TEACHING EXPERIENCE Chairman and Associate Professor, Endodontic Department, University of the Pacific, School of Dentistry-1974-present. Chairman and Assistant Professor, Endodontic Department, University of the Pacific, School of Dentistry-1970-1974. Chief of Endodontics, Mt. Zion Hospital, San Francisco-1971-present. PUBLICATIONS Etiology, Diagnosis and Treatment of the Dental Manifestations of Vitamin D Resistant Rickets: A Literature Review and Case History, JADA Publication pending 1975. Textbook "Pathways of the Pulp", C. V. Mosby (pending Summer 1976). A self-administered Endodontic Quiz. Jour. Calif. Dent. Assn., Sept. 1975. The Sequelae of Accidentally Injecting Sodium Hypochlorite Beyond the Root Apex: A Literature Review and Case History: J. Oral Surg.; Oral Med.; Oral Path., 38:633, 1974. Letter to Editor: "In Vitro and In Vivo Studies on a Composite Resin for the Repair of Incisal Fractures, Jour. Calif. Dental. Assoc., December 1973. Letters to Editor: "Expanded Duties Proposal", Composite, June 1973. Bleaching Tetracycline-Stained Vital Teeth, Jour. Oral Surgery, Oral Med.. Oral Path., 29:465, 1970. The Effects of Acids, Alkalis and Chelating Agents on Dentin Permeability, Jour. Oral Surgery, Oral Med., Oral Path., 29:631, 1970. The Permanent Internal Splint for a Fractured Incisor Root, D. Digest, 74:162, 1968. A Simplified Method for Bleaching Discolored Teeth, D. Digest, 74:301, 1968. CONSULTANT Letterman General Hospital, Presidio, San Francisco, Calif.-1970; Veterans' Administration Hospitals, Palo Alto, Calif., Menlo Park, Calif.-1970-present; Oaknoll Naval Hospital, Oakland, Calif.-1971-present; and, Travis Air Force Base, Calif.-1974-present. POSTGRADUATE AND CONTINUING EDUCATION PRESENTATIONS Conquering Innerspace--University of the Pacific School of Dentistry, San Francisco-1975. Analysis of the Sargenti (N-2) Method: Material-Technique and Dental-Legal Implications: Maryland State Dental Association-1975; Suffoc County Dental Society-1975; UCLA-1975; University of Pennsylvania-1975; Alpha Omega, Vancouver, B.C.-1975; Napa-Solano Dental Society-1975; St. Francis Hospital, Honolulu, Hawaii-1974; and University of the Pacific School of Dentistry, San Francisco 1974. Structure and Management of a Corporate Group Endodontic Practice: University of Southern California-1974-Northern California Academy of Endodontics-1974. One Visit Complete Endodontic Treatment and Endodontic Surgery for Restored Teeth, Mexico City, Mexico-1973. Full Day Course in Endodontics, Chico. Calif.-1973. One Visit Complete Endodontic Treatment: Fresno County Dental Society1973; Stanislaus County Dental Society-1973; and Marysville and Tulare County Dental. One Visit Complete Endodontic Treatment on Anterior and Posterior Teeth, Endodontic Surgery for Restored Teeth and Dowel Preparations, Kuilima, Oahu, Hawaii-1972. Endodontic Armamentarium-Sterilization Procedures and Clinical Application, 76th Annual Scientific Meeting. University of California, School of Dentistry-1972. Endodontic Implants. Hebrew University, Jerusalem. Israel-1971. Endodontic Surgery: Tel-Aviv Endodontic Study Club, Israel-1971 and Israeli Dental Association-1971. "Endo-Perio Lesion," Letterman General Hospital-1971. Advanced Endodontics, University of the Pacific, School of Dentistry, San Francisco-1971. "Endo-Perio Lesion," Letterman General Hospital-1970. Advanced Endodontics, University of California, San Francisco-1970. Permanent Internal Splint for a Fractured Incisor Root: California Dental Association Meeting-1970; National Convention of American Association of Endodontists in St. Louis-1967. MEMBERSHIP Diplomate, American Board of Endodontics; Fellow, International College of Dentists; American Association of Endodontists; Northern California Academy of Endodontics; American Academy of Oral Medicine; Sigma Xi (Honorary Science); Past-President, Alpha Omega, Bay Area Chapter; American Dental Association; California State Dental Association; San Francisco Dental Society; American Association of University Professors; and the Federation Dentaire Internationale. PREPARED STATEMENT OF STEPHEN COHEN, D.D.S., The concept of using formaldehyde-type pastes for filling root canals dates back to the last century. The theory and concept of using formaldehyde containing pastes fell into disrepute as more scientific investigations demonstrated the potential deleterious effects of these pastes. Dr. Angelo Sargenti of Switzerland resurrected the concept of using formaldehyde-containing pastes for filling root canals. Because the formaldehyde "fixed" ("Mummified") the tissue around the root end and the