Researcher lies to ethics review board about drug to treat kids

An Australian researcher lied to an institutional ethics review board, telling them that a “black box” warning on a drug under study, Strattera, had been removed by the Food and Drug Administration (FDA) following further exploration. Here is the story from The Weekend Australian: Researcher Made False Statements Regarding Strattera Trial in Kids

A “black box” warning is a warning that appears on prescription inserts warning users and prescribers of the most serious or life-threatening side effects. Some common examples include the warning of risk of severe bleeding causing death on Warfarin or warnings of the increased risk of suicidal ideation in children and adolescents taking antidepressants. It is the strongest warning that the FDA can issue. In this case, Strattera (being used in a trial with children), has been found to increase suicidal thoughts in children, especially after a change in dosage.

As the story notes, the researcher told the ethics review board that the black box warning for Strettera, a norepinephrine uptake inhibitor (used for the treatment of ADD and ADHD in the States along with off label treatment for unipolar and bipolar depression)had been removed when in fact, it had not been.

While clearly there is fault on the part of a researcher who makes a decision to lie about potentially life-threatening side effects of a trial drug, there are lessons here for ethics review boards:

1. While ethics review boards are not scientific review boards, it is imperative we ensure that a scientific review by an unbiased and discipline-relevant panel has been carried out and that all scientific or clinical concerns have been thoroughly addressed, prior to an ethics review.

2. Ethics review boards must have members with expertise in a variety of areas. Yes, it’s vitally important to have an ethicist, a lawyer and community members on any ethics review board (and it’s required). However it is equally important to ensure that, if you are reviewing drug trials, you have members with expertise in medicine and pharmacology. If not, consult an expert. Or two.

3. Do your homework. Reviewing research protocols takes time. Sometimes it means you have to look things up, ask questions, seek information. What you read on a research proposal is only part of the work you need to do as you review a research proposal. Granted, we do expect that researchers will provide, at the very least, an adequate amount of information in order for us to complete a through and meaningful review. But it is our responsibility, as members of a board with a mandate to protect human participants, to do our homework.

~ by Nancy Walton on January 28, 2009.

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