Journal of the American College of Dentists · Board and their respective employees and officers...

Journal of the

American Collegeof Dentists

New Product Decisions

Fall 2006Volume 73Number 3

A publication promoting excellence, ethics, professionalism,and leadership in dentistry

The Journal of the American College ofDentists (ISSN 0002-7979) is publishedquarterly by the American College ofDentists, Inc., 839J Quince OrchardBoulevard, Gaithersburg, MD 20878-1614.Periodicals postage paid at Gaithersburg,MD. Copyright 2006 by the AmericanCollege of Dentists.

Postmaster–Send address changes to:Managing EditorJournal of the American College of Dentists839J Quince Orchard BoulevardGaithersburg, MD 20878-1614

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While every effort is made by the publishersand the Editorial Board to see that no inaccurate or misleading opinions or state-ments appear in the Journal, they wish tomake it clear that the opinions expressed in the article, correspondence, etc. hereinare the responsibility of the contributor.Accordingly, the publishers and the EditorialBoard and their respective employees andofficers accept no liability whatsoever forthe consequences of any such inaccurate or misleading opinion or statement.

For bibliographic references, the Journalis abbreviated J Am Col Dent and should be followed by the year, volume, numberand page. The reference for this issue is:J Am Col Dent 2006; 73(3): 1-48

Publication Member of the American Association of Dental Editors

Mission

T he Journal of the American College of Dentists shall identify and place before the Fellows, the profession, and other parties of interest those issues that affect dentistry and oral health. All readers should be challenged by the

Journal to remain informed, inquire actively, and participate in the formulation of public policy and personal leadership to advance the purposes and objectives of the College. The Journal is not a political vehicle and does not intentionally promotespecific views at the expense of others. The views and opinions expressed herein donot necessarily represent those of the American College of Dentists or its Fellows.

Objectives of the American College of Dentists

T HE AMERICAN COLLEGE OF DENTISTS, in order to promote the highest ideals in health care, advance the standards and efficiency of dentistry, develop goodhuman relations and understanding, and extend the benefits of dental health

to the greatest number, declares and adopts the following principles and ideals as ways and means for the attainment of these goals.

A. To urge the extension and improvement of measures for the control and prevention of oral disorders;

B. To encourage qualified persons to consider a career in dentistry so that dentalhealth services will be available to all, and to urge broad preparation for such a career at all educational levels;

C. To encourage graduate studies and continuing educational efforts by dentists and auxiliaries;

D. To encourage, stimulate and promote research;E. To improve the public understanding and appreciation of oral health service

and its importance to the optimum health of the patient;F. To encourage the free exchange of ideas and experiences in the interest of better

service to the patient;G. To cooperate with other groups for the advancement of interprofessional

relationships in the interest of the public;H. To make visible to professional persons the extent of their responsibilities to

the community as well as to the field of health service and to urge the acceptanceof them;

I. To encourage individuals to further these objectives, and to recognize meritoriousachievements and the potential for contributions to dental science, art, education,literature, human relations or other areas which contribute to human welfare—by conferring Fellowship in the College on those persons properly selected for such honor.

Journal of the

American Collegeof Dentists

aade

EditorDavid W. Chambers, EdM, MBA, PhD

Managing EditorStephen A. Ralls, DDS, EdD, MSD

Editorial BoardMaxwell H. Anderson, DDS, MS, MEDBruce J. Baum, DDS, PhDNorman Becker, DMDD. Gregory Chadwick, DDSJames R. Cole II, DDSEric K. Curtis, DDSKent W. FletcherBruce S. Graham, DDSFrank C. Grammar, DDS, PhDSteven A. Gold, DDSDonna Hurowitz, DDSFrank J. Miranda, DDS, MEd, MBALaura Neumann, DDSJohn O’Keefe, DDSIan Paisley, DDSDon Patthoff, DDS

Design & ProductionAnnette Krammer, Forty-two Pacific, Inc.

Correspondence relating to the Journalshould be addressed to: Managing EditorJournal of the American College of Dentists839J Quince Orchard BoulevardGaithersburg, MD 20878-1614

Business office of the Journal of theAmerican College of Dentists:Tel. (301) 977-3223Fax. (301) 977-3330

OfficersMarcia A. Boyd, PresidentH. Raymond Klein, President-electJohn M. Scarola, Vice PresidentMax M. Martin, Jr., TreasurerB. Charles Kerkhove, Jr., Past President

RegentsThomas F. Winkler III, Regency 1Charles D. Dietrich, Regency 2J. Calvin McCulloh, Regency 3Robert L. Wanker, Regency 4W. Scott Waugh, Regency 5Patricia L. Blanton, Regency 6Paul M. Johnson, Regency 7Thomas Wickliffe, Regency 8

New Product Decisions4 I Had to Be an American Woman Activist

Cecelia L. Dows, DDS, FACD

5 Articaine and Paresthesia: Epidemiological StudiesDaniel A. Haas, DDS, PhD, FRCD(C), FACD

11 The Ethics of Adopting a New Drug: Articaine as an ExampleBruce Peltier, PhD, MBA and James S. Dower, Jr., DDS, MA

21 Selection of Local Anesthetics in Dentistry: Clinical Impression versus Scientific AssessmentArthur J. Jeske, DM., PhD, FACD and Patricia L. Blanton, DDS, PhD, FACD

25 The Chicken Little Syndrome Ronald S. Brown, DDS, MS, FACD

30 Commercialization of Dental Education: Have We Gone Too Far?Peter M. Spalding, DDS, MS, MS, FACD and Richard E. Bradley, DDS, MS, FACD

Issues in Dental Ethics36 Ethical Reflection in Dentistry:

First Steps at the Faculty of Dental Surgery of Toulouse Olivier Hamel, DDS, PhD, Christine Marchal, DDS, PhD, Michel Sixou, DDS,PhD, and Christian Hervé, MD, PhD

Departments

2 From the EditorHow Thornless Blackberries Got Big Fruit

40 LeadershipFriendly Competition

Cover Photograph: ©2006 Emrah Turudu, iStockphoto.

The art and science of dentistry areadvancing briskly, but not necessarilyarm-in-arm. Perhaps dentists would

not be embarrassed if introduced as“reflective practitioners” or “women ormen of science”; but few would describethemselves that way. It is not the highestform of praise. Only the frauds and quacksknowingly practice contrary to science,but we all expect to be forgiven if wedon’t toil into the night to advance it.

The founders of the AmericanCollege of Dentists were clearly focused onpromoting and recognizing the scienceof dentistry as an essential component ofprofessionalism. (It remains one of theobjectives of the College, as described onthe overleaf of this journal; although itmay be more accurate to say we are nowhurrying to see which way it wentrather than pushing to be first in line foradvancing it.) The first Fellows warnedof the dangers that could come from segmentation in the profession. Was itreally wise to delegate research to theacademy and then to industry? The price in communication, simply readingthe literature, that must be paid now toavoid crippling narrowness is ballooningas the research enterprise grows independently of dentistry.

Try this test. It is required by theFood and Drug Administration thatadvertisements making therapeuticclaims be accompanied by disclaimers;these appear on the second page of drugads. Read any such disclaimer with apen in hand and mark every term or

reflective practitioner of his day, with agarden that was his practice.

By the late 1890s, Burbank had selectively bread the Lawton, theHimalaya, and other commercially suc-cessful types of blackberry with desirablecharacteristics of size, flavor, mass, andearly ripening. This was straightforwardselective breeding using established principles of genetics—breed the best anddiscard the rest. In 1902, David Fairchildof the U.S. Department of Agriculturediscovered a nearly thornless variety ofblackberry in North Carolina. Burbankperfected the thornless nature of thisline, again through selective breeding.

The genetic principle of purifying the line and advancing the most desirable characteristics have beenknown and applied in university andindustry settings for years. Only the bestscientists are funded (and encouraged to collaborate with other successfulresearchers) to maximize highly valuedfeatures. The same is true in professionalschools where very high standards ofselective admissions and retention are used to advance the profession. The process continues to some extentthrough the natural competition in practice. Professions are advanced byselective breeding.

The story of the thornless blackberrywould be completed at this pointthrough this process of purification inbreeding except for one unfortunate circumstance. The berries on the thornless variety were few, small, andtasteless. Burbank’s early attempts tocorrect the problem were predictable

2

2006 Volume 73, Number 3

Editorial

From the Editor

How Thornless Blackberries Got Big Fruit

concept you cannot confidently define.Why is it that evidence-based dentistrysounds like something someone elsedoes—perhaps an academic—and notsomething that happens in the dentaloffice? Why is it that articles on EBD so frequently illustrate the concept withan example of a drug, when most ofdentistry is based on materials and procedures? (The FDA classifies productsthat do not depend on a systemic inter-action with the patient for their effect asdevices; hence cements, composites, andeven antiseptic mouthrinses are devices.)Can it be that research has gotten too goodat the science of biology and dentistrytoo good at the art of patient care?

Unless we reunite the art and science of dentistry—in the person of thepractitioner, and none other—there is arisk of returning to the days when craftand commercialism were the mark ofthe trade, and the public managed toothpullers and elixir peddlers like they did horseshoers.

A key to understanding why much of our recent efforts have only made theproblem worse comes from the story ofthe thornless blackberry. The report isfound in “Small Fruits,” volume IV, in thecollected works of Luther Burbank.Burbank was a practical botanist whodeveloped many of the commercial varieties of potatoes, plums, squash, andother fruits and vegetables we knowtoday. He lived in Santa Rosa, California,at the turn of the last century. Burbankwas a friend of Theodore Roosevelt andHenry Ford and a quintessential exemplarof the Progressive Era, believing that science could be applied to raise the condition of mankind. He was the

(cross the thorny berries having big fruitwith the purified thornless variety) andthey were an abject failure (all the crosseswere thorny plants with big berries).Burbank correctly recognized an exampleof the established genetic principle thatthe result of a dominant and recessivecross has the appearance of the dominantgene pool. But Burbank understoodfrom his earlier work with plums andother fruit that this result only heldbecause he had previously purified thetwo crossed strains. He knew that thesecond generation had unexpressedgenes for both thornlessness and bigfruit. When he crossed the second generation, a few expressed the desiredcombination of characteristics. It wasthese rare few of the new type that were then perfected through traditionalselective breeding.

The National Institute for Dental andCraniofacial Research has demonstratedBurbank’s work in the oral health field.Much hope was held for the scientist-clinician program where dentists wouldbe trained as researchers (DDS-PhD) tocombine the desired features of practiceand research. Practice is a dominantcharacteristic and research is recessive,and almost all of the graduates of thisnow much diminished program are inprivate practice. The last data I sawshowed that NIDCR’s efforts to crossdental and medical research teams hasresulted in more MDs than DDSs as principal investigators on R-01 grants indentistry (guess which is the dominantgene in academic health centers).

3

Journal of the American College of Dentists

Editorial

Evidence-based dentistry is beginningto look like a failure on the same grounds.It is attractive to think that progress canbe manufactured quickly by crossing apurified form of research with a highlyadvanced form of practice—but that ispoor science. The progress will come inthe next generation when some of theresearchers who have a recessive affinityfor the problems of practice collaboratewith some of the dentists who have arecessive affinity for disciplined inquiry.These crosses, to be fertile, will takeplace in nontraditional settings wherethey are free of the fierce “ethnic cleans-ing” that takes place when progress isassociated with breeding true to form.

Perhaps dentists were confused by aMay 2006 insert on “ProfessionallyApplied Topical Fluoride” in JADA(www.ada.org/goto/ebd). The subtitle is“Executive Summary of Evidence-BasedClinical Recommendations” and one-third of the report is a discussion ofwhat “best evidence” (in the pureresearch sense) means. This has becomethe mantra of the EBD community.Greater weight is placed on purificationthrough selective breeding than onenhanced utility through hybridization.To be fair, the ADA statement on evidence-based dentistry (available at the sameWeb site) states that EBD takes place inthe dental office and combines researchfindings, practitioners’ experiences, and patients’ values. The statement ontopical fluoride is correctly labeled asEBR—evidence-based recommendations.

Purification of the lines is what isadvancing briskly now in the art and science of dentistry. The two parts are

moving apart through adherence to twosets of very different standards for whatcounts as excellence and even whatcounts as practice or research at all. Thisis necessary work in some preliminarysense, but it is naive to assume thathighly enriched research will be recog-nized or found of value to practitionersor that highly enriched practice situationswill be at all interesting to scientists. The new work that needs to be donenow, what Burbank called hybridization,involves working with the second generation of these purified strains innatural settings to combine the best features of both. NIDCR has already takensteps in this direction with a researchemphasis on practice-based clinical trials. The ADA is looking for usefulapproaches. The dental schools are a natural incubator—but probably not theresearch-intensive ones.

The founding vision of the AmericanCollege of Dentists is as vital today as it was in 1920. Dentists must exhibitboth the art and science of dentistry;those are not functions that can be delegated. Thornless blackberries shouldhave big fruit.

Only the frauds andquacks knowingly practice contrary to science, but we all expect to be forgiven if we don’t toil into the night to advance it.

Cecelia L. Dows, DDS, FACDShort Hills, New Jersey My mother was born in Poland,

the eldest of five children, andwas sent at age nine years to

learn elementary sewing in Krakow. Shewas stranded on what was intended tobe a brief visit to New Jersey; and so thestory begins.

My mother sewed for women wholiterally adopted her and became herAmerican family. She progressed fromusing commercial patterns to designingher own, eventually becoming a designerfor a New York salon in the early 1940s.Among the passions I inherited from my mother were creativity, hard work,and enjoyment of handwork.

As a child in Bayonne, I had theadvantage of learning leadershipthrough volunteer work with the RedCross and the Council of Social Agenciesand received an excellent high schooleducation. In college at FordhamUniversity, I was a member of the firstclass to include female students and wasthe first woman science major. My jobafter college was doing chemical analysisfor the Standard Oil Company at theirBayway Refinery (again the first femaleto hold such a position), but I sensedthat something was missing. My motherand sister convinced me to apply to dental school. Only two (Columbia andNew York University) of the sevenschools to which I sent applications were accepting women. I was the onlywoman in my class and the first in arotating general internship at the JerseyCity Medical Center Hospital.

I began my solo general practice inBayonne in 1948. Part of my work wassupported by the Belleville Foundation,and one and one-half days each week I conducted a clinic for indigents and collected epidemiological data that formedthe basis for reports to the foundation. I met and married a Native-Americanveteran in 1952 and we shared forty-seven happy years.

I relocated my practice to Short Hills,New Jersey, in 1955. I also taught at theUniversity of Medicine and Dentistry ofNew Jersey as a clinical instructor and asthe full-time Director of Auxiliary Per-sonnel, leading the effort that resulted infull accreditation for that program.

There is no shortage of opportunitiesto serve the profession of dentistry, and I did so in the chairs of the Esse County(New Jersey) Dental Society and in various roles with the New Jersey DentalAssociation. I also enjoyed my work aspresident and editor of the Pierre FauchardAcademy of New Jersey. During my lifetime I have seen a dramatic change in the role of women in dentistry. Atfirst, I was the only woman in the room when I looked around to see who wasbecoming a professional and who wasstepping forward to serve. Now I am inwonderful company.

There is no mystery why I want tosupport the American College of Dentists.The College does good work and is theepitome of human integrity and commit-ment. There is no shred of prejudice inthis group. The College welcomed thisAmerican woman activist. ■

4


I Had to Be an American Woman Activist


Dr. Dows has donated$500,000 to establish the Dr. Cecelia L. Dows SectionActivity Fund for the College.This fund will support the work of the College in ethics,excellence, professionalism,and leadership at the locallevel. Dr. Robert Shekitka,Chairman of the New JerseySection of the AmericanCollege of Dentists, recentlyannounced Dr. Dows’ donationat the annual meeting in Las Vegas.

At first, I was the onlywoman in the room when I looked around tosee who was becominga professional and whowas stepping forwardto serve. Now I am inwonderful company.

Daniel A. Haas, DDS, PhD, FRCD(C),FACD

AbstractPermanent paresthesia following a localanesthetic injection is a possible adverseevent. Epidemiological studies have suggested that the 4% solutions used indentistry, namely prilocaine and articaine,are more highly associated with this occurrence. This article reviews the epidemiological evidence regarding articaine and paresthesia.

Local anesthetics are very safe drugs.Even though this is a correct state-ment, adverse events occur simply

due to the sheer volume of injectionsgiven. Dentists in the U.S. administerover 300,000,000 cartridges every year(Malamed, 2004). Thus, even rareevents, such as permanent paresthesia,will be noted. The first study to suggestthe possibility that articaine is morehighly associated with paresthesia waspublished in 1995 (Haas & Lennon).Since that time the scientific literaturehas been slowly accumulating that con-siders the possibility that local anestheticneurotoxicity itself can cause paresthesia.The purpose of this article is to reviewthe epidemiological evidence for theassociation between articaine and paresthesia in dentistry.

ParesthesiaWhat is meant by paresthesia thatresults from an intraoral injection oflocal anesthetic? Paresthesia is part of a more general grouping of nerve disorders known as neuropathies. Thesemay manifest as a total loss of sensation(i.e., anesthesia), a burning or tinglingfeeling (i.e., dysesthesia), pain to a normally non-noxious stimulus (i.e.,allodynia), or increased pain to all stimuli(i.e., hyperesthesia). For the purposes ofthis article, the term paresthesia will beused to describe prolonged completeanesthesia or an altered sensation thatpersists beyond the expected duration ofaction of a local anesthetic injection.Paresthesia is a known risk from oral

surgical procedures and it is assumedthat the cause in that case is direct traumato the nerve. However, paresthesia canalso occur following nonsurgical dentistry,when local anesthesia is achieved to permit operative dentistry or scaling.The majority of these cases are transientand resolve within eight weeks. Thosethat last beyond that time frame are usually considered irreversible. It is thelatter that are clearly the main concern,as there is no definitive treatment of this neuropathy. The focus of this article is on the nonsurgical permanentparesthesias that occur in dentistry.

There are several proposed mecha-nisms for paresthesia following localanesthetic injection. These include hemorrhage into the neural sheath,direct trauma to the nerve by the needlewith possible scar tissue formation, andneurotoxicity of the local anesthetic.Only if the latter mechanism is correctcould one find potential differencesbased on the type or the amount of localanesthetic used.

5


Articaine and Paresthesia: Epidemiological Studies


Dr. Haas is Associate Dean,Clinical Sciences, Faculty ofDentistry, Chapman Chair inClinical Sciences, Professorand Head of Dental Anesthesia,Faculty of Dentistry, Professor,Department of PharmacologyFaculty of Medicine, Universityof Toronto, and Active Staff,Sunnybrook Health SciencesCentre. He can be reached [email protected]

Epidemiological StudiesArticaine has been available in Germanysince 1976 and in Canada since 1983. In 1995, there was a publication of a retrospective study conducted to look atthe incidence of permanent paresthesiafrom 1973 to 1993 inclusive in Ontario,Canada (Haas & Lennon, 1995). Thedatabase accessed was from the groupthat administered malpractice insuranceto all licensed dentists in that province.At the time of the study there wereapproximately 6,200 dentists in Ontario.Only prolonged (i.e., permanent) paresthesia from nonsurgical cases wascounted in this study. The conclusionwas that there was an overall incidenceof one irreversible paresthesia out ofevery 785,000 injections. Compared with the other local anesthetics, a higherincidence was noted when articaine orprilocaine were used. The lingual nervewas involved in 64% of the cases, withthe inferior alveolar nerve involved inthe vast majority of the remainder.There was no association with any otherfactor, such as needle gauge.

A follow-up study was done using thesame methodology with the data from1994 to 1998 inclusive (Miller & Haas,2000). For this time period, the incidenceof nonsurgical paresthesia in dentistrywas 1:765,000, very similar to the previous finding. The conclusions werethe same in that prilocaine and articainewere more commonly associated withthis event compared to the other localanesthetics. The lingual nerve wasinvolved in 70% of the cases, with theinferior alveolar involved in the vastmajority of the remainder. It was esti-mated that the incidence of permanentparesthesia from either prilocaine orarticaine approximated 1:500,000 injections for each drug, which was five-fold higher than that found with

lidocaine or mepivacaine. In both studies,there were no reports of paresthesiafrom bupivacaine.

The reasons for these findings werespeculative. What articaine and prilocainehave in common is that they are theonly 4% solutions used in dentistry. This means that the concentration of the drug is 40 mg per mL. The otheragents available in dental cartridges inthe U.S. and Canada are all more dilute.Lidocaine is a 2% solution, mepivacaineis either 2% or 3%, and bupivacaine is 0.5%. This led to the considerationthat it was not the specific drug that wasthe factor, but maybe the concentrationadministered.

