On the PBAC rejection of Truvada as PrEP

A couple of (lengthy) comments on the ‪#‎PrEP‬ decision today:

1. Don’t blame PBAC

We’re all angry and disappointed by this decision, but it’s important we’re clear where our anger is directed. A fair few of the comments I’ve seen in the last couple of hours have expressed anger at PBAC for making the decision the way they did. But it’s Gilead, not PBAC, we should be angry with.
PBAC operates to a very narrowly-defined mandate: its one and only task is to determine whether drug listing are cost-effective. For a novel intervention like PrEP, that means comparing the cost of what the drug company is offering with the cost of doing nothing. Simply put, if the benefit is greater than the cost, the drug gets recommended; in this case, the cost outweighed the benefit.

PBAC also only considers the application made by the drug company. To protect its profits, Gilead chose to make their application based on only approving PrEP for people at very high risk of HIV (specifically, those with a greater than 3% risk of infection in 12 months), and at a high cost (we don’t know the exact cost they quoted, but we can assume it’s not much different from the current PBS price of $750/month). PBAC quite rightly questioned how practical or feasible it would be for doctors to determine which of their patients had a greater than 3% annual risk of HIV infection, and made it crystal clear they would prefer to see an application that would make PrEP available to everyone who could benefit, at an appropriately reduced price.

Let’s be clear: those pills cost a few sets each to make, and Gilead had a choice about how to structure its PBAC application. It chose to take a path that would give it the best return while denying PrEP to the majority of people who could benefit from it. That proposal would have seen hundreds of needless HIV infections every year, because its not just people at highest risk who get HIV.

2. The language of the decision

A couple of phrases in the PBAC decision seem to have inflamed people’s passions. I think some clarity is needed.

“attempts to restrict the eligible population by quantifying an individual’s future risk of HIV infection based on self-reported future behaviour, and limiting access to those with a predicted annual risk of infection of 3% or higher, may not be feasible or acceptable to clinicians and consumers.”

This, I think, is unproblematic. PBAC is saying that Gilead’s proposal to limit the use of PrEP to people at high risk “may not be feasible or acceptable.” It would require clinicians to make an assessment of the annual risk of HIV infection based on the patient’s self-reported behaviour. This is likely to be both inexact and practically impossible – if you were a doctor, could you make this judgement in a meaningful way? As PBAC goes on to say, far better to make the drug more widely available and let doctors and patients decided together if they feel the benefit outweighs the risk for that person.

“The PBAC noted that the efficacy of Truvada was highly dependent on adherence, and that it is not clear if subjects at high risk of contracting HIV due to self-reported low adherence to safer sex practices would also have lower adherence to medication.”

This sentence has a lot of people riled up, who have characterised it as saying ‘if gay men can’t be bothered using condoms, why would they bother taking PrEP?’ I think the statement refers back to the earlier questions about the viability of limiting PrEP to people at high risk. Many people at highest risk of HIV have difficulty with safe sex for quite legitimate structural reasons – homelessness, poor mental health, substance abuse issues, low literacy, etc. Limiting PrEP to that group could artificially increase the proportion of PrEP users who have adherence problems (due to the same structural factors) and consequently, this may not be the most efficient way to use the drug. Again, if the price were lower, it could be prescribed based on patient choice rather than arbitrary criteria, and we know most medicines work best when used that way.

Today’s decision has been a huge disappointment, but it’s not the end of the road. It often takes several application to PBAC before a new drug or indication is approved, and Gilead should be encouraged to resubmit. But we as a community have to hold the company to account – its next application must be structured around delivering the best public health outcomes, not the highest profits. Gilead stands to make a lot of money out of PrEP, even if they reduce the price radically, which is what they have to do before we get the outcome we want and need. The gay community has been doing its part to combat this disease for 30+ years, while Gilead and other drug companies have profited massively from it. It’s time for them to come to the table and do their part to prevent, not just profit from, HIV infections.

In the meantime, unfortunately there will be dozens or hundreds of needless HIV infections. We need to do what we can to minimise those, and to care for the unlucky ones who slip through the cracks.

Pills cost pennies, Gilead’s greed is ruining lives.

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Australia’s HIV transmission rate falls

New data out of the Kirby Institute shows that the rate of HIV transmission in Australia has fallen, returning to a downward trend that has been the norm for more than a decade. So why are the papers saying that HIV infections are ‘at an 20-year high‘?

As I have been arguing for several years (see this post from 2013 and this one from 2010) the use of raw diagnoses as the only measure of progress against HIV in Australia fails to take account of the reality that there are more people living with HIV every year. With a greater HIV-positive population, in any HIV prevention scenario a greater number of new diagnoses can be expected. Because this is the case, simply looking at the number of new diagnoses tends to mask the considerable success we have had in combating HIV.

