DIOXIN DOSE RESPONSE - IS IT REAL?
Sent in by our neighbor to the north in Canada, Kelly Franklin
Time to Update Environmental Regulations
“Should public health standards for endocrine-disrupting compounds be based upon sixteenth century dogma or modern endocrinology?” by John Peterson Myers, PhD, and Fred S. vom Saal, PhD
Does 'the dose make the poison?'
Extensive results challenge a core assumption in toxicology by Pete Myers, Ph.D. and Wendy Hessler
http://www.environmentalhealthnews.org/sciencebackground/2007/2007-0415nmdrc.html
“…some pollutants, drugs and natural substances don't adhere to this logic, as can be seen in the photograph above. Instead, they cause different effects at different levels, including impacts at low levels that do not occur at high doses. Sometimes the effects can even be precisely the opposite at high vs. low. Because all regulatory testing has been designed assuming that "the dose makes the poison," it is highly likely to have missed low dose effects, and led to health standards that are too weak.”
My comments;
As you read the above links, bear in mind that dioxin even at the highest levels of concentrations do not seem to be classified as a poison per se. Yet, we know for the herbicide Veteran, toxicology is being evaluated that way by VA and IOM and then the Veteran is denied for many many issues that are not dose responsive.
We all know, or should know, of the fatal flaws of the Ranch Hand Study in assuming cohorts that were included in the non-exposed group but were in fact exposed.
In addition, we know from Congressional transcripts that Dr. Chan, Kwai-Cheung, Director, Special Studies and Evaluations, National Security and International Affairs Division, General Accounting Office testified when discussing the Ranch Hand Study and I quote; “If we find there's a correlation, we then want to make sure that there is a statistically significant relationship. Once we have that, we want to make sure there's a linear dose response. That means the more stuff you have the worse you get... We want to establish cause-and-effect.”
That, as these articles conclude, is not the way to look at toxicology. While it may apply to some toxic chemicals that do not have the in-body persistence over life at very low (minuscule) levels of dioxins; it does not apply to dioxins and dioxin-like furans.
He also testified; “there’s a fundamental problem between the gathering of the scientific evidence and research in general, versus policymakers in terms of their intent.”
And therein lays the problem. For 40 years Veterans have suffered for this philosophical difference between what science wants, to make a life time career of study after study until “cause and effect” are established, and what Congress, tasked with making a decision knowing there are too many unknowns and considering the current state of science, says it wants for the Veteran.
The government by its own admission, after 25 years of flawed assumptions and analysis, still wants to establish cause and effect. The Courts ruled cause and effect is not required, that only a significant correlation of increased risk is needed to establish Service Connection and that was the intent of Congress. However, the Department of Veterans Affairs and the IOM continue to ignore Congress, which has not provided the proper challenges or oversight. The Department and the IOM also continue to ignore the Courts, which have not provided Veterans remedies for what has gone on for the last 40 years, and what is worst of all, they continue to ignore science, and while searching for cause and effect have denied dying and disabled Veterans their benefits.
As one of our research comrades put it just today:
‘I’d just like to point out that in the USEPA’s 2nd Reassessment of Dioxin, begun in 1991; researchers George Lucier and Chris Portier for NIEHS “suggested that there was no threshold for some of dioxin’s effects.”’ In addition, new research suggested that “dioxin acted like a hormone, disrupting many systems in the body.” This information, and much more was compiled in a 91 page report prepared by the Center for Health, Environment and Justice (CHEJ) dated November 1999 called The American People’s Dioxin Report. I also included Dr. Lucier comments in a report given at a Public Hearing of the NAS/IOM in September 1992.
The EPA has also concluded that for some disorders dose responses do not exist.
