The anti-psychiatry Church of Scientology seized on LeFever's findings to buttress its claim that ADHD is a made-up disorder

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In light of concerns over Gretchen LeFever's research methods, Eastern Virginia Medical School shut down her latest follow-up study last month and placed her on administrative leave from her position as associate professor. LeFever stands by her work and says the survey discrepancy is ''tantamount to a clerical error.'' JOSH PARKER

By BILL SIZEMORE, The Virginian-Pilot © January 24, 2005

NORFOLK - In addition to sand, sea and sailors, Hampton Roads suddenly acquired a reputation three years ago for fidgety kids.

A local researcher, Gretchen LeFever of Eastern Virginia Medical School, burst onto the national scene with some startling and worrisome findings: Southeastern Virginia was a hotbed of overmedication for attention deficit/hyperactivity disorder, or ADHD. That's the medical term applied to people who are so inattentive, unfocused and impulsive that they have difficulty learning and developing social skills.

LeFever reported that an astounding 17 percent of Hampton Roads schoolchildren - three to six times national estimates - had been diagnosed with the disorder and that the vast majority were being medicated for it.

Her findings brought into question whether local doctors were too liberally treating children for ADHD.

"CBS Evening News" reported that a "staggering increase" in ADHD diagnoses had become "a problem of epic proportions in Southeastern Virginia."

CNN, PBS, NPR, newspapers all over the country, even Popular Science magazine, cited LeFever's research.

Virginia's General Assembly responded to the publicity surge with legislation to study and then rectify the problem. LeFever received hundreds of thousands of dollars in government grants to do follow-up research.

Three years later, LeFever's dramatic findings and research methods are under attack on multiple fronts.

Two state government studies of ADHD medication rates turned up much lower estimates than LeFever's. A Regent University doctoral student, who tried to replicate her research for his dissertation, also discovered far fewer local children identified with ADHD.

Concerns about LeFever's methods led two local elementary schools to withdraw from her latest follow-up study. And after a subsequent internal review, EVMS recently shut down the study before it could be completed and placed LeFever, an associate professor, on leave.

Next month, the peer-reviewed journal that initially published LeFever's findings in 2002 will have a correction after a discrepancy was discovered between her published article and the wording of the survey she used to generate her data.

LeFever, 44, stands by her work and insists that it proves ADHD is widely overdiagnosed and overmedicated. In a recent interview, she said the discrepancy was "tantamount to a clerical error and did not undermine the validity of the report."

In public appearances, she has continued to characterize her findings as accurate.

"We pretty consistently have rates of ADHD diagnosis as reported by parents that are three to six times higher than national estimates," she said Oct. 29 at a national conference of an ADHD support group in Nashville, Tenn.

Her critics are equally resolute, saying there is now ample evidence that her research is flawed - that, in fact, the epidemic of ADHD diagnosis she described never existed, at least not on the scale she reported.

But they worry that the scenario she has laid out - needless multitudes of pill-popping children - has so permeated the popular media that untold numbers of parents have been dissuaded from getting their children the treatment they need to ward off lifelong difficulties in school, on the job and in their personal relationships.

An object lesson in the fallibility of scientific studies, the episode marks the second shutdown of pediatric research at EVMS in two years and has left the school scrambling to strengthen oversight of its researchers' work, especially where children are involved.

There probably have been people with the symptoms of ADHD for millennia, but not until the 20th century did it become a medical diagnosis. Today it is considered the most common mental health disorder of childhood and, for many sufferers, is increasingly becoming recognized as a lifelong condition.

Children and adults with ADHD typically find it hard to organize or finish a task, to pay attention to details, or to follow instructions.

They are easily distracted. They find it difficult to sit still for long, whether for a meal or a homework assignment. They may interrupt others, speak at inappropriate times or have trouble waiting their turn.

In the 1930s, scientists made a paradoxical discovery: Treating hyperactive children with chemical stimulants seemed to calm them down and helped focus their attention on their schoolwork.

As such drugs proliferated in recent decades, the use of stimulants such as Ritalin, Adderall and Dexedrine for ADHD skyrocketed.

To some people, the trend was alarming. One of those was Gretchen LeFever, a clinical psychologist with graduate degrees from the University of Illinois in Chicago.

Since 1994 she has been on the faculty at the Center for Pediatric Research, a joint venture of EVMS and Children's Hospital of The King's Daughters. Before that, she worked in the pediatrics department at the Naval Medical Center in San Diego. She came to Hampton Roads when her husband, a Navy psychologist, was transferred to Virginia.

