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God Sharon, I admire your powerful writing and knowledge. I am so proud

of you.

>

> Quote from LAWeekly article:

>

> " Phoenix-based toxicologist Wax, president of the American

College of

> Medical Toxicology, backs up Kelman and Veritox. “Their opinions

are grounded

> in good science. They are not going out on a ledge saying something

without

> support.â€

>

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http://web.archive.org/web/20010414084457/ictm.com/main.html - 12/2/01

INDOOR AIR AND HEALTH: CLEAR-CUT, EQUIVOCAL, AND UNLIKELY

by E. Gots, M.D., Ph.D.

" ...For the most part, hazardous exposures arise from direct contact

with or inhalation of the agents [mold] or their spores. "

---------------------------------------------

In , snk1955@... wrote:

>

> Quote from LAWeekly article:

>

> " Phoenix-based toxicologist Wax, president of the American

College of

> Medical Toxicology, backs up Kelman and Veritox. “Their opinions

are grounded

> in good science. They are not going out on a ledge saying something

without

> support.â€

>

> From a paper Wax published showing where Dr. Wax, Pres of

ACMT, works:

>

> " From the Department of Medical Toxicology, Good Samaritan Regional

Medical

> Center, Phoenix, Arizona.

> Received for publication Jan 16, 2002; accepted Feb 11, 2002. Reprint

> requests to (P.M.W.) Department of Medical Toxicology, Good

Samaritan Regional

> Medical Center, 925 McDowell Rd, 2nd Fl, Phoenix, AZ

> 85006. E-mail: _paul.wax@..._ (mailto:paul.wax@...)

>

>

> Who does Dr. Wax work with?

>

> Wallace, MD, FACMT

> Director of Samaritan Occupational and Environmental Toxicology

Services

>

> _Faculty_ (http://medtoxfellowship.com/faculty/wallace/index.htm)

>

>

>

> Where else does Dr. Wallace work?

>

> VeriTox Biographical Sketches

> L. Wallace, MD, FACMT

>

> L. Wallace, MD, FACMT is Director of Medical Toxicology at

VERITOX®. He

> is board-certified in Medical Toxicology and is a certified Medical

Review

> Officer.

> Who authored the ACMT position on mold and what are it's key

findings based

> upon?

> ACMT position statement on mold:_ACMT Net_

> (http://www.acmt.net/cgi/page.cgi?aid=12 & _id=52 & zine=show)

Prepared by the ACMT Practice Committee. Primary

> authors: Sudakin and Tom Kurt

> Who is Sudakin? See below disclosure for ACMT. He is an

employee of

> VeriTox

>

>

> What did ACMT (that is government funded) use as reference for their

> statement of " not plausible " ?

> Subj: Re: ACMT Position Statement on mold-related illness

> Date: 2/29/2008 12:06:10 P.M. Pacific Standard Time

> From: SNK 1955

> XXXXX_@..._ (mailto:XXXXX@...)

> CC: SNK 1955

>

> Friday, February 29, 2008 AOL: SNK 1955

> Dear Dr. Brent,

> Thank you for your reply. Please call me Sharon. As I am certain

you are

> probably aware, the mold issue can be a rather contentious one. I

hope you will

> forgive me, but I am always very blunt and direct with my

> communications as I find this to be the best way to effectively relay

> information in the fewest words possible.

> There is a problem with your ACMT mold statement in that a key

aspect, used

> by the defense in mold litigation is not the current accepted

scientific

> understanding of the matter. Your paper is being cited by the

defense in mold

> litigation in an effort to defeat a mold toxin injury claims. Both

of your

> authors, Dr. Sudakin and Dr. Kurt are prolific expert witnesses for

the defense in

> such litigation. There are a few areas I could go into detail, but I

believe

> I can explain the problem to you while just addressing one sentence.

> _http://www.acmt.net/cgi/page.cgi?aid=12 & _id=52 & zine=show_

> (http://www.acmt.net/cgi/page.cgi?aid=12 & _id=52 & zine=show)

> " With respect to mycotoxins in indoor air, exposure modeling studies

have

> concluded that even in moldy

> environments, the maximum inhalation dose of mycotoxins is

generally orders

> of magnitude lower than

> demonstrated thresholds for adverse health effects.(3,7,8) "

[implied, in

> humans] In reality, the modeling studies your authors of this

paper, Dr.

