The trouble with Public Health: HIV/AIDS in Canada as a case in point

Here's my latest Editorial from the February issue of Bioethics

It has been known among HIV/AIDS specialists for many years that infected people are for all practical intent and purposes unable to transmit the virus on to their sex partners, provided they consistently take anti-HIV medicines that render the amount of the virus in their bloodstream undetectable. Common sense would have suggested that Public Health authorities should have acted on this knowledge and ensured that it is deployed in such a way that it contributes toward the maximisation of desirable public health objectives, in this case, obviously the reduction in number of new infections. Public Health agencies should have revamped existing policies demanding that infected people disclose their HIV status to their sex partners to no disclosure required where ‘your viral load is undetectable for 12 months’ or some such figure. This would have dramatically increased the attractiveness of getting tested, of getting infected people discovered in a more timely fashion, getting them treated in a more timely fashion, and ultimately getting their viral load to undetectable in a more timely fashion. The predictable result of this policy change: A significant reduction in new HIV infections. Common sense and Public Health are sadly all too often residing in different realities.

Nothing of this sort occurred during the last few years. HIV infected people with undetectable viral loads were prosecuted for not disclosing their status. Public Health agencies, when given a chance, would disclose their HIV status to their sex partners. The contact tracing Public Health surveillance machine remained in overdrive in countries such as Canada. About 200 carriers of the virus were prosecuted over the years in that country alone. None of this served the public health objective just outlined, and none of this was evidence driven. Rather, it was driven by views on HIV/AIDS that may have had a place in the 1980s to early 1990s when AIDS was considered as a serious public health concern. Today, with negligibly low new infections rates, it is worth asking why HIV remains high on the agenda of Public Health agencies. HIV is clearly not a public health concern in Canada and most other countries of the global north. My suspicion is that the threat of prosecution serves purposes unrelated to HIV, they serve to control consenting adults’ sexual behaviours.

Much is made of the fact that an estimated 1:5 Canadians who are infected with the virus are unaware of their infection. What is typically not mentioned by the same Public Health officials is that they have gone out of their way to make it difficult for Canadians who are HIV infected to find out about their infection. Because the contact tracing government Public Health agencies want to know about each infected Canadian, by name and address, they cannot permit people at risk to test themselves with tests they can conveniently buy down south in the United States in every pharmacy. Unsurprisingly, a different government agency, the drug approval regulator Health Canada, has swung into action and threatened people with prosecution who import and resell reliable, US FDA approved, HIV self-tests into Canada, lest they would find out whether they are infected and Public Health not having their names and addresses on their records. You might not be surprised to learn that while STI testing and treatment is ostensibly free and anonymous at the country's Public Health agencies, in reality patients must show their provincial health insurance cards or else they are out of luck if they carry an STI but fail to provide the said card. The UK's NHS unsurprisingly manages public health in a manner somewhat more focused on infection control than administration.

It is no surprise then that in a country where government surveillance has been prioritised over and at the same time conflated with public health, people at risk of HIV infections remain reluctant to get tested. They have no reason to trust Public Health to act in a timely fashion in response to evidence.

In late 2017, Canada's federal government noticed after much studying what has been known for years about HIV transmission risk and undetectable viral loads. Both federal and provincial justice ministers appear to be finally acting in response to the existing evidence. Prosecutions of HIV infected people with undetectable viral loads who do not disclose their status to their sex partners are likely to be a thing of the past in that country.1

The main lesson I am suggesting we take away from this episode of HIV/AIDS prevention in Canada is to ask that Public Health agencies' policies should be held to public health outcomes, otherwise they serve no purpose. The cavalier approach to civil liberties taken not only by Canada's Public Health agencies, one that was not evidence based for many years, must be replaced by a policy approach based transparently on the latest scientific evidence. A golden rule in most public health ethics documents is that limitations on civil rights (in this case ownership of one's confidential health information) must be justified by significant benefits in public health outcomes, i.e., the public interest. HIV disclosure policies executed by Public Health agencies have failed this test for a very long time. Public Health agencies in Canada in particular have lost trust and support among people at risk of HIV infection because they lost sight of public health outcomes while focusing on Public Health administration and control. A paradigmatic case of how not to implement efficient infection control policies.

