Why Are We Waiting? PreP Now!

prepaccessnow

Why is it left up to a few individuals to tackle the challenge of making PreP available now, while well-resourced organisations set up for the purpose wring their hands apologetically?

Do you know to avoid passing on HIV? Have protected sex. Do you know how to avoid the blame for not providing the best protection available? Pass the buck.

In studies now too numerous to list (but not too hard to find online), it’s been shown that people with HIV who take the anti-retroviral drugs that suppress the virus, can’t pass the virus to their sexual partners. Used for this purpose, drugs like, for example, Truvada, are approved by the Therapeutic Goods Administration (TGA) and available at subsidised cost on the Pharmaceutical Benefits Scheme (PBS).

So far, so good.

Now comes the kicker. People who don’t have the HIV virus, and who regularly take Truvada, basically can’t catch HIV. The drug stops the virus gaining a foothold in your body. As a result, Truvada is now also being used for PreP.

PreP stands for Pre Exposure Prophylaxis (you can see why they shortened it). It means taking drugs anti-HIV drugs as a protection against catching HIV in the first place.

Great! Provided you take the drug regularly, even if you slip up and have bareback sex, you shouldn’t catch HIV. You might still get HepC, syphilis, or gonorrhoea, or chlamydia, but you’re 99% certain not to get HIV.

The catch is that the TGA hasn’t approved the use of Truvada and other anti-HIV pills for this purpose – only to treat people who already have the virus. Which means you can’t get it on the PBS. That makes it expensive. Too expensive.

Now you, like me, might be wondering why, if the drug is already approved to treat HIV, why can’t it just be approved to prevent it? The science is in, we know it works. There are 30,000 people around the world taking Prep, and not one has become infected with HIV. This is where the buck-passing begins. The Department of Health passes the buck to the manufacturer, Gilead.

On giving the green light Truvada to be used as PrEP, a spokeswoman said: “To extend the use of a medicine already registered in Australia, it is necessary for the sponsor of the product to submit an application to the TGA with safety and efficacy data supporting the use of the additional indications. This is a commercial decision for the sponsor of the product, Gilead Sciences.”

Of course, the Minister for Health, Sussan Ley, could find ways round this if the political will was there, but it’s not.  As a result, the TGA isn’t expected to approve PreP till 2017 at the earliest, with the PBS some time after that.

Not entirely coincidentally, this is when the drugs are due to come off patent, making them very significantly cheaper.

The first patents for both active ingredients in Truvada (emtricitabine and tenofovir disoproxil fumarate) will have expired by July 2017. This is the earliest possible date that a generic [i.e. cheap] version of the drug could become available.

https://www.flickr.com/photos/otto-yamamoto/7114592521/in/photolist-bQG9ui-bBMh3w-bBMkBm-fKkgUD-bQG9oP-bBMs85-bBMs2J-bQG96p-bQG8Zk-bQG8UK-bBMrEE-bQG8KB-bBMruG-bQG8ye-bQG8rF-bQG8kB-bQG8dg-bQG86Z-bQG82p-bBMqN5-bBMqG9-bBMqAd-bBMquL-bBMqq1-bQG7tp-bQG7mP-bBMq91-bQG7b4-bBMpXj-bQG6XP-bQG6R6-bBMpDj-bBMpzh-bQG6AP-bBMpoQ-bQG6rR-bBMpcu-bQG6fD-bBMp1u-bQG66i-bQG61g-bQG5Up-bBMoCC-bBMon3-bBMod9-bQG58i-bQG4RP-bBMnCb-bBMnxj-bBMnmY

ACT-UP / Occupy Wall St – All Night Images

This is by no means certain, however. The Financial Times suggested back in 2013 that Truvada, as a combination drug, might not be fully off patent till 2021. Since when there have been a raft of patent lawsuits (summarised here) which suggest the earliest date for a generic version might be December 2017. We simply do not know for sure.

The Victorian government isn’t waiting: they are putting in place a scheme to allow GPs to prescribe Truvada for PreP as soon as possible. The NSW government, meanwhile, is vastly extending a trial to cover more than 3,000 people.

