The vested interests and one-sided reporting that I mentioned in my last post are muddying the waters as various East African countries try to draft laws to control the rampant counterfeiting that blights the lives of their people. The Ugandan attempts at law-making in this area have today been branded as "threatening access to medicines", for example. The fact that the Ugandan lawyers' efforts are supported by some EU funding is given as evidence of dark commercial motives.
The issues in counterfeiting are not simple, and there are huge grey areas. The provision of good quality drugs at a price that the average African can afford is an objective that we should all share. The first problem comes when those drugs are unauthorised copies of patented medicines developed by another entity. The justification propagated by some generic producers who specialise in supplying Africa is that they are merely trying to help the poor people by providing these drugs. No they're not. They are spotting a way to make excellent profit from someone else's R&D investment by selling cheaper copies without a licence.
The second problem is that "access to medicines" is used as a cover for those who wish to keep open some of the very useful informal distribution channels that allow them to rack up even better profits by mixing in fake drugs with "genuine" (in the sense of containing at least some active ingredient) consignments.
I am not an apologist for the pharmaceutical industry or the EU. I don't deny that western nations and international drug companies could and should do more to equalize access to health around the globe. However, I have travelled in East Africa and spoken to some of the desperate government officials trying to stem the tide of shoddy fake products (from inadequate malaria pills to ineffective brake pads) that kill their citizens every day. We should provide them with every assistance in their task. It is far easier to err on the side of strict legislation and then ease restrictions where necessary than to try to tighten up soft laws post-hoc.
Showing posts with label Africa. Show all posts
Showing posts with label Africa. Show all posts
Monday, 15 March 2010
Friday, 12 March 2010
Avoiding a Pharmaceutical "Scramble for Africa"
The Indian government is to embark on another generic drugs sales drive in Africa. The main objective of the aggressive campaign is to persuade African countries not to introduce laws under which (as the Indians see it) some generic drugs will be treated as counterfeit drugs.
Anyone who has travelled widely in Africa will recognise the desperate need for affordable, high quality medicines. The Indian pharmaceutical industry, with its low cost base and rising quality levels, is well placed to fill that need with good quality, off-patent drugs. They already have a strong grip on the African pharmaceutical trade, especially in Anglophone countries. China is also waking up to the potential of Africa as an export market for pharmaceuticals.
The problem is that India and China are also major sources of fake medicines. The European Commission has compiled data from customs seizures, previously reported in the Financial Times, that show India to be the market leader in terms of their share of counterfeit drugs seized in the EU, but I suspect that China is not far behind. The worst fake drugs are shoddy, sub-standard products. Often made from inert building materials, they may contain toxic impurities and little or no active ingredient.
The grey area is drugs which are copies of someone else's intellectual property. They may be reasonable quality but are not authorised and therefore could be classed as counterfeit. Africa needs good, cheap medicines but not at any price. The legitimate Indian generic industry is too often a cover for unscrupulous operators to make quick profits from useless fakes.
The better way forward is for generics to mean just that. The term should apply to patent-expired products, and makers of generic products should not try to copy the brand attributes (appearance, logo etc) of the original. For their part, multinational drug companies need to do much more to speed up access to their medicines in developing countries. It is starting to happen but we need more effort.
The great need for medicines means there is room for many pharmaceutical producers in Africa. However, unless we are careful then the African people will be exploited again in another "land-grab" as competing interests vie to harvest the commercial potential as cheaply as possible.
Anyone who has travelled widely in Africa will recognise the desperate need for affordable, high quality medicines. The Indian pharmaceutical industry, with its low cost base and rising quality levels, is well placed to fill that need with good quality, off-patent drugs. They already have a strong grip on the African pharmaceutical trade, especially in Anglophone countries. China is also waking up to the potential of Africa as an export market for pharmaceuticals.
The problem is that India and China are also major sources of fake medicines. The European Commission has compiled data from customs seizures, previously reported in the Financial Times, that show India to be the market leader in terms of their share of counterfeit drugs seized in the EU, but I suspect that China is not far behind. The worst fake drugs are shoddy, sub-standard products. Often made from inert building materials, they may contain toxic impurities and little or no active ingredient.