The more children LeFever saw in her clinical practice, the more convinced she became that parents, teachers and doctors were slapping an ADHD label on troublesome students and putting them on medication without thorough evaluation.

To test that hypothesis, she began a series of studies among local public schoolchildren.

Perhaps her most alarming findings were those published in the January 2002 issue of the p eer-reviewed journal Psychology in the Schools. Before publishing an article, a peer-reviewed journal submits it to a panel of scholars in the author's academic field for review.

LeFever sent surveys to parents of 1,644 children in three Norfolk elementary schools - Fairlawn, Little Creek and St. Helena - in 1998. Her findings were based on surveys returned by parents of 808 children in grades 1-5.

LeFever reported that 17 percent of the children - and 33 percent of the white boys - had been diagnosed with ADHD. Moreover, she reported, almost all of those children - 84 percent - had been put on chemical stimulants to treat the condition. National estimates of ADHD prevalence at the time were in the 3 to 5 percent range; more recent estimates have ranged as high as 7 percent.

Sharon Margulies, principal at Little Creek at the time, said LeFever's point of view was readily apparent.

"Her take on it was that we were overdiagnosing and overmedicating children," Margulies, who is now retired, said in a recent interview.

LeFever cited the findings of her Norfolk study first in Psychology in the Schools, then in a subsequent article in The Scientific Review of Mental Health Practice, and in a paper for the Lexington Institute, a conservative Washington think tank. As her popularity grew, she debated around the country with experts who took the opposite view: that the disorder is, if anything, underdiagnosed.

LeFever was quoted on the subject in publications from the New York Post to the Sacramento Bee. "CBS Evening News" showed children at Malibu Elementary School in Virginia Beach filing into the school nurse's office at lunchtime for their medication. The report was headlined "Too Many Kids on Too Many Drugs?"

The anti-psychiatry Church of Scientology seized on LeFever's findings to buttress its claim that ADHD is a made-up disorder. The conservative Washington magazine The Weekly Standard featured LeFever prominently in an article headlined "Readin', Ritalin and ' Rithmetic: Education's New Three R's." The author left readers with the rhetorical question: "Are we really prepared to redefine childhood as an ailment, and medicate it until it goes away?"

LeFever used her Norfolk findings to land a $450,000 grant from the U.S. Department of Education to conduct a pilot "positive behavioral management" program in a Virginia Beach elementary school as an alternative to drug therapy for behavior problems. She also was one of three ADHD researchers awarded $750,000 each by the Centers for Disease Control and Prevention to conduct a three-year multi site study intended to clear up lingering uncertainty about the true prevalence of the disorder.

LeFever's work caught the attention of state lawmakers, too. Del. Robert Tata, R-Virginia Beach, persuaded the General Assembly to spend $16,500 on two successive statewide studies of ADHD prevalence and treatment.

Del. John J. Welch III, R-Virginia Beach, didn't wait for the study results. In 2002 he successfully championed a new law prohibiting school personnel from recommending mind-altering medications for any student.

"I said, 'I don't need a study.' The numbers were already there," Welch said in a recent interview. "I kept reading about it in the newspaper. . Around here it was, 'Little Johnny 's hyperactive. Let's put him on Ritalin.' Why try to stifle kids' energy? It just needs to be better directed."

When the statewide study results came in, however, they provided little corroboration for LeFever's findings.

The first survey, conducted by the state Department of Education, found that 1.5 percent of Virginia schoolchildren were taking ADHD medications at school.

That survey undoubtedly missed some children because newer, longer-acting stimulants make it unnecessary to administer a dose during the school day.

The second study, conducted by the state Department of Health, was more comprehensive. It reviewed eight ADHD prevalence studies conducted over a 20-year period and found that LeFever's 17 percent rate was by far the highest reported. The rest ranged from 2.9 percent to 11.4 percent.

Based on a sample of prescription claims data, the department estimated that 5 to 6 percent of Virginia children ages 6 to 10 had prescriptions filled for ADHD medications in 2001. Those numbers put the state in line with national estimates.

The study did find higher numbers of stimulant prescriptions in Eastern Virginia than elsewhere in the state, but not on the scale that LeFever found in her Norfolk study.

LeFever dismissed the two state studies as "woefully underfunded" and insufficiently rigorous.