Meanwhile the Victorian AIDS Council is petitioning Health Minister Sussan Ley to fast-track Prep approval – you can sign up here – but neither the VAC or their NSW counterpart ACON are getting involved in any attempt to facilitate access to the drugs themselves.They refute allegations that they aren’t doing enough, and claim to have legal advice that it would be too risky to take the “Dallas Buyers Club” route.

That hasn’t stopped a group of frustrated gay men doing just that: you can find out how to get cheap generic Truvada for yourself from them at PrePAccessNow.

There is a precedent for this sort of well-mannered organised civil disobedience in the face of government indifference. Over in the US, Elizabeth Taylor ran her own drug running operation for what few drugs were available for people dying of AIDS.

https://www.flickr.com/photos/alan-light/1096429048/in/photolist-2ETua7-aaEiv2-aaH8km-9EKHy1-9EGMPB-9EGMSc-9EGMQR-vNxoeE-98ifXV-qauUXJ-w6a2qx-vRbn6R-w3QLHf-aVjaRx-aVjaQ6-BvXYbj-BvXYZU-pn8CmP-vbEETh-4fCkDM-6rSXi7-Bnwcmd-Bx6fC6-Bnwd1j-AzFe9F-9V8Mrb-v99d2o-jBo1o-v996aC-BygU92-9GCGxU-rxKbbv-nqDqmM-9vJwk9-vNErbM-w5vLK1-v9hyMK-pmoYJM-q1JKkZ-M4qeU-qhYUFT-qr9uH3-9tNnXw-9FezXb-9geWz9-5wEnqJ-9FeyA9-dfztSB-vbDKPS-ikNvag

photo by Alan Light

Queensland AIDS Council was born out of the same sort of civil disobedience.

‘‘The big thing in Queensland, Brisbane was who came to the rescue of this situation and it was the (the Catholic order) Sisters of Mercy in a big, big way. The nuns gave us a house [and]….. went to the government and said ‘we need funding to take care of these people who are dying’.’’

‘‘And so they got the funding and what they used to do was slip some of it to the Queensland AIDS Committee and they would saying something like ‘you know what needs to be done with this money, we don’t’.’’

The money was usually delivered to the committee by a nun who concealed it in a brown paper bag in her habit.

But the AIDS Councils seem to have forgotten their own history, speaking instead of ‘going through processes’, of ‘pressing’ the Minister (as if she were a grape harvest), starting petitions, and generally wringing their hands.

(For a different point of view on this see David Menadue The AIDS Councils Are Working.)

Yes, there is always a ‘process’, but that doesn’t mean it should be rigidly adhered to, or even respected when there are lives at risk. Governments can change, ignore or detour round their processes if the will is there. It’s up to “our” organisations to hold their feet to the fire and stiffen that will. And in case they hadn’t noticed, Tony Abbott isn’t PM any more.

And if that doesn’t work, there are always other ways of doing things (remember ACT-UP) which might not please the politicians, perhaps because it will remind them that their true role is to be the servants of the public and not masters. I suppose it might create a bump in the road for those who seek to parlay their work in the sector into a political career, but that can scarcely be a consideration.

Thankfully we appear to have some young guys with the spunk to get on and light those necessary fires, stir up debate with their provocative posters, and even source generic drugs.

Because the need for PreP is not in 2018, it’s now. We are seeing a steady rise in new infections which we can seriously dent, perhaps even stop altogether, if we get PreP now, but not if we wait till 2018. And stopping new infections is THE primary task of AIDS organisations.

It seems shameful that a small group of guys are left to get together and organise PrePAccessNow for themselves, with their own resources. It seems the AIDS Councils are happy for other people to take risks with their sexual health, and perhaps (though I seriously doubt it) legal risks as well, while protecting their own careers and their budgets by sheltering behind these excuses.

 

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About the author

Veteran gay writer and speaker, Doug was one of the founders of the UKs pioneering GLBTI newspaper Gay News (1972) , and of the second, Gay Week, and is a former Features Editor of Him International. He presented news and current affairs on JOY 94.9 FM Melbourne for more than ten years. "Doug is revered, feared and reviled in equal quantities, at times dividing people with his journalistic wrath. Yet there is no doubt this grandpa-esque bear keeps everyone abreast of anything and everything LGBT across the globe." (Daniel Witthaus, "Beyond Priscilla", Clouds of Magellan, Melbourne, 2014)