 estimated [before the practice was ended]
Navy submariners who received NRI treatments from 1944 into the 1960s. The
Navy Bureau of Medicine and Surgery claimed in their 1992 concurrently
published reply to my letter in the NEJM, that the military personnel
irradiated trainees treated with NRI in the initial experiment had a "right
to privacy" rather than a "right to know" as I had written, given that they
were potentially at risk.
The Navy reply in 1992 about initial human experiments on submariners, and
the testimony of the Navy Surgeon General [as well as the then Air Force
Surgeon General] in Aug. 1994 before a US Senate hearing organized by Sen.
Lieberman [D-CT] were not just unethical, but in my opinion reprehensible
and even illegal. It was not just a conscious "failure to warn" in the
present, but an attempt to distort the state of present knowledge of
radiation risk related to a NRI treatment the submariners and aviators
received by Government initiative.
The Navy refused to even admit from 1992 to 1994, after my initial letter to
the NEJM, that the initial treatments were experimental, something confirmed
in 1995 when I obtained stacks of internal Navy documents. My local US
Senator John Chaffee [RI-R] at the time, and former Sec. of the Navy under
Nixon who I had discussed the NRI issue, and took an interest in it because
of the submariner link, ordered a Senior Admiral in 1994 to turn over any
documents I requested with no delay. It helped thay Chaffee had a
significant role in approving budgets for the military through his position
on a Senate appropriations committee.
After I asked for certain documents, and with the clout of Sen. John
Chaffee, I quickly received a stack of internal Navy documents about a foot
high, about the Navy's involvement with NRI. I did not have to file a FOIA
request which would have taken forever, and most likely would have proven
fruitless. In reviewing these internal documents on NRI, I found the
protocol [Navy Research Project X-434] and the doctor's hand written logbook
for the first submariner NRI experiment carried out in 1945.
The ACHRE tried to ignore NRI, both in the Navy sub service and AAF, and in
an experiment on Baltimore children, in its deliberations for some very
unethical and self-serving reasons too complex to review here. Nonetheless,
I was able to force this experiment onto the agenda of ACHRE though an
initiative I organized on behalf of vets and children who were treated in
large numbers with NRI. In the end, in its Final Report in 1995, NRI was
calculated by ACHRE to have the highest risk to health of any of the 4,000
human rad experiments it reviewed. I authored a Commentary on NRI to the HPS
Newsletter titled "Assessing the Effects of Nasal Radium Treatment"
published June 1995.
I mention the above because as I wrote in my HPS Commentary:
"Initial nasal radium experimental subjects don't match the media
stereotyped 'human radiation experimental subjects' popularized last year.
Experimental [and later clinically] treated subjects were not poor,
minority, or retarded patients , or prisoners treated in secret by seemingly
'mad' scientists, but the 'best and the brightest' of US servicemen'..."
The initial experiments were not secret but performed openly and promptly
reported in the open medical literature in 1945 and 1946". The experimental
treatment of 7,613 AAF crewmembers in 1944 [at bases all around the world
from which bombers and fighter plans departed or trained], according to the
published paper were reported in the literature:
Anonymous.The use of radium in the aerotitis control program of the Army Air
Forces. Annals of Otology, Rhinology, and Laryngollogy. 54:650-724;
1945
The NRI experimental treatments were performed on AAF personnel because, for
example one of 3 men coming back from bombing runs over Europe ended up in
the Infirmary due to serious complications from their inability to equalize
pressure to the middle air. It was a wartime emergency and I don't know how
much was shared with the servicemen about the nature of the radiation
exposure, or its potential risks which were poorly understood. The major
concern at the time was beta burns to the tissue near the Eustachian tube
[total dose of 20 Gy to the nasopharnx], not long term cancer risk which was
not considered--although a few forward looking scientists did warn about
potential long-term cancer risk starting in 1948.