Footnote

1. 1
   Harris, K. (2017, December 1). Liberals want to limit prosecutions of people who do not reveal status to sex partners. CBC NEWS. Retrieved from http://www.cbc.ca/news/politics/liberals-hiv-criminalization-1.4428395

Grinding my gears - Truvada marketing

I don't know whether you watch Family Guy, but if you do you will recall Peter going on to become a minor TV celebrity in an episode where he goes on rants about whatever it is that's grinding his gears, as he puts it so succinctly.

Take this commentary in that spirit - I may have missed relevant information (aka Peter …). I know that HIV prevention/Tx folks check on this blog every now and then. Consider yourselves invited to enlighten me if I missed a beat.

So, Truvada marketing by WHO and other assorted HIV prevention folks is grinding my gears in a big way these days. WHO reportedly advises that sexually active HIV negative gay men in sero-discordant relationships should go on Truvada. What grinds my gears is that to date there is not a single documented case of HIV transmission from an HIV positive guy on HAART whose viral load is undetectable, courtesy of that medication, to his sex partner. For the sake of the argument, assume that there are in fact a (very) small number of such transmissions happening. How can that be a good reason for advising every HIV negative gay man in such a relationship to initiate a regime of - frankly - fairly toxic drugs for ever (i.e. while he is sexually active)? Unlike Gilead's information on its Truvada website, the UK NHS provides a clearer picture of what you HIV negative gay guys can expect if you choose to join the Truvada train. These ain't sugar pills.

What grinds my gears it that we have zero clinical evidence that folks who take Truvada prophylactically, and say, successfully, throughout their sexually active lives, fare any better than those who wait with going on HAART until they sero-convert. What one would want to know, obviously, is whether folks who wait for a possible infection and then get treated, fare any worse in terms of mortality/morbidity than those who have boarded the Truvada train at gigantic cost to the health care system or their insurance company or to themselves. The truth is, we don't know that. This hasn't stopped WHO from marketing Truvada busily on behalf of Gilead, the drug's manufacturer.

Some have argued that folks would typically only need to use Truvada for a few weeks prior to an unsafe sexual encounter and then possibly use post-exposure prophylaxis afterwards. So, the argument continues, they'd be better off than those who'd sero-convert and have to take HAART for the rest of their biological lives. I'm sure Gilead's sales executives quietly laugh at this logic, because none of us plan for an unsafe sexual encounter (you know, in the real world nobody will say, hey, I'm going to have unsafe sex in six weeks time, lemme go on Truvada now, when unsafe sex done, I'll stop it again - sex doesn't quite work like that). In any case, post-exposure prophylaxis works in around 92-95% of cases, so why not stick to such a regime if you had unsafe sex with someone who's HIV positive and doesn't have an undetectable viral load.

Now, this was what I consider the strongest rationale for advising sexually active men to go on Truvada as a means of HIV prevention. Apparently, WHO hasn't quite left it there and went all out, it recommends that all 'men who have sex with men consider taking antiretroviral medicines as an additional method of preventing HIV infection'. This quote is from WHO's own press statement on the release of its report.

Talking about grinding my gears, this definitely does. For starters, the majority of sexually active gay men do not become HIV infected. And yet, WHO thinks they all should go permanently on highly expensive  - prices admittedly vary, in Canada they're at 1100 $ p/month, in South Africa at a more palatable 9$/month - and fairly toxic drugs. At this point in time we do not even know what the impact on their health would be 20 years down the track. As mentioned earlier, even for those who might become infected we do not know whether they might not be better off beginning treatment after they got infected than using comparable drugs throughout their lives to prevent an infection.

Let me cut thru the chase here: If WHO was an honest organization, it would concede that the only sound motive for advising all sexually active gay men to begin taking Truvada is a public health rationale, and not the health of those who take those drugs. Incidentally, that makes sense, WHO does mostly public health stuff anyway. If all or most sexually active gay men would take Truvada, we'd probably be able to get rid of the bug over a generation or two. This would come at a medium to potentially high price paid by the majority of gay men who would take this drug even though they'd not have caught the bug anyway.

That being said, I'm not trying to persuade anyone not to go on Truvada, I don't know whether it's a good or a bad idea, what grinds my gears is that in the absence of crucial clinical questions being settled, sweeping recommendations are made by WHO with a view to putting perfectly healthy gay men throughout their sexually active lives on seriously heavy medication with a side-effects list as long as your weekend shopping list. This is dangerous, because the absence of vital clinical evidence suggests there ought not to be consensus advice of this sort.

