Wall Street Journal (pg. A1)
December 23, 2005


'Clarification' of Chinese Study Absolved Chromium-6; Did Author
Really Write It?; Echo of Erin Brockovich Case

By Peter Waldman.

[Fourth in a Series]

During China's Cultural Revolution 40 years ago, a city doctor named
Zhang JianDong was banished to the countryside of northeastern China.
He arrived to a public-health emergency.

A giant smelter was spilling large amounts of chromium waste into the
groundwater. Well water was turning yellow. People were developing
mouth sores, nausea and diarrhea. Dr. Zhang spent the next two decades
treating and studying the residents of five villages with chromium-
polluted water.

In 1987, he published a study saying they were dying of cancer at
higher rates than people nearby. He earned a national award in China
for his research. In America, federal scientists translated it into
English, and regulatory agencies began citing it as evidence that a
form of the metal called chromium-6 might cause cancer if ingested.

Then in 1997, Dr. Zhang, in retirement, appeared to retract his life's
work. A "clarification and further analysis" published under his name
in a U.S. medical journal said there was no cancer link to chromium in
the villages after all. This new conclusion, like the earlier one,
soon found its way into U.S. regulatory assessments, as evidence that
ingested chromium wasn't really a cancer risk.

Yet Dr. Zhang didn't write the clarification, judging by voluminous
testimony and exhibits in a lawsuit in a California state court. The
court papers indicate that the second study was conceived, drafted,
edited and submitted to medical journals by science consultants
working for the lawsuit's defendant, a utility company being sued for
alleged chromium pollution. The consultants paid Dr. Zhang about
$2,000 for research assistance on the second study.

That study didn't deny that the polluted area had a higher rate of
cancer deaths. But it said factors other than chromium were the likely
cause. This was a statement that Dr. Zhang, now dead, had explicitly
disputed in a letter to the consultants. Yet he and a Chinese
colleague appeared, to anyone reading the report, to be its sole
authors. The litigation consultants didn't disclose their role to the
journal that published it.

For years, scientists thought chromium-6 in drinking water might, at
some level of exposure, pose a cancer risk. The first Zhang study,
while recognized as flawed, was one reason for this view. Now many
scientists think the metal doesn't pose this risk, and once again a
Zhang report is a factor behind their view. How risky the metal
actually is or isn't matters, because it has shown up in soil or water
in parts of 37 states, according to the U.S. Agency for Toxic
Substances and Disease Registry.

Regulators in California, after investigating the second Zhang report,
have concluded it is dubious. They have reverted to the original dark
view of chromium-6 and are moving to propose a strict limit on it in
groundwater. The action could ultimately require a costly cleanup,
because a third of wells tested in the state exceed the envisioned
limit. Costs would grow if other states followed California's lead.

The conflicting Zhang studies show what can happen when the line
between advocacy and science blurs. The consultants pursued the second
round of Chinese research with the clear aim of rebutting California
plaintiffs' arguments, court documents show. But once that second
report entered the realm of peer-reviewed science literature, it took
on a life of its own in regulatory assessments of the chemical.

The consultants who worked on the second report defend it as good
science. And, rejecting the notion that they ghost-wrote it, they say
that Dr. Zhang was kept informed of what it said through phone calls
and through an early draft that was translated into Chinese for him.

Chromium, once hailed as a miracle metal for its corrosion resistance
and durability, is part of stainless steel and has been used in
countless products from jewelry to fenders, under the name chrome. The
legacy of this wide use is that hundreds of U.S. industrial sites are
tainted with chromium-6, also called hexavalent chromium.

This variant -- so named because its atoms have six electrons
available to interact with other atoms -- is widely used in alloys,
paints and wood preservatives. It has long been known that breathing
particles of it can raise lung-cancer risk, but the effect of
ingesting it has been hotly contested. That's because digestion
converts some into "trivalent" chromium, a form that not only isn't
toxic but is an essential nutrient in minute amounts. The U.S.
National Toxicology Program is currently conducting long-term rodent
studies to try to ascertain at what level chromium-6 might be an oral

The China story is part of a more familiar one, that of Erin
Brockovich, the feisty paralegal (played by Julia Roberts in the movie
named after her) who helped a California town's residents win $333
million from a utility that had leaked chromium into their water. In
1995, arbitrators hearing the Brockovich case asked the defendant,
PG&E Corp., about the original Zhang study. Lawyers for PG&E then
assigned a consulting firm to look into it, telling the firm, as a
former lawyer for PG&E recalls, "to follow up, to see if they could
make contact and get some of the underlying data."

