Allegations of fake scientific research reach new high

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 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 record 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.

Eventual breakdown

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 seven-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 many might realize.

Allegations of research misconduct reached record highs last year -- the Department of Health and Human Services received 274 complaints, which was 50 percent 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.

Congressional hearings

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 percent of 3,247 researchers who responded admitted to falsification or plagiarism. (One in three admitted to some type of professional misbehavior.)

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 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. "You're sprinting near the end and taking it all you can not to fall off."

A lousy cheater

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 honors, 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 analyzed 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 counseled 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 license 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 license 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.

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.