Cleveland infants

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Answers Prove Elusive in Mold-Linked Deaths

By Mark Moran, MPH

WebMD Medical News

http://www.ehw.org/Healthy_House/HH_Toxic_Mold.htm

July 26, 2000 (Cleveland) --

In 1994, a dark fungus gained notoriety as an apparent cause of a

frightening condition striking a number of Cleveland infants, some

of whom died.

Six years later, opinions remain divided about stachybotrys

chartarum. Some see it as simply the most publicized of a host of

indoor molds affecting human health. Others view it primarily as an

insurance liability disaster in the making for countless homes and

office buildings with water damage.

But to others, it is a potent symbol of the difficulty of linking

environmental exposure and human disease -- and of formulating

public policy in the face of scientific uncertainty.

Local and national public health leaders agree the controversy has

obscured the overwhelming consensus among scientists that mold and

water-damaged housing are threats to human health. But they are

almost as unanimous that the connection between stachybotrys and the

malady that struck the infants, called pulmonary hemosiderosis, is

far less conclusive.

" No one has ever claimed causation, " says Dorr Dearborn, MD, PhD,

associate chief of the pediatric pulmonary division at Rainbow

Babies and Children's Hospital of the University Hospitals of

Cleveland.

It was Dearborn who originally alerted the CDC about a rash of

infants with what appeared to be pulmonary hemosiderosis, a

condition in which victims cough up blood from their lungs.

In response to his call, the CDC sent a team of researchers to the

city to assess the situation. The result was a " case-control " study

in which measures of stachybotrys in homes of infants with the

disease were compared to those without it. The study suggested a

link between the mold and the disease, reporting 10 cases of what

appeared to be pulmonary hemosiderosis associated with stachybotrys

chartarum in the home.

But last year, the CDC released a new report that suggested

shortcomings in the original study. The report called into question

the small size of the study, the way mold calculations were done,

and the diagnosis of pulmonary hemosiderosis, which the CDC says is

not a disease but a condition that accompanies a host of ailments.

The agency's conclusion: Scientific evidence is insufficient to link

stachybotrys chartarum to pulmonary hemosiderosis.

Dearborn, who was one of the investigators in the case-control

study, defends the study and says more cases of pulmonary

hemosiderosis locally and nationwide have been reported in

conjunction with stachybotrys. Over the past seven years, there have

been 45 cases of pulmonary hemorrhage in young infants and 16

deaths, he says.

Dearborn acknowledges that the study was too small, but says it was

the CDC that stopped the trial before it could gather enough data to

make a more convincing case.

Tom Sinks, PhD, a CDC epidemiologist, says that when the agency

responds to an urgent request for an investigation, its mission is

to rapidly assess a situation, not to do long-term research. " We do

not have the luxury in these situations to do the most exquisite

type of research, " he tells WebMD. " Our purpose is not to start

something we can't finish. "

Sinks says the CDC recognizes the link between mold and human

health, and urges people to take preventive action when there is

water damage in the home. But regarding a connection between

stachybotrys and hemosiderosis, the evidence is too weak to justify

policymaking, he says.

That conclusion generated controversy about the way the CDC handled

the case. Ruth Etzel, MD, an epidemiologist formerly with the CDC

who headed the original study, says the agency's review of the work

is " dead wrong " and that the CDC has sought to bury the connection

between mold and disease.

" Normally, when a new idea is presented, you do more work and test

it further in other places, " says Etzel, who says she left the CDC

as a result of the controversy and is now director of the division

of epidemiology and risk assessment at the food safety and

inspection service of the USDA. " What happened here was that instead

of moving forward, a decision was made to put a stop to our work. "

She says the current scientific consensus on the dangerous health

effects of mold stems largely from the Cleveland study. " Previously,

most physicians thought of mold as quite innocuous, " she tells

WebMD. " We were able to focus on mold in a way that the medical

world had never done before. "

Both Dearborn and Etzel acknowledge that showing an association is

not the same as saying the mold caused the deaths. " You can't prove

causation from epidemiologic studies, " Dearborn says. " All you can

do is show that there is a correlation. "

Dearborn says stachybotrys may have played a role in the deaths of

the Cleveland infants along with other factors, such as second-hand

smoke or underlying genetic problems. The exact relationship between

the mold and those other factors is unknown, he says.

" This is a difficult game at any time in history, " says

, PhD, a biochemist at Carlton University in Ottawa, Canada,

and an expert on fungal toxins. " You can't have a cut-and-dried

scientific discussion without having all the facts. With regard to

stachybotrys, we don't have all the facts. "

illustrates the problem by recalling alflatoxin, a mold that

grows on crops, now known to be a potent carcinogen. " In the early

1970s when the FDA made a decision to regulate the substance, the

epidemiologic studies showing it was a human carcinogen were very

weak, " says. " Everyone agreed it was weak, but it was the

best anyone could do. "

It wasn't until the early 1990s that the FDA decision was proven

well-founded, when the ability to measure alflatoxin in the blood

was refined and the substance was shown to be one of the most potent

carcinogens known, says.

Stu Greenberg, executive director of Environmental Health Watch, a

local environmental advocacy group, says that in the Cleveland case,

the scientific complexities of risk assessment were obscured by the

drama of dying babies. " It raises the question for public health

leaders, 'how do you take action in the absence of solid data?' "

Greenberg says.

He cites the " precautionary principle " to suggest that heightened

concern was probably warranted. " When there is a potential risk to

human life, you can't wait for the body count, " Greenberg says. " You

have to take prudent action, even though you may not be certain. "

In wake of the original report, the Cuyahoga County Board of Health

and the Cleveland Department of Public Health initiated an expensive

program designed to find and remove stachybotrys from the homes of

newborns in east Cleveland.

Terry Allan, MPH, the Cuyahoga County board's director of community

health services, tells WebMD the program has had only limited

success. The difficulty of reaching inner-city populations and

entering homes to fix water damage is similar, he says, to that

confronting public health leaders trying to improve vaccination

rates in medically underserved areas.

He defends the effort despite the fact that no one has proved the

mold made babies sick. " How long does it take to discover

causality? " Allan asks. " Do you ever get that definitive study? Not

very often. At some point, public health leaders have to make a

decision based on what they know today. "

Allan says the stachybotrys prevention effort is continuing, but

will be folded into a larger project looking at all kinds of mold

and moisture in low-income housing. This year the Cuyahoga County

Board of Health received $3.1 million from the U.S. Department of

Housing and Urban Development to track mold and moisture in low-

income homes, to determine their relationship to disease, and to

make repairs.

Meanwhile, the link between stachybotrys chartarum and pulmonary

hemosiderosis awaits further research. Dearborn says he is

conducting studies on the effects of airborne stachybotrys spores on

animals.

He believes the Cleveland babies may have served as " canaries in the

coal mine " -- that is, indicators of something foul in Cleveland's

inner-city environment.

" They are telling us that our inner city is not a healthy

environment, " he says, " and that indoor pollution problems may be a

very significant player in the increase in inner-city childhood

asthma. "

© 2000 Healtheon/WebMD. All rights reserved.

University Hospitals, Cleveland -- Pulmonary Hemosiderosis and

Stachybotrys Mold

<http://gcrc.meds.cwru.edu/stachy/default.htm>

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