A similar, but very carefully designed experiment [ the Navy Project X-434 ]
was performed starting in 1945 before the end of WWII on about 800
submariners. Submariners were all volunteers. If they could not equalize
pressure in a challenging pressure test, they could not serve. Pressure
equalization ability was critical in the diesel subs of the day because when
the sub was submerged but near the surface, the snorkel was extended and the
diesel engines were drawing air through the snorkel. If a enemy plane or
ship was spotted they would immediately dive and the cover on the snorkel
would slam shut while the air intake pumps were still running. Failure to be
able to equalize pressure could lead to immediate bursting of eardrums --so
no submariner could serve without open Eustachian tubes, and swollen
adenoids prevented this. Thus the experimental program was initiated in 1945
[after the irradiator design was perfected by Johns Hopkins] in Groton, CT
to test the effect of using Ra-226 sources to shrink the adenoids. This
experiment was also promptly reported in the open medical literature. See:
Haines, H.L; Harris, J.D. Aerotitis media in submariners. Annals of Otology
Rhinology, and Laryngology. 55:347-71; 1946
There was also a US gov't sponsored experiment on about 500 Baltimore 3rd
graders [in the fall of 1948 ] conducted by Johns Hopkins and followed
through 1953 to study hearing loss with and without NRI treatments. This
study involved using dummy applicators on a group of controls, and NRI on
the treated group to determine enlarged adenoids and treatment with NRI
might limit middle ear infections in young children [otitis media] and
greater hearing loss. Based on later [1979 Ph.D thesis at Johns Hopkins
School of Public Health] actual epidemiological data this group of Baltimore
children would have a risk of developing fatal brain cancer alone of
8.8/1000 vs. 1/1000 -- the level chosen by ACHRE for medical notice and
followup. NRI irradiation of children This group of NRI treated children
was judged by ACHRE to have the highest risk of cancer death of any of the
4,000 human experiments it reviewed. The risk of cancer death to the NRI
experimental group was THE only group to exceed the pre-selected threshold
for medical notice and followup [ 1 death per 1,000 treated ] which they
had expected no experiment would exceed. However, the risk of cancer death
was 8.8 per thousand just for brain cancer. Nonetheless, the ACHRE refused
to recommend any medical notice or follow-up for NRI treated children.
If you want to read about the ACHRE ignoring the NRI treatment of children
because they carried out the experiment and wanted to deny it was a problem,
see a copy of Testimony I presented to the so-called Glenn Committee --the
US Senate Committee on Governmental Affairs on 'Human Radiation Experiments'
======================================
http://farber.info/reap/sgovt0396.html
"NASAL RADIUM IRRADIATION
& THE ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS-- A FAILURE OF
PROCESS:
BAD SCIENCE
BAD MEDICINE
BAD ETHICS"
Testimony submitted to a Hearing of the US Senate Committee on Governmental
Affairs on 'Human Radiation Experiments'
Washington, DC
March 12, 1996
=====================================
The above testimony I prepared, documents in detail a total breach of ethics
by the ACHRE which in refusing to act honestly about NRI irradiation of
Baltimore schoolchildren violates their charter, and basic principles of
warning a group of people who may be at risk. In this case the NRI
treatments were administered by Johns Hopkins in 1948 and despite the
charter of the ACHRE to right the wrongs of the past, and to bring good
science and ethics to righting the wrongs of the past, the ACHRE ignored
the only rad experiment that exceeded their threshold for medical notice and
follow-up. Their vote to not provide medical notice and follow-up for the
NRI treated schoolchildren was 13-l. The one committee member voting for
notice was Dr. Eli Glatstein, the only medical doctor on the committee.
Opposition to medical notice and follow-up of the NRI child experimental
subjects in Baltimore treated by Johns Hopkins physicians was led by the
ACHRE Chairman, Dr. Ruth Faden, then head of bioethics at Johns Hopkins
School of Public Health who failed to recuse herself from a vote on an
experiment conducted by Johns Hopkins. So much for ethics.
In the end, the ACHRE vote to ignore medical notice and follow-up of
Baltimore schoolchildren, despite the elevated risk justifying such notice
came down to the following. When I asked Dr. Glatstein, why the 13-1 vote
of the ACHRE for no notice and followup was so strongly against his
recommendation to do so, he said the Committee could not bring itself to
vote in favor of medical notice and follow-up of the NRI treated children,
because he said:
"It was not considered acceptable in today's political climate."
When I asked him why he did not file a Minority Report putting his opinion
into writing in the Final ACHRE report that the Baltimore experimentally
treated children in 1948 deserved medical notice and followup, as he clearly
stated in a publically available internal Committee memo, I had obtained, he
stated:
"You have to remember Mr. Farber. I was appointed by the President to serve
on this Committee, and it's not considered polite to make waves."
So much for the ACHRE righting the wrongs of the past and doing the right
thing. In the end, the conclusions and recommendations of ACHRE were
politically expedient and aimed at protecting Johns Hopkins from
embarrassment for conducting experiments in the past that put a group of
children at risk and developing the radium irradiator, and popularizing NRI.
