Showing posts with label big pharma. Show all posts
Showing posts with label big pharma. Show all posts
Tuesday, August 30, 2011
Without Addressing Determinants of Health, Technical Fixes May be Useless
There is an interesting conflict between the findings of two different pieces of malaria research. One piece from Tanzania claims that mosquito numbers have decreased over a number of years to such an extent that fewer and fewer people are being infected.
Whereas scientists in Kenya agree, but claim that malaria infections are lower because of public health measures, such as "well-managed control programmes which involved distribution of nets, effective medicines and vector suppression".
It looks as if there will have to be a meta-study to resolve the issue: has malaria declined because of successful public health measures, because malaria spreading mosquitos are in decline (for one or more reasons), or is malaria prevalence merely cyclical, as has been found with some other diseases?
The Tanzanian-Danish study is adamant that the decline in malaria is not attributable to human interventions, apparently. This conclusion is unlikely to be popular among public health donors, who tend to attribute success to their efforts and failures to something that can remain quite mysterious.
Rumors about the possible influence of climate change have arisen, predictably, but that's a pretty amorphous determinant, at best. But, as scientists, they have to say something.
Despite the claims about distribution of nets in countries such as Kenya and Tanzania, I have talked to many who do not have nets, do not have enough nets, can't afford insecticide treated nets, or don't live in conditions that make nets useful, for example, they don't sleep in a bed or share the bed with so many people the net is useless.
Other articles have mentioned the fact that nets are often used for things far removed from their intended purposes. And so called 'free' nets are often sold, sometimes at too high a cost for the most needy.
And when it comes to drugs, there have been many articles lately, bemoaning the fact that 'fake' drugs (a term that fails to distinguish between generic versions of drugs, counterfeits and placebos) are responsible for sickness, death and resistant strains of malaria. Clearly, the drug industry wants public money to be used to ensure that they extract as much as they can from those living in the greatest poverty.
So all these scientists and experts really do have themselves in a tangle. Declines in numbers of mosquitoes have been equally sharp in villages without mosquito nets, though some articles would make you think there was no such thing as a village that didn't have nets.
Interestingly, a long way from East Africa, insecticide resistance has been linked to an increase in malaria in Senegal. Apparently, mosquitoes have become resistant to the insecticide used on bednets and malaria incidence is now higher than it was before the reduction campaign.
In addition to resistance in the mosquitoes, older children and adults are becoming more susceptible to the disease, which is an entirely separate matter. People's immune response is increased by frequent exposure to malaria, but it then drops once exposure is reduced. This research also acknowledges that the increase in the disease had been forseen for some time.
Sometimes these 'vertical' public health programs, ones that aim to address only one disease, seem a bit futile. For example, attempts to eradicate polio by using an improved vaccination without improving people's living conditions, especially their access to clean water and good sanitation, seem like a bit of a loser.
Similarly with malaria, many people who are most at risk from malaria live in areas with a lot of stagnant water and little control over waste disposal. The same people risk numerous water borne, hygiene related and other diseases, not just the economically viable ones. Perhaps the obsession with technical fixes, yet again, is getting in the way of providing people with what is vital for their survival and their health: decent living conditions.
Thursday, May 5, 2011
UNAIDS Now Open About Being Pharmaceutical Industry Mouthpiece
The English Guardian has suddenly noticed that "Beating copyright infringement in the third world could be as simple as making products affordable". I have argued this on several occasions in the last few years, including here and here, but I would not be the first person to make this point.
However, I'm happy to hear that Joe Karaganis and others have spent three years researching the issue and come up with the Media Piracy in Emerging Economies report. But I don't expect that to make much difference to the position of people in developing countries.
It is also worth stressing that intellectual property (IP) protection, one of the most popular forms of trade protection among those who ostensibly oppose trade protection, is not paid for by those who benefit from it; it is paid for by consumers, in rich and poor countries alike. It's like a kind of tax that we pay to protect the interests of the rich. And it can represent well over 90% of the revenue that IP owners receive.
The report is also important in being independent, unlike much of what we read about IP, copyright issues, piracy, counterfeiting, fakes and whatever else industry is currently whining about.
We might think that everyone can do without luxury goods, especially people who are also short of water, food and medicine. However, various multinationals are doing everything in their power to control water, somehow or other, they already control food to a large extent and the drug industry is almost entirely run on profits inflated by IP protection.
There may be a lot of talk from Bill Clinton, Bill Gates, the World Trade Organization (WTO), UNAIDS and others about generic medicines and making drugs affordable. But prices of vital drugs are also protected by the same means as other goods. Even drugs whose cost has 'dropped' from the astronomical thousands of dollars per year to not much more than 100 dollars, are protected. The ultimate price charged is 100% controlled by the rich and powerful.
Therefore, the 'South African Generic Medicines Association' may sound touchy-feely enough, what with the 'African' and the 'generic' bits. But it is as much part of the pharmaceutical industry as AVAC or any of these other front groups that claim to be trying to keep costs down and make pharmaceutical products more accessible.
A speech by Paul de Lay of UNAIDS makes it clear who his intended audience is and who stands to benefit from any agreements that are made when it comes to generic drug pricing. The prices discussed may seem affordable when compared to the ridiculous prices they are replacing. But in reality, they are only affordable to the aid industry, not to the people who need them.
And the aid money going towards overpriced generic drugs is effectively another subsidy for those who ostensibly despise subsidies. This is money that could be better spent on the care people need, beyond the mere distribution of drugs, nurses, doctors, other health personnel and much else. But it is not the needs of HIV positive people that are being served here.
Incidentally, de Lay's speech mentions what he considers to be three areas of discussion, HIV prevention, treatment and health delivery. In reality, all three of these refer to drugs, to be paid for by aid money. To date, a relatively small percentage of HIV spending has gone towards prevention, but the industry has agreed that putting more people, HIV positive and negative, on drugs will prevent HIV transmission. And health delivery may sound like more than drugs, but it isn't really. Just read the speech.
It's wonderful how the interests of UNAIDS and the HIV industry as a whole now matches the interests of the global pharmaceutical industry. In fact, UNAIDS' HIV strategy can be summed up in one word: drugs. You can waste a lot more words on it, and you can be sure that UNAIDS and others will, but in the end, drugs are it.
De Lay advocates TRIPS (Trade Related Intellectual Property Rights), TRIPS Plus, Economic Partnership Agreements (EPA) and all sorts of other institutions and instruments that only point to one thing: intellectual property and the protection of the very rich against the very needy. The consortium of partners includes the wHO, the World Bank, the Gates Foundation (financed by IP protection) and a few others.
So it's official: the entire HIV industry, fronted by UNAIDS, is run by and for big pharma, and much of the aid industry will continue to subsidise and represent the interests of other industry sectors. The whole pretense of humanitarian motives can now be abandoned, as no one was fooled anyway. But, more worryingly, few seem to object to this either.
However, I'm happy to hear that Joe Karaganis and others have spent three years researching the issue and come up with the Media Piracy in Emerging Economies report. But I don't expect that to make much difference to the position of people in developing countries.
It is also worth stressing that intellectual property (IP) protection, one of the most popular forms of trade protection among those who ostensibly oppose trade protection, is not paid for by those who benefit from it; it is paid for by consumers, in rich and poor countries alike. It's like a kind of tax that we pay to protect the interests of the rich. And it can represent well over 90% of the revenue that IP owners receive.
The report is also important in being independent, unlike much of what we read about IP, copyright issues, piracy, counterfeiting, fakes and whatever else industry is currently whining about.
We might think that everyone can do without luxury goods, especially people who are also short of water, food and medicine. However, various multinationals are doing everything in their power to control water, somehow or other, they already control food to a large extent and the drug industry is almost entirely run on profits inflated by IP protection.
There may be a lot of talk from Bill Clinton, Bill Gates, the World Trade Organization (WTO), UNAIDS and others about generic medicines and making drugs affordable. But prices of vital drugs are also protected by the same means as other goods. Even drugs whose cost has 'dropped' from the astronomical thousands of dollars per year to not much more than 100 dollars, are protected. The ultimate price charged is 100% controlled by the rich and powerful.