> Sudakin and Dr. Kurt, cite have concluded nothing of

relevance in

> understanding human heath effects from exposure to mycotoxins that

are found

> within water damaged buildings. Toxins within water damaged

buildings offer a

> very complex environment. It is not now, nor has it ever been accepted

> scientific methodology to conclude the implausibility of human

illness from exposures

> in such environment by solely using toxicological studies that

examine animal

> and

> cellular models. To only examine one route of exposure to one

mycotoxin at a

> time does not reflect a real world human situation. People are exposed

> simultaneously to multiple myco and other toxins via all routes of

> exposure - inhalation, dermal, ingestion in water damaged buildings.

> To quote a knowledgable friend with regard to only addressing inhaled

> mycotoxins when denying human

> poisoning from the microbial contaminants found in water damaged

buildings,

> " is like focusing on a spark plug to study engine failure when

everything

> from alloys of components, to compression, to fuel is wrong. "

> As is noted in the Institute of Medicine, Damp Indoor Spaces and

Health

> Report,

> _http://www.nap.edu/catalog.php?record_id=11011#toc_

> (http://www.nap.edu/catalog.php?record_id=11011#toc)

> IOM Executive Summary:

> “Toxicologic studies, which examine such responses using animal

and cellular

> models, cannot be used by themselves to draw conclusions about human

health

> effects.â€

> IOM Chapter 4 Mycotoxins

> Summary:

> “Except for a few studies on cancer, toxicologic studies of

mycotoxins are

> acute or short-term studies that use high exposure concentrations to

reveal

> immediate effects in small populations of animals. Chronic studies

that use

> lower exposure concentrations and approximate human exposure more

closely have

> not been done except for a small number of cancer studies.â€

> IOM Chapter 4 Mycotoxins

> Summary

> Considerations in Evaluation of Evidence

> “Most of the information reviewed in this chapter is derived from

studies in

> vitro (that is studies in an artificial

> environment, such as a test tube or a culture medium) or animal

studies. In

> vitro studies, as explained

> below, are not suitable for human risk assessment. Risk can be

extrapolated

> from animal studies to human

> health effects only if chronic animal exposures have produced

sufficient

> information to establish noobserved-

> adverse-effect levels (NOAELs) and lowest-observed-adverse-effect

levels

> (LOAELs).

> Extrapolation of risk exposure from animal experiments must always

take into

> account species differences

> between animals and humans, sensitivities of vulnerable human

populations,

> and gaps in animal data.â€

> In addition, just two months prior to the inception of this ACMT

position

> statement (June 2006), the IOM

> Report was used in a court case in California to have the modeling

theory

> the authors cite as reference in

> support of the sentence discussed, to be disallowed to be presented

before

> the courts on the exact same

> point. The judge called it a " huge leap " to go from a modeling

theory to

> conclude the implausibility of human

> illness from the matter at hand. I would be inclined to believe

that author

> Sudakin was well aware of this

> fact, as it was his employer, VeriTox, whose modeling theory was

disallowed

> and a principal of the same

> company that was testifying as the defense expert, Coreen Robbins

(April

> 2006). The ACMT paper appears

> to be in retaliation and meant to diffuse the usage of the IOM

report when

> your authors are functioning as

> expert witnesses for the defense in mold litigation - as they both

often do.

> As ACMT is partially government funded to advance the understanding of

> poisoning and two of your board

> members are government employees of the EPA and FDA, I am hoping

the matter

> at hand is simply an

> oversight. But, the matter could be viewed as an abuse of taxpayer

dollars

> -an esteemed medical

> association to whom we have outsourced much say in environmental

medicine,

> promoting a litigation

> defense argument not founded upon sound scientific princlples. (my

apologies

> - I told you I was direct)

> The three references cited in support of the statement, " With

respect to

> mycotoxins in indoor air, exposure

> modeling studies have concluded that even in moldy environments,

the maximum

> inhalation dose of

> mycotoxins is generally orders of magnitude lower than demonstrated

> thresholds for adverse health effects.

