The Health of the Poor: a Valuable Commodity for Big Pharma

Roger Tatoud wonders out loud about medicalisation of sex in OpenDemocracy but I would be more worried about medicalisation of health. PrEP operates by putting HIV negative people on antiretroviral (ARV) drugs in the hope that this will reduce their susceptibility to the virus. And 'treatment as prevention' advocates claim that putting HIV positive people on ARVs will ensure that they are less likely to transmit the virus to HIV negative people.

Both processes are part of what some claim is a new paradigm. However, treatment is not prevention. It may play a part in prevention programs but it is not thereby a prevention paradigm. And PrEP is of little use without other prevention measures, such as condom use. In fact, condom use on its own is probably just as effective as condom use in conjunction with PrEP.

I've only managed to see the first page of an article by Vinh-Kim Nguyen and others, entitled 'Remedicalising an epidemic: from HIV treatment as prevention to treatment is prevention'. But they seem to be arguing something along similar lines.

Prevention has long been underfunded and transmission rates are not declining in many countries outside of Africa. As for the African countries with declining transmission rates, it is not really clear why they are declining. Declines in incidence started long before most prevention programs came into existence. This was also long before significant rollout of ARVs.

But a few tens of millions of HIV positive people is not a big enough market for the pharmaceutical industry, they have to put tens, or even hundreds, of millions of people on drugs even though they are not sick.

A Technical 'Solution' in Search of a Problem

In an article on self-testing for HIV in aidsmap.com:

"Dr Renee Ridzon of the Bill and Melinda Gates Foundation warns that self-testing is going to be necessary if antiretroviral-based prevention methods such as microbicides and pre-exposure prophylaxis become available, simply to accommodate the volume of regular testing that will be necessary to use these methods safely."

No surprise that the Foundation would be involved in anything to do with medicalization of health and the use of technical solutions in the absence of adequate health facilities, health personnel and even more general health (as opposed to disease) issues such as water and sanitation, air quality, living conditions, etc.

This sounds very much like a solution in search of a problem, a phenomenon that makes up a very significant proportion of Big Pharma sponsored health 'research' (the Foundation being an integral part of Big Pharma).

I've discussed this in more detail on my HIV in Kenya blog.

Drop Everything, A Vaginal Gel Has Been Developed

Chi Mgbako writes an article entitled "International donors must fund female-controlled HIV prevention gel", but this raises a number of issues.


Is a vaginal gel, as Mgbako and others argue, female controlled? One would think that if it is, so are oral contraceptives. Yet, the majority of women in many developing countries opt for injectible contraceptives. They say their husbands object to them taking contraceptives, so they get an injection every three months, possibly running the risk of picking up some blood-borne infection at the clinic, perhaps even HIV. Will the same husbands that object to oral contraceptives ignore vaginal gels? Has this even been tested?

Also, this article mentions a number of things that are in need of change, such as domestic violence and gender inequality. These are in need of change regardless of HIV transmission. Is the author advocating that these and other social problems be ignored as long as vaginal gel is paid for by international donors and some (rather small) percentage of HIV infections are possible prevented?

I don't think the author is making the argument that these other social problems are insignificant or that HIV reduction should be chosen over other social problems. Rather, it needs to be made clear that that is something international donors do.

Numerous social problems have been alluded to as causing HIV transmission, allowing HIV transmission, assisting HIV transmission, etc. But most of these problems are independent of HIV, they existed before HIV and they won't just go away on their own.

But HIV programs have a tendency to ignore contexts to the extent that HIV testing clinics are set up in areas where people are dying of contaminated water related diseases, respiratory infections, intestinal parasites and other treatable and preventable conditions. HIV programs are, no matter how much those in the HIV industry would like to argue otherwise, deflecting attention from real and preventable problems.

And to what end? That we might be able to reduce HIV transmission by 39% (in ideal, trial related scenarios)?

Finally, if the gel is so good, why have funders not come up with the funding? Is there something they know that we are not allowed to know? Other HIV related drugs have made billions, why are international funders drawing back from this one?