I can't wait for NICE to step in here and call this nonsense for what it is, a marketing exercise.

Canadian Supreme Court reaches sensible decision on HIV transmission

Today the Canadian Supreme Court reached a sensible verdict on the tricky issue of the criminalisation of HIV transmission. It found - essentially - that folks who are HIV infected, on HIV medicine, and who have a low viral load (note, it is not a requirement that there is an undetectable viral load) and who use condoms, are under no obligation to disclose their HIV status to their sexual partners.

The main logic of the Court's decision is that if there is no significant risk of bodily harm (as is the case if the above mentioned conditions are met) the legal requirement to inform one's sexual partners of one's infection falls by the wayside.

Of course, many AIDS activists will be annoyed by this decision as it maintains the criminalisation of non-disclosure in cases where someone's viral load is not low, or where someone is not using a condom at the same time that his or her viral load is low, etc.

However, this decision makes a powerful, and sensible case to people at significant risk of HIV infection to get tested, and to get on HIV medication (both to protect their health and that of people they choose to have sexual intercourse with), as well as to use condoms each time they have sex with people they have not disclosed their HIV status to. In fact, this line of reasoning was developed in a paper I published in 2011. You can find it here, the argument runs from p. 310ff.

It might be worth noting that this decision by the Court was unanimous, something quite remarkable, considering the Harper government's recent appointment of four judges to the Court.

Truvada and HIV Pre-exposure Prophylaxis

So the US FDA has finally approved Truvada as an HIV Pre-Exposure Prophylactic (or PrEp if you fancy acronyms). I am not sure what to make of this, to be honest. The proposition here is to prescribe a chemotherapeutic to perfectly healthy people so they can protect themselves against HIV, at a cost of 13900 US$ per annum. What other protections are available? Use condoms. If you've sex with someone who's HIV positive and you want to have unsafe sex, make sure they're on HAART. If they are, the additional protection daily chemotherapy would offer to perfectly health people is close to non-existent and certainly not worth the cost paid. If you live in a society with high HIV prevalence, the odds are that it's a developing country. Your healthcare system should likely not even consider paying for such a prevention strategy, it's simply not cost effective, considering competing health needs in your society.

The drug was tested mostly on folks in high-risk groups who engage in somewhat unusual high-risk behaviour such as having plenty of unprotected sex with folks they do not know or folks they know to be HIV infected (the press release says nothing about the question of whether the latter group included folks who were known by their risk-taking participants to be on HAART), sex workers, etc. So, if you happen to belong to a group of people who engage in high-risk sexual behavior, you likely are disciplined enough to take daily chemotherapeutic drugs to compensate for your risk-taking. Really? This explains probably a 42% efficacy when compared to the placebo control. Adherence might have been a bit of an issue there...  That might also explain why the FDA requires Gilead to keep track of everyone who's (supposedly ) taking Truvada and gets infected anyway. Drug resistance seems a serious concern. Little seems to be known about pregnancy and Truvada, so that's being tested while the drug is being marketed. - Who knows, there might be a market in this high-risk segment of the population, even though it seems unreasonable to me that someone who enjoys such thrills should go on chemotherapy while healthy. Might they might not better wait until they're infected? Equally, in societies where the prevalence of HIV is very high (say, Sub-Saharan Africa), is the proposition to hook large numbers of perfectly health people on these heavy hitting drugs, 'just in case'?

As I said, I'm not sure what to make of this, but I am surprised about the logic of prescribing chemotherapy to healthy individuals as a 'just in case' strategy. Good for the shareholders of Gilead, the maker of Truvada though. You're making money off 'treating' the healthy... To be fair, it is anything but unusual that healthy people are being subjected to treatment in prevention efforts. Just think of flu vaccines, Hep B vaccination and so on and so forth. However, in the case under consideration the proposition is lifelong chemotherapy. That has quite a different ring and quality to it. We should take our time to discuss the pro's and con's of such a prevention strategy carefully, instead of diving headlong into it.

Ethical considerations in the use of anti-retrovirals for HIV prevention

Call for Papers

Evidence-based approaches to reducing sexual transmission of HIV has remained a major challenge in responding to the HIV pandemic.  The past 18 months has witnessed a substantial shift in this landscape.  Controlled trials have demonstrated that the treatment of individuals with HIV infection reduces the risk of viral transmission to uninfected sexual partners (treatment as prevention).  Additional evidence suggests the possibility of providing anti-retroviral medications to uninfected individuals may reduce the risk of acquiring HIV infection from sexual partners (PrEP— Pre-Exposure Prophylaxis).

