UnprovenMethodsof CancerManagementDimethylSulfoxide(DMSO)

After careful study of the literature andother information available to it, the American Cancer Society does not have evidence that treatment with dimethylsulfoxide (DMSO), either by itself or combined with laetrile and procaine hydrochloride (KH3). results in objective benefitin the treatment of cancer in human beings.Lacking such evidence, the American Cancer Society would strongly urge individuals afflicted with cancer not to participatein treatment with DMSO.

The following is a summary of information on DMSO in the American CancerSociety files as of June 1. 1982. No implication of agreement by the Society withthe contents of any proponent material isto be construed because of the Society'sreference to it.

BackgroundDimethyl sulfoxide, also known as DMSO,is a by-product of the paper-making industry. and has been used as an industrialsolvent since the 1940s.' Tests of DMSOfor treating human illnesses began in themid-l960s. but were discontinued by voluntary agreement between all sponsoringpharmaceutical firms and the Food andDrug Administration.Thiswas done because of the question of safety. especiallywith regard to eye changes in experimentalanimals.'

Proponents

The principle proponent of DMSO is Mrs.Mildred Miller, owner/Administrator, Degenerative Disease Medical Center (a subsidiary of Health Medical Center, Inc.),1245 Las Vegas Boulevard South, Las Vegas. Nevada 89l04.@ Mrs. Miller is alsoEditor of Preventive Health News, amonthly tabloid that promotes DMSO asa treatment for such diseases as arthritis,mental illness, emphysema, and cancer,and author of a book called, “¿�ALittle DabWill Do Ya!―4=s

ProponentClaimsAccording to an information summarypacket distributed by the DegenerativeDisease Medical Center, in the past twoyears the Center has treated 30 patientswith advanced brain tumors using intravenous and oral laetrile, DMSO. and “¿�metabolic therapy,―which consists of vitamins,enzymes. and coffee retention enemas.They claim that their study indicated thatthe 30 patients are in various stages ofregression.Sixpatientsexhibiteddecreasein size of the tumor to total remission. “¿�Ofthe six patients, two have had completeregressionof cancer.―Thiswas basedonbrain scan results. “¿�Twohave had partialregression based on independent brain scansand two have had prolongation of life.―6

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After an exhaustivesearchof the availablemedical and scientific literature in May1982, the American Cancer Society hasbeen unable to obtain any evidence thatthisstudyhasbeenpublishedtherein.7

The American CancerSocietyhasalsolearned that the “¿�metaboliccancer therapy―developed by Harold Manner, PhD.founding Chairman of the Metabolic Research Foundation. 518 Zenith Drive,Glenview, Illinois 60025. is currentlybeing administered at the DegenerativeDisease Medical Center in conjunctionwith DM50.'

Treatment with DMSO is usually administered intravenously. According to theproponents, it is given initially because ofits solvent activity.@

The rationale for the procedure contends that the cancer patients' immune systems form a shell around the cancer cell.DMSO penetratestheshellandbecomesavehicle for any other medication that isadministered.5 The regimen used to treatcancer patients is laetrile plus “¿�metaboliccancer therapy―and procaine hydrochloride (KH3).―

In additionto itssolventactivity,DMSO has been prescribed to control“¿�withdrawalsymptoms―cancer patientsexperience when taken off conventionalcancer therapy. The substance is administered with intravenous injection on a 24-hour basis.5The book “¿�ALittle Dab WillDo Ya!―describesDMSO asa palliativeand antidepressant when taken by cancerpatients.5

Laetrile is administered orally as wellas intravenously.' Treatment includes“¿�metaboliccancer therapy―(referred toabove).5 Metabolic therapy consists of adetoxification program—various forms offasts and enemas (including coffee enemas) are used to cleanse the body. Enzymes are used in the treatment, as wellas an emulsified form of vitamin A.'

