Fungal Treatment Study/Late-Night Rant

October 7, 2004

Group-

At risk of sounding stupid, I am a bit

perplexed by this brief article I came across… (See below.)

What point would testing have on “healthy

adults,” when we are all aware of the fact that

in most instances invasive fungal

infections occur in immune-compromised individuals?

While I understand it’s only “Phase

1,” what relevance, if any would this study have?

If proven to be “safe” for

these 32 human guinea pigs, what happens next? Any silent FDA

people out there?? I understand the

need to develop treatments for disease. I understand

that medication is often necessary and a

last resort – especially with invasive fungal diseases.

I guess I’m just blown away by the

rapidity of the manner in which new drugs are thrown onto the

market with testing times becoming shorter

and shorter and no one looking at possible long-term effects.

(Many recent examples on that one…)

I am frustrated that many people don’t seem to realize that

if we would incorporate good building

science techniques from the get go, start taking “green building”

more serious, and educate consumers, we

could perhaps reach that place and point where life isn’t

boiled down to “taking a pill”

to fix everything. How boring and lazy we’ve become in that regard…

Everyone has the ability to help change the

world – or at least how it is perceived.

Time to climb off the soap box. I

apologize in advance for the twists and turns of my somewhat sleepy,

but ever feisty brain!

Impetuous Imp,

Stacey Champion

“If you can’t lower Heaven,

raise Hell!” -Mother

Indevus launches

fungus-treatment study

Boston Business Journal

Indevus Pharmaceuticals inc. of Lexington has launched an

early-stage human clinical trial to test a treatment for invasive fungal

infections.

The Phase I clinical trial will involve

32 healthy volunteers and test drug safety, how well the subjects tolerate the

compound and whether the treatment can fight fungus.

An earlier Phase I test of the compound,

known as Aminocandin, produced positive results, the company said.

In July, the company announced plans to

buy back up to 2.5 million shares of its common stock, though it emphasized

that enough cash remained to fuel growth and launch its new Sanctura drug to

treat overactive bladders.

October 7, 2004

Phase 1 Studies:

Phase 1

includes the initial introduction of an investigational new drug into humans.

These studies are closely monitored and may be conducted in patients, but are

usually conducted in healthy volunteer subjects. These studies are designed to

determine the metabolic and pharmacologic actions of the drug in humans, the

side effects associated with increasing doses, and, if possible, to gain early

evidence on effectiveness. During Phase 1, sufficient information about the

drug's pharmacokinetics and pharmacological effects should be obtained to

permit the design of well-controlled, scientifically valid, Phase 2 studies.

Phase 1

studies also evaluate drug metabolism, structure-activity relationships, and

the mechanism of action in humans. These studies also determine which

investigational drugs are used as research tools to explore biological

phenomena or disease processes. The total number of subjects included in Phase

1 studies varies with the drug, but is generally in the range of twenty to

eighty.

J. , Ph.D.

Chief Biological Safety Officer

Baylor Research Institute

3434 Live Oak

Dallas, TX 75204

FAX:

steveph@...

From: Stacey Champion

Sent: Thursday, October 07, 2004

2:39 AM

To: iequality

Subject: Fungal

Treatment Study/Late-Night Rant

Group-

At risk of sounding stupid, I am a bit

perplexed by this brief article I came across… (See below.)

What point would testing have on

“healthy adults,” when we are all aware of the fact that

in most instances invasive fungal

infections occur in immune-compromised individuals?

While I understand it’s only

“Phase 1,” what relevance, if any would this study have?

If proven to be “safe” for

these 32 human guinea pigs, what happens next? Any silent FDA

people out there?? I understand the

need to develop treatments for disease. I understand

that medication is often necessary and a

last resort – especially with invasive fungal diseases.

I guess I’m just blown away by the

rapidity of the manner in which new drugs are thrown onto the

market with testing times becoming shorter

and shorter and no one looking at possible long-term effects.

(Many recent examples on that

one…) I am frustrated that many people don’t seem to realize

that

if we would incorporate good building

science techniques from the get go, start taking “green building”

more serious, and educate consumers, we

could perhaps reach that place and point where life isn’t

boiled down to “taking a pill”

to fix everything. How boring and lazy we’ve become in that

regard…

Everyone has the ability to help change the

world – or at least how it is perceived.

