segunda-feira, agosto 28, 2006
Testing, testing 1,2,3
 Anand Grover is a practicing lawyer in India and the Project Director of the Lawyers Collective HIV/AIDS Unit having its offices in Mumbai, Delhi and Bangalore. He can be contacted at firstname.lastname@example.org.
Opt-out routine testing—a flawed strategy
The next point I want to address is the very important issue of opt-out routine testing.
For years testing for HIV has based on the Voluntary Counseling and Testing (VCT) model. From early 2004, Botswana, which is hailed as an ideal, had actively adopted opt-out routine testing in its program. In June 2004, UNAIDS recommended the routine offer of testing based on the Botswana model. This model is now being followed in other countries including Kenya, United Kingdom and some places in the United States, in particular San Francisco. The current US CDC and WHO recommendations too reflect this.
The change was heralded not only because of the fundamental change in the treatment scenario of HIV, the success of the triple combination therapy from 1996, but more fundamentally on account of the availability of cheap supply of first line generic ARV drugs, primarily from India. However, it may be pointed out that some commentators have gone as far as stating that, “Current guidelines restrict the use of routine testing to settings in which antiretroviral therapy is available. We believe that the recommendations should support routine testing wherever basic HIV care and prevention are available.”
What is the opt-out routine testing model? Basically, nearly all patients are tested for HIV as a routine part of medical visits unless they explicitly refuse. In contrast to the VCT model, there is very little or no emphasis on pre-test counseling. In addition, all patients should receive essential information about HIV and be informed about the right to refuse. Moreover consent is effectively done away with.
There is quite an active debate on this issue. Let me attempt to summarize its contours.
Firstly, it is the case of the proponents of opt-out routine testing that the pre-test counseling model that had been adopted earlier in the HIV epidemic may have been valid in the era when there was no treatment available. However, now that treatment is available the pre-test counseling model is redundant. Secondly, in the context of availability of treatment, it is important that people test so that treatment is made available to them. Thirdly, pre-test counseling takes a lot of time and resources that are better utilized for testing. Fourthly, it has only created HIV/AIDS exceptionalism, which has only fuelled the societal stigma around HIV. Finally, as a result, pre-test counseling has dissuaded persons from taking an HIV test or created a barrier or impediment to testing and therefore the very delivery of treatment.
These are all vital issues and no doubt we will have a lot of opportunities to debate these throughout this week. There is indeed a need for extensive debate on this issue. Therefore let me also add a few points that I think that are important in this very vital debate.
Undoubtedly the vast majority of the People Living With HIV do not know that they are HIV- positive. It is in their interest to know that they are indeed HIV-positive so that they can protect themselves by taking appropriate treatment and also protect others. Therefore scaling up of testing is of the utmost necessity. There can be no two opinions on this proposition. The real question is how this should be done and whether opt-out routine testing is the best option globally in the circumstances that obtain today or in the near future. Questioning the modalities of opt out routine testing does not in any detract from the commitment to universal access.
ART delivery is not possible throughout the world
It is clear that the opt-out routine testing model is conditional on the universal access to treatment. Unfortunately, with all my optimism on all issues, I am apprehensive that universal access will not be a reality in the near future for the vast majority of People Living With HIV in developing countries.
At the global level, the 3 by 5 initiative was able to reach only approximately 50% of its target by 2005.
In my country, India, where the estimate of People Living With HIV in 2006 is nearly 5.2 million in the adult population (15 to 49 years), anywhere from 500,000 to 700,000 require ART. However the Government of India’s target is to provide free first line treatment to only 188,000 and that too only by 2010. As yet there is no provision for the second line drugs that will be increasingly required.
Most of the funding for the provision of ARV drugs comes from the Global Fund. According to the UN 2006 Report on the Global AIDS Epidemic, the funding gap for Global Fund is US $6 billion in 2006 and will increase to US $8.1 billion and 2007. Huge efforts have to be made to close this gap.
What this means is that ARV treatment may not be available to a vast majority of the People Living With HIV. In that case the opt out routine testing is not really a practical option at all.
The principles of consent need to be protected and promoted
My other concern with opt-out routine testing is the fact that it does away with consent, which is a precious human right.
