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Dear Dr. Lipsey,

Today I posted to the web site the article I wrote based on our conversation from January. Since the site is password protected, sending you the link won't allow you to read it. So I am pasting it below. I hope it meets your approval. Thanks again for talking to me!

Funding for Mold Research: Where is it?

According to L. Lipsey, Ph.D. of Lipsey & Associates, Inc. in ville, Fla., to answer the question of ³where is the funding for mold & shy;related research?² you first have to answer ³where is the profit?² These are questions Dr. Lipsey gets downright passionate about.

Dr. Lipsey received his Ph.D. from the University of Illinois at Urbana & shy;Campaign in 1972 studying the biology of fungicides, pesticides that kill mold. He is now a consulting toxicologist and finds himself testifying in over 60 cases each year related to toxins and fungi. Dr. Lipsey recently spoke with Publishing about his thoughts on why there may never be adequate studies conducted on the effects of mold spores and mycotoxins on the human system.

³It¹s a sad situation when people who are very sick from chronic exposures to significant levels of highly pathogenic molds don¹t have any guidelines for what is safe in a house, much less standards for remediation,² he said. ³And nobody is willing to stick their necks out because the basic research has not been done for human subjects.²

According to Lipsey, research is lacking because no company has a way of making a profit from the prevention of mold exposure. He compared mold contamination to termite infestation. Major chemical companies are willing to conduct research on how to eradicate termites from homes and buildings because they can design products based on that research. Currently, the profit in the mold industry is not in the development of products but in the removal and destruction of contaminated materials.

In light of this lack of corporate motivation, what organizations should be conducting mold & shy;related research? Lipsey said there are a number of federal organizations that should appropriately be studying various aspects of mold and human health. For example, the U.S. Dept. of Health and Human Services¹ Centers for Disease Control and Prevention (CDC) is the lead federal agency for developing and applying disease prevention and control, environmental health, and health promotion and education activities designed to improve the health of the people of the United States. The CDC also has an agency called the National Institute for Occupational Safety and Health (NIOSH) that is responsible for conducting research and making recommendations for the prevention of work & shy;related disease and injury.

The U.S. Environmental Protection Agency is another federal agency that should be investigating mold and human health. The EPA was established to protect human health and to safeguard the natural environment.

Finally, don¹t forget the state health departments. In general, they have the authority to enforce statutes pertaining to public health for the prevention and suppression of disease and injury and are responsible for planning and coordinating health resources throughout each state.

The EPA includes statements on its Web site indicating that research and data collection are being conducted on topics such as the environmental conditions that permit building material colonization by fungi and the subsequent development of contamination sources, although much of this information is a year or more old. According to information posted by the EPA¹s Indoor Environment Management Branch (IEMB) on ³Children¹s Health Initiative: Toxic Mold,² last updated in March 2001,(1) data collected over the last five years regarding a variety of building materials and fungi ³is in the process of being transitioned to a Standard Guide for the American Soecity of Testing and Materials (ASTM).²

Unfortunately, several individuals at ASTM¹s headquarters in Conshohocken, Pa. were unaware of the development of any such standard, including the staff managers of the committees on sampling and analysis of atmospheres and on performance of buildings. According to Luciw, staff manager of the committee on sampling and analysis of atmospheres, it is not uncommon for committee members to talk to one another about a potential standard for as long as six months before any formal action is taken. Once a standard is formally entered onto the committee list, the standardization process could take several years. According to Luciw, there is ³nothing on the horizon² for the development of any mold & shy;related standard at ASTM, as far as he is aware.

Lipsey points to the CDC as the organization with the primary responsibility to conduct mold & shy;related epidemiology(2) studies. ³The CDC had a wonderful opportunity to study the effects of mold on human health with the infants in Ohio,(3) but they copped out because that type of research is time consuming and expensive,² Lipsey said.

Lipsey observed that without organizations such as the CDC taking the lead in mold & shy;related research, it has been left to judges and juries to decide on a case & shy;by & shy;case basis whether mold exposures have caused claimants¹ injuries. ³The CDC ought to take the bull by the horns and do an epidemiological study on mold poisoning,² Lipsey said. Without it, judges and juries will continue to be placed in the positions of making medical decisions.

