Date: Thu, 10 Jun 2004 08:51:05 -0400
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Subject: Cancer Study Publication Problems
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Stories from the 2 most recent issues of the
Chronicle of Higher Education.

I think it raises important issues about occupational health research...

- Ralph

From the June 4 issue:

Boston U. Researcher Presses Ahead With Plans to
Publish Cancer Study That IBM Wants to Stifle


A JURY OF PEERS: Richard W. Clapp's study of
cancer risks among semiconductor workers at IBM
manufacturing plants never made it to a widely
watched trial in which the corporation prevailed
in February.

But the study, which suggested that those workers
were at greater risk of dying of cancer than
average Americans were, may yet see the light of
day in a medical journal, despite IBM's
insistence that publication would violate a court

In his study, Mr. Clapp, a professor of
environmental health at Boston University,
cross-referenced the company's death-benefit file
with another IBM file that included employee work
histories and job titles. From that process, he
says, he was able to draw statistical conclusions.

He says the analysis is similar to the one he
used in studies of deaths of veterans from the
Vietnam War, work that was published in
peer-reviewed journals in 1988 and 1991. He
submitted his new study for publication in a
forthcoming special issue of the journal Clinics
in Occupational and Environmental Medicine, about
health dangers in the electronics and
semiconductor industries.

Four peer reviewers had read and approved Mr.
Clapp's article, which he wrote with Rebecca A.
Johnson, a colleague from a private consultancy.

Then, in late March, as reported last month in
the journal Science, Mr. Clapp withdrew his
submission, having learned of a stern letter sent
by IBM's lawyers to lawyers for plaintiffs who
had sued the company.

The IBM lawyers contended that the information
that the professor had analyzed as a consultant
to the plaintiffs -- data about employees whose
families had sought death benefits from IBM
-- was provided to him under confidential
conditions, which prevent him from making that
data, or any analysis of it, public.

In addition to invoking confidentiality as a bar
to publication of the study, the company has also
denounced Mr. Clapp's paper as "guesswork." It is
a "litigation-driven, biased analysis of an
unscientific file of data," says Christopher
Andrews, an IBM spokesman.

Mr. Andrews says the files that Mr. Clapp
analyzed included data on all IBM employees, not
just those who worked in semiconductor
manufacturing. The data identified where the
employees lived at the time of their death, but
nothing about where they might have worked
throughout their lives, or the nature of their

Mr. Clapp says his analysis is sound, and that
IBM's charges are spurious. "The lawyers by no
means directed what we were doing," he says.

He also dismisses the company's claim of
confidentiality. IBM's lawyers introduced his
study into evidence during a deposition with him
in August of last year, he says, and they
questioned him about it. After that, he says, it
was up to those lawyers to take action to keep
the analysis private. If it was intended to be
confidential, he says, "it should have been
stamped as such" within a few weeks of the

Mr. Clapp, who now has conferred with his own
lawyer and another at Boston University, says he
is convinced that he should publish his analysis,
both because doing so is in the public interest
and because, legally, he argues, IBM no longer
has the right to keep it confidential. He told
The Chronicle that he will proceed with his
attempt to have the study published, despite
written warnings from IBM's lawyers that doing so
would violate a court order.

"I'm going ahead," he says.

IBM faces about 200 lawsuits filed by current and
former workers and their families, who contend
that the company has concealed information about
cancer-causing toxic chemicals used in the
plants. The case for which Mr. Clapp was hired
was brought by two former employees from IBM's
manufacturing plant in San Jose, Calif. In
February, after a four-month trial, a jury found
that IBM was not liable for their cancers.

Mr. Clapp's study was excluded from that trial.
The judge, agreeing with IBM, determined that the
analysis did not specifically identify chemicals
to which the plaintiffs might have been exposed,
and so was not relevant to the case.

IBM officials maintain that Mr. Clapp's study is
not relevant at all. The company spokesman, Mr.
Andrews, points instead to another study, now
nearing conclusion, by Elizabeth Delzell, a
professor of epidemiology at the University of
Alabama at Birmingham.

That study, being conducted with IBM's
cooperation and $4.4-million in support from the
company, is a "retrospective mortality and
cancer-incidence study" of employes at three
manufacturing plants: Burlington, Vt.; East
Fishkill, N.Y.; and San Jose. IBM commissioned
the study in 1999.

Both IBM and Alabama rejected a reporter's
request to review the sponsored-research
agreement for information on the methodology
being used or what, if any, publication
restrictions might exist. Ms. Delzell declines to
discuss the work, except to say that the contract
with IBM "guarantees that we have complete
control over what we study."

Mr. Andrews says IBM expects the study to be
completed by the end of this year. "We're going
to stand by it," he says.

