Thursday, December 4, 2003

Three Maryland researchers have admitted fabricating interviews with teenagers for a study on AIDS prevention that received more than $1 million in federal funds.

Lajuane Woodard, Sheila Blackwell and Khalilah Creek were employed by the University of Maryland at Baltimore’s department of pediatrics as researchers on the study, funded by a grant from the National Institutes of Health (NIH).

The three admitted they made up interviews with teenagers, which they had claimed took place from May to August 2001, for the study on preventing the transmission of HIV, the virus that causes AIDS. The fabrication was first reported in the journal Research USA.

The study was designed to evaluate the impact of “safe sex” counseling on black teens in Baltimore housing developments. Congressional staffers said the study, titled “Effectiveness of Standard Versus Embellished HIV Prevention,” received more than $1 million in NIH funds in 1999.

“It is terribly troubling that federally funded research on a topic as sensitive and important as HIV prevention for children, some as young as 13, would be intentionally manipulated,” said Rep. Mark Souder, Indiana Republican and chairman of the House subcommittee on criminal justice, drug policy and human resources. “If not caught, the lives of countless children may have been put at risk by ineffective, perhaps dangerous, prevention messages developed from this fabricated research.”

Results of the Baltimore study were published in January in the journal Pediatrics by a group of nine researchers led by Ying Wu of West Virginia University.

The study’s objective was to determine whether enhancing an existing AIDS prevention program called Focus on Kids by adding “parental monitoring” would have an effect on the children involved.

Editors of Pediatrics said yesterday they were investigating the reported fabrications.

The study involved “817 black youths aged 12 to 16 years,” and found that youth whose families participated in the enhanced Focus on Kids program showed “significantly lower rates” for a variety of risk behaviors, including sex without condoms and use of cigarettes and alcohol.

The Focus on Kids program is a widely used “safe sex” curriculum advertised by its publisher, ETR Associates, as “proven effective.”

“We would not comment on this,” said Constance Burr, spokeswoman for the National Institute for Mental Health, the NIH division which funded the study. Officials at the Office of Research Integrity had no response to the report.

In the past year, House Republicans have repeatedly criticized NIH funding of sex research projects, including a $147,000 grant to a Northwestern University professor who paid women to watch pornography while measuring their sexual arousal.

In July, the House rejected on a 212-210 vote a measure sponsored by Rep. Patrick J. Toomey, Pennsylvania Republican, that would have eliminated federal funding for five sex studies.

But investigation of federally funded sex research has come under fire by critics, including Rep. Henry A. Waxman, California Democrat. In October, responding to a list of research grants questioned by some House Republicans, Mr. Waxman wrote to Health and Human Services Secretary Tommy G. Thompson: “I urge you in the strongest possible terms to denounce this scientific McCarthyism. Imposing ideological shackles on this research would be a serious public health mistake.”

More recently, the New England Journal of Medicine denounced congressional probes of research grants. Such scrutiny risks turning sex research into a “political football,” warned the journal’s editor, Dr. Jeffrey Drazen.

“Science should have oversight from Congress but it ought not to be at the level of specific grants,” Dr. Drazen told United Press International.

But Mr. Souder said the admissions of fabrication in the Baltimore HIV study show the importance of congressional oversight.

“This scandal underscores the need for oversight of all federal programs — even NIH — to ensure taxpayer dollars are not misspent and science is not manipulated,” the congressman said.

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