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How the company tried to discredit U.S. study
Thursday, June 22, 2000
By ANDREW SCHNEIDER
WASHINGTON -- Two decades ago, a U.S. government study concluded that workers at R.T. Vanderbilt Co. talc mines were dying from asbestos-related disease.
But an unauthorized collaboration between Vanderbilt and two government scientists tried to discredit the study, and influenced a federal agency to abandon efforts to regulate the asbestos fibers found in the talc.
Even though the scientists were ultimately disciplined for their unreported relationship with Vanderbilt and left their government jobs, the renegade report they produced is still hindering efforts to protect workers and consumers, health officials say.
In 1980, the National Institute for Occupational Safety and Health published a study examining the health of miners and millers in the talc mines around Gouverneur, N.Y. It documented health problems caused by two forms of asbestos -- tremolite and anthophyllite -- and a significant increase in asbestos-related diseases.
The agency, responding to a request for a health hazards evaluation from the talc miners and their union, used company records to identify 710 men who worked with the ore between 1947 and 1978. NIOSH found the death rate from non-malignant respiratory disease in that group to be almost three times higher than what was expected. Lung cancer cases occurred at twice the expected rate.
"This means that it was very unlikely that an excess of deaths that large would have occurred by chance," Dr. Elizabeth Ward of the agency's Division of Surveillance, Hazard Evaluations, and Field Studies said last week.
"We continue to believe that these are valid scientific reports," she added.
"NIOSH's position on these studies was there was asbestos in the talc," Ward said. "I'm not sure what more I can say."
Now, 20 years later, NIOSH stands by its studies.
Dr. John Dement, who headed the NIOSH team doing the Vanderbilt studies, says he hasn't "backed down at all.
"There's a lot of semantics being played again in regard to the definition of asbestos, but the lung and (its lining) doesn't care about what it's called. That mine has asbestos fibers of biological significance which have caused and most likely, continue to cause, health problems for the miners and others exposed to them," says Dement, now a Duke University professor. He still specializes in occupational safety and health research.
Vanderbilt denounced the studies when they were published, and still does today.
The studies were incorrect, flawed and criticized by the NIOSH's own scientists, says John Kelse, Vanderbilt's corporate risk manager.
The part about the internal criticism is true.
In 1986, John Gamble, an epidemiologist assigned to NIOSH's Division of Respiratory Disease Studies in Morgantown, W.Va., criticized the agency's 1980 study.
But the facts behind his criticism launched an investigation by NIOSH Executive Officer Larry Sparks and the inspector general for the Department of Health and Human Services.
The investigators said they found "frequent private visits and contacts" between Vanderbilt officials and Gamble and Bob Glenn, who headed the respiratory disease division. The investigators' report said "complimentary meals and travel" were accepted, and there was an "enormous, continuing conflict of interest" that tainted the work done by Gamble and Glenn.
The investigators examined what they termed a "private" four-year relationship between a handful of NIOSH scientists and Vanderbilt officials, including Hugh Vanderbilt, the company president. They documented scores of letters and more then 14 meetings -- many lasting a full work day -- that senior NIOSH officials knew nothing about.
The discussions began in 1984 when Vanderbilt officials contacted Gamble to express concerns over the 1980 report and its impact on the definition of asbestos that the Occupational Safety and Health Administration was about to make into law, NIOSH documents showed.
This "project" was "intentionally concealed" from NIOSH staff and its director, the investigators determined, adding that there was no research protocol and there was no peer review. The tradition in NIOSH and other government agencies for researchers to share information and seek opinions from other scientists apparently never happened.
Since it was unauthorized, the epidemiologist's work would be of no value to Vanderbilt if it wasn't made public. So, according to the investigators, members of the Morgantown lab "developed a strategy" to have Vanderbilt request a Health Hazard Evaluation to update the critical 1980 study. Glenn assigned the job to Gamble, who had been privately meeting with Vanderbilt.
Just two weeks after being given the assignment, Gamble submitted a "preliminary" 22-page report with 47 references to Glenn. It criticized most NIOSH's findings in the original Vanderbilt study.
On July 8, 1986, even before the report was submitted, Vanderbilt's Kelse contacted Glenn, requesting a copy, the investigators found.
Other NIOSH scientists raised concerns over how the report was done.
