Palmitoylethanolamide is a great break-through in pain management, due to its proven efficacy in a significant number of painstates and inflammatory conditions.
The compound however is known since 1957 and patents to protect its use are therefore impossible. Some companies however, since 1999 developed and patented special palmitoylethanolamide formulations and production processes, to deliver high quality products.
A number of double blind placebo-controlled studies are conducted in the past in more than 3000 patients based on PEA formulated in tablets.
Recently new special (micronized and ultramicronized containing) palmitoylethanolamide formulationshave been developed and explored, also in around 2000-3000 patients.
This all gave rise to much debate related to these various patented formulations. For instance:
One of the headers in the paper is:
Unconventional marketing and communication efforts by Epitech Group S.r.l., Innovet Italia S.r.l. and Prismic related to micronized and ultramicronized PEA
These highly debatable marketing communications were hidden in a recent scientific pharmacological review paper published in Pharmacol Res. (March 3, 2014) by the group of professor Cuzzocrea (Impellizzeri et al.,2014) and related to palmitoylethanolamide and its value for the treatment of Chronic Kidney Disease. A number of statements (5) made in this paper were incorrect and misleading, related to the efficacy of a specific patented formulation of palmitoylethanolamide, while the studies were conducted without such formulations.
Kriek points out a clear conflict of interest in the Pharm Res paper, not mentioned: one of the authors, James Attley is currently Vice President (VP) Business Development and Licensing of Prismic, a company developing together with Epitech a special PEA formulation for kidney disorders.
According to Kriek, one needs to draw a totally different conclusion based on the facts. It is not PEA in the (patented) ultramiconized and micronized formulations that is active in protecting the kidney, but PEA in its pure form (not micronized, neither ultramicronized). He makes it clear that marketing motives were the driving force behind the choice of the authors to misrepresent the scientific facts as done in their paper.
One of the major findings of Kriek is the fact that the Italian companies Innovet and Epitech also manipulated Wikipedia: Members of the patent-holding companies repeatedly tried to amend the Wikipedia chapter on PEA, by inserting marketing-driven information on micronization and ultramicronization PEA formulations and their brand names.
He documented this fact by analyzing the backside of WIKI were IP addresses can be found and changes can be tracked.
As the conclusion of the paper is not presented in PubMed we herewith give an verbatim quote:
The authors presented the data discussed as facts to prove and make plausible that PEA in the ‘ultramicronized’ formulation leads to a number of positive results that were summarized in this article. The writer of this letter to the editor has made it clear that the statements of the authors related to the ‘ultramicronized’ formulation have no foundation in the facts presented.
Each scientific article needs to represent the facts correctly and unbiased, which sadly enough is not the case at all. The writer of this letter to the editor suggests that there is only one sound conclusion based on all the data presented: PEA in a non-ultramicronized formulation leads to all the positive results, PEA being a nephroprotectant compound.
We have demonstrated that conflicts of interest that arose in 2014 are still important aspects to deal with, and that reporting conflicts of interest does not necessarily help to achieve objective papers.
Debate ongoing and relevance for patients
The debate is still ongoing, but for the time being it is for patients probably the best to follow a simple strategy.
First the quality of the production process of PEA needs to be secured and needs to follow a special procedure. These procedures have only been described and patented by Epitech, Innovet and Russell Science.
Secondly the purity of the PEA used in the formulation needs to be optimal, and preferably proven with an certificate of analysis. While Russell Science documented the purity with such a certificate, various papers on PEA formulations of Epitech also show that these formulations are based on pure PEA. Although there is one difference, the Epitech formulations contain a number of excipients, the Russell Science formulation does not contain those.
Kriek R. Marketing messages in pharmacological papers and scientific chapters: The case of palmitoylethanolamide and its formulations. Pharmacol Res. 2014 Apr 24. pii: S1043-6618(14)00047-4. doi: 10.1016/j.phrs.2014.04.007. [Epub ahead of print]
Kriek R. Palmitoylethanolamide: problems regarding micronization, ultra-micronization and additives.
Inflammopharmacology. 2014 Mar 20. [Epub ahead of print]
Impellizzeri D, Esposito E, Attley J, Cuzzocrea S. Targeting inflammation: new therapeutic approaches in Chronic Kidney Disease (CKD). Pharmacol Res. 2014 Mar 3. pii: S1043-6618(14)00020-6. doi: 10.1016/j.phrs.2014.02.007.