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Mnging Scl Cnflct c and Alt Med Rec Antineoplastons

Mnging Scl Cnflct c and Alt Med Rec Antineoplastons

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Published by: Andrew McLeod on Nov 26, 2011
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Integrative Cancer Therapies
 http://ict.sagepub.com/content/3/1/59The online version of this article can be found at:DOI: 10.1177/15347354042634482004 3: 59
Integr Cancer Ther 
Mitchell R. Hammer and Wayne B. Jonas
Managing Social Conflict in Complementary and Alternative Medicine Research: The Case of Antineoplastons
Published by: 
can be found at:
Integrative Cancer Therapies 
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at Cranfield University on November 26, 2011ict.sagepub.comDownloaded from 
10.1177/1534735404263448Hammer,JonasConflictManagementin Research
Mitchell R.Hammer,PhD,and Wayne B.Jonas,MD
From December 1991 to December 1995, the National Can-cer Institute (NCI) initiated phase II clinical trials of A10and AS2-1 (antineoplastons) infusions in patients with diag-nosedprimarymalignantbraintumors.Fouryearsandmorethan a million dollars later, these studies were stopped be-fore it was possible to determine the effectiveness of antineoplastons.BothNCIandDrBurzynski,thedeveloperof antineoplastons, accused one another of attempting toundermine the project. In an effort to determine why thisstudyfailedtobecompleted,thedirectoroftheNationalIn-stitutes of Health Office of Alternative Medicine (OAM), who sponsored the study, commissioned a detailed analysisoftheconflictsthatledtothestudy’sclosure.Theintentwasto understand the social dynamics surrounding this failedstudy and to develop a method for managing and possibly  preventing such failures in the future. This clinical trial wasextremely complex and comprehensive. It involved hun-dreds of memoranda, letters, and telephone and fax corre-spondence among a wide number of parties over a 4-year period. All correspondence and other documents from theOAM as well as documentation from NCI were thoroughly examined. In addition, in-depth interviews with key individ-uals involved in the antineoplaston study were completedand incorporated into the analysis. At least 10 areas of con-flictemergedfromtheanalysisincludingissuesaroundpro-duction, quality, and delivery of antineoplastons;commencement of the trial; the role of Dr Burzynski in thetrial; types and combinations of cancers; choice of clinicalinvestigators; need for communication; criteria for patient selectionandtreatment;andevaluation.Eachoftheseissuesclearly represented a difference of opinion between the 2main parties around scientific protocols. Yet contentionaround these substantive, “scientific” disagreementsreflected conflict in attunement (trust, power, and affilia-tion) between Dr Burzynski and NCI. This article summar-izes the findings from this case study.
Keywords: antineoplastons; cancer; controversies in science; social management of science; conflict management 
In this issue,
Integrative Cancer Therapies 
publishes anupdate from several case series of the controversialcancer treatment called antineoplastons, reported by Dr Stanislaw Burzynski. As in the past reports by Dr Burzynski, this report claims remarkable resultsfrom antineoplastons in hundreds of individuals withaggressive and advanced cancers. It is a sad commen-tary on our scientific community that it is now morethan a decade since the National Cancer Institute(NCI)attemptedtovalidatetheclaimsofDrBurzynski withoutsuccessfullycompleting thestudyorresolvingthe issue of its efficacy. And thus, we still ask the ques-tion: Are these effects real?This current update by Dr Burzynski may feed thefire of controversy, but it will not help patientsfaced with critical decisions who have cancer. If Dr Burzynski’s claims are true, we continue to failthousands of patients by not verifying these claimsand, if valid, using this therapy. If these claims are not true, we are subjecting hundreds of other patients totheanxiety,costs,andpossiblyneglectbynotknowingiftheyaremakinggoodchoicesbytakingthistherapy. We are focused on why NCI’s attempts to verify Dr Burzynski’s claims failed. And why have they andothers such as the National Center for Complemen-tary and Alternative Medicine (NCCAM) not madefurther attempts to independently investigate theseclaims? Itis our belief thatthe reasons have to do withhow controversy in science is managed and how thesocial aspects of science can undermine the goals of science in controversial areas.Controversy in science is ubiquitous, and for con-cepts included within the socially acceptable bound-aries of debate, it is resolved through discussion,debate, publication, peer review, and funding deci-sions by those who manage scientific knowledge. Forconcepts that lie outside those boundaries, conven-
Conflict Management in Research
3(1); 2004pp.
MRH is at the International Peace and Conflict Resolution Pro-gram, School of International Service, American University, Wash-ington,D.C.WBJisattheSamueli InstituteforInformation Biology,Alexandria, Virginia.
Wayne B. Jonas, MD, Director, Samueli Insti-tute for Information Biology, 1700 Diagonal Road, Suite 400, Alex-andria, VA 22314.E-mail: wjonas@siib.org.
DOI: 10.1177/1534735404263448
 at Cranfield University on November 26, 2011ict.sagepub.comDownloaded from 
