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Researcher To Be Sacked After Reporting High Rates of ADHD - BMJ

Sun, 10 Apr 2005

The BMJ reports that Dr. Gretchen LeFever, a clinical psychologist and professor at Eastern Virginia Medical School, whose published reports (since 1995) have raised the alarm about a spiraling increase in elementary school children being diagnosed with ADHD, and then medicated with psychostimulant drugs, is being fired for alerting the public about this medically unjustifiable practice.

Dr. LeFever's work "has become a model of ADHD intervention being watched by communities across the nation." National alarms were raised when the results of her 2002 published study revealed that the diagnosis of ADHD among children in grades 2 to 5 had risen to 17%. Her findings were validated last year by a Medco study.

What is especially alarming is her finding that: "Of the children in our study with ADHD, 84% were on ADHD medication."

Her findings - and that of other independent scientists who have the courage to make their critical findings public - have raised public concerns and have led, at least, one HMO - California Blue Cross - to instate a policy restricting the prescribing of psychotropic drugs for children to specialists. See: Sacramento Bee report, 2002 (below)

Dr. LeFever is being dismissed on the basis of what appears to be a trumped up charge of "scientific discrepancy": In Dr LeFever's published report the wording of a survey question differed from the actual question used for her 2002 study.

In the original survey parents were asked: "Does your child have attention or hyperactivity problems, known as ADD or ADHD?" The published version of the question was "Has your child been diagnosed with attention or hyperactivity problems known as ADD or ADHD?"

Does anyone seriously believe that this is a significant change that would have affected the outcome of the survey???

Dr. LeFever joins the ranks of Drs. Nancy Olivieri and David Healy who put their professional and moral responsibility to "do not harm" to patients, above career advancement and above their academic institution's financial interests. Medical institutions' finances have become intertwined with the pharmaceutical industry - sometimes indirectly through intermediaries such as Monarch Research, Scirex, KAI Reearch Inc, Aerosol Research, SIMR, Quest, etc.

In light of recently uncovered evidence of these drugs' serious, life-threatening risks, it would be unconscionable for Dr. LeFever NOT to disclose her alarming findings.

SSRI antidepressants are not the only psychotropic drugs prescribed for children that put children's lives at risk. Psychostimulants--Ritalin, Adderall, Cylert (pemoline)--and Straterra--all of which are prescribed for children diagnosed with ADHD, are now the center of new controversy. Researchers are finding that psychostimulants are addictive, cause liver damage, sudden deaths, and there are indications of increased risk of cancer.

Adderall has been linked to sudden deaths, leading Health Canada to withdraw the drug. The FDA merely issued a warning about the risk and added a boxed warning about the addictiveness of Adderall, like any other amphetamine.

Two weeks ago, Cylert (pemoline), a drug approved for ADHD in 1975, was withdrawn because of reported cases of liver damage in users. See: Attention deficit drug to be pulled from market Manufacturer says it plans to discontinue Cylert, The Associated Press, March 25, 2005

Sttratera, marketed as "a non-stimulant" is the fastest growing drug prescribed for ADHD. After causing sever liver injury, the FDA requires that a bold warning be included in the drug's label.

A Ritalin study conducted at the University of Texas, MD Anderson Cancer Center, found that ALL 12 children who were enrolled in a Ritalin trial "experienced an increase in chromosome abnormalities three months after starting Ritalin."

This is an indication of a possible increased risk of cancer for children prescribed Ritalin. "Researchers from the University of Texas M.D. Anderson Cancer Center in Houston and the University of Texas Medical Branch at Galveston recruited a dozen children with ADHD for the study. The children were about 8 years old and had been prescribed Ritalin at normal therapeutic doses (20-54 mg/day) but had not begun taking it. Their chromosomal level was measured before exposure to Ritalin and after just three months.

The researchers found a threefold increase in the level of chromosomal damage in the samples taken after the children were started on Ritalin. "It was pretty surprising to me that all of the children taking [Ritalin] showed an increase in chromosome abnormalities in a relatively short period of time." See: http://www.ahrp.org/infomail/05/03/11.php

Professor David Antonuccio said of Dr. LeFebre's , "This is a case of shooting the messenger. Dr LeFever has since been vindicated by recent CDC [Centers for Disease Control and Prevention] data and other studies showing alarming increases in the use of psychotropic drugs in children."

Contact: Vera Hassner Sharav
212-595-8974

BMJ 2005;330:691 (26 March), doi:10.1136/bmj.330.7493.691
Researcher to be sacked after reporting high rates of ADHD
New York
Jeanne Lenzer

A US researcher who said that doctors and psychologists may be overdiagnosing attention deficit hyperactivity disorder (ADHD) in children has been placed on administrative leave "with intent to terminate" her employment. The move came after charges of scientific misconduct against her, and her computers have been seized.

Dr Gretchen LeFever, a clinical psychologist and associate professor in the department of paediatrics at the East Virginia Medical School, was notified that the school intends to terminate her employment with effect from the end of March.