Those who made the decision to publish Mr.
Clapp's study also stand behind their man. Joseph
LaDou, guest editor of the special issue of
Clinics in Occupational and Environmental
Medicine and director of the International Center
for Occupational Medicine at the University of
California at San Francisco, says he understands
that the study has some shortcomings. But he is
eager to publish it nonetheless.

"It's the most definitive cancer study to date,
despite its limitations, and for that reason it
should be before the scientific community," he

The special issue of the journal is due out in November. Section: Research &
Publishing Volume 50, Issue 39, Page A15

Copyright  2004 by The Chronicle of Higher Education

Thursday, June 10, 2004:

Elsevier Rejects Disputed Study on IBM Workers,
but Authors May Pursue Other Publishing Options

Elsevier rejects disputed study on IBM workers,
but authors may pursue other publishing options

Cuban government orders study group from American college to leave

Another women's institution, Lesley College of
Massachusetts, chooses to go coed

Nationwide strike and violence shut down higher education in Nepal

Under peace accord in Sudan, 3 universities will move back to rebel-held region

A leading publisher of scholarly journals has
rejected a controversial study by a Boston
University professor and a colleague that had
already passed the peer-review process. The
article suggests that workers at IBM
semiconductor plants were at a higher risk of
dying of cancer than the population as a whole.

The publishing company, Elsevier, said its
decision was not based on concerns about legal
retribution by IBM, which maintains that the
authors do not have a right to publish the
article. Rather, Elsevier said that its journal,
Clinics in Occupational and Environmental
Medicine, publishes "only review articles," not
original research, which it says can be found in
the article.

IBM has denounced the study as flawed and
contends that the authors, Richard W. Clapp and
Rebecca A. Johnson, are bound by a court order
barring them from publishing the study because it
is based on data that were provided as part of a
court case under conditions of confidentiality.
Mr. Clapp maintains that the confidentiality
restrictions no longer apply (The Chronicle, June

Mr. Clapp is a professor of environmental health
at Boston University. Ms. Johnson is a private
consultant who helped Mr. Clapp with computer
analysis of the data.

The rejection from Elsevier came in an e-mail
message from Catherine Bewick, the company
executive who oversees the journal and others in
Elsevier's Medical Clinics of North America
series. The message was sent to Joseph LaDou,
guest editor for a forthcoming special issue on
the semiconductor industry.

Ms. Bewick did not return telephone calls or
respond to e-mail messages seeking comment. Her
office said she would be out all week for
personal reasons. Elsevier's director of
corporate communications, Eric Merkel-Sobotta,
said on Wednesday that "the article was rejected
by a guest editor because it was in the wrong

Dr. LaDou, who is director of the International
Center for Occupational Medicine at the
University of California at San Francisco, said
that characterization was "totally untrue."

"I've never said anything of the kind," he said.

Dr. LaDou said it appeared that Elsevier was
"taking the easy way out." He said he does not
consider the article to be original research but
an analysis of IBM's data, "to the extent that
they were willing to share it."

He has been eager to publish the study, which he
considers important despite its limitations. He
acknowledged that the work is not technically a
"review" article because it does not distill
information from previously published studies.

Dr. LaDou said seven of the nine other authors
whose articles are scheduled to appear in the
special issue of Clinics have told him that they
would be willing to withhold their articles -- a
sort of boycott -- unless the study by Mr. Clapp
and Ms. Johnson were published in that journal or
in some other appropriate journal.

As an alternative, Dr. LaDou had hoped to be able
to publish the article in a forthcoming special
issue of the Journal of Occupational and
Environmental Medicine, of which he is also a
guest editor. It is scheduled to appear at about
the same time as the Clinics special issue, in

Dr. LaDou had tried to get the article approved
based on its prior peer review. But on Wednesday
that plan fell apart. The editor in chief of the
Journal of Occupational and Environmental
Medicine, Paul Brandt-Rauf, said that while he
was not concerned about the legal issues related
to IBM, he would still want to submit the article
to peer review, or examine the comments of the
prior peer-reviewers, before accepting it. That
could take several months.

Articles in that journal, which is published by
the American College of Occupational and
Environmental Medicine, often include original

Mr. Clapp could not be reached for comment on
Wednesday, but he has previously indicated that
he might also pursue publishing options with two
other journals that have also expressed interest
in the study. One of them is an online journal.

Since online journals often have shorter
turnaround times for reviewing articles, Dr.
LaDou said that if Mr. Clapp decided to go that
route, he would refrain from pursuing the boycott
of the Elsevier special issue until it became
known whether the online journal would publish
the Clapp-Johnson study.

Copyright  2004 by The Chronicle of Higher Education

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