Tuesday 16 March 2010
Monday 15 March 2010
Africa Needs Anti-Counterfeiting Laws, However Imperfect
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.
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.
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 9 March 2010
Why Drugs Cost A Lot
In my pharmaceutical career, I have worked with many talented scientists and managers. We have all been trying to discover, develop or sell innovative new drugs to address real medical needs. This is a very long process - often upwards of ten years between research discovery of a "lead compound" and launch of the marketed drug. Finding a new blockbuster is highly unlikely. Many pharmaceutical scientists go through brilliant careers, and add greatly to the world's scientific knowledge, without discovering anything that makes it to the market. I certainly managed that last clause.
But failure in drug R&D is not (usually) due to ineptitude. To a first approximation, all drug candidates fail - often very expensively in late-stage clinical trials or, even more disastrously, after launch (eg Vioxx). Even if the drug candidate works well against its biochemical target in an in vitro ("test tube") setting, it will most likely be inactive in vivo (real life) and will often be downright toxic. When I worked in antibiotics research, I personally discovered several, chemically-interesting, new ways to kill bugs. The problem was that my wonderdrugs always killed cultured mammalian cells just as effectively as they killed bacteria or fungi. Since I consider myself a cultured mammal, I wasn't going to try the Jekyll-and-Hyde route to further testing.
New drugs have to be safe, especially if they treat non-life-threatening conditions. They are tested until such time as we can think of no more feasible precautions to take. Only then will drug regulators allow them to be sold. Pharmaceutical R&D is therefore a high and inhospitable plateau of expensive and sustained failure, with very occasional peaks of scientific triumph.
All of the this adds up. Scientists and their equipment are not cheap. Clinical trials can cost ten thousand dollars per enrolled patient. These are fixed costs - payable whether the drug is a new blockbuster or a very expensive addition to the universe of known placebos. The tiny number of successes have to repay the costs of all the failures and the "opportunity costs" of not doing something more productive with the investors' money. That's why, on average, the true development cost of a new drug is probably close to a billion dollars.
That's also why innovative new drugs have to command relatively high prices. Is the pharmaceutical industry as efficient as it could be at R&D? Does it spend too much on selling and promotion? Do branded drug prices need to be quite so high? Those are separate questions.
But failure in drug R&D is not (usually) due to ineptitude. To a first approximation, all drug candidates fail - often very expensively in late-stage clinical trials or, even more disastrously, after launch (eg Vioxx). Even if the drug candidate works well against its biochemical target in an in vitro ("test tube") setting, it will most likely be inactive in vivo (real life) and will often be downright toxic. When I worked in antibiotics research, I personally discovered several, chemically-interesting, new ways to kill bugs. The problem was that my wonderdrugs always killed cultured mammalian cells just as effectively as they killed bacteria or fungi. Since I consider myself a cultured mammal, I wasn't going to try the Jekyll-and-Hyde route to further testing.
New drugs have to be safe, especially if they treat non-life-threatening conditions. They are tested until such time as we can think of no more feasible precautions to take. Only then will drug regulators allow them to be sold. Pharmaceutical R&D is therefore a high and inhospitable plateau of expensive and sustained failure, with very occasional peaks of scientific triumph.
All of the this adds up. Scientists and their equipment are not cheap. Clinical trials can cost ten thousand dollars per enrolled patient. These are fixed costs - payable whether the drug is a new blockbuster or a very expensive addition to the universe of known placebos. The tiny number of successes have to repay the costs of all the failures and the "opportunity costs" of not doing something more productive with the investors' money. That's why, on average, the true development cost of a new drug is probably close to a billion dollars.
That's also why innovative new drugs have to command relatively high prices. Is the pharmaceutical industry as efficient as it could be at R&D? Does it spend too much on selling and promotion? Do branded drug prices need to be quite so high? Those are separate questions.
Friday 5 March 2010
Internet Pharmacies Target Academics
The BBC reports today that a fake drug scam has hijacked some UK college websites. Online searches for drugs such as Viagra, Cialis etc would give search results which included the websites of academic institutions. When the user clicked on these sites they were instead taken to online "pharmacy" sites where they were offered the medicines they had originally searched for.
