AccountabilityinResearch,21:389–400,2014 Copyright©Taylor&FrancisGroup,LLC ISSN:0898-9621print/1545-5815online DOI:10.1080/08989621.2014.882780 Blood Money: Bayer’s Inventory of HIV-Contaminated Blood Products and Third World Hemophiliacs Leemon McHenry, Ph.D.1and Mellad Khoshnood, B.A.2 1DepartmentofPhilosophy,CaliforniaStateUniversity,Northridge,California,USA 2DepartmentofMedicine,UniversityofLouisvilleSchoolofMedicine,Kentucky,USA Thisarticlepresentsanoverlookedcaseofresearchmisconductandviolationsofbasic principles of medical and business ethics. When Bayer’s Cutter Laboratories realized that their blood products, Factor VIII and IX or antihemophiliac factor (AHF), were contaminated with human immunodeficiency virus (HIV), the financial investment in the product was considered too high to destroy the inventory. Cutter misrepresented the results of its own research and sold the contaminated AHF to overseas markets in Asia and Latin America without the precaution of heat treating the product rec- ommended for eliminating the risk. As a consequence, hemophiliacs who infused the HIV-contaminatedFactorVIIIandIXtestedpositiveforHIVanddevelopedAIDS. Keywords: AIDS, antihemophiliac factor (AHF), Bayer, Cutter Laboratories, hemophilia,hepatitis,humanimmunodeficiencyvirus(HIV),ThirdWorld INTRODUCTION Pharmaceutical companies uniformly claim to embrace moral values as one of their highest obligations to patients. Bayer, for example, claims “to help patients around the world by preventing, alleviating and curing disease” as part of their mission: “Science for a Better Life” (Bayer, 2013). Marketing strategies that are concealed from the public contrast sharply, however, with the image provided by public relations campaigns. Given the importance of what is known in relatively small legal circles as “the hemo case,” we believe that a fuller account merits exposure in the biomedical literature. Although there were several media reports, the two most important that came to the Address correspondence to Leemon McHenry, Department of Philosophy, California State University, Northridge, 18111 Nordhoff Street, Northridge, CA 91330, USA. E-mail:[email protected] 390 L.McHenryandM.Khoshnood public’s attention included an article in The New York Times (Bogdanovich and Koli, 2003) and a German documentary called Tödlicher Ausverkauf: Wie BAYERAIDSnachAsienimportierte(DeadlySale:HowBayerImportedAIDS intoAsia)(Koch,2004). Other cases on record reveal that companies use people outside of the United States and Europe to market a product that is potentially deadly. For example, in the 1970s and 1980s, the Swiss-based Nestlé Corporation aggressively marketed breast milk substitutes, particularly in less economi- cally developed countries, which contributed to the unnecessary suffering and deaths of babies largely among the poor in Africa (Ferriman, 1999). Moreover, the World Health Organization (WHO) has long been concerned with the complaint that the Third World is the dumping ground by pharmaceutical companiesforunwanted, obsolete,andpoorqualitydrugsratherthansupply- ingessentialmedicinesfortheworld’smostpressinghealthproblems(D’Arcy, 1985,p.983;Charev,2012,p.93).Whilethehemocaseinvolvedhumanimmun- odeficiencyvirus(HIV)–infectedhemophiliacsintheUnitedStatesandabroad, our account below focuses attention on the marketing and distribution of con- taminatedbloodproductsinAsia,theso-called“dumping”aspectofthelarger bodyofcaseslitigated. Whereasthevastmajorityofincriminatingdocumentsfromlitigationdis- appear as a result of settlement agreements or defense attorneys’ successful arguments for maintaining the confidentiality designation of the documents, the documents cited below are part of the public record as attachments to motions that were made public. Many others became public when used as