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Money alone is not going to treat us out of the HIV epidemic

Why HIV “prevention does not work” has been the subject of recurrent discussions during the past weeks. It all started with a thought-provoking article published online by Frontiers in LA, “a one-stop source of content for Southern California’s LGBT community” (welcome to the Ghetto) by Michael Liberatore who wrote that “if pharmaceutical companies were supplying the cash to develop [HIV/AIDS] treatments, couldn’t they just as easily stall the development of newer, less profit-friendly treatments to assure that their bank accounts continue to swell?”

The article is worth reading and raises some serious questions, and though peripheries is no friend of the “Big pharma”, one cannot always agree with the columnist. Nevertheless, the recurring conversation was about the belief that money or drugs will “make prevention work” and “treat us out of the epidemics”.

Indeed, it is not just about money or the Pharmaceutical industry but about how the money is used. PEPFAR with its numerous and often criticised ties is a good example but there are many others. For example, in an interview for the Singapore-based network Fridae.com Jan Wijngarden emphasises some very important issues on how to do prevention in the MSM population which is more vulnerable than other to HIV infection. Wijngarden’s main point is that prevention has to reach those who are supposed to be reached and I would add something often overlooked, that the target need to have a stake in the fight.

When it comes to Africa where AIDS is “hyperpandemic”, bending the arm of the Big Pharma or throwing money at African Governments or local NGOs to buy drugs is one thing, but if there is no supply chain (from road to clinics and to nurses) or even no identified people to treat,or worse, no political will, it won’t work. We often talk about corporate responsibility but what about non-profit responsibility? It is often “implied and obvious” but how accountability is there in the non-profit sector? The one that goes beyond “we have provided ARV to 3 million people” (Are these people still on ARV? Alive? How is their health? Did that change something in their community? What was the impact on a larger scale?). In a paper on the impact of PEPFAR the authors, carefully underlining their own limitations, concluded that “After 4 years of PEPFAR activity, HIV-related deaths decreased in sub-Saharan African focus countries compared with control countries, but trends in adult prevalence did not differ.”

Accountability in the non-profit sector is finally being recognised and emphasised and it needs to be discussed further and translated into something real. Indeed, there are reasons to be afraid and sceptical when reading statement such as “UNAIDS estimates that the funds needed annually to deliver adequate prevention programs to sub-Saharan Africa alone would be approximately US$2 billion”. Lest we forget, several world economists (and rock stars) have been telling us that for some time that we “only” need to put X million dollars in African country Z to lift it out of poverty. 50 years and 3.5 trillion dollars later, the African people are still waiting for this to work. Meanwhile, GAP, Motorola and Armani are making profit selling (Red) branded products and rock stara are lecturing us, tax payers whose contribution to the World Bank and IMF, constitute the largest amount of money given to fight HIV/AIDS in Africa with various level of success.

We really need to think hard, look at what has been done during the last 25 year, probably throw away most of it and start again from the bottom: Who is most vulnerable ? Strikingly, MSM have just been “officially” recognized (or rediscovered) as most-at-risk at the last AIDS Conference in Mexico. What will make people practice safe sex? What will make someone vulnerable come forward to take an HIV test? What will make them accept to start treatment and adhere to it? How can treatment be delivered and patients reached, then how much will it cost, rather than blanket covering whole population with impersonal messages and dollars hoping the epidemic will treat itself out.

Re-stating the obvious, HIV prevention and treatment is a complex problem and as much as requesting more money to buy more drugs is much more appealing than requesting dollars to built roads, there is little point of shelving drugs that can be distributed or having brand new and shiny clinics in the middle of nowhere with no staff and no road leading to them.

Some governments have started to understand some of this. The UK Department for International Development (DFID) recently recognised that “Trade is critical for generating economic growth and reducing poverty. Without good quality infrastructure – roads, rail, and ports – the cost of trade and transport rises”. DFID Minister of State Gareth Thomas then announced “£100 million for the implementation of an innovative and comprehensive transport and cross-border trade reform programme along the ‘North-South Corridor’, combined with a broader package of regional trade-related reforms.” Recognizing that trade can’t happen without adequaye infrastructure comes late but is welcomed. It is regrettable that the Minister did not go one step further and recognised that the fight against HIV can’t be won without similarly good infracstructure and also aknowledge that trade development could contribute to the HIV/AIDS epidemic (both in a positive and negative way) and then implement along the North South corridor of trade a corridor of HIV prevention and treatment.

