Wednesday 26 November 2008
Thursday 16 October 2008
Tobacco Menance
Tobacco cuts across the rural-urban divide, with bidis currently accounting for 77% of the smoked tobacco मार्केट
As India bans smoking in public places from October 2, communications specialist Deepanjali Bhas argues the war on tobacco has to be fought both on the demand and supply side। WHO estimates 800,000 deaths each year due to tobacco use, expected to rise by another hundred thousand by 2010.
Nearly 800,000 deaths per year in India are attributed to one of the biggest public health issues in the country - tobacco consumption.
Even as Union Minister for Health Anbumani Ramadoss announced early September that, starting October 2, 2008, smoking in offices and private establishments – covering shopping malls, cinema halls, public/private workplaces, hotels, banquet halls, discotheques, canteens, coffee houses, pubs, bars, airport lounges and railway stations - would be banned in line with the revised rules of the Act pertaining to the prohibition of smoking in pubic places, the issue of tobacco consumption still receives minimal attention.
India has some of the strictest laws in place to stem tobacco consumption, but they are rarely implemented. Cigarette manufacturers continue to make money in India, even as they are on the retreat in western nations.
Serious health issue
Young India is a happy playground for advertisers who peddle smoking, with 50% of its population under the age of 24. A study by the University of Texas’ School of Public Health, published in June 2008, titled Associations Between Tobacco Marketing and Use Among Urban Youth In India, says that smoking is becoming increasingly popular among Indian children, some as young as sixth-graders.
India accounts for 12% of the world’s smokers and there are nearly 8 lakh deaths every year on account of tobacco use, according to World Health Organisation estimates। This figure is expected to touch 9.3 lakh by 2010. Lung cancer is assuming epidemic proportions in India, according to the Indian Society of Medical and Paediatric Oncology (ISMPO), while chewing tobacco or gutkha is strongly linked to oral cancer.
Non-governmental organisations actively fighting in the anti-tobacco domain maintain that tobacco consumption is a serious public health issue. Yet it has never received the recognition it deserves; nor does the average citizen regard the issue with any seriousness.
Even as the smoking population is dropping in developed countries, the numbers in India and China are on the rise। Stringent legislation enacted in India in 2004 has only made cigarette companies more creative; they make their presence felt through lifestyle brands and event sponsorships. That the law itself is barely implemented is another matter.
Tobacco cuts across the rural-urban divide, with bidis currently accounting for 77% of the smoked tobacco market. A recent study by the Centre for Global Health Research at the University of Toronto, Canada, states that 1 million Indians will die from smoking-related illnesses in the next 24 months.
The study (A Nationally Representative Case-Control Study of Smoking and Death in India), done by scientists from India, Canada and the UK, covered nearly 1.1 million homes across India. It found that men who smoke bidis lose six years of their life, women lose eight, and men who smoke cigarettes lose 10 years.
As India bans smoking in public places from October 2, communications specialist Deepanjali Bhas argues the war on tobacco has to be fought both on the demand and supply side। WHO estimates 800,000 deaths each year due to tobacco use, expected to rise by another hundred thousand by 2010.
Nearly 800,000 deaths per year in India are attributed to one of the biggest public health issues in the country - tobacco consumption.
Even as Union Minister for Health Anbumani Ramadoss announced early September that, starting October 2, 2008, smoking in offices and private establishments – covering shopping malls, cinema halls, public/private workplaces, hotels, banquet halls, discotheques, canteens, coffee houses, pubs, bars, airport lounges and railway stations - would be banned in line with the revised rules of the Act pertaining to the prohibition of smoking in pubic places, the issue of tobacco consumption still receives minimal attention.
India has some of the strictest laws in place to stem tobacco consumption, but they are rarely implemented. Cigarette manufacturers continue to make money in India, even as they are on the retreat in western nations.
Serious health issue
Young India is a happy playground for advertisers who peddle smoking, with 50% of its population under the age of 24. A study by the University of Texas’ School of Public Health, published in June 2008, titled Associations Between Tobacco Marketing and Use Among Urban Youth In India, says that smoking is becoming increasingly popular among Indian children, some as young as sixth-graders.
India accounts for 12% of the world’s smokers and there are nearly 8 lakh deaths every year on account of tobacco use, according to World Health Organisation estimates। This figure is expected to touch 9.3 lakh by 2010. Lung cancer is assuming epidemic proportions in India, according to the Indian Society of Medical and Paediatric Oncology (ISMPO), while chewing tobacco or gutkha is strongly linked to oral cancer.
Non-governmental organisations actively fighting in the anti-tobacco domain maintain that tobacco consumption is a serious public health issue. Yet it has never received the recognition it deserves; nor does the average citizen regard the issue with any seriousness.
Even as the smoking population is dropping in developed countries, the numbers in India and China are on the rise। Stringent legislation enacted in India in 2004 has only made cigarette companies more creative; they make their presence felt through lifestyle brands and event sponsorships. That the law itself is barely implemented is another matter.
Tobacco cuts across the rural-urban divide, with bidis currently accounting for 77% of the smoked tobacco market. A recent study by the Centre for Global Health Research at the University of Toronto, Canada, states that 1 million Indians will die from smoking-related illnesses in the next 24 months.
The study (A Nationally Representative Case-Control Study of Smoking and Death in India), done by scientists from India, Canada and the UK, covered nearly 1.1 million homes across India. It found that men who smoke bidis lose six years of their life, women lose eight, and men who smoke cigarettes lose 10 years.
Initiated by the WHO in 2003, the Framework Convention on Tobacco Control is the only global treaty of its kind to control tobacco consumption
This is a disease burden that cannot be ignored, according to Healis from the Sekhsaria Institute of Public Health, Mumbai, whose research shows a significant causal association between bidi smoking and tuberculosis. An extensive longitudinal study carried out by Healis and an international group of researchers, between 1991 and 2003, among bidi-smoking men, showed that at least 32% of deaths due to tuberculosis could be attributed to bidi smoking.Tuesday 16 September 2008
HEALTH TOURISM
Medical Tourism and Public Health By Amit Sen Gupta
Written by dsf
Sunday, 09 May 2004
THE most recent trend in privatisation of health services is medical tourism, which is gaining prominence in developing countries. Globalisation has promoted a consumerist culture, thereby promoting goods and services that can feed the aspirations arising from this culture. This has had its effect in the health sector too, with the emergence of a private sector that thrives by servicing a small percentage of the population that has the ability to “buy” medical care at the rates at which the “high end” of the private medical sector provides such care. This has changed the character of the medical care sector, with the entry of the corporate sector. Corporate run institutions are seized with the necessity to maximise profits and expand their coverage. These objectives face a constraint in the form of the relatively small size of the population in developing countries that can afford services offered by such institutions. In this background, corporate interests in the Medical Care sector are looking for opportunities that go beyond the limited domestic “market” for high cost medical care. This is the genesis of the “medical tourism” industry.
MEDICAL TOURISM AS AN INDUSTRY
Medical tourism can be broadly defined as provision of ‘cost effective’ private medical care in collaboration with the tourism industry for patients needing surgical and other forms of specialized treatment. This process is being facilitated by the corporate sector involved in medical care as well as the tourism industry - both private and public.
In many developing countries it is being actively promoted by the government’s official policy. India’s National Health policy 2002, for example, says: “To capitalise on the comparative cost advantage enjoyed by domestic health facilities in the secondary and tertiary sector, the policy will encourage the supply of services to patients of foreign origin on payment. The rendering of such services on payment in foreign exchange will be treated as ‘deemed exports’ and will be made eligible for all fiscal incentives extended to export earnings”. The formulation draws from recommendations that the corporate sector has been making in India and specifically from the “Policy Framework for Reforms in Health Care”, drafted by the prime minister’s Advisory Council on Trade and Industry, headed by Mukesh Ambani and Kumaramangalam Birla.
