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HHS: Faulty research removed two years ago

By STEVE MITCHELL, United Press International

WASHINGTON, Dec. 5 (UPI) -- Despite news reports that recent, federally funded research on the effectiveness of a sex education program may have included fabricated data, the researchers involved actually were exposed more than two years ago and the skewed information was excluded from the final study, the Department of Health and Human Services said Friday.

"It was found two years ago and the data in question were removed right away from the database and were not published," Alan Price, associate director of HHS's Office of Research Integrity, told United Press International.

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The study, which was funded by the National Institutes of Health and appeared in last January's issue of the journal Pediatrics, found teens who participated along with their parents in an educational program had lower rates of sexual intercourse and unprotected sex than kids who went through the program on their own. The program featured messages about both abstinence and safe-sex practices.

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The ORI reported in the Dec. 2 issue of the Federal Register that three data collectors -- who were not listed on the study as authors -- employed by the University of Maryland at Baltimore's department of pediatrics admitted to falsifying interviews with some teens.

A story in Friday's Washington Times quoted Rep. Mark Souder, R-Ind., an abstinence proponent, as saying: "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."

However, the skewed interviews were detected in August 2001 by the study's own principal investigator, Dr. Bonita Stanton, then at UMBC. Stanton, who now is at Children's Hospital of Michigan, told UPI she promptly notified the ORI at that time.

In addition, Stanton tossed out all the interviews the three data collectors -- Lajuane Woodard, Sheila Blackwell and Khalilah Creek -- had conducted.

In an interview with UPI, Souder accused the researchers of "contrived research to try to make an ideological point." He added: "It's a fairly significant fabrication because on the abstinence side we don't have to fabricate the data."

Stanton rejected Souder's contentions.

"Absolutely no fabricated data were used in any of these analyses and we went out of our way to make sure any of the (information collected by) these data collectors ... was eliminated ... even if it looked good," she said.

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Indeed, UMBC temporarily halted the study in 2001 and asked a panel of professors from several different institutions to review it to ensure the questionable data collectors had not tainted the conclusions.

Stanton also dismissed Souder's accusations she was ideologically driven. "This was not trying to make an argument for or against abstinence or safe-sex education," she said. "The purpose was to look at ways to bring parents back into the loop to get them to talk to their children."

Though some of the education program in question did discuss components of safe sex and abstinence, a lot of it was about encouraging parents to talk to their children and find out who their friends are and where they are going, Stanton said.

Souder questioned why the NIH did not inform Congress of the falsified data. Told the HHS, which oversees the NIH, had already concluded its investigation into the matter and published it in the Federal Register, a daily publication about federal government activities that is available to both members of Congress and the public, Souder said, "That's news to me."

He added, however, the report contained in the Register may not be sufficient. "We're certainly not going to buy without further detail that the rest of study was fine," he said.

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Souder, who serves as chairman of the House Government Reform subcommittee on criminal justice, drug policy and human resources, said he already had requested further information about the research from HHS. Depending on the information the agency provides, Souder said his committee would consider launching an investigation.

The HHS, however, considers its investigation into the matter closed, Price said. The three data collectors have been banned from participating in any federally funded research for three years, and none of the nine scientists listed as authors on the paper, including Stanton, was cited for any wrongdoing, he said.

Asked if the fabricated data had any bearing on the study's conclusions, Price said, "I doubt it seriously." The fabricated interviews were a "relatively small part of the study" and appear to have been removed before Pediatrics published it, he said.

If there was any lingering doubt about the study's conclusions, Stanton noted the data collection continued for an additional 12 months after the three questionable data collectors had been removed from duty. The original conclusions still held, she said. "We still see ... involving parents in these discussions with their youth does sustain these protective behaviors," she added.

--

Steve Mitchell is UPI's Medical Correspondent. E-mail sciencemail@upi.com

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