The grey area is drugs which are copies of someone else's intellectual property. They may be reasonable quality but are not authorised and therefore could be classed as counterfeit. Africa needs good, cheap medicines but not at any price. The legitimate Indian generic industry is too often a cover for unscrupulous operators to make quick profits from useless fakes.
The better way forward is for generics to mean just that. The term should apply to patent-expired products, and makers of generic products should not try to copy the brand attributes (appearance, logo etc) of the original. For their part, multinational drug companies need to do much more to speed up access to their medicines in developing countries. It is starting to happen but we need more effort.
The great need for medicines means there is room for many pharmaceutical producers in Africa. However, unless we are careful then the African people will be exploited again in another "land-grab" as competing interests vie to harvest the commercial potential as cheaply as possible.
Tuesday, 2 March 2010
"Peak Health": Avoiding Global Malaise
I have previously discussed the Peak Oil issue and the applicability of that concept and metaphor to productivity levels in the pharmaceutical industry - Peak Pharma. Further navel-gazing leads me to wonder if "Peak Health" might also occur - a point that history will look back on as the beginning of the decline in global well-being.
In many developing countries, the traditional diet of locally produced plant staples supplemented with locally reared meat is being replaced by imported grain, industrial meat and processed foods. This has reduced the incidence of disastrous famine and the extra calories have allowed societies to show gains in average height, infant survival rates etc. However, the "Western" diet - promoted by the international food industry and gradually taking over world culture - is high fat, high sugar, low fibre. Apart from smoothing out supply and demand, the exchange of traditional diets for global food will eventually have a bad effect on health.
We in the developed world are encouraging developing nations to go from "thin malnutrition" with calorie deficit to "fat malnutrition" with calorie excess. To use a Roman Empire analogy, we are in danger of going from barbarism to decadence without passing through civilisation.
In developed countries, where food is now so easily available and cheap that a quarter of all purchased food is wasted , obesity is reaching epidemic proportions, triggering rises in diabetes, heart disease and cancer.
Peak Health
Unless we act soon we are in danger of passing a point of global "Peak Health". As the world's people get richer, on average, we expect our lives to get healthier and our quality of life to carry on improving. But environmental, social and health factors may slow down and even erode the gains that society has previously enjoyed.
Peak Mammoth
Although prehistoric humans may not have had the "nasty, brutish and short" life that is commonly assumed, it certainly involved hard work and risk. Being badly wounded by a tusk, spear or fall was probably often fatal, but the fossil evidence seems to show that during their short lives prehistoric people were in good physical shape. Most of the time, calorie intake balanced calorie output. But the hunter-gatherer life is precarious and we learned (and evolved) to let the good times roll. The fat put on when food was briefly abundant was a lifesaver when times were hard. Those who could efficiently convert excess calories to weight tended to survive famine and reproduce. Even after the transition from hunter-gathering to farming, having a calorie intake barely sufficient for survival was the daily reality for most of mankind until quite recently - and of course still is for many. But the evolutionary irony is that the survival mechanisms which brought us through the ice ages are obsolete. Now that calories are permanently in oversupply for many of us, we are storing reserves for a famine that never comes.
We have made great strides in controlling or eradicating the factors that have killed people over the millennia, through modern medicine, more efficient agriculture, better understanding of nutrition, and the mechanization of arduous tasks. The data for life expectancy over time show the results - an average human will live around twice as long as their great great grandfather. This last two hundred years in global health has been like the discovery phase of the oil industry, with major leaps forward and continuously improving "output".
However, the horsemen of the apocalypse haven't necessarily been defeated. They may just have changed tactics. Our own prosperity, the very thing that drove these initial improvements in our collective well-being, may yet prove to be the brake on global health.
Peak An Pie
On average, we eat more and do less physical work than our ancestors. Most of the world doesn't need to risk spearing the mammoth any more, when they can get a mammoth burger (super-size me!) brought to their cave.
