Calmare Therapeutics Inc (fka CTTC)

[Fair Play]

Potential Conflict of interest. Some official references

The comments on the - potential - conflict of interest is not an accusation, but derived from the public statements correctly made by the author himself . Conflict of interest and ethical issues in research field is analyzed in a general or specific way in the official scientific literature, and by the FDA.

source: https://neurology.wisc.edu/publications/2009/Neuro_26.pdf
Misha-Miroslav Backonja, MD, PhD, has served on the Speakers Bureau for Eli Lilly and Company and Pfizer Inc; has worked as a consultant to Allergan, Inc., Eli Lilly and Company, Johnson & Johnson, Medtronic,Inc., Merck & Co., Inc., NeurogesX, Pfizer Inc, and UCB Pharma; and has received research/grant support from Allergan, Inc., Eli Lilly and Company, Johnson & Johnson, Merck & Co., Inc., and NeurogesX.

source: www.mayoclinicproceedings.org/article/S0025-6196(11)61475-4/fulltext
Dr Backonja receives grant and research support from Pfizer Inc, NeurogesX Inc, and Avanir Pharmaceuticals. He is a consultant to Pfizer Inc and Eli Lilly and Company.

FDA general concerns
Bramstedt KA. A study of warning letters issued to clinical investigators by the United States Food and Drug Administration. Clin Invest Med. 2004 Jun;27(3):129-34. PubMed PMID: 15305804.

Abstract
PURPOSE:
This study explores the ethical issues contained in warning letters issued to clinical researchers by the Food and Drug Administration (FDA) in the USA.
METHODS:
The online FDA Warning Letter Index was reviewed for letters issued to drug and device researchers in the USA and Canada under the violation subject "Clinical Investigator" for the period February 2002 through February 2004. The resultant letters were evaluated for the presence of 7 research ethics themes: deviation from investigational plan; informed consent; adverse event reporting; study reporting; study supervision; institutional review-board approval; and misconduct.
RESULTS:
Thirty-six FDA warning letters addressing violations of 58 protocols were issued to researchers during the 25 months studied. Researchers performing pulmonary medicine studies received the most warning letters (12), followed by oncology (10) and cardiology (9) researchers. The most common regulatory violations were deviation from the research plan, a flawed or nonexistent consent process, and failure to report or late reporting of adverse events. Three warning letters (8%) mentioned study misconduct, including data fabrication.
CONCLUSIONS:
Warning letters are informative about good practice, ethics and participant protection in research. As distressing as the content in an FDA warning letter may be to investigators receiving it, that information can become an educational tool for all members of the research team. These letters are also informative as to what the FDA is looking for when they audit clinical trials