Vayarin didn’t work for ADHD
This month Enzymotec, the makers of Vayarin, quietly announced on their website that they would no longer sell its product in the U.S. This leaves patients who have been taking it in a quandary without support. While the company’s announcement cites “a lack of alignment with our business strategy” as an explanation, no one gives up business that is going well.
The difficulty with Vayarin is that the research did not support its benefit in ADHD in children. Yes, I know, “They had clinical studies” that said it worked and in here lies the problem. The double blind placebo controlled study of 200 children actually showed it didn’t work on any of the 8 scales rated by teachers and worked on only 1 of 8 parent rated scales. The company then extracted a subset of children with inattentive subtype and reviewed that data. With this data, they were able to find some positive findings. This analysis is called “post hoc” (after the fact) and is not kosher in research data interpretation. Therefore, the company went on to cherry pick positive findings and put them in promotional and advertising materials. You 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.
The general public has no way of discerning the quality of the research and simply relies on media stories, promotional materials and patient testimonials. Keep in mind that the placebo effect in psychiatric trials can be as high as 25%. So, you have no way of knowing whether your friend who says “this is great” is getting a medication effect or just placebo response. Don’t feel badly. A lot of prescribers were unaware of the gerrymandering of the data being served up as clinical benefit.
What’s the lesson for you?
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 nutriceuticals are being marketed and sold. Design a trial to optimize the outcome, manipulate the data, cherry pick positive findings, and lay out promotional materials to prescribers and the public, knowing that few will critically review the data. Research has shown the omega fatty acids can be helpful in ADHD but its contribution to improvement is about 15%. So, it may help but not a lot.
Take home messages:
- Moderate your hope of benefit with healthy skepticism. Use proven treatments with years of high quality clinical research.
- Be mindful of the marketing techniques of all nutriceuticals and medications.
- Read original research trial abstracts online at www.pubmed.gov
- Seek out true expert opinions when considerting complementary and alternative treatments (CAT) for any medical condition.
- If you try CAT, write down the target symptoms to change, write down any changes each month for 3 months. Then decide if it really helps.
This blog in an edited version is posted at www.Additudemag.com
David W. Goodman, M.D., FAPA