Was Vayarin a Proven ADHD Treatment? Questioning Nutraceutical Clinical Studies
ADHD expert David W. Goodman questions the research that linked Vayarin to improved ADHD symptoms, and advises both prescribers and patients to be mindful when reading clinical effectiveness claims.
Earlier this week, the maker of VAYA products quietly announced that it would no longer sell Vayarin, Vayarin Plus, or Vayacog to consumers in the U.S. This abrupt disruption leaves patients who have been taking these medical food products in a quandary. While the announcement from parent company Enzymotec cites “a strategy of primarily serving as an ingredient supplier to other companies rather than engaging with consumers directly” as an explanation, I would argue the reasons may go deeper.
The truth is that research did not support Vayarin’s promised benefits for children with ADHD. Yes, it’s true the company cited “clinical studies” that said it worked — and herein lies the problem. The double-blind, placebo-controlled study of 200 children actually showed it didn’t work on any of the eight scales rated by teachers and worked on only one of eight parent-rated scales.
The company then extracted a subset of children with inattentive ADHD and reviewed that data. With this data, it was able to extract some positive findings. This analysis is called “post hoc” (after the fact) and is not kosher in research data interpretation. The company cherry-picked positive findings and put them in promotional and advertising materials. A consumer or prescriber would have had to read the original published research with an expert’s eye to see the true “no different from placebo” findings. In December 2015, I wrote a blog reviewing this study in detail and it remains posted at www.addadult.com.
Neither prescribers nor the general public — in reading media stories, promotional materials, and patient testimonials — have a good way of discerning the quality of clinical research. Keep in mind that the placebo effect in psychiatric trials can be as high as 25%. So, patients have no way of knowing whether a friend who says “this is great” is experiencing a true medication effect or just placebo response. And prescribers are often unaware of the gerrymandered data being served up as clinical benefit.
What Does That Mean for Prescribers and Patients?
While initial medication trials make headlines, the science of effective treatment is in research replication. In my opinion, the Vayarin example is illustrative of how nutraceuticals are being marketed and sold in the U.S. today: Design a trial to optimize the outcome, manipulate the data, choose only positive findings, and lay out promotional materials to prescribers and the public, knowing that few will critically review the data. For example, research has shown the omega fatty acids can help ADHD symptoms, but their contribution to improvement is only about 15%. The supplements may help, but not a lot.
If you’ve been recommending Vayarin or other similar nutraceuticals for ADHD:
- Moderate hopes of benefit with healthy skepticism. Use proven treatments with years of high-quality clinical research.
- Be mindful of the marketing techniques of all nutraceuticals and medications.
- Read original research trial abstracts online at pubmed.gov.
- Seek out true expert opinions when considering complementary and alternative treatments (CAT) for any medical condition.
- If you prescribe or try complementary or alternative treatments (CAT), write down the target symptoms to change, plus changes observed each month for three months before deciding if it really helps.
David W. Goodman, M.D., FAPA, is a member of the ADDitude ADHD Medical Review Panel.