GROWTH OF THE MEDICAL TOURISM INDUSTRY
The countries where medical tourism is being actively promoted include Greece, South Africa, Jordan, India, Malaysia, Philippines and Singapore. India is a recent entrant into medical tourism. According to a study by McKinsey and the Confederation of Indian Industry, medical tourism in India could become a $1 billion business by 2012. The report predicts that: “By 2012, if medical tourism were to reach 25 per cent of revenues of private up-market players, up to Rs 10,000 crore will be added to the revenues of these players”. The Indian government predicts that India’s $17-billion-a-year health-care industry could grow 13 per cent in each of the next six years, boosted by medical tourism, which industry watchers say is growing at 30 per cent annually.
In India, the Apollo group alone has so far treated 95,000 international patients, many of whom are of Indian origin. Apollo has been a forerunner in medical tourism in India and attracts patients from Southeast Asia, Africa, and the Middle East. The group has tied up with hospitals in Mauritius, Tanzania, Bangladesh and Yemen besides running a hospital in Sri Lanka, and managing a hospital in Dubai.
Another corporate group running a chain of hospitals, Escorts, claims it has doubled its number of overseas patients - from 675 in 2000 to nearly 1,200 this year. Recently, the Ruby Hospital in Kolkata signed a contract with the British insurance company, BUPA. The management hopes to get British patients from the queue in the National Health Services soon. Some estimates say that foreigners account for 10 to 12 per cent of all patients in top Mumbai hospitals despite roadblocks like poor aviation connectivity, poor road infrastructure and absence of uniform quality standards.
Analysts say that as many as 150,000 medical tourists came to India last year. However, the current market for medical tourism in India is mainly limited to patients from the Middle East and South Asian economies. Some claim that the industry would flourish even without Western medical tourists. Afro-Asian people spend as much as $20 billion a year on health care outside their countries – Nigerians alone spend an estimated $1 billion a year. Most of this money would be spent in Europe and America, but it is hoped that this would now be increasingly directed to developing countries with advanced facilities.
PROMOTION OF MEDICAL TOURISM
The key “selling points” of the medical tourism industry are its “cost effectiveness” and its combination with the attractions of tourism. The latter also uses the ploy of selling the “exotica” of the countries involved as well as the packaging of health care with traditional therapies and treatment methods.
Price advantage is, of course, a major selling point. The slogan, thus is, “First World treatment’ at Third World prices”. The cost differential across the board is huge: only a tenth and sometimes even a sixteenth of the cost in the West. Open-heart surgery could cost up to $70,000 in Britain and up to $150,000 in the US; in India’s best hospitals it could cost between $3,000 and $10,000. Knee surgery (on both knees) costs 350,000 rupees ($7,700) in India; in Britain this costs £10,000 ($16,950), more than twice as much. Dental, eye and cosmetic surgeries in Western countries cost three to four times as much as in India.
The price advantage is however offset today for patients from the developed countries by concerns regarding standards, insurance coverage and other infrastructure. This is where the tourism and medical industries are trying to pool resources, and also putting pressure on the government. We shall turn to their implications later.
In India the strong tradition of traditional systems of health care in Kerala, for example, is utilised. Kerala Ayurveda centres have been established at multiple locations in various metro cities, thus highlighting the advantages of Ayurveda in health management. The health tourism focus has seen Kerala participate in various trade shows and expos wherein the advantages of this traditional form of medicine are showcased.
A generic problem with medical tourism is that it reinforces the medicalised view of health care. By promoting the notion that medical services can be bought off the shelf from the lowest priced provider anywhere in the globe, it also takes away the pressure from the government to provide comprehensive health care to all its citizens. It is a deepening of the whole notion of health care that is being pushed today which emphasises on technology and private enterprise.
The important question here is for whom is ‘cost effective’ services to be provided. Clearly the services are “cost effective” for those who can pay and in addition come from countries where medical care costs are exorbitant - because of the failure of the government to provide affordable medical care. It thus attracts only a small fraction that can pay for medical care and leaves out large sections that are denied medical care but cannot afford to pay. The demand for cost effective specialized care is coming from the developed countries where there has been a decline in public spending and rise in life expectancy and non-communicable diseases that requires specialist services.
MEDICAL TOURISM AND PUBLIC HEALTH SERVICES
Medical tourism is going to only deal with large specialist hospitals run by corporate entities. It is a myth that the revenues earned by these corporates will partly revert back to finance the public sector. There is ample evidence to show that these hospitals have not honoured the conditionalities for receiving government subsidies - in terms of treatment of a certain proportion of in patients and out patients free of cost. If anything, increased demand on private hospitals due to medical tourism may result in their expansion. If they expand then they will need more professionals, which means that they will try to woo doctors from the public sector. Even today the top specialists in corporate hospitals are senior doctors drawn the public sector. Medical tourism is likely to further devalue and divert personnel from the public sector rather than strengthen them.
Urban concentration of health care providers is a well-known fact – 59 per cent of India’s practitioners (73 per cent allopathic) are located in cities, and especially metropolitan ones. Medical tourism promotes an “internal brain drain” with more health professionals being drawn to large urban centres, and within them, to large corporate run specialty institutions.
Medical tourism is going to result in a number of demands and changes in the areas of financing and regulations. There will be a greater push for encouraging private insurance tied to systems of accreditation of private hospitals. There is a huge concern in the developed countries about the quality of care and clinical expertise in developing countries and this will push for both insurance and regulatory regimes. The potential for earning revenues through medical tourism will become an important argument for private hospitals demanding more subsidies from the government in the long run. In countries like India, the corporate private sector has already received considerable subsidies in the form of land, reduced import duties for medical equipment etc. Medical tourism will only further legitimise their demands and put pressure on the government to subsidise them even more. This is worrying because the scarce resources available for health will go into subsidising the corporate sector. It thus has serious consequences for equity and cost of services and raises a very fundamental question: why should developing countries be subsidising the health care of developed countries?
Written by dsf
Sunday, 09 May 2004
THE most recent trend in privatisation of health services is medical tourism, which is gaining prominence in developing countries. Globalisation has promoted a consumerist culture, thereby promoting goods and services that can feed the aspirations arising from this culture. This has had its effect in the health sector too, with the emergence of a private sector that thrives by servicing a small percentage of the population that has the ability to “buy” medical care at the rates at which the “high end” of the private medical sector provides such care. This has changed the character of the medical care sector, with the entry of the corporate sector. Corporate run institutions are seized with the necessity to maximise profits and expand their coverage. These objectives face a constraint in the form of the relatively small size of the population in developing countries that can afford services offered by such institutions. In this background, corporate interests in the Medical Care sector are looking for opportunities that go beyond the limited domestic “market” for high cost medical care. This is the genesis of the “medical tourism” industry.
MEDICAL TOURISM AS AN INDUSTRY
Medical tourism can be broadly defined as provision of ‘cost effective’ private medical care in collaboration with the tourism industry for patients needing surgical and other forms of specialized treatment. This process is being facilitated by the corporate sector involved in medical care as well as the tourism industry - both private and public.