corticosteroids masked the true biological reaction, the concept enjoyed temporary popularity amongst the dentists who did not understand the full implication of using these materials. The compounds of "N-2" type pastes (R-C, RC-2A, RC-2B, RET-B, etc.) contain certain ingredients which are potentially harmful when brought in contact with the tissues that surround roots.1 These "N-2" type compounds are not always safe or effective, even when used in accordance with "directions." The "directions"-as stated by Dr. Angelo Sargenti (the "inventor" of this material)—recommend overfilling some root canals (i.e., forcing "N-2" paste beyond the end of the root). As presently sold by small manufacturers, no dosage or directions for usage are given. Nor is there any warning of complications, side-effects, or potential harmful sequellae. The potential for harm to humans, when root canals are intentionally or inadvertently overfilled with "N-2" paste is dramatic. There is ample documentation to show that amongst the untoward signs and symptoms that may develop when root canals are overfilled with "N-2" pastes are parasthesia (i.e., numbness of the jaw) and developing oral-antral communication (i.e., acquired cleft palate).* Bizarre though it may be, there was a case where "N-2" paste may have been the proximate cause of death." 3 Additionally, there is compelling experimental evidence to show that the heavy metal compounds of lead and mercury, which are found in all compounds of “N-2", may be deposited in remote sites, such as the liver, spleen, kidneys and bone marrow when root canals are overfilled." Present scientific evidence demonstrates that formaldehyde-which is also found in all "N-2" compounds, causes biologic insults to bone and surrounding soft tissues." Although these "N-2" pastes have been banned in several countries, are listed as Group "D" (Unacceptable) in the 35th Edition of Accepted Dental Therapeutics, and are listed as "non-approved" by the Federal Food and Drug Administration,' a substantial number of dentists in the United States continue to use these drugs. Because most State and Federal agencies have been reluctant or indifferent to exercise control over the manufacture and distribution of these "N-2" pastes by small manufacturers, "quality control" appears to be lacking. As a result, there are a number of biopsy specimens to show that the percentage of lead and formaldehyde compounds is astonishingly higher than the percentages shown on the pre-printed prescription forms." To the best of my knowledge, there is no endodontic department, dental school or reputable dental institution in the United States that advocates the use of "N-2" pastes for endodontic (root canal) therapy." Based on the aforestated experimental studies, microscopic experimentations, toxicologic analyses and clinical case reports, I am of the opinion that "N-2" pastes have not been established to be safe and effective, a prerequisite to FDA approval. 12 Presently, California prohibits these "N-2" type drugs from being manufactured or distributed by commercial companies. Additionally, the California Dental Association has notified its member dentists of the position of Federal and State drug agencies regarding the use of "N-2". Dr. James Hull, director of the Nebraska Division of Dental Health, has sent letters to every dentist in the State, cautioning them about the potential harmful effects of "N-2" pastes." 13 In my communication with the Federal Food and Drug Administration, there appears to be an understanding of the problems relating to the easy manufacture and abuse of this non-approved drug; nevertheless, to date, there has been no enforcement or compliance action. In consideration of the scientific evidence which strongly suggests the potentially harmful effects of this drug, I believe its continued usage constitutes an imminent health hazard. There are generally and widely accepted alternatives for root canal treatment that are readily available to the general public which can provide excellent, predictable results with minimal risk and considerable benefit. Accordingly. I believe the Federal Food and Drug Administration should fulfill its mandated regulatory function by obtaining injunctions against the manufacture and distribution of "N-2" pastes and publish in the Federal Register warning notices against future shipments of this drug. Mr. FOUNTAIN. I want to thank all of you gentlemen for your presentations. Perhaps in light of so many things in the country today, I should say courageous, as well as helpful, statements. Before we begin the questioning period, I would