Altman, Lawrence K. "Flawed Study Raises Questions on U.S. Research," New York Times, 15

 

Altman, Lawrence K. "Flawed Study Raises Questions on U.S. Research," New York Times, 15
March 1994, p. C14.

"Reports that a Canadian researcher falsified data in a major breast cancer study and that leaders
of the study and Federal health officials delayed disclosing the situation are raising serious
questions about the quality of medical research, and honesty of medical researchers and the
various ways studies are done.

"The investigation also raises issues of medical and academic politics, such as how soon medical
practice should be changed by results of experimental studies. Many practitioners prefer to wait
for additional experience after initial reports in medical journals because they are aware than
scientists are often under pressure to include enough patients to meet their quotas and face a need
to publish to continue to get grants. And they remember that results of some studies turned out to
be flawed.

"Then there is the growing criticism of the peer review system that editors of journals use to
screen manuscripts for publication. There is a widespread misconception that scientific journals
examine the raw research data. They do not. They evaluate the summaries of filtered data, which
can make it difficult, if not impossible, to detect fabrications.

"Even the centers that coordinate large studies involving many hospitals deal primarily with
derivative data. The coordinating centers often do not get original documents, except when they
conduct random audits or when suspicions are raised about the nature of a scientist's research."

The flawed study is described here as having involved 5,000 physicians at 484 additional
academic centers and community hospitals in the U.S. and Canada. It was headed by Bernard
Fisher of Pittsburgh. It has cost "tens of millions" and been going on for more than two decades.

The falsifications discovered were made by Roger Poisson who fabricated data on more than 100
of the 1,511 patients he enrolled as his part of 22 studies from 1975 until 1991.

Poisson's statements to federal officials "creates the impression of an emotionally charged
researcher who deliberately ignored what he saw as trivial rules of the study more than a
dispassionate scientist who stove for objectivity and precision."

In a written reply to ORI, he is reported to write: "‘I always feel sorry for a nice case to be denied
the right to enter a good protocol just on account of trivial details: a difference of a few days in
the data of surgery because the patient took a long time to decide.'

"‘When I lost a patient who did not wish to participate,' he said, ‘I always took it as a personal
defeat, knowing that the best protocol with the best biostatisticians is useless unless enough
patients are registered,' he said."

"He described the pressures he felt in asking a patient to participate in the study. ‘People who are
no on the front line of the battle have no idea how frustrating it can be to prepare an eligible
patient for the trial, with several pep talks and a great deal of discussion, explanation for the
informed consent and to convince the patient to participate and - at the last moment - to realize
that the patient' is ineligible for what he perceived to be a technicality, Dr. Poisson said. "It is a
feeling of let down and of frustration.'

"Dr. Poisson also wrote:

"‘In several ways, I have been the victim of my own success. Was I dishonest? How many times
have I heard, ‘Dr. Poisson, I cam to consult you because you have been highly recommended to
me. I heard from several sources that you don't operate without good reason or remove a breast
needlessly. My other surgeon wanted to do a radical mastectomy on me. What do you think?'"

Poisson seems to think his transgressions were minor, merely white lies. "‘Why would someone
in my position knowingly take such enormous risks with so few precautions, if I had realized that
I was committing such a crime? Had it been intentional, I would surely have been much more
circumspect, and used a professional, or certainly a more skilled, well-coached and sophisticated
staff.'"

Sad to relate: "Detection of the falsifications in the breast cancer surgery study seems to have
grown out of a fluke observation. The Office of Research Integrity report said that in June 1990
staff members in Pittsburgh found in their files two reports of a breast cancer operation for one
patient at St. Luc's Hospital. The patients appears to be identical, except that they had different
dates of surgery, and the discrepancy determined whether they were eligible for the study."

Subsequent audits revealed that 5 to 10 percent of the patients' files contained irregularities. A
complete review of the 1,511 cases at St. Luc's revealed repeated violations.

In January, 1993, a letter was sent Dr. Fisher urging him to review what auditors had found and
warning that these errors had been undetected for over a decade. Another concern: the small
number of audits Fishers' reviewers had done. The errors of St. Luc's had not been caught.

Dr. Judith Swazey, the Acadia Institute in Bar Harbor, Me., suggests: "‘when cases like this
come out, it justifies one explanation for their (clinicians') conservatism (in therapeutics),
...games do go on in research.'"