In view of scarce resources, there will inevitably be a need to prioritize who will get anti-retroviral drugs; those who are sick, those who can transmit HIV, those at risk for acquiring HIV. Research that focuses on the balance between efficiency and equity will be involved.  Ethical frameworks for guiding decision-making at the clinical level as well as the macro social policy level will be essential.

Among the questions that will need to be discussed are:  

i.                    What rights claims can uninfected persons make for access to ARVs for prophylactic purposes when millions across the globe are dying from AIDS because they cannot access ARV treatment? 

ii.                   What moral claims can justify the provision of ARV therapy to those who do not yet clinically require treatment as a way of reducing the risks of HIV transmission?

iii.                  What normative issues are raised in making the determination that there is sufficient evidence to demonstrate the effectiveness of either PrEP or Treatment for Prevention? 

iv.                 How should the social and biological vulnerability of women to HIV infection inform discussion about the allocations of resources for either PrEP or treatment as prevention? 

v.                  If there is a risk that PrEP will increase the risk of drug resistance and compromise treatment options for those already infected, what ethical questions must be confronted? 

vi.                 What conceptions of procedural fairness and inclusiveness should shape decision making processes about these allocation decisions?

vii.                How should current research findings inform the ethics of trial design?

viii.               Given current evidence what moral issues involving the protection of research subjects should be considered in determining the extent of ancillary services and care that should be provided in prevention trials? 

This issue of Developing World Bioethics will be guest edited by Ronald Bayer (email: rb8@mail.cumc.columbia.edu) and Quarraisha Abdool Karim (email: abdoolq2@ukzn.ac.za), Mailman School of Public Health, Columbia University, New York, NY  10032  USA.

Deadline for submissions: 31 July 2012

Interesting developments on the AIDS frontiers

I suspect you might have missed one or another of the big-news events on the AIDS fronts. Nobel laureate and current president of the AAAS David Baltimore used his keynote address to the AAAS meeting this year to suggest that there's a distinct possibility (not to say high likelihood) that we won't be getting a successful preventive HIV vaccine ever.

The excitement over findings that male circumcision might drastically reduce HIV risk should be somewhat cooled down, because another study since discovered in the USA that that actually wasn't the case for circumcised black and latino men who have sex with other men.

Another piece in the puzzle is a consensus statement from HIV/AIDS specialists in Switzerland who declared that it is impossible for an HIV infected person to pass the infection on to his or her sex partners if she's on HAART and has a viral load of less than 40 copies/ml. In other words, successful medical control of the infection renders infected people non-infectious for all intent and purposes.

Indeed, it has even been suggested by some scientists that pre-exposure prophylaxis might work (ie people who are at high risk of getting infected should take AIDS drugs as a preventative means). Of course, today's AIDS drugs are essentially chemotherapeutics, so to suggest that healthy people at risk of HIV infection take them permanently (or at least while they engage in high-risk activities) seems a difficult to accept proposition, yet it might well work (just as post-exposure prophylaxis works) while there's no vaccine.

However, all of these discussions seem to be indicative of an ever-growing desperation among HIV specialists resulting from the absence of a working vaccine. The ongoing AIDS epidemics among the peoples of Southern Africa and the Caribbean suggest strongly that only so much can be achieved by throwing condoms at people... and so much, quite possibly, just isn't good enough. This is not the type of politically correct message the safe sex industry likes to hear, but surely the pandemic would not continue to run at such high speed if the safe sex campaigners had made significant inroads during the last few decades. To be fair, it might be that safe sex is currently more or less all there is, but it would be wrong to pretend that it is 'working' as they say.

Of course, living in North America these days, I do have access to truly bizarre religious cable channels. This crowd is actually trying to persuade Africans not to use condoms and instead be abstinent. I watched a fundraising programs from them the other day, in which these folks deliberately spread falsehoods such that condoms have little holes in them thru which HIV can spread anyway, and other such nonsense. It boggles the mind. The biggest lies were peddled by a guy in a black (long) skirt with a white collar - he claims, of course, to never have had sex in his whole life. These are the types of characters that, in yet another wave of Western colonialism, travel to Africa and try to persuade rural Africans to forgo the use of condoms when they've sexual intercourse.