Procainehydrochloride(KH3)isusedin every condition treated at the clinic asan adjunct to the treatment already given.There is no charge for this portion of thetreatment. The substance is mixed with theintravenous injections daily or it can beadministered “¿�intramuscularly,intra-arte

rially, andorally, in tablet form.―Capsulesare also available, but there is a charge iftaken in this form.'

Procaine hydrochloride is used as ananti-aging medication developed by AnnaAslan,M.D.,a physicianandDirectorofthe Institute of Geriatrics in Bucharest,Rumania. It is alsoknown undervarioustradenamessuchas“¿�GH3,Gerovital, or KH3.―It is claimed that when given intravenouslyto cancerpatients, procaine hydrochlorideincreasesthespeedwithwhichtheirpainis relieved.'―

The periodoftreatmentforcanceratthe Center is four weeks.The costof treatmentis$4,000.The patientisgiven,foruseathome,a90-daymaintenancesupplyof enzymes and laetrile for oral administration and “¿�ofcourse the diet.―'2

On January19,1982,theAmericanCancerSociety receiveda letter from Mrs.Millerinwhichsheindicatedthatshewasinterestedin sharing the resultsof “¿�almostthree years of clinical study into chronic,degenerativediseaseswhich include cancer as well asarthritis, cardiovasculardisease,scleroderma,Parkinson'sdisease,andsimilar diseases.―3

The substances used in treatment of thediseases include DMSO, laetrile, and procaine hydrochloride (KH3).'3

Mrs. Miller further stated, “¿�Wedo notdiagnose—onlytreat.―“¿�WehavefoundDMSO with laetrile, and the entire metabolic program extremely effective in braintumors, and some other varieties.―3

In reply to Mrs. Miller's letter, theSociety requested documentation for theresearch that had been conducted. ‘¿�@OnFebruary 16, 1982, the Society receivedtwo paperback books—―ALittle Dab WillDo Ya!―and “¿�KH3—Turnthe Tide withProcaine Hydrochloride.―'4

Evaluation

In 1972,theNationalAcademy of Sciences-NationalResearchCouncilevaluated data available to the Food and DrugAdministration on the use of DMSO inhumans.Only a small numberof scientificreports could be usedas the basis for conclusions on the toxicity and effectiveness

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of DMSO. The NAS/NRC found that evidence on DMSO did not warrant generalapprovalofthedrug,andthatitproduceddeleterioussideeffects, particularly on theskinandeyes.―

In December1981,theAmerican Cancer Society Medical Library conducted asearchof the medical and scientific literature and obtained copies of two clinicalpaperslistedinAnnalsoftheNew YorkAcademy of Sciencesand VestnikDermatologiiI Venerologii.6.7Threescientific paperswere obtained from Annals oftheNew York Academy ofSciencesandCancerTreatmentReports.@-@°

The abovedataweresubmittedtotwoconsultantsforevaluation.Theirindependentconclusionswerethat noevidencehadbeenprovidedthatDMSO hasanticanceractivity against human cancer.222

Litigation

In August 1981, Anson Bilger, on behalfof himself and other Medicare recipients.alongwithMildredMilleroftheDegenerative DiseaseMedical Center and JohnOftendal.M.D. fileda class-actionsuitagainsttheAetnaLifeandCasualtyCompany for its denial of claims for reimbursement under the federal MedicareSupplementary Medical Insurance Benefits program. The requested reimburse

References

mentwas fortreatmentthatinvolvedtheadministrationof DMSO forarthritisorcancer at the Degenerative Disease Medical Center operated by Mildred Miller.Aetna had refusedreimbursementbecausethe U.S. Food and Drug AdministrationhadnotapprovedDMSO forsuchuse.23.24On February8. 1982, the U.S. DistrictCourt for the District of Nevadadismissedthe chargesbrought againstthe Aetna Lifeand Casualty Company.2'