The consulting firm was ChemRisk. It was founded 18 years ago by a
prominent toxicologist, Dennis Paustenbach, who has consulted for
dozens of companies and serves as a Bush appointee on a board of
scientific advisers to the U.S. Centers for Disease Control and
Prevention. According to a tally in a textbook he edited, he helped
save industry hundreds of millions of dollars in cleanup costs for
chromium pollution in New Jersey. His firm was paid more than $7
million for this help, Dr. Paustenbach has testified.

ChemRisk assigned an affiliate in Shanghai to track down Dr. Zhang,
and it found him at his home in JinZhou in northeast China. ChemRisk
then hired Dr. Zhang at $250 a month to consult.

His 1987 study focused on five villages downstream of the JinZhou
Ferroalloy Co. smelter. Village wells were polluted with chromium. His
study said the contaminated area had a higher death rate from all
cancers, but especially stomach and lung, than the surrounding region.

ChemRisk scientists didn't dispute that. But they sought to determine
whether individual villages' levels of chromium exposure correlated
with their death rates. The idea was that if chromium was really the
culprit, then the death rate ought to be highest in the villages with
the most exposure to chromium.

Unfortunately, Dr. Zhang's data weren't good enough to determine
individual villages' exposures to chromium. So as a surrogate,
ChemRisk looked at villages' distances from the pollution source -- on
the theory that the shorter this distance was, the more chromium
exposure the village probably got.

They concluded that cancer death rates weren't always higher the
closer the village was to the pollution source. That finding led them
to doubt that chromium was to blame for the five-village area's
overall higher cancer death rate.

A ChemRisk biostatistician wrote in a 1995 internal memo that he
foresaw two "products" for PG&E from ChemRisk's work with Dr. Zhang.
One was a report that could be the basis for trial exhibits showing
"the absence of the association between cancer and groundwater
exposure to hexavalent chromium," said the memo. Like many others, it
is on file in state court in Los Angeles County, where PG&E -- the
defendant in the Erin Brockovich case -- is again facing litigation by
residents alleging chromium pollution.

The other product, wrote the ChemRisk scientist, William Butler, would
be a report to be submitted to a peer-reviewed journal, with Dr. Zhang
as the lead author. Dr. Butler requested a budget of $25,000, which he
said would cover 60 hours of his own time to, among other tasks,
"interpret data" and "write reports." He budgeted Dr. Zhang's
contribution as "research assistance."

Dr. Butler added: "It is at times difficult to convince Dr. Zhang of
the importance to us of the specific details of his studies so that we
can execute our own analyses."

Three weeks later, ChemRisk faxed Dr. Zhang a draft of a new study of
the five villages, translated into Chinese. While reiterating the
overall higher cancer death rate, it offered ChemRisk's new analysis
saying village distances from the smelter didn't always correlate with
death rates. Dr. Zhang wrote back that "I totally agree with what you
wrote: 'There is no positive correlation between cancer mortality and
the distance of the village to the pollution source or the level of
contamination." "

However, Dr. Zhang had previously told ChemRisk he never tried to
assert such a link. And after reading the draft, he told the firm he
didn't accept its conclusion that "lifestyle of the residents and
other environmental factors unrelated to chromium contamination" might
explain the overall higher death rate for the contaminated area.

"This is only an inference; it is inappropriate to consider it as a
cause," he wrote to ChemRisk, in a letter filed in California state
court. Dr. Zhang instructed the consulting firm to replace that
assertion with a vaguer one mentioning several possible variables, as
well as the need for more research.

Yet the report, as later published, even more strongly linked the
higher cancer mortality to lifestyle and other non-chromium factors.
Instead of saying these might be the cause, the published report
called them the "likely" cause.

The published report then went further and stated flatly that the
higher rate of cancer death in the five villages was "not a result of
the contaminated water." Neither stomach-cancer nor lung-cancer deaths
"indicated a positive association with hexavalent chromium
concentration in well water," the published article said. Neither of
those statements was in the draft that was translated into Chinese for
Dr. Zhang to read.