In Vitro StudiesIs there evidence for a dose-dependentneurotoxicity of local anesthetics?Several in vitro studies support thishypothesis. As early as 1976, it was notedthat rats injected with lidocaine at thetrigeminal ganglion exhibited inhibitionof rapid axonal transport in distal nervesegments in a dose-dependent manner(Fink & Kish, 1976). An investigation of the effects of lidocaine on restingmembrane potentials and action potentials in single crayfish giant axonsshowed a dose-dependent effect resultingin irreversible conduction blockade withcomplete loss of resting membranepotential at higher doses (Kanai et al.,1998). High concentrations of local anesthetics, such as 5% lidocaine, havebeen shown to result in irreversible con-duction block, an effect not found with1.5% lidocaine (Lambert et al., 1994).

Histologic studies have primarilysupported the hypothesis that local anesthetics have neurotoxic potential(Kalichman et al., 1989; 1993), althoughone study using microinjections into rat sciatic and cat lingual nerves showedno significant effect (Hoffmeister et al.,1991). This latter study, however, sufferedfrom a potential methodologic problemof using no control group, using a 6



There are several proposed mechanisms for paresthesia followinglocal anesthetic injection.These include hemorrhageinto the neural sheath,direct trauma to the nerveby the needle with possiblescar tissue formation, and neurotoxicity of thelocal anesthetic.

sample size of five for each group, andinjecting only twenty microliters of localanesthetic into the rat sciatic nerve.Conversely, the opposite findings to thislatter study were shown when a salinecontrol group was used, the sample size increased to sixteen, the volumeinjected in the rat sciatic nerve wasincreased to fifty microliters, and theeffects assessed electrophysiologically(Cornelius et al., 2000).

In a study investigating neuronalcytoplasmic calcium concentrations andneuronal cell death, it was shown thatlidocaine in concentrations less than 1%caused minimal changes, whereas 2.5%and, to a greater degree, 5% lidocainecaused much larger changes and celldeath (Johnson et al., 2002). When theconcentrations were kept the same, lidocaine and prilocaine had equivalentneurotoxicity in rats (Kishimoto et al.,2002). In a study looking at lidocaine,mepivacaine, bupivacaine, and ropiva-caine, all of these local anestheticsproduced growth cone collapse and neurite degeneration (Radwan et al.,2002), suggesting that neurotoxicity isnot restricted to one agent. A proposedmechanism for this irreversible nerveinjury is membrane disruption, charac-teristic of a detergent effect (Kitagawa et al., 2004). Other studies also supportthe hypothesis that all local anestheticshave the potential for neurotoxicity, aneffect that is dose-dependent (Selander,1993; Kalichman, 1993).

Clinical StudiesArticaine was introduced in the U.K. in1998. Since that time a number of lettersto the editors of British journals reportedan apparent increase in prolonged pares-thesia following articaine administration(van Eden & Patel, 2002; Pedlar, 2003).A follow-up letter identified only a small

number of official reports regarding articaine and paresthesia with the U.K.Committee on Safety of Medicines andasked dentists to use this reporting system as required (Randall, 2003).

Articaine’s introduction into the U.S.in 2000 coincided with a publication ofits efficacy (Malamed et al., 2000), andshortly thereafter followed by a publica-tion on its safety (Malamed et al., 2001).These two studies were based on thefindings from a multi-center randomizedcontrolled trial (RCT) on 1,325 subjectscomparing administration of 4% articainewith 1:100,000 epinephrine to 2% lidocaine with 1:100,000 epinephrine.The study on efficacy showed that articaine was comparable to lidocainefor mandibular blocks, a finding replicatedin RCTs published since that time(Malamed et al., 2000; Claffey et al., 2004;Mikesell et al., 2005; Ram & Amir, 2006).The study on safety concluded that theadverse event profile was similar to that found with lidocaine.

A prospective study of nonsurgicalpermanent paresthesia conducted in the U.S. just prior to articaine’s releasefound that lidocaine was the drug usedin 48% of the cases and prilocaine in47% of the cases when the type of drugwas known (Pogrel & Thamby, 2000).They estimated that, at the time of theirwriting, lidocaine accounted for 62% of all local anesthetics used by dentistsand prilocaine accounted for 13%. Thishigher proportion for prilocaine wasconsistent with that previously reported(Haas & Lennon, 1995). The authorsalso determined that 79% of the casesinvolved the lingual nerve, a finding alsoconsistent with that reported previouslyby Haas and Lennon. It was estimatedthat the overall incidence of permanentparesthesia for each inferior alveolarnerve block ranged from 1:26,762 to1:160,571. Malamed and colleagues concluded that “Perhaps every full-timepractitioner will find that he or she has

one patient during his or her career who has permanent nerve involvementresulting from an inferior alveolar nerve block.”

One interesting question is why isthe lingual nerve the most commonnerve affected? To answer this, an elegantstudy published in 2003 examined thehistologic characteristics of lingualnerves in twelve cadavers (Pogrel et al.).This study showed a range in the numberof fascicles present within this nerve;anywhere from one to eight inclusive.Four of them (33%) had only one fascicle.The authors speculated that a unifascicu-lar nerve may be injured more easilythan one with multiple fascicles. To date,this appears to be the most plausibleexplanation for the finding of thepredilection of the lingual nerve for permanent paresthesia.

In 2003, a review of paresthesia associated with administration of localanesthetics was published (Dower,2003). This review analyzed previousstudies (Haas & Lennon, 1995; FDA, 1998;Miller & Haas, 2000; Malamed et al.,2000; 2001; CRA, 2001) and by making a number of alternative assumptionsdetermined an incidence of paresthesiafor articaine of 1:220,000—higher thanthat previously reported. Specifically, it was stated that articaine had a twenty-fold higher rate of paresthesiathan lidocaine and that prilocaine had afifteen-fold higher incidence. Articaine’srate for paresthesia for lingual ormandibular blocks was estimated to beas high as 2% to 4% when used formandibular or lingual blocks.

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Articaine was introduced in 2000 inDenmark. Recently, a Danish study(Legarth, 2004) was conducted thatused a format similar to the one carriedout by Haas and Lennon in Canada in1995. Using data from the Danish DentalAssociation’s Patient Insurance Scheme,the author reviewed reports of paresthe-sia from 2002-2004 in that country. Inthis time period, thirty-two lingual nerveinjuries were registered. Articaine wasgiven in 88% of the cases, even though it constituted only 42% of the market.Mepivacaine, as the 3% formulation, was given in the other 12% of cases, and it constituted 22% of the market.Lidocaine, with 22% of the market, hadno reports of paresthesia. Prilocaine had12% of the market, and no reports ofparesthesia. Interestingly, in Denmark,prilocaine is formulated as a 3% solution,not 4% as found in the U.S. and Canada.This incidence of paresthesia was1:140,000 for articaine and 1:540,000 for mepivacaine.

Another recent publication usedstandardized tests of neurosensory function to determine the cause of injection injury to the oral branches ofthe trigeminal nerve (Hillerup & Jensen,2006). This prospective study of fifty-sixconsecutive patients demonstrated neurologic evidence of neurotoxicity, not mechanical injury, which resulted in irreparable damage. Consistent withprevious clinical studies, the lingualnerve was the most common nerveinvolved, accounting for 81% of thecases, with the inferior alveolar nervemaking up the rest. There was also a significant difference in the drugs associated with this neurologic injury. In these patients, articaine was shown tocontribute to more than a twenty-foldincrease in paresthesia compared to allother local anesthetics combined. Theauthors noted a substantial increase inthe number of injection injuries since

articaine was introduced into the Danish market.

The conclusions of these authorswere subsequently questioned in a letterto the editor, pointing out that the paresthesias almost exclusively involvedthe lingual nerve during a traditionalmandibular block and rarely othernerves or other blocks (Malamed, 2006).Yet, this letter did not explain why arti-caine was still the most common localanesthetic associated with the damage ofthis one nerve compared with otheragents that are also used to block thisnerve. Furthermore, Hillerup and Jensendemonstrated that their neurologicalassessment demonstrated neurotoxicityand not mechanical injury. As well, thestatement in the letter, “At this time there exists absolutely no scientific evidence to support the concluding comment regarding the use of otherlocal anaesthetics for mandibular blockanalgesia in place of articaine 4%,” couldbe considered to be not quite correct.While it is true that no RCT has madethis demonstration, a number of otherscientific studies have, be they prospec-tive (Hillerup & Jensen 2006) orretrospective (Haas & Lennon, 1995).RCTs are not the only scientific studiesused to guide clinical decision making,as will be discussed below.

Most recently, in the U.S., two newRCTs were published that compared the formulations of articaine with different concentrations of epinephrine:1:100,000 and 1:200,000, investigatingcardiovascular effects (Hersh et al.,2006) and efficacy (Moore et al., 2006).The sample sizes were 14 and 126,respectively, and no differences inadverse events were noted between

8



It appears that it is not the drug per se that isresponsible, but simply the higher concentrationthat predisposes these formulations to this possibility.

the two formulations of articaine with epinephrine.

Clinical Application of theEvidenceHow does the practicing dentist makeuse of this information? Should a dentistwait for the publication of a RCT provingthat articaine and prilocaine are morelikely to cause permanent paresthesiathan other local anesthetics? Because ofthe rarity of this event, elucidation ofthese local anesthetic risk factors is statistically problematic, a finding thathas occurred elsewhere in the field ofanesthesiology (Hopwood, 1993). Withincidences estimated to be anywherefrom 1 in 26,700 (Pogrel & Thamby,2000), 1 in 140,000 (Legarth, 2004), 1 in 220,000 (Dower, 2003), to 1 in785,000 (Haas & Lennon, 1995), itwould take an unrealistically large RCTto detect a statistically significant difference. The largest RCT on articainepublished to date had a sample size ofonly 1,325 (Malamed et al., 2000), far too small to be able to detect a statisticallysignificant difference if one were to exist.None of the RCTs involving articaine orprilocaine published to date has a samplesize large enough to detect this potentialdifference. No conclusions regarding permanent paresthesia should be madefrom these particular studies. To quoteHillerup and Jensen (2006), “Since theincidence of injury as such is extremelyrare, the finding of nerve injury in aclinical trial is comparable with the finding of a needle in a haystack.” Giventhis reality, they go on to say, “This feature imposes a methodological obstacle to the power of conclusion fromprospective clinical studies on injectioninjuries, and circumstantial evidence,experimental research and retrospectivesurveys on great number of patientsmust be taken into account.”

ConclusionIn conclusion, the scientific data arestrongly suggestive that the 4% localanesthetic solutions used in dentistry,namely articaine and prilocaine, areassociated with an increased likelihoodof permanent paresthesia. It appears thatit is not the drug per se that is responsible,rather the higher concentration that predisposes these formulations to thispossibility. This outcome most ofteninvolves the tongue, and can leave theaffected patients with an incapacitationfor the rest of their lives.

Dentists must always take intoaccount the risks and benefits whendetermining the appropriateness of everyprocedure and therapeutic decision. In2005 the Royal College of Dental Surgeonsof Ontario, the governing body for dentists in that province, published anadvisory to its members and concluded,“Until more research is done, it is theCollege’s view that prudent practitionersmay wish to consider the scientific literature before determining whether touse 4% local anaesthetic solutions formandibular block injections.” (RoyalCollege of Dental Surgeons of Ontario,2005) Their conclusion is warranted.Unless there is evidence of a demonstrablebenefit to the use of these particulardrugs, their risks make their selectiondifficult to justify for mandibular or lingual blocks. Today, unless extenuatingcircumstances are present, the availableepidemiological evidence appears to support a dentist’s decision to avoid theuse of articaine and prilocaine formandibular and lingual blocks, and torestrict their use to other injections. ■

ReferencesClaffey, E., Reader, A., Nusstein, J., Beck,M., & Weaver J. (2004). Anesthetic effica-cy of articaine for inferior alveolar nerveblocks in patients with irreversible pulpitis.Journal of Endodontics, 30, 568-571.Cornelius, C. P., Roser, M., Wietholter, H.,& Wolburg, H. (2000). Nerve injuries due tointrafascicular injection of local anesthet-ics experimental findings. Journal ofCraniomaxillofacial Surgery, 28 (suppl 3),134-135.CRA Newsletter. (2001). Articaine HCL 4%with epinephrine 1:100,000–update ’05.29(6), 1-2.Dower, J. S. (2003). A review of paresthe-sia in association with administration oflocal anesthesia. Dentistry Today, 64-69.FDA Center for drug evaluation andresearch approval package for: Applicationnumber 20-971. (1998). Statistical Review,1-19.Fink, B. R, & Kish, S. J. (1976). Reversibleinhibition of rapid axonal transport in vivoby lidocaine hydrochloride. Anesthesiology,44 (2), 139-146.Haas, D. A., & Lennon, D. (1995). A 21 yearretrospective study of reports of paresthe-sia following local anestheticadministration. Journal of the CanadianDental Association, 61, 319-330.Hillerup, S., & Jensen, R. (2006). Nerveinjury caused by mandibular block analge-sia. International Journal of OralMaxillofacial Surgery, 35, 437-443.Hoffmeister B. (1991). Morphologic veranderungen peripherer nerven nachintraneuraler lokalanasthesieinjektion.Dtsch Zahnarztl Z, 46, 828-830.Hopwood, M. B. (1993). Statistics: Can weprove an association for a rare complica-tion? Regional Anesthesia, 1, 428-433.Johnson, M. E., Saenz, J. A., DaSilva, A.D., Uhl, C. B., & Gores, G. J. (2002). Effectof local anesthetic on neuronal cytoplasmiccalcium and plasma membrane lysis(necrosis) in a cell culture model.Anesthesiology, 97, 1466-76.Kalichman, M. W. (1993). Physiologicmechanisms by which local anestheticsmay cause injury to nerve and spinal cord.Regional Anesthesia, 18, 448-452.

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Kalichman M. W., Powell, H. C., & Myers,R.R. (1989). Quantitative histologic analysisof local anesthetic-induced injury to rat sciatic nerve. Journal of Pharmacology andTherapeutics, 250, 406-413.Kalichman, M. W., Moorhouse, D. F.,Powell, H. C., & Myers, R. R. (1993).Relative neural toxicity of local anesthetics.Journal of Neuropathology andExperimental Neurology, 52, 234-240.Kanai, Y., Katsuki, H., & Takasaki, M.(1998). Graded, irreversible changes incrayfish giant axon as manifestations oflidocaine neurotoxicity in vitro. AnesthesiaAnalgesia, 86, 569-573.Kishimoto, T., Bollen, A. W., & Drasner, K.(2002). Comparative spinal neurotoxicity ofprilocaine and lidocaine. Anesthesiology,97, 1250-1253.Kitagawa, N., Oda, M., & Totoki, T. (2004).Possible mechanism of irreversible nerveinjury caused by local anesthetics.Anesthesiology, 100, 962-967.Lambert L. A., Lambert, D. H., & Strichartz,G. R. (1994). Irreversible conduction blockin isolated nerve by high concentrations oflocal anesthetics. Anesthesiology, 80,1082-1093.Legarth, J. (2005). Lesions to the lingualnerve in connection with mandibular analgesia. Tandlaegebladet, 109, 10. Malamed, S. F. (2004). Handbook of LocalAnesthesia. Mosby, 5th edition, 285.Malamed, S. F. (2006). Nerve injury causedby mandibular block analgesia [letter].International Journal of Oral MaxillofacialSurgery, 35, 876-877.Malamed, S. F., Gagnon, S., & Leblanc, D.(2000). A comparison between articaineHCl and lidocaine HCl in pediatric dentalpatients. Pediatric Dentistry, 22, 307-311.Malamed, S. F., Gagnon, S., & Leblanc, D.(2001). Articaine hydrochloride: a study ofthe safety of a new amide local anesthetic.Journal of the American DentalAssociation, 132, 177-185.Malamed S. F., Gagnon, S., & Leblanc, D.(2000). Efficacy of articaine: a new amidelocal anesthetic. Journal of the AmericanDental Association, 131, 635-642.

Mikesell, P., Nusstein, J., Reader, A., Beck,M., & Weaver, J. (2005). A comparison ofarticaine and lidocaine for inferior alveolarnerve blocks. Journal of Endodontics, 31,265-270.Miller, P. A., & Haas, D. A. (2000). Incidenceof local anesthetic-induced neuropathies inOntario from 1994-1998 [abstract]. Journalof Dental Research, 79SI, 627.Pedlar, J. (2003). Prolonged paraesthesia[letter]. British Dental Journal, 195, 119.Pogrel, M. A., Schmidt, B. L., Sambajon, V.,& Jordan, R. C. K. (2003). Lingual nervedamage due to inferior alveolar nerveblocks a possible explanation. Journal ofthe American Dental Association, 134, 195-199.Pogrel, M. A., & Thamby, S. (2000).Permanent nerve involvement resultingfrom inferior alveolar nerve blocks. Journalof the American Dental Association, 131,901-907.Radwan, I. A. M., Saito, S., & Goto, F.(2002). The neurotoxicity of local anesthet-ics on growing neurons: a comparativestudy of lidocaine, bupivacaine, mepiva-caine, and ropivacaine. AnesthesiaAnalgesia, 94, 319-324.Ram, D., & Amir, E. (2006). Comparison ofarticaine 4% and lidocaine 2% in paedi-atric dental patients. International Journalof Paediatric Dentistry, 16, 252-256.Randall, C. (2003). Anaesthetic solutions[letter]. British Dental Journal, 195, 482.Royal College of Dental Surgeons ofOntario. (2005). Paraesthesia followinglocal anaesthetic injection. Dispatch, 19, 26.Selander, D. (1993). Neurotoxicity of localanesthetics: Animal data. RegionalAnesthesia, 18, 461-468.VanEden, S. P., & Patel, M. F. (2002). Letterto the editor: Prolonged paraesthesia following inferior alveolar nerve blockusing articaine. British Journal of Oral andMaxillofacial Surgery, 40, 519-520.

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None of the RCTs involving articaine or prilocaine published to date has a sample sizelarge enough to detect this potential difference. No conclusions regardingpermanent paresthesiashould be made from these particular studies.

Bruce Peltier, PhD, MBA and James S. Dower, Jr., DDS, MA

AbstractThe introduction of articaine as a localanesthetic agent and the number of reported cases of paresthesia are used to develop issues surrounding dentists’responsibility to investigate the evidenceassociated with product claims and toevaluate the use of treatments throughvarious appropriate ethical lenses. The evidence on safety and efficacy of articaine are reviewed, followed by a discussion of various relevant ethical perspectives, including standard of care,professional codes, normative principles,weighing interests, and a hierarchy of core values. The authors recommendagainst the use of articaine.

New products continuouslyappear in dentistry. They aregenerally most welcome, as they

promise to enhance dental practice andimprove patient care. However, the processthat dentists use to decide about newproducts and whether to incorporatethem into daily practice has not beenelucidated very clearly in the literature.When a new product becomes available,how does one decide if it is safe and efficacious? What responsibilities do dentists and others have to ensure thatpatients are consistently treated in safeand effective ways?

While there are numerous sourcesfor information about new products, allsources are not of equal value or validityand dentists may not always be willingor able to effectively access them. Someof these sources of information can bedifficult to decipher and others downrightmisleading. Yet all would agree that den-tists must take personal and professionalresponsibility for the products that theyuse in the treatment of patients.

This essay uses the controversial andinteresting case of articaine to exploreethical aspects of the introduction of anew product into dental practice.

BackgroundFor the past century, dentists have usedlocal anesthetics routinely and frequentlywith nearly no serious adverse effects.Until recently, there were five such anesthetics available for use by Americandentists. Because adverse effects were so

rare, few statistical data were availablefor scrutiny. Most dentists felt that anydangers associated with local anesthesiawere likely the result of overdose or perhaps a paresthesia caused by directneedle contact with a nerve. Paresthesiasrelated to local anesthesia were generallythought to occur about once in a dentist’scareer, if that. Paresthesia is typicallydefined as persistent numbness or anes-thesia that lasts well beyond normalexpectations. Such numbness is thoughtto resolve, on average, within eightweeks, but can last longer and in rarecases become a permanent condition.There is no current treatment that canreverse or remedy this damage.

Until recently, American dentists primarily used lidocaine and mepiva-caine and less frequently, prilocaine,bupivacaine, and etidocaine. Articaine(Septocaine) has been available for useby Canadian dentists since 1985 and forsome European dentists before that. In1995, Haas and Lennon published a

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The Ethics of Adopting a New Drug: Articaine as an Example


Dr. Peltier is Professor ofDental Practice and Dr. Doweris Associate Professor ofRestorative Dentistry, both atthe University of the Pacific,Arthur A. Dugoni School ofDentistry, San Francisco. Dr. Peltier can be reached [email protected].

retrospective study of twenty-one yearsof nonsurgically induced paresthesiafrom Ontario in the Journal of theCanadian Dental Association. Theyfound that factors such as patient age,gender, or needle gauge were not correlated with frequency of paresthesias,but that two local anesthetics, articaineand prilocaine, both used in a 4% solution,were associated with significantly moreparesthesias than the other anesthetics.In a follow-up study a year later, Millerand Haas (1996) found that these significantly different rates of paresthesiascontinued to exist. A subsequentCanadian study by Miller and Haas (2000)again showed that use of articaine andprilocaine between 1994-1998 was associated with significantly higher ratesof paresthesia. During this same timeperiod, a laboratory study in experimentalneurology (Kalichman et al., 1993)injected rats with varied concentrationsof four local anesthetics and concludedthat increased concentrations were asso-ciated with higher levels of nerve injury.

