[ RadSafe ] Human Radiation Experiments --was: Re: Five men and a bomb DRAFT 909 FRI

[Mark Ramsay]

thanks, a really interesting read.

Rgs

mark


Sent from my iPad

On 21 Jul 2012, at 03:29, "Stewart Farber" <SAFarber at optonline.net> wrote:

> 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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