Monday, December 26, 2005

Heckuva job, Dennis

In a long, superb, and frankly shocking article in the Wall Street Journal (subscription only), Peter Waldman details how a consultant ghostwriter successfully cast doubt on an important Chinese study of the cancer causing effects of chromium VI.

The story starts forty years ago when Dr. Zhang Jian Dong was sent for "re-education" into the countryside during the Cultural Revolution. The rural area he found had groundwater contamnated by chromium wastes from a state-owned smelter.

The well water was 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. (Peter Waldman, WSJ, December 23, 2005, p. A1)
Dr. Zhang retired, but in 1997 published what amounted to a retraction of his work in The Journal of Occupational and Environmental Medicine.
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.
But now court documents indicate Dr. Zhang didn't write the second article. He allegedly saw a Chinese translation of an early draft, was paid $2000 as a consultant by utility-hired scientists who did write it, and they then slapped his name on it (but not the source of funding or any of the true authors' names). The utilities who paid for it were being sued for chromium pollution.

Dr. Zhang is now dead, but it is known he disputed a statement in the paper that the drinking water was not responsible for the cancers. The revisionist study is now under attack by scientists:
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 ground water. 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.
So we know Zhang only saw an early draft, objected to some statements that found their way into the final version, and his name was falsely (and perhaps fraudulently) affixed to the paper as senior author.

Who were the authors of the study, then? The good folks at ChemRisk, prominent consultants who have become wealthy in the "doubt industry," scientists whose objective is to manufacture uncertainty about science inconvenient for their corporate clients.
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.
These are just a few of the nasty items in Waldman's long and detailed article. If you can get access, read the whole thing. There is another long report at the Environmental Working Group website.

ChemRisk is run by hired-gun toxicologist Dennis Paustenbach, and he was eminently satisfied by the results:
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.' "


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.
Heckuva job, Dennis. Sigh.