Therefore, the 'South African Generic Medicines Association' may sound touchy-feely enough, what with the 'African' and the 'generic' bits. But it is as much part of the pharmaceutical industry as AVAC or any of these other front groups that claim to be trying to keep costs down and make pharmaceutical products more accessible.
A speech by Paul de Lay of UNAIDS makes it clear who his intended audience is and who stands to benefit from any agreements that are made when it comes to generic drug pricing. The prices discussed may seem affordable when compared to the ridiculous prices they are replacing. But in reality, they are only affordable to the aid industry, not to the people who need them.
And the aid money going towards overpriced generic drugs is effectively another subsidy for those who ostensibly despise subsidies. This is money that could be better spent on the care people need, beyond the mere distribution of drugs, nurses, doctors, other health personnel and much else. But it is not the needs of HIV positive people that are being served here.
Incidentally, de Lay's speech mentions what he considers to be three areas of discussion, HIV prevention, treatment and health delivery. In reality, all three of these refer to drugs, to be paid for by aid money. To date, a relatively small percentage of HIV spending has gone towards prevention, but the industry has agreed that putting more people, HIV positive and negative, on drugs will prevent HIV transmission. And health delivery may sound like more than drugs, but it isn't really. Just read the speech.
It's wonderful how the interests of UNAIDS and the HIV industry as a whole now matches the interests of the global pharmaceutical industry. In fact, UNAIDS' HIV strategy can be summed up in one word: drugs. You can waste a lot more words on it, and you can be sure that UNAIDS and others will, but in the end, drugs are it.
De Lay advocates TRIPS (Trade Related Intellectual Property Rights), TRIPS Plus, Economic Partnership Agreements (EPA) and all sorts of other institutions and instruments that only point to one thing: intellectual property and the protection of the very rich against the very needy. The consortium of partners includes the wHO, the World Bank, the Gates Foundation (financed by IP protection) and a few others.
So it's official: the entire HIV industry, fronted by UNAIDS, is run by and for big pharma, and much of the aid industry will continue to subsidise and represent the interests of other industry sectors. The whole pretense of humanitarian motives can now be abandoned, as no one was fooled anyway. But, more worryingly, few seem to object to this either.
Monday, April 11, 2011
'Counterfeiting' is a Problem That Can Only Be Solved By Big Pharma
If a business produces something and sells it for a price that covers costs and also gives a decent profit, that's a good model. Others may make the same thing, so a business needs to make the best and work hard to make sure they are not undercut. But most people will pay for something good rather than something that isn't up to scratch, if they can afford it.
However, if a business produces something and sells it for a price that is a complete distortion of the above business model, it is worthwhile for someone else to produce the same thing and charge a lot less. They don't even have to cut costs, they can just accept a lower profit. And those who have no chance of affording the expensive product may well be able to afford the cheaper one.
This is an oversimplification, but it is roughly what the pharmaceutical industry does, charges an outrageous price for something because they can. In addition, the industry depends on a form of protectionism called 'intellectual property rights'. Arguably, this has its uses, even that it is vital, but it is still a form of protectionism.
Often, the research that pharmaceutical companies claim to spend so much on is done by publicly funded, or partially publically funded, institutions. But there is little or no return to the public. And the amount spent on PR and marketing far exceeds what is actually spent on research.
So when someone else makes the same product but demands less for it, the industry reacts by resorting to all sorts of tricks to make sure the competition is destroyed. Competition, when you don't have a high level of trade protection, is not appreciated by the pharmaceutical industry.
The word 'counterfeit', therefore, can mean all sorts of things. It can mean a generic version of a branded drug, a fake version of a branded drug, a substandard version of a branded drug and probably other things. But a generic version of a branded drug is not a counterfeit and claiming that it is one threatens to deny lifesaving treatments to many people in developing countries.
If drug companies don't want generic versions of their drugs to be produced, they should produce affordable versions themselves. There is clearly a huge market for them and a very good profit to be made. Dropping the price to affordable levels would also make the production of substandard and fake drugs a lot less tempting, perhaps not even worth the effort.
But instead of encouraging the production of generic drugs, the EU and, of course, the entire pharmaceutical industry, want to make sure affordable versions of drugs are not produced. They are currently trying to rope India into signing a 'trade agreement' whereby it will no longer be possible for the country to produce cheap drugs. Yet another form of protectionism.
India is one of the main sources of affordable drugs for developing countries. Some drugs will cost many times, perhaps even tens or hundreds of times more, just because they are protected by the sort of regulation that big industry claims to detest.
There is no doubt that some drugs are fake, made of materials that have no effect or are harmless, and this is unacceptable. But as long as ridiculous profits are made from drug pricing models, people will always find ways of selling their versions, no matter how useless or dangerous. It's not as if copyrighted drugs are always effective, or that they are never dangerous, either.
The pharmaceutical industry, already protected and subsidised in so many ways, wants more public money to be used to 'regulate' drug supplies in developing countries. Multinationals refuse regulation for themselves, but they seem to love the idea of regulating any competition.
Big Pharma have effectively created counterfeiting and many other related problems themselves, it's how they keep their profits so inordnately high. So they should sort it out themselves. If people object to the danger to the health and lives of so many people, they should aim their objections at the industry, the problem, not the mere symptoms of the problem.
The Science and Development Network have a selection of articles on the subject of 'counterfeit' drugs and some of the many issues involved. But the article doesn't really point out that Big Pharma don't lose out from counterfeiting because most of those who buy cheap drugs will never be able to afford the expensive versions.
However, if a business produces something and sells it for a price that is a complete distortion of the above business model, it is worthwhile for someone else to produce the same thing and charge a lot less. They don't even have to cut costs, they can just accept a lower profit. And those who have no chance of affording the expensive product may well be able to afford the cheaper one.
This is an oversimplification, but it is roughly what the pharmaceutical industry does, charges an outrageous price for something because they can. In addition, the industry depends on a form of protectionism called 'intellectual property rights'. Arguably, this has its uses, even that it is vital, but it is still a form of protectionism.
Often, the research that pharmaceutical companies claim to spend so much on is done by publicly funded, or partially publically funded, institutions. But there is little or no return to the public. And the amount spent on PR and marketing far exceeds what is actually spent on research.
So when someone else makes the same product but demands less for it, the industry reacts by resorting to all sorts of tricks to make sure the competition is destroyed. Competition, when you don't have a high level of trade protection, is not appreciated by the pharmaceutical industry.
The word 'counterfeit', therefore, can mean all sorts of things. It can mean a generic version of a branded drug, a fake version of a branded drug, a substandard version of a branded drug and probably other things. But a generic version of a branded drug is not a counterfeit and claiming that it is one threatens to deny lifesaving treatments to many people in developing countries.
If drug companies don't want generic versions of their drugs to be produced, they should produce affordable versions themselves. There is clearly a huge market for them and a very good profit to be made. Dropping the price to affordable levels would also make the production of substandard and fake drugs a lot less tempting, perhaps not even worth the effort.
But instead of encouraging the production of generic drugs, the EU and, of course, the entire pharmaceutical industry, want to make sure affordable versions of drugs are not produced. They are currently trying to rope India into signing a 'trade agreement' whereby it will no longer be possible for the country to produce cheap drugs. Yet another form of protectionism.
India is one of the main sources of affordable drugs for developing countries. Some drugs will cost many times, perhaps even tens or hundreds of times more, just because they are protected by the sort of regulation that big industry claims to detest.
There is no doubt that some drugs are fake, made of materials that have no effect or are harmless, and this is unacceptable. But as long as ridiculous profits are made from drug pricing models, people will always find ways of selling their versions, no matter how useless or dangerous. It's not as if copyrighted drugs are always effective, or that they are never dangerous, either.
The pharmaceutical industry, already protected and subsidised in so many ways, wants more public money to be used to 'regulate' drug supplies in developing countries. Multinationals refuse regulation for themselves, but they seem to love the idea of regulating any competition.
Big Pharma have effectively created counterfeiting and many other related problems themselves, it's how they keep their profits so inordnately high. So they should sort it out themselves. If people object to the danger to the health and lives of so many people, they should aim their objections at the industry, the problem, not the mere symptoms of the problem.
The Science and Development Network have a selection of articles on the subject of 'counterfeit' drugs and some of the many issues involved. But the article doesn't really point out that Big Pharma don't lose out from counterfeiting because most of those who buy cheap drugs will never be able to afford the expensive versions.
