Sargenti Opposition Society
			WHAT YOUR DENTIST MAY NOT TELL YOU but you need to know before your next root canal

The following quote is the closing comments from the Consumer Representative, Jean Frazier, PhD, at the 1993 FDA Dental Products Panel meeting where Sargenti Paste/N2 was denied approval by the FDA.  The concern regarding informed consent expressed by Dr. Frazier is exactly what the Alabama Dental Board did when they sanctioned three dentists for injuring a patient with Sargenti Paste.  You can NOT ask a patient to consent to negligent, substandard care.

DR. FRAZIER: I would like to make a brief statement. As consumer representative, having listened very intently to the entire day's conversation, one of the things that consumers expect, I think, is that their dental professional provider will do no harm, similar to a physician. The patient consumer needs to expect not to be harmed.

I think that consumers who are in pain or in need of procedures such as endodontics can be vulnerable to harm because they might be more likely to go ahead and give informed consent without really, clearly hearing any detailed description of a particular procedure. So I see a problem in perhaps the informed consent procedures that could be utilized with this type of thing.

A second kind of comment that I would make is that, regardless of how old a supposed protocol might have been, the research clearly does not meet scientific standards of today and consumer responses to being harmed are not going to care whether such a protocol of eight years ago, ten years ago, twenty years ago was followed.

So I feel very strongly that this material has not met the scientific standards that consumer groups would want to believe that their health care providers would use to judge efficacy and safety of a given product.