In many developing countries it is being actively promoted by the government’s official policy. India’s National Health policy 2002, for example, says: “To capitalise on the comparative cost advantage enjoyed by domestic health facilities in the secondary and tertiary sector, the policy will encourage the supply of services to patients of foreign origin on payment. The rendering of such services on payment in foreign exchange will be treated as ‘deemed exports’ and will be made eligible for all fiscal incentives extended to export earnings”. The formulation draws from recommendations that the corporate sector has been making in India and specifically from the “Policy Framework for Reforms in Health Care”, drafted by the prime minister’s Advisory Council on Trade and Industry, headed by Mukesh Ambani and Kumaramangalam Birla.
GROWTH OF THE MEDICAL TOURISM INDUSTRY
The countries where medical tourism is being actively promoted include Greece, South Africa, Jordan, India, Malaysia, Philippines and Singapore. India is a recent entrant into medical tourism. According to a study by McKinsey and the Confederation of Indian Industry, medical tourism in India could become a $1 billion business by 2012. The report predicts that: “By 2012, if medical tourism were to reach 25 per cent of revenues of private up-market players, up to Rs 10,000 crore will be added to the revenues of these players”. The Indian government predicts that India’s $17-billion-a-year health-care industry could grow 13 per cent in each of the next six years, boosted by medical tourism, which industry watchers say is growing at 30 per cent annually.
In India, the Apollo group alone has so far treated 95,000 international patients, many of whom are of Indian origin. Apollo has been a forerunner in medical tourism in India and attracts patients from Southeast Asia, Africa, and the Middle East. The group has tied up with hospitals in Mauritius, Tanzania, Bangladesh and Yemen besides running a hospital in Sri Lanka, and managing a hospital in Dubai.
Another corporate group running a chain of hospitals, Escorts, claims it has doubled its number of overseas patients - from 675 in 2000 to nearly 1,200 this year. Recently, the Ruby Hospital in Kolkata signed a contract with the British insurance company, BUPA. The management hopes to get British patients from the queue in the National Health Services soon. Some estimates say that foreigners account for 10 to 12 per cent of all patients in top Mumbai hospitals despite roadblocks like poor aviation connectivity, poor road infrastructure and absence of uniform quality standards.
Analysts say that as many as 150,000 medical tourists came to India last year. However, the current market for medical tourism in India is mainly limited to patients from the Middle East and South Asian economies. Some claim that the industry would flourish even without Western medical tourists. Afro-Asian people spend as much as $20 billion a year on health care outside their countries – Nigerians alone spend an estimated $1 billion a year. Most of this money would be spent in Europe and America, but it is hoped that this would now be increasingly directed to developing countries with advanced facilities.
PROMOTION OF MEDICAL TOURISM
The key “selling points” of the medical tourism industry are its “cost effectiveness” and its combination with the attractions of tourism. The latter also uses the ploy of selling the “exotica” of the countries involved as well as the packaging of health care with traditional therapies and treatment methods.
Price advantage is, of course, a major selling point. The slogan, thus is, “First World treatment’ at Third World prices”. The cost differential across the board is huge: only a tenth and sometimes even a sixteenth of the cost in the West. Open-heart surgery could cost up to $70,000 in Britain and up to $150,000 in the US; in India’s best hospitals it could cost between $3,000 and $10,000. Knee surgery (on both knees) costs 350,000 rupees ($7,700) in India; in Britain this costs £10,000 ($16,950), more than twice as much. Dental, eye and cosmetic surgeries in Western countries cost three to four times as much as in India.
The price advantage is however offset today for patients from the developed countries by concerns regarding standards, insurance coverage and other infrastructure. This is where the tourism and medical industries are trying to pool resources, and also putting pressure on the government. We shall turn to their implications later.
In India the strong tradition of traditional systems of health care in Kerala, for example, is utilised. Kerala Ayurveda centres have been established at multiple locations in various metro cities, thus highlighting the advantages of Ayurveda in health management. The health tourism focus has seen Kerala participate in various trade shows and expos wherein the advantages of this traditional form of medicine are showcased.
A generic problem with medical tourism is that it reinforces the medicalised view of health care. By promoting the notion that medical services can be bought off the shelf from the lowest priced provider anywhere in the globe, it also takes away the pressure from the government to provide comprehensive health care to all its citizens. It is a deepening of the whole notion of health care that is being pushed today which emphasises on technology and private enterprise.
The important question here is for whom is ‘cost effective’ services to be provided. Clearly the services are “cost effective” for those who can pay and in addition come from countries where medical care costs are exorbitant - because of the failure of the government to provide affordable medical care. It thus attracts only a small fraction that can pay for medical care and leaves out large sections that are denied medical care but cannot afford to pay. The demand for cost effective specialized care is coming from the developed countries where there has been a decline in public spending and rise in life expectancy and non-communicable diseases that requires specialist services.
MEDICAL TOURISM AND PUBLIC HEALTH SERVICES
Medical tourism is going to only deal with large specialist hospitals run by corporate entities. It is a myth that the revenues earned by these corporates will partly revert back to finance the public sector. There is ample evidence to show that these hospitals have not honoured the conditionalities for receiving government subsidies - in terms of treatment of a certain proportion of in patients and out patients free of cost. If anything, increased demand on private hospitals due to medical tourism may result in their expansion. If they expand then they will need more professionals, which means that they will try to woo doctors from the public sector. Even today the top specialists in corporate hospitals are senior doctors drawn the public sector. Medical tourism is likely to further devalue and divert personnel from the public sector rather than strengthen them.
Urban concentration of health care providers is a well-known fact – 59 per cent of India’s practitioners (73 per cent allopathic) are located in cities, and especially metropolitan ones. Medical tourism promotes an “internal brain drain” with more health professionals being drawn to large urban centres, and within them, to large corporate run specialty institutions.
Medical tourism is going to result in a number of demands and changes in the areas of financing and regulations. There will be a greater push for encouraging private insurance tied to systems of accreditation of private hospitals. There is a huge concern in the developed countries about the quality of care and clinical expertise in developing countries and this will push for both insurance and regulatory regimes. The potential for earning revenues through medical tourism will become an important argument for private hospitals demanding more subsidies from the government in the long run. In countries like India, the corporate private sector has already received considerable subsidies in the form of land, reduced import duties for medical equipment etc. Medical tourism will only further legitimise their demands and put pressure on the government to subsidise them even more. This is worrying because the scarce resources available for health will go into subsidising the corporate sector. It thus has serious consequences for equity and cost of services and raises a very fundamental question: why should developing countries be subsidising the health care of developed countries?
Tobacco Industry
Tobacco Industry and its Tryst with Death By Prabir Purkayastha
Written by dsf
Tuesday, 11 April 2006
After denying for the last fifty years that tobacco is either addictive or harmful, tobacco companies are now trying to negotiate their future with the US Government. They have agreed to pay up to $300 billion over the next 20 years provided they are given total immunity against future damages in US and outside. Obviously, the US tobacco companies and the US Government both feel that US laws supersede all international laws. And if this is not enough, the cynical nature of these negotiations are that if the US government is paid off for the damage inflicted on US citizens, it should satisfy all victims -- in US or elsewhere -- and the tobacco companies can continue with business as usual. Three hundred billion may seem like big bucks, except for the huge profits king tobacco earns. After the negotiations became public, tobacco shares rose in the US stock market.
