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Source-Omega Claims JAMA Meta-Study Unethical; Calls for Ban of the Word Omega-3 on Drug Labels

Source-Omega Claims JAMA Meta-Study Unethical; Calls for Ban of the Word Omega-3 on Drug Labels
Chapel Hill, NC, September 20, 2012 --( Source-Omega says the Food and Drug Administration may need to ban the use of the word omega-3 on all drug labels and descriptions. That is, if omega-3 is only a food word. This is at issue because the company says the September 12th JAMA study also misleads those benefiting from current practices.

Source-Omega’s position is that the context of the controversial study was antiquated and is therefore unreliable. The company reasons that the JAMA meta-study assumed omega-3 food is a drug in a questionable study design.

The company says that the study is unethical because populations were not treating heart disease by use of supplements and foods, which is illegal unless approved by a review board.

The September 12th JAMA study referenced food and supplement omega-3 intakes in the context of a drug benefit although the nutritional activity was originally defined as a food.

The Source-Omega company said that omega-3 was not an approved treatment and not available on a uniform basis and therefore cannot be analyzed as if all people, dietary backgrounds and ethnicities are the same.

"There was no standard of care. The JAMA meta-study is an ethically compromised drug analysis because it asks if an unapproved therapy approach yielded therapeutic good in the context of a disease. The original pooled studies analyzed risk reductions in non-therapeutic formats, unless part of an actual study protocol. That is misleading. Drug studies are supposed to have a burden of specificity," says Dr Scott Doughman, PhD, CEO and Chief Scientific Officer at Source-Omega.

That point could carry some significance if it were to come to a public health debate on the topic. The recommendation of a supplement or a food would not have been allowed in practice, is still largely not allowed, and was not widely available at the time reports were made. This says the intent of the original studies or practices were not approved drug trials, the company argues.

Although the September 12th JAMA study referenced food and supplement omega-3 intakes, the use of these data in the context of a drug would not be allowed according to modern clinical regulatory standards, such that the context of the use of food as a drug is still not allowed without prior authorization.

About Omega-3 Labeling:
The word omega-3 is shorthand for omega-3s and omega-3 fatty acids. It represents multiple chemical structures, all of which have omega-3 in their commonly used names, as descriptions of the category of omega-3 fatty acids in foods. Using omega-3 as a drug name is actually jargon and is not allowed by the letter of the law, which defines omega-3 as a name for a food ingredient.

Omega-3 ethyl esters are indeed named on drug labels. Drugs traditionally must have labeling that differentiates from food and non-scientific jargon. In the USA, the labeling of a food as a drug is harshly regulated by the FDA, but the labeling of a drug as a food is being allowed in practice.

Dr Doughman says “The word omega-3 is advised here to be too vague and non-pharmaceutical, non-organic-chemistry, and not legally allowable on a drug label. That the word omega-3 is used to describe, market, and sell a drug puts all omega-3 foods at risk of being regulated as a drug and could limit individual freedoms and the right to a second opinion. A negative result is non-conclusive data. The study and labeling questions may still need to go through proper clearance by a human ethics board," says Dr Doughman, a former NIH fellow in Public Health at the University of North Carolina, Chapel Hill.
Contact Information
Source-Omega, LLC
Gene Wolf
11312 US 15-501 North, Suite 107-122
Chapel Hill, N.C. 27517, USA

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