This is were mainstreaming HIV/AIDS (and the money to fight the epidemic) comes into the big picture, but we are not there yet. Money and drugs are still needed to fight AIDS, probably more than ever with increasing HIV prevalence, but what you do with it is as important if not more than as how much you get.

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Once in Africa, an HIV Story (Pt. 2)

This is the second part of a true story told through a friend, a first person account of the life of Nhlanhla , a nurse in a Sub-Saharan country afflicted by HIV and AIDS (read part 1 here). Names, places and minor details have been changed to protect people’s privacy. It is a story of fear, stigma, discrimination but also of hope, the everyday story of a young woman whose life, on revealing to her family that she is HIV positive, spirals into hell and despair.

“A few days later I visited Nhlanhla at home. She had found a nice little home for her family, and I tried to say what an achievement that had been. But the house is a very long way off the main road and with no services around at all. There is no electricity or running water. They have to buy water and coal – but when I was there they had very little water and no money for coal so were cooking with wood. Her mum is a lot sicker than she had led me to believe and can hardly move – she sat vacant on a mat the entire time I was there. Her children were there when I visited but have since gone to two different relatives in order to access school – and I have no idea how Nhlanhla has managed the school fees for both but am guessing this is why she is so broke. Her sister is younger than her and obviously very submissive, and after meeting her I could better understand how the second suicide attempt happened at home as she really is not in a position to intervene (this is difficult to explain but she is like the house keeper who is completely financed by her older sister, so is not suppose to challenge her older sister, if that makes sense). I also met Nhlanhla’s aunty who lives elsewhere. Nhlanhla has only disclosed her HIV status to this auntie’s husband but he recommended her not to tell any of the other family members! This aunty is her late father’s sister – and it is her blood line relatives who threw her mother, sister and children out of the paternal homestead on accusations of witchcraft and threatened to burn them to break the spell – hence leading to the house in this area. So basically Nhlanhla really does not have any other family to go to and has no contact with any of her mothers kin at all.

When I was there Nhlanhla told me she had not taken her anti-depressants that day as she felt ‘too tired’. I again expressed the need to take them every day and each day I have spoken to her since she confirmed she had taken them. She went to a GP in town for pains in her back (not her own GP as she couldn’t get an appointment) and he gave her pain killers and sleeping tablets (she assured me she told him about the anti-depressants).

She had agreed to go to her own GP about starting ART treatment, and she did visit him. The back pain was still there so she had an X-ray which apparently identified a lung infection but she couldn’t tell me what type – so she is now on antibiotics as well. The GP wanted to admit her to hospital but she refused. The GP wanted to do another CD4 count before he started her on treatment (her last count was 167). Apparently her main concern about ARVs is a common side effect here of extended breasts and stomach. I have spoken to a friend of mine about this who works in the Department of Health services. He says this is mainly related to D4T in the first line regiment. She is completely refusing to go to the government services as she feels everyone knows her there. So we have advised her to speak to the GP about swapping D4T for AZT. In this way if her private health insurance through work runs out and she transfers to the DoH services then they will continue her on AZT and this will reduce the chance of the side effect she is most concerned about.

Nhlanhla is due to go back to the GP and I have asked one of our doctors to speak to her and offer to accompany her. She is officially back at work and her direct line manager at the clinic was the person who eventually found her after the first suicide attempt so knows about her situation – but she still refuses to disclose her status to her manager. She wants to be back at work to take her mind off other things and keep her busy. Her manager will keep a close eye on her at the clinic and I am hoping this will support our efforts to get her into regular psychological sessions.

As you can see this is not a simply case – she is obviously seriously depressed and the psychologist does not think that she is out of risk yet in terms of being about to make stable and rational decisions. I am also worried about her declining CD4 count – she had a number of quite extended illnesses. I really hope that she does start ARV treatment soon.

It is funny that in writing this down it almost feels like we are all too involved – but unfortunately this is the reality of this area in terms of the support that people need. It is all very time consuming and emotionally draining for all involved – but hopefully we will get her through! As usual the main people are offering all their support despite having their own challenges.

I am always reminded how lucky I was to just happen to be born in the UK!”

Nhlanhla’s mother died a few months ago.

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Disco dosing: when your Disco kills you, the Western Way.

methA few weeks ago, Steve Weinstein, editor-In-Chief of the Boston-based Edge, commented on “Disco dosing”, the alleged Gay-men practice of taking a cocktail made of a psychostimulant, methamphetamine, an antiretroviral, Tenofovir, and a drug used to treat pulmonary arterial hypertension Viagra, better known for its ability to correct erectile dysfunction, before going clubbing. Such mix even has a name: “MTV”.