Articaine became available fromSeptodont for use in a 4% solution in theUnited States in April 2000, and it hasbeen met with enthusiasm here. Articainehas a good reputation among many dentists who are likely to report that theymiss fewer mandibular blocks resultingin fewer follow-up injections, and some-times they can use infiltrations for anesthesia of teeth on the mandible.

A pharmacology project thesis onarticaine and lidocaine written by aNorwegian dental student provides anexample of the kind of anecdotal “buzz,”based on the clinical experiences of dentists that often passes for evidence indentistry (Johansen, 2004). “One of the

reasons why articaine instantly becameso popular in many countries was due toits excellent efficacy. Dentists claimedthat they seldom missed with the inferioralveolar nerve block, and that buccalinfiltration in the maxillary arch oftenwas enough before an extraction of amolar, because of articaine’s bone penetration properties. This seeminglyexcellent efficacy is reported from manydentists from around the world, basedon their daily clinical practice.”

The problem is that no controlled, empirical evidence exists to support theperceived benefits to dentists, and evidenceexists that seems to point to increasedrisk to patients.

The product insert from the manu-facturer’s (Septodont) FDA study ofarticaine described 11 paresthesias associated with 882 patient visits (oneparesthesia in every 88 visits). The insertalso includes a second, additional list ofadverse events that occurred in one ormore patients “at an overall rate of lessthan one percent.” (One percent wouldequal eight or nine patients in the 882studied.) Included on this list are “pares-thesia, hyperethesia, and neuropathy.”This additional list seems to imply thatmore than eleven total paresthesias actually occurred. Using the same data,the “Safety Summary” from Septodont’sFDA application (Septodont, 1998) for approval of articaine reported 21paresthesias in the 882 patient exposuresto articaine (Section 8.5.3.5). This repre-sents one chance in 44 of paresthesiaper exposure.

In May 2000, JADA published an article by Malamed, Gagnon, and Leblanc(2000) that reported on this same studybut did not mention the numerous neuropathies seen in the product insertor the 21 paresthesias reported to theFDA by Septodont in their application.The authors of the JADA study concludedthat “4% articaine was well tolerated in882 subjects.” This article also reportedthat articaine produced no significant

improvement in efficacy when comparedto lidocaine. In a second report on thesame FDA study data Malamed, Gagnon,and Leblanc (2001) concluded that “articaine is a well-tolerated, safe, andeffective local anesthetic for use in clinicaldentistry.” This “safety report” was, however, not published until nine monthsafter the original article on the same data(Malamed, Gagnon, & Leblanc, 2000).Also, the 2001 “safety report” listed theadverse events during the study as being11 paresthesias and 7 hypesthesias (not hyperesthesias as listed in the product insert).

A recent report by Danish researchers(Hillerup & Jansen, 2006) examined 56patients with injection injury to oralbranches of the trigeminal nerve whichwere “caused by unilateral administrationof inferior mandibular nerve block forconservative dental procedures” andfound that “articaine produced a morethan 20-fold higher incidence of injectioninjury when applied for mandibularblock analgesia.” They noted the “decisiverole of the concentration of analgesicsolution” and went on to write that “theassociation of an increased incidence ofinjection injuries with the introductionof articaine 4% also in Denmark is remarkable.”

Given the above, one might forgivethe general dentist for being confused.

Ethical ConsiderationsThe history, data, product insert, andreports in the literature beg the question:Should American dentists use articaine?If so, why, and how should it be used?What ethical obligations do dentists andothers have when a new productbecomes available, how should theymake decisions about using it, and whatshould they say to patients?

There are several generally acceptedtools in bioethics that can be applied to

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this problem, but no such discussionshould begin without reference to thatwell-known and well-worn adage,“Primum non Nocere,” (First, do no harm).This principle seems immediately relevantand helpful, but upon closer examination,it is less useful than one might imagine.The principle is fine, but much too limitedto be of great value. Obviously, we do not want to harm patients, and they certainly do not wish to be harmed, butavoidance of harm is not enough. Onerecent analysis in the medical literaturedescribed non nocerum as “laudable butobviously deficient.” (Smith, 2005) AsLouis Lasagna put it forty years ago, “Toobserve this advice literally is to denyimportant therapy to everyone, sinceonly inert nostrums can be guaranteedto do no harm.” (Lasagna, 1967) Ourpatients don’t come to us so that we willnot harm them; they come to us forhelp. We have to provide an importantservice while managing the inevitablepotential dangers in some effective way.

Standard of CareMost conscientious doctors wouldanswer the articaine question in generalterms in the following way. “Don’t useany procedure, product, or drug that youdon’t understand. Make sure that youare trained adequately and that you areclear about the risks and benefits topatients before adopting something new.Check things out and make sure that thenew drug is safe when used in the waythat you intend to use it. Ensure that youcan competently apply that new drug,product, or procedure before you exposepatients to potential harm.”

That said, every dentist knows ofinstances when a colleague (or evenhimself or herself) has attended trainingon a weekend and begun to use a newprocedure on Monday. Patients arerarely aware of the fact that dentistslearn much of their profession by treatingthem. One recent survey of surgeons

regarding something called “innovativesurgery” came to the following conclu-sions: “Respondents (doctors) expresseda fairly prudent stance when judginghypothetical innovative scenarios”; and“Some forms of innovation (meaningsurgery) clearly fall under the currentregulations for human subjectresearch….” (Reitsma & Moreno, 2005)

It seems clear that while the standardof care requires that we practice safely at all times, it does not help us to decidewhere to draw difficult lines about what is new or innovative and what iscompletely safe or safe enough.

ADA Principles of Ethics and Code of Professional ConductIt is somewhat surprising to note thatthe current ethics code of the AmericanDental Association (ADA, 2005) does notspecifically address the issues discussedin this paper. In closely related topics,the code recommend that the dentistkeep knowledge and skills current andknow one’s own limitations (Section 2).The code warns against making “unsub-stantiated representations” to patientsabout treatments that are not basedupon “accepted scientific knowledge orresearch….” (Section 5.A.2.) When discussing the sale of products to patients,the code says “In the case of a health-related product, it is not enough for thedentist to rely on the manufacturer’s ordistributor’s representations about theproduct’s safety and efficacy. The dentisthas an independent obligation to inquireinto the truth and accuracy of suchclaims and verify that they are foundedon accepted scientific knowledge orresearch” (Section 5.D.2.)

With regard to adverse events suchas paresthesias, the code also requires

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Yet all would agree that dentists must takepersonal and professionalresponsibility for the products that they use inthe treatment of patients.

that dentists make a report when theysuspect that an adverse effect has takenplace, and the code specifically mentionsa report to the FDA in cases of “seriousadverse events.” (Section 5.D.1.)

Beyond the generally accepted standard of care and formal ethics codes,the three formal methods of analysis that bioethics has to offer are these: a)deontological approach, using normativeprinciples; b) utilitarian analysis, whichweighs competing interests; and c) Ozarand Sokol’s “central values of dental practice.” Each will be considered in turn.

Normative PrinciplesThis relatively simple method of ethicaldecision-making is popular in organizeddentistry. The American College ofDentists (2000) and the AmericanDental Association (2005) both use normative principles in their officialguidelines and codes, and the ADA’s current code of ethics is essentiallyorganized around the principles ofpatient autonomy, nonmaleficence,beneficence, and veracity, weighted inthat order.

The goal in using this decision-making method is to practice in alignmentwith the principles and to use them asguidelines when faced with an ethicalchallenge. Analyzing the use of articaineusing the principle of non-maleficence,one would ask: “Does the use of thisanesthetic have the potential to causeharm to patients?” The answer to thatquestion is certainly “yes.” A moresalient question has to do with the likeli-hood or probability of harm (what arethe real-life chances of this happening?)along with the question of seriousnessand longevity of damage.

The next principle, beneficence,requires that dentists act on behalf ofpatients’ interests and do some positivegood. The differential benefit of articainerelative to the other available anestheticsmust be rated and it must be shown thatarticaine, indeed, provides benefits topatients that are similar or superior tothe benefits that the other anestheticsprovide. The ethical calculus that weighs benefits against risks is probablysomething that most dentists considerintuitively, but it is not an easy or tidytask, especially when benefits are difficult to define and studies are notavailable. Dentists commonly believethat articaine offers advantages andsome even speculate that the molecularbiology and pharmacology would dictatethat articaine should be superior. But atthis point in time, there is no clinicalresearch to back up those widely heldperceptions. At the same time, there isempirical evidence (as noted above) thatarticaine is more dangerous than othercommonly used dental anesthetics.

Veracity mandates that we simply(or not so simply, sometimes) tell thetruth. Assuming that no one is lyingabout the dangers or benefits of articaine,that patients are told the straight storyin clear language, and that researchreports do not intentionally distort ormisrepresent data, this principle does not pose a problem.

The principle of patient autonomybrings up the challenging question ofinformed consent, and there is disagree-ment about this matter in the dentalliterature (Orr & Curtis, 2005; Dower,Indresano, & Peltier, 2006; Jacobsen,2006). Because of patient autonomy,patients have a right to choose treatments,as they are the ones who must live withthe consequences of that treatment.Participation is voluntary, and patientsmust have adequate information withwhich to make their choices. There areseveral components of informed consent,one of which is the requirement to

provide information about risks, benefits,and alternatives to the treatment proposedby the dentist. From a legal standpoint,dentists must disclose material risks, thatis, risks that might cause a reasonablepatient to decline the proposed treatment.The ACLU’s guide to patient rights(Annas, 1989) interprets this to meanthat “even a 1 in 10,000 risk of deathmust always be disclosed, but not a 1 in10,000 risk of a two-hour headache.”

As Orr & Curtis (2005) observe, “…ahealthcare professional ordinarily is notobligated to enumerate each and everycomplication that might occur secondaryto a proposed treatment—only commonand serious complications.” Dentistsmust ask themselves about thresholds ofcommonality or seriousness. At whatpoint is a risk considered common? Is itimportant to talk to patients about therisk of paresthesia if it is only going tooccur once in a dentist’s entire career?What if it is likely to occur in 11 out ofevery 882 times a drug is injected? Whatif it is likely to occur in 21 out of every882 times a drug is injected?

At what point is a risk serious? Ifnumbness is temporary, is it serious?What if the numbness lasts two weeks,or two months (a commonly used paresthesia benchmark)? What if it lasts forever? These are difficult andimportant questions. Given appropriateinformation, patients might opt for the use of a 2% rather than a 4% anesthetic solution.

In deciding about informed consent,dentists are sometimes encouraged toask the question, “What would most dentists do in this situation? Would thereasonable dentist inform the patientabout this particular risk.” (Rule &Veatch, 2004) There is evidence thatmost general dentists do not discusslocal anesthesia alternatives with theirpatients, while specialists and dental

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anesthesiologists are more likely to doso. (Orr & Curtis, 2005)

There is at least one more way toview the informed consent problem.Imagine what a reasonable and compe-tent patient might decide if told thefollowing by their dentist: “I intend touse a local anesthetic that I favor. In my experience, I don’t ‘miss’ my firstinjection to numb the lower teeth asoften as with other local anesthetics, and I think that this new anesthetictends to last longer. However, there is no scientific evidence to support myexperience, and there are studies thatseem to show that you are at a twenty-times higher risk of paresthesia than if I use the older anesthetics, eventhough the risk of that happening is stillquite low, perhaps only 1 or 2 percent of the time.”

Weighing InterestsA utilitarian approach begins with identification of sets of interests held byvarious parties. Whose interests are atstake, what are they, and how weightyor important do they seem? With localanesthesia both the patient and dentisthave important interests. The dentist isdesirous of quick, reliable, profoundanesthesia of adequate duration, andwhile these things are important topatients, the typical patient’s most pressing interest is to have the mostcomfortable experience possible. Dentists,based upon numerous anecdotal reports,seem to think that they are less likely to “miss” their first mandibular blockinjection if they use articaine. These dentist interests are weighed against anyadvantage or danger faced by patients.As noted above, there is evidence thatthe risk of adverse events from articaine is significantly higher thanthat of other anesthetics, and such

events can include temporary or permanent problems. Patients can experience lip or tongue numbness ordysfunction, speech impediment, drooling,loss of taste or perverted taste, loss offeeling in half of the lower lip and a lipor tongue that feels several times thenormal size. Besides the more commonparesthesias, the patient also risks havinga permanent lingual nerve dysesthesiaexperienced as a scalded sensation onthe tongue. These are not trivial problems,to be sure.

It would be unfortunate, of course,and arguably unethical, if the time, comfort, or efficiency-related interests of dentists overruled the health risks to patients of use of this anesthetic, especially when other drugs haveworked safely and well for years.

Ozar and Sokol’s “Central Values” This method asserts that dentistry, likeall other professions, has a set of specificvalues that members of the professiongenerally agree upon. Ozar and Sokol(1994) rank the six most important values and propose that their hierarchybe used to make ethical decisions. Inother words, higher values trump lower ones. The values, in order ofimportance are:1. The patient’s life and general health.2. The patient’s oral health.3. The patient’s autonomy.4. The dentist’s preferred pattern

of practice.5. Esthetic values.6. Efficiency in the use of resources.

The hierarchy demands that threatsto life and general health be given thehighest priority, followed by dangers to a patient’s oral health. This impliesthat if paresthesia concerns about a“new” drug like articaine are non-trivialin frequency and seriousness, that drugshould not be used, even though its useis perceived to honor values found lower

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The problem is, no controlled, empirical evidence exists to supportthe perceived benefits todentists, and evidenceexists that seems to point to increased risk to patients.

in the hierarchy, such as “the dentist’spreferred pattern of practice” or “effi-ciency in the use of resources.” In thismodel, dentists are not permitted to favor a preferred practice pattern or timeefficiency over the patient’s general ororal health.

Discussion of ArticaineThe adoption of a new procedure orproduct (particularly a new drug) istaken seriously by any professional, asthere is much at stake, and it is difficultto forget the cautionary examples (e.g.,Thalidomide, Fen-Phen, and Vioxx).

In general, a new drug must be evaluated in the following ways. First, it must not cause common or seriousharm. Second, the benefit-to-risk ratio of use of the new drug must be equal toor better than that of other availabledrugs. Third, the interests of involvedparties must be identified and weighed,and patient interests must be weightedat or above the level of the interests ofdoctors. Fourth, the question ofinformed consent must be considered:Does the risk require that patients bealerted and given options?

First, the question of how commonthe harm. The data indicate that articaineis significantly riskier than previousanesthetics, especially those used in a 2%or 3% solution. Articaine, a 4% solutiondental anesthetic, seems to pose a signif-icantly higher risk of paresthesias whenused in mandibular block injectionsthan other local anesthetics, especiallylidocaine, mepivacaine, and bupivacaine.

Based on the data in the Haas andLennon (1995) study, Dower (2003) estimated that articaine was twenty

times more likely to cause a paresthesiathan lidocaine. This assertion is supportedby other reports (Haas & Lennon, 1995;Miller & Haas, 1996, 2000; Hillerup &Jensen, 2006). The increased paresthesiarate with articaine has been noted bydental clinics (Clinical Research AssociatesReport, 2005); governmental agencies(U.K. Mersey Adverse Drug ReactionsNewsletter, 2003/4; see also DenmarkMedicines Agency Pharmacovigilance[www.dkma.dk] study of adverse reactions from anesthetics for dentaltreatment, 17 August 2005); and dentalinsurance carriers (Emery & Webb, Inc.9/5/2006; Royal College of DentalSurgeons of Ontario, Canada, Dispatch2005; Milgrom P. et al., 2000). It shouldbe noted that the agency recordingadverse events with drugs for theEuropean Union, Eudravigilance, doesnot publish or report adverse events.

Based on this information, it seemsill-advised to use this drug for mandibu-lar blocks, although it may have otherimportant uses in general dentistry thatpose little significant risk. Even if theoccurrence of paresthesias in the studywere only the 11 listed in the table of theproduct insert, an 11/882 paresthesiafrequency would be an astonishing statistic. For example, at the University of the Pacific there are about 170 dentalchairs. If a general dentist treats tenpatients each day during a four-day workweek, he or she might produce twoparesthesias each month if articainewere used exclusively.

The issue of seriousness of harm isdifficult to discuss. American dentistshistorically have little experience with orexposure to paresthesias. Prior to 4%solutions, dentists expected, at the most,one paresthesia in their career, and theytypically figured that it was a result ofphysical needle contact with a nerve.Also, when they thought about paresthe-sias, they expected that the numbnesswould resolve shortly. But if the afore-mentioned FDA study, along with the

Canadian and Danish reports, are to bebelieved, dentists should prepare them-selves for the eventuality of “adverseevents” related to their use of articaine.At the risk of alarmism, it must be notedthat these events can be life-changing for patients unfortunate enough to experience them. It must also be notedthat they have a significant impact as wellon the life and career of the dentist involved.No dentist wants to be responsible forthe kinds of things that people withparesthesias or dysesthesias experience.

The next ethical question inquires asto whether risks are outweighed bypotential benefits of using articaine formandibular block injections. There aretwo parts to the answer to this question.The first has to do with “whose risks?”(which party is subjected to possibleharm), and who gets the benefit? Itseems possible to make the case that it is the dentist who receives most of thebenefit (in terms of time and generalefficiency) and it is the patient who is subjected to most of the potential danger. There are exceptions to this conclusion, to be sure. Patients whotruly hate each moment in the dentalchair certainly benefit from a speedierappointment. Conversely, dentist putthemselves in legal harm’s way if theiruse of articaine exposes them to lawsuitsand anecdotal experience shows thatdentists experience great sadness whenone of their patients endures a serious“adverse event.”

The second part of the question has to do with the amount of benefit.Based on scientific studies, includingSeptodont’s own study (1998), there isno evidence of increased benefit in termsof the amount of product used, onset ofanesthesia, duration of anesthesia, orpain relief compared to other availablelocal anesthetics. If the relative risk of aparesthesia is increased approximately

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twenty-fold, would not there have to be a concomitant increase in benefit topatients to justify a switch from lidocaineto articaine? Fortunately, the likelihoodof a paresthesia with the use of a 2% and3% local anesthetics is extremely small.Given that, it seems clearly unethical ifdentists use a more dangerous anestheticfor reasons of their own convenience orprofessional comfort. Patient well-beinginterests must carry more weight thanthe practice pattern interests of doctors.The authors recommend that dentistsrefrain from using articaine for inferioralveolar blocks until additional researchcan document adequate safety for patients.

General Recommendations:Adopting New ProductsEvery dentist is confronted with newdrugs, products, and procedures in theircareer, and it is reasonable to assumethat the pace of innovation is accelerating.In the case of local anesthesias, only ahandful have been available to dentistsover the past several decades and theirsafety has not been much of an issue.As a result, it is possible that dentistshave been “lulled to sleep” regarding therisks that might be associated with anew drug. They are not used to taking a rigorous and independently cautiousapproach to any new drug, especiallylocal anesthetics. Dentists are under-standably eager to adopt any newproduct or procedure that will enhancethe experience of the dental appoint-ment for their patients or streamlinecare, and most of the products that come onto the dental market are not ofthe kind that could pose much risk ordanger to patients.

A local anesthetic is different. It isinjected directly into a patient’s body tissue and is potentially quite dangerous.As Orr asserts (in Malamed, 2004),“local anesthetic administration involves injecting or otherwise administeringpotent pharmaceutical agents.” Thus, itis fair to assert that dentists have a

greater duty to ensure that they under-stand the drug and its characteristicsprior to its use. Orr goes on to write “it is incumbent on the healthcare professional to also make an independentand reasonable effort to identify potentialdisadvantages to new modalities.”

The introduction of articaine intoAmerican dental practice provides a goodexample and, perhaps, a cautionary tale.Here are recommendations that logicallyderive from the case of articaine.