> (3,7,8) " [implied, in humans] are:

> (3) American College of Occupational and Environmental Medicine.

Evidence

> Based Statement: Adverse Human Health Effects Associated with Molds

in the

> Indoor Environment. 2002.

> _http://www.acoem.org/guidelines/article.asp?ID=52 Authored_

> (http://www.acoem.org/guidelines/article.asp?ID=52 Authored) by Dr.

Sudakin's employer and

> discussed on the front page of the Wall Street Journal (Jan 2007) for

> it's conflicts of interest and science questioned by many -

including a

> co-author of the IOM Report.

> _http://moldwarriors.com/SK/WSJOnlineJan92007.pdf_

> (http://moldwarriors.com/SK/WSJOnlineJan92007.pdf)

> (7) Kelman BJ, Robbins CA, Swenson LJ, Hardin BD. Risk from inhaled

> mycotoxins in indoor office and

> residential environments. Int J Toxicol 2004 January;23(1):3-10.

> Authored by Dr. Sudakin's employer and disallowed before the courts

in April

> 2006 with the IOM Report being the primary document used to

discredit. (will

> attach documentation) The modeling theory of VeriTox has been parroted

> several times, but has never been reproduced to conclude the

implausibility of

> human illness from exposure within water damaged buildings. It is a

novel,

> non-sequitur.

> (8) Islam Z, Harkema JR, Pestka JJ. Satratoxin G from the black mold

> Stachybotrys chartarum evokes olfactory sensory neuron loss and

inflammation in the

> murine nose and brain. Environmental Health Perspectives. [online

Feb 27,

> 2006] Available at _http://dx.doi.org/10.1289/ehp.8854_

> (http://dx.doi.org/10.1289/ehp.8854) . makes the exact opposite

conclusion, stating it has NOT been

> " concluded " mycotoxins within an indoor environment cannot cause

human illness.

> (sorry for the double negative).

> This paper specifically calls out the differences between Sudakin's

employer,

> VeriTox principals Hardin et al, and the IOM Report.

" Incidences of

> indoor S. chartarum contamination often generate costly litigation and

> remediation, are extensively reported by the media, and have evoked

intense public

> and scientific controversy (Hardin et al. 2003). The IOM panel

suggested that

> although in vitro and in vivo research on S. chartarum and its

mycotoxins

> suggests that adverse effects in humans are indeed " biologically

plausible, "

> their association with building related illnesses requires rigorous

validation

> from the perspectives of mechanisms, dose response, and exposure

assessment

> (IOM 2004). "

> While it is scientifically correct to state more research is needed,

such as

> the IOM does, it is not scientifically correct to profess to prove a

negative

> based on incomplete data, such as your ACMT paper does. That is the

primary

> difference between the two papers in regard to human illness from

mycotoxin

> exposure within a water damaged building.

> ACMT reference (8) also specifically states that these authors'

paper is to

> be used for the furtherance of

> understanding satratoxin effects on olfactory and brain injury in

humans

> exposed in water damaged

> buildings. This in no way supports the proposition that these authors

> believe modeling theories have concluded the implausibility of an

unachievable

> threshold level of mycotoxins within an indoor environment before

symptoms

> indicative of poisoning occur in humans. These authors clearly

state that dose

> response in

> humans and therefore relevant threshold levels are yet to be

determined.

> " Taken together, our observations that the OE and OB are targets of

SG and ISF

> should be a critical consideration in future studies of

damp-building-related

> illnesses and the potential etiologic role of S. chartarum. The

profile of

> induced cytokines and MIP-2 is likely to contribute to OSN

apoptosis as well as

> accompanying rhinitis and mild focal encephalitis observed in the

present

> study. In the future, it will be necessary to ascertain the

dose-response

> effects and latency of recovery in nasal tissue after chronic

exposure to

> satratoxins alone, as well as the contributions of spore matrix, or

coexposures to

> other indoor air contaminants such as endotoxin. "

> I am in San Diego. I understand your upcoming meeting is in San

Diego in

> March. I also understand there will be a meeting of the ACMT Board

members. If I

> could, I would like to come speak before your board about

> retracting this paper from being a position statement

representative of the

> members of ACMT. It is harmful to

> those who are being made ill from mold exposure within an indoor

environment

> and are exhibiting symptoms

> indicative of poisoning. And it is contributing to the promotion of

> misinformation over an already complex and

> confusing issue.

