Hardin, Kelman, Saxon reply to JACI regarding ACOEM Mold Statement

[Guest guest]

To the Editor:

The September 2006 issue of the Journal included a series of letters

commenting on the American Academy of Allergy, Asthma and Immunology (AAAAI)

Position

Statement, “The Medical Effects of Mold Exposure.†Responses were made on

behalf of the AAAAI and the authors of the Position Statement. One letter_1_

(http://www.jacionline.org/article/PIIS0091674906020185/fulltext#bib1#bib1)

offered no scientific critique of the AAAAI statement but instead criticized an

earlier Evidence-Based Statement issued by the American College of

Occupational and Environmental Medicine (ACOEM)_2_

(http://www.jacionline.org/article/PIIS0091674906020185/fulltext#bib2#bib2) and

its authors. As the authors of

that statement, we feel a response is appropriate. We respond as individuals

and not as representatives of either ACOEM or the AAAAI.

Kilburn et al_1_

(http://www.jacionline.org/article/PIIS0091674906020185/fulltext#bib1#bib1) are

wrong when they assert that the ACOEM Statement was “

based solely on the mathematic extrapolation from a single rat study.â€

An actual reading of the ACOEM statement will show that most of the

literature cited pertains to human beings, although it also contains

calculations

made to estimate airborne spore concentrations that would be comparable to

exposures in inhalation studies of purified T-2 toxin (rats, mice, and guinea

pigs)_3_

(http://www.jacionline.org/article/PIIS0091674906020185/fulltext#bib3#bib3) ,

_4_

(http://www.jacionline.org/article/PIIS0091674906020185/fulltext#bib4#bib4) and

intratracheal (rats)_5_

(http://www.jacionline.org/article/PIIS0091674906020185/fulltext#bib5#bib5) ,

_6_

(http://www.jacionline.org/article/PIIS0091674906020185/fulltext#bib6#bib6) or

intranasal (mice)_7_

(http://www.jacionline.org/article/PIIS0091674906020185/fulltext#bib7#bib7)

instillations

of spores. Kilburn et al_1_

(http://www.jacionline.org/article/PIIS0091674906020185/fulltext#bib1#bib1)

assert that those calculations “have been

questioned,†but the publication_8_

(http://www.jacionline.org/article/PIIS0091674906020185/fulltext#bib8#bib8)

they cite makes no mention of the ACOEM statement

or of the calculations it contains. The ACOEM conclusion that “delivery by

the inhalation route of a toxic dose of mycotoxins in the indoor environment

is highly unlikely at best†was based on the strength and quality of the

total

body of scientific and medical evidence available at the time.

The AAAAI states agreement with the ACOEM statement and the Institute of

Medicine_9_

(http://www.jacionline.org/article/PIIS0091674906020185/fulltext#bib9#bib9)

report with respect to mycotoxin-mediated diseases, but it is

incorrect to say that the AAAAI statement “relies†on the ACOEM statement.

The

AAAAI statement is an independent re-examination of the science pertaining to

indoor mold. It is significant that with the accumulation of additional years

of

information, the overall evaluation is unchanged.

Kilburn et al_1_

(http://www.jacionline.org/article/PIIS0091674906020185/fulltext#bib1#bib1)

incorrectly characterized Veritox, Inc (formerly GlobalTox,

Inc) as “a defense litigation support corporation.†Veritox, Inc, provides

clients with a variety of consulting services, many unrelated to litigation,

and is retained by both plaintiffs and defendants. Individually, Drs Hardin,

Kelman, and Saxon all have been retained by both plaintiffs and defendants.

However, current medical and toxicological science precludes our support for

claims of mycotoxin-induced health effects as a result of exposure to mold

spores or fragments in nearly all residential, office, and school

environments.

Like ACOEM_2_

(http://www.jacionline.org/article/PIIS0091674906020185/fulltext#bib2#bib2) and

the Institute of Medicine,_9_

(http://www.jacionline.org/article/PIIS0091674906020185/fulltext#bib9#bib9) the

AAAAI_10_

(http://www.jacionline.org/article/PIIS0091674906020185/fulltext#bib10#bib10)

has done a

service by providing a concise overview of what mold-related health effects

actually can or cannot be supported with sound science. Patients who believe

their health has been harmed by indoor mold benefit from evidence-based medical

practices. Misdirected medical evaluations and treatments that lack a sound

basis in medical science and that address unproven etiologies do not contribute

to identification and effective treatment of root causes for the patient's

distress.

