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.
Showing posts with label statistics. Show all posts
Showing posts with label statistics. Show all posts
Friday, 12 March 2010
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
Is Anti-Counterfeiting A Health Economics Activity?
After three days of conference presentations, intensive discussion and rubber chicken, I am on my way home from unusually chilly Florida with a case full of business cards, brochures, white papers etc. One of the difficulties expressed by several pharma industry speakers was obtaining the budgets necessary to do a comprehensive job. Putting patient protection programmes together costs money and these brand protection teams are often minimally funded.
It occurs to me that "product protection" is really just another way of ensuring that the patient gets the maximum benefit from the medical intervention that the drug represents. In this respect, it is effectively a branch of health economics and outcomes research (HEOR). Companies are happy to spend shedfuls of money on these disciplines because they give insight into how their medicines can best be used and how they can get optimal reimbursement levels. Is it time to view patient benefit more holistically and include the avoidance of harm?
In this case, and to take a purely local example, maybe the UK's National Institute for Health and Clinical Excellence (NICE) should review the effectiveness of anti-counterfeiting solutions?
I'm only partly joking here. One of the difficulties that we face in highlighting the issue of fake drugs is the lack of established protocols for sampling fake drugs, for compiling statistics, and for quantitively evaluating the effectiveness of countermeasures.
Until we standardise our methods and use rigorous statistics (or as stringent as the data will allow) then we will struggle to make our case as effective as it could be. By using the methods (and budgets) of our colleagues in HEOR, maybe we could find the elusive financial returns-on-investment for product protection, and improve patient outcomes at the same time at the same time.
It occurs to me that "product protection" is really just another way of ensuring that the patient gets the maximum benefit from the medical intervention that the drug represents. In this respect, it is effectively a branch of health economics and outcomes research (HEOR). Companies are happy to spend shedfuls of money on these disciplines because they give insight into how their medicines can best be used and how they can get optimal reimbursement levels. Is it time to view patient benefit more holistically and include the avoidance of harm?
In this case, and to take a purely local example, maybe the UK's National Institute for Health and Clinical Excellence (NICE) should review the effectiveness of anti-counterfeiting solutions?
I'm only partly joking here. One of the difficulties that we face in highlighting the issue of fake drugs is the lack of established protocols for sampling fake drugs, for compiling statistics, and for quantitively evaluating the effectiveness of countermeasures.
Until we standardise our methods and use rigorous statistics (or as stringent as the data will allow) then we will struggle to make our case as effective as it could be. By using the methods (and budgets) of our colleagues in HEOR, maybe we could find the elusive financial returns-on-investment for product protection, and improve patient outcomes at the same time at the same time.
Thursday, 18 February 2010
Have We Passed "Peak Pharma"?
Peak Oil
The world output of oil has been increasing ever since we first figured out how to get it out of the ground. But oil isn't produced, in the sense of a sustainable conversion of one thing to another, it is extracted from a finite reservoir. Peak Oil is the point at which oil extraction volumes start to go down not up. The date of Peak Oil is controversial, but the consensus is that it is very soon or may even already be behind us.
This is a healthcare-focused blog so why am I dwelling on energy issues? There are health consequences of Peak Oil - health services and products in developed nations are heavily oil-dependent. As oil prices rise with decreasing supply, healthcare will have to adapt itself to the new reality. But it is more the Peak Oil concept itself that interests me, and I think the mountain metaphor works for the medical sector as well.
Peak Pharma
I wonder if the world has passed "Peak Pharma", at least in the sense of drug profits per patient? Have we passed the most lucrative era for medicines? As companies move into developing markets and de-emphasise high-priced blockbusters their average prices, and therefore their revenue and profit per sale, will decrease and they will have to work harder and harder to make the same returns. Price pressure from local politicians, higher levels of authorised and unauthorised copies, increasing levels of counterfeits - all of these will mean that pharma cannot just translate its Western model to the developing world at a slightly lower price and hope to succeed.
Very basic market analysis shows that in 2007 the top 100 blockbuster drugs generated sales of $252.5 billion, accounting for 35.5% of the total global pharmaceutical market. As these drugs fall away, it will take a whole lot of work to just maintain the current business model. Companies who try to maintain their position and merely adjust the status quo slightly will fail.
The industry needs to accelerate its move to diversify away from a rigid, product-led model to a flexible, service/product hybrid. Relying on revenues from drugs alone is a sunset strategy.
The world output of oil has been increasing ever since we first figured out how to get it out of the ground. But oil isn't produced, in the sense of a sustainable conversion of one thing to another, it is extracted from a finite reservoir. Peak Oil is the point at which oil extraction volumes start to go down not up. The date of Peak Oil is controversial, but the consensus is that it is very soon or may even already be behind us.
This is a healthcare-focused blog so why am I dwelling on energy issues? There are health consequences of Peak Oil - health services and products in developed nations are heavily oil-dependent. As oil prices rise with decreasing supply, healthcare will have to adapt itself to the new reality. But it is more the Peak Oil concept itself that interests me, and I think the mountain metaphor works for the medical sector as well.
Peak Pharma
I wonder if the world has passed "Peak Pharma", at least in the sense of drug profits per patient? Have we passed the most lucrative era for medicines? As companies move into developing markets and de-emphasise high-priced blockbusters their average prices, and therefore their revenue and profit per sale, will decrease and they will have to work harder and harder to make the same returns. Price pressure from local politicians, higher levels of authorised and unauthorised copies, increasing levels of counterfeits - all of these will mean that pharma cannot just translate its Western model to the developing world at a slightly lower price and hope to succeed.
Very basic market analysis shows that in 2007 the top 100 blockbuster drugs generated sales of $252.5 billion, accounting for 35.5% of the total global pharmaceutical market. As these drugs fall away, it will take a whole lot of work to just maintain the current business model. Companies who try to maintain their position and merely adjust the status quo slightly will fail.
The industry needs to accelerate its move to diversify away from a rigid, product-led model to a flexible, service/product hybrid. Relying on revenues from drugs alone is a sunset strategy.
Monday, 18 January 2010
Deep Thought
Elvis died at 42. Maybe, if he'd lived, the King would be still be cool at seventy five this year, or maybe he'd be turning out embarassing elevator muzak, but sadly we'll never know.
As all Douglas Adams aficionados know, "42" is also the answer - after 7.5 million years of calculation by a specially built supercomputer - to the Ultimate Question of Life, The Universe and Everything. So I'm hoping for big things in the next twelve months.
Unfortunately, as in the book, the Ultimate Question itself remains frustratingly unknown for most people. Maybe this is why many men have a mid-life crisis at around my age. But a Porsche 911 doesn't fit my new (and largely bogus) green image and the current Mrs Davison has also put her foot down firmly and pre-emptively on the notion of a trophy wife.
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