Allegations of fake research reach new highs in United States

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Allegations of fake research reach new highs in United States
10/07/2005 3:30:00 PM

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(AP) - On the night of his 12th wedding anniversary, Dr. Andrew
Friedman was terrified.


This brilliant surgeon and researcher at Brigham and Women's Hospital
and Harvard Medical School feared that he was about to lose everything
- his career, his family, the life he'd built - because his boss was
coming closer and closer to the truth:
For the past three years, Friedman had been making up data in some of
the respected, peer-reviewed studies he had published in top medical
journals.

"It is difficult for me to describe the degree of panic and irrational
thought that I was going through," he would later tell an inquiry panel
at Harvard.

On this night, March 13, 1995, he had been ordered in writing by his
department chair to clear up what appeared to be suspicious data.

But Friedman didn't clear things up.

"I did something which was the worst possible thing I could have done,"
he testified.

He went to the medical records room, and for the next three or four
hours he pulled out permanent medical files of a handful of patients.
Then, covered up his lies, scribbling in the information he needed to
support his study.

"I created data. I made it up. I also made up patients that were
fictitious," he testified.

Friedman's wife met him at the door when he came home that night. He
wept uncontrollably. The next morning he had an emergency appointment
with his psychiatrist.

But he didn't tell the therapist the truth, and his lies continued for
10 more days, during which time he delivered a letter, and copies of
the doctored files, to his boss. Eventually he broke down, admitting
first to his wife and psychiatrist, and later to his colleagues and
managers, what he had been doing.

Friedman formally confessed, retracted his articles, apologized to
colleagues and was punished. Today he has resurrected his career, as
senior director of clinical research at Ortho-McNeil Pharmaceutical
Inc., a Johnson & Johnson company.

He refused to speak with The Associated Press. But his case, recorded
in a two-metre-high stack of documents at the Massachusetts Board of
Registration in Medicine, tells a story of one man's struggle with
power, lies and the crushing pressure of academia.

The story itself is more common than most people might realize.

Allegations of research misconduct reached record highs in the U.S.
last year - the Department of Health and Human Services received 274
complaints, which was 50 per cent higher than 2003 and the most since
1989 when the federal government established a program to deal with
scientific misconduct.

Chris Pascal, director of the federal Office of Research Integrity,
said its 28 staffers and $7 million annual budget haven't kept pace
with the allegations. The result: Only 23 cases were closed last year.
Of those, eight individuals were found guilty of research misconduct.
In the past 15 years, the office has confirmed about 185 cases of
scientific misconduct.

Research suggests this is but a small fraction of all the incidents of
fabrication, falsification and plagiarism. In a survey published June 9
in the journal Nature, about 1.5 per cent of 3,247 researchers who
responded admitted to falsification or plagiarism. (One in three
admitted to some type of professional misbehaviour.)

Some cases have made headlines:

-On July 18, Eric Poehlman, once a prominent nutrition researcher, will
be sentenced in federal court in Vermont for fabricating research data
to obtain a $542,000 federal grant while working as a professor at the
University of Vermont College of Medicine. He faces up to five years in
prison. Poehlman, 49, made up research between 1992 and 2000 on issues
such as menopause, aging and hormone supplements to win millions of
dollars in grant money from the federal government. He is the first
researcher to be permanently barred from ever receiving federal
research grants again.

In 2001, while he was being investigated, Poehlman left the medical
school and was awarded a $1 million chair in nutrition and metabolism
at the University of Montreal, where officials say they were unaware of
his problems. He resigned in January when his contract expired.

-In March, Dr. Gary Kammer, a Wake Forest University rheumatology
professor and leading lupus expert, was found to have made up two
families and their medical conditions in grant applications to the
National Institutes of Health. He has resigned from the university and
has been suspended from receiving federal grants for three years.

-In November 2004, federal officials found that Dr. Ali Sultan, an
award-winning malaria researcher at the Harvard School of Public
Health, had plagiarized text and figures, and falsified his data -
substituting results from one type of malaria for another - on a grant
application for federal funds to study malaria drugs. When brought
before an inquiry committee, Sultan tried to pin the blame on a
postdoctoral student. Sultan resigned and is now a faculty member at
Weill Cornell Medical College in Qatar, according to a spokeswoman
there.