The law in common law countries, (i.e. English speaking and the erstwhile British Commonwealth), is quite clear. As the US Supreme Court judge, Justice Cardozo, put it in his classic statement, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation on his patient without his patient’s consent commits an assault, for which he is liable in damages.” This proposition has been accepted in common law jurisdictions that have held that every person’s body is inviolate. The exceptions are limited to emergencies, persons who are not conferred the legal capacity to consent (who are not of “sound mind” and those who are minors in law) when the doctrine of necessity may come to the rescue of the health care provider. In JWB and SMB’s case, Justice Brennan of the High Court of Australia pointed out that international human rights instruments also adopt the same principles. On that basis, he held that human dignity required the protection of the physical integrity of a human being.
The necessity of taking consent not restricted only to treatment. It also applies to diagnostic testing. Significantly it has been held by the House of Lords in England that, “there is no doubt that a person of full age and capacity cannot be ordered to undergo a blood test against his will.” The House of Lords added a warning, which is relevant for our purposes and said, “The real reason is that English law goes to great lengths to protect a person of full age and capacity from interference with his personal liberty. We have too often seen freedom disappear in other countries not only by coups d’etat but by gradual erosion, and often it is the first step that counts. So it would be unwise to make even minor concessions.”
As Justice Brennan, in the case of JWB and SMB, pointed out, such principles are now adopted in international humanitarian law. Do we need to sacrifice such important principles adopted by domestic and international law for scaling up HIV testing? I would respectfully submit that such principles cannot be sacrificed easily. At the minimum there must be compelling reasons to do so. Are scaling up of treatment and the Botswana model compelling enough reasons? That is the key question.
The doctor-patient relationship is inherently unequal for reasons of knowledge, skill that the doctor possesses and trust reposed by the patient in the doctor. The opt out routine testing model also wrongly assumes that everyone is equally empowered. With such inequality will patient be able to refuse even if s/he is informed of her/his right to refuse?
Necessary information is given to the patient to enable her/him to give consent. The skill that the doctor possesses and the trust reposed by the patient remains intact though modified. However, knowledge is imparted. The information assists the patient to make a decision. Though consent has been well rooted in the common law tradition, informed consent is of recent origin. Most jurisdictions now accept that consent means informed consent and it implies at least informing the patient about the benefits, risks and alternatives. From Canterbury v Spence in the US, it has traversed through Riebl v Hughes in Canada, and to an extent accepted in Pearce v United Bristol Healthcare Trust NHS.The trend is clear. Even outside HIV the trend has been to adopt informed consent principles.
While in developed countries informed consent is well-rooted not only in the law but also in practice, more particularly in the health care setting, that is not the case in most developing countries.
In India for instance, as is the case with a lot of the erstwhile Commonwealth countries, the principles of consent developed in the common law of England are readily followed by judicial authorities. However, these principles are not strongly rooted at the field level in the health care set up. Thus, for example, consent is a formality in case of admission to a hospital and surgical interventions in India. Consent is not really voluntary. Informed consent in the health care setting is not a reality even in major interventions outside HIV.
It is in this context that HIV came on the legal scene in India and perhaps in a lot of the developing countries. The HIV epidemic in developing countries, in one sense, provided an opportunity to reaffirm the principles of consent and confidentiality in the legal sphere and try to firmly root them in the health care set up. Most of our advocacy efforts in the last ten years have been to promote and protect these principles in the health care system. I would say that we have achieved some measure of success. However, given that these require a change in the mind-set of the heath care provider, who is most interested in getting a job done, it has been a long haul with a lot of resistance. Ironically one of the factors that assisted us in the advocacy to reaffirm these basic principles was the lack of treatment for HIV and the enormous stigma associated with it. We are a long way off from getting these principles accepted at the ground level in practice. In this scenario if opt-out routine testing is recommended globally the clear message for all the medical fraternity in the developing world would be to test all persons without consent, i.e. mandatory testing.
Even the proponents of opt-out routine testing fear that such a policy may turn out to be coercive. Thus, Kevin De Cock has this to say, “Careful guidance is required, however, to determine how to implement such testing without coercion and how to limit the negative social consequences of a pre-marital diagnosis of HIV infection, especially for young women.” I fear that in most developing countries implementation of the test will in fact be with coercion.