Meanwhile, Tim Tjersland, a doctoral student in psychology at Regent University, attempted to replicate LeFever's research for his dissertation. He used still another methodology: examining school medical records of nearly 8,000 Chesapeake students in grades 1 through 5, a sample 10 times larger than LeFever's.

Tjersland found that only 5 percent of those students had been identified with ADHD.

LeFever said Tjersland's findings are suspect because some parents might not have disclosed their children's ADHD diagnosis to school officials.

But William L. Hathaway, a psychology professor at Regent and Tjersland's faculty adviser, said Tjersland's work raises serious questions about LeFever's findings.

"I can't say for sure that Gretchen's findings are wrong, but they stand in stark contrast to lots of other studies," Hathaway said.

Russell A. Barkley, a professor of psychiatry at the Medical University of South Carolina and one of the nation's leading experts on ADHD, said he is "exceptionally skeptical" of LeFever's research methods and conclusions. Barkley, who has debated LeFever on the topic, estimates that only about half of Americans with ADHD are getting appropriate treatment for the disorder.

"The biggest problem is under identification and very erratic access to care," he said. "It's not overmedication."

But LeFever's findings have taken hold in the public consciousness, said Tjersland, who works as a psychology resident in Virginia Beach.

"I do a lot of screening for ADHD, and every single day I run into parents who say, 'I know it's overdiagnosed and overmedicated in this area,' " Tjersland said. "It has permeated people's perception, and it's all based on that one study. It's like an urban legend."

One result of that perception may be that some ADHD sufferers don't get the help they need, said Jeffrey Katz, a clinical psychologist in Virginia Beach.

"To some degree she sparked this whole debate," Katz said of LeFever's research. "I'm concerned that parents have been dissuaded from getting their child evaluated."

That was not her intent, LeFever said.

"Looking at the number of children who are treated, I don't think there's substantial evidence to suggest that," she said. "I would hope that parents would be informed health-care consumers. . If my work fostered more discussion between parents and their children's doctors, I think that's a good thing."

In her Norfolk study, it was the observations of schoolchildren by their parents - not trained medical professionals - that led LeFever to her conclusions.

LeFever's research questionnaire asked local parents:

"Does your child have attention or hyperactivity problems, known as ADD or ADHD?"

However, in the Psychology in the Schools journal article LeFever referred repeatedly to "diagnosis" of ADHD, which means that a medical professional would have had to determine that a child has the disorder. And in an appendix published at the end of the article purporting to reproduce the survey questions, the key question was worded differently:

"Has your child been diagnosed with attention or hyperactivity problems known as ADD or ADHD?"

In an interview, LeAdelle Phelps, editor of the journal, characterized the difference in wording as a "minor discrepancy." But it was substantial enough that Phelps is publishing a correction the February issue. The correction appeared last week in the journal's online edition.

LeFever said her research assistants were working on several differently worded surveys at the time, and the incorrectly worded question was submitted to the journal by mistake. She said she does not believe the difference in wording is crucial.

She did not include the word "diagnosis" in the survey, she said, "because we would be encountering people with limited reading skills. We strive whenever possible to put things in simple language."

LeFever's critics say relying on the observations of lay people and passing that off as professional diagnosis is bad science.

"Those are clearly very different things to me," said Katz, the Virginia Beach psychologist. "At the least, the survey question is not very well worded. Everybody has problems with attention. The question is to what degree, and whether there is impairment."

David O. Antonuccio, a professor of psychiatry at the University of Nevada School of Medicine who co-authored one of LeFever's articles arguing that ADHD is overdiagnosed, conceded that the wording of the survey question could have yielded an inflated number.

"It sounds like a mistake that needs to be corrected," Antonuccio said. ". I believe Dr. LeFever is a responsible researcher, and when issues like this are raised, she would do what's needed to fix them."

Attacks on LeFever's work began to accelerate last spring when the EVMS administration received an anonymous complaint about her methods, prompting an eight-month internal review.

A panel of three administrators concluded that the discrepancy in the wording of the survey question "was the result of an honest error and does not appear to involve any intentional misrepresentation," according to an Aug. 5 report.

But the panel asked LeFever to report the discrepancy to the journal and recommended that "in connection with any future presentations about this study, additional efforts be made to clarify the approaches that were used to assess ADHD diagnosis."

EVMS administrators also examined LeFever's most recent work: the multi site ADHD prevalence study funded by the CDC, which studied elementary schoolchildren in Virginia Beach and Portsmouth.

