WVU researchers hid legal conflict, records show

WHEELING, W. Va. - West Virginia University researchers took money from U.S. taxpayers and plaintiff lawyers, hid the conflict of interest, and produced questionable research for the benefit of the lawyers.

A journal that published their study of solvent exposure among CSX railroad workers in 2006 admitted last year that five out of eight authors "provided expert testimony in legal cases involving exposure to solvents."

The journal didn't explain that this fact sullied the researchers' work, for the authors signed statements declaring they had no conflicts of interest.

The researchers had testified against CSX on behalf of workers whose lawyers paid a nonprofit institute at WVU for the testimony.

Lead researcher Marc Haut testified last year that he received half of each payment.

The journal didn't confess what Ohio Circuit Judge Arthur Recht revealed in May: the lawyers supplied clients as research subjects.

Though researchers promised they would exclude workers in litigation, they interpreted the promise as license to include workers with past and future lawsuits.

For that reason and others, Recht rejected the study as evidence in trials over claims that seven workers suffered brain damage.

Recht found no evidence that the study was reasonably reliable or appropriate, adding that "the evidence demonstrates the opposite."

He found that the study wasn't designed to be capable of proving cause and effect. He also found that the authors relied on magnetic resonance images although the federal grant that supported them specified a more precise instrument.

Origins of the study

The idea for the study started 11 years ago when University of Pittsburgh researcher Lisa Morrow applied to the Centers for Disease Control and its National Institute for Occupational Safety and Health to study effects of long term solvent exposure on the brain.

Both groups rejected it. She revised it, resubmitted it, and both groups rejected it. She revised it and resubmitted it, and in 2001 both groups awarded a three-year grant.

Morrow subcontracted most of the work to West Virginia University where Haut led the research as principal investigator.

To create a study group, the university recruited 31 CSX workers out of 258 who had seen university doctors about solvent exposure. The university found 31 other subjects for a control group.

In 2004, Morrow applied for an extension and received it.

In June 2006, the Journal of Occupational and Environmental Medicine published "Corpus Callosum Volume in Railroad Workers with Chronic Exposure to Solvents," by Haut, Morrow and six others.

"This study supports the hypothesis that occupational exposure to solvents affects the anterior white matter of the brain and is related to extent of exposure and degree of cognitive change," Haut wrote.

The Louisville Courier-Journal wrote about the report under a headline declaring, "Study shows solvents damaged workers' brains."

In a Sept. 5, 2006, article, Haut told Courier-Journal reporter James Bruggers, "We were able to identify a change to the structure of the brain."

The Huntington Herald-Dispatch reprinted the story the next day.

Into the courtroom

A month later, CSX -- defending itself in a 2001 Ohio County suit against clients of the Pittsburgh law firm of Peirce, Raimond and Coulter -- served a subpoena on Haut for MRI results and other data.

WVU's board of governors resisted the subpoena. At their direction, assistant state attorney general Kristi McWhirter asked Recht to quash it.

"Although Dr. Haut has been named as an expert witness by the plaintiffs in this action, he has not been retained as such by the plaintiffs and in fact became aware that he had been named an expert witness only after receipt of the subpoena," McWhirter wrote in a Nov. 21, 2006, motion.

She wrote that a federal certificate of confidentiality prohibited disclosure of information that might identify subjects of sensitive research.

She went on to invoke freedom of the press.

"Dr. Haut clearly meets the definition of an individual engaged in a news gathering activity," she wrote.

The next day, the Peirce firm pulled out of the case. Eventually another Pittsburgh firm -- Caroselli, Beachler, McTiernan and Conboy -- would handle it.

CSX lawyer James Turner, of Huddleston Bolen in Huntington, answered that the information belonged to citizens of the United States.

"The research data is property of the public and Dr. Haut cannot deprive CSX of access to it by claiming a proprietary interest," he wrote in a Dec. 6, 2006, response.

He wrote that Haut issued reports on 72 plaintiffs in the case.

In 2007, Recht ordered Haut to disclose exposure histories, interviews, tests and MRIs for all research subjects after removing data that might identify subjects. He ordered CSX to pay Haut for the time to produce the data "at his acknowledged standard rate of $250 an hour."