With less physical activity and more calories, obesity, diabetes, cancer, heart disease and other chronic conditions are starting to exact a heavy toll on our collective health and wellbeing. The explosion in counterfeit drugs, my own minor obsession, has the potential to add to this mix unless controlled. Will global average lifespan eventually decline? It has happened already in Russia.
Peak From Behind The Sofa
So what to do about it, if Peak Health and its aftermath does become a danger to our kids and future generations?
To continue the oil analogy, maybe there are undiscovered reserves of health, waiting to be found? New medical advances could counteract the declining health factors discussed above, but that's not the right way forward and we shouldn't rely on it. Medical research has a habit of taking longer than expected to deliver results.
We could certainly change the way we distribute healthcare. By focusing on prevention, diagnosis, treatment and cure - in that order - we can change global healthcare priorities for the better. This doesn't have to achieved by social engineering or hugely expensive public health systems. There are great business opportunities to be had in the next fifty years by doing healthcare differently from how it was done in the previous half century.
Another, entirely impractical but probably effective, approach would be to ration food globally. The physical fitness of UK citizens was never better than when food was rationed during and after the Second World War. Calorie restriction (with adequate nutrition) seem to extend lifespan in many species.
How about taking an economic approach, with a tax on saturated fat, or on the artificial addition of sugars to processed foods? A carefully-designed, selective levy on certain harmful food ingredients and additives could both curb consumer demand and shift manufacturing patterns away from the most harmful foods.
Peak Optimism
Maybe the Peak Health idea is half-baked scaremongering about an issue that boils down to individual freedom and choice. None of the top-down approaches discussed above are easy, and we all have to take individual responsibility for our actions in making healthier choices, but my hunch is that we also should do something collectively at the policy level to prevent Peak Health (and the subsequent downslope) becoming reality.
In many developing countries, the traditional diet of locally produced plant staples supplemented with locally reared meat is being replaced by imported grain, industrial meat and processed foods. This has reduced the incidence of disastrous famine and the extra calories have allowed societies to show gains in average height, infant survival rates etc. However, the "Western" diet - promoted by the international food industry and gradually taking over world culture - is high fat, high sugar, low fibre. Apart from smoothing out supply and demand, the exchange of traditional diets for global food will eventually have a bad effect on health.
We in the developed world are encouraging developing nations to go from "thin malnutrition" with calorie deficit to "fat malnutrition" with calorie excess. To use a Roman Empire analogy, we are in danger of going from barbarism to decadence without passing through civilisation.
In developed countries, where food is now so easily available and cheap that a quarter of all purchased food is wasted , obesity is reaching epidemic proportions, triggering rises in diabetes, heart disease and cancer.
Peak Health
Unless we act soon we are in danger of passing a point of global "Peak Health". As the world's people get richer, on average, we expect our lives to get healthier and our quality of life to carry on improving. But environmental, social and health factors may slow down and even erode the gains that society has previously enjoyed.
Peak Mammoth
Although prehistoric humans may not have had the "nasty, brutish and short" life that is commonly assumed, it certainly involved hard work and risk. Being badly wounded by a tusk, spear or fall was probably often fatal, but the fossil evidence seems to show that during their short lives prehistoric people were in good physical shape. Most of the time, calorie intake balanced calorie output. But the hunter-gatherer life is precarious and we learned (and evolved) to let the good times roll. The fat put on when food was briefly abundant was a lifesaver when times were hard. Those who could efficiently convert excess calories to weight tended to survive famine and reproduce. Even after the transition from hunter-gathering to farming, having a calorie intake barely sufficient for survival was the daily reality for most of mankind until quite recently - and of course still is for many. But the evolutionary irony is that the survival mechanisms which brought us through the ice ages are obsolete. Now that calories are permanently in oversupply for many of us, we are storing reserves for a famine that never comes.