First and foremost, dentists need toexamine risks related to the adoption ofany new product into practice. They mustconduct this examination themselves.They should be cautious about thesources that they rely upon. Luckily,there are only a few dental proceduresthat are potentially truly dangerous.Others pose important risks to a patient’sdentition or esthetic appearance, butlocal anesthetics are in a category of special importance. Since there are onlyfive local anesthetics available for use in the United States now, it seems reasonable to expect every dentist toexamine each of the drugs in detailbefore using it, and most of this learningprocess takes place in dental school.However, the vast majority dental students’clinical experience is with 2% lidocainewith 1:100,000 epinephrine and theirdidactic instruction in the various localanesthetics is rather brief and may wellbe in advance of their clinical experiences.Dower (1998) conducted a survey offifty-three local anesthesia course directors in the United States and foundthe “typical” program consisted of fifteenhours of didactic instruction covering allaspects of local anesthesia. When a newanesthetic comes into the market or isnew to a dentist’s use, he or she needs toput reasonable and adequate time and

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It seems clear that whilethe standard of carerequires that we practicesafely at all times, it doesnot help us to decidewhere to draw difficultlines about what is new or innovative and what is completely safe or safe enough.

effort into some independent research.At the very least, every dentist shouldstudy the product insert that comes witha new drug. This does not seem likemuch to ask, as such inserts are typicallyonly two pages long (of admittedly smallprint) and are readily available.

Second, dentists must read any prod-uct reviews published in mainstream,peer-reviewed journals in the literature.This is a common and easy recommen-dation to make, but it is not as simple or straightforward as it might seem.Dentists need to read more than just theabstract and conclusions sections ofresearch reports, as authors do notalways come to the same conclusionsthat readers might come to, given thesame data. Published studies regardingthe safety and efficacy of articaine inJADA (Malamed, Gagnon, & Leblanc,2000; 2001) provide an example of thisproblem, as some of the data could onlybe characterized as alarming, or if notalarming, certainly noteworthy. The firstJADA article written by Malamed,Gagnon, and Leblanc in April of 2000highlighted the following in large-font,italicized bold print set out in the middleof the page: “We found articaine to bewell-tolerated in 882 subjects, and that itprovided clinically effective pain reliefduring most dental procedures.” A dentist who is only scanning this articlewould certainly read that statement andperhaps move on, coming to the conclu-sion that the study had demonstratedthat articaine was a superior new drugthat is quite safe. The last sentence of the article concludes that, “Articaine canbe used effectively in both adults andchildren.” If they did not read through

the entire paper, readers would havemissed the statement that “furthermore,we observed no significant difference inpain relief between subjects in the 4 percent articaine with epinephrine1:100,000 group and those in the 2 percent lidocaine with epinephrine1:100,000 group.”

There is certainly room for reasonablepeople of integrity to come to differingconclusions about this study, the data,and the reports, but it is indisputably difficult for the practicing general dentistto come home after a long day at theoffice and sift through these data. Evenso, these questions do not relieve thedoctor of responsibility for the drugs heor she injects into patients.

A related recommendation is thatdental schools spend curricular timereviewing the basics of scientific methodsand research design, with an emphasison evidence and empirical data. Studentsshould be explicitly taught how to readproduct inserts. Such an emphasis might also have the effect of stressingthe responsibility to do so throughoutone’s career.

More research on articaine is neededif disputes are to be resolved andanswers to critical safety questions are to be had. This is unlikely to happen,however, as the drug is FDA approved,and there is little motivation for themanufacturer to fund future research. It is really up to academic centers to conduct research now, and experimentaldesigns may have difficulty gettingapproval from institutional review boards(IRB) or human subjects committees.Any research that is done ought to alsoaddress the possibility that articaine is“safe” in some uses and “risky” in others(i.e., mandibular block injections). Any future research should be designedand reported in a way that isolatesmandibular block data from other kindsof injection results, since nearly allparesthesias are associated with block

injections. This would clear up some of the existing confusion, given the pos-sibility that articaine is more dangerousin block injections only. It is certainlypossible, even likely, that articaine iscapable of providing enhancements andadvantages to dentists and patientswhen used in the safest ways.

We recommend that dentists thinkhard about whether the use of a newlocal anesthetic requires a discussion ofthe rationale and risks with patients,especially if they intend to use articainefor a mandibular block. Orr’s chapter on“Legal Considerations” is again helpful(in Malamed, 2004). “The preparedhealthcare professional should be able toarticulate exactly what the goal of theadministration of a local anesthetic isand how that is technically accomplished.For instance, why was a particular anesthetic and needle chosen?” Oneimportant question is this: Shouldpatients have a role in the decision tochoose an anesthetic that makes it easierfor a dentist to successfully perform ablock if there are empirical data implyinga twenty times higher risk of paresthesia?Given adequate information, it seems reasonable to imagine that some patientsmight respond with, “No thanks, Doc, I’d prefer that you go ahead and usegood old lidocaine, the one that you’veused so safely and effectively for my dentistry in the past.”

Dentists are also urged to be cautiousabout their sources of information.Although this may seem obvious, it isworth mentioning: Information aboutnew products in “glossy” dental trademagazines that are not peer reviewedmust be treated as suspect, especially ifthey are presented in the form of anadvertisement. Manufacturers of dentalproducts do not have the same orienta-tion to patient safety that dentists must

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maintain. Pharmaceutical companiesoperate in the ethical domain of thecommercial marketplace, while dentistsuse the “ethics of care” to guide theirpractice. The underlying dimensions ofthese two disparate ethical domains arefundamentally different (Nash, 1994;Peltier, 2002). Commercial companiesare expected to compete and deliver profit. Dentists are expected to maintain atransparent and cooperative relationshipwith patients and other professionals.Patients, unlike “customers” are not in aposition to adequately evaluate the drugs and procedures that dentists use,so they are forced to trust us. Therefore,we have an obligation to be trustworthyand open.

Likewise, endorsements by high-profile figures should not be absorbedwithout personal scrutiny. Dentalexperts sometimes have a vested interestin one product over another. It is theend-user’s responsibility to decide forhimself or herself, based upon a reasonable examination of the science,whether or not to expose patients to newproducts or especially, to new drugs.Dentists must also beware of the “buzz”that often surrounds new products, procedures, and drugs in dentistry, as itcan be persuasive, but does not qualifyas “science.” Here is an example of thekind of information that contributes tothe “buzz.” It is from a Web site that ispresented as a dentist’s site:

“Septocaine is a new form of localanesthetic for difficult-to--numb teeth. Itis twice as strong as normal Novocain,and, because it diffuses into the soft tissue faster and more completely, it ismuch more effective. I first discoveredSeptocaine about three years ago, whena patient of mine presented with asevere toothache and I was worriedabout whether or not I could get hernumb. I called a friend of mine—anendodontist in Fresno—and asked him

what he would use. He told me about awonderful new anesthetic, Septocaine,which he said he used routinely in hisendodontic practice. I used it in this difficult case, and we have been using it ever since.”

This is simply not the kind and qualityof information that is acceptable foradoption of a new drug that will beinjected into the tissue of patients. It isremarkable, partly because this dentistclaims to have chosen to use a new drugbased simply on the recommendation ofa colleague, after apparently conductedno independent inquiry into the newdrug’s safety or efficacy. We owe ourpatients much more than this.

A recent editorial in a pathologyjournal (Myers, 2006) makes a powerfulclosing argument for caution by quotingthe Institute for Medicine’s 1999 report:“It is simply not acceptable for patientsto be harmed by the same health caresystem that is supposed to offer healingand comfort. There will be no excuses;the levels of safety with which we havecontented ourselves are not the standardto which we will be held accountable as we go forward.” ■

ReferencesAmerican College of Dentists (2000). Ethics handbook for dentists.American Dental Association (2005).Principles of ethics and code of professional conduct.Annas, G. J. (1989). The rights of patients:The basic ACLU guide to patient rights.Carbondale, IL: Southern Illinois UniversityPress.Clinical Research Associates Newsletter.(2005). 29 (6), 1-2.Dower, J. (1998). A survey of local anesthesia course directors. AnesthesiaProgress, 45 (3), 91-95.

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No dentist wants to be responsible for thekinds of things that peoplewith paresthesias ordysesthesias experience.

Dower, J. (2003). A review of paresthesiain association with administration of localanesthesia. Dentistry Today, February, 64-69.Dower, J., Indresano, A. T., & Peltier, B. N.(2006). More about informed consent[Letter]. Journal of the American DentalAssociation, 137 (4), 437-438.Emery & Webb, Inc. (2006). Malpracticealert: local anesthesia. September 5.Haas, D. A. & Lennon, D. (1995). A 21 year retrospective study of reports ofparesthesia following local anestheticadministration. Journal of the CanadianDental Association, 61 (4), 319-330.Hillerup, S., & Jensen, R. (2006). Nerveinjury caused by mandibular block analgesia. International Journal of OralMaxillofacial Surgery, 35, 437-443.Jacobsen, P. (2006). Local anesthesia andinformed consent [Letters]. Journal of theAmerican Dental Association, 137 (4), 436-437.Johansen, O. (2004). Comparison of arti-caine and lidocaine used as dental localanesthetics. Project thesis, Institute ofClinical Dentistry, University of Oslo.Lasagna, L. (1967). The therapist and theresearcher. Science, 158, 246-247.Malamed, S. F., Gagnon, S., & Leblanc, D.(2000). Efficacy of articaine: a new amidelocal anesthetic. Journal of the AmericanDental Association, 131, 635-642. Malamed, S. F., Gagnon, S., & Leblanc, D.(2001). Articaine hydrochloride: a study ofthe safety of a new amide local anesthetic.Journal of the American DentalAssociation, 132, 177-184.Malamed, S. F. (2004). Handbook of localanesthesia. 5th ed. St. Louis: ElsevierMosby.Mersey Adverse Drug ReactionsNewsletter (2003/4). Prolonged paraesthe-sia with articaine. Issue 23.

Milgrom, P., Getz, T., & Silver, I. (2000).Neuropathic injuries caused by injections.SAFECO Property & Casualty InsuranceCompanies Dental Claims and InsuranceNews. Miller, P. A., & Haas, D. A. (1996).Incidence of local anesthetic-induced neu-ropathies in Ontario in 1994. Journal ofDental Research, 75SI, 247. Miller, P. A, & Haas, D. A. (2000). Incidenceof local anesthetic-induced neuropathies inOntario from 1994-1998. Journal of DentalResearch, 79Sl, 627. Myers, J. L. (2006). How safe is safeenough? Archives of Pathology andLaboratory Medicine, 130, August, 1103-1105.Nash, D. A. (1994). A tension between twocultures…Dentistry as a profession anddentistry as proprietary. Journal of DentalEducation, 58 (4), 301-306.Peltier, B. (2002). Care and commerce: doctors don’t sell stuff. Mouth (TheJournal of the American Student DentalAssociation), 22 (2), 10.Orr, D. L. (2004). Legal considerations. In S.F. Malamed. Handbook of local anesthesia.5th ed. St. Louis, Elsevier Mosby.Orr, D. L., & Curtis, W. J. (2005). Obtainingwritten informed consent for the adminis-tration of local anesthetic in dentistry.Journal of the American DentalAssociation, 136, 1568-1571.Ozar, D., & Sokol, D. (1994). Dental ethicsat chairside. St. Louis: Mosby-Year Book.Reitsma, A. M., & Moreno, J. D. (2005).Ethics of innovative surgery: U.S. surgeons’definitions, knowledge, and attitudes.Journal of the American College ofSurgeons, 200 (1), 103-110.Royal College of Dental Surgeons ofOntario DISPATCH (2005). Paraesthesiaalert, important member advisory. 19 (3),26.Rule, J. T., & Veatch, R. M. (2004). Ethicalquestions in dentistry. Chicago:Quintessence.Smith, C. M. (2005). Origin and uses of primum non nocere—Above all, do noharm! Journal of Clinical Pharmacology,45, 371-377.

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The authors recommendthat dentists refrain from using articaine forinferior alveolar blocks until additional researchcan document adequatesafety for patients.

Arthur J. Jeske, DM., PhD, FACD andPatricia L. Blanton, DDS, PhD, FACD

AbstractSince its introduction to in the UnitedStates about six years ago, 4% articainewith 1:200,000 epinephrine has been usedby dentists as a local anesthetic agent.This article reviews three claims that havebeen advanced regarding articaine: highdiffusibility, reduced incidence of failure in block injections, and effectiveness inachieving anesthesia when used in casesinvolving irreversible pulpitis.

This issue of the Journal brings into sharp focus the challenges that daily confront dentists with

regard to the rational selection of newly-introduced products. As a dental localanesthetic which had been associatedwith very attractive clinical properties atthe time of its introduction in the UnitedStates in 2000, articaine (Septocaine)promised to be a pharmacologic tool withwhich the practitioner could increaselocal anesthetic success rates, reduce oreliminate the need for palatal/lingualinjections, and overcome anesthetic failures associated with irreversible pulpitis, primarily by token of a uniquechemical feature (the presence of a thiophene ring in the place of a benzene ring).

Reports persist of the unique advantages of articaine over establishedproducts, such as lidocaine, both as clinical impressions and findings in clinical studies and have been reinforced periodically in dental trade publications,in which some clinicians claim to haveincreased their mandibular anesthesiasuccess rates to 99% or 100% afterswitching to articaine. While there is nodoubt that a dentist’s experience withlocal anesthetics is variable due to theinherent variations in drug response,neuroanatomic variations, and other factors, individual claims of increasedeffectiveness must be evaluated critically,using the best scientific evidence at handbefore agents with a long history of safety and efficacy are replaced with anew product (Blanton & Jeske, 2003).

In this spirit, the present articlebriefly considers clinical and scientificevidence, at times contradictory, forthree claims commonly associated witharticaine: 1) “high diffusibility,” 2)decreased failure rates of mandibular/inferior alveolar block injections, and 3) the ability to overcome failures oflocal anesthesia associated with irreversible pulpitis.

“High Diffusibility”One clinical observation commonlybelieved to indicate the extent to which a local anesthetic diffuses into sites ofaction is its success rate in producingexcellent local anesthesia by infiltrationin the mucobuccal fold at the level of the apex of the tooth to be instrumented,and by penetration to soft- and hard-tissue sites not ordinarily anesthetized

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Selection of Local Anesthetics in Dentistry: Clinical Impression versus Scientific Assessment


Dr. Jeske is Professor and Chair, Department ofRestorative Dentistry andBiomaterials University ofTexas Dental Branch–Houston.He also maintains a privatepractice limited to periodonticsin Dallas and can be reachedat Arthur.h.jeske.uth.tmc.edu.

Dr. Blanton is ProfessorEmeritus, Department ofBiomedical Sciences, BaylorCollege of Dentistry, The Texas A&M University SystemHealth Science Center inDallas, where she practices.Dr. Blanton is a Regent of the College.

with this technique, e.g., palatal anesthesia following buccal infiltrationin the maxilla. Additional claims associated with articaine in this regardinclude its ability to produce pulpal anesthesia of mandibular teeth by simplebuccal infiltration over the relativelymore dense cortical plate of bone thatcharacterizes the mandible.

Long before its becoming availablein the U.S., a well-designed, scientificstudy showed that articaine producedonly a 5% incidence of palatal and lingualanesthesia after buccal infiltration,which was the same low rate as thecomparator drug prilocaine under identical conditions (Haas, Harper, Saso, & Young, 1990). The same studydemonstrated that articaine produced no significantly greater success rate forpulpal and soft tissue anesthesia, and hadno significantly more rapid onset thanprilocaine. Shortly afterward, Vahatoloand others reported that 4% articainewith 1:2000,000 epinephrine did notresult in statistically superior onset ofanesthesia in maxillary lateral incisorswhen compared to lidocaine 2% with1:80,000 epinephrine (Vahatalo, Antila,& Lehtinen, 1993). Similarly, anotherstudy failed to show differences in success rates for infiltration anesthesiaof maxillary canines (Olveira, Volpato,Ramaciatto, & Ranali, 2004), and astudy in pediatric patients did not revealdifferences in local anesthetic outcomesamong mepivacaine, prilocaine, andarticaine (Wright, Weinberger, Marti, &Plotzke, 1991).

Shortly after its introduction in the U.S., Malamed and others (2000;2001) published results of a randomized,double-blind, multi-center clinical trials

that compared the clinical characteristicsof 4% articaine with 1:100,000 epineph-rine versus 2% lidocaine with 1:100,000 epinephrine. In these well-designed scientific studies, articaine was shown to be equally efficacious with lidocaine,with comparable efficacy, volumes, time to onset, and duration of action,none of which were statistically signifi-cantly different from values for 2%lidocaine with epinephrine. Thesereports concluded that 4% articaine “isan effective agent acting in the standardlidocaine-epinephrine-mepivacainerange,” and further concluded that articaine’s clinical performance was notsufficiently different to qualify it as areplacement for lidocaine.

Shortly following publication of outcomes of the multi-center trails ofMalamed and colleagues, Clark et al(2002) reported that administration of1.8 mil lidocaine 2% with 1:100,000 epinephrine infiltrated labially signifi-cantly improved local anesthesia ofmandibular lateral incisors followingconventional inferior alveolar block.This report confirmed that earlier gener-ation anesthetics, such as lidocaine,which purportedly lack the diffusibilityof articaine, can be effective when usedfor mandibular anterior infiltration.However, the contribution of contralateralmental nerve crossover innervation,with penetration of sensory fibers intothe buccal cortical plate of the anterior mandible, cannot be discounted, since blockade of such sensory fiberswould not be depend on penetration of the anesthetic through the bony cortical plate.

Two more recent studies (Berlin etal., 2005; Kanaa et al., 2006) exemplifythe continued contradictory findinginvolving claims of superior clinicalcharacteristics (e.g., diffusibility) of articaine. In the first study, the efficacyof 4% articaine with 1:100,000 epineph-

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In toto, the scientific evidence from dental clinical studies neitherrefutes nor confirms asuperiority of articaine over other agents in routine dental local anesthesia or its ability to improve success in the presence of irreversible pulpitis.

rine was compared with that of 2% lidocaine with 1:100,000 epinephrine for periodontal ligament injections ofnon-diseased mandibular first molars.While articaine showed a slight advantagein onset time (1.3 minutes vs. 2.2 minutes),local anesthetic success rates were notstatistically significant, although some-what better values (were reported forarticaine (86%) than for lidocaine (74%)(Berlin et al., 2005). A later study report-ed the comparative success rates of thesetwo agents in producing pulpal anesthe-sia of mandibular first molars followingbuccal infiltration. In this report, 4%articaine with 1:100,000 epinephrineproduced significantly higher successrates (64.5%) than 2% lidocaine withthe same vasoconstrictor concentration(38.7%) (Kanaa et al., 2006).

Since 1962, at least three studies of ocular complications of dental localanesthesia have been reported, implicatingthe diffusibility of the local anesthetic as a contributing factor (Cooper, 1962;Penarrocha-Diago & Sanchis-Bielsa, 2000;Magliocca, Kessel, & Cortright; 2006).Penarrocha-Diago and Sanchis-Bielsa(2000) suggested that the “improvedanesthetic diffusion” of articaine throughsoft tissue and bone could account formany of the ophthalmic findings. Mostrecently, Magliocca and others (2006),using two 1.7-ml cartridges of 4% arti-caine delivered to the posterior superioralveolar nerve and the greater palatinenerve, reported a case of transientdiplopia following these maxillary injections. This group did acknowledgethat the various bony and vascularanatomical pathways could explain theoccurrence of such ophthalmologic complications. These studies raise thequestion of enhanced anesthetic diffusionthrough soft tissue and bone as well asthe potential of the volume of solutionor the specific chemical properties of 4%articaine in playing a role in neurological(often transient) disturbances.

Increased Success Rates ofMandibular AnesthesiaAs noted previously, multi-center controlledclinical trials conducted in the U.S. didnot establish a significantly higher rateof success for articaine than that seenwith other amide agents when anesthesiawas tested by performance of a variety of invasive dental procedures (Malamed,Gagnon, & Leblanc, 2000; 2001).Recently, in a well-designed double-blind,randomized, crossover human study,Mikesell and others (2005) comparedlocal anesthetic outcomes in fifty-sevenhuman subjects using the same agentsfor their comparison. When administeredusing conventional inferior alveolarnerve block technique, no significant differences in success rates between articaine and lidocaine were observed,although considerable variationsbetween molar, premolar and incisorteeth were noted.

Improved Local Anesthetic SuccessRate in Irreversible PulpitisPerhaps the most challenging situationfor pain control in dentistry is the needfor producing profound local anesthesiaof a tooth or teeth that exhibit the signs and symptoms of irreversible pulpitis (“toothache”). In this chronicinflammatory state, neural expression oflocal anesthetic-resistant, voltage-gatedsodium channels and peptide mediatorswould be expected to impair local anesthetic effectiveness (Robinson,Boissonade, Loescher et al. 2004). Inthat regard, one study has scientificallyevaluated the comparative success ratesof articaine and lidocaine for inferioralveolar nerve block in patients withdocumented irreversible pulpitis inmandibular posterior teeth. Neitheranesthetic produced clinically acceptable

success rates, which were 24% and 23%for articaine 4% and lidocaine 2%,respectively (Claffey, Reader, Nusstein,Beck, & Weaver, 2004).

