This release describes a phase 3 trial of a new formulation of an existing drug, methylphenidate, used to treat attention deficit hyperactivity disorder (ADHD). The use of a delayed-release form of the drug was intended to allow children to take the drug at night and then feel the positive affects when they wake and before school — a time that often is stressful for both child and family. The release states that children taking the drug showed “statistically significant improvement” in their morning routines compared to those receiving a placebo but doesn’t define what those improvements are.
The release also left out costs, alternative treatments and potential conflicts of interests among study co-authors.
The release explains that the period between when a child with ADHD awakens and begins school can be especially trying for both child and parent. Medications can take time to take effect and in that window, the child’s ability to function adequately is reduced, stressing both them and their parents. The idea of a medication they could take at bedtime that would “kick in” when they wake in the morning might offer a remedy to this problem. However, future studies comparing the delayed release version of the stimulant drug to other ADHD stimulants are needed to show superiority. Comparing to placebo alone is not enough.
Journalists writing about ADHD drug treatments and parents of children diagnosed with ADHD should note there are ongoing debates among experts about over-treatment and under-treatment of ADHD in youth. It’s best to become informed about the harms and benefits of stimulant drugs before drawing conclusions.
There is no mention of the cost of methylphenidate in this release. While the price of the existing forms of this drug are readily obtainable, this research touts a new extended/delayed release form of the medicine and therefore, it is conceivable that the price will be different, and more than likely higher.
As far as benefits of this new drug go, the release only states that it “led to significant improvement in ADHD symptoms and functional impairment first thing the next morning, compared to a placebo.” It adds that, “children taking the delayed-release stimulant did not have to wait for a morning dose to take effect and also benefited from improved symptoms later in the afternoon and evening.” There is no explanation of the degree of improvement among children taking the drug compared to those on a placebo, and therefore, readers are at a loss to gauge the real value of the new formulation.
Moreover, the new formulation is compared to placebo, but it is already known that stimulants are superior to placebo for most ADHD-related outcomes. If the novel element of this new (and presumably more expensive) formulation is that it improves morning symptoms compared to standard early AM dosing, then a more appropriate control group (or perhaps a 3rd volunteer group) would have been morning dosing of standard formulation methylphenidate.
The release addresses possible harms with use of this new formulation of the drug by saying, “the main adverse effects of appetite suppression and insomnia being those commonly reported for other formulations of methylphenidate.” The study itself offers more detail and a breakdown of what proportion of participants experienced these effects but most were considered to be mild.
The study published in the Journal of Child and Adolescent Psychopharmacology describes the research as a “3-week, randomized, double-blind, multicenter, placebo-controlled, parallel-group, forced-dose titration trial” which would give readers confidence in the integrity of the research methods. Unfortunately, the release only describes it as “a phase 3 study of children ages 6-12 years.” It doesn’t even tell us how many children were enrolled in the trial. (According to the journal article there were 161 participants, half assigned to the active drug and half to placebo.) One glaring omission in describing the benefits and evidence is that the release didn’t tell us which symptoms were being assessed and which tools were used to make the assessments.
And as noted above, the delayed-release drug was only tested against placebo and not the original standard drug or any other drug. We still don’t know whether this new (and presumably more expensive) formulation is actually superior to standard dosing of methylphenidate.
There is no mention in the release about the funding for the research or any information about potential conflicts of interest among the researchers. The published research paper, however, readily discloses that the study was supported by a pharmaceutical manufacturer and that the lead researcher is a paid consultant to that company. Numerous other potential conflicts among the research team are also outlined in the paper. All of these financial ties should have been mentioned in the release.
Methylphenidate is one of many drugs available for the treatment of ADHD but this release doesn’t name any of the other drugs or any non-drug therapies. The release doesn’t even say how the delayed release version of methylphenidate compares to standard dosing of the drug.
The release offers no information about the possible availability of the new formulation of methylphenidate. It only mentions that the research was a “phase 3 trial,” which some readers will recognize must occur before a drug gets FDA approval for its use. In this case, it’s unclear whether the new formulation is in the drug approval process.
The release suggests that the trial showed the delayed release form of an existing drug positively affected the quality of life for young children with ADHD and their families. However, it remains unclear whether this formulation is indeed superior — or novel — in comparison to standard dosing of methylphenidate since that wasn’t part of the trial.
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