I’ll restate my position. We no longer need to review these studies or seek new articles relating to our position as veterans exposed to herbicides. The proof is already there and we still waste time in looking at these reports. We’re being buried in what the government and the chemical industry wants to happen - continued reports, epidemiological studies, dose responses, risk management, exposure models, ad infinitum. Studies have been done in New Jersey, Michigan, Massachusetts, West Virginia, Wisconsin, Missouri, The Netherlands, Italy, Sweden, Denmark World Health Organization (IARC), National Toxicology Program, NIEHS, USEPA, NIOSH, and on and on. Why do more? The government chooses to believe the flawed CDC and USAF Ranch Hand Studies so they may deny Veterans and their families.
While a government entity and government contractor (DVA, NAS/IOM) denies Veterans compensation based on some impossible unproven linear response and some manipulated exposure index, another government body, the real toxicology experts (EPA) says there is no dose response to certain medical issues, even if the damaging process is identified. The damaging process goes in a radial direction to affect multiple systems and multiple organs.
More than that, the Seveso dioxin disaster, which had a central distribution point, investigating scientists found to their own surprise that some cancers as well as AML were observed more in Zone R, the least exposed, than in Zone A + B. For STS and esophageal cancers statistical significant increases were only found in Zone R; the least contaminated.
Trying to fight the establishment on these exact issues is not a new subject to me. The VACEH which operated from 1979 to 1991 also seemed to be less than objective taking these same extreme views (e.g., with respect to the role of dose-response testing). These views were used as tool for 12 years to deny Veterans and their Widows. The VACEH was finally abolished for its prejudicial philosophy as it applied to the fundamental principle of finding in favor of the Veteran, but it was replaced by the IOM from 1991 to present with what looks like the same flawed philosophy and prejudices.
While dose-response is important, what is more important is the method of ingestion, rate of ingestion, length of ingestion, and exposure to other amplifying and synergetic toxic chemicals which impact the vast variety of epidemiological consequences.
Synergistic Responses:
“When two or more hazardous material exposures occur the resulting effect can be greater than the effect of the individual exposures. This is called a synergistic or potentiating effect.”
Since Vietnam veterans were exposed to so many different chemical compound mixtures, the effects on us were greatly amplified and much greater than medical issues created by a single chemical or single chemical exposure.
Agent Orange and Agent White when mixed together, then ingested via air, food, water, and skin, had to be one of the most toxic carcinogenic cocktails ever designed by mankind. Someone must have been on drugs or sniffing glue to not realize that they were creating such highly toxic mixtures. Maybe they stood too close to the mixing beaker for too long. Then add in arsenic-based cacodylic acid and Dapsone and it is a wonder any exposed Veteran is still alive.
Other Factors Affecting Toxicity:
“Rate of entry and route of exposure; is, how fast the toxic dose is delivered and by what means. Age can affect the capacity to repair tissue damage. Previous exposures can lead to tolerance, increased sensitivity, or, make no difference. State of health, physical condition, and life style can affect the toxic response. Pre-existing disease can result in increased sensitivity. Environmental factors such as temperature and pressure may also affect the exposed individual as well as other host factors, including genetic predisposition and the sex of the exposed individual.”
IOM compares studies that are not representative of the Herbicide Veterans
Experience and says; ‘see no problem was found as to an association.’
These decisions are made by using a gold standard assessment which is totally flawed, meaning it has "multiple flaws" as applied to any and every assessment, while Veterans have no recourse, no real legal channel to confront the assessment’s validity or the guilt, innocence, collusion or fraud of the other party.
If one takes a group of Veterans and performs a serum test for dioxin or adipose tissue tests for dioxin (which I am still not convinced are equal in actual real time body burden) to measure forty year after exposure from 10 parts per thousand (ppt) to 45 ppt residual levels, what are the results? Those that were less than 2.5 ppt to 5 ppt are discounted because of some mistake of, as the articles suggest, low levels could not cause any or minimal harm even with the persistence in the body over life.
What is really accomplished if one does not know the many issues discussed above as they relate to the effect of toxic chemicals on the human body. Does measuring a single dioxin dose 30 years after the fact in and by itself conclude the ingestion rates or methods of ingestion or the synergistic effect of a contaminant? Does measuring a single dioxin dose 30 years after the fact tell the story of the individual’s health at time of exposure, or his or her predisposition, sensitivity, or lack of sensitivity?