exhibitsincourtcasessuchasChang,Y.etal.vs.BayerCorporationandBaxter HealthcareCorporation,CivilActionNo.3:04–CV–01925andInreFactorVIII or IX Concentrate Blood Products, Product Liability Litigation, MDL No. 986. The following report is based upon a selection of those documents produced and made public in litigation against Bayer that were posted in May 2013 on the Drug Industry Document Archive (DIDA) at the University of California, SanFrancisco.Manymoredocumentsthatwereproducedindiscoveryremain sealedbythecourtsand,therefore,havenotbeenreleasedtothepublic. HEMOPHILIA AND FACTOR CONCENTRATE BLOOD PRODUCTS Hemophiliacs either produce inadequate concentrations or no concentrations of various pro-coagulation proteins that are present in normal human blood. A normal, healthy individual who gets a cut will bleed for a short time and then the blood will clot, thereby stopping any further bleeding. In the case of hemophiliacs, once they get a cut, they will continue to bleed for a long period of time. Many bleeding episodes involve spontaneous bleeding into leg and arm joints, causing severe crippling, or life-threatening bleeding in the brain. In situations where a severe cut or internal bleeding occurs, death may BloodMoney 391 follow from significant blood loss. Before antihemophiliac factor (AHF) was discovered, hemophiliacs had to be hospitalized and infused with blood prod- ucts such as fresh frozen plasma and whole blood to control severe bleeding. AHFwasalife-changingdiscoverythatallowedhemophiliacstolivefairlynor- mallives.Itisacompositionofvariouspro-coagulationproteins(FactorsII,IV, VIII, IX, X, etc.) derived from the blood of so-called normal, healthy donors. AHF is produced by pooling plasma to create a “lot” comprised of 1,000 to 50,000 individual donations. Once the frozen blood product or cryoprecipitate fromthesecombinedplasmapoolsischemicallytreatedtoproducethefreeze- dried AHF product, the powder from each lot is placed into handy vials that arereconstitutedwithsalineandinjectedintravenouslybythehemophiliac. It is well known that individuals with a history of IV drug use, prisoners, and promiscuous gay males are at high risk for prevalence of viral diseases, such as hepatitis B, hepatitis C, and HIV, that are transferred through expo- sure to human blood. As early as 1975, Szmuness et al. specifically identified theconnectionbetweenpromiscuousgaymales’sexualbehaviorandthespread ofhepatitisBinfection.Theyrecommendedthatsuchindividuals“refrainfrom blooddonations”(Szmunessetal,1975,p.494).Duetotheriskoftransmitting andtherebyspreadingdeadlyanddebilitatingdiseases,theUnitedStatesfed- eral government passed a law between the late 1970s and early 1980s that required companies to obtain blood for manufacturing their blood products strictly from normal, healthy individuals. At that time the main companies that produced AHF included as follows: Cutter Laboratories (purchased by Bayer in 1974), Baxter Healthcare, Alpha Therapeutic Corporation, Armour PharmaceuticalCompany,AventiBehring,L.L.C.,andSventis,Inc. HIV-CONTAMINATED AHF In the 1980s, Cutter and other companies targeted categories of plasma donors–-IV drug users, prison inmates, skid row residents, and promiscuous, gay males-–to manufacturer AHF because the donors were readily available and willing to sell blood for cheap and demand was high for AHF. But the companies also wanted this plasma from these high-risk donors to manufac- tureotherlucrativeblood-basedproducts(e.g.,ageneralimmuneglobulin,and antigen specific immune globulins, particularly hepatitis B immune globulin [HBIG]), which had to be manufactured from blood with high levels of anti- bodies. The blood donors Cutter targeted were at high risk for transmitting blood-bornediseases(Cutter,1982b,c). Immune globulins are injectable medications used to increase