Among the areas of concern were whether the children's confidentiality had been adequately protected, whether the research was done with their parents' consent, and whether the work had been properly overseen by EVMS.

Concerns about LeFever's methods prompted two Virginia Beach elementary schools - Malibu and Windsor Oaks - to withdraw from the study.

The confidentiality issue surfaced last January at a PTA meeting at Malibu. When survey forms were passed out to the audience, parents noticed that they had children's names on them.

"The researcher didn't follow the protocol she told us she was going to follow,'' said Diane Jones, assistant superintendent of accountability in the Virginia Beach school system.

Jones said school administrators intervened to tighten the confidentiality procedures.

Ultimately, three other Virginia Beach elementary schools - Kempsville Meadows, Point O' View and Princess Anne - decided to go ahead with the study.

The study also included five Portsmouth schools: Churchland Elementary, Churchland Primary & Intermediate, James Hurst Elementary, S.H. Clarke Academy Elementary and Westhaven Elementary. No confidentiality concerns were raised in Portsmouth.

A second, related issue was parental consent. The research involved two surveys - one for parents and one for teachers. The one for teachers asked them to evaluate each student according to a variety of ADHD criteria: whether the child "talks excessively," "has difficulty waiting in line," "often loses temper" and the like.

LeFever did not ask parents' permission to survey their children's teachers, even though she had promised to do so, Jones said.

A description of the proposed methodology that LeFever's research team provided to the school system includes this sentence: "Informed, signed parental consent is required for enrollment in the study."

LeFever disputes Jones' account. She said Virginia Beach's approval of her research wasn't contingent on parental consent. She said the research team decided that getting parental consent was unnecessary and impractical.

LeFever's two fellow CDC grant recipients, at the University of South Carolina and the University of Oklahoma, gave parents an opportunity to opt out of the study.

Don Tortorice, an adjunct professor who teaches health law and bioethics at the College of William and Mary's Marshall-Wythe School of Law, said the project should have followed Virginia law and the American Medical Association's canons of ethics, both of which require parental consent for children to be used as research subjects.

In effect, the teachers surveyed by LeFever's team were "diagnosing a medical condition," Tortorice said. "The informed consent in writing of the parents should have been obtained."

Last month , EVMS interim dean Gerald J. Pepe terminated the study a year ahead of its scheduled completion date and placed LeFever on administrative leave.

"It's clear that the parents should have given their permission before teachers were asked to complete any surveys about their children's health and/or behavior," Pepe said. "Human subject protection is our first responsibility, particularly when children are involved."

This wasn't the first time the issue had surfaced at EVMS. In 2002, the school shut down a pediatric study by another researcher that involved exposing toddlers in day-care centers to a genetically engineered material derived from a plant virus. The material was intended to mimic germs and show how children spread them. It was considered harmless, but a parent complained because no one asked her consent for her child's participation.

As EVMS administrators looked into LeFever's work, they discovered one more problem: It had been improperly exempted from review by the Institutional Review Board, an EVMS committee that approves and monitors research projects to make sure ethical guidelines are being followed.

In her application to the board, LeFever had indicated that her research subjects were adults, which would have qualified the study for an exemption. "No subjects less than 18 years old," the document reads.

In another section, the application states that parents and teachers would be surveyed "to gather information related to their child's/student's behaviors in home/school."

The exemption was granted. But later, after consulting with a federal research oversight agency, EVMS concluded that was a mistake because the research involved children, not just their parents.

The mistake was the school's, not hers, LeFever said. In her application to the board, she said, "it was abundantly clear that it was an interview with parents about their children."

As a researcher, you rely on the Institutional Review Board "to understand those federal regulations and make sure that you are compliant with them," she said.

Pepe countered that the board relies on researchers to provide clear, accurate information about their work.

"The ultimate responsibility for the ethical conduct of research rests with the investigator," he said.

Last month the EVMS Board of Visitors made a midyear revision to the school's current budget, freeing up $189,000 to hire additional staffing for the Institutional Review Board. The objective is to strengthen the board's ability to scrutinize research proposals.

Meanwhile, the shutdown of LeFever's research means the CDC will get no data from one of three study sites in what was billed as the largest community-based ADHD study ever undertaken in the United States.

It is a setback in the ongoing quest to settle a debate that LeFever herself helped generate.

Here's how she framed it during her October appearance in Nashville:

"The million-dollar question is, how many children really suffer from this disorder? We don't really know."

Reach Bill Sizemore at 446-2276 or bill.sizemore@pilotonline.com.

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