The $48 billion tobacco industry in US consisting of RJ Reynolds, Philip Morris, etc., are huge MNCs with extensive interests abroad. They have been particularly cosy with the US Government, who have threatened countries with action under 301 and Super 301 if they sought to restrain tobacco companies in any way -- even restraints that the consumers in US have been asking for. The tobacco companies have denied that their products are either harmful or addictive. James Morgan, the President of Philip Morris in a sworn statement recently has said that tobacco is no more addictive than candy. Andrew Schindler, president of R.J. Reynolds claimed, again in a sworn statement that tobacco is about as addictive as carrots. From this, to seeking future immunity against all damages while disgorging $300 billion is quite a retreat. It also lays bare the future strategy of the cigarette companies. Expand in the third world where damage suits rarely win and limit damages in US where legal losses can be heavy. Third World lives after all do not matter -- either in US or even in their own countries. Witness what our Supreme Court did to Bhopal victims -- settling for a sum that was well within Carbide’s insurance cover.
Why is the tobacco industry coming for negotiations now when they have strenuously denied that their products are anything but fun? The answer lies in the broad coalition of forces that are now coming up against tobacco. It is no longer possible to manipulate a few influential law makers in the US Senate, buy influence in Washington and stave off all dangers of either legislation or regulation. Recently released secret documents talk of calling in the tobacco backers in Senate -- Jesse Helms being one of them -- to prevent action in Washington. The Presidency has generally been accommodative of the industry, till the rising protest against tobacco makes it expedient to gain public support by attacking the tobacco industry. Both Tony Blair in UK and Clinton in US are now taking an anti tobacco stand, even though it is more token than real.
The spate of law suits in US brought by individuals, generally lost as the tobacco companies argued that they have warned the consumers of the dangers of tobacco. Even after this, if the people want to smoke it is not the problem of the companies. Though the tobacco companies did lose one case last year, where they were asked to pay $750,000 as damages, their defence has pretty much held through. Even in the Florida case recently, the Judge’s instructions to the jury made an adverse verdict against tobacco pretty much impossible.
There are two recent legal developments that have set alarm bells ringing in the tobacco industry. One is the recent ruling of a Federal Judge in New Carolina that the Federal Drug Authority can regulate tobacco as a drug. The other is that 22 State Attorney Generals have joined together to file claims against the tobacco companies on behalf of the states. Their argument is that it is finally the Medicare and Medicaid programs that are run by the state that incur huge losses due to tobacco inflicted diseases, therefore the industry should pay up these costs.
The first, may at first sight seem innocuous. If tobacco content is regulated, so what, the innocent may ask. The answer lies in the way cigarettes have been pushed world wide. Some of the more damning facts, well known in anti tobacco circles but assiduously denied by the industry, is that the nicotine content in cigarettes can be brought down to very low levels so that cigarettes are non-addictive. In such a case, leaving smoking which is so difficult, would become simple. The tobacco industry is fully aware that once nicotine content is brought down, the tobacco industry’s policy of “hook them young and keep them forever” is all but finished.
In one of the developments this year, one of the smaller tobacco companies. Ligett, agreed to co-operate with the state. Though it is one of the smaller players -- having only a mere 2% of the market in US -- its turning virtually state’s witness sent shock waves. It made available secret documents of how the tobacco industry has targeted the young, and suppressed the possibility of lower nicotine cigarettes as addiction was its key weapon for higher profits. The industry even laced cigarettes with various chemicals to enhance the nicotine “kick”. One of such enhances is ammonia, which the tobacco industry calls an "impact booster" for its ability to enhance the delivery of nicotine to the smoker. In another memo from Liggett, the company considered using synthetic ingredients to increase the addictive quality of smoking, "without the severe toxicity of nicotine itself.”
The Ligett documents also show systematic targeting of youth -- there are a large number of documents discussing "more appeal to youth" , "to appeal to young adult women" ,"16-21 -- the formative years", and so on. Obviously, tobacco has never been a habit that kids pick up under peer pressure. There is the tremendous pressure of advertising -- all sports events are sponsored by cigarette companies, the stars on screen smoke (incidentally here to documents now show that the industry used to pay movie stars to do so) and after all you feel the affect only when you are very old. For the youth, old age is out of their conceptual space. Once addicted, tobacco is life long, the cigarette companies make it so with their nicotine “cocktail”. Therefore the importance of catching them young; even a single smoke free generation will kill the tobacco companies. A convert at 16 is then a cigarette consumer for ever. As the smoker marches towards emphysema, lung cancer and heart attacks, the cash registers of the cigarette companies go on ringing.
The tobacco companies shenanigans did not stop here. After years of denying cigarettes were harmful and sponsoring research to show this, they fought a rear guard battle on the effects of second hand smoking. Recent documents brought out by Washington Post show that tobacco giant Philip Morris systematically wooed scientists who might help the company counter the growing consensus on the health risks of second-hand tobacco smoke and "keep the controversy alive". The British American Tobacco Company memo, obtained by The Washington Post, laid out in great detail Philip Morris's presentation at a February 1988 conference of its global strategy for dealing with environmental tobacco smoke. The company was "spending vast sums of money" to find scientists amenable to its cause and funding research by them, the memo said.
There is yet no world wide coalition against tobacco companies. If one looks at their record, they are responsible for deaths, disease and ill health on an unprecedented scale. Yet if we want to control them, forget banning their products, we run counter to WTO and the post GATT regime. Trade is sacrosanct and American companies even more so. People are expendable, unless of of course they are smokers. Then we can talk of smokers rights. The danger to third world is that as the West becomes more organised against tobacco, the tobacco giants will shift more to the Third World. That BAT wants to take over ITC in India is no accident. It is their long term hedge against crumbling tobacco defences in the West. Marx described capital, as dripping of blood at every pore. Their is no better example than tobacco, battening as it does on death and disease of vast numbers of people.
Written by dsf
Tuesday, 11 April 2006
After denying for the last fifty years that tobacco is either addictive or harmful, tobacco companies are now trying to negotiate their future with the US Government. They have agreed to pay up to $300 billion over the next 20 years provided they are given total immunity against future damages in US and outside. Obviously, the US tobacco companies and the US Government both feel that US laws supersede all international laws. And if this is not enough, the cynical nature of these negotiations are that if the US government is paid off for the damage inflicted on US citizens, it should satisfy all victims -- in US or elsewhere -- and the tobacco companies can continue with business as usual. Three hundred billion may seem like big bucks, except for the huge profits king tobacco earns. After the negotiations became public, tobacco shares rose in the US stock market.
The $48 billion tobacco industry in US consisting of RJ Reynolds, Philip Morris, etc., are huge MNCs with extensive interests abroad. They have been particularly cosy with the US Government, who have threatened countries with action under 301 and Super 301 if they sought to restrain tobacco companies in any way -- even restraints that the consumers in US have been asking for. The tobacco companies have denied that their products are either harmful or addictive. James Morgan, the President of Philip Morris in a sworn statement recently has said that tobacco is no more addictive than candy. Andrew Schindler, president of R.J. Reynolds claimed, again in a sworn statement that tobacco is about as addictive as carrots. From this, to seeking future immunity against all damages while disgorging $300 billion is quite a retreat. It also lays bare the future strategy of the cigarette companies. Expand in the third world where damage suits rarely win and limit damages in US where legal losses can be heavy. Third World lives after all do not matter -- either in US or even in their own countries. Witness what our Supreme Court did to Bhopal victims -- settling for a sum that was well within Carbide’s insurance cover.
Why is the tobacco industry coming for negotiations now when they have strenuously denied that their products are anything but fun? The answer lies in the broad coalition of forces that are now coming up against tobacco. It is no longer possible to manipulate a few influential law makers in the US Senate, buy influence in Washington and stave off all dangers of either legislation or regulation. Recently released secret documents talk of calling in the tobacco backers in Senate -- Jesse Helms being one of them -- to prevent action in Washington. The Presidency has generally been accommodative of the industry, till the rising protest against tobacco makes it expedient to gain public support by attacking the tobacco industry. Both Tony Blair in UK and Clinton in US are now taking an anti tobacco stand, even though it is more token than real.