the recip- ient’s antibody levels. This product was particularly useful for healthcare professionalsexposedtoneedlesticksandinfectiousdiseasesaswellastourists visiting areas of the world with high levels of hepatitis B. If exposed to a dis- ease like hepatitis B, it was useful to have a boost of antibodies promptly to 392 L.McHenryandM.Khoshnood defend against illness. These were expensive and very profitable products at thetime.Inordertosellsuchproductsasefficaciousmedications,theproducts hadtohaveahighlevelofantibodiesandinordertoharvesthighlevelsofthe antibodies,themanufacturerspurchasedplasmafromdonorswhowouldlikely have been exposed to the targeted diseases (e.g., hepatitis). In the late 1970s and early 1980s, promiscuous gay males and prisoners were widely exposed to hepatitis B, so acquiring plasma from those populations would likely har- vest sufficient levels of antibodies to warrant selling it as HBIG or a general immuneglobulin. OneofCutter’sstrategiestoacquirebloodwiththehighlevelsofantibodies was to purchase plasma from advertisers in gay men’s magazines in which blooddonationsweresolicitedforthebettermentofhepatitisresearchandthe creation of a vaccine. One such advertisement typical of those in 1981 reads as follows: “Have you ever had hepatitis? Have you ever been in contact with hepatitis? Now you can make it pay, as much as $650 extra each month. And, at the same time, you’ll be helping to contribute to the health and welfare of other Gay men” (Cutter, 1981a). Cutter laboratories was inspected in 1981 to determine whether it was in compliance with the law regarding use of high- risk donors and found to be “in compliance in all areas except for the practice ofacceptingdonorsintotheprogramwhohaveapasthistoryofillegalIVdrug use”(Cutter,1981b). By1982,theCentersforDiseaseControl’s(CDC)MorbidityandMortality WeeklyReportincludedthealarmingdiscoverythathemophiliacstreatedwith AHF (heterosexuals without a history of IV drug abuse) had contracted a rare form of pneumonia, pneumocystis carinii pneumonia, frequently diag- nosedinAIDSpatients.TheCDCnotedthat“pneumocystiscariniipneumonia has not been previously reported among hemophilia patients who have had no other underlying diseases and have not had therapy commonly associated withimmunosuppression”(CDC,1982,p.14).Alsoin1982,basedonstudiesin which chimpanzees injected with AHF developed “AIDS-like symptoms” that includedpneumocystiscariniipneumonia,itappearsthatCutter,inparticular, hadstrongevidencethatAHFcouldtransmitHIV(Cutter,1982a). Once a person is infected with HIV, the virus incorporates itself into the DNA and targets the CD + T cells (the white blood cells that are necessary 4 in the production of acquired and adaptive immunity within the body). AIDS (acquiredimmunodeficiencysyndrome)developsastheHIVvirusspreadsand destroys more and more CD + T cells with the result that there is greater 4 susceptibility to common infection. At that stage, defined clinically when the cell count is below 200 CD + T cells, individuals require a great deal of med- 4 ical intervention to survive infections that healthy individuals could fight off effortlessly. According to Cutter documents from 1982, the FDA asked Cutter “to vol- untarilyexcludeplasmacollectedfromknownhomosexualsfrompools”usedin BloodMoney 393 theproductionofAHFspecificallyfromareassuchasNewYork,SanFrancisco andHollywood(Cutter,1982b,c).Inresponse,Cuttersuggestedtoeducatethe high-risk populations in an attempt to have individuals voluntarily exclude themselves from donating centers (1982c). While it was reported that “there had been no cases of AIDS reported in prisons,” Cutter scientists knew that it tookseveralyearsforHIVtodevelopintoAIDS.The“etiologyofthesyndrome and the insufficient time” suggested that such a judgment was premature (Cutter,1982c).EventhoughtherewasariskoftransferringHIVviatheAHF product,Cuttermadethedecisionnottoexcludesuchhigh-riskdonors. By 1983 Baxter Healthcare had developed a heat-treat process to deacti- vatevirallyAHFproductsandwasgrantedaFDAlicenseforthenewproduct (Leveton et al., 1995, p. 92). The very idea of heat treating AHF to reduce theriskofbloodbornediseasewascounterintuitivesincetheprocessinvolved using plasma that had been immediately frozen to prevent the coagulating proteins from denaturing at room temperature and thereby eliminating the effectivenessoftheproductforstoppingbleedingepisodes.Cutter’scompetitor, Baxter, nonetheless pioneered this successful process and thereby threatened Cutter’s market share. As Cutter began to develop the heat-treated AHF fol- lowingtheirownexperimentswithchimpanzeesin1983,theyconcludedthat, “At this point, the data clearly support that our pasteurization procedure has inactivated non-A non-B hepatitis” (Cutter, 1983a). In fact, Cutter’s own medicaladvisercautionedthat“oncethisproductislicensed,itwouldbeuneth- ical to place a patient on other therapy” (Cutter, 1982d). Cutter’s filing for an FDA license would depend on “satisfactory clinical results and successful introductionoftheprocessintomanufacturing.”Cutterconcludedasfollows: The recent concern about AIDS and its possible transmission by an infec- tiveagentshouldencouragearapidreviewandapprovalofthesubmission.Even without hard data, it is certainly logical that a heated product, with no sacrifice of clinical efficacy, should be potentially safer than one not heated. Such a prod- uctshouldbemadeavailabletothosewhoselifedependsonitinasrapidatime frameaspossibleevenwithoutthefinalunequivocaldemonstrationofitsfreedom fromhepatitisand/orAIDs.(Cutter,1983a) Instead of following this advice, Cutter continued to market the non-heat treated AHF manufactured from the pooled plasma of thousands of donors whowerescreenedusingonlyvoluntary,self-reportingmethods.TheBiological Bulletin from Cutter’s Marketing Services affirmed that Cutter believed that screening procedures had reduced “the possibility that AIDS may potentially be transmittedthrough certain blood products” sothecompany “reinforced its existingprogramofdonorscreeningtoassurethattherawmaterialforitsqual- ity plasma products continue[d] to be of high quality” (Cutter, 1983b). At the same time Cutter denigrated the use of the heat-treated AHF on the alleged basisthatithadnotbeenshowntobeeffectiveforcompleteviraldeactivation 394 L.McHenryandM.Khoshnood (Cutter, 1983c). By May of 1984, however, Cutter had tested its own non-heat treated AHF and determined that HIV survived the manufacturing process, but that HIV did not survive the heat-treated AHF viral-deactivation process (Cutter, 1982a,d, 1984a). The inconsistency in their position, we believe, is explained by the fact that Cutter wanted to protect its market share through saleofitsinventorynon-heattreatedAHF. CUTTER’S MARKETING PLAN By 1984, Cutter’s inventory included both heat-treated and non-heat treated AHF.Thecompanybegantheprocessofreviewingitsinternationalmarketsto determineifexcessinventoriesofnon-heattreatedAHFcouldbesold(Cutter, 1984b, 1985a). It found these willing markets in countries where it predicted, accordingtothe1985FarEastRegionPreliminaryMarketingPlan,that“AIDS will not become a major issue amongst Asian hematologists during 1985” (Cutter, 1985a). AIDS hysteria had not reached these countries, according to Cutter, because the region has so many other health hazards of greater, more com- monconcern...InTaiwan,forinstance,where16%ofthepopulationarecarriers ofHepatitisB,ahemophiliacisapttosufferasmuchriskroutinelyusingcryopre- cipitateorbloodaswithAmerican-madeconcentrates.Withtheseconsiderations inmind,wehavenoimmediateplanstointroduceKoate-HTorKonyne-HT[Heat TreatedFactorsVIIIandIXAHF].