StATS: Allegations of scientific misconduct (August 1, 2005)

A recent email in the IRBForum highlight allegations of scientific misconduct and cites a news report in BMJ,

This report describes, Dr. Gretchen LeFever, a researcher at East Virginia Medical School, who is being fired. Dr. LeFever has published controversial research on the prevalence of attention deficit hyperactivity disorder (ADHD) disorders in children.

The article describes an allegation that may have lead to her firing:

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?

There is indeed a difference between the two questions, but normally this sort of thing is handled by publishing a letter in the same journal. There is also an allegation that Dr. LeFever jeopardized the rights of children in a survey study of parents that the Institutional Review Board (IRB) had originally declared exempt from consent requirements, a ruling that was later changed

Dr. LeFever alleges that she is being fired not for misconduct or for ethical violations but because her research criticized the overuse of drugs in children with ADHD. An interesting quote from one of her critics also appears in the article.

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.

Additional commentary on this case can be found at:

It reminds me of a similar allegation of misconduct from 20 years ago. Dr. Herbert Needleman published a paper in 1979 that showed a relationship between lead levels in children's teeth and a decline in intelligence scores. There was a dispute about some of the methods that Dr. Needleman used that escalated into a charge of scientific misconduct.

It is not surprising that Dr. Needleman's work made him a frequent target of criticism by the lead industry, or that he was once forced to defend himself against charges of scientific fraud and misconduct. Not only was he exonerated, but he fought for and won the right for those accused of such charges to an open hearing with legal representation – a right that has benefited the entire scientific community. www.heinzawards.net/recipients.asp?action=detail&recipientID=29

Not everyone was impressed with Needleman’s work, though. Critics uncovered many problems. Needleman didn’t control for the confounding factor of child’s age. Factoring in age yielded few significant results. Needleman excluded from his analysis children who were “lead poisoned” but without impaired intelligence. Needleman omitted other results that didn’t support his conclusion. Needleman was subsequently accused of scientific misconduct. Though he was ultimately not convicted of scientific misconduct, he wasn’t vindicated either. www.junkscience.com/foxnews/fn031601.htm

Who are we to believe when such strong accusations are hurled from both sides? Allegations like this are difficult for an outsider like me to sort out. Certainly, allegations of misconduct provide a weapon that has the potential for abuse. If you don't like the results of the research, the best way to attack it is to get the researcher fired for misconduct. Not even tenure can protect your job if a charge of misconduct sticks.

On the other hand, we do need protection against research fraud. GlaxoSmithKline was sued in June 2004 for their failure to disclose unfavorable information about one of their drugs, Paxil.

The civil suit, filed by New York state's attorney general, Eliot Spitzer, charges the drug company with “repeated and persistent fraud” in concealing the results of studies that suggested that paroxetine was ineffective in treating depression in adolescents. It is the first time a US public authority has pursued a drug company for misreporting trial data. GlaxoSmithKline faces US lawsuit over concealment of trial results. Dyer O. Bmj 2004: 328(7453); 1395. [Medline] [Full text] [PDF]

Certainly you have to look at the source of the accusation because any allegation of fraud might be politically motivated. A better indication of problems would come from an independent assessment from a review panel.

What about fraudulent research that never gets uncovered? There is no simple way for person like you or me to detect fraud. There are reforms in the peer-review system that can help. For example, researchers who publish a paper should submit their protocol as well as the research publication. Any deviations from the research protocol would be open for review. Not all deviations are fraudulent deviations, of course, but a peer reviewer would be able to assess this.

Protection for whistle-blowers can lead to abuse of the system, but such protection is still important to allow colleagues and subordinates of a fraudulent researcher to voice concerns without fear of losing their jobs.

Further reading

This page was written by Steve Simon while working at Children's Mercy Hospital. Although I do not hold the copyright for this material, I am reproducing it here as a service, as it is no longer available on the Children's Mercy Hospital website. Need more information? I have a page with general help resources. You can also browse for pages similar to this one at Category: Ethics in research.