Some Disturbing Considerations Relating to PrEP Trials

I’m not sure why Aegis have an article about PrEP entitled ‘hope and excitement greet first successful microbicide’ so soon after worries being raised that the money to do further required tests has not been forthcoming. These refer to the CAPRISA 004 trial, which received the most hype during the Vienna AIDS Conference only a few months ago.

Anyhow, the article notes that “Behavioural messages that encourage abstinence, monogamy and use of condoms have had […] only a limited long-term impact on the spread of HIV in that region.” The article calls for HIV prevention strategies to be made relevant, though they are not talking about making them relevant to the possibility that some HIV is not sexually transmitted.

A popular claim about PrEP (and other technological fixes) is that they can be applied by women and are “under their control”. There may be some truth in this. Yet, oral contraception has long been available without most women choosing to avail of it. Many instead opt for injectable versions, thus putting themselves at higher risk of being infected with HIV and other viruses as a result of unhygienic health practices.

Injectable versions of contraception are very popular with married women and sex workers, though perhaps for different reasons. Married women say they are not willing to risk having their husband interfere if they keep oral contraceptives at home, which they have to take regularly. It remains to be seen whether attitudes towards PrEP gel are any different. Is it really ‘under the control of women’?

The question is pertinent because unsafe health care practices are not under any clients control, whether male or female. People might be able to take precautions but they have to know that such practices could lead to infection and they have to know what they can do to protect themselves. The HIV/AIDS industry, in this instance, doesn’t seem to be interested in the strategy being under the control of those who face the risks.

The CAPRISA 004 trial, despite widely repeated claims, did not establish what risks were reduced among those taking part. Was it just the risk of sexual transmission that was reduced or was it also the risk of non-sexual transmission? The difference is crucial.

The article notes that the trial results were not affected by frequency of sex. But sexual activity was not very high during the trial and it decreased over time, as did use of the Tenofovir gel. However, HIV transmission over the course of the trial was extremely high, even among the intervention group.

It is also noted that “average viral load was not significantly different” between the intervention and control groups. The ‘Test and Treat’ strategy, which was being hyped as much as PrEP two years ago, claims that placing every HIV positive person on antiretroviral drugs will reduce viral load and therefore reduce transmission. But there is now evidence that low viral load may not be so closely related to rates of HIV transmission, something I have recently discussed on my other blog, HIV in Kenya.

The Aegis article warns that the results need to be viewed with caution; this can not be stressed enough. These trials, CAPRISA 004 in particular, seem to take little notice of how HIV might be transmitted among the populations taking part in their research. If HIV is not all transmitted sexually, such trials will continue to produce invalid results and people will continue to be exposed unnecessarily to the risk of infection with HIV and other blood-borne viruses.

Do Family Health International Care About Women or Funding?

A quick look at the HIV/AIDS and Malaria Indicator Survey for Tanzania (or any other African country) will show that 'HIV' always means 'sexually transmitted HIV'. The so called 'ABC' strategy (Abstain from sex, Be faithful to one sexual partner, use a Condom) is still about as far as the global HIV industry has got in terms of HIV prevention. Over 50%, often over 80% of people between the ages of 15 and 49 know about at least one of these methods of reducing the risk of sexually transmitted HIV.

It would be more comforting if a higher percentage of people knew about all the ways of preventing HIV, but that would need to include non-sexual transmission, as well. People answering questions about ABC are prompted but it takes a lot more prompting to get people to suggest non-sexual modes of HIV transmission. Such modes are deemed not to be important enough to include in the Survey. Some people know about them, rather surprisingly, but how many know how to avoid or prevent non-sexual HIV transmission?

PrEP and a handful of other interventions are also aimed at sexual transmission of HIV. While some drugs may also reduce non-sexual transmission, this is not their aim. And telling people they could take antiretroviral drugs to avoid being infected with HIV when they pay a visit to a health facility, a dentist's surgery or the hairdresser might not be the best way of selling the technology.