Here’s a graph that shows (in pink) the ‘HIV transmission rate’ (the number of new infections recorded per 100 people living with HIV) in Australia over the last 13 years:

HIV tx rate 2013


The blue line shows the official HIV stats, and there’s no doubt they have trended upwards over the period. That’s nobody’s idea of good news, least of all mine. We want to turn that line around (and I think we will soon).

The pink line is my estimate of the HIV transmission rate. As you can see, it has actually fallen in nine out of the last 11 years and, despite a rise last year, it looks to be trending downwards. That is a good sign that, despite the rising population of PLHIV, the percentage of people who pass HIV on has been falling. That is a marker of success that is ignored by the official reports.

The use of the transmission rate as an alternative to the raw numbers isn’t just my idea: the US National HIV/AIDS Strategy uses it. The CDC uses it. Peer-reviewed epidemiological studies use it.

I am not suggesting we should ditch the reporting of the raw numbers – they are a useful and important measure. Governments and health economists care, as they should, about the numbers of people who will need medical care and support into the future. But they are less helpful when measuring the success of HIV prevention campaigns. A rise in infections doesn’t mean that prevention is failing unless the rise is greater than that which can be attributed to the increased PLHIV population. In fact, as the graph above shows, in most recent years the rise in infections is below that natural increase and that means we have had some measure of success – not that you’d know it from reading media reports or Kirby Institute press releases.

Stories headlined ‘HIV infections at a 20-year high’ suggest that, 20 years ago, things were better than they are now. They weren’t: people were dying in droves. The rate of HIV infections in 1994 was unnaturally low because a large proportion of PLHIV were seriously ill and dying. Suggesting that we have an alarming rise in new infections 20 years later, when we have twice as many people living with HIV and most of them are leading healthy, productive (and sexually active) lives is blinkered pessimism.

Disclaimer: as with my previous posts on this topic, I have to point out that I am neither an epidemiologist nor a statistician, and while my estimate is based on published data from the Kirby Institute, I don’t have access to the detailed data on which it is based. 

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It’s not true, is it?

HIV-positive shirt

The International AIDS Conference is starting in Melbourne in a few days. I’m in a convenience store , wearing this T-shirt that says ‘HIV Positive’. There’s music playing, in a language I don’t understand.

“I like the music,” I tell the clerk.

“You probably can’t understand what she’s saying. It’s in Persian – Farsi.”

I hand over my purchases.

“It’s not true, is it?” he says, pointing to my T-shirt as I pay.

“Yes, it is true.” He makes a screwed-up smile, unsure whether I’m pulling his leg. A moment of silence. “Really?”

I tell him about the AIDS conference, and something about the importance of positive people being visible. Another moment of silence.

“You know, when I tell people I’m from Iran, they make assumptions about me, too. It’s good to meet you, my friend.” He shakes my hand and I leave.

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A blunt instrument

The following article about HIV criminalisation, by David Mejia Canales and me, was originally published on the Law Institute of Victoria Young Lawyers’ Blog last week. (Yes I have been published on a ‘young lawyers’ blog – I am aware that is amusing on several levels). 


The International AIDS Conference will be held in Melbourne in July. The conference, one of the largest in the world, attracts tens of thousands of activists, politicians, scientists, doctors and a diverse group of community members affected by HIV.

With the world’s eyes on Melbourne during the conference, it’s timely that we revisit our criminal laws with regards to HIV transmission.

Did you know that s 19A of the Victorian Crimes Act is the only law in any Australian jurisdiction that specifically criminalises the transmission of HIV?  The maximum penalty under the section is 25 years’ imprisonment – equivalent to armed robbery or aggravated crimes of violence.

Section 19A was introduced in 1993 to placate community fears of robberies with HIV-infected blood-filled syringes, but no HIV-positive person has ever been convicted of such a crime. Instead, the law has only ever been used for allegations of sexual transmission.

So is s 19A a good law? It’s only produced one conviction in 20 years (and this was for attempt); it was intended to be used to punish robbers armed with HIV laden syringes but has only been used to lay charges against people who have allegedly transmitted HIV through sex.

This is not to say that intentional transmission of a serious disease like HIV should not be a crime – there’s no doubt it should. But other sections of the Crimes Act are capable of being used should such a scenario occur. Not only that, we have public health processes that can be triggered when HIV transmission occurs, and which are focused on achieving positive behaviour change rather than punishing past wrongs.

