Want to show you some close associates from the LA Weekly Article

[Guest guest]

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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