SummaryIn toto, the scientific evidence from dental clinical studies neither refutes nor confirms a superiority of articaineover other agents in routine dental local anesthesia or its ability to improve success in the presence of irreversible pulpitis.

However, statistical outcomes of such studies may not outweigh clinicalimpressions of practitioners whose practice of local anesthesia is believed tobe positively impacted by a new agent.There are likely several reasons for theseapparently “clinically significant” observations, including increased vigilance of clinical outcomes and closerattention being paid to technique ofadministration, among others. Is a one- to two-minute faster onset of localanesthesia onset clinically significant?That question, and other relevant ones,can be answered only by individuals andfor their individual reasons. Is an overallsuccess rate of 64% for articaine, whencompared with 38% for lidocaine, clini-cally significant? If observed in a singledental practice over a relatively shortperiod immediately following a switch to a new primary local anesthetic, theanswer would most likely be “yes.” Suchobservations would be felt most signifi-cantly in the patient who has frequentlyexperienced failed anesthetic blocks butexhibits excellent local anesthesia uponadministration of the new agent. In suchcases, previous anesthetic failures have

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been documented to be predictive offuture failure (Kaufman, Weinstein, &Milgrom, 1984) and it is likely that boththe patient and the practitioner wouldprefer the most recently administeredlocal anesthetic and block technique for future injections.

Tests of anesthesia used in the studiesof Malamed and his colleagues (2000;2001), in which the subjects rankedanesthetic efficacy during both “simple”procedures (single extractions and routineoperative procedures) and “complex”procedures (multiple extractions, alve-olectomies, mucogingival procedures),all in a double-blind manner, are robust,as are tests which use electric pulptesters, with appropriate unanesthetizedcontrols. These clinical-scientific goldstandards should be applied in the clinician’s decision-making processwhen a new local anesthetic is beingconsidered for incorporation into a dental practice. However, clinical judgment and experience are equally relevant factors for an individual practitioner in selecting from the relatively few but safe and efficaciousinjectable amide local anesthetics currently available. ■

ReferencesBerlin, J., Nusstein, J., Reader, A., Beck,M., & Weaver, J. (2005) Efficiency of articaine and lidocaine in a primaryintraligamentory injection administeredwith a computer-controlled local anestheticdelivery system. Oral Surgery. OralMedicine and Oral Pathology, OralRadiology and Endodontics, 99, 361-366.Blanton, P. L, & Jeske, A. H. (2003). The key to profound local anesthesia: neuroanatomy. Journal of the AmericanDental Association, 134, 753-759.Clark, K., Reader, A., Beck, M., & Meyers,W. J. (2002). Anesthetic efficiency of aninfiltration in mandibular anterior teeth following an interior alvedar nerve block.Anesthesia Progress, 49, 49-55.Claffey, E., Reader, A., Nusstein, J., Beck,M., & Weaver, J. (2004). Anesthetic effica-cy of articaine for inferior alveolar nerveblocks in patients with irreversible pulpitis.Journal of Endodontics, 30, 568-571.Cooper, J. C. (1962). Deviation of the eyeand transient blurring of vision aftermandibular nerve anesthesia, Journal ofOral Surgery, Anaesthesia, and HospitalDental Service, 20, 151-152.Haas, D. A., Harper, D. G., Saso, M. A., &Young, E .R. (1990). Comparison of articaineand prilocaine anesthesia by infiltration inmaxillary and mandibular arches.Anesthesia Progress, 37, 230-237.Kanaa, M. D., Withworth, J. M., Corbett, I.P., & Meechan, J. G. (2006). Articaine andlidocaine mandibular buccal infiltrationanesthesia: a prospective, randomized,double crossover study. Journal ofEndodontics, 32, 296-298.Kaufman, E., Weinstein, P., & Milgrom, P.(1984). Difficulties in achieving local anesthesia, Journal of the AmericanDental Association, 108, 205-208.Magliocca K. R., Kessel, N. C., & Cortright,G. W. (2006). Transient diplopia followingmaxillary local anesthetic injection. OralSurgery. Oral Medicine and Oral Pathology,Oral Radiology and Endodontics, 101, 730-733.

Malamed, S. F., Gagnon, S., & Leblanc, D.(2000). Efficacy of articaine: a new amidelocal anesthetic. Journal of the AmericanDental Association, 131, 635-642.Malamed, S. F., Gagnon, S., & Leblanc, D.(2001). Articaine hydrochloride: as study ofthe safety of a new amide local anesthetic.Journal of the American DentalAssociation, 132, 177-185.Mikesell, P., Nusstein, J., Reader, A., Beck,M. ,& Weaver, J. (2005). A comparison ofarticaine and lidocaine for interior alveolarnerve blocks. Journal of Endodontics, 31,265-270.Olveira, P. C., Volpato, M. C., Ramaciatto,J. C., & Ranali, J. (2004). Articaine and lig-nocaine efficacy in infiltration anaesthesia:a pilot study. British Dental Journal, 197,45-46.Penarrocha-Diago M., & Sanchis-Bielsa, J.M. (2000). Ophthalmologic complicationsafter intraoral local anesthesia with arti-caine. Oral Surgery. Oral Medicine andOral Pathology, Oral Radiology andEndodontics, 90, 21-24.Robinson, P. P., & Boissonade, F. M.,Loescher, A. R., et al. (2004). Peripheralmechanisms for the initiation of pain following trigeminal injury. Journal ofOrofacial Pain, 18, 287-292. Vahatalo, K., Antila, H.,& Lehtinen. R.(1993). Articaine and lidocaine for maxillaryinfiltration anesthesia. AnesthesiaProgress, 40, 114-116.Wright, G. Z., Weinberger, S. J., Marti, R.,& Plotzke, O. (1991). The effectiveness ofinfiltration anesthesia in the mandibularprimary molar region. Pediatric Dentistry,13, 278-283.

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Ronald S. Brown, DDS, MS, FACD

AbstractCase report articles or any articles thatreport serious consequences from a particular therapy should be evaluated with reasonable suspicion. The concerns of these articles may prove to be correct or not in time and therefore, it is necessary to take a wait-and-see posture.In time, the publication of similar casereports should generate further concern, or the lack of secondary case report articles backing up the initial report would tend to dismiss concern. Obviousfailures in critical thinking and informationgathering should be noted.

As I remember the story, ChickenLittle was frightened by fallingflotsam and jetsam and ran

around the neighborhood warningeveryone that the sky was falling. Heencouraged everyone to take cover orrisk injury. Of course, within the contextof the story, Chicken Little happened tobe wrong. The story was about abjectpanic and individuals who do not collectand process information in a reasonablemanner and thereby encourage otherindividuals to panic.

It is true that meteors and space junk (flotsam and jetsam) sometimesdescend onto the earth. Ultimately, thisspace material presents a potential riskfor anyone outside the protection of asturdy shelter. There is always someinfinitesimal probability that one of uscould be beaned by a meteor and experience serious health consequences.But should the threat prevent anyonefrom leaving his or her shelter andgoing for a walk? The answer to thiskind of question requires formulating a risk-benefit analysis. This kind ofanalysis is also critical for the clinician’sdecision-making process with regard toformulating patient therapies. Is the benefit worth the risk? Personally, Idon’t think twice about going for a walk,because the chance of being hit by afalling meteor or other space debris isdrastically insignificant. But there areother concerns that might make me

think twice. Journal editors and authorshave a responsibility to provide the read-ership with balanced, unbiased resultsand sufficient information so clinicianscan determine both benefits and risks.

There are many recent articles indental journals that suggest possible serious issues and concerns. Such articles often advise restraint or avoidingexpressing professional opinions regarding particular therapies or cautionconcerning the use of medical histories,materials, or drugs. Caution is a hallmarkof incomplete science as well as the personal views of authors. Advice not to act has both positive and negativepotential in the clinical setting. Someresearch studies have the potential toeducate clinicians in safeguarding thehealth of patients. Others warn practitioners off from actions that arebeneficial to patients. It is also possiblethat unnecessary therapies—costing timeand money and having unsatisfactoryside effects—will be used because of

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The Chicken Little Syndrome


Dr. Brown is Professor,Department of Oral DiagnosticServices, Howard UniversityCollege of Dentistry,Washington, [email protected]

misconceptions about available alterna-tives. It is certainly important forclinicians to be aware of the potentialhealth consequences reported by in theliterature. But it may be even moreimportant for clinicians to use criticalthinking to evaluate the relevance of therisks and the fears presented. Criticalthinking is paramount in evaluating theaccumulated evidence provided byresearch studies, epidemiologic studies,commentary articles, and case reports.

True NegativesContinuing with the Chicken Little analogy, it is important for clinicians torealize that sometimes the sky is reallyfalling. Marx (2003) reported in 2003that avascular necrosis secondary to bisphosphonate therapy for cancerappeared to be a clinical problematicside-effect of the cancer pharmaco-chemotherapy. Migliorati (2003)followed a month later with anotheralert concerning this potential problem-atic condition. However, Tarassoff andCsermak (2003), representing NorvartisPharmaceuticals, countered shortlythereafter that Marx and others wereincorrect. They reported that theirsearch of the literature did not revealany association between bisphosphonateadministration and osteonecrosis ineither humans or animals. They citedseveral references regarding the success-ful treatment of osteonecrosis withbisphosphonates. In time, further casereports accumulated evidence that avascular necrosis is indeed a side effectof bisphosphonate administration andappears to be a significant risk factor forpatients on bisphosphonates (Miglioratiet al., 2006, 2005). Presently, evenNorvartis has noted approximately 600

reported cases of biophosphonate-inducedosteonecrosis. The conclusion is that theclinical observations of Marx and othersconcerning a possible association withthe drug category of bisphosphates andthe side effect of avascular necrosis werecorrect. Sometimes the sky is falling.

But in my opinion, it is unfair to criticize Tarassoff and Csermak as beingunethical merely because they wereincorrect. In rereading their response,their opinions appear to be reasonablysupported by their arguments and theliterature available at the time of theresponse. Certainly, their opinions mayhave been colored by their relationshipwith Norvartis. But they openly disclosedthis connection.

False NegativesBut oftentimes the sky is not falling, andit was only flotsam and jetsam. Severalexamples are presented demonstratingarticles in which readers were alerted to potential problems which, with thepresent evidence available, have not beendemonstrated to be health concerns.

Silver or dental amalgam restora-tions have been controversial almostfrom their first use. In the nineteenthcentury, many dentists considered dentalamalgam to be substandard. But with G.V. Black’s research, dental amalgambecame the mainstay of restorative den-tistry. Several dentists promoted theconcept that because mercury is toxic,therefore dental amalgam had a toxiceffect. This particular viewpoint has beenadvocated for over a hundred years.When composite restorative materialbecame a viable alternative, fears of toxicity became more pronounced.Composite material certainly has a vastlyimproved esthetic and cosmetic appear-ance compared to dental amalgam.However, research and epidemiologicalstudies have repeatedly demonstrated thesafety and efficacy of dental amalgam.When compared to composite dentalrestorations, dental amalgams last con-

siderably longer and are less expensive.A recent investigation by the Food andDrug Administration (Associated Press, 2September 2006) once again pronounceddental amalgam a safe and effective dental restorative material.

Economic considerations may havebecome entangled with evaluation ofsafety of amalgam restorations. Dentistscharge more for composites and composites generally do not last as longas amalgams. Under such circumstancesit may be difficult to get a fair hearingfor the safety of amalgam. Many dentistshave only a limited understanding ofheavy metal toxicology and mercury and dental amalgam toxicology issues. A favorite trick of the Chicken Littlecrowd is to assert that there is “no safelevel of a potentially hazardous material”or alternatively “there is no acceptablelevel of risk.” As stirring as such slogansappear, they make no practical sense asall of us accept risk in heating our housesor driving to our offices. Toxicity is relatedto dose, and trace amounts of a toxicmaterial below the minimal levels oftoxic exposure are not problematic. Todate, there are only a few reports ofadverse reactions secondary to allergyand lichenoid reactions with regard to themercury within dental amalgams andcertainly no serious life-threateningmedical conditions have ever beenreported (Abraham et al., 1984; Mackert,1991; Mackert & Berglund, 1997; Magos& Clarkson, 2006; Vimy & Lorscheider,1985; Vimy & Lorscheider 1996; Wahl,2001a; 2001b). With regard to dentalamalgams, it appears that the sky is not falling.

The issue of drug interactionsbetween local anesthesia formulationscontaining the vasoconstrictor epineph-rine and other drugs has also receivedunreasonable concern in the dental literature (Yagiela, 1999; Goulet et al.,1992). Many articles have discouraged

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clinicians from utilizing epinephrinelocal anesthetic formulations concomi-tantly with tricyclic antidepressants andnonselective beta adrenergic blockingdrugs. Mito and Yagiela (1988) reporteda case of drug-induced hypertension possibly due to the combination of propranalol, a nonselective beta blocker,with the vasoconstrictor levonorderfrinused in a local anesthetic formulation.However, levenordorfrin happens to havevery little beta-two adrenergic receptoractivity which makes its effect on bloodpressure more similar to norepinephrinethan epinephrine. Both norepinephrineand levenordorfrin have much greaterbeta-one receptor activity compared to their beta two activity. Beta-oneadrenergic receptor activation increasesblood pressure and beta-two adrenergicreceptor activation decreases blood pressure. There are numerous casereports of increased hypertension due tonorepinephrine local anesthesia formu-lations even without combining withnon-selective beta blockers. Epinephrine-containing local anesthesia formulationshave not been implicated in significantlyincreasing blood pressure (Brown &Rhodus, 2005; Rhodus & Little, 2003).Furthermore, there has never been areported case of increased hypertensiondue solely to an epinephrine-based localanesthetic formulation combined with a nonselective beta blocker with regardto medications used by millions ofpatients (Brown & Rhodus, 2005).Nevertheless, this so-called interactionbetween epinephrine containing localanesthesia formulations and nonselectivebeta blockers is noted in many articlesand texts.

With regard to a supposed interactionbetween epinephrine containing localanesthesia formulations and tricyclicantidepressants, the literature is just asastonishing. In 1973, Boakes and others incorrectly suggested the seriousness ofa trycyclic antidepressant and epinephrinecontaining local anesthesia formulation

drug interaction in misquoting informa-tion from a 1972 article by Boakes andcolleagues. Three inadequately designedstudies with a very limited number ofsubjects were reported to confirm thisso-called interaction (Boakes et al., 1973; Svedmyr, 1968; Yagiela et al.,1985). However, there has never been areported clinical case of such an interac-tion occurring with regard to these twomedications despite their having beenused by millions of patients. Nevertheless,this putative interaction between epi-nephrine containing local anesthesiaformulations and tricyclic antidepressantsis often cited in myriad articles and texts(Brown & Rhodus, 2005).

A recent publication dramatizedconcern regarding long QT syndrome(LQTS) and dentistry (Karp & Moss,2006). LQTS is associated with torsadede pointes arrhythmia and sudden deathsyndrome in adolescents and in regardto particular drug toxicities and druginteractions. A history of syncope wasnoted as a possible finding in patientswith LQTS. The recommendation wasmade to refer dental patients with a history of routine syncope for completecardiovascular work-ups. This wouldresult in the considerable health dollarexpense with unknown gain. Certainlyparticular drug interactions have beenimplicated in dental treatment as mor-bidity and mortality factors with regardto the torsade de pointes arrhythmia.(Carlson & Morris 1996; Gallagher et al.,1998; Walker & Hendeles, 1979; Wynn,2005). Therefore, such drugs as terfena-dine, erythromycin, digoxin, cisapride,theophylline, sevoflurane and ketocona-zole are implicated as problematic withrespect to inducing torsade de pointesarrhythmia when combined with oneanother or at toxic dosage levels.

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Journal editors andauthors have a responsibility to providethe readership with balanced, unbiased results and sufficient information so clinicianscan determine both benefits and risks.

Patients with LQTS are at greaterrisk with regard to these drug interactionsand torsade de pointes arrhythmia(Cubeddu, 2003; Tong et al., 2001).

However, in a review of the Englishlanguage case reports, there are at present only two case reports with clinical dental implications which maybe related to LQTS (Strickland et al.,1993; Gallagher et al., 1998). Neither ofthese cases was related to routine dentaltherapy. Both cases were anesthesia orsurgical hospital cases; one related to apartial glossectomy and selective neckdissection and the other related to thedrug sevoflurane.

Furthermore, epinephrine infusionsin concentrations relevant to dental therapy are currently utilized withrespect to the diagnosis of LQTS (Vyas et al., 2006). However, epinephrine andlocal anesthesia formulations have notbeen implicated clinically as problematic.On the contrary, epinephrine withinlocal anesthetic formulations with respectto the utilization of two to three cartridgesappears to be safe and effective for medically complex patients with cardiacdisease (Brown & Rhodus, 2005; Rhodus& Little 2002). Epinephrine in localanesthesia formulations have never been reported to contribute to LQTS sudden death. Therefore, as epinephrinecontaining local anesthetic formulationshave been used in millions upon millionsof patients, if there was even the slightestrisk of such a causal relationship, lethalcases would tend to have been reportedin the literature. Certainly, it is importantfor dental clinicians to consider LQTS as a medical diagnosis particularly withregard to drug toxicities and interactions,but once again, the sky does not appearto be falling.

DiscussionWith regard to “true negatives”, clinicalobservation would tend to demonstraterepeated cases in which the procedure ordrug resulted in negative consequences.Certainly, negative consequences in thefield are not always reported. However, if the particular concern is clinically significant, it is expected that enoughnegative cases would be prevail to allowfor continued publication of negativecase reports.

With regard to “false negatives”, the lack of clinical significance isdemonstrated with the lack of publishedcase reports. The lack of the documenta-tion of further incidences of negativefindings in regard to a particular drug or therapy is initial evidence that thedrug or procedure does not tend to have clinically significant negative consequences. Almost all drugs and procedures have the potential for nega-tive consequences. Reports concerningthe negative clinical aspects of a drug orprocedure without backup case reportsshould be questioned especially whenthe drug or procedure has been utilizedfor an extended period of time.

Clinicians and journal editors havean ethical responsibility to report andpublish reports concerning risks associ-ated with clinical practice includingadverse drug reactions. As an example,the many reports concerning BON havealerted clinicians and the public as to the reality of this serious drug side effect.However, it is also the responsibility ofeditors, reviewers, authors, and cliniciansto enforce objectivity in reporting boththe potential positive and negativehealth issues. Some journal editors promote “comment” articles followingarticles reporting potentially controversialtopics. Some editors insist that phrasessuch as “further case reports and con-trolled studies are necessary to evaluatethe topic presented” are to be includedwithin the conclusion of such articles.

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Clinicians and journal editors have an ethicalresponsibility to report and publish reports concerning risks associated with clinicalpractice including adverse drug reactions.

It is also the ethical responsibility ofauthors quoting such articles and studiesto provide an objective prospective of the topic quoted in order for the reader-ship to have a balanced view of the risksand benefits and an appreciation for critical thinking. ■

ReferencesAbraham, J. E., Svare, C. W., & Frank, C.W. (1984). The effect of dental amalgamrestorations on blood mercury levels.Journal of Dental Research, 63 (1), 71-73.Brown, R. S., & Rhodus, N. L. (2005).Epinephrine and local anesthesia revisited.Oral Surgery, Oral Medicine, OralPathology, Oral Radiology, andEndodontics, 100 (4), 401-408.Boakes, A. J., Laurence, D. R., Lovel, K. W.,O’Neil, R., & Verrill, P. I. (1972). Adversereactions to local anesthetic/vasocon-strictor preparations: a study of the cardiovascular responses to Xylestesin and Hostacain-with-noradrenaline. BritishDental Journal, 133, 137-140.Boakes, A. J., Laurence, D. R., Teoh, P. C.,Barar, F. S. K., Benedikter, L. T., & Prichard,N. C. (1973). Interactions between sympa-thomimetic amines and antidepressantagents in man. British Medical Journal,1(5849), 311-315. Carlson, A. M., & Morris, L.S. (1996).Coprescription of terfenadine and erythro-mycin or ketaconazole: an assessment ofpotential harm. Journal of the AmericanPharmacology Association, NS 36 (4), 263-269. Cubeddu, L. X. (2003). QT prolongation andfatal arrhythmias: a review of clinicalimplications and effects of drugs.American Journal of Therapeutics, 10 (6),452-457.FDA review dental amalgam. (2006).British Dental Journal, 201 (6), 331.Gallagher, J. D., Weindling, S. N.,Anderson, G., & Fillinger, M. P. (1998).Effects of sevoflurane on QT interval in apatient with congenital long QT syndrome.Anesthesiology, 89 (6), 1569-1573. Goulet, J-P., Perusse, R., & Turcotte, J-Y.(1992). Contraindications of vasoconstric-tors in dentistry: Part III. Oral Surgery, OralMedicine, Oral Pathology, 74, 692-697.