Botswana cannot be the only model
The opt-out routine testing model is largely based on the experience in Botswana. What is the experience there? According to Alexander Jarvis, in a study of antenatal clinics in Botswana’s second city, Francistown, it was found an increase in uptake of women testing for HIV from just over 75 percent in the last four months of the VCT approach to 90.5 percent in the first three months of the new policy of opt-out routine testing. But compare that to other countries and you realize that it is not a great jump. What are the figures for India? In 2005, across India nearly 1,134,839 had registered on the PMTCT program. 88.13% of those counseled in the PMTCT program went in for the HIV test. Another case in point is Uganda where 95% of those who were counseled in home visits agreed to test for HIV. Of these, 88% were first-time testers. Therefore Botswana does not appear to be a case that needs to be followed globally.
Can we do something about the Counseling?
Apart from jettisoning effective consent the other change in opt-out testing is to effectively do away with pre-test counseling.
Counseling strategies were developed in the era when treatment was not available to the People Living With HIV. Pre-test counseling prepared a person not only for the test but also for the consequence of coping with a positive result without any treatment. It could not have possibly prepared one for treatment that became available later. As the treatment situation changed in the HIV context, both in terms of triple combination being found effective and the drugs becoming affordable and accessible, protocols for counseling, both pre-test and post-test needed to be overhauled drastically. However that does not appear to have been done.
It is well documented that though the process of counseling was changed over a period of time, the content did not change to include information about availability of treatment even after treatment became available.
What about Botswana? Why were people in Botswana not going in for testing? One would expect that a person informed of the benefits of testing would opt for testing. Undoubtedly, fear of stigma and stigma is a factor that dissuades a person from testing. Was not the health care system in Botswana tackling stigma? What about counseling in Botswana? Was there a problem in the content of pre-test counseling or in the way that it was administered? In a report according to Dr. Howard Moffat, medical superintendent at Princess Marina Hospital in the capital, Gaborone, “People who were not sure they wanted to know their HIV status often emerged from counseling determined not to be tested.” He added, “I think the medical profession itself ... played a major role in creating this fear of AIDS and this quite irrational reluctance to be tested.” According to the same report, “Doctors here believe pulling patients aside for special counseling is intimidating and helps fuel the stigma that keeps patients from seeking help.”
It appears, therefore, that the manner in which counseling was being administered in Botswana raises a lot of concerns. We do not know about the content of counseling. But it appears that it was the pre-test counseling that pushed persons away from testing. Thus, pre-test counseling which was meant to help People With HIV to cope with life had become a tool of terror in the hands of the health care providers. If that be the case, one can hardly come to the conclusion that pre-test counseling in the manner that it is to be actually administered has become an impediment.
In these circumstances, I would submit that serious issues arise about the content of counseling and the manner that it is to be administered. Certainly it does not warrant a global strategy of testing based on the Botswana model of opt-out routine testing.
How do we ensure non-discrimination?
All the proponents of opt-out testing articulate that the model should be adopted on the basis of certain guarantees and/or assurances. Kevin De Cock states, “We recommend routine testing for HIV for persons in key occupations, with guarantees of confidentiality, protection against discrimination, free treatment for infected persons, and post-exposure prophylaxis as appropriate.” Edwin Cameron states, “There must be some assurance that the consequence of diagnosis will not be discrimination and ostracism; and the patient should be secure that the testing procedure and its outcome will be treated as confidential.”
It is difficult to understand how these guarantees or assurances would, especially in the context of pervasive stigma, have any meaning in real terms. Unfortunately, it is impossible to control stigma because it operates in silent, secretive and subversive ways. The law only steps in much later, after the event, after the damage has been done. Even then, at best, it compensates the individual in monetary terms but cannot restore the damage that is caused to the psyche of an individual.
The real challenge is to control stigma within communities and within individuals. We should focus our energies on that. What we need is a massive investment in programs to de-stigmatize HIV and make People Living With HIV acceptable in society. With such general awareness, the content of pre-test counseling has to change making an HIV test a positive step to be taken rather than frightening the person away from it. Pre-test counseling is essential not only because it is the only entry point of information for persons who may test negative but also for those who test positive so that messages of prevention, safety, treatment availability and adherence are imparted. The more that ART becomes the norm, the more the money and resources that will have to be spent on counseling, even post-test. Pre-test counseling will become a routine part of the counseling continuum.