Upon further review �

CSX hired University of Michigan neurology professor Kirk Frey to review the data. In 2008, his opinions prompted Turner to depose Haut in a Kentucky case.

Turner told Haut, "That data that you generated from those MRI films was subpoenaed by me on behalf of CSX and it has been reviewed," Turner told Haut during a Jan. 18, 2008, deposition in that Greenup County, Ky., case. "Would you be interested in publishing with other researchers that have looked at that same data set?"

"My understanding was that when we released that data, that kind of thing was not going to happen with that data," Haut said.

"What kind of thing?" Turner asked.

"That whoever that data went to was not going to look at and evaluate those scans and publish that kind of information," Turner replied. "You don't own that data."

Turner later asked Haut if plaintiff lawyers referred research subjects.

Haut said he didn't believe that was the case.

Turner asked if everybody had litigation resolved in the past.

"Did everybody have litigation at one point?" Haut asked.

Turner said, "Yeah, the litigation was just over by the time they were in your study?"

Haut said, "I don't think that's true for everyone."

Turner asked if he could determine whether or not anyone in the study had been involved in litigation. Haut said he didn't know.

Turner read Haut's line in the Courier-Journal about a change in brain structure and said, "You actually didn't identify a change, did you?"

Haut said, "No. When I hear that, without being too puny, I would change the word, change, to a difference."

Haut said, "I would say we identified a difference in the volume of the brain and the size of the brain."

Turner said, "The entire brain volume or just the volume of one structure in the brain?"

Haut said, "The volume of one structure, the corpus callosum."

Turner showed him a blank disclosure form of the Journal of Occupational and Environmental Medicine and asked if he completed a form like it.

Haut said he assumed he did.

Turner said there was no indication in the published paper that Haut or others indicated that they ever provided expert testimony.

"That is something that we should acknowledge and I don't see that acknowledged in the paper," Haut replied.

Turner said he would pay $500 for the deposition and asked Haut if he would keep it.

"It is payable to University Health Associates," Haut said, adding that his department would give a portion back to him.

Turner asked the percentage, and Haut said 50 percent.

Turner asked how much money he made in the last five years for being involved in litigation, and Haut said he had no idea.

Former litigants?

In another deposition in the same Greenup County case, Alan Ducatman, chair of the community medicine department in WVU's medical school, said he billed at $700 an hour.

"I get none of it," Ducatman said.

Turner asked if he negotiated a salary increase to accommodate the fact that he wasn't taking any of the money.

Ducatman said he had negotiated.

"If we're doing this it's legitimate for us to not be doing something else and so that's the way we have negotiated and I think that's really reasonable," he said.

Turner asked if persons in previous litigation qualified for the study. Ducatman said yes.

Turner asked if there were former litigants in the study.

"I assume so," Ducatman replied. "I think it's logical to conclude so."

Turner persisted.

"It may be an important question to you," Ducatman said. "It was never one to me for study purposes."

Turner asked if it would have been better to study subjects who never had been litigants.

"This is a neuro imaging study," Ducatman said. "The part of your brain where you can see whether or not you've been a litigant is hard to find.

"It would be ideal if these folks never had a vested interest. However, their vested interest goes beyond litigation, past, present or future. Their vested interest is implicit in their concern about their health.

"These are discussions actually we had at the outset."

"It was determined that it was appropriate to permit those people in?" Turner asked.

"That's correct," Ducatman replied.

'I doubt anybody will care'

Turner asked if the plaintiff in the Kentucky case at issue was a study subject.

"I do not know," Ducatman said. "You would have to ask him."

Turner repeated Haut's line about substituting "difference" for "change," and Ducatman said it should have been difference.

"Most readers would be more than sophisticated enough to read it and understand what we mean," Ducatman said.

Turner showed him the journal's disclosure form.

"I talked with Marc about that," Ducatman said. "He advised me that it's not true, that it's a mistake.

"When I looked at it, I thought that I was a consulting physician and not giving expert testimony; and I thought that it was about neuro imaging and not about the people."

Ducatman said he asked Haut to write to the journal.

"What happens from that point?" Turner asked.

"I doubt anybody will really care," Ducatman said. "We will have corrected the record and the journal may decide to do any number of different things but I doubt anybody will care.

