RECENT DEVELOPMENTS

Organ Donation, Discrimination After Death,Anti-Vaccination Sentiments, and Tuberculosis Management

John Coggon & Bill Madden & Tina Cockburn &

Cameron Stewart & Jerome Amir Singh &

Anant Bhan & Ross E. Upshur &

Bernadette Richards

Received: 5 March 2012 /Accepted: 7 March 2012 /Published online: 18 April 2012# Springer Science+Business Media B.V. 2012

The British Medical Association ReinvigoratesPublic Debates on U.K. Organ Donation Policy

The British Medical Association (BMA), Britain’sunion and professional association for doctors and med-ical students, is well-positioned both to spark and con-tribute to important social and political debates. In a

recently published and highly publicised report, it hassought to do so in relation to policies concerning organtransplantation (BMA 2012). Inevitably, much of thedebate that this report prompted in the media focusedon the ethically more controversial questions: For ex-ample, its publication has reignited discussions on “elec-tive ventilation.” But the report, whilst presenting the

Bioethical Inquiry (2012) 9:125–133DOI 10.1007/s11673-012-9370-2

J. CoggonResearch Fellow, Institute for Science, Ethics,and Innovation, University of Manchester,Manchester, UKe-mail: John.Coggon@manchester.ac.uk

B. MaddenNational Practice Group Leader, Medical Law,Slater & Gordon; Adjunct Fellow, School of Law,University of Western Sydney,Sydney, Australiae-mail: bill.madden@slatergordon.com.au

T. CockburnSchool of Law, Queensland University of Technology,Brisbane, Australiae-mail: t.cockburn@qut.edu.au

C. StewartCentre for Health Governance Law and Ethics, Sydney LawSchool, The University of Sydney,Sydney, Australia

J. A. SinghCentre for the AIDS Programme of Research in SouthAfrica (CAPRISA), University of KwaZulu-Natal,Durban, South Africae-mail: singhj9@ukzn.ac.za

J. A. SinghSandra Rotman Centre for Global Health,University Health Network,Toronto, Canada

J. A. SinghDalla Lana School of Public Health and JointCentre for Bioethics, University of Toronto,Toronto, Canada

A. BhanMcLaughlin-Rotman Centre for Global Health,University Health Network and University of Toronto,Toronto, Ontario, Canadae-mail: anant.bhan@srcglobal.org

R. E. UpshurSunnybrook Health Sciences Centre,2075 Bayview Ave, E3-49,Toronto, ON M4N 3M5, Canadae-mail: ross.upshur@sunnybrook.ca

B. Richards (*)Adelaide Law School, University of Adelaide,North Tce Adelaide, South Australia 5005, Australiae-mail: bernadette.richards@adelaide.edu.au

BMA’s ethical stance on a wide range of practical andpolicy questions concerning organ donation, is far froma controversial or partisan polemic. Rather, it is writtenin the spirit of engaged, public discussion, with a view todeveloping a consensus, improving U.K. health care,and saving many lives. It provides an accessible re-source for anyone interested in a wide range of recentdevelopments regarding organ donation policy in theUnited Kingdom, along with substantial amounts ofinformation of use and relevance to an internationalaudience.

The report can be seen to work from two basicpremises. The first is that organ transplantation repre-sents an inadequately achieved social good, whichshould be optimised within an ethically and democrat-ically constrained system that accommodates andrespects a diversity of views on the moral legitimacyand desirability of organ donation. The second is thatpolicy proposals should be based on the best possibleempirical evidence of their efficacy. This can entaillearning lessons from other jurisdictions, but demandssensitivity to the fact that practices are defined in partby local particularities that must be accounted for.Having introduced the practical and legal back-grounds, the report analyses two distinct means ofimproving the United Kingdom’s approach to organdonation: first, by developing the infrastructure; sec-ond, by increasing the number of donors through theintroduction of different policies.