Karp, J. M., & Moss, A. J. (2006). Dentaltreatment of patients with long QT syn-drome. Journal of the American DentalAssociation, 137 (5), 630–637. Mackert, J. R., Jr., & Berglund, A. (1997).Mercury exposure from dental amalgamfillings: absorbed dose and the potentialfor adverse health effects. Critical Reviewsin Oral Biology and Medicine, 8 (4), 410-436.Mackert, J. R., Jr. (1991). Dental amalgamand mercury. Journal of the AmericanDental Association, 122 (8), 54-61. Magos, L., & Clarkson, T. W. (2006).Overview of the clinical toxicity of mercury.Annals of Clinical Biochemistry, 43, 257-268.Marx, R. E., (2003). Pamidronate (Aredia)and zoledronate (Zometa) induced avascu-lar necrosis of the jaws: a growingepidemic. Journal of Oral andMaxillofacial Surgery, 61 (9), 115-117.Migliorati, C. (2003). Biophosphanates andoral cavity avascular bone necrosis.Journal of Clinical Oncology, 21 (22), 4253-4254.Migliorati, C. A., Casiglia, J., Epstein, J.,Jacobsen, P. L., Siegel, M. A., & Woo, S. B.(2005). Managing the care of patients withbisphosphonate-associated osteonecrosis:an American Academy of Oral Medicineposition paper. Journal of the AmericanDental Association, 136 (12), 1658-1668. Migliorati, C. A., Siegel, M.A., & Elting, L.S. (2006). Bisphosphonate-associatedosteonecrosis: a long-term complication ofbisphosphonate treatment. LancetOncology, 7 (6), 533.Mito, R. S., & Yagiela, J. A. (1988).Hypertensive response to levonordefrin in apatient receiving propranolol: report ofcase. Journal of the American DentalAssociation, 116, 55-57.Rhodus, N. L., & Little, J. W. (2003). Dentalmanagement of the patient with cardiacarrhythmias: an update. Oral Surgery, OralMedicine, Oral Pathology, Oral Radiology,and Endodontics, 96 (6), 59-68.Strickland, R. A., Stanton, M. S., & Olsen,K. D. (1993). Prolonged QT syndrome: peri-operative management. Mayo ClinicProceedings, 68 (10), 1016-1020.Svedmyr, N. (1968). The influence of a tri-cyclic antidepressant agent (protryptyline)on some of the circulatory effects of nora-drenaline and adrenaline in man. LifeScience, 7, 77-84.

Tarassoff, P., & Csermak, K. (2003).Avascular necrosis of the jaws: risk factorsin metastatic cancer patients. Journal ofOral and Maxillofacial Surgery, 61 (10),1238-1239.Tong, K. L., Lau, Y. S., & Teo, W. S. A caseseries of drug-induced long QT syndromeand Torsade de Pointes. SingaporeMedical Journal, 42 (12), 566-570.Vimy, M. J., & Lorscheider, F. L. (1985).Intra-oral air mercury released from dentalamalgam. Journal of Dental Research, 64(8), 1069-1071.Vimy, M. J., & Lorscheider, F. L. (1996).Renal function and amalgam mercury.American Journal of Physiology, 271, R941-5.Vyas, H., Hejlik, J., & Ackerman, M. J.(2006). Epinephrine QT stress testing in theevaluation of congenital long QT syndrome:diagnostic accuracy of the paradoxical QTresponse. Circulation, 113 (11), 1385-1392.Wahl, M. J. (2001a). Amalgam—resurrec-tion and redemption. Part 1: the clinicaland legal mythology of anti-amalgam.Quintessence International, 32 (7), 525-535. Wahl, M. J. (2001b). Amalgam — resurrec-tion and redemption. Part 2: The medicalmythology of anti-amalgam. QuintessenceInternational, 32 (9), 696-710. Walker, J., & Hendeles, L. (1979). Theinteraction of erythromycin and theo-phylline in the asthmatic dental patient.Journal of the American DentalAssociation, 99 (6), 995-996. Wynn, R. L. (2005). Drugs and the QT inter-val—implications for dentistry. GeneralDentistry, 53 (2), 94-97.Yagiela, J. A. (1999). Adverse drug interac-tions in dental practice: interactionsassociated with vasoconstrictors. Journalof the American Dental Association, 130,701-709. Yagiela, J. A., Duffin, S. R., & Hunt, L. M.(1985). Drug interactions and vasoconstric-tors used in local anesthetic solutions.Oral Surgery, Oral Medicine, OralPathology, 59, 565-571.

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Peter M. Spalding, DDS, MS, MS, FACDand Richard E. Bradley, DDS, MS, FACD

AbstractEarly U.S. dental training involved a closerrelationship between commercialism andeducation, which was strongly counteractedby university affiliations at the beginningof the twentieth century. With recentdecreases in public support for higher education, schools have become increasinglydependent on private revenue sources,including corporate support. There are ethical risks as well as benefits from dentalschools establishing business partnershipswith corporations. In 2002, a private, for-profit company was responsible for the inception and direct funding of anorthodontic postgraduate program at a private U.S. university. In the last fouryears, this company has begun funding two additional orthodontic programs, bothassociated with U.S. public dental schools.Such partnerships with academic institutionsrepresent unique corporate relationshipswith dental education that are fraught withethical risks. The dental profession needs topreserve the appropriate autonomy of dentaleducation from commercial influences in order to prevent erosion of academicand ethical standards that are critical to professional integrity and public trust.

Early U.S. dental education involveda more intimate relationshipbetween commercialism and

training than it does today. Until themid-nineteenth century, the conventionaleducational model was the Europeanone dating back to the Middle Ageswhere dentists were informally trainedartisans with their education consistingof an apprenticeship for two or threeyears under a dental practitioner.Although some dentists had previouslycompleted limited medical training, most had none and their prior educationranged from minimal literacy to a college degree. Medical education wasfaced with similar circumstances.Physicians were the first to formalizemedical training by creating academicinstitutions, helping legitimize medicalpractice as a profession rather than atrade. Dentistry followed suit in 1840when two physicians who later becamedentists founded the first formal dentalinstitution in the world, the BaltimoreCollege of Dental Surgery. However, the first dental schools were created asproprietary institutions with no actualuniversity affiliation.

Following medicine’s lead to furtherprofessional legitimacy, the first U.S.dental school was placed within a uni-versity in 1868 at Harvard University.Subsequently, most dental schools werefounded in affiliation with universities.This association with higher educationhas provided academic credibility fordental education during the twentieth

century and university policies havebeen a valuable source for dental schools to assist in maintaining theirown academic and professional integrity.This affiliation also has provided a degreeof separation from the influence of corporate culture that had been so dominant in mainstream Americansociety since the Industrial Revolution.However, this independence from corporate influence required a growingdependence on government fundingthrough the mid-twentieth century inorder to meet U.S. public oral health-care needs.

Substantial reductions in governmentsupport for higher education began inthe late 1970s. Academic institutionshave faced progressively declining stateand federal financial support since that time, combined with increased competition for scarcer resources andaccelerated change that is requiringinnovative tactics to survive and prosper.There are mounting demands by the

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Commercialization of Dental Education: Have We Gone Too Far?


Dr. Spalding is AssociateProfessor and Interim Directorof the Advanced SpecialtyEducation Program inOrthodontics and DentofacialOrthopedics and Dr. Bradleyis currently Professor ofSurgical Specialties at theUniversity of NebraskaMedical Center College ofDentistry. Dr. Bradley is PastPresident of the AmericanCollege of Dentists, Presidentand Dean Emeritus of BaylorCollege, and former Dean ofUNMC College of Dentistry. Dr. Spalding can be contactedat [email protected]

public for dental schools to becomemore efficient and financially self-reliant, requiring schools to supplementtheir traditional revenue sources withalternatives to maintain and enhancetheir academic, research, and servicemissions. This has created a climatewhere dental institutions have becomevulnerable to corporate interests.Commercial companies have become an obvious potential alternative revenuesource, resulting in a trend where business partnerships that link academicand corporate cultures are increasing(Bok, 2003).

Analyzing RelationshipsIndividuals engaged in academics andthose involved in business have very disparate missions. The academic culture prides itself on the altruistic academic values of seeking truth andcommunicating knowledge and under-standing, whereas corporate culture isfocused on production and profit as itsprincipal purposes. Dental deans havehistorically been trained in research andteaching to serve as intellectual leadersrather than trained to supervise largeorganizations as business managers.Business success is quantifiable in terms of cost per production unit andinvestment return, whereas academicsuccess has much less reliable indicatorsto determine teaching effectiveness orresearch value. Academics and business-men have traditionally had opposingviews on the value of openness.Academics strive to develop a more comprehensive base of knowledge andto publish to enhance the common good,while businesses typically profit fromkeeping secrets from their competitors.Academic research has typically beencharacterized by curiosity-driven investigation that is viewed as superfluous

in the corporate environment, wheremeasurable productivity is what matters.

Despite these dramatic differences inmission and motivation, dental education,as well as the rest of higher education,has a long history of association withcommercial enterprises. Perhaps thegreatest influence has been in the areaof research. Although some degree ofcorporate funding of dental academicresearch has been present for most ofthe last century, legislation such as theBayh-Dole Act of 1980, which permitteduniversities to license patents fromresearch paid from public funds, and theexpansion of the biogenetics industryhave created a surge of corporate supportfor dental research in the last quartercentury (Thursby & Thursby, 2003).

Outside of research, most corporatefunding in dental schools has been limitedto support of the physical facilities andclinic operations with donations for capital projects, such as buildings, clinics,or research centers, and donated or discounted dental materials. Althoughthere has been much less history of corporate funding for dental schoolteaching and service missions, there hasbeen growth during recent decades inpartnerships between dental institutionsand industries that support these activities.Educational activities such as endowedprofessorships, symposia, educationalmaterials, scholarships and fellowshipshave received corporate funding. Whilethere are many instances of eager companies underwriting continuingeducation programs sponsored by dentalschools, there is minimal evidence ofthis activity affecting the formal dentalor postgraduate academic curricula.Although commercial influence is present in some service activities, suchas “Give Kids a Smile” or “Bright Smile,Bright Future,” they do not appear to beaffecting the direction of the service mission for dental schools.

It is useful to consider the range ofbusiness partnerships that exist betweendental schools and corporations. Perhapsthe most limited partnership is where abusiness donates money, dental materials,or equipment for undesignated use by the institution. Although such a partnership does not stipulate how thesedonations must be used, their acceptanceusually permits the company to advertisetheir association with the dental school.This association serves to improve thecredibility of the corporation, increasingtheir competitive position in the market-place by implied endorsement from theacademic institution. This relationshipalso indirectly enhances the corporation’spublic image by virtue of the dentalschool’s own public reputation.

A deeper level of partnership is wherethe corporate funding has a designateduse to support the educational, research,or service mission programs. While thedental school has less flexibility withhow they can use the money or materials,it still bears some obligation to the corporation. Examples would include

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Academic institutionshave faced progressivelydeclining state and federalfinancial support sincethat time, combined withincreased competition forscarcer resources andaccelerated change that isrequiring innovative tacticsto survive and prosper.

funding for educational activities limitedto one dental specialty program, fundingfor research conducted in one specificarea or restricted to a particular line ofresearch, or funding for a program toprovide clinical care to the local indigentpopulation. This level of commitment bythe school does not include any supervi-sion by the corporation over the conductof these sponsored activities nor does itrequire specific services in return.

An even deeper level of partnershipis where the funding has a designateduse and there is a reciprocal obligationfor services, restrictions on product use,or display of the corporate logo or name by the dental school. A commonexample of this type of commitmentwould be corporate research funding inreturn for product testing or technologytransfer. Although private funding ofdental research has been present formost of the history of dental education,the Bayh-Dole Act has increased this type of support during the last quartercentury. Another example of this level of corporate obligation is substantiallydiscounted or free dental products, ranging from clinic chairs to dentalimplants to mouthwash and toothpaste,in exchange for their exclusive use in the clinics. A final example would befunding of capital construction in returnfor naming a building, room, or clinicafter the corporation.

The greatest level of corporate obligation by the dental school is wherethe institution is required to permitsome extent of corporate participationor management of the educational,research, or service activities in returnfor corporate support. An examplewould be joint participation of corporateresearch and development employeeswith dental faculty researchers on a project whose outcome is important tocorporate product development. Anothercircumstance would be if the corporationhas any influence on recruitment orselection of, or contractual employmentobligation to the company by, faculty,students, or staff. Corporate participationin development or implementation of theeducational curriculum is another exam-ple of this extreme level of partnership.

It is of vital importance that the benefits and risks of corporate relation-ships with dental schools be identified in order to determine the appropriatelevel of commitment by the institution to the company that can justify the revenue obtained. The potential benefitsare principally related to finances whilerisks involve intangibles such as reputation (see sidebar).

A simple risk-benefit analysis todetermine the prudence of corporatefunding for dental schools is a challenge,particularly due to the greater difficultyin quantifying the ethical risks againstthe more easily measurable financialbenefits. Revenue is immediate, tangible,and useful to meet pressing needs. Valuessuch as integrity and public trust aremore intangible and their compromisesaccumulate over time so that they oftenare not obvious until much later.

Dentists and dental educators shouldcarefully reflect on the ethical issuesthat are relevant in determining the

appropriate relationship that corporationsshould have with dental academic institutions. The integrity of our dentalschools is dependent on the maintenanceof institutional autonomy of their

educational, research, and service mission activities. If this integrity is compromised, the subsequent decline in public trust will increase the risk ofgovernment intervention that may further limit dental school autonomy.

What are the appropriate boundariesthat should be maintained between acorporation and a dental school toassure adequate autonomy? Most wouldagree that recruitment of students or faculty should be independent of anycorporate influence. Similarly, it is anethical breach to have any corporateinvolvement in the development or content of predoctoral or postgraduatedental curricula. However, there are subtler ways that our educational activities may be influenced. Exclusiveuse of specific dental products in theclinic or avoiding the presentation ofalternative products in the classroomlimits student exposure to the range ofpossibilities, undermining the educationalvalues of objectivity and critical inquiry.In terms of the school’s research mission,corporate-sponsored research is vulnera-ble to erosion of the values of openness,independence, and objectivity that good science requires. Even corporate-supported service activities of the dentalschool may be affected in a way thatcompromises its integrity if the service isportrayed in a manner that appears asadvertisement for the company ratherthan benevolent in nature.

A Contemporary ExampleIn 2002, a unique corporate partnershipwith dental education was initiated by aprivate company to fund an orthodonticspecialty program at a private university.This new for-profit business, describedby its founder as a “practice transition/staffing company,” provided the opportu-nity for selected academic institutions to have orthodontic postgraduate programs supported by the company

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The response of dentaleducation to these pressures should includecaution as well as creativity and innovation.

(Johnston, 2002). In the subsequent two years, the company funded the construction of facilities for new large orthodontic graduate programs in twoadditional locations at public dentalinstitutions. In 2004, a failed attemptwas made by the company to expand the existing orthodontic program at athird public dental school.

This new corporate-dental academicbusiness partnership involves unprece-dented amounts of commercial financialsupport for the academic institution inexchange for specific obligations to thecompany. The company promised over$3 million of initial money to each schoolto develop an orthodontic program,including capital construction and hiringof faculty. In addition, the company provided funding of stipends and benefitsfor twelve orthodontic residents (representing 75% of each class) per yearwith a thirty-year financial commitmentto the programs of more than $1 million

annually. In return, the academicinstitution was obligated to develop andmaintain an accredited orthodontic postgraduate program and to accept aminimum of twelve applicants each yearwilling to work for the company followinggraduation. The selected orthodontic residents that were funded by the company during their academic programare contractually obligated to provideorthodontic care for a salary at locationsdesignated by the company for sevenyears duration following their graduation.

This corporate-academic partnershiprepresents a new, unique, and dangerousparadigm for dental education, since itincludes direct corporate funding of education and capital construction inexchange for corporate involvement inrecruitment and corporate obligationsby the graduating student. One dental

administrator has characterized the contractual agreement with the ortho-dontic residents as being comparable toexisting postgraduate scholarshipsoffered by the U.S. armed services, theIndian Health Service, and the NationalHealth Service Corps (Landesman,2004a; 2004b). However, the purpose for these government programs is toprovide a cost-effective method of training dentists as specialists to workfor these public service organizations.Public service rather than profit is themotive for the funding and the numberof students recruited varies based onneed rather than producing specialists toassure an ever-expanding market share.

The company’s founder andspokespersons from each of the two public dental schools to become contrac-tually involved have characterized theaims of the company as being altruisticin nature and have promoted them in

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Sidebar. Benefits and Risks to Dental Education of Corporate Partnership

Benefits • Undesignated revenue in the form of funding or commercial products.

• Enhanced resources, improving recruitment and retention of students, faculty, and staff.

• Revenue designated for teaching or research support.

• Revenue designated for service activities, enhancing public visibility and support for the institution.

• Gaining advantage over competing dental schools by establishing contracts with specific companies first.

Risks• Conflicts of interest, undermining individual faculty and institutional integrity (e.g., suppression of research

results that were not in the commercial interests of the corporation).

• Damage to the morale of the dental academic community from the loss of collegiality and trust(e.g., resentment and loss of respect if faculty are engaged in activities primarily for the good of the

corporation rather than the dental school).

• Decreased public trust in, and professional reputation of, the dental school (e.g., perception that the institution has compromised its objectivity or impartiality of research and teaching activities).

• Dependence on corporate support leaves dental school vulnerable to change in partnership (e.g., change in the corporate management or mission due to market changes; partnership no longer viewed as profitableby corporation; or corporate financial difficulties prevent it from continuing funding).

• Compromised reputation of dental school if corporation becomes involved in illegal behavior (e.g., corporationexposed for attempting to maintain profits or stockholders with unlawful activities).

this manner in the media (Ellis, 2003;Knight, 2003). They have asserted thatthe corporate-educational partnership is a means of addressing the currentshortfall in the number of U.S. ortho-dontists being graduated to replaceretiring orthodontists (Johnston, 2002;Landesman, 2004a). The company’sfounder has stated that another purposefor the corporation is to address the lackof “U.S. qualified” orthodontic faculty byproviding them with “increased salaries”as compared to the conventional level(Johnston, 2002). It was further statedthat the program will increase the diversity of orthodontists since they will recruit dentists who are “fromdiverse and economically disadvantagedbackgrounds” who “could never affordan orthodontic specialty program.” A final altruistic aim is that the programresidents will provide care to “economi-cally disadvantaged patients” andgraduating orthodontists will “providelow-cost care to children in underservedareas” (Landesman, 2004a). No mentionwas ever made in the press releases ofthe company’s clear profit motive.

It has been maintained that the contractual agreement with the company provides complete academicinstitutional autonomy in selection ofstudents and curricular developmentand implementation. However, it is clearfrom the partnership agreement that the company is directly involved inrecruitment of the applicants for theorthodontic program. Those applicantsthat are interested in committing toseven years of employment with thecompany following graduation in returnfor their financial support during theireducation must first be determined “eligible” by the company before beingrecommended to the academic institu-tion (Landesman, 2004a). While the“candidates” must be “acceptable” to theinstitution and it makes the ultimateselection of residents, the potential company-sponsored applicant poolappears to be screened first by the corporation. It seems difficult to maintainthat resident selection is autonomousfrom the corporation when they are sointimately involved in recruitment. The contract states, “… each [company]sponsored resident shall meet the admis-sion requirements established” by thedental school and it has been stated thatthe school has the privilege not to selectresidents for all twelve positions if theyare not qualified (Landesman, 2004a).However, there is an institutional obliga-tion to the corporation that at leasttwelve are to be selected each year andthe contract provides for the company to “recommend additional candidates” if there is not a “sufficient number of…candidates recommended by” the company admitted to the orthodonticprogram. In fact, the contract stipulatesthat in just over three years after the program’s inception, the dental school“will consider expanding the program in order to accommodate up to sixteen…sponsored residents per year”(Landesman, 2004a).

Although it is maintained that thecompany-recommended applicantsselected for twelve positions each yearare qualified by university standards, aspokesperson for one of the public dental schools stops short of saying theyare as competitive as the dentists whoapply through the conventional processfor their four remaining positions,admitting that there are two separateapplicant pools. The inevitable conse-quence of this type of admissionagreement is that less-qualified applicantswho are willing to sign a corporate contract will be considered for selectionover more qualified applicants who arenot interested in a corporate obligation.It is a paradox that such an arrangementpromotes the partnership with the company in part for its intention toenhance the overall diversity, and therefore quality, of orthodontists byadmitting financially disadvantaged dentists. In fact, it is hard to imaginethat any qualified and competitive applicant has been prevented fromaccepting an offer for specialty trainingdue to financial circumstances. Federalstudent loans always are available forresidents and the combined debt incurredwith predoctoral and postgraduate train-ing is easily managed in the lucrativespecialty practice of orthodontics following graduation. Another promotionof the partnership is that cheaper ortho-dontic care will be made available to thelocal indigent population, a boast thatcan be made by any orthodontic pro-gram. The assertion that the orthodonticgraduates that work for the companywill provide low-cost care in practiceremains to be seen.

