the concentration of lead may be as high as 25 percent rather than 11 percent which is found on the preprinted prescription forms. The Australian Dental Association found likewise. [Next slide.] The area shaded in blue states that they found almost 26 percent of lead oxide. This was not shown on the label. [Next slide.] The American Endodontic Society in 1974 stated that in their research of lead they found that in the proper concentration lead poisons can be beneficial. I submit that there is no concentration of lead, in organic or inorganic form, that is biologically acceptable to the body. I would refer once again to Goodman and Gilman as one of the most definitive texts to emphasize this particular point. [Next slide.] Let us consider what happens. In March of 1975 a biopsy was performed on a patient for whom this material was passed beyond the end of the root and ended up in the bone that surrounds the root. A toxicological analysis was done on this material. It was found that the concentration of lead and formaldehyde was startling, and astonishingly higher than that which was found on the preprinted prescription forms. [Next slide.] Let us consider formaldehyde. The proponents of this material state that it was never intended to be a biological material because of its formaldehyde content. [Next slide.] Once again I refer to Goodman and Gilman about the pharamacological basis of therapeutics. They point out basically that formaldehyde is an embalming fluid. That is basically what it is. [Next slide.] Let us consider something that I am particularly troubled by. A very good and effective drug for the right ailment, and that is, corticosteroids. Corticosteroids definitely have a place in modern treatment in medicine and dentistry today. What we are concerned about is the indiscriminate use of corticosteroids for all patients under all conditions regardless of what the diagnosis may be. [Next slide.] The proponents of this material state that, in fact, this material accelerates healing. We find a completely contradictory statement in this definitive text by Goodman and Gilman where it is pointed out that corticosteroids, rather than helping the healing process, in fact delay the healing process. [Next slide.] This material could not be all bad, obviously. If it were all bad I would submit that we would probably not be here today investigating this particular aspect of our communication with various governmental agencies. It has certain socially redeeming values, if I may put it that way. [Next slide.] That is zinc oxide and eugenol. Is it a new idea? It is not. Zinc oxide and eugenol have been used in root canal treatments and other treatments for several generations. [Next slide.] In Philadelphia, in September of 1973, Dr. Sargenti stated that this paste which contains formaldehyde cannot be perfectly nonirritating, which is an understatement, in the area which surrounds the end of the root. But his observations for 20 years authorizes him to conclude that the material is reasonably well tolerated. I submit, however, that when this material is taken up by the body and absorbed by the body and distributed throughout the body, then where does this material go? It goes in the bone marrow. It ends up in the liver, in the kidney, in the spleen, in the digestive tract, and other organs of the body. [Next slide.] To substantiate some of the rationale for the use of this material, the proponents of this technique have used various studies. Allow me to illustrate one for emphasis. An animal experiment was done on one dog. Based upon what was found on this single animal, conclusions were made and therefore treatments were recommended. On the other hand, when a number of other studies were done which showed contradictory results and showed the harmful effects of this material, then the comment was made "that direct conclusions concerning human conditions cannot be drawn from preliminary animal studies." I suggest you cannot have it both ways. Either we believe in studies and scientific investigations or we do not. [Next slide.] This is what really shocks me most of all. In two different documents by the American Endodontic Society, there is the following information: "Today enough material is available to assess the method directly on the highest experimental animal, man." And, again, "Animal studies are of no purpose as both material and technique have already been successfully applied on the ultimate experimental animal, man." I suggest that the Food and Drug Administration takes a dim view of people who like to perform treatment on the ultimate experimental animal. We will consider that in just a moment. [Next slide.] It is stated by the proponents of this technique that under certain conditions it is OK to pass this material beyond the end of the root because it can cause no harm. [Next slide.] Let us consider that statement right out of Dr. Sargenti's book itself. It states, and this photograph is right from his book, that in treating gangrenous teeth a small quantity of this material may be overfilled. It shows it beyond the end of the