They have a couple little problems with their response:

1. Kilburn, Gray Kramer never asserted: " Kilburn et al_1_

(http://www.jacionline.org/article/PIIS0091674906020185/fulltext#bib1#bib1) are

wrong when

they assert that the ACOEM Statement was “based solely on the mathematic

extrapolation from a single rat study.â€

The exact quote was:

The finding of “highly unlikely at best†is based solely on the mathematic

extrapolation from a single rat study and calculated by the litigation

defense corporation principals.

2.Another wrong quote: " they cite makes no mention of the ACOEM statement or

of the calculations it contains. The ACOEM conclusion that “delivery by the

inhalation route of a toxic dose of mycotoxins in the indoor environment is

highly unlikely at best†was based on the strength and quality of the total

body of scientific and medical evidence available at the time. "

Wrong again. From the Kilburn et al: " The ACOEM position states, 'Levels of

exposure in the indoor environment, dose response data in animals, and

dose-rate considerations suggest that delivery by

the inhalation route of a toxic dose of mycotoxins in the indoor environment

is highly unlikely at best, even for the hypothetically most vulnerable

subpopulations.†Of the 83 references “reviewed†by the ACOEM, only one

comes to

the conclusion that human illness is “highly unlikely at best.†It was

written by an ACOEM author and fellow principals in the litigation defense

support corporation.4 The finding of “highly unlikely at best†is based

solely on

the mathematic extrapolation from a single rat study and calculated by the

litigation defense corporation principals. The extrapolations have been

questioned by

credentialed scientists active in the field of mold and mycotoxin research "

..[note: the one of the 83 that support this is the one authored by Gots and

Kelman in 2000 that AIHA legitimized. (Thanks a lot guys, who are my friends

from AIHA!)

3.The three also wrote: " The AAAAI states agreement with the ACOEM statement

and the Institute of Medicine_9_

(http://www.jacionline.org/article/PIIS0091674906020185/fulltext#bib9#bib9)

report with respect to mycotoxin-mediated

diseases "

Wrong again. They failed to mention that Dr.Ammann, author of the chapter

on mycotoxins for the IOM report, also wrote a letter to the Editor of the

JACI regarding the deceit of the paper in Sept. I have seen writings of hers

since that call the AAAAI paper a total embarrassment to the association. No

matter how they try to spin it, the IOM does NOT CONDONE what they did to come

up with " highly unlikely at best " .

4. " Veritox, Inc, provides clients with a variety of consulting services,

many unrelated to litigation, and is retained by both plaintiffs and

defendants. "

Really? Then why does the disclosure that is attached to their Reply state:

" Disclosure of potential conflict of interest: B. D. Hardin owns stock in

Veritox, is employed by Veritox, has served as an expert witness for the

defense in mold litigation and received compensation for that testimony, and

has

written papers on the effects associated with mold. B. J. Kelman owns stock in

Veritox, is employed by Veritox, has served as an expert witness for the

defense in mold litigation and received compensation for that testimony, and

has

written papers on the effects associated with mold. A. Saxon has served as an

expert witness for the defense in mold litigation and received compensation

for that testimony and has written papers on the effects associated with

mold; he has no financial relationship with Veritox, Inc.,and has never

received

any compensation from that company.

5. " Like ACOEM_2_

(http://www.jacionline.org/article/PIIS0091674906020185/fulltext#bib2#bib2)

...... the AAAAI_10_

(http://www.jacionline.org/article/PIIS0091674906020185/fulltext#bib10#bib10)

has done a service by providing a

concise overview of what mold-related health effects actually can or cannot be

supported with sound science. . "

Service for who?

6. " Misdirected medical evaluations and treatments that lack a sound basis

in medical science and that address unproven etiologies do not contribute to

identification and effective treatment of root causes for the patient's

distress.

I agree with this one wholeheartedly. So does that mean they will be

retracting their non-sequitur finding of the implausibility of human illnesses

from

mycotoxin exposure indoors that is just borrowed data from a rodent study

and some math applied by Hardin and Kelman?

7. Tellignly, they failed to answer a KEY question asked of them in the

Kilburn et al:

" Are the members of the Academy of the opinion that it is accepted

scientific protocol for 2 influential medical associations to deduce that all

human

illness is “highly unlikely at best†and “its occurrence is improbableâ€

based

solely on questioned math from a rodent study? We ask the authors of the

Academy position paper to cite any epidemiologic or mechanistic research that

supports the statements of “highly unlikely at best†or “its occurrence

is

improbable.†We are not aware of the existence of any such studies, other

than

the articles by the defense litigation support corporation mentioned above. "

This is actually becoming sad and pathetic. They need to give it up.

Everyone knows what they did to conclude the implausibility of human illness

from

indoor mycotoxin exposure was nothing more than the result of a slight of

hand and some turned blind eyes.

Sharon Kramer