The spate of law suits in US brought by individuals, generally lost as the tobacco companies argued that they have warned the consumers of the dangers of tobacco. Even after this, if the people want to smoke it is not the problem of the companies. Though the tobacco companies did lose one case last year, where they were asked to pay $750,000 as damages, their defence has pretty much held through. Even in the Florida case recently, the Judge’s instructions to the jury made an adverse verdict against tobacco pretty much impossible.
There are two recent legal developments that have set alarm bells ringing in the tobacco industry. One is the recent ruling of a Federal Judge in New Carolina that the Federal Drug Authority can regulate tobacco as a drug. The other is that 22 State Attorney Generals have joined together to file claims against the tobacco companies on behalf of the states. Their argument is that it is finally the Medicare and Medicaid programs that are run by the state that incur huge losses due to tobacco inflicted diseases, therefore the industry should pay up these costs.
The first, may at first sight seem innocuous. If tobacco content is regulated, so what, the innocent may ask. The answer lies in the way cigarettes have been pushed world wide. Some of the more damning facts, well known in anti tobacco circles but assiduously denied by the industry, is that the nicotine content in cigarettes can be brought down to very low levels so that cigarettes are non-addictive. In such a case, leaving smoking which is so difficult, would become simple. The tobacco industry is fully aware that once nicotine content is brought down, the tobacco industry’s policy of “hook them young and keep them forever” is all but finished.
In one of the developments this year, one of the smaller tobacco companies. Ligett, agreed to co-operate with the state. Though it is one of the smaller players -- having only a mere 2% of the market in US -- its turning virtually state’s witness sent shock waves. It made available secret documents of how the tobacco industry has targeted the young, and suppressed the possibility of lower nicotine cigarettes as addiction was its key weapon for higher profits. The industry even laced cigarettes with various chemicals to enhance the nicotine “kick”. One of such enhances is ammonia, which the tobacco industry calls an "impact booster" for its ability to enhance the delivery of nicotine to the smoker. In another memo from Liggett, the company considered using synthetic ingredients to increase the addictive quality of smoking, "without the severe toxicity of nicotine itself.”
The Ligett documents also show systematic targeting of youth -- there are a large number of documents discussing "more appeal to youth" , "to appeal to young adult women" ,"16-21 -- the formative years", and so on. Obviously, tobacco has never been a habit that kids pick up under peer pressure. There is the tremendous pressure of advertising -- all sports events are sponsored by cigarette companies, the stars on screen smoke (incidentally here to documents now show that the industry used to pay movie stars to do so) and after all you feel the affect only when you are very old. For the youth, old age is out of their conceptual space. Once addicted, tobacco is life long, the cigarette companies make it so with their nicotine “cocktail”. Therefore the importance of catching them young; even a single smoke free generation will kill the tobacco companies. A convert at 16 is then a cigarette consumer for ever. As the smoker marches towards emphysema, lung cancer and heart attacks, the cash registers of the cigarette companies go on ringing.
The tobacco companies shenanigans did not stop here. After years of denying cigarettes were harmful and sponsoring research to show this, they fought a rear guard battle on the effects of second hand smoking. Recent documents brought out by Washington Post show that tobacco giant Philip Morris systematically wooed scientists who might help the company counter the growing consensus on the health risks of second-hand tobacco smoke and "keep the controversy alive". The British American Tobacco Company memo, obtained by The Washington Post, laid out in great detail Philip Morris's presentation at a February 1988 conference of its global strategy for dealing with environmental tobacco smoke. The company was "spending vast sums of money" to find scientists amenable to its cause and funding research by them, the memo said.
There is yet no world wide coalition against tobacco companies. If one looks at their record, they are responsible for deaths, disease and ill health on an unprecedented scale. Yet if we want to control them, forget banning their products, we run counter to WTO and the post GATT regime. Trade is sacrosanct and American companies even more so. People are expendable, unless of of course they are smokers. Then we can talk of smokers rights. The danger to third world is that as the West becomes more organised against tobacco, the tobacco giants will shift more to the Third World. That BAT wants to take over ITC in India is no accident. It is their long term hedge against crumbling tobacco defences in the West. Marx described capital, as dripping of blood at every pore. Their is no better example than tobacco, battening as it does on death and disease of vast numbers of people.
GENETICS WORLD
The Brave New World Of Genetics
Prabir Purkayastha
25 June, 2006
AFTER the reading of the human genome, there are daily advances that research on genetics is reporting: from chimpanzee-human differences to a new world free of disabilities, superior intelligence and human happiness, all implanted into our genes. The hype of genetic technology and its promise of course is very much a marketing drive of global multi-nationals investing billions of dollars in genetic research: they are more solutions in search of problems rather problems that were awaiting a solution.
First the good news. Human beings are much closer to chimpanzees than we thought earlier. A new genetic study in Nature has shown that the pictures showing George Bush making faces and in postures very similar to chimpanzees (www.bushorchimp.com) is not merely fortuitous but a clear result of our genetic affinity to our closest cousins, the chimps. As an aside, these pictures recently appeared in a Belgian official police manual showing the importance of body language in reading of humans, much to the anger of the US administration and embarrassment of the Belgian government. The study in Nature (put on-line by Nature but not yet published) titled “Genetic evidence for complex speciation of humans and chimpanzees” by Patterson et al, shows that the split of human population from the chimpanzee one was of a longer duration than thought earlier, with the split becoming complete only about 5.4 to 6.3 million years ago. This not only reduces the time of the split from about 7 million years ago as thought earlier, but also shows that there were considerable gene flows (mating) between the two sets of populations for about a million years.
COMPLEX TREE OF EVOLUTION
Why is this so startling? Previously, it was believed that the split between two sets of populations tend to be sharp and the hybrid population generally tends to be sterile. The above study shows that this is not really the case and for quite some time, at least for the proto human and proto chimpanzee population, this did not hold true. The basis of these conclusions is also interesting. The team calculated the genetic distance of various sites on the two populations and found that the X chromosome had the smallest distance or the most similarity, consistent with the hypothesis that the two populations mated with each other even after starting to separate. Any two species that mate would be expected to have similar X chromosomes as long as hybridisation continued. A messy divorce rather than a clean break!
The other impact of this chimp human split is that it spoils the party for those that believe that there is a uni-linear model of development in which the human population evolved from the lower apes and we are at the top of the evolutionary tree. There is a hominid population which pre dates this break showing that the current branch split later from the chimpanzee family than some of the other hominid branches. The tree of evolution is considerably more complex than a simple model in which nature worked over billions of years to produce us as the apex of evolution. That we are more successful is incidental: nature had no specific plans for us as different for what it had for chimpanzees or any other species.
While the genetic research has much to say about the past, the big bucks are in the future and not in finding out about migration patterns and chimpanzee. While genetic tools are indeed powerful, laying bare the genome of humans to mice (as also plants), the promise of immediate technology is not proving as fruitful. We will not look at agriculture and genetically modified organisms in this article but look at the new genetic technology in terms of what it holds for the immediate future of the human species.
UNNECESSARY HYPE
The common fallacy in the world of science is that any great scientific advance must immediately yield substantial dividend in terms of utilisable technologies. It is this utilitarian model of science (and also technology) that governs much of the debate on funding as well as the hype regarding science. It is this same hype which convinced the world that since we know E = MC2, we must also be able to utilise this knowledge either through nuclear fission or fusion to give us inexhaustible source of energy. This was the basis of predictions of eminent scientists that by the end of 20th century, there will be no need to metre energy, as it will become virtually free. I am afraid this is the same hype that biotechnology is seeing today.