Tuesday, November 9, 2010
The Insatiable in Pursuit of the Uneatable
For all the blubbering Western powers, such as the EU and the US, do over aid and development, they show their true colours when it comes to trade. Western trade policies with developing countries are designed to increase their own markets, increase their supply of cheap raw materials and labour, destroy anything that may create even the smallest bit of competition and, in general, retain their position of dominance and exploitation.
The EU is currently trying to push India into signing a trade agreement that will threaten the supply of cheap and affordable antiretroviral (ARV) medications to developing countries. India is one of the few countries in a position to produce generic equivalents of branded versions that demand extortionate prices. The issue is, ostenibly, over whether India should be allowed continued access to the data they need to produce the drugs cheaply.
The EU is happy to spend enormous sums of money on this kind of pursuit, far more than they spend on 'aid'. And even though EU and US money is going towards the purchase of a lot of ARVs used in developing countries, they seem content to pay more for, presumably, a lot less of an identical product in the future. And this is at a time when all sorts of crazy policies are being discussed to increase the number of people on ARVs to several times present levels. (There is some discussion of these policies on my other blog, which deals with Pre-Exposure Prophylaxis and other technical 'fixes' for HIV.)
The apparent contradiction in vastly increasing the cost of products that their own funding will be used to purchase in ever increasing quantities is not really a contradiction at all. So called 'aid' money is mainly used as a subsidy for their own industries, especially the pharmaceutical industries. And compared to the amount of money that goes into promoting the interests of Big Pharma, aid money is little to write home about, anyway.
Despite claiming to have the interests of developing countries, including India, at heart, the EU seems intent on destroying the Indian generic drug industry. If developing countries, especially African countries, cease to be a market for these affordable drugs, there will be no other viable markets large enough to sustain the sector.
You might think that this would mean the EU is scoring an own goal but it is just what Big Pharma would like. They have never really wanted a supply of affordable generic drugs, why would they? They couldn't care less who buys their drugs as long as they pay a price that keeps their profit margins at levels they are accustomed to.
A few million Africans may die but that's just collateral damage to the pharmaceutical industry. And the thought of millions of Africans dying could make for a great publicity campaign to increase the amount of money the EU and the US are willing to pay for overpriced drugs. With competition out of the way, top prices are guaranteed. That's how the free market works, it appears.
Just in case you thought all that free market (for developing countries), anti-subsidy (except for wealthy countries) liberalism had been entirely discredited by recent global financial crises, think again. Those who gained from the policies of the past are doing very well, thank you, it's ordinary people who are, as always, paying the price. According to an article by War on Want, the deregulation that has caused so many problems is to continue. Clearly it didn't cause any problems for some people.
And talking of maintaining policies that have caused devastation up to now, the EU is busy pushing biofuels as a 'green' alternative to fossil fuels. Not only is biofuel production not a green alternative in any sense, production of biofuel in large quantities requires even greater exploitation of developing countries than is seen at present.
Vast tracts of land in developing are currently being used to produce food and raw materials for Westerners. But these tracts of land are nothing to what is being grabbed to supply Western cars with cheap fuel. The question of whether there will be land enough left over for developing countries to grow enough food to survive is not really being asked by the land grabbers. Water, in short supply in many countries, will become even scarcer in the pursuit of 'green' biofuels.
Production of biofuels will involve large scale destruction of environments to make way for factory production methods needed to produce 'cheap' fuel. The process of grabbing land is already underway, has been for several years. Perhaps the EU hopes that any increase in carbon emissions will occur in countries too poor to measure the pollution or to do anything about it.
The extent to which Western powers exploit developing countries should never be forgotten when the subject of 'charity beginning at home' comes up. Rich countries may be looking for ways to reduce spending but what they spend on development is a mere pittance, much of it never reaching the supposed recipients. The best thing rich countries could do is reduce their levels of exploitation. Then, whether they continue providing aid and how much they provide may cease to be relevant.
The EU is currently trying to push India into signing a trade agreement that will threaten the supply of cheap and affordable antiretroviral (ARV) medications to developing countries. India is one of the few countries in a position to produce generic equivalents of branded versions that demand extortionate prices. The issue is, ostenibly, over whether India should be allowed continued access to the data they need to produce the drugs cheaply.
The EU is happy to spend enormous sums of money on this kind of pursuit, far more than they spend on 'aid'. And even though EU and US money is going towards the purchase of a lot of ARVs used in developing countries, they seem content to pay more for, presumably, a lot less of an identical product in the future. And this is at a time when all sorts of crazy policies are being discussed to increase the number of people on ARVs to several times present levels. (There is some discussion of these policies on my other blog, which deals with Pre-Exposure Prophylaxis and other technical 'fixes' for HIV.)
The apparent contradiction in vastly increasing the cost of products that their own funding will be used to purchase in ever increasing quantities is not really a contradiction at all. So called 'aid' money is mainly used as a subsidy for their own industries, especially the pharmaceutical industries. And compared to the amount of money that goes into promoting the interests of Big Pharma, aid money is little to write home about, anyway.
Despite claiming to have the interests of developing countries, including India, at heart, the EU seems intent on destroying the Indian generic drug industry. If developing countries, especially African countries, cease to be a market for these affordable drugs, there will be no other viable markets large enough to sustain the sector.
You might think that this would mean the EU is scoring an own goal but it is just what Big Pharma would like. They have never really wanted a supply of affordable generic drugs, why would they? They couldn't care less who buys their drugs as long as they pay a price that keeps their profit margins at levels they are accustomed to.
A few million Africans may die but that's just collateral damage to the pharmaceutical industry. And the thought of millions of Africans dying could make for a great publicity campaign to increase the amount of money the EU and the US are willing to pay for overpriced drugs. With competition out of the way, top prices are guaranteed. That's how the free market works, it appears.
Just in case you thought all that free market (for developing countries), anti-subsidy (except for wealthy countries) liberalism had been entirely discredited by recent global financial crises, think again. Those who gained from the policies of the past are doing very well, thank you, it's ordinary people who are, as always, paying the price. According to an article by War on Want, the deregulation that has caused so many problems is to continue. Clearly it didn't cause any problems for some people.
And talking of maintaining policies that have caused devastation up to now, the EU is busy pushing biofuels as a 'green' alternative to fossil fuels. Not only is biofuel production not a green alternative in any sense, production of biofuel in large quantities requires even greater exploitation of developing countries than is seen at present.
Vast tracts of land in developing are currently being used to produce food and raw materials for Westerners. But these tracts of land are nothing to what is being grabbed to supply Western cars with cheap fuel. The question of whether there will be land enough left over for developing countries to grow enough food to survive is not really being asked by the land grabbers. Water, in short supply in many countries, will become even scarcer in the pursuit of 'green' biofuels.
Production of biofuels will involve large scale destruction of environments to make way for factory production methods needed to produce 'cheap' fuel. The process of grabbing land is already underway, has been for several years. Perhaps the EU hopes that any increase in carbon emissions will occur in countries too poor to measure the pollution or to do anything about it.
The extent to which Western powers exploit developing countries should never be forgotten when the subject of 'charity beginning at home' comes up. Rich countries may be looking for ways to reduce spending but what they spend on development is a mere pittance, much of it never reaching the supposed recipients. The best thing rich countries could do is reduce their levels of exploitation. Then, whether they continue providing aid and how much they provide may cease to be relevant.
Friday, September 10, 2010
HIV Drug Resistance is a Consequence of Irresponsible Drug Use
The availability of antiretroviral drugs (ARV) for HIV treatment, especially in high prevalence countries, has been welcomed by many, and rightly so. Only an estimated one third of people who need treatment are currently receiving it in Kenya and accurate figures about how many people are being successfully treated are probably not available. But the situation is a lot better that it was in the early 2000s, when drugs were still unaffordable (to donors, they will probably always be unaffordable to most Africans) and only a few thousand people were able to access them.
There have long been warnings about careful management of ARV rollouts. One of the main worries was about resistant strains of HIV developing in large numbers of people where the treatment program was not being administrated well. Because, while the cost of ARVs is high, the cost of second line ARVs, needed when resistance develops to first line drugs, can be five to ten times higher. But eventually, a lot of resistance will develop because people are not responding to treatment it or are not taking it according to requirements.