I (and many others) have blogged about internet pharmacies before, but this is a cunning new angle. By routing the search through the psychologically safer ground of an academic website, the criminals may perhaps fool the unwary into assuming some kind of endorsement of the online pharmacy.
Internet pharmacies, with very few exceptions (probably not enough for a tetrapod to run out of digits when counting them) are very risky and dangerous. Do not be fooled by the search route, logos, associations or any claimed endorsements. Check everything thoroughly. VIPPS is one of the few reliable quality schemes.
If you are trying to get prescription medicine online without a prescription then try using breath mints instead - much cheaper, less toxic, and just as efficaceous as whatever turns up in the post from the internet harmacy ("p" deliberately omitted).
I (and many others) have blogged about internet pharmacies before, but this is a cunning new angle. By routing the search through the psychologically safer ground of an academic website, the criminals may perhaps fool the unwary into assuming some kind of endorsement of the online pharmacy.
Internet pharmacies, with very few exceptions (probably not enough for a tetrapod to run out of digits when counting them) are very risky and dangerous. Do not be fooled by the search route, logos, associations or any claimed endorsements. Check everything thoroughly. VIPPS is one of the few reliable quality schemes.
If you are trying to get prescription medicine online without a prescription then try using breath mints instead - much cheaper, less toxic, and just as efficaceous as whatever turns up in the post from the internet harmacy ("p" deliberately omitted).
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.
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.
Thursday 25 February 2010
Seek And Ye Shall Find
Interesting stuff yesterday at the Florida conference I'm attending on pharmaceutical anti-counterfeiting. A drug company explained their process for risk assessment. They use thirty-six questions to get managers to drill deeply into possible product vulnerabilities, but the most important are the first three:
1. Has this product ever (to your knowledge) been counterfeited?
2. Has this product ever (to your knowledge) been diverted (ie sold in unauthorised channels or markets)?
And here is the killer question:
3. Have you ever checked 1 and 2 thoroughly (by market surveys etc)?
Many of the operating companies and managers that answered yes to 1 and 2 could not say yes to 3.
Question 3 is the critical point here. Unless you really look hard, you don't know whether you have a counterfeiting and/or diversion problem. If you dont know what your problem is, you can't begin to address it and patients will remain at risk.
1. Has this product ever (to your knowledge) been counterfeited?
2. Has this product ever (to your knowledge) been diverted (ie sold in unauthorised channels or markets)?
And here is the killer question:
3. Have you ever checked 1 and 2 thoroughly (by market surveys etc)?
Many of the operating companies and managers that answered yes to 1 and 2 could not say yes to 3.
Question 3 is the critical point here. Unless you really look hard, you don't know whether you have a counterfeiting and/or diversion problem. If you dont know what your problem is, you can't begin to address it and patients will remain at risk.
Wednesday 24 February 2010
Florida
This week I am in Florida for the 5th Global Forum on Pharmaceutical Anti-Counterfeiting . Held every two years or so, it brings together industry, regulators and vendors to discuss the issues around fake drugs and countermeasures. Unlike the last two events, I'm not presenting or exhibiting this time, so I'll have chance to stand back and take in the mood of the industry.
Florida is the setting for Katherine Eban's expose of the fake drug scandals in "Dangerous Doses" (well worth a read if you havent done so) so it's fitting that we are here. After the stasis of the last few years, I hope that we will have something to report other than earnest hopes this time. The drug industry and western governments have dragged their heels for far too long on the issue of drug supply chain safety. Things are now starting to move, but its time we got on with it.
Florida is the setting for Katherine Eban's expose of the fake drug scandals in "Dangerous Doses" (well worth a read if you havent done so) so it's fitting that we are here. After the stasis of the last few years, I hope that we will have something to report other than earnest hopes this time. The drug industry and western governments have dragged their heels for far too long on the issue of drug supply chain safety. Things are now starting to move, but its time we got on with it.
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