Disco dosing has been around for years. It was reported that Gay men were taking the antiretroviral Tenofovir before going on the prowl for the weekend and enjoy unprotected sex, hopping that the drug will protect them pre-emptively against any HIV virus they may come into contact with. In 2005 the LA Times wrote:

“Taking a T.” That’s what HIV-negative gay men call the growing practice of downing the AIDS drug tenofovir and, with fingers crossed, hoping it protects them from the virus during unprotected sex. It’s being sold in packets along with Viagra and Ecstasy in gay dance clubs — and even prescribed by physicians, say doctors and AIDS prevention experts. The trend has alarmed public health officials.”

Then, a survey conducted at gay pride events in four cities by the U.S. Centers for Disease Control and Prevention found that “7% of uninfected men had taken an AIDS medication before engaging in risky behavior and that about a fifth had heard of someone who had.”

Meanwhile and possibly with delay, the medical and scientific community has adopted the approach under the name of PrEP: Pre-Exposure Prophylaxis.

Both Viagra and Methamphetamine have well described properties and known effects but what about the prophylactic use of antiretrovirals for HIV prevention?

The idea that taking an antiretroviral before being exposed to the HIV virus could protect against infection dates back to the early 90s when it was shown that Zidovudine could reduced the risk of mother to child HIV transmission by approximately two thirds the in pregnant women with mildly symptomatic HIV disease. Since then, Prevention of Mother to Child transmission (PMTCT) is commonly carried out with a combination of AZT and nevirapine in resource limited settings and has been endorsed by the WHO, but not by the FDA (another of these tickling incongruity).

However, there to date no evidence that Tenofovir taken before unprotected sex could protect against HIV. In fact there are currently several clinical trials in preparation which purpose it to test this hypothesis. A few years ago such clinical research was the object of a serious debate when a trial of daily Tenofovir in Cambodian sex workers had to be cancelled under the pressure of ill-informed AIDS activists.

To date, only one trial has been completed in Ghana, four have been cancelled, and seven are planned in the forthcoming years, all detailed and tracked by the useful PrEP Watch website.

The jury is not out yet; it has not even been convened, so let’s focus on the other component of the MTV cocktail.

“Meth” is a a psychostimulant that increases sexual drive but can also cause impotence, hence the need to take Viagra to counteract this embarrassing side effect. Meth and Viagra are a dangerous cocktail for the health of the party goer. Meth alone, or in combination with Viagra, has also been associated with an increase in unsafe sex practice, hence an increased risk of HIV infection. Though data about Meth use amongst MSM are inconsistent, its effects on sexual behaviour are well known and characterised.

There are complex and multiple reasons why men and in particular but not exclusively Gay men, use these cocktails of drugs and they might boiled down to the necessity to perform sexually, especially after hours of jumping up and down in a night club. But a parallel with the Disco Matanga springs to mind. Psychotropics, drugs or alcohol are used along or to facilitate sex, leading to unsafe sex practices and further spread of the HIV epidemic as a consequence.

Drug use amongst gay men is still a problem and not merely because it affects the user’s health but because it is linked to an increase in unsafe sex acts. As such, drug use is rarely part of HIV prevention intervention that tends to focus on either one or the other, as if they were two different and unrelated issues.

HIV prevention is changing, and in the process needs to be much more comprehensive and aggressive when it comes to messaging. There has been a trend during recent years to abandon the finger waving approach for that of providing information because it was believed that when faced with a difficult choice, well informed people would take the right decision, make the right choice. There is little evidence of this happening. Education may provide people with a choice but not with the will to take the right decision. And how strong is the will when under the influence of psychotropic drugs?

In Africa young people are being infected during disco funeral because they know little about HIV and because alcohol make them more vulnerable to HIV. In the developped World, well informed men under the influence of a different kind of psychotropes are not behaving any better whilst partying over the weekend. In both case a deadly virus has found a way to spread by exploiting its host behaviour.

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Access to life-saving medicines in Thailand: The US bullies are back

Access to life saving medicines is once more at the heart of trade negotiations between Thailand and the US. And again the US administration and businesses have chosen to bully the Thai government in advance of a meeting in Washington prior to the release of the Special 301 Report» that impacts on trade conditions between the US and its partners.