On changing the infrastructure, there is a high levelof agreement with an earlier report by the OrganDonation Taskforce (2008), which was set up by theU.K. government in 2006. Notably, the BMA is sup-portive of a transition to a situation where “all doctorswho care for dying patients should see the offer oforgan donation as part of their role” (BMA 2012, 18).It also supports the proposition that modest stepsshould be taken to optimise a living patient’s chancesof donating organs posthumously if that patient is veryclose to death and has a wish to become a posthumousdonor, even where such steps are not indicated by thepatient’s narrowly understood medical interests. An-other notable point is the BMA’s continued rejectionof the general acceptability of conditions being at-tached to the question of who will receive a person’sposthumously donated organs.

The BMA report praises the developments follow-ing the taskforce’s report, noting that its recommenda-tions have largely been implemented. However, it

argues that it is important to sustain the momentumthat has grown and suggests some areas that requirefurther attention. In particular, the infrastructuralreforms need to continue to drive toward increasingreferrals for donation, reducing relatives’ refusals ofconsent to donation, considering extending brain stemdeath testing to neonates, and developing consistentacceptance criteria for organs. As well as emphasisingthe need to maintain the political will to see develop-ments in infrastructure, the report stresses that

[w]hatever systems are put in place, organ dona-tion must continue to be managed and co-ordinated in a coherent fashion and to be seenas an integral part of the end-of-life care path-way. It is only if these changes are protected thatthe major advances that have been made can bemaintained and we can begin to build on the newinfrastructure (BMA 2012, 35).

The report then moves to consider possible policies—both ones that the BMAwould and would not support—to increase the number of donors. Donation policyrequires consideration of matters concerning both livingand deceased donors. In regard to living donors, theemphasis lies on voluntariness and the “gift relationship,”leading the BMA to reject arguments for a market inorgans. In regard to deceased donors, on whom mostattention in the report is focused, the BMA has for sometime been a strong public advocate of an “opt-out” sys-tem to govern donation policy. More specifically, it sup-ports a “soft” system of “opt-out with safeguards” (BMA2012, 46), which is described as follows:

Under an opt-out system everyone would beassumed to want to donate organs after theirdeath unless, having received information aboutthe system, they had chosen to opt out of dona-tion during their lifetime. … [The “soft” versionof this] system has built-in safeguards, so thatthe family is always consulted and asked aboutany unregistered objection and there is scope notto proceed with donation if this would causesevere distress to the family (BMA 2012, 46).

The BMA gives an outline of the practical issuesthat would need to be addressed if such a policychange were actually to make a difference. (The task-force had not been convinced in 2008 that a move toopt-out would achieve the desired effect.) In particular,

126 Bioethical Inquiry (2012) 9:125–133

there would need to be a large publicity campaign,designed to make people think about their wishesconcerning posthumous donation. This would alsoneed to pre-empt any possible backlash against dona-tion (e.g., to stop a suspicious public from opting-outin protest or because of unfounded concerns that doc-tors motivated to increase donation rates will not servetheir patients’ best interests). Also, a database wouldhave to be established, in which people’s preferenceswould be recorded. The new system would change theapproach to relatives, who now would not be asked forconsent, but asked if they knew of an unregisteredobjection. And more broadly, it would change the“philosophy” of donation, making it the norm.

From the perspective of scholars following devel-opments in bioethics, particularly those interested inU.K. bioethics, the report provides an interesting rep-resentation of the state of recent and contemporarydebates. It suggests that the locus of important bioethicalinquiry into organ donation has moved in great partbeyond “pure philosophy” or battles over who ownsterms such as “consent.” Although moral argumentsreceive substantive attention, the most vexing questionsseem to be practical rather than philosophical. The de-bate appears principally to have shifted to assessing whatcan be done to improve outcomes (i.e., increase donationrates) within, or through realisable amendments to, exist-ing political and infrastructural constraints. This is not tosay that morality is not important, simply that the moralargument is only a part of what needs to be assessed. TheBMA is concerned about moral imperatives against, forexample, coercion and “mandated choice,” and sees theidea of donation as a gift and clinical need as fundamen-tal ethical principles and the basis of prioritising alloca-tion. In the context of dominant public and academicdebates about “nudge” theory (Thaler and Sunstein2009; Cabinet Office 2010), it is notable, too, how theBMA sees value in information campaigns. However,the structure of the report is such that the different policyproposals considered to have the potential to increasedonation rates are evaluated according to various ques-tions: their (probable) effectiveness; ethical considera-tions; practical considerations; public opinion; and onlythen expression of the BMA’s own view.

