GMW: Allegations of Fake Research Hit New High/Government Scientists With Ties t

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GMW: Allegations of Fake Research Hit New High/Government

Scientists With Ties to Companies

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Sat, 16 Jul 2005 11:49:20 +0100

 

 

 

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1.Review Finds Scientists With Ties to Companies

2.Allegations of Fake Research Hit New High

3.The bottom line is to improve the corporate bottom line

 

STATISTICS

 

The N.I.H. is investigating 103 government scientists

 

44 have violated ethics rules on collaborating with pharmaceutical

companies

 

9 of the scientists may have violated criminal laws

 

Allegations of fake research reached record highs in the U.S. last year

- 50 percent higher than 2003

 

In a survey published June 9 in the journal Nature, 1 in 3 of

respondents admitted to some type of professional misbehavior

 

QUOTES

 

" The ethical problems are more systemic and severe than previously

known " (item 1)

 

" some government researchers were paid thousands of dollars by drug

makers " (item 1)

 

" 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 " (item 2)

 

" I'm getting checks waved at me from Monsanto and American Cyanamid and

Dow, and it's hard to balance the public interest with the private

interest. It's a very difficult juggling act, and sometimes I don't know

how to juggle it all. " (item 3)

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1.Review Finds Scientists With Ties to Companies

By DONALD G. McNEIL Jr.

New York Times, July 15 2005

http://www.nytimes.com/2005/07/15/politics/15ethics.html

 

Forty-four government scientists have violated ethics rules on

collaborating with pharmaceutical companies, a preliminary review by the

National Institutes of Health shows.

 

Nine of the scientists may have violated criminal laws, the report

said.

 

The review was outlined in a July 8 letter the agency's director, Dr.

Elias A. Zerhouni, sent to the House Energy and Commerce Committee,

which is investigating conflicts of interest by government researchers.

 

Because the N.I.H. is investigating 103 people who have been accused of

ethics violations, Dr. Zerhouni had asked the committee to keep his

letter confidential. But its leaders - Representatives Joe L. Barton,

Republican of Texas and John D. Dingell, Democrat of Michigan - said in a

statement yesterday that they were releasing it because of " the

compelling public interest. "

 

" The ethical problems are more systemic and severe than previously

known, " Mr. Barton said.

 

The institutes' review found that the 44 scientists had either failed

to disclose income from outside work, had failed to get permission to

consult or had done the work on government time rather than their own.

 

Eight of the scientists no longer work for the institutes and are not

subject to administrative punishment, the review said. It did not

describe what criminal laws might have been violated in the nine cases

that

were turned over to the inspector general of the Department of Health

and Human Services.

 

Of the 103 people being investigated, 37 have been cleared, Dr.

Zerhouni said in his letter, which did not name any researcher.

 

In February, Dr. Zerhouni banned all consulting deals between agency

researchers and drug or biotechnology companies. For the top scientists,

he also forbade owning shares in such companies, accepting gifts worth

more than $200 and accepting many research prizes.

 

The rules are not final, and Dr. Zerhouni has said he could lose

talented scientists to agencies that are less strict. Committee

leaders are

urging him to make the rules final.

 

The investigations Dr. Zerhouni's letter cited concern deals made

before the ban, which followed disclosures that some government

researchers

were paid thousands of dollars by drug makers.

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2.Allegations of Fake Research Hit New High

U.S. Fielded Record 274 Scientific Misconduct Complaints Last Year, 50

Percent More Than in 2003

By MARTHA MENDOZA

The Associated Press

http://abcnews.go.com/Technology/wireStory?id=925476 & CMP=OTC-RSSFeeds0312

 

Jul 10, 2005 - Allegations of misconduct by U.S. researchers reached

record highs last year as the Department of Health and Human Services

received 274 complaints 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.

 

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.)

 

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.

 

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.

 

Some other 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 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 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. "

 

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.

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3.The bottom line is to improve the corporate bottom line

http://ngin.tripod.com/pblinks2.htm

 

Texas entomologist John Benedict blames the system. " The universities

are cheering us on, telling us to get closer to industry, encouraging us

to consult with big business. The bottom line is to improve the

corporate bottom line. It's the way we move up, get strokes.... We

can't help

but be influenced from time to time by our desire to see certain

results happen in the lab. "

 

Private industry contributes 10 percent of Texas A & M's whopping $41

million annual agricultural research budget, and Benedict says he knew

Monsanto was contributing money to his research. " All of these companies

have a piece of me, " Benedict says. " I'm getting checks waved at me from

Monsanto and American Cyanamid and Dow, and it's hard to balance the

public interest with the private interest. It's a very difficult juggling

act, and sometimes I don't know how to juggle it all. "

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