Compulsory licensing (CL) has been the casus beli of an ongoing battle started when the junta government led by Surayud Chulanont issued compulsory licences for antiretrovirals and anti-cancer drugs in September 2006 in accordance with the TRIPS agreements part of the Doha convention. These CL were not issued without difficulty and the pharmaceutical industry in its various emanations and stooges, was not prepared to give up without a dirty fight.

The ‘Empire’ did and is still doing its best to discredit, threaten and intimidate Thailand and as the USTR is reviewing the status of its trade partners in preparation of the next Special 301 report, the bullies suggested that Thailand status should be downgraded even further from the Priority Watch List (PWL) to the Priority Foreign Countries (PFC) listing. Such downgrading would only make it harder for Thai businesses to trade with US businesses.

Though Thailand’s decision to issues Compulsory Licences was not violating its legal obligations» under World Trade Organization rules (the previous 301 special report complained, without justification, that “the lack of transparency and due process exhibited in Thailand represents a serious concern”), the deception continues on the part of the pharmaceutical industry, US lobbyists (such as USA for Innovation which website has gone offline and was suspected to be one of former Prime Minister Thaksin’s incarnations) , lazy journalists, think tanks on the Pharma’s payrol , and zealot bloggers.

These self righteous and self appointed guardians of the US Intellectual Property consider that some kind of moral values (understand double-standard) prevail over international WTO agreements. Indeed they consider it fair for the US, a developed country, to use the TRIPS agreements to rip off third world and developing countries of their IP (and even developed countries), but that Thailand’s use of the same international treaty is totally unacceptable, unjustifiable and just plain “theft”. They also challenge the legality of previous CL since they were issued by a military government though neither the legality of these CL nor the sovereignty of the Thai government that issued them has ever been questioned by the US Administration. But to no avail, the Zealots continue to condemn those who condone the CL as colluding with the military. This is forgetting that in 1991-92, it is a military government led by Anand Panyarachun that implemented the 100% condom programme in Thailand’s brothels and amongst sex-workers, successfully preventing a generalised epidemic amongst the Thai population. If they were to follow their logic, they should also condemn the 100% condom programme.

More than two years after the first CL being issued and thousand of life being saved, deputy Commerce Minister Alongkorn Ponlaboot is torn between giving up under the lobbyist’s pressure and therefore putting the life of thousands at risk or taking a stand and fighting the bully back.

Let’s examine the recriminations of the American Businesses on IP rights violations in the pharmaceutical domain as summarised in the Bangkok Post.

ip

  • Thailand has unclear policy on compulsory licensing

What has happened since 2006 should show that Thailand has a very clear policy on CL, that of issuing CL on overpriced life-saving medicines using international WTO agreements: “The government will continue to impose compulsory licensing (CL) on essential but expensive drugs” as reported by The Bangkok Post. Compare that to recent CL issued by the US on F22 fighter parts or the Blackberry. Prime Minister Abhisit and the Public Health Ministry have made it clear that “The Public Health Ministry will enforce CL only when necessary by consulting with the private sector especially the Pharmaceutical Research and Manufacturers Association.”

  • Thailand is likely to issue more CL without prior discussion with drug firms

Not only Thailand has in the past spent a lot of time talking to an often deaf Pharmaceutical Industry, but when it comes to issuing CL under the TRIPS agreement, Thailand is under no obligation to engage in preliminary talks. The US admninistration and Lobbyists are adopting here a very deceptive approach: they sould be well aware of the conditions necessary to issue CL since they are on the top of the list of country using the TRIPS to issue CL on a broad range of items (see above).

  • Fake drugs in Thailand are rampant and punishment is light

Another deceptive approach to CL that consists in conflating generics with counterfeit drugs. As noted elsewhere, it “is like conflating sex work with trafficking. One provides services people want at a price they agree to pay, the other is illegal and dangerous. But waging war on the first is almost certainly going to make it harder to wipe out the second.”

Indeed fake drugs may be rampant in Thailand, but these have nothing to do with the right of a country to produce generic drugs, which are identical to and as efficient as brand names, with only the price as difference. Fakes are fakes.