The report concludes by stating:

The BMA hopes that the publication of this reportwill encourage and facilitate debate—amongsthealth professionals, policy-makers and the

public, with a view to reaching broad agreementabout the way forward (BMA 2012, 68).

It is to be hoped that this broad agreement will bereached. The report certainly achieves its other aims.

—John Coggon

Discrimination After Death?

The question of whether the manner of the perfor-mance of an autopsy on the body of an HIV-positiveperson can amount to discrimination was recentlyconsidered by the New South Wales Court of Appealin Sydney Local Health Network v QY and QZ [2011]NSWCA 412.

The relevant legal protections against discriminationconsidered by the court are statutory in nature, estab-lished in New South Wales by the Anti-DiscriminationAct 1977 (NSW)1 (“the Act”); hence, the determinationwas necessarily focused on the interpretation of theprovisions of that particular statute.

Facts

Mr. B was HIV-positive at the time of apparent suicidein late 2007 ([81], [83]). The Coroner directed a fullpostmortem be conducted by the Department of Fo-rensic Medicine, which formed part of the SydneyLocal Health Network.

The Department of Forensic Medicine did not re-construct the body after the autopsy, in line with aninternal occupational health and safety policy that didnot allow reconstruction in the case of bodies withcertain conditions, one of them being HIV-positivestatus ([83]). The Department of Forensic Medicinereleased the body to a private undertaker. Whilst notprevented by law from proceeding to reconstruct, theundertaker advised that—due to the state in which thebody was received—reconstruction was not feasible([84]).

Application

The primary application that eventually led to thepresent Court of Appeal decision was made by QY, a

1 Other statutory protections exist in Australia. See, for exam-ple, the Disability Discrimination Act 1992 (Cth) and the Anti-Discrimination Act 1991 (Qld).

Bioethical Inquiry (2012) 9:125–133 127

long-time friend of the deceased, and QZ, who was hishomosexual partner ([82]). They claimed to be “asso-ciates” of the deceased within the meaning of the Actand aggrieved, as they were forced to reveal to mem-bers of the deceased’s family (who were previouslyunaware of Mr. B’s condition) the reason for B’s deathand why his body had not been reconstructed ([84]).

QY and QZ complained of discrimination by thecoronial services managed by the Department of Fo-rensic Medicine on the grounds that they sufferedunlawful discrimination due to the condition in whichthe body of their deceased associate was returned tothem after forensic pathology. They claimed they weretreated differently, as compared to next of kin whoserelatives die free of disability ([85]). This was becausethe regular practice of the Department of ForensicMedicine was to reconstruct the body after a postmortem and before releasing it ([167]).

Specifically, QY and QZ alleged there was discrim-ination in the provision of services within the meaningof s 49M: “It is unlawful for a person who provides…services to discriminate against a person on the groundof disability … by refusing to provide the person withthose … services” ([6]).

The relevant definition of discrimination on theground of disability appears in s 49B:

(1) A person (the perpetrator) discriminatesagainst another person (the aggrieved person)on the ground of disability if, on the ground ofthe aggrieved person’s disability or the disabilityof a relative or associate of the aggrieved person,the perpetrator:(a) treats the aggrieved person less favourablythan in the same circumstances, or in circum-stances which are not materially different, theperpetrator treats or would treat a person whodoes not have that disability or who does nothave such a relative or associate who has thatdisability.

The contravention of s 49B(1) was said to haveoccurred at the time that the Department of ForensicMedicine returned Mr. B’s body to QY and QZ in anunreconstructed state. It was argued that, by returningMr. B’s body to them in an unreconstructed state—adecision made on the basis Mr. B’s disability (consti-tuted by being HIV-positive)—the Department treatedQY and QZ less favourably than it would have treateda person whose associate had no disability ([8]).

The application was initially dismissed, but an Ap-peal Panel reversed the decision of the Magistrate andremitted the case for trial. Essentially it did so becauseit considered that a “person” under the Act included adeceased person ([91]).

Sydney Local Health Network successfully soughtleave to appeal that decision and a review by the Courtof Appeal ([104]).