like to place in the record several documents which have a bearing on the testimony of Dr. Martin. Dr. Martin referred to his visit to Congressman Gude's office, and I am placing into the record a copy of the letter that Congressman Gude sent to FDA as well as a copy of his October 10, 1975, press release in which he urged the FDA, and I quote from page 2 of the release; “*** to immediately impose a ban on any further dissemination of this substance until such time as its safety and effectiveness can be demonstrated." I might add that Congressman Gude is a member of our Government Operations Committee. [The documents referred to follow:] Dr. ALEXANDER M. SCHMIDT, CONGRESS OF THE UNITED STATES. Commissioner, Food and Drug Administration, HOUSE OF REPRESENTATIVES, Washington, D.C., October 2, 1975. DEAR COMMISSIONER SCHMIDT: It has recently come to my attention that a substance utilized in endodontics referred to as "N2" has never received ap proval from the Bureau of Drugs, but that it is being distributed throughout the country through a "prescription order" system. No action has been taken by the FDA to approve or ban this substance or to take other appropriate action in order to protect the health of our citizens who may be treated with this particular drug. I understand that the manufacturers of N2 submitted an application for new drug status in 1962, but that they withdrew their application in 1969 prior to receiving FDA approval because they were unable to furnish the Administration with sufficient scientific evidence to prove that the drug was safe for its intended use. Since that time, the supporters of the drug have been providing this material to individual practitioners through the use of "order blanks" by which the drug is compounded by pharmacists and mailed interstate for use by a particular dentist. Oftentimes, these orders are of sufficient quantity to treat several patients, and not just one individual, according to information which I have received. Furthermore, in a letter dated November 1, 1972 by Dr. Ronald R. Scherzberg, Assistant to the Director, Division of Regulatory Operations, Office of Compliance, it was stated that “(i)f the formulation listed on the pre-printed prescription form is not generally recognized as safe and effective for its intended uses, we would consider the preparation subject to new drug clearance procedures." Serious question has been raised by the dental community in recent years concerning the safety of N2, and this information was brought to the attention of the FDA in January of this year. The information included articles from professional publications and letters from almost 30 of the nation's dental schools, as well as several foreign dental associations, indicating that the compound, as well as the Sargenti technique, are subject to serious question relative to safety. Included in the materials was an indication that N2 has been banned in Norway, Sweden and Australia, and that the material has been embargoed in California. I understand that members of the Bureau staff have recommended that N2 be banned immediately, but that other members of the staff would prefer to subject N2 to the entire review process, feeling that there is insufficient information to properly evaluate the safety of the drug. It has now been nine months since material was formally presented to the FDA which indicated that the vast majority of the dental community believed that N2 was not a safe drug. This belief was based on scientific evidence to a very large degree, and has been acted upon in several foreign countries to ban N2 from the marketplace. To date, FDA has not made a decision on this potentially deleterious substance. I strongly urge you to immediately impose a ban on any further dissemination of this substance, until such time as its safety and effectiveness can be demonstrated. I believe that the FDA owes it to the American public. as well as to the dental profession and the drug's supporters, to act with more swiftness than has thus far been apparent in resolving this entire dispute. I look forward to your response to both the issue of the safety of N2, as well as the reasons for the delay in making a final determination on this matter. Sincerely, (Signed) GILBERT GUDE. NEWS RELEASE FROM CONGRESSMAN GILBERT GUDE Congressman Gilbert Gude, R-Md., has asked the Food and Drug Administration and the State of Maryland to ban the use of a compound called “N2” which is currently in use in dental root canal procedures, pending proof of its safety. "Serious question has been raised by the dental community in recent years concerning