  • There is no protection of exclusive data in Thailand

This issues is a larger and more technical one. It refers to the data generated during the development of a new drug or of an existing drug for a different use. This data is very precious and usually belongs to the people who have produced it (often at a cost). It may for example comes out from a clinical trial conducted to test the efficacy of a drug against a placebo (an inactive compound). It is however common practice for this data to belong to all those who have been involved in its production. For instance, in the case of a clinical trial conducted in Thailand, with Thai volunteers ready to put their life at risk so that a pharmaceutical company can test a new drug, the data would belong to the industry and its Thai collaborators. The Thai government may even have a view that this data belongs to the Thai people.» Technically and as a consequence, all parties involved can use the data. What the Pharma wants is the exclusive use of data that have been generated on the back of volunteers in this case not considered better than guinea pigs.

  • Thailand new Product Liability Act poses legal threat to drug companies that conduct clinical trials of new drugs in the country.

This is beyond belief. What the Liability for Damages Arising from Unsafe Products Act 2551 B.E. sets out is a law that provide protection to the consumer for damages caused by “Unsafe product” that “cause or may cause damage, regardless of whether it was caused by negligence during the production process or the design process or by no guidelines being given for storage, or warning, or information related to the product, or guidelines being given but in an incorrect manner or vaguely so as to be improper when considering the condition of the product, including the normal method of use and storage for the product.”

Similar laws exist in all Western countries and aims at protecting the people by preventing unscrupulous businesses to sale dangerous products. To suggest that such law poses a legal threat to drug companies says a lot about how the industry considers its market and the people who are ready to put their life at risk so that drug can be tested before being overpricely sold later.

There is therefore little of weight supporting the American businesse’s concerns other than them not being able to milk consumers and patients more than they already do. Following an uproar from advocacy and civil society groups at the news that the Thai government may relinquish on its rights to past and future issuance of CL before it meets with the United States Trade Representative (USTR) in Washington, Alongkorn Ponlaboot finally announced that “The Commerce Ministry has no policy and no right to stop further use of compulsory licences on additional drugs” and that The government will continue to impose compulsory licensing (CL) on essential but expensive drugs.”

Alongkorn Ponlaboot deserves praise for standing against the U.S. bullies. But rest assured that the Pharmaceutical Industry and other lobbyists won’t stop here. There is much more at stake than the Thai market behind this war. The Thai may be leading the way and opening Pandora’s box from which will emerge further CL issued by bigger markets such as China. By trying to prevent CL in Thailand, it is their future interests in growing markets that they are trying to protect. But instead of fighting for outdated patenting system and IP rights they should better invest in developing new drugs (rather than recycling old ones or spending so much in PR) and on finding innovative ways to recoup their initial investment. It is probably too much asking.

The “Special 301” Report is an annual review of the global state of intellectual property rights (IPR) protection and enforcement, conducted by the Office of the United States Trade Representative (USTR) pursuant to Special 301 provisions of the Trade Act of 1974 (Trade Act). The 2007 Special 301 review process examines IPR protection and enforcement in 79 countries. Following extensive research and analysis, USTR designates 43 countries in this year’s Special 301 Report in the categories of Priority Watch List, Watch List, and/or Section 306 Monitoring status. This report reflects the Administration’s resolve to encourage and maintain effective IPR protection and enforcement worldwide.
For a detailed examination of this issue, see the report from American University’s Washington College of Law’s Program on Information Justice and Intellectual Property. See also several peripheries postings on the subject.
This would not be a Thai specificity, it is country dependent and the Pharma would know that and have to accept it.
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Getting high on Sustiva (Efavirenz) in South Africa

sustiva-ground2The BBC reports on South African Children as young as 15 shooting up with grounded HIV anti-retrovirals sometimes mixed with painkillers and marijuana.

“I couldn’t believe it. I was shocked at first, these were school boys in their school uniforms,” documentary-maker Tooli Nhlapo told the BBC World Service’s Outlook programme.

“They take a pill and grind it, until it is a powder. Some also mix it with painkillers and others mix it with marijuana,” said Ms Nhlapo. “They showed me how they roll it and smoke it.”

The pills are either bought from nurses, patients or stolen. It seems that smocking the pills has hallucinogenic and relaxing effect.

Looking at the side effects of Efavirenz, which include dizziness, insomnia, impaired concentration, somnolence, abnormal dreaming, euphoria, confusion, agitation, amnesia, hallucinations, stupor, abnormal thinking, and depersonalization, this is rather unsurprising. The consequences are that some HIV infected people are not getting their treatment, other are not properly adhering to it and all are exposing themselves to a resurgence of the virus in their body with serious consequences.

According to Dr Kas Kasongo, an advisor on an anti-retroviral drugs panel in South Africa, the phenomenon is widespread in townships.

Human imagination and despair have no limit.

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