Vayarin and deceptive marketing
Vayarin is marketed as a “medical food” for the treatment of ADHD. Vayarin contains Phosphatidylserine 75 mg, Eicosapentaenoic acid (EPA) 21.5 mg, and Docosahexaenoic acid (DHA) 8.5 mg. These ingredients are omega3 fatty acids. The recommended dose is 4 pills daily.
The company sponsored a 15-week, double blind, placebo controlled trial followed by an open-label extension for additional 15 weeks in children ages 6-13 conducted in Israel. Two hundred children were randomized to receive either Vayarin or placebo and then 150 children continued in a 15-week open-label extension trial.
The bottom line: The primary measure to evaluate whether there was a statistically significant reduction in ADHD symptoms was teacher observations on 8 behavioral rating scales. The findings: No difference on any of the 8 scales.
The secondary measure was parent observations on the same 8 rating scales. There was only 1 positive finding out of 8: reduction in global: restless/impulsive scale. This is hardly an endorsement for effective outcome.
So, in their ads and presentations, how are they showing improvement?
After the company found no differences in the complete data set, they selected a subgroup of patients based on hyperactivity/impulsivity scores. This subgroup contains about half the number of subjects from the original 200 children. In this group, only 2 of 8 teacher ratings were positive (ADHD index and DSM-IV Hyperactive/Impulsive scales) and only 4 of 8 parent ratings were positive. While these findings may provide further guidance for later research, they cannot be accepted as demonstrating a positive effect because the data has been parsed to find a positive finding.
In the open-label extension, children on Vayarin remained on it while those children on placebo were changed to Vayarin. Open-label trials don’t generate high quality data because there is an expectation that “drug” is going to help. This is a bias similar to the placebo effect. Yet despite this potential bias, only 2 of 8 teacher ratings were positive and 5 of 8 parent ratings were positive. Well, we might expect that parents who know their children were changed to the “drug” would rate behaviors as improved. This is one of several possible interpretations of the data.
As my mentor used to say, “torture statistics long enough and they will confess to anything”. I have written this blog because I’m particular disturbed by the deliberate misuse of research data to mislead the public. Because the FDA does not directly regulate supplements and “medical foods”, there is limited oversight in the accurate presentation of “research” findings. When I last reviewed the literature on omega3 fatty acids for my book (2009), there were 5 placebo controlled studies of which 3 had not demonstrated reduction in ADHD symptoms. Negative studies are often not published so they can’t be considered in the totality of the research. When negative studies are published, they often receive little attention and are forgotten.
Why bother to post this blog? My goal for people with ADHD is to provide accurate medical information upon which to make treatment decisions. People side tracked by inaccurate claims spend money and time pursuing unnecessary and ineffective treatments to the profit of others. For those of you who follow my occasional blogs, you gain “behind the curtain” insights that allow you to make informed decisions about your care.
As always, thank you for your interest in my thoughts. Happy Holidays.
David W. Goodman, M.D.