However, even Lipsey recognizes the many challenges inherent in studying the effects of mold poisoning. For starters, it is difficult to get a statistically significant result when the subject of study incorporates so many variables. No two houses are alike. No two families are alike. Exposure to the study organisms must be controlled. Exposure to other organisms must be limited. To overcome such obstacles and design an epidemiological study, Lipsey said that the first step would be to gather together the country¹s experts. Their task would be to define the problem and set up a study protocol. The next step? ³Go after funding,² he stated.

Endnotes

1. http://www.epa.gov/appcdwww/crb/iemb/child.htm

2. Epidemiology: 1. a branch of medical science that deals with the incidence, distribution and control of a disease in a population 2. the sum of the factors controlling the presence or absence of a disease or pathogen

3. Dr. Lipsey was referring to the clusters of infants from the Cleveland, Ohio area who were suspected of suffering from Stachybotrys & shy;induced lung hemorrhage in the early 1990s. Deficiencies in data collection and evaluation were cited as the reason for the CDC¹s later retraction of the original study conclusions that a link existed between mold exposure and the infants¹ illnesses. One of the principle investigators, Dorr Dearborn, M.D., Ph.D. of Rainbow Babies and Children¹s Hospital, Case Western Researve University in Cleveland, is currently conducting a new study on this topic. It is interesting to note that, in referring to the Cleveland reports, the previously mentioned IEMB Web document on the children¹s health initiative stated that ³[t]he deficiencies in the original study cited by the recent CDC investigators may not be entirely realistic of field investigations involving human subjects, nor is it sufficient cause to dismiss the original conclusions. It is without dispute that significant exposure to S. atra as well as other hydrophilic molds might well result in severe lung disease in infants.² For more information on the Cleveland clusters and Dearborn¹s research, please see ³Stachybotrys Induced Hemorrhage in the Developing Lung: Report on a Clinical Trial² that appeared in the premier issue of COLUMNS & shy;Mold.

DR. RICHARD L. LIPSEY

PROFESSOR AND TOXICOLOGIST

UNIVERSITY OF NORTH FLORIDA (OSHA)

UNIVERSITY OF FLORIDA MEDICAL CENTER-JAX

(POISON CONTROL)

DR. R. LIPSEY WEBSITE(www.richardlipsey.com)

Dear Dr. Lipsey,

Today I posted to the web site the article I wrote based on our conversation from January. Since the site is password protected, sending you the link won't allow you to read it. So I am pasting it below. I hope it meets your approval. Thanks again for talking to me!

--

Editor, COLUMNS-Mold

610-344-7888

Funding for Mold Research: Where is it?

According to L. Lipsey, Ph.D. of Lipsey & Associates, Inc. in ville, Fla., to answer the question of ³where is the funding for mold­related research?² you first have to answer ³where is the profit?² These are questions Dr. Lipsey gets downright passionate about.

Dr. Lipsey received his Ph.D. from the University of Illinois at Urbana­Campaign in 1972 studying the biology of fungicides, pesticides that kill mold. He is now a consulting toxicologist and finds himself testifying in over 60 cases each year related to toxins and fungi. Dr. Lipsey recently spoke with Publishing about his thoughts on why there may never be adequate studies conducted on the effects of mold spores and mycotoxins on the human system.

³It¹s a sad situation when people who are very sick from chronic exposures to significant levels of highly pathogenic molds don¹t have any guidelines for what is safe in a house, much less standards for remediation,² he said. ³And nobody is willing to stick their necks out because the basic research has not been done for human subjects.²

According to Lipsey, research is lacking because no company has a way of making a profit from the prevention of mold exposure. He compared mold contamination to termite infestation. Major chemical companies are willing to conduct research on how to eradicate termites from homes and buildings because they can design products based on that research. Currently, the profit in the mold industry is not in the development of products but in the removal and destruction of contaminated materials.

In light of this lack of corporate motivation, what organizations should be conducting mold­related research? Lipsey said there are a number of federal organizations that should appropriately be studying various aspects of mold and human health. For example, the U.S. Dept. of Health and Human Services¹ Centers for Disease Control and Prevention (CDC) is the lead federal agency for developing and applying disease prevention and control, environmental health, and health promotion and education activities designed to improve the health of the people of the United States. The CDC also has an agency called the National Institute for Occupational Safety and Health (NIOSH) that is responsible for conducting research and making recommendations for the prevention of work­related disease and injury.

The U.S. Environmental Protection Agency is another federal agency that should be investigating mold and human health. The EPA was established to protect human health and to safeguard the natural environment.

Finally, don¹t forget the state health departments. In general, they have the authority to enforce statutes pertaining to public health for the prevention and suppression of disease and injury and are responsible for planning and coordinating health resources throughout each state.

The EPA includes statements on its Web site indicating that research and data collection are being conducted on topics such as the environmental conditions that permit building material colonization by fungi and the subsequent development of contamination sources, although much of this information is a year or more old. According to information posted by the EPA¹s Indoor Environment Management Branch (IEMB) on ³Children¹s Health Initiative: Toxic Mold,² last updated in March 2001,(1) data collected over the last five years regarding a variety of building materials and fungi ³is in the process of being transitioned to a Standard Guide for the American Soecity of Testing and Materials (ASTM).²

Unfortunately, several individuals at ASTM¹s headquarters in Conshohocken, Pa. were unaware of the development of any such standard, including the staff managers of the committees on sampling and analysis of atmospheres and on performance of buildings. According to Luciw, staff manager of the committee on sampling and analysis of atmospheres, it is not uncommon for committee members to talk to one another about a potential standard for as long as six months before any formal action is taken. Once a standard is formally entered onto the committee list, the standardization process could take several years. According to Luciw, there is ³nothing on the horizon² for the development of any mold­related standard at ASTM, as far as he is aware.

Lipsey points to the CDC as the organization with the primary responsibility to conduct mold­related epidemiology(2) studies. ³The CDC had a wonderful opportunity to study the effects of mold on human health with the infants in Ohio,(3) but they copped out because that type of research is time consuming and expensive,² Lipsey said.

Lipsey observed that without organizations such as the CDC taking the lead in mold­related research, it has been left to judges and juries to decide on a case­by­case basis whether mold exposures have caused claimants¹ injuries. ³The CDC ought to take the bull by the horns and do an epidemiological study on mold poisoning,² Lipsey said. Without it, judges and juries will continue to be placed in the positions of making medical decisions.

However, even Lipsey recognizes the many challenges inherent in studying the effects of mold poisoning. For starters, it is difficult to get a statistically significant result when the subject of study incorporates so many variables. No two houses are alike. No two families are alike. Exposure to the study organisms must be controlled. Exposure to other organisms must be limited. To overcome such obstacles and design an epidemiological study, Lipsey said that the first step would be to gather together the country¹s experts. Their task would be to define the problem and set up a study protocol. The next step? ³Go after funding,² he stated.

Endnotes

1. http://www.epa.gov/appcdwww/crb/iemb/child.htm

2. Epidemiology: 1. a branch of medical science that deals with the incidence, distribution and control of a disease in a population 2. the sum of the factors controlling the presence or absence of a disease or pathogen

3. Dr. Lipsey was referring to the clusters of infants from the Cleveland, Ohio area who were suspected of suffering from Stachybotrys­induced lung hemorrhage in the early 1990s. Deficiencies in data collection and evaluation were cited as the reason for the CDC¹s later retraction of the original study conclusions that a link existed between mold exposure and the infants¹ illnesses. One of the principle investigators, Dorr Dearborn, M.D., Ph.D. of Rainbow Babies and Children¹s Hospital, Case Western Researve University in Cleveland, is currently conducting a new study on this topic. It is interesting to note that, in referring to the Cleveland reports, the previously mentioned IEMB Web document on the children¹s health initiative stated that ³[t]he deficiencies in the original study cited by the recent CDC investigators may not be entirely realistic of field investigations involving human subjects, nor is it sufficient cause to dismiss the original conclusions. It is without dispute that significant exposure to S. atra as well as other hydrophilic molds might well result in severe lung disease in infants.² For more information on the Cleveland clusters and Dearborn¹s research, please see ³Stachybotrys Induced Hemorrhage in the Developing Lung: Report on a Clinical Trial² that appeared in the premier issue of COLUMNS­Mold.

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