It is in this context that I would respectfully disagree with Edwin Cameron who, while supporting opt-out routine testing, has made the point that though pre-test and post-test counseling are both useful they should not be carried out at the expense of draining away time and energy of health care personnel whose priority should be diagnosis, testing and treatment. The point is not of pitting one against the other but viewing pre-test counseling as an essential aid to testing.
 “Financing the Response to AIDS”, Chapter 10, in 2006 Report on the Global AIDS Epidemic, UNAIDS, 2006, p. 249, available at http://www.unaids.org/en/HIV_data/2006GlobalReport/default.asp.
 Schloendroff v Society of New York Hospital, 211 NY 125, pp. 129–130 (1914).
 In England: Sidaway v Governors of Bethlem Royal Hospital,  AC 871, St. George’s Healthcare NST v S,  3 All ER 673 (CA); In Canada: Reibl v Hughes,  2 S.C.R.. 880 : (1980) 114 DLR (3d) 1, Mallet v Shulman, (1990) 67 DLR (4th) 321 (Ont CA); In Australia: Secretary, Department of Health v JWB and SMB,  HCA 15 : (1992) 66 ALJR 300.
 S v S,  3 All ER 107.
 JWB and SMB supra note 13.
 See Lawrence Gostin, “The HIV Infected Health Care Professional: Public Policy, Discrimination, and Patient Safety”, (1990) 18 (4) Law, Medicine and Health Care, 303–10.
 464 F.2d 772 (DC Cir. 1972).
 Reibl supra note 13.
  EWCA Civ 865 (20 May 1998) : (1998) 48 BMLR 118 (CA) (basing the doctor’s obligation to inform on the significant risk to the patient).
 De Cock supra note 9, p. 441.
 Alexandra Zavis, “Bostwana adopts new approach to HIV tests”, courtesy South African Press Association, 5 January 2006, available at http://ww4.aegis.org/news/sapa/2006/SA060102.html.
 “UNGASS India Report”, National AIDS Control Organisation, Ministry of Health and Family Welfare, Government of India, New Delhi, 2005, available at data.unaids.org/pub/Report/2006/2006_country_progress_report_india_en.pdf.
 See “High discordance rates among Ugandan ART clients new prevention approaches”, AIDSMAP News, available at http://www.aidsmap.com/en/news/0619D2A9-1319-41D6-8515-244E05F2B60F.asp
 See Nicholas Sheon, “Theory and Practice of Client Centered Counseling and Testing”, Center for AIDS Prevention Studies, University of California, San Francisco, HIV Insite Knowledge Base Chapter, June 2004, reviewed in January 2006, available at http://hivinsite.ucsf.edu/InSite?page=kb-07-01-04. See for example, “HIV Counseling and Testing”, Family Health International, available at http://www.fhi.org/en/Topics/Voluntary+Counseling+and+Testing+topic+page.htm.
 Alexandra Zavis supra note 23.
 De Cock supra n. 9, p. 442.
 “AIDS: Building on Hope and Reason”, (Speech delivered by Justice Edwin Cameron, Judge, Supreme Court of Appeal at South Africa, Bloemfontein, at Oxford University on 23 June 2006).
 See “United Kingdom National Guidelines on HIV Testing”, British Association of Sexual Health and HIV, June 2006, available at http://www.bashh.org/guidelines/2006/hiv_testing_june06.pdf ; Erin Allday, “City health agencies move to streamline HIV testing San Francisco drops counseling requirement”, San Francisco Chronicle, 18 May 2006, available at http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2006/05/18/BAGHTITPRQ1.DTL.
 See “Revised Recommendations for HIV Testing of Adults, Adolescents and Pregnant Women in Health Care Settings” (Draft March 2006), available at www.hwadvocacy.com/update/newCDCrecomendations.pdf.
 See Kevin M. De Cock et al, “Unfinished Business—Expanded HIV Testing in Developing Countries”, New England Journal of Medicine, 354;5 (2 February 2006), 440, p. 440, available at content.nejm.org/cgi/reprint/354/5/440.pdf .
 See Sheri D Weiser et al, “Routine HIV Testing in Botswana; A Population-based Study on Attitudes, Practices and Human Rights Concerns”, Public Library Of Science Medicine, July 2006, volume 3, issue 7, 1013, p. 1014, available at medicine.plosjournals.org/perlserv?request=get-document&doi=10.1371/journal.pmed.0030261.