(Cutter,1985a) The1985MarketingPlanstatesasfollows:“Ifweseeaneedforaheat-treated product in the Far East, we will react to the demand swiftly. Otherwise, we willtrytocontinuetodominatethemarketswithlow-coststandardKoateand Konyne [Factors VIII and IX AHF]” (Cutter, 1985a). Instead of destroying the high-risk non-heat treated AHF in their inventories, Cutter determined that they would need to “sell as much of it as possible, even at marginal prices” (Cutter, 1985a). The marketing plan lamented the fact that Cutter was forced toterminateitsbusinessinNewZealandin1982whenAIDSbecamean“issue” there, but optimistically identified India, Philippines, Indonesia, Thailand, HongKong,Taiwan,Singapore,Malaysia,Brunei,Korea,Pakistan,SriLanka, Burma, and Nepal as possible markets for the non-heat treated AHF (Cutter, 1985a).ThroughoutLatinAmerica,Argentina,Venezuela,ColumbiaandCosta Rica were the main markets to which non-heat treated AHF was exported (Cutter,1983d). Heat-treatedAHFwouldbeintroducedinAsiaonly“ifnecessarytodefend againstthefearofAIDS”(Cutter,1985a).ACuttermemoof1984unequivocally asserted that the supply of regular AHF would need to be exhausted before the heat-treated product could be introduced in the Far East. Since, however, the production costs of the heat-treated AHF would be more expensive, the BloodMoney 395 companywasfacedwiththeproblemofhavingtosellthenew,moreexpensive product at the same price as contaminated AHF under the existing contract (Cutter, 1984c). In a 1985 memo to a Hong Kong consignee, Cutter expressed regret for its failure to supply heat-treated AHF “due to a shortage of human plasma in the U.S. and rapid increase in demand for [heat-treated AHF],” but assuredtheconsigneethattheregularAHFisnot“hazardous”andisthe“same fineproductwehavesuppliedforyears”(Cutter,1985b). Cutter discussed a plan internally to deal with the growing controversy. WhenAsianphysicianspracticingintheUnitedStatesrelocatedinHongKong, theyknewthattheheat-treatedproducthadbecomethestandardofcareinthe UnitedStatesandsurmisedthatCutterwasprobablysellingoffexcessstocks of non-heat treated AHF to less developed countries. In Hong Kong, 40% of pediatrichemophiliacshadtestedpositiveforHIV,andsotherewasademand fortheheat-treatedAHF.Inthemeantime,Cutter’scompetitorswere“stirring up trouble by pushing their heat treated products” (Cutter, 1985c). Cutter’s responsewastoobtain350vialsofheat-treatedAHFtosatisfythemostvocal patientsandconcludedthat,“Itappearstherearenolongeranymarketsinthe FarEastwherewecanexpecttosellsubstantialquantitiesofnonheattreated [AHF]”(Cutter,1985c). Meanwhile in the United States, Cutter and the other manufacturers of AHF were faced with the threat that the FDA could revoke their licenses for the non-heat treated AHF if the manufacturers continued selling the product. In spite of large AHF inventories held by the manufacturers and the poten- tial expense of heat treating the inventory, the head of the FDA, Dr. Harry Meyer,proclaimed“hedidnotwantanyattentionpaidtothefactthattheFDA had allowed this situation to continue for so long, and he would like the issue quietly solved without alerting the Congress, the medical community and the public”(Cutter,1985d).In1985,Cutterdiscontinuedthemanufactureanddis- tributionofallnon-heattreatedAHF(Cutter,1985e).Inouropinion,however, bythistimethedamagewasdone. TAIWANESE HEMOPHILIA-AIDS CASES While a 1984 marketing memo states categorically that there would be no majorrecallssinceit“coulddepriveCutterofupto$2millionworthofsalesin theFarEastRegionduring1984,”(Cutter,1984d)latein1983,Cutterdidrecall voluntarily 16 lots of AHF because plasma regularly donated from an AIDS victim had contaminated their supply. Vials of tainted AHF were distributed to 304 domestic and 14 international consignees (Cutter, 1983d). In