Issues

Sydney Local Health Network’s substantive responseto the case brought by QY and QZ was that thedeceased could not be a “person” and, in any event,that QY and QZ could not be “associates” of a de-ceased person. Those terms required interpretation inthe context of the Act.

Other issues were considered, such as the possibil-ity of a statutory protection of a doctor conducting apost mortem under the then Coroners Act 1980 (NSW)([153]–[166]).

Young JA wrote the lead judgment, finding that thedeceased was not a person under the Act ([128]) and thatQY and QZ were not his associates ([145]). MacfarlanJA agreed with Young JA as to the interpretation of theterm “associate” ([76]), as did Campbell JA ([54]). Thatfinding was sufficient for the appeal to succeed and forthe argument of QY and QZ to fail. Costs of the appealwere payable by the respondents ([178]).

Was the Deceased a “Person”?

Justice Young had little difficulty in holding that thedeceased was not, at the relevant time, a person withinthe meaning of the Act, commenting that: “The wholecontext of the Act points to a person being a livingperson who may suffer from the discrimination”([117]). Justice Macfarlan did not find it necessary todecide that question, noting that for the reasons givenby Campbell JA—who was not “persuaded that it isonly a living person who can be a ‘person’ within themeaning of the Act” ([2])—the issue was one of somecomplexity, which may be resolved in different waysdepending upon the context in which it arises ([77]).

Were QY and QZ “Associates” of the Deceased?

Whilst the Act also permitted an application by arelative, neither QY nor QZ met the s 4 definition that

128 Bioethical Inquiry (2012) 9:125–133

required they be “any person to whom the person isrelated by blood, marriage, affinity or adoption.”

QY and QZ applied under the s 4 definition thatstipulates “associate of a person means: (a) any personwith whom the person associates, whether socially orin business or commerce, or otherwise, and (b) anyperson who is wholly or mainly dependent on, or amember of the household of, the person.” The crucialfinding by Young JA was shortly stated:

The definition of “associate” focuses on anyperson with whom the person associates. AsMr B was not a person at the time of the allegeddiscrimination and as a deceased person at thattime does not have people with whom he asso-ciates at that time, it must follow that neither QYnor QZ are associates who can complain ofdiscrimination ([145]).

Campbell JA ([2]) and Macfarlan JA ([75]) agreedwith this conclusion.

Despite being raised during oral submissions, therewas no full consideration in the judgments as to theambit of s 49P of the Act ([129]–[140]), which pro-vides that “nothing in this part renders unlawful dis-crimination against a person on the ground ofdisability if the disability concerned is an infectiousdisease and the discrimination is reasonably necessaryto protect public health.”

An Incidental Issue—Immunity

Obiter comment was made by Young JA as to thepossible application of s 52A of the Coroners Act1980 (NSW): “Nothing done by a medical practitioneror other person in good faith for the purposes ofmaking a post mortem examination, or a special ex-amination or test, pursuant to a direction under thisAct subjects the person personally to any action, lia-bility, claim or demand.”

Under that section, he said, one would think that themedical practitioners who were involved in the postmortem would be exempt from any civil liability([157]). There was also a suggestion that there wasno liability with a postmortem being conducted underthe direction of the Coroner forming a part of thejudicial process ([162], referring to s 44B of the Judi-cial Officers Act 1986 (NSW); thus, the Local HealthNetwork was not vicariously liable ([163]).

—Tina Cockburn and Bill Madden

Anti-Vaccination Sentiments and Health CareComplaints

Recently, the NSW Supreme Court has upheld claimsby the Australian Vaccination Network (AVN) that itshould not be forced to placed warnings on its websiteregarding the information it promotes on vaccinationrisks (Australian Vaccination Network Inc v HealthCare Complaints Commission [2012] NSWSC 110).

The AVN is a northern NSW-based group thatclaims to provide educational materials on vaccinationbut is viewed by many as being anti-vaccination innature. Two complaints were lodged against the AVNwith the Health Care Complaints Commission(HCCC) alleging that the AVN had engaged in mis-leading or deceptive conduct in order to dissuadepeople from being or having their children vaccinated.After investigating the claims, the HCCC ordered theAVN to publish a disclaimer on its website and, whenthe AVN refused to do so, the HCCC issued a publicwarning:

The AVN’s failure to include a notice on its web-site of the nature recommended by the Commis-sion may result in members of the public makingimproperly informed decisions about whether ornot to vaccinate, and therefore poses a risk topublic health and safety (HCCC 2010, ¶9).