tionalscienceandmedicineusuallyhandlecontrover-sies by ignoring them or restricting discussion in con-ferences, allowing publication only of certainperspectives and limiting research resources in thoseareas. Until recently, the area of complementary andalternativemedicine (CAM)wasoutsidethesebound-aries. With the creation of the NCCAM and its prede-cessor, the Office of Alternative Medicine (OAM), anattempthasbeenmadetobringCAMintotheprocessof mainstream science.However, many areas of CAM remain too contro- versial to address, even by those agencies designatedto investigate them. Part of the reason these areas arenot investigated is that those agencies have not devel-oped systems for the management of social conflict inscience.Failuretoproperlymanagethesocialconflict inCAMresearchcanundermineattemptsatresearch-ing CAM therapies. This is especially prominent foralternative cancer treatments in which emotions andclaims run high. In this article, we summarize a de-tailed investigation into the conflict that underminedthe NCI attempt to verify Dr Burzynski’s claims anddiscusshowsuchfailurestomanagethesocialprocessin controversial areas might be addressed in thefuture.From December 1991 to December 1995, NCI ini-tiated phase II clinical trials of A10 and AS2-1(antineoplastons) infusions in patients with diag-nosed primary malignant brain tumors. This effort  was undertaken with the cooperation of the OAM at the National Institutes of Health (NIH) andDr Stanislaw Burzynski, the developer of the anti-neoplaston treatment. The effort at research on anti-neoplastons occurred after numerous case reports of successful treatment of several cancer types by Dr Burzynski. A team from NCI and OAM traveled toDrBurzynski’sclinicinHouston,Texas,andevaluatedseveral dozen records for accuracy of diagnosis, typeof treatment, and patient response. Members of thisteam felt there was sufficient preliminary evidencefromthesecasestowarrantaformalprospective study of the safety and efficacy of antineoplastons in 2 typesof aggressive cancer, glioblastoma and astrocytoma.These studies were developed with Dr Burzynski as aconsultantandinitiated attheMayo Clinic andSloan-Kettering Cancer Center in New York. Four yearsand almost a million dollars later, these studies werestopped before it was possible to determine the ef-fectiveness of antineoplastons. Both NCI andDr Buryzinski accused the other of attempting toundermine the project.Inanefforttodetermine whythisstudyfailed tobecompleted, the OAM director (W.B.J.)commissionedthe first author of this article to perform a detailedinvestigation of the conflict dynamics that led to theclosure ofthestudy.Thegoalsweretounderstandthesocial dynamics surrounding this failed study and todevelop amethodformanagingandpossibly prevent-ing such events in the future. In addition to a detailedstudy of antineoplastons, the OAM organized a seriesof meetings and a report to specifically evaluate anddevelopasystemforthemanagementofsocialconflict in controversial CAM areas. The purpose of that re-portwastosummarize findingsfromthedetailedcasestudycompletedontheantineoplastonclinicaltrial.*This clinical trial was extremely complex and com-prehensive,involvinghundredsofmemos,letters,andtelephone and fax correspondence among a widenumberofpartiesovera4-yearperiod.
 Allcorrespon-dence and other documents from the OAM as well asdocumentationfromNCIwerethoroughlyexamined.In addition, in-depth interviews with key individualsinvolved in the antineoplaston study were completedand incorporated into the analysis.
Social Management:A Conceptual Framework 
Two fundamentalfeaturesofconflictare directly rele- vant to the conduct of research on controversial top-ics. First, conflict involves important incompati-bilities among contending parties.
 As Rubin et alsuggested, conflict involves a “divergence of interest,or a belief that the parties’ current aspirations cannot be achieved simultaneously.”
 A second element of conflict involves perceivedinterference by one or more parties in the goal-seekingcapabilityoftheother.
 AsFisheremphasizes,conflict interference reflects “attempts by the partiestocontrol each other,andantagonisticfeelings by thepartiestowardeachother.”
Perceivedincompatiblegoals coupled with interference comprise 2 coreaspectsofaconflictdynamicthatcanariseinresearchstudiesofcontroversialtopics.Itispreciselythesecon-flict elements that often lead to contentious (win/lose) behavior between parties.
The conceptual framework used in this case study of the antineoplaston clinical trial is best charac-terized as a social management approach that isgrounded in an examination of the functional mean-ingofinteractionthattakesplaceunderconditionsof 
Hammer, Jonas
3(1); 2004
*The analysis and recommendations in this article are not intended to convey assessment as to the legitimacy of anti-neoplastons as a therapy for brain tumors or other cancers.
See M. R. Hammer, Burzynski antineoplaston case study: con-flict issues and recommendations. Office of Alternative Medicinereport, National Institutes of Health, 1996; M. Hammer, The man-agement of dispute and judgment process in controversial comple-mentary and alternative medicine research. Office of AlternativeMedicine Report, National Institutes of Health, 1996.
 at Cranfield University on November 26, 2011ict.sagepub.comDownloaded from 

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