Scary stuff. Well, it seems there's always someone out there to make matters worse, and the religious squad is never far from where that happens. As ever, due to some waffle about religious freedom, they cannot even be held accountable in a court of law for spreading lies.

Stuart Rennie on HIV Prevention

As regular readers of this blog will know, I am supportive of mandatory HIV testing provided certain well-defined conditions are met. Stuart Rennie seems to disagree. Here I reproduce his take on the issue. It's well worth reading. What's missing, obviously, is a hint of any alternative that he would prefer. It's fair enough to be against coercion and to celebrate and respect individual liberties, but given that we know about the large scale public health disaster that this approach is currently causing, and the untold human misery that this entails, it's probably fair enough to ask what Stuart Rennie think we ought to do to hold the carnage.

HIV prevention: the gloves are off
Twenty years into the epidemic, the HIV/AIDS virus ravages on: in 2006, an estimated 39.5 million people in the world were living with HIV, 4.3 million were newly infected, and 2.9 million AIDS-related deaths. Of the deaths, 2.1 million occurred in sub-Saharan Africa. As for new HIV infections, South Africa alone is estimated to have 1500 ... per day. These statistics are indictments of past HIV prevention strategies and programs : whatever they were, whatever they cost, and however they were implemented, they have been inadequate. The question then becomes: what strategy changes should be adopted?

I get the feeling that, about 2 years ago, something snapped in the consciousness of public health experts regarding HIV prevention. Enough was enough. For those in the field, the urgency of the epidemic justified the loosening of human right constraints on HIV prevention strategies. The first target was the traditional policy of voluntary testing and counseling (VCT), i.e. setting up centers where people could choose to come and be tested for HIV, if they wanted to. Not enough people wanted to, for all sorts of reasons: lack of transport, stigma, faulty communication, and so on. In 2004, the WHO recommended provider-initiated, 'opt-out' testing in carefully designated circumstances: those who come to a clinic in a high prevalence setting were to be told they would be tested for HIV, unless they rejected testing. The CDC soon followed suit with similar policies. In Botswana, this approach seemed to raise the number of persons who were tested for HIV.

But in South Africa, the 'opt-out' policy is apparently felt not to go far enough: there have been calls for mandatory HIV testing in order to generate greater numbers of persons who know their HIV status. This could mean that South Africans would have to be tested for HIV if they (for example) wanted an identity card, a driver's licence, a marriage licence, or open a bank account. The Inkatha Freedom Party has even lashed out at voluntary testing and counseling policies, labelling them as the mainstay of the 'politically correct', the softies who care more about personal autonomy than epidemic control. VCT, in other words, is for pussies. Not everyone is buying it, of course.

Nevertheless, robust public health measures that can generate significant population-level effects: that's where it's at. Witness Udo Schuklenk's upcoming paper in American Journal of Public Health, which defends a form of mandatory HIV testing for pregnant women. Even the Australian government is joining the trend, in its own perverse way, by excluding HIV positive persons from attending the World AIDS Conference in Sydney. Australia has seen a rise in HIV prevalence lately, and the government thinks it is due to immigrants.

Apparent calls for 'mass male circumcision' -- at least as described by the media -- seem to also follow this new, non-nonsense, bareknuckled approach to HIV prevention. Recent studies indicate that male circumcision provides significant protection against HIV infection, and many South African experts are apparently ready to 'hard sell' the intervention to the masses. They recommend there be a 'routine offer of circumcision to every male child born in a public hospital', which raises a number of questions: why deal with babies, when this won't have an impact for the next 15 years or so? How will communities respond to such aggressive policies? Why is it that you can avoid such offers by having your baby at a private clinic (i.e. being wealthy)? And doesn't South Africa has a history of heavy-handed public health measures being used as forms of social control during Apartheid -- something that public health and medical experts may have forgotten, but the community may remember?

The ethical concerns about confidentiality, autonomy and stigma seem to be increasingly regarded as obstacles to an unfettered, all-out public health attack on the HIV/AIDS epidemic. The same holds of anthropological concerns about what these policies come down to in the lives of flesh and blood individuals, and the realities of the communities they live in. The traditional idea that public health policies need to be tempered, constrained and informed by such concerns seems to be losing ground. Will these 'tough love' approaches to HIV prevention turn the tide? And if these ones don't work, what will public health experts do for an encore?