We have made great strides in controlling or eradicating the factors that have killed people over the millennia, through modern medicine, more efficient agriculture, better understanding of nutrition, and the mechanization of arduous tasks. The data for life expectancy over time show the results - an average human will live around twice as long as their great great grandfather. This last two hundred years in global health has been like the discovery phase of the oil industry, with major leaps forward and continuously improving "output".
However, the horsemen of the apocalypse haven't necessarily been defeated. They may just have changed tactics. Our own prosperity, the very thing that drove these initial improvements in our collective well-being, may yet prove to be the brake on global health.
Peak An Pie
On average, we eat more and do less physical work than our ancestors. Most of the world doesn't need to risk spearing the mammoth any more, when they can get a mammoth burger (super-size me!) brought to their cave.
With less physical activity and more calories, obesity, diabetes, cancer, heart disease and other chronic conditions are starting to exact a heavy toll on our collective health and wellbeing. The explosion in counterfeit drugs, my own minor obsession, has the potential to add to this mix unless controlled. Will global average lifespan eventually decline? It has happened already in Russia.
Peak From Behind The Sofa
So what to do about it, if Peak Health and its aftermath does become a danger to our kids and future generations?
To continue the oil analogy, maybe there are undiscovered reserves of health, waiting to be found? New medical advances could counteract the declining health factors discussed above, but that's not the right way forward and we shouldn't rely on it. Medical research has a habit of taking longer than expected to deliver results.
We could certainly change the way we distribute healthcare. By focusing on prevention, diagnosis, treatment and cure - in that order - we can change global healthcare priorities for the better. This doesn't have to achieved by social engineering or hugely expensive public health systems. There are great business opportunities to be had in the next fifty years by doing healthcare differently from how it was done in the previous half century.
Another, entirely impractical but probably effective, approach would be to ration food globally. The physical fitness of UK citizens was never better than when food was rationed during and after the Second World War. Calorie restriction (with adequate nutrition) seem to extend lifespan in many species.
How about taking an economic approach, with a tax on saturated fat, or on the artificial addition of sugars to processed foods? A carefully-designed, selective levy on certain harmful food ingredients and additives could both curb consumer demand and shift manufacturing patterns away from the most harmful foods.
Peak Optimism
Maybe the Peak Health idea is half-baked scaremongering about an issue that boils down to individual freedom and choice. None of the top-down approaches discussed above are easy, and we all have to take individual responsibility for our actions in making healthier choices, but my hunch is that we also should do something collectively at the policy level to prevent Peak Health (and the subsequent downslope) becoming reality.
Friday, 26 February 2010
Le Plus Ca Change...
...Le plus c'est la meme chose. Today is the last day of the Florida anti-counterfeiting conference. It has been well organised and attended by a good mix of interesting and senior people with a lot to say about counterfeit medicines. There have been new developments in tactical approaches to anti-counterfeiting which will make a difference in the detection of fake drugs. But, strategically-speaking, I feel as if I've seen this deja vu somewhere before. In recent years things have not moved on at the pace that the increasing risk to patient safety warrants.
There are some noble exceptions. Nigeria, for example, is doing great work. Dr Paul Orhii, Director General of their drug regulator NAFDAC , gave a good insight into how his country is tackling the counterfeit threat using hand-held devices to differentiate real from fake drugs in the field.
The real quantum leap in approach will only come when a global, or at least multi-regional, approach is decided upon, authorised, funded and rolled out. At the moment we are still in the realm of individual, relatively small pilot studies which show the potential of Technology X in a controlled environment. We need to take a deep breath and implement a drug verification system on a wide scale, exposing it to the real world threats of criminal attack and realising that it may not be perfect first time. Only by road-testing and refining such systems can we start to make a real difference. The current drug traceability projects, though laudable, are the equivalent of learning to drive on a private road. We know how to work the car, but we need to get used to traffic on the highway before we can go very far.
There are some noble exceptions. Nigeria, for example, is doing great work. Dr Paul Orhii, Director General of their drug regulator NAFDAC , gave a good insight into how his country is tackling the counterfeit threat using hand-held devices to differentiate real from fake drugs in the field.