Taiwan, however,theconsigneewastoldthatonlytwolotswerebeingrecalled(Cutter, 1983e).Thisdidnotmeantheotherlotsofnon-heattreatedAHFweresafefor hemophiliac use. This evidence appears to support the conclusion that Cutter knew certain lots were contaminated with HIV and, even amongst those lots, 396 L.McHenryandM.Khoshnood therewasaninconsistency,atleastinTaiwanastohowtherecallwastreated. Cutter assured the consignee that the withdrawal was “a precautionary mea- sure as there [was] no evidence that these products will transmit the disease. There have been no reports of adverse reactions involving the lots containing theplasmafromthedonor”(Cutter,1983e). In Taiwan alone, as alleged in the complaint filed in Chang, Y. et al. vs. Bayer Corporation and Baxter Healthcare Corporation, thirty-four Taiwanese hemophiliacs or partners of hemophiliacs developed AIDS as a result of infusing HIV-contaminated AHF. Many of those individuals died from AIDS complications. CONCLUSION In our view, the main issue of research misconduct concerns the manner in which Cutter represented the results of its own research by withholding data on the safety of the non-heat treated AHF to patients in Asia and Latin America. This appears to have occurred at the critical point in 1984 when Cutter’sresearchrevealedthatHIVsurvivedthenon-heattreatedAHFbutnot the heat-treated AHF. Cutter then had to decide what to do with the contam- inated inventory. The documents produced by Cutter unambiguously describe a strategic business plan to sell off its inventory of HIV-contaminated AHF blood products in what were considered Third World countries at the time. Sincetheseplanswereproposedbytop-levelmanagementinthecompany,they cannot be dismissed as the behavior of a few individuals who failed to follow corporatepolicies.Infact,JohnHink,aformerCutteremployeewhowasinter- viewed for his role in overseas marketing of HIV-contaminated AHF said as follows: Whenwechangedtothenew,heatedproduct,andthebossaskedforadeci- sion what to do with the stock of the old product, it was decided, instead of throwing it into the trash, we would rather sell it to other countries. And that led to the loss of human life and damages to human health. I think that I have mademistakes.IthinkIcouldhavedonethingsbetter.(Koch,2004) Seldom,ifever,aresuchplansmadewithrespectforthedignityofhumanlife; few in marketing departments seem to be even vaguely aware of the impor- tanceofbasicprinciplesofmedicalandbusinessethics.Theirpartnershipwith medicinecommitsthemtothesameprinciplesgoverningmedicalpracticesuch asnon-malfeasance,beneficenceandinformedconsent.Asindividualsengaged in business, they are morally obligated to follow basic precepts of honesty, integrity, fairness and accountability. Many of these principles overlap with theirlegalobligations.IfCutterexecutives wereaware ofanysuchprinciples, theywerenotunderstoodtobeuniversalprinciplesofmoralitysincetheywere apparently not applied to persons at a great distance or to those outside of BloodMoney 397 a severely limited moral community. In short, we think the evidence reveals that Cutter treated persons in terms of abstract categories of markets to be manipulated merely as a means toward the company’s financial end, not as ends in themselves deserving of health and life itself. Apparently, many died asaresult. ItshouldnotbeoverlookedthatCutterinfectedchimpanzeeswithviruses for the sake of experiments that were meant to benefit humans. Even if one were to accept speciesism as a defensible moral position justifying such a practice, in this case the results of animal testing were not communicated to patients who infused the non-heat treated AHF or their physicians and thus thechimpanzees’liveswereofnoutilitytothispopulation. When Bayer acquired Cutter, it took ownership of assets and liabilities, including the legal