root, just like that biopsy which was submitted for toxicological analysis also showed. [Next slide.] Then the literature by the proponents of this material state that a small quantity of this material extruded into this area stimulates the healing of the pathologically changed structures. [Next slide.] There is additional information which they presented recently which points out that even gross accidental overfilling of the N2 pastes, whether intentional or accidental, is of no consequence because no significant hazard can occur. [Next slide.] Let us consider exactly what can happen when this material is forced bevond the end of the root. Very harmful effects can occur, for example, when this material goes beyond the end of the root and is absorbed in and around the sinus area. Where does it go? I suggest that it goes to the liver, to the kidneys, to the spleen, to the bone marrow, and to the digestive tract, and throughout our bodies, and that is the area of our concern. [Next slide.] There were several papers published, but I will summarize them briefly. One was by Dr. Hans Orlay, where he pointed out that this material, when intentionally or unintentionally is forced beyond the end of the root, causes what is called parasthesia, which is numbness of the jaw. The material was absorbed but the tooth had to be extracted. The material was absorbed, but the patient had parasthesia 6 months later, [Next slide.] He showed another incident where it ended up in the sinus of another patient, and it required a surgical procedure in order to remove that material. [Series of slides.] Dr. Ehrmann from Australia published a paper several years ago where he, too, showed this material was forced beyond the end of the root and, not by coincidence, it ended up in the main nerve canal in the lower jaw, the mandibular canal. That caused once again this parasthesia, which is a sensation of numbness in the lower jaw. That patient had that for many months, and I do not know that it has ever cleared up. [Next slide.] It has been suggested to all dentists that everyone should be using N2 paste because, after all, everyone is using it and why should you be the last on the block not to use it. These are the alleged statements. [Next slide.] Let me illustrate. "Today it may be said without being contradicted that the N2 method represents one of the most widely used endodontic treatments in the world." [Next slide.] I would like to point out what Dr. Ostby had to say about this material. On the basis of analysis by the Commonwealth Bureau of Standards, the material was banned in Australia. It was outlawed in Norway. The material is forbidden in Sweden. [Next slide.] Ironically enough, this material was even prohibited from use in Dr. Sargenti's own country, Switzerland. For example, this is a letter from the dean of the University of Switzerland in Berne, where he points out that the use of this material is not advocated nor taught in any of the country's four dental schools. [Next slide.] The Australian Dental Association, on the bottom. line and magnified on the right, states "This product is therefore declared a prohibited import under the above position of the Therapeutic Substances Act." [Next slide.] New York City has begun the process of prohibiting the use of this material by the dentists in the foster child program, for example. Recently the proponents of this material say "As a matter of fact. the material recommended for use by our society is not N2." They state that it is not N2. I suggest that whether we call it N2 or RC2A or RC2B or RETB, to quote Gertrude Stein, "a rose, is a rose, is a rose; by any other name it smells just as sweet." [Next slide.] The statement has been made by the proponents of this material that dentists using this technique may be subject to litigation since this drug has not been approved by the FDA. It should say the American Dental Association, In the reply of the American Endodontic Society, it states that the "Council on Dental Therapentics of the ADA has stated that this material is not within their purview, and as such has not been granted either approval or disapproval." [Next slide.] Let us examine the facts. In May of 1962 the Journal of the American Dental Association specifically stated in a major paper that this material is considered to be in category group D, and that means unacceptable to the dental community. 