However, a related worry is that of transmitted resistance. Those who are not on ARVs can acquire a strain of HIV which is already resistant to first line drugs. A study in Zambia has found that almost 6% of HIV positive people who are in need of treatment are resistant to first line drugs. It's all very well to say the people involved can be treated with second line drugs. But in addition to the massive increase in costs involved, second line drugs are just not as widely available.
The trouble with resistance, whether acquired or developed, is that it will eventually reach high levels. In countries where ARV programs have long been available, resistance can be as high as 20%. Coupled with this, recent WHO guidelines recommend starting ARV treatment at an even earlier stage in disease progression (though some question the wisdom of this). That sounds great but, not only are numbers of people on treatment in African countries very high, health services and health infrastructures are weak, very weak.
Similar circumstances have already given rise to resistant, multi-drug resistant and extensively drug resistant TB. The problem doesn't get resolved by the production of stronger drugs unless the circumstances that gave rise to resistance are also resolved. Many people in Kenya who are HIV positive also have TB. But many who don't have HIV do have TB. 50% of people with TB are not HIV positive. These are two separate epidemics, despite considerable overlaps. Resistance in either TB or HIV treatment will fuel at least one, perhaps two devastating epidemics.
Monitoring and testing for poor adherence to treatment and resistance are expensive. African countries are struggling to implement the most basic treatment services, let alone such advanced facilities. Some of the costs may go down, but unless broad health systems are developed, the lack of adequate facilities, trained personnel and equipment will mean that the majority of people are still vulnerable.
You can't expect weak health services to implement massive, high technology programs. Yet, this is what seems to be expected of African health services. The majority of people have little or no access to primary health care, water and sanitation, adequate food and levels of nutrition, some of the most basic aspects of health. People die of diarrheal conditions and respiratory problems. What chances have they with HIV and TB?
The HIV agenda has been driven by the desire of pharmaceutical companies to sell drugs at the highest price they can get to the largest number of people possible. Not only is resistance, acquired and developed, a consequence of allowing Big Pharma to drive the HIV agenda. Resistance is also an excellent way of increasing their profits further. But what about the epidemics? What about people who are HIV positive and those who are in danger of becoming infected?
If donors, governments and the HIV industry can accept that preventing and treating HIV is not just a matter of distributing ever increasing quantities of drugs, the agenda should include other items, such as the need for more and improved hospitals, more and better trained and motivated personnel, better equipment and supplies. People must be able to access primary health care, not a bunch of kiosks that give out drugs, almost willy-nilly. And good health also requires good infrastructure, education, food security and a whole lot of other things.
It's the job of Big Pharma to sell drugs but it's not the job of UNAIDS, the WHO, national governments, academic institutions and other parties to support them and their excesses. Prevention of further transmission of HIV is getting lost in the process of selling drugs. Some even believe that prevention of HIV transmission will be effected by greater consumption of drugs. This is not the case. Countries that are devastated by epidemics are not just markets; epidemic and endemic diseases will not be eradicated by treating them as commercial opportunities. Use of drugs for HIV treatment must be responsible, which it is not at present.
(For a discussions about pre-exposure prophylaxis (PrEP) and resistance, see my other blog.)
There have long been warnings about careful management of ARV rollouts. One of the main worries was about resistant strains of HIV developing in large numbers of people where the treatment program was not being administrated well. Because, while the cost of ARVs is high, the cost of second line ARVs, needed when resistance develops to first line drugs, can be five to ten times higher. But eventually, a lot of resistance will develop because people are not responding to treatment it or are not taking it according to requirements.
Even in countries with relatively well established treatment programs, drugs of all description are in short supply. Uganda is now depending on emergency funding just to supply existing patients with ARV drugs, let alone dealing with new patients or ones who are affected by resistance. Taking the drugs in accordance with requirements can be impossible for many people.
However, a related worry is that of transmitted resistance. Those who are not on ARVs can acquire a strain of HIV which is already resistant to first line drugs. A study in Zambia has found that almost 6% of HIV positive people who are in need of treatment are resistant to first line drugs. It's all very well to say the people involved can be treated with second line drugs. But in addition to the massive increase in costs involved, second line drugs are just not as widely available.
The trouble with resistance, whether acquired or developed, is that it will eventually reach high levels. In countries where ARV programs have long been available, resistance can be as high as 20%. Coupled with this, recent WHO guidelines recommend starting ARV treatment at an even earlier stage in disease progression (though some question the wisdom of this). That sounds great but, not only are numbers of people on treatment in African countries very high, health services and health infrastructures are weak, very weak.
Similar circumstances have already given rise to resistant, multi-drug resistant and extensively drug resistant TB. The problem doesn't get resolved by the production of stronger drugs unless the circumstances that gave rise to resistance are also resolved. Many people in Kenya who are HIV positive also have TB. But many who don't have HIV do have TB. 50% of people with TB are not HIV positive. These are two separate epidemics, despite considerable overlaps. Resistance in either TB or HIV treatment will fuel at least one, perhaps two devastating epidemics.
Monitoring and testing for poor adherence to treatment and resistance are expensive. African countries are struggling to implement the most basic treatment services, let alone such advanced facilities. Some of the costs may go down, but unless broad health systems are developed, the lack of adequate facilities, trained personnel and equipment will mean that the majority of people are still vulnerable.
You can't expect weak health services to implement massive, high technology programs. Yet, this is what seems to be expected of African health services. The majority of people have little or no access to primary health care, water and sanitation, adequate food and levels of nutrition, some of the most basic aspects of health. People die of diarrheal conditions and respiratory problems. What chances have they with HIV and TB?
The HIV agenda has been driven by the desire of pharmaceutical companies to sell drugs at the highest price they can get to the largest number of people possible. Not only is resistance, acquired and developed, a consequence of allowing Big Pharma to drive the HIV agenda. Resistance is also an excellent way of increasing their profits further. But what about the epidemics? What about people who are HIV positive and those who are in danger of becoming infected?
If donors, governments and the HIV industry can accept that preventing and treating HIV is not just a matter of distributing ever increasing quantities of drugs, the agenda should include other items, such as the need for more and improved hospitals, more and better trained and motivated personnel, better equipment and supplies. People must be able to access primary health care, not a bunch of kiosks that give out drugs, almost willy-nilly. And good health also requires good infrastructure, education, food security and a whole lot of other things.
It's the job of Big Pharma to sell drugs but it's not the job of UNAIDS, the WHO, national governments, academic institutions and other parties to support them and their excesses. Prevention of further transmission of HIV is getting lost in the process of selling drugs. Some even believe that prevention of HIV transmission will be effected by greater consumption of drugs. This is not the case. Countries that are devastated by epidemics are not just markets; epidemic and endemic diseases will not be eradicated by treating them as commercial opportunities. Use of drugs for HIV treatment must be responsible, which it is not at present.
(For a discussions about pre-exposure prophylaxis (PrEP) and resistance, see my other blog.)
Wednesday, September 8, 2010
Pre-Exposure Prophylaxis, Till Death Do Us Part
Pre-exposure prophylaxis (PrEP) involves putting HIV negative people on antiretroviral drugs (ARV) with the aim of protecting them from HIV infection. So far, such a use of ARV does not give 100% protection. However, like male circumcision and the use of topical microbicides, it could be used along with condoms. Or you could just use condoms.
But the ultimate aim is to develop PrEP that allows people to have safe sex without using condoms (otherwise they will tempt very few). Cynics even suggest that the aim is to allow men who have sex with men (MSM) in rich countries to have unprotected sex, but I don't quite buy that.
The fact that a lot of the clinical trials are taking place in developing countries doesn't mean the people there will eventually benefit from PrEP. But to the pharmaceutical companies that sell ARVs, developing countries represent a huge potential market. That's as long as donors can be persuaded to pay for the drugs. Costs are far beyond what people or governments in developing countries can afford.
There are many questions to be raised about how much the use of PrEP could really help reduce HIV transmission. But my question is about who, exactly, would be the targets of a PrEP program in developing countries, taking Uganda as an example (because I happen to have the Ugandan Modes of Transmission Survey handy).