Time to climb off the soap box. I

apologize in advance for the twists and turns of my somewhat sleepy,

but ever feisty brain!

Impetuous Imp,

Stacey Champion

“If you can’t lower Heaven,

raise Hell!” -Mother

Indevus launches

fungus-treatment study

Boston Business Journal

Indevus Pharmaceuticals inc. of Lexington has launched an early-stage

human clinical trial to test a treatment for invasive fungal infections.

The Phase I clinical trial will involve

32 healthy volunteers and test drug safety, how well the subjects tolerate the

compound and whether the treatment can fight fungus.

An earlier Phase I test of the compound,

known as Aminocandin, produced positive results, the company said.

In July, the company announced plans to

buy back up to 2.5 million shares of its common stock, though it emphasized

that enough cash remained to fuel growth and launch its new Sanctura drug to

treat overactive bladders.

FAIR

USE NOTICE:

This site contains copyrighted material the use of

which has not always been specifically authorized by the copyright owner. We

are making such material available in our efforts to advance understanding of

environmental, political, human rights, economic, democracy, scientific, and

social justice issues, etc. We believe this constitutes a 'fair use' of any

such copyrighted material as provided for in section 107 of the US Copyright

Law. In accordance with Title 17 U.S.C. Section 107, the material on this site

is distributed without profit to those who have expressed a prior interest in

receiving the included information for research and educational purposes. For

more information go to: http://www.law.cornell.edu/uscode/17/107.shtml.

If you wish to use copyrighted material from this site for purposes of your own

that go beyond 'fair use', you must obtain permission from the copyright owner.

This e-mail, facsimile, or letter and any files or attachments transmitted with it contains information that is confidential and privileged. This information is intended only for the use of the individual(s) and entity(ies) to whom it is addressed. If you are the intended recipient, further disclosures are prohibited without proper authorization. If you are not the intended recipient, any disclosure, copying, printing, or use of this information is strictly prohibited and possibly a violation of federal or state law and regulations. If you have received this information in error, please notify Baylor Health Care System immediately at 1- or via e-mail at privacy@.... Baylor Health Care System, its subsidiaries, and affiliates hereby claim all applicable privileges related to this information.

October 7, 2004

I agree .. seems to me we're getting into a vicious cycle here since current anti-fungal drugs have been known to compromise liver function, even cause serious liver damage or liver failure in some individuals.

These very drugs diminish the capability of the liver to filter out toxins to which we are exposed on a daily basis. With a compromised liver comes a compromised immune system, and our tolerance for fungal contaminants becomes less and less, So will we be prescribed more drugs to counteract these effects too ? Seems like the pharmaceutical industry is the only winner in this scenario.

e Indoor Environmental Testing Inc.

Fungal Treatment Study/Late-Night Rant

Group-

At risk of sounding stupid, I am a bit perplexed by this brief article I came across… (See below.)

What point would testing have on “healthy adults,” when we are all aware of the fact that

in most instances invasive fungal infections occur in immune-compromised individuals?

While I understand it’s only “Phase 1,” what relevance, if any would this study have?

If proven to be “safe” for these 32 human guinea pigs, what happens next? Any silent FDA

people out there?? I understand the need to develop treatments for disease. I understand

that medication is often necessary and a last resort – especially with invasive fungal diseases.

I guess I’m just blown away by the rapidity of the manner in which new drugs are thrown onto the

market with testing times becoming shorter and shorter and no one looking at possible long-term effects.

(Many recent examples on that one…) I am frustrated that many people don’t seem to realize that

if we would incorporate good building science techniques from the get go, start taking “green building”

more serious, and educate consumers, we could perhaps reach that place and point where life isn’t

boiled down to “taking a pill” to fix everything. How boring and lazy we’ve become in that regard…

Everyone has the ability to help change the world – or at least how it is perceived.

Time to climb off the soap box. I apologize in advance for the twists and turns of my somewhat sleepy,

but ever feisty brain!