Regulations say an evaluation of this type must have input from not only the company, but also from the union and other concerned government agencies.
"All information used by the investigators was supplied solely and directly by Vanderbilt or its consultants," the report said.
It also listed other troubling departures from policy, including Gamble bypassing the chain of command and reporting directly to Glenn.
About the same time -- June 17, 1986 -- OSHA issued a new standard which defined tremolite and anthophyllite as asbestos -- the same fibers found in NIOSH's 1980 study as the likely cause of the death and illness of Vanderbilt's miners.
Three days later, Vanderbilt filed a challenge for review in the U.S. Court of Appeals. Almost immediately, Vanderbilt's Kelse wrote to Gamble, saying that his study was "the best hope" in the company's effort to overturn the OSHA standard.
It was July 1, 1986, when Dr. Donald Millar, NIOSH's director, first learned of the unsanctioned study. That morning, Hugh Vanderbilt and a lawyer showed up at the agency's Atlanta headquarters to pick up the study and the supporting memos under a Freedom of Information Act request. Glenn had hand-carried the material to Atlanta so Vanderbilt could get it quickly.
In December 1987, Millar was called by Labor Secretary William Brock, who said he had met with Vanderbilt officials. He wanted to know why OSHA had not been told about Gamble's study and questioned what NIOSH's position was on its 1980 report and how it was defining asbestos.
Millar quickly wrote to OSHA, saying that "the NIOSH definition and policy regarding asbestos has not changed."
On June 8, 1992, OSHA decided to eliminate the part of its standards which would have regulated the asbestos found in Vanderbilt's mine, based in part on "certain NIOSH staff memos which have recently been brought to its attention."
One NIOSH official characterized the impact of the "spoon-fed study" accepted by OSHA as "a bell that couldn't be unrung."
In the conclusion to its report, the investigators wrote:
"Based on their inappropriate actions in the course of pursuing the studies of workers employed by the R.T. Vanderbilt Co., appropriate disciplinary action is being taken."
Glenn said this week that neither he nor Gamble was "fired or let go."
"Let's say the scientific views by some in NIOSH differed with others, including ours. I thought that's what scientists were suppose to do. You know, debate and argue."
Gamble could not be reached for comment.
John Kelse, director of risk management for Vanderbilt, said yesterday: "It was an internal conflict. If you want to have a good study done, the company has to be involved. How can you have your plant studied if you're not part of the process? I don't see that as any conflict of interest."
Millar convened a "board of scientific counselors" to review the the study that Vanderbilt wanted released so badly. The board concluded that the "updated study supports the finding of an excess risk for lung cancer and non-malignant respiratory disease which was observed in these workers by NIOSH researchers in 1980."
Glenn said the study that he and Gamble did wasn't unauthorized nor was there a conflict of interest, "but I really don't want to go into all the details."
When asked how he balanced his, Gamble's and Vanderbilt's views that there wasn't harmful asbestos in the talc with the documented cases of hundreds of miners being sickened and killed by asbestos, he answered: "I'd have to see the medical studies, but I'm not a doctor."
Neither OSHA nor the Mine Safety and Health Administration has made any effort to change the controversial ruling, which has left the miners without help for decades.
"The fact that these fibers, which are respirable, can get into the lungs, can cause disease, but are not regulated, means that these miners and the people who use their products are not being protected under federal standards as they should be," says Dr. Richard Lemen, a former associate director of NIOSH and a former assistant surgeon general who teaches at Emory University.
"Although OSHA has not formally announced that it intends to reopen the record for further rulemaking, it is closely monitoring the toxicological data and hazard information on asbestos and other mineral fibers. If these data indicate that workers may be at significant risk of material impairment of health, OSHA will initiate rule making," an agency spokesperson said yesterday.
Lemon said the effect of Gamble's study on NIOSH scientists' desire for credible and unbiased research "should not be underestimated."
"It was indeed a low point to the morale of the institute, but at the same time a very significant event as the institute took quick steps to assure such behavior would not recur," Lemen said.
Nevertheless, miners in all mines that have asbestos as a contaminant -- including talc, vermiculite and taconite -- continue to work under health regulations that fail to take the contested fibers into account.
P-I senior national correspondent Andrew Schneider can be reached at 206-448-8218 or andrewschneider@seattle-pi.com
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