You might think an obvious target for PrEP would be sex workers. But in the 2009 survey, Ugandan sex workers were estimated to contribute 0.91% of HIV incidence. If you add in their clients and the partners of their clients, that still only comes to an estimated 10.5%. PrEP rollout for these groups, assuming you could actually round them all up, would be very expensive. But it doesn't look like it would have much impact on the overall epidemic.
The largest single group, contributing 43% of total incidence, consists of mutually monogamous couples engaging in heterosexual sex. Bizarre as it may sound, most HIV in Uganda, a virus that is difficult to transmit sexually, is transmitted by very low risk sex.
Those engaging in multiple partnerships, along with their partners, make up 45% of incidence, so perhaps they would be good targets. Again, it would be a mammoth task to round up such a large number of people, let alone distribute drugs to them all and ensure that most of them took the drugs most of the time for as long as they continue to be sexually active.
Think of it this way, Kenya has several hundred thousand HIV positive people on ARVs, that's less than 1% of the population. Around 99% of that money comes from donors. And even that few hundred thousand people is beyond what the countries health services can manage, despite all the donor funding.
The sad truth is that, either you 'target' much of the sexually active population of Uganda, which is not really targeting, more scattergunning, or you will not have any sizable impact on the epidemic. But PrEP is simply not the sort of intervention that you can roll out to a large sector of your population.
An article about the costs involved in rolling out PrEP in Australia cites very high costs just for basic, first line drugs. At up to and beyond 10,000 dollars per person, for the rest of their life, this will not even be discussed in developing countries. And while the drugs will be available at far lower cost in places like Uganda, you are talking about millions of potential recipients. Resistance to first line drugs may only amount to 3 or 4% (if they are lucky) but you can multiply that five or ten times to calculate the addition to costs.
The drugs will be available at far lower prices because drug companies have an uncanny way of knowing just how much they can squeeze out of a 'marketing' situation. Rich countries will pay hefty sums for worthless drugs, or drugs worth very little but in huge quantities. Just look at Tamiflu and the stockpiles of it. They will pay less to purchase drugs for developing countries, but the quantities will be mind boggling and Western run institutions will agree to any price once it's in the hundreds of dollars, apparently.
Talking of Tamiflu, one of the main proposed PrEP drugs is Tenofovir, discussed in glowing terms and voluminous quantities during the Vienna Aids Conference. Another is called Truvada, a combination drug. Gilead is involved in all three.
Another name that crops up is Bill Gates and his Foundation, who are never far away if there is money to be made out of intellectual property. But what will the benefits of PrEP be? If Modes of Transmission Surveys like the one for Uganda are correct, almost everyone that has sex in high and medium HIV prevalence countries is at risk. They can't all be put on preventive drugs, even if it were possible to afford such an intervention.
It may sound as if I am claiming that an almost entirely useless HIV prevention strategy is being advocated for by the very pharmaceutical industry that stands to gain billions from it. And that's exactly what I am claiming. Big Pharma expect billions more dollars, on top of the billions they have already received, to flow from persuading donors to pay for up to tens of millions of healthy people to be put on drugs for a large part of their life, with little or no benefit and possibly a lot of damage. In a nutshell: pre-exposure prophylaxis or PrEP. Remember the name.
NB: I have set up a new blog to discuss the subject of pre-exposure prophylaxis or PrEP.
NB: I have set up a new blog to discuss the subject of pre-exposure prophylaxis or PrEP.
Tuesday, August 10, 2010
Manufacturing Markets for Big Pharma
There’s a distinct tension between two articles I came across recently on generic antiretroviral drugs (ARV). The first, entitled ‘PEPFAR success critically dependent on use of generic ARVs, study shows’, claims that use of generic ARVs have allowed PEPFAR (the US President’s Emergency Plan for Aids Relief) to reach its target of getting 2 million people on treatment in low and middle-income countries. The article describes how use of generics has overcome various objections from some US politicians, who were well lobbied by the pharmaceutical industry and its cronies.
I would guess that what pharmaceutical companies settled for was to be in control of generics, rather than wishing their use to be banned. They would have wanted to control who produced generics, where and at what price. There’s no reason to lobby against them if they bring in a healthy profit. We are told that PEPFAR saved around 323 billion dollars by using generics. Regardless of whether they would really have spent that much money on overpriced pharmaceutical products, pharmaceutical companies still took in hundreds of millions of dollars. Anyone with shares in the industry need have no worries about that.
The article concludes that “Drugs are no longer the main driver of treatment costs”, which is good to hear. But it is interesting to note that drugs for sick people are potentially just a small part of the ARV market. A much hyped microbicide, a gel containing the ARV Tenofovir, is aimed at women who are HIV negative. And the same Tenofovir is behind the current pre-exposure prophylaxis trials (or ‘PrEP’, the process of taking antiretrovirals to reduce the likelihood of being infected with HIV), amply supported by Bill Gates’s Foundation. PrEP could potentially be used by any HIV negative person, though it may be targeted especially at men who have sex with men and perhaps commercial sex workers.
Current estimates are that in excess of 30, perhaps nearly 40 million people are HIV positive. That sounds like a vast market for ARVs when you consider that people will have to take them for the rest of their lives. But this is nothing compared to the number of people who could be customers for microbicides, PrEP and any other ways of selling ARVs that the pharmaceutical industry dream up. In Africa alone, the potential market could run into hundreds of millions of people. It is to be wondered if PEPFAR will still have the stomach for that. Gates needn’t worry, the Foundation stands to gain if microbicides and PrEP get off the ground.
In case hundreds of millions of customers doesn’t satisfy Big Pharma, and it won’t keep them happy for long, newer versions of ARVs are constantly being produced with improvements or claimed improvements. These are gradually replacing older versions. And those on ARVs, sooner or later, develop resistance to first line drugs. Second line drugs can cost many times more, but without them people will die. Third line drugs are still beyond the reach of developing countries, despite all the donor money available for treatment. It’s not clear where all the money will come from as it will exceed PEPFAR, the World Bank’s Global Fund and Bill Gate’s savings many times over. But things are going well for Big Pharma so far.
The second article is entitled ‘HIV generics under threat from tighter patenting rules’. This is about the pharmaceutical industry lobbying that is still going on to persuade governments, and anyone else who will listen, to create intellectual property laws that prevent generics from being produced. The US and the EU are the main culprits, as usual. Although generics can be produced once a ‘voluntary licence’ has been obtained, the original patent holder still gets a big say in how the drugs can be distributed, how they are priced and where they are sold.
Some object to this on the grounds that it leaves too much power in the hands of the patent holders. As I suggested above, the pharmaceutical industry likes to be able to control things and it seems unlikely that they would have conceded anything without getting their pound of flesh. Far from trying to relax intellectual property laws so that poor countries with high HIV prevalence can benefit, the US and the EU have been trying for some time to make it more difficult for countries like India, the biggest producer of generic ARVs, to produce these drugs. And there have been efforts, some of them successful, to prevent other countries from buying them. An example is Kenya, and other African countries are now trying to create similar laws.
Given the weight behind increasing the cost of ARVs, it seems very odd that PEPFAR should be fighting to reduce them. Are we supposed to believe that PEPFAR is in conflict with the government that allowed it so many billions of dollars? Could PEPFAR be a champion of fair intellectual property and trade laws that benefit poor people in poor countries? This is difficult to accept. The PEPFAR billions were unlikely to have been forthcoming in the first place unless they stood to benefit the US industry as a whole and Big Pharma in particular.
The World Trade Organization (WTO) has talked the talk of allowing developing countries access to ARVs by giving them a nominal right to produce generic ARVs under a compulsory licence. But this has had little impact in practice. And in case it should ever any impact, the US and EU are busy trying to get developing countries to sign up to Free Trade Agreements and Economic Partnership Agreements so that whatever the WTO has done is irrelevant.
Big Pharma seems to have used a classic bargaining trick; they have started the bidding at a price many times higher than would be reasonable. They have then been in a good position to accept a price a few times lower, probably set by parties who had an interest in maximizing pharmaceutical company profits. Giving the industry so much control means that they can add in the pretence that there is some level of competition, though there is unlikely to be any. A spokesperson for UNITAID, Ellen ‘t Hoen, said that “financing for HIV had to remain strong, as even the lowest-cost drugs needed an assured market”. So that’s the level of competition!