liabilities that resulted from the thousands of HIV/AIDS cases.Bayerhaspaidover$600millioninsettlementsforwhattheyhavecalled in Taiwan “humanitarian aid” rather than compensation for wrongful death (Cutter, 1998). In spite of over 2,700 cases worldwide litigated on the basis of dumping, the company maintained that Cutter had “behaved responsibly, ethicallyandhumanely”(BogdanovichandKoli,2003). CHRONOLOGY 1975: Szmuness et al. identify the connection between promiscuous gay males’ sexual behavior and the spread of hepatitis B infection and recom- mend that promiscuous gay males not be used as plasma donors due to the riskoftransmittingbloodbornediseases. 1980s: Cutter and other companies target categories of plasma donors–-IV drugusers,prisoninmates,skidrowresidents,andpromiscuousgaymales. January1982: Cutter scientists learn of competitors’ development of “hepatitis–free”AHF. July1982: The Centers for Disease Control reported that hemophiliacs treated with AHF had contracted a rare form of pneumonia, pneumocystis carinii,frequentlydiagnosedinAIDSpatients. August1982: FDA meets with AHF manufacturers and recommends that they stop using plasma from centers catering to gay males due to the AIDS scareamongstthehemophiliacommunity. December1982: Cutter scientists find that chimpanzees given non-heat treatedAHFdevelopAIDS-likesymptoms. January1983: Cutter scientists send internal memo stating that heat- treated AHF would most likely be safer and decrease risk of HIV and hepatitistransmissiontopatients. July1983: Cutterdenouncesthesafetyofcompetitors’heat-treatedAHF. November1983: Cutter recalls 16 lots of AHF after discovering that a blood donorhaddiedofAIDS. 398 L.McHenryandM.Khoshnood November1983: Cutter informs Taiwan businesses that the recalled lots of AHFwereduetoapatientwhowas“suspected”ofhavingAIDS. May1984: Cutter’sheat-treatedAHFisapproved. November1984: InternalCuttermemodiscussestheneedtosellexcessnon- heattreatedAHFtoThirdWorldcountriesinordertolimitlossofprofits. November1984: Cutter responds to inquiries from Taiwan AHF businesses astowhyheat-treatedAHFisnotbeingsupplied. 1984–January1985: Cutter marketing plan for 3rd World countries dis- cusses need to sell non-heat treated AHF to prevent loss of potential 2milliondollars. May1985: FDA requests that Cutter cease production of non-heat treated AHF. June1985: Cutterstoppedmakinganddistributingnon-heattreatedAHF. ACKNOWLEDGMENTS The authors wish to acknowledge critical evaluation and legal review from MichaelL.Baum,Esq.,FrancesM.Phares,Esq.,andRonaldGoldman,Esq. Wealsothanktwoanonymousreviewersformanyhelpfulsuggestions. Disclosure Leemon McHenry is research consultant for the law firm of Baum, Hedlund,Aristei&Goldman,LosAngeles,California. REFERENCES Bayer. (2013). Bayer: Science for a Better Life. Available at http://www.bayer.com/en/ mission–values.aspx.LastaccessedFebruary20,2013. Bogdanovich, W. and Koli, E. (2003). 2 Paths of Bayer Drug in 80’s: Riskier Type WentOverseas.NewYorkTimes.DrugIndustryDocumentArchive.#55NewYork TimesstoryregardingBayer’sdumpingofinfectiveproductinoverseascountries. Available at http://dida.library.ucsf.edu/tid/fgu13j10. May 22, 2003. Last accessed December8,2013. Centers for Disease Control. (CDC). (1982). Morbidity and Mortality Weekly Report. June1981throughMay1986,ReportsonAIDS,July. Charev, N. (2012). The World Health Organization between North and South. Ithaca, N.Y.:CornellUniversityPress. Cutter.(1981a).DrugIndustryDocumentArchive.#54Advertisementsinvariousgay magazinesforplasmadonorsexposedtohepatitis.Availableathttp://dida.library. ucsf.edu/tid/xeu13j10.LastaccessedMay17,2013. Cutter. (1981b). Drug Industry Document Archive. #27 Letter from Cutter’s Oakland plasma center to Cutter. Available at http://dida.library.ucsf.edu/tid/zeu13j10. May19,1981.LastaccessedMay17,2013.