Impetuous Imp,

Stacey Champion

“If you can’t lower Heaven, raise Hell!” -Mother

Indevus launches fungus-treatment study

Boston Business Journal

Indevus Pharmaceuticals inc. of Lexington has launched an early-stage human clinical trial to test a treatment for invasive fungal infections.

The Phase I clinical trial will involve 32 healthy volunteers and test drug safety, how well the subjects tolerate the compound and whether the treatment can fight fungus.

An earlier Phase I test of the compound, known as Aminocandin, produced positive results, the company said.

In July, the company announced plans to buy back up to 2.5 million shares of its common stock, though it emphasized that enough cash remained to fuel growth and launch its new Sanctura drug to treat overactive bladders.

FAIR USE NOTICE:This site contains copyrighted material the use of which has not always been specifically authorized by the copyright owner. We are making such material available in our efforts to advance understanding of environmental, political, human rights, economic, democracy, scientific, and social justice issues, etc. We believe this constitutes a 'fair use' of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, the material on this site is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes. For more information go to: http://www.law.cornell.edu/uscode/17/107.shtml. If you wish to use copyrighted material from this site for purposes of your own that go beyond 'fair use', you must obtain permission from the copyright owner.

October 8, 2004

Thanks

for your comments e.

What I

have to say is very personal in nature, but me being me, I feel it needs to be

said. As some of you know, and for

those of

you who don’t, I got into this industry from dealing with a personal

situation in my home. At the time, I knew

very

little about mold, and not being a big T.V. fan, hadn’t been bombarded by

the “Toxic Mold “ sensationalized horror

stories.

We had lived in our home for 6 months when my family started getting sick.

At 8 months the problem finally

manifested

itself. Along with feeling like I had the flu that wouldn’t go away,

headaches from hell, and constant sinus

problems

(as did the rest of my family) I started having weird “spells.”

Prior to this, I was a very healthy young woman.

Two

months after being out of our house I was at an EIA Conference in Vegas, was

walking through the lobby of a hotel,

and did

the Nestea Plunge backwards onto a marble floor. A nurse had witnessed

the event and when I came to, asked me

if I had

epilepsy. What??? I was taken to the emergency room, where I

brought up my high fungus (and probable bacteria) exposure,

which of

course was shrugged off. CAT scan showed nothing, blood work showed an elevated

white blood cell count. They

sent me

home.

This

happened several more times over the course of the next couple years.

Emergency room visits, same response… I then became

a

consultant after coming to the realization that I couldn’t help change

the world all at once, and would have to take one baby

step at

a time. Knowing what I knew after my countless hours of research, I was a

PPE Nazi when out in the field! The seizures

continued

to occur more frequently, although I was learning to recognize the symptoms

quicker, thus keeping myself from actually

losing consciousness.

Being a normal, stubborn human being, I kept telling myself everything was

okay.

Finally

just a couple of months ago, when it was affecting my life to the point where I

was having anxiety attacks about conking

out in

public places, I got persistent and wouldn’t let them shrug me off any

longer. This was affecting my life. I would be completely

drained

after an “episode” sometimes for two days. I asked them to

humor me and prescribe an EEG. As it turned out I have

“abnormal

brain wave activity” in my right temporal lobe. The MRI showed

nothing in their opinion that would be causing my seizures,

but it

did show a 1.5 – 2.5 cm cyst in my right sinus cavity which has been

shrugged off by everyone, including my neurologist, as not

being a

really big deal – common with chronic sinusitis, which we all know

according to the Mayo Clinic Study is mostly caused

by

fungus! I’m still dealing with this aspect… I was

diagnosed by my neurologist as having epilepsy which basically boils down to

having

had more than one or two seizures with no known cause such as high fever,

etc. At least 45% of people diagnosed never know how

or why

they are having seizures.

I am on

anti-seizure medication now, which I felt was necessary for me to get a handle

on all of this. The down side is that I have to

have

blood work done on a monthly basis to check my liver and white blood cell

count, as the medication I’m on has the ability

on rare

instances to completely knock out your white blood cells, which is not an okay

thing in my line of work. The medication

is very

hard on your body and the thought of being on it for the rest of my life makes

me sick. I have no idea if it is somehow tied

to my

home. I probably never will.