> Thank you for your consideration of the matter. Should you require

more

> documentation or have questions,

> please do not hesitate to ask.

> Sharon Kramer

> Attachments: -Frye Ruling, Harold Case, Brief and Supplemental

Brief.

> Disclosure: I am currently in litigation with the principals of

VeriTox, Inc

> and their President, Bruce Kelman.

> They have sued me for libel for five words " altered his under oath

> statements " . Nothing more. The matter is

> currently in the courts. You can read of the case, my writings and the

> testimony in question at:

> _http://moldwarriors.com/SK/index.htm_

(http://moldwarriors.com/SK/index.htm)

> Below is an overview of the California -Frye ruling as

published by

> Mold Columns:

> Mold Columns

> Publishing

> May 25, 2006

> ....Defendants called Saxon, M.D., of UCLA Medical School;

and Coreen

> A. Robbins, MHS, Ph.D., CIH

> of Veritox in Redmond, Wash.

> Robbins countered plaintiffs’’ experts’ opinions on mold

hazards and the

> remediation procedures and opined that the couple could have moved

back into the

> house after Westmont’s repair work was completed.

> Judge Kenney held a -Frye hearing before trial and limited

Robbins’s

> testimony by precluding any reference to animal studies of mold

hazards.

> Reviewing Robbins’ deposition testimony, Judge Kenney concluded

that the

> basis for her testimony on

> mycotoxins and human exposure was a literature review, which he found

> insufficient.

> 'Also, when I reviewed the DHS report from April of 2005, DHS,

Department of

> Health Services was talking

> about the fact that they were unable to establish personal exposure

levels

> at this point in time based on a lack of sufficient information,

and yet Dr.

> Robbins is asking to take an even greater step and go beyond

establishing, for

> example, a personal exposure level and jump to modeling, which is

far more

> tenuous and far more unreliable even in establishing something that

is as hard

> as a personal exposure level. So those are the difficulties I’m

having with

> Dr. Robbins’ testimony,' Judge Kenney said. The judge said that

he is

> familiar with the use of animal studies and derivative models for

humans and that

> such models are commonly accepted in the scientific community, but

he said he

> is not sure such models for mycotoxin exposure would pass a

-Frye test

> for admissibility.

> 'My fundamental problem is in looking at it from a Frye

standpoint I

> just didn’t see kind of acceptance in the scientific community

with regard to

> what she had done that would allow it to be sort of presented as

such,' Judge

> Kenney said. 'Modeling has severe limitations, and one of the

difficulties I

> was having here was this reliance upon animal studies to jump to a

modeling

> conclusion generally with †" again, I’m speaking from my own

experience

> because there is nothing here in this transcript †" generally one

will use the data

> that one can receive either from animal exposure studies or other

information

> to then input in a model to make a determination with some degree of

> reliability,' the judge continued. 'Here I’m not hearing any of

those things. I’m

> hearing essentially this jump from a literature review to a

postulated model

> to a no harm result "

> In a message dated 2/29/2008 7:14:35 A.M. Pacific Standard Time,

> XXXXX_@..._ (mailto:XXXXX@...) writes:

> Dear Ms. Kramer,

> I understand that you have been calling ACMT regarding the above

position

> statement. Your calls have

> been referred to me since I am the current Chair of the Practice

Committee,

> from which the Position

> statement was derived, although I was not the committee Chair at the

time

> the mold document was

> generated I would be very happy to look into any concerns that you

have

> about our Position Statement. If you would be kind enough to send

me your

> specific concerns in writing I will investigate them and to get

> back to you.

> Best regards.

> Brent, M.D., Ph.D.

>

>

>

>

>

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