"It's really hard to change your neuro imaging because somebody was deposed."
Turner asked if involvement of researchers in litigation might interest readers if former litigants were study subjects.

"The disclosure that former litigants are in it is already in the paper," Ducatman replied.

"It actually doesn't say that," Turner said. "It never said, doesn't say, that you could be included and be a former litigant."

"I hear you from an attorney's perspective trying a case," Ducatman said. "I find it hard to accept that you don't like the wording of how we said who was included and who was excluded. �

"If the goal of this line of questioning is to attack us because we made a mistake on how we submitted it, I get it. If it's about me because you can't do something better, then I get it.

"If by being former litigants, you think that all of these men made up this preposterous story about their exposure, not to mention what is found in the waste streams outside the plant, the water, then you have a point."

PET vs. MRI

At a 2008 hearing, CSX lawyer Scott Winkelman of Washington told Recht that, "Within the 31 who say they were exposed there is every reason to think, and now the authors say, that former litigants, perhaps even litigants in this court, were within the test population."

Winkelman said the original goal was to look at positron emission tomography, or PET.

"The actual study, as it turns out, had nothing to do with PET," Winkelman said during the May 1, 2008, hearing in Wheeling.

Turner told Recht that Haut conceded he didn't measure a change and that Haut failed to disclose conflicts of interest to journal readers.

Turner called to the stand Michigan professor Frey, director of the university's division of nuclear medicine and co-director of its movement disorders clinic.

Frey said PET relies on tracers that give off subatomic particles as they decay. He said it allows very accurate high resolution images where tracers have deposited.

He said MRI provides images of body parts based on distribution of water molecules. He said it conveys little or no information about function.

Turner asked if Haut measured cerebrospinal fluid volume. Frey said they didn't.

Frey, who had measured it, said he found no difference between the groups.

Turner asked if researchers relied on memories of people who felt they were brain damaged for accurate recall of solvent exposure.

Frey said that was implied in the design.

Turner asked what memory function the corpus callosum serves. "None that I am aware of," Frey said.

The journal's next issue, May 2008, admitted that "author disclosures were incomplete."

A little box with "Erratum" for a headline advised that Haut, Ducatman, Morrow, and authors Michael Parsons and Allene Scott provided expert testimony in solvent cases.

'An interesting statement'

Recht held a hearing this January to take testimony from the neurologist he had asked plaintiffs to produce, but they brought no neurologist forward.

CSX brought forward James Albers, another Michigan neurology professor. Recht asked him if the study provided evidence of brain damage related to solvents.

"No, what it purported to find was atrophy of one portion of one white matter track," Albers said, adding that the statistical significance was borderline and a more sensitive technique didn't substantiate the differences that were reported.

On cross examination, plaintiff lawyer John McTiernan of Pittsburgh asked if Albers would agree it was difficult to find a group that hadn't been in litigation.

"I don't think that's hard at all from the past, unless all of these workers are involved in some form of litigation," Albers replied.

Albers said he was involved in a study in the 1980s, and no one was involved in litigation.

McTiernan asked if he only saw people that come to litigation.

"Yes, and isn't that an interesting statement?" Albers replied. "Why don't these people come to standard conventional medical centers for evaluations?"

He said Frey never saw a diagnosis of this syndrome other than in litigation.

"There's something wrong with what's going on," he said.

He called it psychosocial diagnosis.

Recht told Albers he hadn't seen or heard from a neurologist who would disagree.

"Why is that?" Recht asked.

"I think you have to ask the plaintiff's attorneys," Albers replied.

"The occupational physicians are looking more toward compensation continually than attempting to make the proper -- well -- determining the cause," Recht said. "This seems to be compensation driven versus medically driven."

No support of theory

The May 19 order Recht signed four months later found that, "Although the hypothesis in question involves allegations of brain injury, plaintiffs have failed to produce a neurologist or any competent neurological evidence in support of their theory."

Recht wrote that the study did not and could not measure changes in brains. He found the results questionable due to significant bias in selection of study subjects.

"Indeed, some of the litigants were likely former litigants, which further fuels the possibility of exaggerated reports of exposure," he wrote.

He identified remaining plaintiffs in the case as John Childers, Charles Clemons, Marvin Ferrell, Phillip Knipp, Jack Little, John Schneider and Kenneth Tschop Jr.