I guess

the point of all of this is to share my story to the extent that I was what

would be considered “healthy.” I wasn’t

immune-compromised

when we

moved into our house. My son, now almost six, is prone to upper respiratory

infections. Can I prove any of this?

Maybe

not scientifically. Do I believe it’s real? Yes.

When you’re

out in the field, keep these things in mind, as there is so much we have yet to

learn; about our brain chemistry

and how

it reacts with different things, about our genetic make-up, inhalation of

mycotoxins and other things, etc., etc.

It may

not affect you today or tomorrow, but you never know about the future…

Best

Regards,

Stacey

Champion

Flawed

Superstar

From: e

Sent: Thursday, October 07, 2004

9:20 PM

To: iequality

Subject: Re: Fungal

Treatment Study/Late-Night Rant

I agree .. seems to me we're getting into a vicious

cycle here since current anti-fungal drugs have been known to compromise liver

function, even cause serious liver damage or liver failure in some

individuals.

These

very drugs diminish the capability of the liver to filter

out toxins to which we are exposed on a daily basis. With a

compromised liver comes a compromised immune system, and our tolerance for

fungal contaminants becomes less and less, So will we be prescribed more drugs to

counteract these effects too ? Seems like the pharmaceutical

industry is the only winner in this scenario.

e

Indoor

Environmental Testing Inc.

Fungal

Treatment Study/Late-Night Rant

Group-

At risk of sounding stupid, I am a bit

perplexed by this brief article I came across… (See below.)

What point would testing have on

“healthy adults,” when we are all aware of the fact that

in most instances invasive fungal

infections occur in immune-compromised individuals?

While I understand it’s only

“Phase 1,” what relevance, if any would this study have?

If proven to be “safe” for

these 32 human guinea pigs, what happens next? Any silent FDA

people out there?? I understand the

need to develop treatments for disease. I understand

that medication is often necessary and a

last resort – especially with invasive fungal diseases.

I guess I’m just blown away by the

rapidity of the manner in which new drugs are thrown onto the

market with testing times becoming shorter

and shorter and no one looking at possible long-term effects.

(Many recent examples on that

one…) I am frustrated that many people don’t seem to realize

that

if we would incorporate good building

science techniques from the get go, start taking “green building”

more serious, and educate consumers, we

could perhaps reach that place and point where life isn’t

boiled down to “taking a pill”

to fix everything. How boring and lazy we’ve become in that

regard…

Everyone has the ability to help change the

world – or at least how it is perceived.

Time to climb off the soap box. I

apologize in advance for the twists and turns of my somewhat sleepy,

but ever feisty brain!

Impetuous Imp,

Stacey Champion

“If you can’t lower Heaven,

raise Hell!” -Mother

Indevus launches

fungus-treatment study

Boston Business Journal

Indevus Pharmaceuticals inc. of Lexington has launched an

early-stage human clinical trial to test a treatment for invasive fungal

infections.

The Phase I clinical trial will involve

32 healthy volunteers and test drug safety, how well the subjects tolerate the

compound and whether the treatment can fight fungus.

An earlier Phase I test of the compound,

known as Aminocandin, produced positive results, the company said.

In July, the company announced plans to

buy back up to 2.5 million shares of its common stock, though it emphasized

that enough cash remained to fuel growth and launch its new Sanctura drug to

treat overactive bladders.

FAIR

USE NOTICE:

This site contains copyrighted material the use of

which has not always been specifically authorized by the copyright owner. We

are making such material available in our efforts to advance understanding of

environmental, political, human rights, economic, democracy, scientific, and

social justice issues, etc. We believe this constitutes a 'fair use' of any

such copyrighted material as provided for in section 107 of the US Copyright Law.

In accordance with Title 17 U.S.C. Section 107, the material on this site is

distributed without profit to those who have expressed a prior interest in

receiving the included information for research and educational purposes. For

more information go to: http://www.law.cornell.edu/uscode/17/107.shtml.

If you wish to use copyrighted material from this site for purposes of your own

that go beyond 'fair use', you must obtain permission from the copyright owner.

FAIR USE

NOTICE: