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
INTEGRATIVE CANCER THERAPIES
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: firstname.lastname@example.org.