The real quantum leap in approach will only come when a global, or at least multi-regional, approach is decided upon, authorised, funded and rolled out. At the moment we are still in the realm of individual, relatively small pilot studies which show the potential of Technology X in a controlled environment. We need to take a deep breath and implement a drug verification system on a wide scale, exposing it to the real world threats of criminal attack and realising that it may not be perfect first time. Only by road-testing and refining such systems can we start to make a real difference. The current drug traceability projects, though laudable, are the equivalent of learning to drive on a private road. We know how to work the car, but we need to get used to traffic on the highway before we can go very far.
Monday, 22 February 2010
Groundhog Days for Pharma
A little late in February (Groundhog Day is 2 Feb) I am struck by the applicability of the "life repeats itself" idea to the pharmaceutical industry. We are currently in the early phase of the movie, where Bill Murray is depressed and trapped by being forced to wake up and relive the same day every day.
Every few months we hear that one bloated and inefficient company is merging with another one. Each time, an almost identical press release is issued promising "significant economies of scale" and "research synergies" due to the "complementary pipelines" of the combined behemoth.
The merged company is still inefficient, but the numbers are a bit bigger now. Support functions are merged and streamlined, sales reps are culled, R&D projects terminated, manufacturing sites mothballed. This generates fake numbers that make it look like the merged company is addressing the real issues, but underneath it is still the same animal. It soon has to look for another company to swallow to keep generating the momentum its investors demand.
Until we move to the "late phase" of the movie, and start adapting to the healthcare situation in the 21st century, pharma's Groundhog Day is destined to repeat itself. There are huge opportunities to do good things, explore new business models and break the cycle, but we have to start thinking differently.
If we are ever to develop economic healthcare for all, from cradle to grave, Utah to Uganda, it will involve more than just finding a few blockbusters. It will need more than just drugs. The "drug industry" needs to start providing a genuine service to its customers, and to focus on keeping them in good health, not just medicalising and treating any deviations from optimum well being. Pharma must engage with patients much more directly, and learn to love health as much as illness, if it is to have relevance in the next hundred years.
Every few months we hear that one bloated and inefficient company is merging with another one. Each time, an almost identical press release is issued promising "significant economies of scale" and "research synergies" due to the "complementary pipelines" of the combined behemoth.
The merged company is still inefficient, but the numbers are a bit bigger now. Support functions are merged and streamlined, sales reps are culled, R&D projects terminated, manufacturing sites mothballed. This generates fake numbers that make it look like the merged company is addressing the real issues, but underneath it is still the same animal. It soon has to look for another company to swallow to keep generating the momentum its investors demand.
Until we move to the "late phase" of the movie, and start adapting to the healthcare situation in the 21st century, pharma's Groundhog Day is destined to repeat itself. There are huge opportunities to do good things, explore new business models and break the cycle, but we have to start thinking differently.
If we are ever to develop economic healthcare for all, from cradle to grave, Utah to Uganda, it will involve more than just finding a few blockbusters. It will need more than just drugs. The "drug industry" needs to start providing a genuine service to its customers, and to focus on keeping them in good health, not just medicalising and treating any deviations from optimum well being. Pharma must engage with patients much more directly, and learn to love health as much as illness, if it is to have relevance in the next hundred years.
Monday, 8 February 2010
Counterfeit Drugs and the Parallel Bogus Universe
The worldwide growth in mobile phone use has now reached even the poorest consumers. Cellphones are the first electronic product verification method to reach a majority of the world’s people, and the internet will soon follow. Some brands are taking advantage of this trend to help them combat counterfeit products, by offering consumer authentication of their products via text messaging, websites, or visible serial numbers. Some companies hit hard by counterfeits sold on the internet have now even decided to sell their products directly to consumers via the web, with their own additional security.
These systems allow the consumer to be directly involved in the verification of their product, and give the opportunity for the brand owner to send marketing messages whilst verifying their product's authenticity. Unfortunately, many of the consumer-based verification systems which rely on telephone helplines or websites are vulnerable to the “parallel universe” problem.