Soon after, the AVN lost its charitable status underthe Charitable Fund Raising Act 1991.

The AVN then went to court to argue that theHCCC’s decisions were beyond power, as the AVNwas not a “health service provider.” Adamson J found(at [45]) that the HCCC only had the power to regulatehealth service providers and that required that the “ser-vice … has a concrete (even if indirect) effect on aparticular person or persons … within jurisdiction.Complaints about health services that have a tendencyto affect a person or group, but which cannot be shownto have had an effect, would appear to be excluded.”After analysing the evidence, Adamson J found (at [59–60]) that the AVN had not affected the health care of aparticular person:

59 Although I find that both complaints concernthe health service that the plaintiff provides, thehealth service has not been shown to “affect theclinical management or care of an individualclient”. Although it might have that tendency,

Bioethical Inquiry (2012) 9:125–133 129

and although the plaintiff hopes to have thateffect, I do not consider this to be sufficient toestablish that it has had that effect.60 I do not consider the evidence to be reliedupon by the HCCC to be sufficient that there wassuch a causal link, or that any link could beestablished in respect of “an individual client”.Had the HCCC apprehended that such would berequired to found jurisdiction, it presumablycould have readily obtained such evidence fromone of the complainants. However, the ease withwhich it might have done so is not the test. It didnot do so. As I have found, the evidence adducedbefore me is not sufficient to bring the com-plaints within s 7(1)(b) of the Act.

On that basis, the court found that the HCCC hadno power to investigate the claims against the AVN orissue its direction and public warning. The decision issignificant in the way that shows a jurisdictional gapin the HCCC’s powers to investigate and curb theprovision of misleading health information. Perhapsanother tack would be for other regulators such as theAustralian Competition and Consumer Commission toinvestigate the AVN for misleading and deceptiveconduct, but that entity’s powers are based on compa-nies being involved in “trade and commerce.”

—Cameron Stewart

TB Management in India: Public Health, Ethics,Social Considerations, and Human Rights

India accounts for about one-fifth of the global burdenof tuberculosis (WHO 2010b). In 2008, there werealmost 100,000 cases of multidrug resistant tubercu-losis (MDR-TB) (WHO 2010c), which amounts tomore than 20 percent of the global incidence (Bhatia2010). Traditionally, TB diagnosis in India, like sim-ilar resource-constrained settings elsewhere, has beenhampered by slow turnaround times. However, thenew Xpert MTB/RIF test has demonstrated sensitivedetection of TB as well as Rifampicin-resistance direct-ly from untreated sputum in less than two hours(Boehme et al. 2010). It thus holds the promise ofadvancing TB surveillance by yielding rapid, reliable,and accurate TB diagnosis. Notwithstanding its short-comings—high cost, limitations in testing only forRifampicin-resistance, detection of a relatively smallnumber of mutations, and inability to indicate which

patients are sputum smear-positive (Small and Pai2010)—its introduction in resource-constrained settingspromises to change the TB landscape. India’s currentTB management strategy, however, in which the statesector relies primarily upon smear microscopy for TBdiagnosis while the country’s private sector heavilyuses serological testing to diagnose TB (Specter2010), presents a growing public health humanitariandisaster and serious opportunity cost and, thus, meritsurgent revision. This work considers the ethical impli-cations of the wide misuse of serological TB tests in theIndian health sector. It also briefly reviews some of thesocial and human rights implications of introducing theXpert MTB/RIF test in India.