In theory, s 19A was intended to protect the public, but what happens in practice is it acts as a disincentive to knowing your HIV status while reinforcing perceptions that people living with HIV are dangerous or malicious. This does no one any good.

Laws don’t exist in a vacuum.  You probably didn’t learn about s 19A at law school, and you definitely didn’t learn about the incredible social baggage a discussion about HIV and transmission brings.

Here are four things you can do today to know more about the fascinating junction of law, human rights and HIV:

  • Register for Beyond Blame: Challenging HIV Criminalisation, an International AIDS Conference affiliated event about the criminalisation of HIV, not just in Victoria but around the world. The event is free to attend but you must register. Keynote speaker: Hon Michael Kirby. Registrations here: http://beyondblame.eventbrite.com.au
  • Contact organisations like Living Positive Victoria or the Victorian AIDS Council, they can organise speakers or information sessions for you or your organisation to understand HIV and the human rights issues surrounding it. www.vicaids.asn.au and www.livingpositivevictoria.org.au
  • Take part in the hundreds of events during the International AIDS Conference, for more details: www.aids2014.org
  • Consider volunteering or donating to the HIV/AIDS Legal Centre, a community legal centre assisting HIV positive Victorians. For details: http://www.vac.org.au/plc-legal-assistance

What do you think? Is it possible to have a constructive discussion about HIV and decriminalisation of HIV without the fear and hysteria that usually comes with discussions about HIV?

About the authors: David Mejia-Canales is a lawyer and Vice President of the Victorian AIDS Council. Paul Kidd is an HIV activist, current law student at La Trobe University and the Chair of the HIV Legal Working Group at Living Positive Victoria.

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How HIV criminalisation harms prevention, wrecks lives and doesn’t stop a single infection


My op-ed in this week’s Star Observer:

Criminal law processes have been criticised internationally because they provide a disincentive to knowing your HIV status – instead of protecting people from HIV, they actually have a negative impact on prevention. In September, UNAIDS recommended that criminal prosecutions should only occur where HIV transmission actually occurs and where it can be shown that the accused intended to transmit HIV. The report also condemned the use of laws that criminalise non-disclosure of HIV status, such as those in NSW and Tasmania, and HIV-specific criminal laws, such as Victoria’s section 19A.

Read the full article on the Star Observer website.

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Why marriage equality advocates should thank George Brandis

The High Court decision is in, and the Marriage Equality (Same Sex) Act 2013 (ACT) is no more. Five days after the first same-sex marriages were celebrated in Canberra, those marriages are now void and the law is no more.

Naturally, a lot of people are disappointed that what seemed like an achievable path to same-sex marriage has now been shut off. But as I blogged earlier today, the notion of pursuing separate marriage laws for each State or Territory seems woefully misguided, especially as what that would achieve might well be the enactment of some sort of same-sex marriage framework, but it certainly isn’t the ‘marriage equality’ it’s been sold to us as.

Instead of lamenting the Court’s entirely sensible and reasoned (and unanimous) decision to invalidate the ACT law, we should thank George Brandis and the Commonwealth government for their efforts in illuminating the pathway to genuine marriage equality – an amendment to the Marriage Act 1961 (Cth) that reforms the institution of marriage to be genuinely inclusive of all people – not just heterosexual and homosexual couples, but bi, trans* and intersex people too.

Brandis could have just let the ACT law pass quietly and, barring some other party having standing to challenge it, the States and Territories could have each passed their own little same-sex marriage laws, people would have gotten frocked up in rainbow bow ties and mums would cry – and the hets-only federal law would have continued as the gold standard with no further political agitation for change. Real marriage under the Marriage Act, marriage-lite on a state-by-state basis. Instead, the momentum for change will just grow, and now there is only one way forward: the federal law must be amended.

Thanks, George. You just painted a big rainbow target on your own forehead.

Some more observations on the judgment over the fold.

Continue reading

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Same-sex marriage and the High Court

Australia saw its first same-sex marriages over the weekend, in Canberra. The predictable 12:01 a.m. ceremonies, the newspaper pictures of beaming gay couples in matching outfits, the rainbow flags and lofty statements about our rights, all overshadowed by the High Court case that threatens to undo it all after a few days.

For five days, the ACT has been the first jurisdiction in Australia to legislate for same-sex marriage, and later today we’ll know if that law has withstood a constitutional challenge from the federal government. My guess is that the court will strike the ACT marriage law down, and with it those 12:01 am marriages.