The ability to read the genetic code and being able to modify it are two different things. Genetic engineering promises to rectify defects in the genetic code by inserting a healthy gene, therefore the concept of gene therapy. While it is possible some day this might become feasible, it is clear that this cannot be done with existing technologies in the near future. All the techniques we have today, take a shotgun approach in which the healthy gene is virtually sprayed into the patient’s cell nucleus (using generally therapeutic DNA combined with a virus as a vector) and this attaches to various different sites than the gene’s actual position. In the only on-going trials for gene therapy thought to be successful, out of the original 10 children suffering from SCID (severe combined immune deficiency) of whom 9 had been cured, 4 have now developed leukaemia. SCID leads to children being born with no immune system forcing such children to live in sterile “bubbles”. While it may be argued that leukaemia and living in a normal environment is preferable to living within a sterile bubble, that leukaemia has resulted on such a large scale indicates the limited utility of current methods of gene therapy. The studies with laboratory mice also show similar high incidence of cancer in those undergoing gene “therapy”.
ISSUES OF RISK AND ETHICS
It is clear that the current gene therapies have seen limited success. But that is not the only issue in gene therapy. New issues are risk and also new ethical concerns. Risks arise in gene therapies, as we have no data from the past for such experiments and the persistence of such agents through the patient’s offsprings. Gene replacement can lead to modifications in what are called germ-line cells – sperm cells or ova – and therefore once inserted represents a long-term risk. As viruses are used as vectors, they also introduce additional risks of their own. The other issue is the ethical one whether we can make modifications for future generations who have not given their consent. Any modifications that are passed on to future generations involve this new ethical issue that we have not addressed in the past. The good thing is that we have some time here still as we have yet to find effective tools for gene transfer without the problems described above. Designer babies bred to outperform the rest and the rich growing more and more distant from such directed evolution is still the stuff of science fiction or media hype. But if we are able to bring about such gene transfers in which we can bind the healthy gene to the specific site where the defective gene lies, then we will have to address the above issues of risk and ethics.
The more immediate issue is one of genetic screening of foetuses – prenatal genetic diagnosis. This is not very dissimilar from issues that already exist: when there is prejudice against the girl child, ultrasonography leads to large-scale abortion of the girl child and sharp distortion in sex ratios. The genetic tests on foetus would not only lead to worsening of the sex ratios as genetic tests are even more conclusive than ultrasound methods, but a whole host of variations in the human gene pool may get filtered out.
The prenatal genetic tests can identify known genetic disorders, particularly if the parents are known to be carriers of such defects. Such tests can help the parents make a choice whether they would like to continue or abort the foetus. In any case, most genetic defects lead to spontaneous abortions. While there may be issues of ethical nature – by doing this are we not weeding out a possible Steven Hawkins or a Homer – the problem becomes far more serious when we look at the way genetic diagnostics is being talked of today.
Genetic diagnostics is now being offered as a solution not for known genetic abnormalities but also for what are seen as statistical risks. These statistical risks are again not related to any known cause and effect mechanisms but a view of genetics in which disease and human behaviour are seen to be largely governed by genes. This brings us back to the old debate that a genetic disposition is only one of the factors in disease and environment which determines whether the predisposition is converted to an actual disease or not. Further, disease is rarely traceable to a single gene: quite often it is a complex of genes and a combination of environmental factors that determine what actually happens. If we try and screen out genetic factors by such crude genetic theories, the result would not be very different than that of finding criminals by looking at their skull type, the favourite of phrenologists of the late 19th and early 20th centuries.
A NEW EUGENIC PROGRAMME?
The danger of all this lies in the simple fact that having invested in this sunrise area of biotechnology, capital is desperately looking for paybacks. Just addressing a small percentage of cases of infertility or genetic abnormalities will not produce large returns. If a mass market is to be developed, mass screening of the population is required. This biotech lobby is joined by the insurance lobby that believes that all statistical correlation with disease should lead to aborting the foetus so that they have to pay out a lot less for medical treatment of the persons insured. They can then use the refusal of screening as a basis for refusing insurance. All this is driving genetic testing in a direction that would fit into a eugenic framework, a framework that was never rejected intellectually by many in the west. It became illegitimate only after Hitler’s genocidal ethnic cleansing of “inferior” races.
The problem with weeding out such variations leaves out the reason why such variation exists in the first place. Quite often, the additional burden of such variation arises from some other evolutionary advantage that exists. If we weed out some of these variations, we may also take out some advantages that this variation gives us. The less the variation in the gene pool, more vulnerable is the population in case there are large-scale environmental changes.
The brave new world of genetically designed future may still be some distance away, but the threat of its insidious arrival through selective abortion and consequent reducing heterogeneity of the gene pool still remains. The heart of this is the belief that all human characteristics are genetically determined –– from disease to obesity. If we press the right buttons and take out these genes, the human population would be better off: this is the new eugenics program. It is time that society wakes up to what is on offer and takes a reasoned stand on this. With large parts of today’s scientific community getting co-opted into this new genetic wisdom and with billions of dollars in profits from their patents, the scientific community cannot be the sole arbiter of such decisions.
There is an urgent need for an informed public debate on the pros and cons of techniques that biotech companies are seeking to market. We need to separate the good from the bad in biotechnology so that good science can proceed and the bad science, like bad money, does not drive out the good from circulation. We therefore also require a strong regulatory framework to address the scope of such techniques and to address the issues of risks and ethics. In India the risks are even more. India could become the happy hunting ground of dangerous clinical trials for this new technology with its people being offered as guinea pigs.
Last Updated ( Friday, 13 July 2007 )
Prabir Purkayastha
25 June, 2006
AFTER the reading of the human genome, there are daily advances that research on genetics is reporting: from chimpanzee-human differences to a new world free of disabilities, superior intelligence and human happiness, all implanted into our genes. The hype of genetic technology and its promise of course is very much a marketing drive of global multi-nationals investing billions of dollars in genetic research: they are more solutions in search of problems rather problems that were awaiting a solution.
First the good news. Human beings are much closer to chimpanzees than we thought earlier. A new genetic study in Nature has shown that the pictures showing George Bush making faces and in postures very similar to chimpanzees (www.bushorchimp.com) is not merely fortuitous but a clear result of our genetic affinity to our closest cousins, the chimps. As an aside, these pictures recently appeared in a Belgian official police manual showing the importance of body language in reading of humans, much to the anger of the US administration and embarrassment of the Belgian government. The study in Nature (put on-line by Nature but not yet published) titled “Genetic evidence for complex speciation of humans and chimpanzees” by Patterson et al, shows that the split of human population from the chimpanzee one was of a longer duration than thought earlier, with the split becoming complete only about 5.4 to 6.3 million years ago. This not only reduces the time of the split from about 7 million years ago as thought earlier, but also shows that there were considerable gene flows (mating) between the two sets of populations for about a million years.
COMPLEX TREE OF EVOLUTION
Why is this so startling? Previously, it was believed that the split between two sets of populations tend to be sharp and the hybrid population generally tends to be sterile. The above study shows that this is not really the case and for quite some time, at least for the proto human and proto chimpanzee population, this did not hold true. The basis of these conclusions is also interesting. The team calculated the genetic distance of various sites on the two populations and found that the X chromosome had the smallest distance or the most similarity, consistent with the hypothesis that the two populations mated with each other even after starting to separate. Any two species that mate would be expected to have similar X chromosomes as long as hybridisation continued. A messy divorce rather than a clean break!