So gushing about vaginal microbicides "giving women a new tool to protect themselves from HIV infection" sounds like humbug when it comes from FHI's Ward Cates. If FHI gave a damn about women being able to protect themselves from HIV, why do they not take so much interest in non-sexual transmission? After all, they have received hundreds of millions of dollars to try to influence women's behavior, in relation to sex, reproduction and health in general. If they are not in a position to warn about non-sexual transmission, who is?

Of course, there is a set of questions about medical injections and about whether the equipment used was taken out of a sealed packet. But these matters do not usually make up part of HIV prevention programs and few programs mention either the risks from medical injections or the steps people can take to reduce the risks of infection with HIV or any other blood-borne viruses. None of the Aids Indicator Survey questions aim to establish how HIV positive people might have become infected.

The company that produces the drug used in the microbicide gel, Gilead, is one of the many multinational drug companies that sponsors FHI. It wouldn't do Gilead, or anyone else betting on sexual transmission of HIV, any good if non-sexual transmission were to play a significant role in the epidemic in African countries. But luckily, there's a whole pack of companies and even funders who have similar interests, which don't include nosocomial or iatrogenic HIV transmission. Who are they? Just take a look at FHI's list of funders.

Big Pharma Predicts PrEP Will Be Great, For Them

There's always a lot of talking up programs that cost heaps of money, never so much reflection on why throwing money at a problem (or at an industry) doesn't have the predicted effect. So it's surprising that an article by the BBC admits that the target to provide everyone who needs antiretroviral drugs (ARV) with them by 2010 has been missed. Only a third of those who need the drugs are receiving them, according to official figures (WHO, UNAIDS, etc).

There's a bit of hedging because WHO guidelines concerning the stage at which people need ARVs has changed, so the overall figure has gone up. But the target would have been missed, regardless. The figures sound very impressive, but it's hard to find a clear statement of how many people have received ARVs and whose supply has, for some reason, been cut off, how many are lost to follow up, how many have died or are not responding to treatment, how many are in need of second line drugs because they have developed resistance to first line treatment, how many are receiving second line drugs, etc.

For instance, some countries highlight incidents where money or drugs are going missing, but it's rarely made clear what impact that has on treatment or HIV transmission. And while articles constantly make statements such as "virtual elimination of mother-to-child transmission of the virus by 2015 is possible", other articles make it quite clear that there is a huge gap between optimistic press releases and what's happening on the ground. Only 24% of Ugandan children who need them are receiving ARVs, 150,000 are living with HIV, nearly 15,000 are born with the virus every year and 16,000 dye of AIDS every year. And Uganda has received far more money, and far more attention, than most other African countries.

It's good to hear that some pressure is being applied to countries with high HIV prevalence to make some of their own revenue available for the epidemic, and perhaps for health as a whole. So far, most of the money for ARV programs has come from external donors, but their funds are drying up. However, given the progress of attempting to put millions of sick people on drugs, how would a program that aims to put far higher numbers of healthy people on drugs fare?

Pharmaceutical Research; Blink and You've Missed it

Only last year, a Cochrane Review of PrEP concluded that "there is no reliable evidence to support the use of any antiretroviral agent for HIV chemoprophylaxis". At the time the study was carried out, only one study met their inclusion criteria and the result of it was not statistically significant.

But it's amazing how much can be achieved in a short time by a multi-billion dollar multinational pharmaceutical industry with ample funding and a high probability of huge profits. Ever since the HIV industry has changed its tune from 'The news is bad, we need more money' to 'The news is good, we need more money', there has been lots of favorable writing about PrEP and related uses of HIV drugs.

The Cochrane Review listed the following implications:

"We advocate well-conducted trials with the statistical power to answer questions about the value of PrEP in preventing HIV infection in various populations and risk groups. Ongoing and future trials should evaluate other important issues, such as behavioural disinhibition and drug resistance, which are some of the major concerns about the use of chemoprophylaxis for HIV."

And already there have been trials which are being interpreted in the most generous terms possible; there have been papers about how disinhibition is not likely to be such a big problem; and even drug resistance is being written about as if it is a mere challenge, not a danger, like drug resistance in relation to other diseases.