62-841 0-76-4 ( [Next slide.] The material in any formulation cannot be found in the "Physicians' Desk Reference." On the other hand, this N2 material can be found in "Accepted Dental Therapeutics." It is listed on page 13 under "Group D, Unacceptable." [Next slide.] In our State, California, the Journal of the California. Dental Association specifically cautioned dentists about the use of this material, mentioning a memorandum that was mailed out by the Food and Drug Administration in April of 1974. Dr. Margaret Clark recently sent à letter to a patient involved in litigation regarding N2. She points out to the patient that dentists who use this material, whether compounded by a pharmacist or a small manufacturer, must assume full responsibility for any adverse reaction. She reemphasizes that the material is not approved. [Next slide.] Let me illustrate some examples of what can happen with the use of this material. On the left, this material was intentionally or unintentionally forced beyond the end of the root and it ended up right down here in the main nerve canal of this patient's jaw. Of course, the tooth had to be removed. The material remains behind in that patient's jaw. That patient at this time regrettably suffers from once again what is called parasthesia, which is numbness of the jaw. I cannot provide more specific information on this case, only because this case is being adjudicated right now in southern California. Let me give you another illustration if I may. [Next slide.] This was an 8-year-old girl where N2 material, once again, was forced beyond the root. When it went beyond the end of the root, it ended up in the lower jaw. Of course, the tooth had to be extracted and, once again, here are remnants of the N2 material right here after the tooth was removed on an 8-year-old girl. What will happen to this girl? In some respects, she remains a dental cripple for the rest of her life. [Next slide.] I just received this case the day I left for this particular meeting. This is a case that happened in San Diego, where. on the right, it shows the material being forced beyond and, actually, not even into the root. This can happen under other conditions, but this dentist unfortunately used this N2 material and it ended up in the lower jaw and around the main nerve canal. As a result, this patient has had two experiences: The first experience is that this patient had intractable pain that cannot be controlled even by narcotic preparations: the second experience that this patient has is parasthesia. [Next slide. What would happen, for example, if conventional pastes were used? What would happen if it ended up in the lower jaw, the main nerve canal? That is exactly what happened here. It ended un in the lower jaw with the conventional paste and this patient experienced no discomfort or pain. The patient did not even know about it even though, as a part of California law, the patient was informed about it nevertheless. [Next slide. When conventional pastes are used, as shown on the left, even when forced bevond the end of the root, the material is absorbed quickly and harmlessly. [Next slide.] There are a couple of bizarre cases which happened recently in California. On the left there is the case where the N2 material was forced beyond the end of a root and, regrettably, this patient ended up with a cleft palate. That is what the suit is all about." On the right, there was a case, bizarre though it may be, where the N2 material was associated as one of the proximate causes of death. [Next slide.] This material has been categorized by California recently, by the California Food and Drug Administration, as functionally embargoed. I recently heard from the attorney general's office, the assistant attorney general, the day I left for this meeting and it was pointed out that the Department of Justice in California has ruled that this material in California may not even be compounded by pharmacists for an individual dentist for an individual patient under any conditions. If that should happen it violates three separate laws. [Next slide.] One of your colleagues, Representative Gude from Maryland, has been urging the Food and Drug Administration to ban immediately the use of this material. [Next slide.] After all else is said and done, I would like to quote from the Hippocratic oath where it states in the original Latin, "Prima non nocere," which means, "If nothing else, let us just be sure that we do not hurt people.' Thank you very much, Mr. Chairman. Mr. FOUNTAIN. Thank you very much, Dr. Cohen. Without objection, Dr. Cohen's prepared statement will be inserted in the record. [Dr. Cohen's curriculum vitae and prepared statement follow:] CURRICULUM VITAE OF STEPHEN COHEN PERSONAL DATA Date of birth: September 23, 1938. Place of birth: New York City. Social Security No. : 057–32-5393. Marital Status: Married (Sandra Cohen). Children: Aaron Scott Cohen, born 8/25/65; and Kevin Bradley Cohen, 1/10/75. Private Practice Addresses: 450 Sutter St. No. 2510, San Francisco, Calif. 94108, (415) 391-8333; 920 Northgate Dr., Terra Linda, Calif. 94903, (415) 479-6444; and home address: 25 Meadowhill, Tiburon, Calif. 94120, (415) 435-0525. EDUCATION AND HONORS B.A. New York University, 1953; M.A. Indiana University, 1961; D.D.S. Indiana University, 1965; Two-year endodontic post-graduate program, University of Pennsylvania, 1965-66, 1968-69. 1965. Outstanding Endodontic Student, Indiana University-C. V. Mosby Award, MILITARY RECORD U.S. Army, April 1966-68; Chief of Endodontics, Ireland Army Hospital 196668; Director of Endodontic program for dental interns and general dental residents, Ireland Army Hospital 1966-68. PROFESSIONAL PRACTICE RECORD Philadelphia-1965-66; New York City and Hempstead, Long Island-1968-69; San Francisco and Terra Linda-1969-present. |