Researchers Feeling Pressure to Fake Data

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 faking -- actually 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 at Harvard.

On this night, March 13, 1995, his department chairman had ordered him, in writing, 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 record room and, for the next three or four hours, pulled out permanent medical files of a handful of patients. Then he 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 7-foot-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 people might realize.

Allegations of research misconduct reached record highs last year -- the Department of Health and Human Services received 274 complaints, 50% more 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% of 3,247 researchers who responded admitted to falsification or plagiarism. (One in three admitted to some type of professional misbehavior.)

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 like menopause, aging and hormone supplements to win millions of dollars in grants from the federal government. He is the first researcher to be permanently barred from 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 said 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 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, Sultan tried to blame a postdoctoral student. Sultan resigned; he is now a faculty member at Weill Cornell Medical College in Qatar, according to a spokeswoman there.

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.

As a result of the hearings, Congress passed a law in 1985 requiring institutions that receive federal money for scientific research to have some system to report rule breakers.

David Wright, a Michigan State University professor who has researched why scientists cheat, said there are four basic reasons: some sort of mental disorder; foreign nationals who learned somewhat different scientific standards; 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.

At the time he started cheating, Friedman was in his late 30s, married and a father of two young children. 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 honors, lectures in Canada, Europe and Australia, and more than 150 articles, book chapters, reviews and abstracts.

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 counseled him to cut back, and from his boss, who demanded that Friedman increase his research and refused to reduce Friedman’s patient load.

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, paid a $10,000 fine to the state of Massachusetts and surrendered his medical license for a year.

In 1999, after successfully petitioning to regain his license, 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.

Mary Anne Wyatt, a retired biochemist in Natick, Mass., is one of several former patients.

“I think it’s not at all surprising that a drug company would hire somebody who is very comfortable with hiding the effects of very dangerous drugs,” said Wyatt, who unsuccessfully sued him.

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.