This is amazing progress, truly amazing. I'm simply amazed.

Good Cop, Bad Cop, No Cop, No Problem

A recent article on PrEP notes, among other things, the problem of 'addressing informal markets'. The article is entitled 'Implementation Science of Pre-exposure Prophylaxis: Preparing for Public Use' and it lists many of the 'challenges' of PrEP, which is useful. But because there are so many challenges, informal markets only get a brief paragraph.

If people are getting drugs for free, they could easily sell them on. If PrEP is intended to be sold to people, the drugs that are currently free can be sold, instead. This is an informal market.

This development of informal markets has occurred at various times in various places. There is evidence that it still occurs, which is not really a problem for the pharmaceutical industry, as long as they are getting paid. But it is a problem that people could end up taking unprescribed drugs and using them for purposes for which they were not intended.

There is also a danger that, as the drug taking will not be monitored, if the person becomes infected with HIV, resistance could develop. Again, this is not a problem for the pharmaceutical industry because they have other, more expensive drugs that they can sell. But the person selling on the drugs could be failing to adhere to their own regime and those receiving the drugs are in danger of developing resistance and even passing that on to others.

If PrEP is to be rolled out as a possible means of preventing HIV transmission, it would want to be very well controlled. The numbers of people involved would be far higher than the numbers currently on antiretroviral drugs (ARV) and this program is not very well controlled. As much as 25-40% of people on ARVs in countries such as Kenya could be lost to follow-up. They just don't have the record keeping capacity in their health services to administrate current levels of ARV roll out, let alone an even bigger roll out of PrEP.

Also, the phrase 'implementation science' in the article title smacks of 'scientists' doing more than a little work to help pharmaceutical companies push their wares on populations who may be very reluctant to buy them if they actually get to know anything about them. Implementation science may or may not be related to the practice of 'medical ghostwriting', where pharmaceutical companies (or people acting for them) write up their 'research' and then get some bona fide scientists to put their name to the paper. How much this happens with regard to PrEP, I couldn't say.

Opportunity and Opportunism in the HIV Industry

There's an article in the July edition of the Journal of the International AIDS Society entitled "Planning for pre-exposure prophylaxis to prevent HIV transmission: challenges and opportunities". The list of 13 authors and their respective institutions reads like a page from a Who's Who of the HIV/AIDS industry. The tone of the article suggests that there is more interest in the opportunities presented by pre-exposure prophylaxis (PrEP); the challenges are made seem quite irrelevant, or at least surmountable. The paper emanated from a meeting sponsored by the Gates Foundation.

In addition to the apparent irrationality of trying to eradicate HIV by putting most sexually active HIV negative people on antiretroviral drugs (ARV), PrEP would seem to be in tension with another, slightly less irrational strategy: 'treatment as prevention'. Treatment as prevention involves treating everyone found to be HIV positive with ARVs, regardless of their disease stage. According to this theory, people who are on ARVs are not very infectious, so they are unlikely enough to transmit HIV for the epidemic to eventually be eradicated.

But a successful treatment as prevention program would obviate the need for PrEP. And a successful PrEP program would make treatment as prevention a serious case of overkill. Perhaps the industry, in its great wisdom, is not advocating for both programs to be implemented in the one place. But both strategies seem to be about maximizing drug use without having much likelihood of effecting substantial reductions in HIV transmission.

PrEP would target HIV negative people and treatment as prevention would target HIV positive people, so the latter would seem to be the more tractable aim. Even in the highest prevalence countries, there are more HIV negative people than HIV positive. But then you have to make the decision, assuming your resources are limited, as to whether you distribute drugs among those who are already sick, to allow them to live longer and to enjoy good health; or distribute drugs among those who are not sick, but who may become infected.

PrEP and treatment as prevention are not complementary strategies, they are clearly in tension. But the tension is not irresolvable. Healthy people don't need drugs. There are other prevention strategies available that PrEP can only overlap with, such as condoms and possibly others. There is also prevention of non-sexual HIV transmission, which has been totally ignored in developing countries so far. But the aim to treat everyone infected, no matter how desirable, will not guarantee the protection of people as yet uninfected.