The pretence that the global pharmaceutical industry is just trying to make its way in a competitive business is sickening enough, when you consider how much effort goes into stacking the odds in their favour. But the expansion of the ARV market to include those thought to be at risk of being infected with HIV is outrageous. UNAIDS and various other commercial interests, academic institutions and the like, view almost all Africans as being at risk of infection with HIV. Yet this same group has failed adequately to describe serious HIV epidemics to the extent that they are in any position to make a useful assessment of risk.
Not only is the carefully crafted market for ARVs huge and expanding, it also enjoys the full protection of ‘global’ trade laws. And judging by the emphasis on microbicides and PrEP at the recent Vienna Aids Conference, the HIV industry appears to see its primary role as helping Big Pharma expand. The right to health has shrunk to a ‘right to treatment’ and those providing ‘the treatment’ have moved in to supply it to the healthy and the unhealthy alike. As for the HIV pandemic, Big Pharma says ‘don’t worry, we have the treatment’. But if health has been reduced to treatment, will there be any resources to ensure that healthy people stay healthy, even to reduce the spread of HIV and perhaps eventually eradicate it? Already, the HIV pandemic seems far too valuable to risk destroying.
(For further discussion of PrEP, see my other blog, pre-exposureprophylaxis.blogspot.com)
I would guess that what pharmaceutical companies settled for was to be in control of generics, rather than wishing their use to be banned. They would have wanted to control who produced generics, where and at what price. There’s no reason to lobby against them if they bring in a healthy profit. We are told that PEPFAR saved around 323 billion dollars by using generics. Regardless of whether they would really have spent that much money on overpriced pharmaceutical products, pharmaceutical companies still took in hundreds of millions of dollars. Anyone with shares in the industry need have no worries about that.
The article concludes that “Drugs are no longer the main driver of treatment costs”, which is good to hear. But it is interesting to note that drugs for sick people are potentially just a small part of the ARV market. A much hyped microbicide, a gel containing the ARV Tenofovir, is aimed at women who are HIV negative. And the same Tenofovir is behind the current pre-exposure prophylaxis trials (or ‘PrEP’, the process of taking antiretrovirals to reduce the likelihood of being infected with HIV), amply supported by Bill Gates’s Foundation. PrEP could potentially be used by any HIV negative person, though it may be targeted especially at men who have sex with men and perhaps commercial sex workers.
Current estimates are that in excess of 30, perhaps nearly 40 million people are HIV positive. That sounds like a vast market for ARVs when you consider that people will have to take them for the rest of their lives. But this is nothing compared to the number of people who could be customers for microbicides, PrEP and any other ways of selling ARVs that the pharmaceutical industry dream up. In Africa alone, the potential market could run into hundreds of millions of people. It is to be wondered if PEPFAR will still have the stomach for that. Gates needn’t worry, the Foundation stands to gain if microbicides and PrEP get off the ground.
In case hundreds of millions of customers doesn’t satisfy Big Pharma, and it won’t keep them happy for long, newer versions of ARVs are constantly being produced with improvements or claimed improvements. These are gradually replacing older versions. And those on ARVs, sooner or later, develop resistance to first line drugs. Second line drugs can cost many times more, but without them people will die. Third line drugs are still beyond the reach of developing countries, despite all the donor money available for treatment. It’s not clear where all the money will come from as it will exceed PEPFAR, the World Bank’s Global Fund and Bill Gate’s savings many times over. But things are going well for Big Pharma so far.
The second article is entitled ‘HIV generics under threat from tighter patenting rules’. This is about the pharmaceutical industry lobbying that is still going on to persuade governments, and anyone else who will listen, to create intellectual property laws that prevent generics from being produced. The US and the EU are the main culprits, as usual. Although generics can be produced once a ‘voluntary licence’ has been obtained, the original patent holder still gets a big say in how the drugs can be distributed, how they are priced and where they are sold.
Some object to this on the grounds that it leaves too much power in the hands of the patent holders. As I suggested above, the pharmaceutical industry likes to be able to control things and it seems unlikely that they would have conceded anything without getting their pound of flesh. Far from trying to relax intellectual property laws so that poor countries with high HIV prevalence can benefit, the US and the EU have been trying for some time to make it more difficult for countries like India, the biggest producer of generic ARVs, to produce these drugs. And there have been efforts, some of them successful, to prevent other countries from buying them. An example is Kenya, and other African countries are now trying to create similar laws.
Given the weight behind increasing the cost of ARVs, it seems very odd that PEPFAR should be fighting to reduce them. Are we supposed to believe that PEPFAR is in conflict with the government that allowed it so many billions of dollars? Could PEPFAR be a champion of fair intellectual property and trade laws that benefit poor people in poor countries? This is difficult to accept. The PEPFAR billions were unlikely to have been forthcoming in the first place unless they stood to benefit the US industry as a whole and Big Pharma in particular.
The World Trade Organization (WTO) has talked the talk of allowing developing countries access to ARVs by giving them a nominal right to produce generic ARVs under a compulsory licence. But this has had little impact in practice. And in case it should ever any impact, the US and EU are busy trying to get developing countries to sign up to Free Trade Agreements and Economic Partnership Agreements so that whatever the WTO has done is irrelevant.
Big Pharma seems to have used a classic bargaining trick; they have started the bidding at a price many times higher than would be reasonable. They have then been in a good position to accept a price a few times lower, probably set by parties who had an interest in maximizing pharmaceutical company profits. Giving the industry so much control means that they can add in the pretence that there is some level of competition, though there is unlikely to be any. A spokesperson for UNITAID, Ellen ‘t Hoen, said that “financing for HIV had to remain strong, as even the lowest-cost drugs needed an assured market”. So that’s the level of competition!
The pretence that the global pharmaceutical industry is just trying to make its way in a competitive business is sickening enough, when you consider how much effort goes into stacking the odds in their favour. But the expansion of the ARV market to include those thought to be at risk of being infected with HIV is outrageous. UNAIDS and various other commercial interests, academic institutions and the like, view almost all Africans as being at risk of infection with HIV. Yet this same group has failed adequately to describe serious HIV epidemics to the extent that they are in any position to make a useful assessment of risk.
Not only is the carefully crafted market for ARVs huge and expanding, it also enjoys the full protection of ‘global’ trade laws. And judging by the emphasis on microbicides and PrEP at the recent Vienna Aids Conference, the HIV industry appears to see its primary role as helping Big Pharma expand. The right to health has shrunk to a ‘right to treatment’ and those providing ‘the treatment’ have moved in to supply it to the healthy and the unhealthy alike. As for the HIV pandemic, Big Pharma says ‘don’t worry, we have the treatment’. But if health has been reduced to treatment, will there be any resources to ensure that healthy people stay healthy, even to reduce the spread of HIV and perhaps eventually eradicate it? Already, the HIV pandemic seems far too valuable to risk destroying.
(For further discussion of PrEP, see my other blog, pre-exposureprophylaxis.blogspot.com)
Friday, July 9, 2010
Will a New HIV Boss at WHO Make a Difference?
The World Health Organization (WHO) has a new head of HIV called Gottfried Hirnschall and he gave an interview recently to IRIN. Apparently he feels that, as a prevention message, abstinence is unrealistic. That's good, but not good enough. Abstinence didn't just fail because it's unrealistic. There's no reason why the option of choosing not to have sex under certain circumstances shouldn't be part of a comprehensive sex education program. It's just better if it's not called 'abstinence' and if it isn't the only trick in the box.
There are probably many reasons why HIV prevention programs have failed in African countries but the one reason that WHO, UNAIDS, CDC and all the main HIV institutions refuse to countenance is that not all HIV is transmitted sexually. They go as far as admitting that a small amount is transmitted non-sexualy, but not enough for them to bother spending money or time on. And sure enough, Hirnschall mentions male circumcision and 'treatment as prevention'.
But what does treatment as prevention involve? Because HIV positive people who are responding to antiretroviral treatment (ART) eventually have a low viral load, they are very unlikely to transmit HIV to their partner. If it were possible to test every sexually active member of a population regularly, say once a year, anyone found HIV positive could be put on treatment.
There are just two small flaws. One is that persuading the majority of sexually active people to be tested even once, even to save their lives, has proved elusive. The second is that the majority of people who are currently in need of treatment are not yet receiving it. Much of the funding for HIV treatment that was so fothcoming in recent years has been cut or flatlined. Just as the WHO released new guidelines that would put more people on ART, there isn't even enough money to keep some people already on treatment in drugs.