Did Dr. Zhang change his mind and sign on to these conclusions?
Documents and testimony by former ChemRisk scientists show that
ChemRisk drafted the text and graphics of the final report in English,
on ChemRisk computers, three months after translating the earlier
draft into Chinese. Dr. Zhang, who died in his late 60s in 1999,
couldn't speak English, the ChemRisk scientists testified.

In depositions, former ChemRisk scientists acknowledged they might not
have translated the final article into Chinese. But they maintained,
and continue to assert, that Dr. Zhang was aware of its contents from
phone conversations and from the early draft he did read. Tony Ye, a
former ChemRisk scientist who speaks Chinese and served as the liaison
with Dr. Zhang, testified that he kept Dr. Zhang "informed" of
everything ChemRisk concluded for the article and that it was
published with Dr. Zhang's "agreement."

Dr. Zhang's son, Zhang Hongzheng, bristles at the idea that his father
would wittingly have retracted his award-winning 1987 findings. Dr.
Zhang was "sure of the relations" between cancer and chromium-6, says
the son, who says he helped his late father in the research. "My
father's 1987 article won an award. It's impossible that he would have
overthrown what he said. That's like saying his previous painstaking
effort was a total waste," the son said in an interview.

In December 1995, ChemRisk submitted the new study of the villages to
the Journal of Occupational and Environmental Medicine. ChemRisk's Mr.
Ye signed the cover letter and gave his own home address and phone
number as contact information, as he did in subsequent correspondence
with the medical journal. His letters to the publication were written
on plain white paper and made no reference to either ChemRisk or PG&E.

Asked why not, a former ChemRisk official said it was because the
study was "not a work product, per se," of the consulting firm. The
official, Brent Kerger, was manager of litigation services for
ChemRisk, which at the time was a unit of an engineering firm called
McLaren/Hart Inc. He and ChemRisk's founder, Dr. Paustenbach, both
testified that ChemRisk had wanted to have credit on the paper but
that Dr. Zhang told Mr. Ye he didn't want to let the consulting firm
share in his authorship.

Mr. Ye, in an interview, said he didn't recall Dr. Zhang ever telling
him that.

PG&E says its role should have been acknowledged when the article was
published. "The lesson in this case is that it's in everyone's
interest to have full transparency," said a spokesman for the utility.
He added that "nothing published in the scientific literature since
[1997] challenges Dr. Zhang's research and conclusions." PG&E paid
ChemRisk about $1.5 million in all for litigation support, according
to Dr. Paustenbach's testimony. Other court documents said that
included about $20,000 for the China research.

The medical journal that published the study required acknowledgment
of research support, both then and now, said its editor, Prof. Paul
Brandt-Rauf of Columbia University. "It sounds like there were some
things that, had I known, I might not have approved of, including not
telling us who their funders were," he said.

One person who did appear on the article -- but seems to have played a
minimal role in it at best -- was Li ShuKun. The article listed her as
co-author. According to Dr. Zhang's son, she was his father's
girlfriend and did no research. Dr. Li, a physician at a health and
anti-epidemic station, wouldn't discuss her relationship with Dr.
Zhang but said he asked her to write the report from his data because
he was busy, and she did so, in Chinese. She said she never saw it
again. Former ChemRisk scientists said they never received a Chinese
draft. They testified in California court that they had no contact
with Dr. Li. They said they added her as a co-author at the request of
Dr. Zhang.

The 1997 article began to influence scientific views. In 2000, the
U.S. Agency for Toxic Substances and Disease Registry updated its
chromium profile, adding a paragraph about the 1997 study. The passage
concluded with the concept Dr. Zhang had pointedly rejected in his
memo to ChemRisk. The entry said the 1997 study's authors "commented
that these more recent analyses of the data probably reflect lifestyle
or environmental factors, rather than exposure to chromium(VI)."

Soon other bodies, such as the Environmental Protection Agency and the
California Department of Health Services, also cited the second study
to that effect. A 2001 report by a special panel of scientists for the
state of California discussed the 1997 paper and concluded there was
no need to tighten chromium-6 standards.

Dr. Paustenbach, the ChemRisk founder, served on this panel. He
resigned before its report was issued because of a public flap over a
perceived conflict of interest, since his firm was a consultant to
chromium defendant PG&E.