Her work has been controversial. She first made headline news in 1999 when she reported that 8% to 10% of elementary school pupils in southeastern Virginia were being prescribed drugs for ADHD, a percentage two to three times the estimated national average (American Journal of Public Health 1999;89:1359-64).

Criticism grew after she published the results of a 2002 study showing that the prevalence of the disorder among children in grades 2 to 5 had risen to 17% (Psychology in the Schools 2002;39:63-71).

In December Gerald Pepe, interim dean of the medical school, wrote to Dr LeFever charging her with "jeopardising the rights of children" and deviating from a research protocol.

Dr LeFever denies the charges and said she believes she is being sacked for reasons relating to her concern about widespread use of drugs. She said the charge that she jeopardised the rights of children arose during a multisite study in which parents and teachers filled out surveys about children and ADHD. The medical school's internal review board had ruled that such a study was "exempt" from consent requirements. It said consent was not needed because the board determined that "study subjects were the adults who answered the survey."

After the charges were made against Dr LeFever the medical school approached the Office of Human Research Protection for clarification and determined that both children and parents were participants and therefore her study was not exempt.

Dr LeFever said many similar studies had been carried out under an exempt status when parents filled out surveys about their children. "I clearly stated what I was doing, and the IRB [internal review board] approved everything I did. If there was a mistake, it was the IRB's."

One of her main critics is Jeffrey Katz, a clinical psychologist in Virginia Beach and the local coordinator of the Children and Adults with Attention-Deficit/Hyperactivity Disorder group. Dr Katz questioned her claim that the condition had been diagnosed in 17% of children in grades 2 to 5.

He said, "When somebody like Dr LeFever makes these claims that are apparently not based on good research, it minimises a very real problem. Parents won't bring their children in for evaluation, because they are afraid that medication will be automatically prescribed. They think it's a bad thing and the sole treatment. But medication can have significant benefits."

In May 2004 an anonymous whistleblower charged Dr LeFever with "scientific misconduct." The whistleblower pointed out a discrepancy between Dr LeFever's published report of the wording of the survey question and the actual question used for her 2002 study. In the original survey parents were asked: "Does your child have attention or hyperactivity problems, known as ADD or ADHD?" The published version of the question was "Has your child been diagnosed with attention or hyperactivity problems known as ADD or ADHD?"

Dr LeFever counters that the difference in wording was a simple oversight resulting from repeated revision of the article. "The findings are validated by the rate of ADHD medication treatment," she said. "Of the children in our study with ADHD, 84% were on ADHD medication."

William Pelham, professor of psychology, paediatrics and psychiatry at the State University of New York, Stony Brook, dismissed the criticism of Dr LeFever over the wording of the survey question as "ridiculous." Dr Pelham, who is also a researcher in ADHD, said the wording used by Dr LeFever and her colleagues is "commonplace" among researchers doing surveys. He added that drug companies' funding of community groups and research has created obstacles for experts who question the use of stimulants.

Julie Zito, associate professor of pharmacy and psychiatry at the University of Maryland, who reported in 2000 that preschool children as young as 2 to 4 years old were increasingly being prescribed stimulants (JAMA 2000;283:1025-30), said that the rise in the use of stimulant drugs is probably due to many factors, including wider diagnostic criteria, direct to consumer advertising, and advocacy for ADHD.

But Dr LeFever's detractors say the altered wording of her survey may have contributed to the high prevalence of ADHD that she reported. Tim Tjersland, a clinical psychologist in Virginia Beach, said he tried to verify Dr LeFever's findings for his doctoral thesis. "We could not replicate [her results]. When people say ADHD is overdiagnosed, that's a very severe and serious accusation."

David Antonuccio, a professor of psychiatry and behavioural sciences at the University of Nevada School of Medicine, said, "This is a case of shooting the messenger. Dr LeFever has since been vindicated by recent CDC [Centers for Disease Control and Prevention] data and other studies showing alarming increases in the use of psychotropic drugs in children."

Officials at the medical school would only confirm that Dr LeFever is on administrative leave but did not respond to other questions about her pending termination.

See: Rapid responses by BMJ readers: http://bmj.bmjjournals.com/cgi/eletter-submit/330/7493/691

SACRAMENTO BEE
Insurer limits kids' access to psychiatric drugs
Only specialists can OK antipsychotics, Blue Cross says.
By Dorsey Griffith -- Bee Medical Writer
Published 2:15 a.m. PDT Monday, September 9, 2002

For nearly a year, one of California's largest health plans, concerned about the growing use of psychiatric drugs in preschoolers, has been informing pediatricians that it will block their youngest patients' access to antipsychotics without a visit to a specialist.

And Blue Cross of California -- with 171,000 members in the Sacramento area -- said this week that the upfront intervention with doctors seems to be working: The plan has had to withhold only a few prescriptions. Blue Cross made the change after reviewing its prescription patterns statewide.