People on ART need to take the drugs every day for the rest of their lives. If they miss their dose too many times, resistance builds up and they need to move to a different drug regime, a far more expensive one. It is very difficult to get credible figures on what percentage of people in African countries are adhering to ART. But numbers of people dying from Aids is suspiciously high in some countries. It would be one thing if those providing people with the drugs could afford the second or third line drugs for those who develop resistance. But some countries are in the position of not even being able to afford first line drugs.
Hirnschall is asked about the shortage of money and he mentions 'task shifting', things like training nurses to do what doctors have been doing up till now. For people who don't mind being seen by a doctor or who really don't need to see a doctor, that's fine. Most people in developing countries don't get to see doctors anyway, they are too scarce. But even nurses are scarce and they are pretty stretched already. Perhaps more nurses will be trained and these ones will not be poached by rich countries.
So much for treatment, though it's not very much. But will those advocating putting more people on treatment get around to preventing new infections? Ok, they like to say that treatment is also prevention, but from a practical point of view, this will not work. People are becoming infected faster than others can be put on treatment and if money for treatment becomes scarce, where will prevention be then?
First of all, not all HIV is transmitted sexually. It needs to be established how much is coming from non-sexual routes, such as unsafe healthcare and other things. And this needs to be dealt with because it sure as hell won't stop by handing out condoms, circumcising men and telling people how to run their sex lives. Hirnschall thinks that a HIV vaccine would be ideal. But what would be ideal would be to establish where most HIV infections are really coming from so that, even if there were a vaccine, we wouldn't need to waste so much money on it.
Second of all, if Hirnschall is worried about where all the money is going to come from if donors are thinking of pulling out he should get on to the issue of generic drugs. He talks about negotiating with big pharma. What's the point of negotiating with them? They want the highest price they can get, they know people in developing countries can't pay it but they think donors can. They will never reduce their prices to a reasonable level. The only way to ensure that drugs are made available at an affordable price is to open up the market to generic producers.
Of course, big pharma don't want that, they don't want to compete, they want to hide behind the protectionism of intellectual property 'rights'. There are companies well able to produce enough generics to supply everyone who needs ART, to scale up treatment and to continue treating people who go on to need second and third line drugs, as many people eventually will. This has to happen some time. It should have happened a long time ago. Will Hirnschall just drag his heels the way all the others are doing?
Is the WHO's new head of HIV just going to give us more of the same? Or is he going to question the behavioral paradigm that says that most HIV is transmitted sexually? And is he going to stop 'negotiating' with the blood suckers in big pharma and open up the drugs market to competition? If his aims are to reduce HIV transmission and eventually eradicate it, and to treat as many HIV positive people as possible, he will have to take both these steps.
There are probably many reasons why HIV prevention programs have failed in African countries but the one reason that WHO, UNAIDS, CDC and all the main HIV institutions refuse to countenance is that not all HIV is transmitted sexually. They go as far as admitting that a small amount is transmitted non-sexualy, but not enough for them to bother spending money or time on. And sure enough, Hirnschall mentions male circumcision and 'treatment as prevention'.
But what does treatment as prevention involve? Because HIV positive people who are responding to antiretroviral treatment (ART) eventually have a low viral load, they are very unlikely to transmit HIV to their partner. If it were possible to test every sexually active member of a population regularly, say once a year, anyone found HIV positive could be put on treatment.
There are just two small flaws. One is that persuading the majority of sexually active people to be tested even once, even to save their lives, has proved elusive. The second is that the majority of people who are currently in need of treatment are not yet receiving it. Much of the funding for HIV treatment that was so fothcoming in recent years has been cut or flatlined. Just as the WHO released new guidelines that would put more people on ART, there isn't even enough money to keep some people already on treatment in drugs.
People on ART need to take the drugs every day for the rest of their lives. If they miss their dose too many times, resistance builds up and they need to move to a different drug regime, a far more expensive one. It is very difficult to get credible figures on what percentage of people in African countries are adhering to ART. But numbers of people dying from Aids is suspiciously high in some countries. It would be one thing if those providing people with the drugs could afford the second or third line drugs for those who develop resistance. But some countries are in the position of not even being able to afford first line drugs.
Hirnschall is asked about the shortage of money and he mentions 'task shifting', things like training nurses to do what doctors have been doing up till now. For people who don't mind being seen by a doctor or who really don't need to see a doctor, that's fine. Most people in developing countries don't get to see doctors anyway, they are too scarce. But even nurses are scarce and they are pretty stretched already. Perhaps more nurses will be trained and these ones will not be poached by rich countries.
So much for treatment, though it's not very much. But will those advocating putting more people on treatment get around to preventing new infections? Ok, they like to say that treatment is also prevention, but from a practical point of view, this will not work. People are becoming infected faster than others can be put on treatment and if money for treatment becomes scarce, where will prevention be then?
First of all, not all HIV is transmitted sexually. It needs to be established how much is coming from non-sexual routes, such as unsafe healthcare and other things. And this needs to be dealt with because it sure as hell won't stop by handing out condoms, circumcising men and telling people how to run their sex lives. Hirnschall thinks that a HIV vaccine would be ideal. But what would be ideal would be to establish where most HIV infections are really coming from so that, even if there were a vaccine, we wouldn't need to waste so much money on it.
Second of all, if Hirnschall is worried about where all the money is going to come from if donors are thinking of pulling out he should get on to the issue of generic drugs. He talks about negotiating with big pharma. What's the point of negotiating with them? They want the highest price they can get, they know people in developing countries can't pay it but they think donors can. They will never reduce their prices to a reasonable level. The only way to ensure that drugs are made available at an affordable price is to open up the market to generic producers.
Of course, big pharma don't want that, they don't want to compete, they want to hide behind the protectionism of intellectual property 'rights'. There are companies well able to produce enough generics to supply everyone who needs ART, to scale up treatment and to continue treating people who go on to need second and third line drugs, as many people eventually will. This has to happen some time. It should have happened a long time ago. Will Hirnschall just drag his heels the way all the others are doing?
Is the WHO's new head of HIV just going to give us more of the same? Or is he going to question the behavioral paradigm that says that most HIV is transmitted sexually? And is he going to stop 'negotiating' with the blood suckers in big pharma and open up the drugs market to competition? If his aims are to reduce HIV transmission and eventually eradicate it, and to treat as many HIV positive people as possible, he will have to take both these steps.
Monday, June 28, 2010
Big Pharma Must Think We Are Idiots
A former British politician called Lynda Chalker who interferes with intellectual property (IP) issues in East Africa, says she is sure that East African IP legislation will not confuse generic and counterfeit drugs on the one hand and fake drugs on the other. But Kenya's Constitutional Court has already ruled that its own Anti-Counterfeit Act, only two years old, does confuse the three phenomena. And the court admits that this could result in people presently receiving affordable antiretroviral (ARV) therapy for HIV being denied the drugs the future. Chalker describes Kenya's decision as a 'drawback' to anti-counterfeiting efforts.
But Chalker herself simply makes the same confusion. She says that 'an anti-counterfeit law is essential in Uganda and east Africa as a whole; one only has to look at the number of deaths arising from counterfeit pharmaceutical products, electronic goods and auto spare parts'. If a drug or produce is causing death or injury, that is a health and safety problem. Branded goods can cause death and injury. Putting a brand name on a product illegally doesn't make it harmful, nor does doing so legally make it safe. The harm comes when the goods are substandard or when drugs are fake, not real drugs at all.
The distinction seems basic enough, but Chalker and the people who put together the original Kenyan bill appear unable to comprehend it. Worse still, Uganda and several other countries seem keen to follow Kenya's lead, despite the Kenyan's change of mind. Chalker and others who follow this tendency to conflate counterfeits, generics and fakes then go on to deny that their stance could jeopardize availability of affordable generic drugs, such as ARVs. But their denial sounds hollow when they go to so much trouble to confuse generics with counterfeits and fakes.