Current Status

In1978theFoodandDrugAdministrationapproveda 50 percentsterileaqueoussolution of DMSO with the trade name of“¿�RIMSO-50―for symptomaticreliefof interstitial cystitis. This concentration is notconsideredstrongenoughto be potentiallyhelpful in dealing with the pain of chronicillnesses.2627Since DMSO is available asanindustrialsolvent(100percentsolution)andisapprovedforveterinaryuseinhorsesanddogs (90 percentsolution). humanpatients and other personscan readily obtainit. .27

Inviewofthelackofdemonstratedeffectiveness,theFDA cautionsthatDMSOshould be restricted to investigational useuntil it can be clearly demonstratedthat itstherapeuticeffects aresufficient to risk thesideeffectsitmay cause.―

1. HHS News Bulletin from the US Dept ofHealthand HumanServices,Foodand DrugAdministration.July25.1980.2.FDA FactSheetfromtheUS DeptofHealth,Education.andWelfare.FoodandDrugAdministration.March,1972.3. LetterfromtheDegenerativeDiseaseMedical Center.August18. 1981.4. DegenerativeDiseaseMedical Center. Preventive Health News, February. 1982.5. Miller M: A Little Dab Will Do Ya!D.M.S.O.:TheDrugofthe80s.QualityAdvertising.pp 1—315.1981.6. Comparative Cancer Therapy—¿�Summary.DegenerativeDiseaseMedical Center. pp 1—3,undated-

7. Bibliography on Dimethyl Sulfoxide, literature search, medical library. American CancerSociety. Inc. 1982.8. Metabolic Research Foundation, information packet. undated.9. Metabolic ResearchFoundation:FactsaboutMetabolic Therapy by Harold W. Manner.Ph.D.. undated.10.Dr.HaroldManner'sTreatment.Preventive Health News. March. 1980.11. Miller M: KH3—Turn the Tide with Procaine Hydrochloride. Quality Advertising. pp1—140.1981.12. Degenerative Disease Medical Center. Preventive Health News. September. 1981.

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oxideintumor-bearingrats.Ann NY AcadSci243:194—208,1975.20.Wood DC. Wood J:Pharmacologicandbiochemicalconsiderationsof dimethylsulfoxide. Ann NY Acad Sci 243:7—19, 1975.21. Dept of Medicine, Downstate MedicalCenter. Brooklyn, New York, personal communication. April 23. 1982.22. Dept of Medicine, Memorial Sloan-Kettering Cancer Center. personal communication,May 15, 1982.23. United States District Court for the Stateof Nevada, summons and complaint. August10, 1981.24. United States District Court, District of Nevada, motion to dismiss. September 2. 1981.25. United States District Court, District of Nevada Pleadings. decision and order, February8, 1982.26. US Food and Drug Administration, personal communication, June 1. 1978.27. Policy Statement on Dimethyl Sulfoxide(D.M.S.O.). Arthritis Foundation, 1980.

13.LetterfromDegenerativeDiseaseMedicalCenter to ACS, January 11, 1982.14. Letter from ACS to Mrs. Mildred Miller,February 26, 1982.15. FDA Consumer Memo on D:M.S.o. fromthe US Deptof Health.Education,and Welfare,Food and Drug Administration,revisedMarch,1980.16. Garrido JC. Lagos RE: Dimethyl sulfoxidetherapy as toxicity-reducing agent and potentiator of cyclophosphamide in the treatment ofdifferent types of cancer. Ann NY Acad Sci243:412—420, 1975.17. KiriyanovIY, et al: The use of colchaminein combination with dimexide for treatmentofskin neoplasias. VestnikDermatologiiI Venerologii 10:59—61,1980.18. FischerJJ, et al: Effect of the radioprotective drugs MEA, D.M.S.O.. and WR-2721 ontumorcontrolandskintoleranceintherat.CancerTreatRep 61:825—833,1977.19.AndreottiPE, etal:Potentiationofantineoplastic compounds by oral dimethyl sulf

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