Statistically, the antipsychotic numbers were very small, but seemed to be on the rise: out of 72,000 preschool-age patients, five were prescribed the drugs in 1999 and nine in 2000. Most, moreover, were being prescribed by pediatricians or family practice doctors.

Though few children are technically affected by the action, it nonetheless signals a recognition by a major health plan that most psychiatric drugs have not been proved safe and effective in young children, whose brains and coping skills still are developing.

It also reflects a broadening awareness that behavior and emotional disorders in children demand thorough evaluations and ongoing care, which primary care physicians may not have the time or skills to provide.

Use of psychiatric drugs including stimulants, antidepressants and antipsychotics in all age groups is rising nationally. An analysis done in May by the National Center for Health Statistics at The Bee's request found antipsychotic use in children under age 18 had surged the most: 281 percent between 1995 and 2000. Most have never been approved for children under 18.

Blue Cross officials say the additional scrutiny has been relatively well accepted by the plan's primary care physicians, and mental health experts generally applaud it as a way to prevent misdiagnosis or premature prescribing of antipsychotics.

"If you look at the research, and what the medications do and the potential side effects, antipsychotic medications have the most potential severe side effects over the long run," said Mike Brase, a child psychiatrist and Blue Cross' chief medical director for behavioral health.

Antipsychotics, such as Risperdal and Seroquel, are approved by the Food and Drug Administration for use in adults diagnosed with schizophrenia, a disorder marked by hallucinations and delusions. In very young children, they may be prescribed to treat extremely aggressive and violent behaviors or self-mutilation, child psychiatrists say.

A 5-year-old who tries to suffocate his 14-month-old sister and doesn't understand that it is wrong is a typical example, said Sacramento child psychiatrist Joseph Sison. "I try not to medicate, but when behavioral interventions don't work, we have to revert to what are basically chemical restraints," he said.

Other large health plans also are monitoring psychiatric prescription practices, and some have similar programs involving other categories of the drugs. PacifiCare, for example, requires confirmation that a child younger than 6 has been clinically diagnosed with attention deficit-hyperactivity disorder, or ADHD, before stimulants can be dispensed.

"According to some data, there has been overusage by some medical professionals in that they were jumping on the drug before they were confirming a diagnosis," said Glenda Owens, spokeswoman for PacifiCare's pharmacy benefit program.

A study of stimulants and other psychiatric drugs conducted in three regions of the United States sparked Blue Cross' interest in studying its prescribing practices.

The study, published in the Journal of the American Medical Association in 2000, found twofold to threefold increases in the use of stimulants such as Ritalin and antidepressants such as Prozac in children 2 to 4 years old between 1991 and 1995. It also found a 20-fold increase in the use of clonidine, a blood pressure medicine used to control insomnia in children with ADHD.

When Blue Cross analyzed its own prescriptions, it turned up a different concern: antipsychotics were largely being prescribed by non-psychiatrists. "These are fairly strong medicines," Brase said. "We thought for this particular class of medications they should not be used in very young children unless there was a good evaluation."

Under the policy change, a pharmacist must put such prescriptions on hold and contact the prescribing doctor.

If the pharmacist determines that the child has seen a specialist, the prescription is filled. If not, the health plan offers to refer the patient to a child psychiatrist or neurologist. Exceptions can be made only if the primary care physician persuades the plan that a child has been adequately evaluated.

The action follows recommendations of the American Academy of Child and Adolescent Psychiatry, which last year said consideration of a psychiatric drug for an infant or child under age 5 "should be very carefully evaluated by a clinician with special training and experience with this very young age group."

A neurologist diagnosed Cathy Hollister's son, Clint, with Tourette's syndrome and ADHD when he was 6.

He since has been treated with a range of medications, including antipsychotics. Hollister, of Sacramento, said she believes many pediatricians can appropriately prescribe the drugs. "I think it depends," she said. "There are probably some pediatricians that are really good at it."

But Dr. Richard Walls, a Southern California pediatrician and member of the American Academy of Pediatrics' committee on drugs, said psychiatric disorders present pediatricians with a dilemma.

"There are many pediatricians who are excellent pediatric behavioral health practitioners comfortable prescribing these medications," Walls said, but they may have too little time to really help the family deal with the ongoing problem and its treatment.

Some insurance companies, he added, won't even pay a pediatrician for an office visit for a behavioral health problem.

A primary care physician may be tempted to prescribe an anti-psychotic to a child who, for example, is extremely agitated, but the doctor should first try to determine the cause of that behavior, according to Dr. Mark Edelstein, a Sacramento child psychiatrist and president of the California Academy of Child and Adolescent Psychiatry.

"The question is: Why is the child so agitated?" Edelstein said. "Is the child anxious? Is the child being abused? Is there something else that should be done instead of medication?"

Then, if the child is experiencing severe psychotic symptoms that could be treated with drugs, he said, "that child should really be seen by a specialist."

About the Writer
The Bee's Dorsey Griffith can be reached at (916) 321-1089

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