The other impact of this chimp human split is that it spoils the party for those that believe that there is a uni-linear model of development in which the human population evolved from the lower apes and we are at the top of the evolutionary tree. There is a hominid population which pre dates this break showing that the current branch split later from the chimpanzee family than some of the other hominid branches. The tree of evolution is considerably more complex than a simple model in which nature worked over billions of years to produce us as the apex of evolution. That we are more successful is incidental: nature had no specific plans for us as different for what it had for chimpanzees or any other species.
While the genetic research has much to say about the past, the big bucks are in the future and not in finding out about migration patterns and chimpanzee. While genetic tools are indeed powerful, laying bare the genome of humans to mice (as also plants), the promise of immediate technology is not proving as fruitful. We will not look at agriculture and genetically modified organisms in this article but look at the new genetic technology in terms of what it holds for the immediate future of the human species.
UNNECESSARY HYPE
The common fallacy in the world of science is that any great scientific advance must immediately yield substantial dividend in terms of utilisable technologies. It is this utilitarian model of science (and also technology) that governs much of the debate on funding as well as the hype regarding science. It is this same hype which convinced the world that since we know E = MC2, we must also be able to utilise this knowledge either through nuclear fission or fusion to give us inexhaustible source of energy. This was the basis of predictions of eminent scientists that by the end of 20th century, there will be no need to metre energy, as it will become virtually free. I am afraid this is the same hype that biotechnology is seeing today.
The ability to read the genetic code and being able to modify it are two different things. Genetic engineering promises to rectify defects in the genetic code by inserting a healthy gene, therefore the concept of gene therapy. While it is possible some day this might become feasible, it is clear that this cannot be done with existing technologies in the near future. All the techniques we have today, take a shotgun approach in which the healthy gene is virtually sprayed into the patient’s cell nucleus (using generally therapeutic DNA combined with a virus as a vector) and this attaches to various different sites than the gene’s actual position. In the only on-going trials for gene therapy thought to be successful, out of the original 10 children suffering from SCID (severe combined immune deficiency) of whom 9 had been cured, 4 have now developed leukaemia. SCID leads to children being born with no immune system forcing such children to live in sterile “bubbles”. While it may be argued that leukaemia and living in a normal environment is preferable to living within a sterile bubble, that leukaemia has resulted on such a large scale indicates the limited utility of current methods of gene therapy. The studies with laboratory mice also show similar high incidence of cancer in those undergoing gene “therapy”.
ISSUES OF RISK AND ETHICS
It is clear that the current gene therapies have seen limited success. But that is not the only issue in gene therapy. New issues are risk and also new ethical concerns. Risks arise in gene therapies, as we have no data from the past for such experiments and the persistence of such agents through the patient’s offsprings. Gene replacement can lead to modifications in what are called germ-line cells – sperm cells or ova – and therefore once inserted represents a long-term risk. As viruses are used as vectors, they also introduce additional risks of their own. The other issue is the ethical one whether we can make modifications for future generations who have not given their consent. Any modifications that are passed on to future generations involve this new ethical issue that we have not addressed in the past. The good thing is that we have some time here still as we have yet to find effective tools for gene transfer without the problems described above. Designer babies bred to outperform the rest and the rich growing more and more distant from such directed evolution is still the stuff of science fiction or media hype. But if we are able to bring about such gene transfers in which we can bind the healthy gene to the specific site where the defective gene lies, then we will have to address the above issues of risk and ethics.
The more immediate issue is one of genetic screening of foetuses – prenatal genetic diagnosis. This is not very dissimilar from issues that already exist: when there is prejudice against the girl child, ultrasonography leads to large-scale abortion of the girl child and sharp distortion in sex ratios. The genetic tests on foetus would not only lead to worsening of the sex ratios as genetic tests are even more conclusive than ultrasound methods, but a whole host of variations in the human gene pool may get filtered out.
The prenatal genetic tests can identify known genetic disorders, particularly if the parents are known to be carriers of such defects. Such tests can help the parents make a choice whether they would like to continue or abort the foetus. In any case, most genetic defects lead to spontaneous abortions. While there may be issues of ethical nature – by doing this are we not weeding out a possible Steven Hawkins or a Homer – the problem becomes far more serious when we look at the way genetic diagnostics is being talked of today.
Genetic diagnostics is now being offered as a solution not for known genetic abnormalities but also for what are seen as statistical risks. These statistical risks are again not related to any known cause and effect mechanisms but a view of genetics in which disease and human behaviour are seen to be largely governed by genes. This brings us back to the old debate that a genetic disposition is only one of the factors in disease and environment which determines whether the predisposition is converted to an actual disease or not. Further, disease is rarely traceable to a single gene: quite often it is a complex of genes and a combination of environmental factors that determine what actually happens. If we try and screen out genetic factors by such crude genetic theories, the result would not be very different than that of finding criminals by looking at their skull type, the favourite of phrenologists of the late 19th and early 20th centuries.
A NEW EUGENIC PROGRAMME?
The danger of all this lies in the simple fact that having invested in this sunrise area of biotechnology, capital is desperately looking for paybacks. Just addressing a small percentage of cases of infertility or genetic abnormalities will not produce large returns. If a mass market is to be developed, mass screening of the population is required. This biotech lobby is joined by the insurance lobby that believes that all statistical correlation with disease should lead to aborting the foetus so that they have to pay out a lot less for medical treatment of the persons insured. They can then use the refusal of screening as a basis for refusing insurance. All this is driving genetic testing in a direction that would fit into a eugenic framework, a framework that was never rejected intellectually by many in the west. It became illegitimate only after Hitler’s genocidal ethnic cleansing of “inferior” races.
The problem with weeding out such variations leaves out the reason why such variation exists in the first place. Quite often, the additional burden of such variation arises from some other evolutionary advantage that exists. If we weed out some of these variations, we may also take out some advantages that this variation gives us. The less the variation in the gene pool, more vulnerable is the population in case there are large-scale environmental changes.
The brave new world of genetically designed future may still be some distance away, but the threat of its insidious arrival through selective abortion and consequent reducing heterogeneity of the gene pool still remains. The heart of this is the belief that all human characteristics are genetically determined –– from disease to obesity. If we press the right buttons and take out these genes, the human population would be better off: this is the new eugenics program. It is time that society wakes up to what is on offer and takes a reasoned stand on this. With large parts of today’s scientific community getting co-opted into this new genetic wisdom and with billions of dollars in profits from their patents, the scientific community cannot be the sole arbiter of such decisions.
There is an urgent need for an informed public debate on the pros and cons of techniques that biotech companies are seeking to market. We need to separate the good from the bad in biotechnology so that good science can proceed and the bad science, like bad money, does not drive out the good from circulation. We therefore also require a strong regulatory framework to address the scope of such techniques and to address the issues of risks and ethics. In India the risks are even more. India could become the happy hunting ground of dangerous clinical trials for this new technology with its people being offered as guinea pigs.
Last Updated ( Friday, 13 July 2007 )
Wednesday 30 July 2008
For Sale
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Commentaries
Physicians for Sale: How Medical Professional Organizations Exploit Their Members
Lawrence Grouse, MD, PhD
Medscape J Med. 2008;10(7):169. ©2008 Medscape
Posted 07/21/2008
Introduction
Scenario 1: You are a medical specialist -- say a pulmonologist -- walking to the intensive care unit to see one of your patients, and you pass a roomful of your colleagues in the hospital auditorium crowding around tables piled with food and drink. Outside in the hall you see a sign on a stand that says, "MEGA Pharma welcomes the attending staff to a Pizza and Pasta Lunch brought to you by GALE FORCE, the new fixed-combination medication for asthma and COPD!" An attractive young woman stands in front of you, asks you to join the luncheon, and hands you a flyer with the program for the talk that will be given.