The article concludes "It is an ethical imperative that we act now to prepare the path to timely implementation [of PrEP]". The only ethical imperative is that we find appropriate treatments and prevention interventions. The imperative to exploit the HIV pandemic to make huge profits is not ethical, whatever else it may be.

Betting on Sex

The behavioral paradigm, which claims that most HIV transmission in African countries is a result of unsafe heterosexual intercourse, is vitally important to the pharmaceutical companies competing to develop HIV drugs. Some HIV transmission is due to heterosexual intercourse, but it is not clear what proportion. Some transmission is also due to unsafe medical and cosmetic practices. But, according to those defending the orthodox view, sex is the problem and only a tiny proportion of the virus is transmitted through any non-sexual route.

Betting on the behavioral paradigm being true, the pharmaceutical industry has been working to widen their markets. They are not only targeting people who are HIV positive but also the far bigger, and more lucrative market, of those who are HIV negative. It is hoped that they can be scared into believing that they are vulnerable, and more to the point, that they need to take some form of drug to protect themselves.

Four of the main means of widening the market for HIV drugs are vaccines, microbicides, pre-exposure prophylaxis (PrEP) and a strategy called 'treatment as prevention'. A maximum of about five million HIV positive people in the world are currently on antiretroviral drugs (ARV). But tens of millions, perhaps hundreds of millions could be potential customers for vaccines, microbicides and PrEP. Even just one of these could increase ARV consumption by tens or hundreds of times.

Treatment as prevention, testing everyone regularly and putting anyone found to be HIV positive on ARVs to reduce their transmission rate, would create a smaller market, but it could still be about ten times the current market.

To help out the pharmaceutical industry a bit more, because they are clearly struggling to make ends meet, there are two further phenomena. The first is the new WHO Guidelines on HIV treatment, which recommend putting HIV positive people on treatment at an earlier stage of disease progression. This could double the current market. The second is the enormous levels of ARV drug resistance that will inevitably develop as a result of all the previous considerations.

Vaccines, microbicides, PrEP and treatment as prevention are all predicated on the behavioral paradigm. While any treatment with ARV drugs may give some protection against any kind of HIV transmission, no one is going to vaccinate against something that they could catch from unsafe medical or cosmetic practices. They will just insist on safe medical or cosmetic practices. No one would put a topical microbicide on their genitals to protect themselves from accidental exposure to contaminated medical equipment during an operation. And people certainly won't be taking PrEP before going to the doctor, dentist, hairdresser or tattoo artist.

If a significant proportion of HIV transmission is as a result of unsafe medical or cosmetic practices, that would really cut into the markets that Big Pharma have been trying to secure for so long. The whole HIV industry and the hoards of academics, consultants, bureaucrats and countless others that work so hard to claim that sex is the problem would have to find other approaches to cutting transmission.

True, it would be far easier to cut transmission if a lot of it turned out to be non-sexual. But easier for whom? Topical microbicides and the like can't be used for much else aside from preventing sexually transmitted HIV. I'm sure there'll still be vast markets for HIV related pharmaceutical products. But without sex, will anyone even care any more? It's hard to imagine who will want to be involved in HIV prevention campaigns without the current emphasis on sex, whether they come from a moral, population control, religious, political, salacious, commercial or almost any other angle.

I don't wish to exaggerate, I'm sure sex plays a big part in HIV transmission. But the world needs to know just how big that part is. And that means investigating the part that non-sexual HIV transmission plays in high prevalence countries. Simply guessing, which is what UNAIDS currently do, is not good enough. People are entitled to know how HIV is being transmitted so that they can protect themselves and others.

The HIV industry, if it is ever to have an impact on the pandemic, also needs to know. They need to let Big Pharma fend for themselves, they'll probably be OK. But many people are being infected with HIV, suffering disease and stigma and passing the virus on to others because they don't know that they can be infected through non-sexual routes and so they don't know how to protect themselves. It's time for the industry to admit they got it wrong, that it's not all about sex, and to start doing something about it.