Someone who has been taken in by this deception pontificates about 'fake' drugs (and doctors) in Uganda in another article. Eleven Ugandan 'legislators' are querying the quality of drugs from India, which is the source of most of Uganda's affordable generic drugs. They note that the price of the same drugs from the UK is higher and wonder why. Perhaps that's a question for Chalker. But usually a huge difference in the price of drugs indicates that the expensive ones are branded versions and the cheap ones are generic versions.
Of course, there may also be counterfeit drugs and fake drugs in circulation. When drugs are priced so that no one in developing countries can afford them, in the hope that aid money will be used to purchase them, it's not surprising that some people will try to cash in on the market for cheap drugs. If the pharmaceutical industry is concerned about the fact that it is quite easy to make a good profit from counterfeit and fake drugs, they need to sort out their own pricing policies, perhaps by taking a look at what the 'market' can tolerate. Otherwise they might be accused of depending on subsidies and of rigging the market, which would be quite intolerable.
Chalker expresses her concern at the 'extra burden counterfeiting places on health services in developing countries'. If she is worried about health services being burdened, it is branded goods she should target. If she thinks that health services will be unable to afford the growing need for ARVs, she needs to champion the cause of those producing affordable generic versions of the grossly overpriced branded drugs that her friends in the pharmaceutical industry produce.
Chalker says that IP laws should be 'well-drafted', which, presumably, all laws should. But well-drafted for whom? Intellectual property is for the benefit of industries like big pharma, not for the benefit of poor people who are sick and dying. IP laws are not, as Chalker seems to think, to protect people from harm, and I don't think anyone who knows about IP would claim something so stupid. That's why human rights activists had to fight for international law to protect people from IP laws and allow poor countries access to affordable generics. I don't believe Chalker is stupid, though. She just thinks that everyone else is.
But Chalker herself simply makes the same confusion. She says that 'an anti-counterfeit law is essential in Uganda and east Africa as a whole; one only has to look at the number of deaths arising from counterfeit pharmaceutical products, electronic goods and auto spare parts'. If a drug or produce is causing death or injury, that is a health and safety problem. Branded goods can cause death and injury. Putting a brand name on a product illegally doesn't make it harmful, nor does doing so legally make it safe. The harm comes when the goods are substandard or when drugs are fake, not real drugs at all.
The distinction seems basic enough, but Chalker and the people who put together the original Kenyan bill appear unable to comprehend it. Worse still, Uganda and several other countries seem keen to follow Kenya's lead, despite the Kenyan's change of mind. Chalker and others who follow this tendency to conflate counterfeits, generics and fakes then go on to deny that their stance could jeopardize availability of affordable generic drugs, such as ARVs. But their denial sounds hollow when they go to so much trouble to confuse generics with counterfeits and fakes.
Someone who has been taken in by this deception pontificates about 'fake' drugs (and doctors) in Uganda in another article. Eleven Ugandan 'legislators' are querying the quality of drugs from India, which is the source of most of Uganda's affordable generic drugs. They note that the price of the same drugs from the UK is higher and wonder why. Perhaps that's a question for Chalker. But usually a huge difference in the price of drugs indicates that the expensive ones are branded versions and the cheap ones are generic versions.
Of course, there may also be counterfeit drugs and fake drugs in circulation. When drugs are priced so that no one in developing countries can afford them, in the hope that aid money will be used to purchase them, it's not surprising that some people will try to cash in on the market for cheap drugs. If the pharmaceutical industry is concerned about the fact that it is quite easy to make a good profit from counterfeit and fake drugs, they need to sort out their own pricing policies, perhaps by taking a look at what the 'market' can tolerate. Otherwise they might be accused of depending on subsidies and of rigging the market, which would be quite intolerable.
Chalker expresses her concern at the 'extra burden counterfeiting places on health services in developing countries'. If she is worried about health services being burdened, it is branded goods she should target. If she thinks that health services will be unable to afford the growing need for ARVs, she needs to champion the cause of those producing affordable generic versions of the grossly overpriced branded drugs that her friends in the pharmaceutical industry produce.
Chalker says that IP laws should be 'well-drafted', which, presumably, all laws should. But well-drafted for whom? Intellectual property is for the benefit of industries like big pharma, not for the benefit of poor people who are sick and dying. IP laws are not, as Chalker seems to think, to protect people from harm, and I don't think anyone who knows about IP would claim something so stupid. That's why human rights activists had to fight for international law to protect people from IP laws and allow poor countries access to affordable generics. I don't believe Chalker is stupid, though. She just thinks that everyone else is.
Sunday, April 4, 2010
Excessive Drug Prices Promote Counterfeit Drug Industry
According to the WHO, lifesaving drugs are not exempt from the trade in counterfeit medicines. But nor are they exempt from the rights of powerful multinational pharmaceutical companies to make obscenely high profits, regardless of the cost in terms of sickness, suffering and death in developing countries. Organisations like WHO and Interpol (effectively, publicly funded) are busy trying to help these poor victims, the pharmaceutical companies, that is. Otherwise, their ability to extract higher and higher profits every year may be compromised.
Yes, the WHO is right, it is cynical to produce counterfeit drugs, some of which may not help the person taking them; some may make them worse or even kill them. But it is also cynical for Big Pharma to put such impossibly high prices on drugs, spend far more on marketing and lobbying than on research, compromise doctors and other health professionals to push their products, produce goods for the rich world while ignoring the poor majority, using people in poor countries as cheap research fodder for drugs intended for the rich world, preventing poor countries from producing and making generic equivalents of overpriced branded drugs, lobbying the WTO (World Trade Organisation) to make laws that protect Big Pharma at the expense of poor countries and generally frustrating any attempts to regulate them, even slightly.
I don't know how many people die from counterfeit drugs but I know that an estimated 14 million die every year from infectious diseases, many of them preventable or treatable. The policies of Big Pharma ensure that the majority of people who need drugs most will never be able to afford them. A notable exception is antiretroviral drugs (ARV) for HIV, which have only been reduced slightly in price and only because they are being paid for by aid money. And no one need worry that production of ARVs on a massive scale at slightly reduced prices causes Big Pharma to suffer in the least. If they didn't get the HIV industry to buy their drugs, the market for them would be miniscule in comparison to what it is now.
So the humbug WHO claim to be worried about ordinary people being exposed to counterfeit drugs. But this is just an excuse to use lots more public money to protect the interests of Big Pharma. Already, public money has gone into the research the pharmaceutical industry claims to do. But most of the costs of drug research are met by publicly funded bidies, such as research institutions, laboratories and universities. Then the drug companies slap a patent on the results and pocket all the profits. If the WHO was really concerned about endangering the public they would lobby Big Pharma to do one simple thing: lower their prices.
But that is one thing the industry will not do. Far from it, they will continue to lobby to be protected so that they can continue to make far bigger profits than most other industries. Lowering their prices, or even lowering their prices to affordable levels for drugs needed most by developing countries, would have little negative impact on their profits. In fact, like with HIV drugs, they may discover a market they have long been ignoring. But they would prefer to fight for their right to charge more than people in developing countries can afford, perhaps by lobbying for aid money to be spent on drugs other than just ARVs.
As long as patented drugs continue to be too expensive for people in developing countries, it will be worthwhile for counterfeiters to target them with their products. As long as Big Pharma lobbies against the production and distribution of generic versions of patented drugs, people in developing countries will have no option but to look for cheaper alternatives. Big Pharma, in its efforts to maximise its profits, is creating the ideal market for counterfeiters. Getting Interpol and the WHO to spend increasing amounts of money and creating more sophisticated law enforcement systems is pointless. Counterfeiters will also become more sopisticated, as they are amply demonstrating.
Why? Because there is good money to be made. Pharmaceutical products don't just include drugs, the number of products that are artificially overpriced because they are produced by this industry is enormous. Who wouldn't grasp the opportunity to take advantage of the opportunity to produce relatively cheap products that can be sold on at ridiculous prices, only slightly less ridiculous than the prices charged by Big Pharma?
It's because I sympathise with vulnerable people, mainly in developing countries, that I think that drug counterfeiting should be stopped. It's not because I think the pharmaceutical industry should be allowed to hold the world to ransom. But I think the industry itself is creating the problem. The cost of drugs needs to be reduced to make them affordable in developing countries and it needs to be possible for developing countries to produce and/or buy generic equivalents of life saving drugs because they will never be able to pay the prices currently demanded by the industry.
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