In many of the parts of the world where counterfeit drugs are a major problem, for example in Africa and South East Asia, the use of technology is still relatively new. If a consumer is told that they can verify their product by calling a helpline or sending an SMS text message with a serial number, they are unlikely to doubt, or to check, the authenticity of the system itself.
Criminals do not stand still and will continually look for ways to get around security systems. To circumvent "phone-in", website or SMS-based systems they can, and do, print counterfeit packaging complete with bogus versions of the serial number, telephone helpline, product website etc. The criminal can then put in place their own "authentication" system (either automatic or simply a poorly paid worker answering manually) which will return a reassuring answer to the customer that the product is genuine. The customer thinks they have validated their product with a foolproof method. In fact the whole system is a parallel, counterfeit world.
The immediate objection to my argument is that serial numbers or codes on products prevent criminals from conducting their business on a large scale, by denying them access to legitimate distribution channels. However, to break an anti-counterfeiting system the counterfeiter does not have to integrate his criminal business activities into it. He merely has to disrupt the official system so that consumer confidence is undermined and it ceases to be credible. As the genuine system falls into disuse, the criminal is free to go about his business as before.
For this reason, physical verification (based on visible and invisible security features) and digital authentication (based on unique serial numbers, codes etc) should still always go hand in hand, however efficient and high-tech the tracking capability becomes.
These systems allow the consumer to be directly involved in the verification of their product, and give the opportunity for the brand owner to send marketing messages whilst verifying their product's authenticity. Unfortunately, many of the consumer-based verification systems which rely on telephone helplines or websites are vulnerable to the “parallel universe” problem.
In many of the parts of the world where counterfeit drugs are a major problem, for example in Africa and South East Asia, the use of technology is still relatively new. If a consumer is told that they can verify their product by calling a helpline or sending an SMS text message with a serial number, they are unlikely to doubt, or to check, the authenticity of the system itself.
Criminals do not stand still and will continually look for ways to get around security systems. To circumvent "phone-in", website or SMS-based systems they can, and do, print counterfeit packaging complete with bogus versions of the serial number, telephone helpline, product website etc. The criminal can then put in place their own "authentication" system (either automatic or simply a poorly paid worker answering manually) which will return a reassuring answer to the customer that the product is genuine. The customer thinks they have validated their product with a foolproof method. In fact the whole system is a parallel, counterfeit world.
The immediate objection to my argument is that serial numbers or codes on products prevent criminals from conducting their business on a large scale, by denying them access to legitimate distribution channels. However, to break an anti-counterfeiting system the counterfeiter does not have to integrate his criminal business activities into it. He merely has to disrupt the official system so that consumer confidence is undermined and it ceases to be credible. As the genuine system falls into disuse, the criminal is free to go about his business as before.
For this reason, physical verification (based on visible and invisible security features) and digital authentication (based on unique serial numbers, codes etc) should still always go hand in hand, however efficient and high-tech the tracking capability becomes.
Monday, 25 January 2010
Fake Drugs in Africa - A Local Perspective
For an African perspective on the fake drug problem, see a very interesting and professional video called "If Symptoms Persist" at http://www.mpedigree.org/home/symptoms.php. This isn't brand new but provides a great local viewpoint (especially the first two-thirds of the 30 minute show) on the counterfeit problem in Ghana and its impact on issues such as malaria and public health. In my experience, the concerns, attitudes and priorities expressed are true of all African states. China is highlighted as the main source of the fake goods.
We need to address the counterfeiting problem now where it hits home hardest (in Africa, Latin America, Southeast Asia) and at its main sources (in China and elsewhere) or it will spread like a virus. Like a new infectious disease, fake drugs have the potential to kill millions unless we take quick action.
We need to address the counterfeiting problem now where it hits home hardest (in Africa, Latin America, Southeast Asia) and at its main sources (in China and elsewhere) or it will spread like a virus. Like a new infectious disease, fake drugs have the potential to kill millions unless we take quick action.
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