On top of all this, the comparison group, which was not ever supposed to be exposed but served in country in the same area(s), was used when many were also sick.
Adding to this is the fact that testing was random, for a single dioxin of many, and that other toxic chemical contaminants were part of the Vietnam Experience but were excluded; or was only random testing due to the cost of benefits for medical anomalies that could have been identified in X % of both groups.
What if anything does this study prove? After considering the scientific data, not much other than we have two cohorts who served in Vietnam whom we know were exposed to herbicides (plural) and by a ratio of five to one are sicker than others that did not serve with various medical anomalies.
Then we have the IOM stating in reviewing studies that the study did not state how they characterized the exposed levels. I would ask given the above and the articles; what difference does that make. If they were exposed in any way shape or form and we know they were exposed and levels do not seem to have some threshold response, who in actuality cares? It only matters if the DVA/IOM wants to use it as some denial tool for the Veterans/Widows/Orphans.
We do not have a factory full of pristine biologically characterized Veterans waiting to be tested to destruction based on various dioxin levels to satisfy the VA/IOM to meet some dose response that does not even exist according to some and only one study with a central distribution point that could even be possibly correlated to some form of dosage that clearly found in some cases “the lower the dose was the more detrimental both in specific medical conditions as well as increased risk of other medical conditions found in the heavier areas of contamination.
The only way to do these studies with all the known and unknowns is by comparing the medical outcomes of those that served in Vietnam regardless of MOS and those that did not serve in Vietnam or spray chemicals with some sort of blind medical evaluation such as done by the Koreans, preferably with the statistics done by an outside house and not part of the study.
http://www.2ndbattalion94thartillery.com/Chas/Impact%20of%20Agent%20Orange%20Exposure%
Remember this is a snap shot in time of persistent toxic chemical effects of those that were have known to have served in toxic chemical areas, called Vietnam.
Being a snap shot in time of a persistent toxic chemical even a close significance should be considered a trend and therefore approved as herbicide associated or strictly service in Vietnam associated. We already have VA precedence’s for this kind of pronouncement and therefore it is “Service Connected.”
Example:
In the non Vietnam Veteran group N number found of a particular testing anomaly or condition = 0 found.
In the Vietnam Veteran group N number found of a particular testing anomaly or condition = 11 found
This was in confirmed Parkinson’s disease.
While the p value of difference did not meet the Holy Grail of p – 0.05 while it did demonstrate a p value of p – 0.1830 which clearly demonstrates an increased risk of incidence from either service in Vietnam or Service in Vietnam in a toxic chemical environment. Does it really make a difference to those men who now have Parkinson’s or their widows? I doubt it.
Considering that we are discussing a degenerating disorder that only shows up when manifestations are observable does anyone really think the p value of 0.1830 will remain in another 10 years and not diverge towards a more significant p –value such as p<0.05? While the N number of 0 may rise some in the non-Vietnam Veteran the prediction must be the trend will diverge not converge. Considering you include those that are going to pass away from this disorder and not just do another snap shot in time as all the Vietnam Veterans are already dead and gone. That also seems to be a nice touch on the part of our government.
Example:
In the non Vietnam Veteran group N number found of a particular testing anomaly or condition = 1 found.
While in the Vietnam Veteran group N number found of a particular testing anomaly or condition = 75 found
This was in confirmed Brain Infarctions.
In this case the p value of difference did meet the Holy Grail and did demonstrate a p value of difference of p – 0.0013; it clearly demonstrates an increased risk of incidence from either service in Vietnam or service in Vietnam in a toxic chemical environment.
Once again the trend found would be expected to diverge even further rather than converge, since this is just a snapshot in time, it is at least as likely as not demonstrating the degenerating effects on the Herbicide Vietnam Veteran regarding brain infarction clearly demonstrating an increased risk of incidence, which is what Congress and our Courts said is all that is required; regardless of some dose response. Denied by DVA/IOM, of course it is.
Kelley