Rethinking Diagnostic Technologies

Tackling TB in India will require a shift in thinkingabout diagnostic strategies. Almost half of TB patientsin India may seek care initially in the private healthcare sector, where serological testing is widespread(Steingart, Pai, and Dowdy 2010; Ghanashyam 2011)and diagnostic, treatment, and reporting practices of-ten do not meet national or international standards forTB (Uplekar et al. 1998; Sehgal et al. 2007).. Currently,the market value for serological testing in India’s privatesector is conservatively estimated at no less than US$15million per annum (Steingart, Pai, and Dowdy 2010;Ghanashyam 2011). In comparison, the Indian govern-ment’s Revised National TB Control Programme’s(RNTCP) total budget in 2008 was US$67 million(Muniyandi et al. 2010). Despite the extensive use ofserological testing in India, no international guidelinesrecommend serological TB tests for clinical use and noserological TB test has been approved by the U.S.Federal Drug Administration. Further, systematicreviews of commercial serological antibody detectiontests for the diagnosis of pulmonary tuberculosis havedemonstrated the shortcomings of this technology forpulmonary TB diagnosis (Pai, Ramsay, and O’Brien2008; Steingart et al. 2007a, b), leading one such studyto conclude that this technology has “little or no role inthe diagnosis of pulmonary tuberculosis” (Steingart etal. 2007b, 1041). This mounting evidence has led theTuberculosis Coalition for Technical Assistance(TBCTA), whose partners include the World HealthOrganization (WHO) and the International UnionAgainst TB and Lung Disease, to declare: “serologicaltests are not of proven value and should not be used in

130 Bioethical Inquiry (2012) 9:125–133

routine practice at this time” (Tuberculosis Coalition forTechnical Assistance 2009, 31). TheWHO expert groupand Strategic and Technical Advisory Group on Tuber-culosis (STAG-TB) have concluded that serology test-ing for TB is unreliable. In July 2011, the WHO issuedan unprecedented negative recommendation regardingthe use of serological tests for active TB diagnosis (StopTB Partnership 2011). Based on this, the laboratorycommittee of the RNTCP issued a letter endorsing theWHO expert group recommendations and advised thecentral TB division in the health ministry to disseminatethe information in India (Deputy Director General, HeadCentral TB Division, Project Director RNTCP 2011).This is a welcome step for TB control in the country.However, just issuing a letter supporting the recommen-dations of the WHO expert group is not enough. TheIndian government needs to actively ban the use of TBserological tests and ensure compliance in the interestsof public health. In addition, the government needs,where feasible, to supplement the use of smear micros-copy with newer, more promising technologies such asXpert MTB/RIF. The Indian government should alsoencourage operational research that considers variouspermutations and combinations of new and existingtechnologies (including smear microscopy but exceptingserology) to determine the optimal mix for India.

Patient care should be centred on evidence-basedpractice. As such, the continuing usage of serologicaltests for TB diagnosis violates patient rights as thetests are unreliable. Further, as serological testing iscomparatively expensive and is usually paid for bypatients directly, it imposes an unjustifiable financialburden on patients. The test results might be used toinitiate treatment that is clinically not indicated, thusputting patients at risk of unnecessary side-effects ofprescribed medications. Alternatively, treatment mightnot be initiated when indicated, leading to TB patientsnot being treated in time. This not only adverselyaffects the patient’s health but also potentially createssignificant public health concerns. Clinical use of suchtests is, thus, clearly unethical and needs to be curbedby physicians and medical associations.

Human Rights, Ethics, and Social Challenges Implicitin Rolling Out the Xpert MTB/RIF Test in India

While the WHO has endorsed rapid diagnostic testssuch as liquid culture (BACTEC/MGIT), molecular lineprobe assays, and rapid strip-based detection and

speciation (WHO 2010a), the rollout of the Xpert test—which demonstrates superior performance to the afore-mentioned technologies—in a resource-constrainedsetting such as India raises numerous challenges.

In instances where novel rapid TB diagnostic tech-nologies such as Xpert MTB/RIF reveal that patientsare infected with drug-resistant forms of TB (and,accordingly, potentially incurable), authorities mayhave to consider imposing relevant liberty-restrictingmeasures on these individuals as a last resort if theyrefuse to comply with infection-control directives.Such measures may affect the infected individual’sliberty, livelihood, and dignity (Singh, Upshur, andPadayatchi 2007; WHO 2010c). Liberty-restrictingmeasures may also necessitate authorities initiatingrelevant social security or assistance mechanisms tosupport those whose rights are being restricted. Thesemight include social security grants where isolation ofthe infected individual is warranted and particularly ininstances where the infected individual is a primary orsole breadwinner and/or caregiver. Such measures willsatisfy the public health ethics principle of reciprocity,which requires the state and society to compensatethose who make sacrifices for the greater good. Suchsocial security or assistance services may even beconstitutionally mandated in some settings (Singh,Upshur, and Padayatchi 2007; WHO 2010a, b, c, d).While the right to social security is not explicitlyrecognised in the Indian Constitution, Article 41 ofthe Indian Constitution states: “The State shall, withinthe limits of its economic capacity and development,make effective provision for securing the right towork, to education and to public assistance in casesof unemployment, old age, sickness and disablement,and in other cases of undeserved want.”2