The Committee simply chose to ignore their findings, and their mission
statement. The ACHRE process turned out to be a farce.
The government threw some money to compensate the Pu injectees or their
families, but ignored the NRI experimentally treated children group with a
much greater risk of cancer mortality. If the ACHRE had recommended notice
and follow-up for the 500 Baltimore 3rd graders treated in 1948 [ who at the
time would be about 55 y.o. ] this would have raised serious questions about
the hundreds of thousands of children across the US who were treated with
NRI as "standard medical practice' after WWII into the 1970s
I was told during this period by an internal contact in the CDC why the CDC
choose to do essentially nothing on the NRI issue. This contact I had within
the CDC told me that the CDC wanted to ignore the NRI issue because if they
did what was warranted:
"It would upset their current research priorities."
The CDC was much more focused on spending $ tens of millions on scaring the
nation about the "downwinders" from Hanford and elsewhere, than in dealing
with a group of about 500,000 NRI treated children who had a much greater
risk of thyroid disease from the direct radiation exposure from inserting a
50 mg Radium source, bilaterally, up a child's nose for a total of 40 min [
four 10 min treatments x 50 mg = 2 gm-min in the older parlance]. Also with
NRI there was strong evidence of an excess risk of a variety of head and
neck cancers and issues related to the high dose to the pituitary in a child
[average age 8], but much younger in many cases.
If you want to read some more background on the NRI issue, take a look at an
Annotated Bibliography I had begun back in the late 1990s. I have not
maintained it, but many of the links still work, and the references can be
obtained through your library. I had established an entity in the mid-1990s
which I called: the "Radium Experiment Assessment Project" [REAP]. The link
to the REAP early Bibliography is at:
http://farber.info/reap/default.htm
Thanks for reading this far if you have had the interest and energy.
Best,
Stewart Farber, MSPH
Farber Medical Solutions, LLC
Bridgeport, CT 06604
SAFarber at optonline.net
203-441-8433
==============================
On Wed, 18 Jul 2012 13:50:44 -0400, Thompson, Dewey L
<DThompson3 at ameren.com> wrote:
>
> --------------------------
> Sent using BlackBerry
>
>
> ----- Original Message -----
> From: radsafe-bounces at health.phys.iit.edu
> <radsafe-bounces at health.phys.iit.edu>
> To: 'The International Radiation Protection (Health Physics)
> Mailing List' <radsafe at health.phys.iit.edu>
> Sent: Wed Jul 18 12:19:43 2012
> Subject: Re: [ RadSafe ] Five men and a bomb
>
> Greetings All,
>
> Having spoken with some of the individuals working on these projects they
> point out that there were always protocols. It is just what are they?
> Who
> is on the panel? And what are the limits?
>
> It has been pointed out to me that it was rare, if ever, there were
> "rogue"
> scientists doing this. It was an extension of Government policy and
> authorized at various levels. It is convenient to look back and say "how
> terrible", but at the time there were other factors under
> consideration. Do
> you think these same decisions would be made today? I am not so sure
> they
> would not, but it depends on the circumstances.
>
> Don't flame me on this, I am just pointing out that nearly all of this
> was
> authorized at various levels and am not so sure it would not be repeated
> if
> necessary.
>
> All the more reason for diligence.
>
> Robert J. Gunter, MSc, CHP
>
> -----Original Message-----
> From: radsafe-bounces at health.phys.iit.edu
> [mailto:radsafe-bounces at health.phys.iit.edu] On Behalf Of S L Gawarecki
> Sent: Tuesday, July 17, 2012 10:13 PM
> To: RadSafe
> Subject: [ RadSafe ] Five men and a bomb
>
> There is some amazing footage in this article:
>
http://www.npr.org/blogs/krulwich/2012/07/16/156851175/five-men-agree-to-sta
> nd-directly-under-an-exploding-nuclear-bomb
>
> It was particularly interesting to me, as I recently finished reading
> "The
> Plutonium Files" by Eileen Welsome, an undertaking that took me a couple
> of
> months. One can't help but cringe at the abuses perpetrated under the
> guise
> of science and national security. Not only does she document the
> experimentation on unknowing medical patients, she also chronicles the
> unprotected exposure of soldiers and sailors to radiation and fallout
> from
> atomic explosions (as in the video).
>
> The good news is that we now have protocols that must be followed for
> protection of human research subjects, and of course strict radiation
> protection standards.
>
> Susan Gawarecki
> _______________________________________________
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