the safety of N2, and this information was brought to the attention of FDA in January of this year," Gude said. "The information included articles from professional publications and letters from almost 30 of the nation's dental schools, as well as several foreign dental associations, indicating that the compound, as well as the Sargenti technique (in which it is used) are subject to serious question relative to safety." Gude said "N2" has been banned in Norway, Sweden and Australia, and has been embargoed in California. Gude said the compound has not been approved by FDA but is already in wide use. Supporters of the compound. Gude said, have been able to skirt this lack of approval by distributing to individual practitioners "order blanks" by which the practitioners can have a pharmacist make up the compound and mail it to them interstate. Root canal procedures are undertaken to remove the pulp, or root, of a tooth when it, the root, has become so damaged by decay or poor circulation that, if left untended, bacterial infection and abscessing would result, leading to the loss of the entire tooth. In the standard procedure, a lengthily trained dental specialist called an endodontist drills a hole in the crown of the tooth and removes the dead pulp with various small instruments specially designed to get into the narrowing, winding canals. The spaces are then filled with a gummy material and a sealer. A synthetic cap or crown is then fitted. The root canal for a single tooth may cost up to $250, with the crown costing perhaps an additional $150. The Sargenti technique, devised and named after a Swiss dentist, uses motorized devices. The root canal is then filled with a special paste under the name of N2 or other trade names. The paste may contain compounds of lead and mercury along with steroid hormones and paraformaldehyde which are supposed to sterilize and protect the root canal against bacterial growth. Critics, however, say the toxic compounds pose a hazard if they leak from the root canal and that paraformaldehyde is highly damaging to tissues. Thus, although the Sargenti treatment may be completed in just one visit and costs under $100 (plus the cost of the crown) some experts have reported serious damage to oral tissues and bone. One woman has charged that the treatment dissolved a part of her palate, requiring plastic surgery. Gude wrote Dr. Richard Crout, director of FDA's Bureau of Drugs, "I understand that the manufacturers of N2 submitted an application for new drug status in 1962, but that they withdrew their application in 1969 because they were unable to furnish FDA with sufficient scientific evidence to prove that the drug was safe for its intended use. "Since that time, the supporters of the drug have been providing this material to individual practitioners through the use of 'order blanks' by which the drug is compounded by pharmacists and mailed interstate for use by a particular dentist "Serious question has been raised by the dental community in recent years concerning the safety of N2 and this information was brought to the attention of FDA in January of this year. It has now been nine months since the material was formally presented to FDA which indicated that the vast majority of the dental community believed that N2 was not a safe drug. "I understand that members of the Bureau staff have recommended that N2 be banned immediately, but that other members of the staff would prefer to subject N2 to the entire review process, feeling that there is insufficient information to properly evaluate the safety of the drug. "I strongly urge you to immediately impose a ban on any further dissemination of this substance until such time as its safety and effectiveness can be demonstrated." The information on N2 was also referred by Congressman Gude to Dr. Neil Solomon, Maryland Secretary of Health and Mental Hygiene, asking for a Maryland ban of N2. Mr. FOUNTAIN. Dr. Martin also testified concerning his visit to the offices of FDA in January of 1975 in Rockville. In that connection I am placing in the record a copy of a January 7, 1975, memorandum of conference between Dr. Martin, who was accompanied by Dr. Siskin, an endodontist from the University of Tennessee, and FDA representatives. The copy of the memorandum was obtained from FDA. Dr. Martin, in your statement you did not mention that anyone accompanied you when vou visited FDA in January of 1975. Were you accompanied by Dr. Siskin? Dr. MARTIN. Yes. I think I did mention that I was accompanied by Dr. Siskin on page 4. Mr. FOUNTAIN. Yes, I must have missed that. [The memorandum referred to follows:] |