Although the ADA Commission onDental Accreditation has determinedthat this type of partnership falls withinthe scope of their standards in terms offollowing the letter of the law, it hasbeen under dispute whether it falls

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It is of vital importance that the benefits and risksof corporate relationshipswith dental schools beidentified in order to determine the appropriatelevel of commitment by the institution to the company that can justifythe revenue obtained.

within the spirit of the law (Fox, 2003).It seems apparent that the CDA did notwrite their rules having imagined thiscircumstance. Because it is legal and norules were foreseen to prohibit it doesnot necessarily make the arrangementethical or prudent from the standpointof the dental profession or dental educa-tion. The intent of the accreditationstandards is to exclude outside entitiesfrom influencing the selection, training,or professional opportunities for dentalstudents and residents. It seems thatwhen a business contract is cunninglywritten to circumvent a strict adherenceto the letter of the regulation, it is disin-genuous to consider it acceptable to theprofessional and academic community.

There are two important concernsthat this new corporate relationshippresents for our profession, one which is financial and practical in nature, andone which is related to the integrity andautonomy of the profession. First, withthe academic institutions receiving thecompany’s funding appearing to bedependent on that ongoing support forprogram infrastructure for the long term, the possibility of the company’sinsolvency or bankruptcy over the thirty-year commitment makes the institutionhighly vulnerable. Indeed, since the original submission of this manuscript,there is evidence that this fear has beenrealized (Littlefield, 2006a; 2006b;2006c; Howard, 2006). The second concern is the precedent this type of corporate-sponsored dental educationrepresents for our profession. If a private, for-profit corporation is permittedto fund an orthodontic program to produce corporate employees, whatwould keep companies from doing thesame for the other dental specialties?Perhaps insurance companies would be interested in funding dental studentsor residents to produce adequateproviders and internal referrals for theirown companies.

SummaryAcademic dental education was createdin the U.S. during the nineteenth centurywithin proprietary institutions that hadno university affiliation. By the twentiethcentury, dental schools had become affiliated with higher education, devel-oping autonomy from private enterprise.Unfortunately, public support for highereducation has been steadily decreasingsince the late 1970s, causing dental edu-cation to become increasingly dependenton private revenue sources, includingcorporate support. The response of dentaleducation to these pressures shouldinclude caution as well as creativity andinnovation to preserve academic autonomythat is vital to its ethical integrity.

We believe that the recent partner-ships with academic institutions by the company described in this articlerepresent not only a significant departurefrom the way dental education has beenfunded in the past, but one that isfraught with ethical risks. Corporateinvolvement in student recruitment andcorporate contractual obligations as arequisite for admission both cross aboundary that compromises our basicacademic principles. Dental practitionersas well as dental educators andresearchers should work together todevelop ethical parameters for establish-ing corporate-academic partnershipsthat maintain the essential traditionalacademic values and the independenceof our dental schools from excessivecommercialism. The profession of den-tistry needs to preserve the appropriateautonomy of dental education from commercial influences in order to preventerosion of academic and ethical standardsthat are critical to professional integrityand public trust. ■

ReferencesBok, D. (2003). The commercialization ofhigher education. Princeton, NJ: PrincetonUniversity Press.Ellis, S. (2003). CU School of Dentistry toconstruct comprehensive oral-facial healthfacility and establish specialty program inorthodontics as Fitzsimmons. Newsrelease, University of Colorado HealthSciences Center, Denver, CO, January 16.Fox, K. (2003). Accreditation issues in spot-light. ADA News, November 17, 9, 18.Howard, K. C. (2006). Regents upset withcompany funding orthodontics program.Las Vegas Review-Journal, August 5.Johnston, M. W. (2002). A new perspectiveto educate orthodontists. SouthernAssociation of Orthodontists News, 12-15.Knight, J. (2003). Dental school deal com-mits students to seven years. Las VegasSun, October 10.Landesman, H. M. (2004a). What has yourstate done for higher education lately?Lecture at the ADEA Advanced EducationSummit, Tucson, AZ, November.Landesman, H. M. (2004b). Innovative part-nerships for dental education. Topic paperpresented at A Santa Fe Group PlanningConference, August 29-30.Littlefield, C. (2006a). Is UNLV taking one inthe jaw over $3.5 million deal with privatecompany to launch orthodontics school?Las Vegas Sun, June 28.Littlefield, C. (2006b). Warnings aboutdonor went unheeded. Las Vegas Sun,August 4.Littlefield, C. (2006c). Dental firm braced:Pay up, then get out! Las Vegas Sun,August 5.Thursby, J. G., & Thursby, M. C. (2003).University licensing and the Bayh-Dole Act.Science, 301, 1052.

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Olivier Hamel, DDS, PhD, ChristineMarchal, DDS, PhD, Michel Sixou, DDS,PhD, and Christian Hervé, MD, PhD

AbstractThe goal of this work is to contribute toethical reflection in the dental professionthrough the example of a survey of ethicalreflection and ethical issues in dentistryconducted at the dental school of Toulouse.A written survey was given to the heads of departments and to the sixth-year students and also to the dental faculty at the hospital dental clinic in order to estimate their level of understanding andconcern about these topics.

Since the end of the 1960s and the advent of autonomy for thefaculties of dental surgery in

France, the teaching of dentistry hasevolved significantly in parallel with scientific progress (Hervé, 1998; Hervé & Canoui, 1993). During that period oftime, there has been development in theevolution of the reflection about medicaltopics in relation to dental practice(muscular dystrophy, AIDS). In addition,because the public is better educated,there has been a significant increase inthe kinds and quantity of questions andrequests for explanations from thepatients in our dental surgeries (infor-mation on recently developed therapiesor the quality of materials used) (Béry,1996). In these respects, developmentsin dentistry have paralleled those inmedicine. But this is not as true in thecase of reflection on issues in ethics.

Ethical Reflection in Dentistry: First Steps at the Faculty of Dental Surgeryof Toulouse

Issues in DentalEthicsAmerican Society for Dental Ethics

Associate EditorsDavid T. Ozar, PhDJames T. Rule, DDS, MS

Editorial BoardPhyllis L. Beemsterboer, RDH, EdHMuriel J. Bebeau, PhDLarry Jenson, DDSBruce N. Peltier, PhD, MBADonald E. Patthoff, Jr., DDSGerald R. Winslow, PhDPamela Zarkowski, RDH, JD

Correspondence relating to the Dental Ethics section of the Journal of the American College of Dentistsshould be addressed to: ASDEc/o Center for EthicsLoyola University of Chicago6525 North Sheridan RoadChicago, IL 60627e-mail: [email protected]

The most recent medical-legal workon patients’ rights results from the lawof March 4, 2002, known as “Kouchner’sLaw.” Respect for the autonomy and dignity of the patients constitutes thecentral theme of this law, which has hadthe effect of instituting participation,information, and consent relating tomedical treatment undertaken. It is anew way for medical practitioners toconsider their patients as co-actors oftheir treatment. This principle of consentwas accepted as ethically fundamental in the field of biomedical research fromthe time of the code of Nuremberg and is now also expressed in the laws pertaining to bioethics. Because of this,it is now firmly established in the dailypractice of general medical practitionersas regards care or prevention.

We wanted to raise the question ofthe role of ethics in the training of oralhealth professionals and their aptitude torespond to these social requests, and todo so in a rigorous, valid, scientific waythat was devoid of any condescending or preconceived attitude. We selected asour research site the Faculty (School) of Dentistry of Toulouse. We wanted to

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Issues in Dental Ethics

Drs. Hamel and Marchal areat the Laboratory of MedicalEthics and Public Health,Faculty of Medicine Paris-Necker, France. Dental Facultyof Toulouse, France; Dr. Sixou,is at the Dental faculty ofToulouse, France; Dr. Hervé,Laboratory of Medical Ethicsand Public Health, Faculty ofMedicine Paris-Necker, [email protected]

learn whether and when this kind ofreflection arises in dental practice andwhether there might be a possible concensus on various ethical questionsin dentistry. We also wanted to see ifthere were any connections betweenthese matters and current universityeducation in dentistry and the practice oforal health care in the hospital trainingclinic. To this end, we surveyed, by meansof a written survey, the department heads,the students, and some of the teachers of the Faculty of Dentistry of Toulouse.(Toulouse is one of sixteen French dentalschools and is part of the second-largestuniversity in France).

Summary of the StudyThe work was carried out through aninvestigation involving the students ofthe sixth year (which is the final year oftheir dental studies), the university headsof departments, and the dental teachersat the hospital oral health clinic. Thequantitative aspect of the results wasobtained by using a written questionnairewhich made it possible to obtain a largenumber of responses.

The following results were foundwith regard to students:• Fifty-one questionnaires were collected

from a group of sixty students, 85%responded.

• A very large positive majority answeredthe question: “Does the teaching ofethics seem desirable to you”? 88%for, 8% against, 4% without opinion.

• Positive answers to the question “Dothe following sets of themes concernethical issues”? are expressed as percentages in Table 1.

The following results were foundwith regard to teachers:• The responses collected did not differ

significantly between the heads ofdepartment responsible for universityeducation and the hospital clinicteachers. For simplicity, only theanswers the hospital-clinic faculty are presented here centre. These consist of responses from seventeenclinic faculty.

• Eighty-eight percent of the respon-dents are favorable to the teaching of ethics.

• The attempts to define ethics are similar to the students’ efforts.

• Positive answers to the question “Do the following sets of themes concern ethical questioning”? areexpressed as percentages in Table 1.

DiscussionThere seems to be a very broad consensusin favor of the development of a universityprogram focused on ethical reflection in dentistry. There were, however, nosuggestions for how to structure it. Thequestion of the legitimacy of the teachersin charge of this mission was posed, butno suggestions were made about how to address it.

The absence of teaching or continuoustraining on the topic of ethics undoubtedlyexplains the hesitations and confusionsencountered in the respondents’ attempts

to define ethics. However, there were nopoints missing from the proposals of thestudents compared with those of theteachers; in fact, some of the students’responses were more informative. Itappears that the few exchanges on ethicalquestions that do take place during various lessons in the dental curriculum(during sessions on medical rights, medical psychology, etc.) interested the students.

The survey also asked respondents toidentify the ethical problems in dentistry.Comparison of answers to this questionleads the authors to these remarks.

Agreement appears on the topics ofinformation and consent. Perhaps thedental profession has an advantage onthis subject compared to other medicalspecialties insofar as the conventionalobligation to provide a financial estimatefor prostheses and other treatments has been a reality in dental practice for

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Many dentists still perceive the formalrequirement of informedconsent as a constraintand not as the pursuit of the ethical ideal of adecision shared betweenthe dentist and his patient.

several years. It is advisable, however, toinsist on the fact that the signed docu-ment only gives an illusion of informedconsent. The way in which the consentis obtained and what the patient under-stands and deliberately consents tocertainly counts as much as the consentform legally, and is ethically moreimportant. In this connection, however,two problems remain, even regardingfinancial matters. Many dentists still perceive the formal requirement ofinformed consent as a constraint andnot as the pursuit of the ethical ideal of adecision shared between the dentist andhis patient. Therefore, continued evalua-tion of the information delivered to thepatient, the quality of comprehension by the patient, and the manner of thiscommunication is needed. Clearly, evenif the informed consent obtained is gen-uine as far as the financial charges for,for example, a prosthesis, is concerned,there still remains an immense amountof work to be done about the consentconcerning all the other types of activitiescarried out in a dentist’s surgery.

A quarter of all people questioneddid not consider the taking into accountof pain as an ethical problem. For some,pain still seems to be only a technicalproblem, solved by treatment. The differences between pain and suffering,physical and psychical, must be carefullystudied and incorporated into dentists’ethical reflections.

Agreement was also general on theethical importance of questions aboutaccess to and exclusion from care.Nevertheless, although the principle andthe benefit of the French “UniversalMedical Coverage” program are widelyaffirmed, some imperfections of the system were inevitably underlined. Somerespondents also noted that these ethicalissues are connected with the questionof the possible duties of the patients.

The survey question relating to ethicalfees yielded conflicting, even negativeopinions. Nevertheless, it seems intimatelyconnected to the preceding question.The question of the ethical justificationof remuneration for practitioners alsodepends on a dialogue with all con-cerned that would include explaining tothe lay participants the complexity ofour work as dentists.

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Table 1: Positive answers to thequestion: “Do the following sets of themes concern ethicalquestioning?”

Students Teachers

Consent 86% 82%

Information 84 82

Human dignity 80 88

Access to /exclusion 78 76from care

Taking pain 74 59into account

Refusal of care 70 53

Quality of the 64 47care given

Law of 4 March 2002 60 53(Kouchner’s Law)

Concept of 54 41medical safety

Concept of 51 29material safety

Question of fees 46 47

Definitions of ethics according to students

Concept of actionto be taken

3% “What is good or not good to do”

3%

Morals of practitioner27%

Set of fixed rules15%

Respect of the person

14%

Conformity withconscience

12%

Various:Respect of the laws;

Humanistic doctrines;Rational attitude;

Concept of principle;Deontology

7%

Guide the behavior5%

“Commanded by morals, recommended by ethics”

5%

Agreement with the current data of science

5%

Concept of values4%

The question relating to the dignityand respect of the person demonstrateda consensus. But, with regard to the definition of ethics, there was a lack ofprecision in respondents’ answers on the meaning of the concept.

Varied answers were obtained on thespecifically ethical important of threeother points: quality of care, proceduralsafety and safety of materials. Especiallyon the first point, respondents identifieda link with the matter of fees, not onlyas a technical matter, but also from anethical perspective.

Other ethical issues relevant to dentalpractice did not appear in the results of the survey. But the authors proposethat the following issues neverthelessdeserve to be addressed. The marketingauthorizations of the biomaterials usedin dentistry constitute an important ethical subject in themselves. There arealso ethical questions related to the consent of patients when such a productis being used by a dentist for the first time(independently of the issue of informedconsent, etc., in formal research), espe-cially with the diversity of the productscurrently available to dentists.

Oral implant surgery has beenexpanding rapidly in France in recentyears. This technique makes it possible toavoid resorting to removable prostheses,which are often badly perceived bypatients. The cost is relatively high andthe amount covered by health insuranceis nil. One teacher mentioned his embarrassment at the idea that the hospital’s dental clinic was not able tooffer such treatment for patients whowere sometimes young and often sociallydisadvantaged as well.

The obligation for continuing educa-tion is now in place in our profession.But it is still common to hear some practitioners say that it is better to usean older but well-mastered technique

rather than a recent poorly assimilatedone! Who does that favor: the reassuredpractitioner or the patient who does notreceive the technically most recent care?The principle of equity towards ourpatients clearly raises a serious ethicalquestion about such a view.

As genetics moves forward, ourpatients’ susceptibility to certain diseaseswith oral repercussions is likely tobecome a source of difficult ethical questions. The impact of our actions on the environment and its protectioncertainly constitutes an ethical questionfor dentistry. Proper disposal of wasteproducts (heavy metals in particular)has been become a matter for ethicalconsideration in recent years; but manyother environmental issues (ionizingradiations, for example) deserve carefulethical consideration.

ConclusionDental ethics has a rightful place withinthe general field of ethics. Medical ethicsdoes not constitute a separated entityfrom the practice of medicine. The same follows when applied to dentistry.Dental practice is characterized by a veryparticular bond between human beingsthat is structured around the problem ofsuffering. Thus, training in professionalethics can lead health professionals froma dissymmetric relation to their patientstowards more reciprocity and exchanges.

Certainly, one objective of the university, and therefore of the State that supports the university, is to traintechnically qualified practitioners capableof caring for the population with thegreatest possible efficiency. This must bea goal, especially when most dental professionals will be in independentpractice, out of the public institutions,for the university that trains them. Thequality of the meticulous work carriedout by dentists is dependent on the moti-vation of those who perform it and thismotivation depends on the development

of the dentist’s self-esteem as a healthprofessional. The presentation of the ethical objective to students, togetherwith a caring attitude towards the otherperson, is a very much needed part of thedental curriculum. Moreover, the educationof dental surgeons as citizens, consciousthat the institution has trained them isan institution of the public that entruststhem with a mission of public health,constitutes a priority for dental schools.

This objective will not be achievedwithout a global view of the only subjectof fundamental importance with whichthe practitioner is faced, namely the per-son and not just the mouth. Awarenessof the social sciences, relevant aspects of psychology, and dental ethics, is thecondition for this.

The survey reported on here hasdemonstrated that the demand for anintroduction to dental ethics, if not spontaneous, is nevertheless real and issomething supported by both studentsand teachers. To this end, the authorspropose to support and develop ethicalreflection with determination within thediscipline of dentistry. The next step is to define, in cooperation with our teaching colleagues and dentists in practice outside the academy, all that isat stake in the ethics of dental practice.■

ReferencesBéry A. (1996). L’exercice libéral de l’odon-tologie; aspects éthiques et juridiques.Thèse pour le Doctorat de l’Université ParisV, mention éthique médicale, Paris.Hervé, C. (1998). L’enseignement et larecherche en éthique médicale. Ethica, 10,1-11.Hervé, C., & Canoui. P. (1993). Plaidoyerpour un enseignement de l’éthique aux pro-fessions de santé. Revue de psychologiede la motivation.

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David W. Chambers, EdM, MBA, PhD, FACD

AbstractCompetition that is characterized by rules, often informal, agreed among mutuallyaccepted participants, and that gives thecompetitors a special, advantageous statuswith others is called friendly competition.Dentists have engaged in it deeply and it is good for the profession. Friendly competition offers the advantages ofspillover of commonly useful informationand technologies, stimulation of innovation,a united and convenient face to customersand suppliers, and standards that promotegrowth. Friendly competition increases thesize of the pie, regardless of market share.Paradoxically, this is even true for the littleguy in the shadow of the giant. If carried to extremes, unfriendly competition leadsto destroying competitors, the confusion of multiple rules, and encouragement ofdisruptive change.

The growing commercialization ofAmerica, and with it all professions,is uncovering some paradoxes.

Among the more interesting is the oxy-moron “friendly competition.” This willobviously be governed by the “rules ofwar” and “regulated free market activity.”The Olympic Games are the oldest exam-ple that pops into mind. And they were apungent blend of rest periods in the pat-tern of internecine strife and individualglory mixed with bribery and scandal.

Why are the great diamond housesof Philadelphia huddled together withina few hundred feet along Sansom Street?The best shopping in London has alwaysbeen on Bond Street. Silicon Valley is asynonym for high tech. Wall Streetmeans financial institutions and MadisonAvenue means advertising. (That we stillbelieve this despite the virtual absence of ad companies on Madison Avenuespeaks to the power of the concept ofconcentrated competition). Cooperativecompetition, concentration of competi-tors, conspicuously resembling thoseseeking the same customers—in a word,“friendly competition”—is the norm andnot the exception.

It may not be easy to give a concisedefinition of friendly competition, butthere are certainly common characteris-tics that typify it. As these characteristicare mentioned, I will give examples from dentistry, since all professions arecomposed of friendly competitors.

Informal Rules Some competitive practices are accept-able and others are not. Cabs can pickup fares on the street; livery services canonly be engaged by prior arrangement.In most cities, the rules about territoryfor taxies, street vendors, and unionactivity are clear and strongly enforced.Dentists are expected to compete basedon their personalities, the attractivenessof their office and their staff, location,technical quality, and the profile of services offered. It is frowned upon tocompete on price, promised outcomes,or by disparaging colleagues’ work. It is legally actionable to compete basedon certain manipulations of insurancecontracts or by performing substandardwork, even if undetected by the public.Often the rules of competition are explicit. There is a manual for scoringcompetitive figure skating (which maycome as a surprise to some). There areunion contracts, practice acts, and codesof ethics. In the professions, ethics codeswere first known as “code of professionaletiquette,” acknowledging the fact thatthey spoke primarily to relationshipsamong professionals and not to profes-sional obligations to patients.

Regardless of what might be in print,the rules of friendly competition cannever be made completely explicit. Therewill always be a personal and unspoken(unspeakable) understanding of what is expected. That is why it is critical toparticipate in organized dentistry. This is also a source of concern over constraint of traded. The Federal TradeCommission sued the California Dental

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Association in the 1990s over the CDA’sassertion that its members aspire to highstandards. It required years of litigationand the U.S. Supreme Court to affirmthe principle that there are valid rules of friendly competition that cannot bemade entirely explicit.