When the panel's report came out, Dr. Paustenbach emailed it to his
former colleague Dr. Kerger, with a note: "Buy a good bottle of wine,
pull up a chair...and then read this. Then, say to yourself 'Yep, I
really finally did something good for society." "

California's Office of Environmental Health Hazard Assessment had also
begun looking into the 1997 study, however, and assigned an
epidemiologist to review it. He found several "limitations and
oddities," he later wrote. For instance, the study called for "further
follow-up of this cohort," implying that it was, itself, a follow-up
of a cohort of villagers, which would make it a particularly rigorous
kind of study. In reality, there was no follow-up of individuals.

The state epidemiologist, Jay Beaumont, described in internal memos
what he suspected were improprieties in the 1997 study. He listed them
under the heading "The Case for Scientific Publication Fraud,"
including: "ChemRisk did virtually all the work and didn't mention
themselves. Zhang maybe did no new work, yet is first author"; and,
"Acknowledgement of funding not made."

Redoing Dr. Zhang's 1987 analysis in greater detail, Dr. Beaumont
calculated that in the overall area with chromium-tainted well water,
the odds of dying from stomach cancer were 81% higher than in adjacent
nonpolluted areas and 69% higher than for the province as a whole.

Dr. Butler, the former ChemRisk biostatistician, says such a
comparison isn't appropriate because the surrounding area includes an
industrial town whose population isn't comparable to that of the five
polluted villages, where farmers live. Minus that town, Dr. Butler
said in a written reply to questions, "I see no...patterns of cancer
rates that challenge the conclusions" of the 1997 study. Dr. Butler
acknowledged four "minor errors" in the 1997 study that he said didn't
change its conclusions.

California's Dr. Beaumont found insufficient evidence to assume that
contamination was higher closer to the smelter, as the 1997 analysis

But ChemRisk's Dr. Kerger maintained that distance was "a reasonable
surrogate for chromium-6 exposure." Using that surrogate, the 1997
report said villages where people presumably got the most chromium
exposure didn't always also have the highest rates of cancer death.

In scientific terms, there was no "dose response." And this, Dr.
Kerger said in his own written response, is "a critical consideration
in determining the validity of a claimed association between chemical
exposures and cancer."

Dr. Kerger maintained that the article didn't represent itself as a
follow-up of a "cohort" of villagers. He said he would agree that use
of the term "cohort" once in the study "was not an ideal choice of

He added: "The bottom line is that all of the text, table and figures
in the final manuscript were considered to be appropriately detailed
and complete by Dr. Zhang and by the peer reviewers."

California's Dr. Beaumont has submitted his own analysis to a science
journal, where peer reviewers have given him comments, according to a
spokesman for his agency. California regulators have set aside the
2001 report by a special panel of scientists, partly because of Dr.
Beaumont's analysis. Based on many studies besides those in China,
they are expected soon to propose a "public health goal," or safe
limit, for chromium-6 in drinking water.

This would be the nation's first such limit focused just on the most
toxic form of chromium. Currently, water standards exist only for
total chromium. The EPA's is 100 parts per billion, and California's
is 50 ppb. For chromium-6, California is likely to propose a safe
limit of only about three ppb to six ppb, early drafts suggest.

A standard that strict could compel widespread cleanup. The metal has
already been found above three ppb in more than 1,200 water sources in
California. If other states or the EPA followed California's lead,
treatment and litigation costs could soar nationwide.

Meanwhile, the second Zhang study is still having an influence.

Ore-processing plants in northern New Jersey once produced millions of
tons of chromium waste that was used as landfill throughout Hudson and
Essex counties near New York City. Chromium-6 has turned up in Jersey
City Little League diamonds and, this fall, near the Weehawken-
Manhattan ferry terminal.

ChemRisk's Dr. Paustenbach has been instrumental over the years in
persuading New Jersey regulators to ease cleanup standards for the
metal. An article he co-wrote was cited in a recent New Jersey report
that concluded it still wasn't known whether chromium-6 is
carcinogenic when ingested. One plank of the Paustenbach argument:
that Dr. Zhang's "follow-up study" didn't find a cancer link.

New Jersey's chief risk analyst, Alan Stern, says he's aware Dr. Zhang
published an earlier study tying chromium in water to cancer deaths --
the study that California regulators now believe is accurate. But, he
says, "we haven't read it because it's in Chinese."


Ivy Zhang in Shanghai contributed to this article.