As much as that decision will dash the hopes of many supporters of marriage equality in Australia, I think it’s the right thing for the Court to do. I have been following the case with interest: I even watched some of the online video of the oral arguments. To my only partially-trained eyes, the Commonwealth’s argument seems pretty sound: the constitutional framers’ intention was clearly to have a single system of marriage in Australia (indeed, they explicitly argued against the patchwork approach of the US and other countries) and the passage of the Marriage Act in the early 1960s was the, albeit delayed, achievement of that goal. The Commonwealth has exercised its power under the Constitution to define the boundary between people who are ‘married’ and those who are ‘unmarried’ at law, and that means any state or territory law that tries to redefine that boundary must be invalid.

The ACT’s argument is that, because the Commonwealth Act only regulates opposite-sex marriages, that leaves an open space for States and Territories to regulate same-sex marriage. But both Acts are trying to achieve the same legislative end – determine who can claim the status of marriage, and I don’t see how the High Court can realistically leave the ACT law in place. We’ll know in a few hours.

In any case, I don’t think the approach of pursuing marriage reform on a state-by-state basis is right. If we are pushing for marriage equality, that can only mean reforming the existing institution of marriage – not the creation of a set of parallel institutions that all claim the status of ‘marriage’. For marriage equality to be real, we need one institution that treats all relationships the same way, not a series of separate-but-equal attempts to circumvent the Commonwealth Parliament’s failure to legislate.

Australians in de facto relationships, which in every jurisdiction includes same-sex couples, already enjoy nearly identical rights to those who are married, so the idea that we can achieve ‘marriage equality’ by setting up nine different systems of marriage across Australia seems hopelessly misguided. It’s hard for me to see how this is a step forward.

Unlike our cousins in the US, Australia’s push for marriage equality is largely symbolic. We don’t depend on the status if marriage for practical rights, because we already have de facto relationship rights that are virtually indistinguishable from those enjoyed by married people. That doesn’t mean we shouldn’t continue pushing for the Marriage Act to be reformed – we should, and it’s hard to find anyone who doesn’t believe that, eventually, reform will come. But the push for state and territory based same-sex marriage laws turns marriage in Australia into a Rube Goldberg contraption of interacting and conflicting provisions that change when you cross from one state to another: that may be fine for people who want to wear matching suits and pledge their commitment at 12:01 am ceremonies in chilly Canberra (and who can blame them?) but it’s not ‘marriage equality’.

I fully expect that, later today, the High Court will strike down the ACT marriage law, and Canberra’s five days of rainbow weddings will be over. When that happens, we should not see it as a step backwards for marriage equality, but a step towards it. Because it’s only by changing the Commonwealth Marriage Act that we can achieve the equality we say we want.

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HIV infections are going up – or are they?

Lots of discussion over the last couple of days about the recently released annual surveillance report for HIV, which shows a big jump in the number of HIV notifications for the last year, especially in NSW. Obviously any rise in HIV is concerning and I’ll leave it to the experts to debate the likely causes of that rise, but as I have previously argued, a seemingly important measure of the infection rate remains unreported.

Three years ago, I argued that HIV infections aren’t going up, they’re going down – if you consider that the number of new infections must be a function of the number of people living with HIV, the picture over the last few years is starkly different. I’ve updated the data from that post in the chart below (click it for a larger version):

HIV infections 2000-2012

The pink line on the chart shows the number of new diagnoses per 100 people living with HIV, based on the Kirby Institute data. There has been a noticeable increase in that measure over the last year but this follows a long period of decline from a high in 2002 of 6.29 to a low in 2011 of 4.60 (incidence per 100 PLHIV).

My argument here is that, whenever an HIV infection occurs, one HIV-positive person is the source of that infection, and as the number of people living in the community with HIV rises, some rise in the total number of new infections is inevitable. The picture over the last few years shows that rise has been lower than would be predicted by the increase in the HIV-positive population alone, which I think is a strong sign that HIV prevention efforts have been working.

The increase in the last 12 months – from 4.60 to 4.87 (incidence per 100 PLHIV) – represents a 6 percent rise in infections, and while that’s lower than the 10 percent rise in the raw numbers, it’s definitely worrying. But it’s a single data point and we won’t know for a year or two if that is the beginning of a sustained rise or just a blip in the trend.

It’s understandable that researchers, government and the media are troubled by the annual jump in new infections (and it has been an annual event for many years now) but, as long as positive people are remaining healthy and sexually active, at least part of that rise is directly explained by the increase in the population of people who are available to be the source of new infections.

The usual caveats apply: I am neither an epidemiologist nor a statistician, and the only data I have to work with is that published in the surveillance reports. Happy to be corrected on any of the data or to be (politely) disagreed with as to my interpretation of it.

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