MembershipCompetition generally is open to all comers in the public interest, especiallyin the United States. The limitations that are set on free-for-all competitionconcern the relationships between competitors and customers. Friendlycompetition takes place with voluntarycollaboratives such as the trade associa-tions for agricultural or manufacturinggroups, collaboratives of universities that vie for the same pools of applicants,groups of community organizations that jostle for limited funding to deliveryservices to the same underserved andprofessional groups.

Formal membership in groups thatpromote friendly competition is based onlegal status and rigorous qualificationsand on agreement to abide by writtenrules and codes. Actual membership lists exist. In reality, the boundaries arevague and porous. They can best beunderstood by observing the pattern ofinformation and interaction. Those that break or bend the rules of friendlycompetition find themselves on the edge.They do not hear about the new oppor-tunities until they become publiclyknown; they are not invited to partici-

pate in the good deals. In dentistry,those who compete in an unfriendlyfashion get few referrals, are kept outsidethe informal channels where new materials and regulations are discussed,and are not invited to the policy table.

Concentration In friendly competition, there may beskirmishing for who gets the soft seatsor how sits in the bow of the boat, butthere is also a clear understanding thatall will take their turns at rowing andwill bail like mad if the water gets toochoppy. It is understood that a rising tide benefits all.

Friendly competitors congregatebecause they recognize that they canwin by getting a relatively bigger piece ofpie or by making the pie bigger for allcompetitors. The Magnificent Mile forshopping in Chicago and a ProfessionalPlaza in Anywhere, America, achieve apresence in the public’s mind that scat-tered individuals cannot. Concentrationhas the further advantage of enhancingintergroup competitive position. Dentistsdo not so much compete with each otherfor the few hundred dollars they are paidper family as they do with appliancestores, vacations, saloons, and sportingevents. Dentists do not so much hassleover regulations and acceptable practiceswith each other as they do with stateand federal agencies, consumer advocacygroups, and the uninformed public.

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Leadership

Concentration amongfriendly competitors isgrounded in the belief that there is substantialbenefit to coordinatedcompetition between united members of thegroup in their dealingswith other groups.

Concentration among friendly competitorsis grounded in the belief that there is sub-stantial benefit to coordinated competitionbetween united members of the group intheir dealings with other groups.

Friendly Competition with GorillasMy father gave me good advice aboutlearning to play basketball. He suggestedthat when I went to the YMCA to get into a pickup game, I should first watchthe general level of competition in thevarious games that were going on simul-taneously. He said if I wanted to havefun I should pick a game where the general talent level was almost as goodas my own. On the other hand, if I wanted to get better I needed to get intogames where the play was on a littlehigher level than my own. Does anyoneremember the laughing predictionswhen it was announced that the AFCwas going to play the established, “muchstronger” NFC in the Superbowl? Overtime, we all compete at the general levelof the league we play in. Prudence sug-gests that we compete with the best.

But what about extremes? Who cancompete with Wal-Mart? It is undeniablethat Wal-Mart has reorganized muchmore than the merchandizing of commodities in America. More than 90% of Americans have shopped Wal-Mart in the past twelve months. On food alone, the typical American who shops there saves 15% per year. Thepresence of a Wal-Mart also stimulates

savings generally. If there is a Wal-Martin town, but you do not buy food there,you save 10% on your annual food billcompared to your counterpart who livesin a town without a Wal-Mart—but thereare not many of those. Ninety percent ofAmericans live within fifteen miles of aWal-Mart store, and the companyemploys 1.8 million Americans.

But the effect is greater. Wal-Marthas stimulated innovation in manufac-turing, transportation, and inventorycontrol. It has certainly put some firmsout of business. But research shows that it is not all bad for competitors.When small players engage in friendlycompetition with giants they actually dobetter than previously if they are locatednear the competitive goliath and if theyoffer a differentiated product. WholeFoods and other upscale gourmet markets are thriving in the shadow ofWal-Mart. Anybody—tire stores, stationers,and dentists—does better when locatednear a major draw. That is why radiologyservices, testing laboratories, and medicalequipment rental organizations are foundnear hospitals. The support servicesthese organizations provide explains why,thinking in the other direction, there areentire buildings devoted to medical anddental services in most large cities.

Rewards of Friendly CompetitionWhy is there so much more high-qualitycomputer software for the Microsoft format than for the Mac (Mac only excelsin the tight market for professionalgrade graphics)? Why is open-sourcesoftware such as Java worrying

Microsoft? Why are Americans betterinformed about the workings of our government than almost any othercountry? Why are we overweight? Whyare our universities better than ourgrade schools? Why is American dentistrythe best in the world? The answer in eachcase is a robust system of friendly com-petition. It benefits customers, suppliers,the public, and the competitors.

SpilloverSome knowledge is transferred formally,as in schools or at CE courses. Muchknowledge is passed informally, by con-tact. This is what my father had in mindwhen he urged that I play with basketballplayers who were better than I ratherthan reading books about basketball. We learn as we play and the more weplay, the more we learn. Innovationsspread most quickly in informal networks(even faster than in formal ones). This is why the hallways and not the lecturerooms at state scientific sessions are thehot places. It is also why dentists whopractice in isolation are least likely to beup to date on techniques that work,things to avoid, market and regulatorytrends, and reliable information aboutunfolding political events. There is noeffective formal system for furnishingthis information to them.

In the technology literature, this isknown as the spillover effect. The valuableknowledge and precautions are higheramong organizations that interact (andcompete) than among isolated similar

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organizations. This can only beexplained by assuming that benefits spillover and become generally available toall who are close enough to catch it.Lawyers and bail bondsmen congregatein county seats and state capitals andthey add to what the legislators canaccomplish (I guess). High tech concen-trates around major universities in theSilicon Valley, Route 128 near Boston,and outside Seattle. They are there forthe spillover.

InnovationPersonally, I believe the best dental practices are disproportionately grouppractices. That environment encouragesdiscussion concerns, rapid sharing ofideas, consideration of alternatives, andcompetition against standards. All of this leads to innovation. Good enoughcannot long hide from public scrutiny, and the scrutiny of one’s peers is bothknowledgeable and apt to be stimulating.Study clubs have served the same function of driving innovation in anatmosphere of supportive competition.

Protected, anticompetitive marketsdampen innovation as any dentistknows who lives where he or she canonly receive service from one vendor fordental supplies or for the family car.Perhaps the young dentists who are tryingto shoulder their way into already satu-rated suburban markets while avoidingthe rural and urban markets knowsomething. The management literatureon high-end start-up firms demonstratesthat they have a better chance of survivalin a highly competitive market than inan underserved one. The reason is that

competition forces the innovations thatlead to strength. Market share is a smallissue compared to market viability.

Customers and Suppliers Dentists are not alone in confusing pricewith cost. The fee for a crown is only partof what it sets a patient back to get thatcare. There is lost work, transportation,child care, and a welter of psychologicalfactors. In some urban areas, the cost of parking is approaching the cost of aprophy. When patients can cluster theirhealth behaviors, they become lessdaunting, and the patients are more likely to become engaged. Think for aminute how tempting it is to put offshopping for a new lawn mower if thereare four stores in town and they are asfar away from each other as they can be.All four stores will do better togetherbecause customers are more likely tocome out.

The same is true of suppliers. In fact, that is why Microsoft whips Mac.Microsoft gives away the knowledge ofits operating system to vendors whowrite software and Mac keeps it to itself.More software for you and me to choosefrom; more computers (by far) that runon Microsoft. If dentistry appears to be asomewhat homogeneous and accessiblemarket to manufacturers and suppliers,it will receive better support.

StandardsCompetition promotes uniformity. Notonly is there less difference between thebest and the worst when they are in an

environment of friendly competition,there is better agreement on acceptableapproaches and what constitutes goodoutcomes. Reasonable uniformity isessential for driving out the uncertaintyof economic risk. Patients know enoughto stay away from procedures that havenot been standardized. (Remember theSony Beta versus VHS videotape wars.)Suppliers are unwilling to invest in serving markets that are segmented. The ADA even has a council that addressesissues of standards, although progresshas been slowed by fear of the insuranceindustry.

While there are dangers in commonstandards, the benefits should not beoverlooked. Standards that are known ina field protect individuals and organiza-tions by making known which practicesare acceptable. This reduces guessingand surprise and offers some protectionagainst arbitrary charges of substandardperformance. Standards also speed thediffusion of innovation. It is easier to

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Good enough cannotlong hide in publicscrutiny, and the scrutinyof one’s peers is bothknowledgeable and aptto be stimulating.

distributed knowledge and productivitydo not make the world flat or evenhomogeneous. The evidence is actuallyto the contrary; the work is becomingspiky. Two-thirds of the world’s patentsstill go to the U.S. and Japan. Capital,both financial and intellectual, congre-gates at an increasing rate in about eightcenters in the U.S. Fewer people makemore important decisions. Even in India,the call centers are not uniformly distrib-uted; they are concentrated in Bangalore.

I am not betting on massively distributed, impersonal, pure competition.The friendly type of competition—completewith its personal understandings that willforever defy electronic capture, concentra-tion of resources, and a delicate balance ofinnovation and standardization—appearsto hold a more promising future.

Unfriendly CompetitionThere are a few things to look out for.Each of the three defining characteristicsof friendly competition can be carried toexcess, with consequent negative effect.The railroads established high standardsthat they all abided by for numbers ofemployees required for each task (inorder to “protect the public”). That droveup costs and prevented adaptation to achanging environment. That is a risk allprofessions face. When membership ismade too restrictive, friendly competitionsuffers. The American Medical Associationnow represents about 30% of physiciansand cannot speak with a clear voice topublic issues. Kicking out any memberwho is swimming against the norm is, atsome level, self-defeating. Once outside

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recognize an improvement where there are common ways of taking aboutperformance, common methods to comparing outcomes, and less variationamong claimed results.

Generally, dentists who avoid friendlycompetition with each other open them-selves to greater risk in their involvementoutside the profession. They are less likelyto understand both the formal standardsand the informal ones (such as the standard of care). What is more, theytake a pass on the opportunity to have ahand in crafting standards they prefer.

The Earth Is Not FlatThomas L. Friedman’s brilliant 2005 bestseller affirms that it is. Freidman’s argu-ment is that electronic communicationhas enabled globalization on such ascale that universal competition isinescapable. When we call with questionsabout a malfunctioning panarex, thevoice on the other end may be inBangalore, India, or rural Utah. Themachine was made with parts from sixdifferent countries, but probably notJapan or the United States where thecompany is headquartered. We will beinstructed to ship part of the machine byFedEx for repair. Although the bill comesfrom the manufacturer, none of theiremployees have touched it. Contracttechnicians working on the FedEx airhub in Memphis, Tennessee, actuallyperform the repairs.

Many experts think Friedman iswrong. Greater interconnectivity and

Perhaps the young dentists who are trying to shoulder their wayinto already saturated

suburban markets whileavoiding the rural andurban markets know something. The manage-ment literature on high-end start-up firmsdemonstrates that theyhave a better chance ofsurvival in a highly competitive market than in an underserved one.

the group, deviants both resent the waythey were handled and no longer recog-nize the power of the group to sanctionthem. Concentration of resources canalso be exaggerated to the point whereinnovation is stifled and new recruits nolonger feel welcome.

Defeating versus DestroyingFriendly competition honors winningthe game at the same time it repudiatesdamaging one’s competitor. Dentists tryto work this distinction in offering neededdental care to patients whose formerdentist appears to have negligent whileavoiding disparaging the previous dentist.Good sportsmanship requires giving theother guy a chance and avoiding anyaction that will damage a competitor’scapacity to continue effective competition.This means not taking unfair advantagewhen others are down, not destroyingtheir capacity for future work, and notimpugning their reputations.

Friendly competitors want to win the round but not end the game. Thegoal of the board game Monopoly is notto knock out the opponents. If that weredone at the beginning of the game, thewinner would only have the resourcesdealt when the game began and a littlemore. By continuing to play manyrounds, everyone succeeds since thebank adds to the game $200 every timeany player passes “go.” In dentistry, it is participation in the profession thatmatters, not appearing to make morethan one’s colleagues.

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The Amazing Mississippi Riverboat Pilot Monopoly

Riverboat pilots on the Mississippi were highly trained, contentious men,who steered the steamers the entire up-river or down-river passage of anever-changing and sometimes dangerous journey. Membership in the clubwas managed loosely by the pilots themselves through an apprenticeshipsystem. Throughout much of the 1850s, pilots earned a princely$250/month. As river traffic, especially the glamour trade increased, thepilots saw an opportunity. They formed and association, entirely voluntary,with a few rules such as a $15 initiation fee, prepaid funerals and relief for widows, prohibition against working with non-association partners (all riverboats had two pilots), and a common wage initially set at $400 amonth and eventually reaching about four times that amount. They alsoestablished a written system for sharing up-to-date information about the condition of the river that was shared among association members but not among others.

At first, only the poor quality and unemployed pilots joined and they got no work. That would have been the way it remained except for the factthat the market was rapidly expanding. (A boom market does not alwaysfavor various forms of friendly competition.) Because the apprenticeshipsystem had purposefully kept the number of pilots low and demand wasquickly exceeding supply, captains had no alternative but to replace non-association pilots with pairs of association pilots. Because of the safety information sharing system developed by the association pilots,there were fewer accidents with association pilots, and eventually theinsurance companies refused to underwrite riverboats with non-associationpilots. All pilots joined, salaries soared, increases were passed through to farmers and travelers, and friendly competition for the best positionsturned into joyous competition.

The whole system collapsed within about a year. Someone figured out thatfreight could be taken down the Mississippi on cheap rafts guided by tugs(little freight went up) and passengers came to prefer the faster, lessexpensive, and more direct and flexible train. The Civil War shipwreckedwhat was left of the pilots’ glory.

Multiple GamesWe participate in many games at thesame time. Some run the marathon forthe fastest time (or at least for a time fastenough to satisfy corporate sponsors).Some are trying for a personal best.Others just want to finish. Many arethrilled to be there and be noticed.Friendly competition allows for multiplerules in a single game. It is a strength in a profession such as dentistry thatthere are multiple standards for success(laying aside, of course, irreducible minimal standards for being in thegame). Thank goodness the specialist,the director of a clinic on an Indianreservation, the small-town dentist andthe downtown dentist, the practitionerwho is driven to show a slide of a brillianteight-unit reconstruction, and the

practitioner who puts back together aravaged mouth as well as possible withouthope of adequate compensation can allbe part of dentistry.

What is unacceptable in friendlycompetition is to play by private rules orto damage others’ chances for success bydoing things the group as a whole wouldnot approve of. That is called cheating.Cheats do not stay out of the game asthey play, but they expect to use privaterules that favor them.

The Problem of ChangeFriendly competition is conflicted overthe matter of innovation. The character-istics of concentration (standards,progress, and access to customers andsuppliers) and membership provide context that promotes innovation. When

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Abuses of the Rules of Friendly Competition

Cheating

Free ride

Selective application

Bundling

Partial monopoly

Attempting to gain advantage by actions that are against the rules while disguising the act and hoping not to get caught

Claiming the benefits of group membershipwithout accepting the responsibilities

Using a subset of rules that favors oneself ordisadvantages others

Grouping common, high profit tasks with rarespecialized ones

Excluding other providers for whole marketbut only serving part of it

Overtreating; practicing without a license

Advertising as an unrecognized specialty;avoiding organized dentistry

Upcoding insurance claims

Preventing auxiliaries from offering partial services

Practices that exclude classes of patients

professionals gather at state and otherassociation meetings they celebratewhat is new and promising, and thepride is personal as well as attached tothe innovator. At the same time, friendlycompetitors close ranks quickly againstsome kinds of changes. Don’t expect, forexample, the car industry to come outwith a truly fuel efficient and long lastingautomobile anytime soon. And look formore features you don’t use on your laptopbefore you see any dramatic increases inreliability or reductions in cost.

The seeming paradox can be unraveledby distinguishing between incrementalinnovation and disruptive innovation.Friendly competition is designed to promote enhancements within a market;not to create new markets. Potentialinnovations will be embraced, more orless, as they are seen as offering potentialto the majority of those already in thefriendly competition group. If they arerecognized as creating new rules of com-petition, this signals that new playerswill gain advantage.

The movie industry wants higherdefinition in visuals and sound toenhance the theater experience, but notminiaturization that would vastly extendentertainment. Where did the publicphone booth go, or the travel agent?What about the independent pharmacist?Friendly competition is about gradualexpansions of the market using betterexamples of existing technology. Muchattention goes into deciding whichforms of competition are acceptable andwhich should be forbidden. The use of

auxiliaries in dentistry (embraced inorthodontists’ offices and nursinghomes and reviled in other contexts) is less a matter of health benefit thanmarket integrity.

Competition is GoodDentistry understands friendly competi-tion and performs well under its sway.Friendly competition has been good forthe profession in terms of promotingreasonable innovation, raising the standards of oral health, ensuring astrong form of self-regulation, and elevating the dignity of the profession in the eyes of the public and patients.This is a legacy that organized dentistryand the honoraries such as theAmerican College of Dentists haveworked hard to build, and it should notbe allowed to erode or molder throughill-advised action or neglect.

That said, there are other forms ofcompetition that must be understoodand mastered. There are three issuesthat will define the future of the profes-sion over the next quarter century. Thecurrent generation of leadership willhave a hand in framing the debate, butthose just entering practice now will bethe decision makers. These issues are therole that the new biology will play indental care delivery, access, and com-mercialism. I confidently predict that allthree issues are outside the realm offriendly competition. ■

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Generally, dentists who avoid friendly competition with each other open themselves to greater risk in their involvement outside the profession.

Recommended Reading

Summaries are available for the threerecommended readings marked byasterisks. Each is about eight pageslong and conveys both the tone andcontent of the original source throughextensive quotations. These summariesare designed for busy readers whowant the essence of these references infifteen minutes rather than five hours.Summaries are available from theACD Executive Offices in Gaithersburg.A donation to the ACD Foundation of$15 is suggested for the set of summarieson friendly competition; a donation of$50 would bring you summaries forall the 2006 leadership topics.

Florida, Richard (2005). The world is spiky.The Atlantic Monthly, October, 48-51.

The counter argument to Thomas L.Friedman’s The World is Flat. Floridamakes a strong case that friendly industrycompetition leads to concentration ofsimilar firms, that this concentration isaccelerating, and that it has economicbenefits, both locally and globally.

Kohn, Alfie (1986). No Contest: The Case AgainstCompetition.*Boston, MA: Houghton Mifflin. ISBN 0-395-63125-4; 235 pages; about $12.

Competition is defined as participation is activities where one or a few succeedat the expense of others. Social scienceevidence and logical argument are used to show that competition reducesproductivity and enjoyment, causes overall loss of self-esteem, and poisonsour relationships with others. It is arguedthat competition is not an inevitablemanifestation of human nature, but asocial construct and an individual habitlearned through social reward.

Mayer, Kyle J. (2006). Spillovers and governance: an analysis of knowledge and reputation spillovers in information technology.Academy of Management Journal,49 (1), 69-84.

Although knowledge spillover (availabilityof useful information about the industryto competitive organizations in closegeographic proximity or with whomthere are frequent interactions) benefitsmembers of an industry or group ororganizations generally, different kindsof potential spillover are managed differ-ently. Formal relations (licenses andcontracts) dominate where spillovercould be widely beneficial. When reputa-tion is involved [as in the professions],there is pressure to avoid subcontractorsand seek to extent control of employeeswho might learn valuable information.

Porter, Michael E. (1980). Competitive Strategy: Techniques for AnalyzingIndustries and Competitors.*New York: The Free Press. ISBN 0-02-925360-8; 395 pages; about $35.

A true classic. Many MBA students arefamiliar with the seminal concepts of

generic competitive strategies, industrylife-cycles, buyer selection and strategicgroups without realizing that one manintroduced them together in a singlebook. The outline structure of the text is easy to follow and the writing is crystal clear. This is a combination ofeconomics, marketing, and businessstrategy. It explains how firms work. The book is packed with a wealth ofmaterial and the examples tend to bebrief, so a basic familiarity with businessis helpful. Porter is a professor at theHarvard School of Business and a leading consultant.

Porter, Michael E. (1998). On Competition.*Boston, MA: Harvard Business SchoolBook. ISBN 0-87584-795-1; 485 pages;about $40.

“The performance of any company in a business can be divided into two parts:the first attributable to the average performance of all competitors in itsindustry and the second to whether thecompany is an above- or below-averageperformed in its industry” Porter makesa strong argument for the advantage of industry cooperation andgeographic concentration. He also presents an unusual case that govern-ment efforts directed toward urbanrevitalization are self-defeating andrenewal can only be achieved by an economic engine.

Twain, Mark. (1911).Life on the Mississippi. New York: Harper & Brothers.

The story about the botched attempt ofriverboat pilots to create a monopoly.

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