If inadequate TB treatment facilities (especially forthe treatment of drug-resistant forms of TB) exist inthe public sector, the Indian government may have toconsider home- or community-based isolation andcare. In such instances, relevant training for caregiversand the provision of universal precautions will have tobe made available to health personnel, caregivers, andother individuals at risk of infection. However, themerits of home-based care for drug-resistant forms ofTB in India will have to be given careful thought,particularly in the urban context given the generally

2 The Constitution of India is available at http://lawmin.nic.in/coi/coiason29july08.pdf.

Bioethical Inquiry (2012) 9:125–133 131

overcrowded conditions of most urban informal settle-ments in the country. Aside from the public healthimplications of housing drug-resistant infected indi-viduals in such overcrowded settings, a key ethicalissue here is that, if household contacts of MDR-TBpatients are found to have latent TB infection, there isreally no straightforward treatment option. And inmany countries including India, latent TB infectionis rarely treated.

Because of the stigma associated with TB in somesettings (particularly in the case of potentially incur-able drug-resistant strains), authorities will have toinitiate and/or ramp-up relevant myth-dispelling andstigma-mitigating measures—such as awareness cam-paigns that emphasize that TB is usually curable (ac-knowledging, though, that cure rates are poor inMDR-TB) and that highlight the human rights of thoseinfected. Such measures will satisfy the ethics princi-ple of solidarity, which emphasizes standing by andaiding those who need assistance.

TB Treatment and Management: A Need for RenewedResearch and Funding

Besides the challenges outlined in above, it also is pru-dent to remember that there has been a lack of researchand development focused on new TB drugs. As a diseaseof continuing global health importance, there is a need forthe development of new regimens that offer more effi-cient TB control, especially against the backdrop of risingTB resistance rates. The Indian government and medicalresearch bodies must take a leadership in this area.

TB management in India requires a radical overhauland urgently. This will require moral and politicalfortitude and will undoubtedly have major resource,human rights, ethics, and social implications. Howev-er, maintaining the current status quo is not an optionand will have dire public health implications for thecountry. What’s more, it is morally indefensible.

—Jerome Amir Singh, Anant Bhan, and Ross E.Upshur

Acknowledgments The views expressed by the authors in thesection “TB Management in India: Public Health, Ethics, SocialConsiderations, and Human Rights” are their own. Theseauthors thank Jocalyn Clark, Peter A. Singer, Shane Green,Peter Small, Madhukar Pai, Anjali Nayyar, Sukriti Chauhan,David Gold, and Renaud Boulanger for their comments onearlier drafts of the manuscript.

Contributions Jerome Amir Singh and Anant Bhan draftedthe manuscript. Ross E. Upshur provided key input thereon.

Funding The Bill and Melinda Gates Foundation is the pri-mary source of funding for the project related to “TB Manage-ment in India.” Jerome Singh also receives support from theCentre for the AIDS Program of Research in South Africa,which forms part of the Comprehensive International Programof Research on AIDS funded by the National Institute of Allergyand Infectious Disease at the National Institutes of Health andthe U.S. Department of Health and Human Services. Ross E.Upshur also receives support from the University of Toronto’sJoint Centre for Bioethics through a Canada Research Chair andfrom the Sunnybrook Health Sciences Centre in Toronto. Thefunders had no role in the decision to submit or in the prepara-tion of this paper, other than providing comments on earlierdrafts.

Conflict of interest The authors associated with the section“TB Management in India” work on the ESC2 Program inGlobal Health, which is funded by the Bill and Melinda GatesFoundation. Earlier versions of the manuscript were circulatedto program officers of the funder, who had an opportunity toprovide comments.

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