While the cases are high-profile, scientists have been cheating for
decades.

In 1974, Dr. William Summerlin, a top-ranking Sloan-Kettering Cancer
Institute researcher, used a marker to make black patches of fur on
white mice in an attempt to prove his new skin graft technique was
working.

His case prompted Al Gore, then a young Democratic congressman from
Tennessee, to hold the first congressional hearings on the issue.

"At the base of our involvement in research lies the trust of American
people and the integrity of the scientific exercise," said Gore at the
time. As a result of their hearings, Congress passed a law in 1985
requiring institutions that receive federal money for scientific
research to have some system to report rulebreakers.

"Often we're confronted with people who are brilliant, absolutely
incredible researchers, but that's not what makes them great
scientists. It's the character," said Debbi Gilad, a research
compliance and integrity officer at the University of California,
Davis, which has taken a lead on handling scientific misconduct.

David Wright, a Michigan State University professor who has researched
why scientists cheat, said there are some basic reasons: some sort of
mental disorder; inadequate mentoring; and, most commonly, tremendous
and increasing professional pressure to publish studies.

His inability to handle that pressure, Friedman testified, was his
downfall.

"And it was almost as though you're on a treadmill that starts out
slowly and gradually increases in speed. And it happens so gradually
you don't realize that eventually you're just hoping you don't fall
off," he told a magistrate during a state hearing in 1995. "You're
sprinting near the end and taking it all you can not to fall off."

At the time he started cheating, Friedman was in his late 30s, married
and a father of two young children. Following the path of his father,
grandfather and uncle who were all doctors and medical researchers, he
was an associate professor of obstetrics, gynecology and reproductive
biology at Harvard Medical School and chief of the department of
reproductive endocrinology at Brigham and Women's Hospital.

His reputation was tremendous and his work groundbreaking. His 30-page
resume highlighted numerous awards and honours, lectures in Canada,
Europe and Australia, and more than 150 articles, book chapters,
reviews and abstracts. Of those, 58 were original research articles,
where he had designed studies, conducted clinical trials, enrolled
patients, collected and analysed data and made conclusions.

In the end, investigators found - and Friedman confessed - to making up
information for three separate journal articles (one of them never
published) involving hormonal treatment of gynecological conditions.

He testified that he was working 80 to 90 hours a week, seeing patients
two days a week, doing surgery one day a week, supervising medical
residents, serving on as many as 10 different committees at the
hospital and the medical school and putting on national medical
conferences.

He did seek help, both from a psychiatrist, who counselled him to cut
back, and from his boss, who demanded Friedman increase his research
and refused to reduce Friedman's patient load.

As good as Friedman was as a doctor, surgeon and researcher, he was
actually a lousy cheater. One thing that brought about his demise, in
fact, was that the initials he used for fictitious patients were the
same as those of residents and faculty members in his program.

Unlike many scientists who file immediate lawsuits when they're caught,
Friedman was repentant, resigning from his positions at both Brigham
and Women's, and Harvard.

In 1996, Friedman agreed to be excluded for three years from working on
federally funded research. During the next three years he consulted
with drug companies, he paid a $10,000 fine to the state of
Massachusetts and surrendered his medical licence for a year, became
very active with the American Red Cross, donating more than 500 hours,
and attended several lectures on ethics and record-keeping.

"Andy can never undo the damage that his actions have caused. However,
he has paid the price - his academic career is ruined, his reputation
sullied, and his personal shame unremitting," wrote Dr. Charles
Lockwood, then chair of obstetrics and gynecology at New York
University School of Medicine, in a letter on Friedman's behalf.

In 1999, after successfully petitioning to get his licence reinstated,
he went to work as director of women's health care at Ortho-McNeil
Pharmaceuticals. The job, which he still has, involves designing and
reviewing clinical trials for hormonal birth control, writing package
insert labels and lecturing to doctors. Lately he's appeared on
television and in newspaper articles responding to concerns about the
safety of the birth control patch.

Ortho-McNeil spokeswoman Bonnie Jacobs said the company was well aware
of Friedman's history when it hired him. "He is an excellent doctor, an
asset to our company," she said.

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And he's willing to fudge numbers, at Ortho-MacNeil, they seem to be OK
with that.

TC

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