"Free CME," it says. The other pulmonologist at the hospital is giving a talk that is based on a study in which he had been an investigator. The talk is "The Use of a New, Improved Fixed-Combination Medication as First-Line Therapy for COPD."
Scenario 2: You are attending the annual lung society convention in San Francisco, California, and the conventioneers are walking around with convention bags, pens, programs, inhalers, packages, and even neckties emblazoned with pharmaceutical product names and logos. You notice that these same names and logos are on the placards and signs in rooms and hallways, in the programs, and even on the convention buses.
Prior to the convention, you received letters and postcards for the nightly gala dinners and CME symposia sponsored by pharmaceutical companies with the best-known pulmonology experts as speakers. You notice that there are 3 speakers at each symposium; two of the speakers are giving interesting scientific talks, and one is giving the talk "The Use of a New, Improved Fixed-Combination Medication as First-Line Therapy for COPD." The lung society is providing CME accreditation. You find that many of your clinical colleagues from other countries have been given "grants" from pharmaceutical and other commercial medical and device companies (referred to in this essay as Pharma) to attend the meeting as "consultants."
Scenario 3: A Pharma representative buttonholes you as you enter your office and hands you a free copy of the latest single-sponsored practice guideline from the lung society, and with it an ad slick for GALE FORCE along with free drug samples, peak flow meters, and pens with the GALE FORCE colors and logo. She hands you 3 published, state-of-the-art, randomized controlled trials from the lung society journal written by the top experts in the field and funded by the makers of GALE FORCE that explicitly state the point of view that GALE FORCE is a better choice than the 3 drugs that you currently prescribe.
When I find myself in such ethically questionable situations as those portrayed above, it is natural to wonder what led to their occurrence. A common response to the problems with the US healthcare system is to blame Pharma and their excessive marketing zeal. Several authors have written their perspectives about the events and policies that have crippled US medicine during the past several decades.[1-8] They discuss cutthroat competition within medical coverage providers, the ascension of medicine as a business, predatory marketing practices by Pharma, and the effects of inhumane government policies in damaging US healthcare. Their descriptions of the effects of "corporate medicine" and the inappropriate commercialization of medical practice provide a chilling perspective on some of the problems.
However, except for Dr. Kassirer's article,[9] these works have not emphasized the damaging role of medical professional organizations (MPOs) and their leaders on US healthcare. I believe that it is in large part the dependence of these organizations on Pharma funding that has led them to compromise their professional ethics. Although this influence is also exercised by medical device, biotech, publishing, and diagnostics companies, for simplicity I will include all of these medical commercial organizations in aggregate as "Pharma" because they act in similar ways on MPOs, and the giant multinational pharmaceutical companies wield the greatest influence.
Pharma operates in the realm of business and in accordance with national laws. They are conducting legal businesses regulated by business ethics, whereas physicians and their MPOs are bound by medical ethics. When physicians violate these principles of medical ethics, they lose their professional identity and authority. Although I do not wish to ignore the positive medical and scientific activities of MPOs, in this commentary I lay much of the blame for unduly expensive and inappropriate medical care in the United States at the doors of MPOs. As the above scenarios imply, practicing physicians are constantly bombarded by MPO-abetted promotion from Pharma.
This thesis concerns only those MPOs in which inappropriate Pharma influence can be documented or inferred. In my experience, these tend to be the MPOs that serve the higher-income specialty organizations and are active in governmental lobbying. Their members are prescribers of specific pharmaceutical products relevant to the Pharma that support them. Some MPOs in the United States are not very dependent on Pharma support. Most are, as judged by the listings of the categories of their revenue. I suggest that the largely hidden relationship between MPOs and Pharma enhances the ability of MPOs to promote their specialties' services inappropriately, and it fosters the excessive prescription of expensive, highly-promoted medications. These results would be important factors in the spiraling costs of US healthcare.
--------------------------------------------------------------------------------
Reader Comments on: Physicians for Sale: How Medical Professional Organizations Exploit Their Members
See reader comments on this article and provide your own.
Readers are encouraged to respond to the author at lgrouse@u.washington.edu or to George Lundberg, MD, Editor in Chief of The Medscape Journal of Medicine, for the editor's eyes only or for possible publication as an actual Letter in the Medscape Journal via email: glundberg@medscape.net
Who and What Are for Sale?
The MPOs that have become so dependent on Pharma funding that these funders exert control over MPO policies and cause them to violate precepts of medical ethics;
The MPOs that are fundamentally trade organizations and use their resources to inappropriately increase their specialties' financial status with little regard for the welfare of patients or the public health;
The MPOs (and their foundations) that receive advertising, grants, convention and meeting support, project support, payments in kind for MPO support, and other tangible benefits from Pharma in which the funding from Pharma represents a substantial percentage of their earnings;
The MPOs whose actions violate medical ethics to benefit their Pharma funders and their own members;
The MPO leaders to whom I refer as key opinion leaders (KOLs) who control the policies of their MPOs for their own benefit and the benefit of their Pharma funders;
The KOLs who profit from projects, prestige, honoraria, and connections with Pharma, and reap perquisites, prestige, and influence from the MPOs;
KOLs whose yearly total of Pharma funding represents a substantial percentage of their earnings as practicing physicians or physician educators; and
All physicians whose actions violate medical ethics to benefit their Pharma funders and to generate payments for themselves.
MPOs in the United States
The most relevant history of the dealings of MPOs with Pharma in the United States began in 1905 when the American Medical Association (AMA) urged physicians not to prescribe drugs that were advertised directly to consumers by Pharma, which in those days took the form of smaller patent medicine-formulating companies. Preventing these communications by Pharma put power in the hands of the AMA. The AMA established a Council on Pharmacy and Chemistry that played a similar role to that of the US Food and Drug Administration (FDA) today with respect to drugs. The AMA Council would not approve any drug that was directly advertised to the public. This regulatory authority enabled the AMA to stand between Pharma and their customers.
Revenues for AMA journal advertisements rapidly became the principal source of funds for the Association. The relationship of AMA and Pharma paved the way for the current economic structure of medical professional organizations in the United States.[10] What has changed in recent times is that with the rise of specialty MPOs and the collapse of power of the AMA, the control of professional communication to patients in the United States is predominantly wielded by the specialty MPOs rather than the AMA. The MPOs have simply replicated the initial AMA strategy.
What Do MPOs Do?
Most MPOs in the United States have followed the pattern of the AMA in that they operate as trade organizations, advocating for the financial benefit of the organization and its members. The MPOs' major roles, which they do not emphasize publicly, appear to be fund-raising, lobbying for their specialty, and applying political influence on healthcare payers and providers. Although they publicly emphasize their role in postgraduate education and publishing, I believe that these activities are undertaken in large part to generate funds from Pharma.
Who Are the Specialists, and How Many of Them Are in the United States?
Prior to 1950, about 75% of physicians in the United States were general practitioners (GPs) and did not consider themselves to be specialists; that is, they took a year of internship after medical school and then began to practice general medicine.
In contrast, today almost all physicians in the United States consider themselves specialists, even those in primary care practices. Only about 13% of US physicians are GPs or family doctors.[2,11] Today, after their medical school graduation, almost all physicians take a residency training program in a specialty and sometimes further fellowship training for subspecialty education.
There are approximately 850,000 physicians in the United States; there are about 550,000 physicians who practice what used to be considered specialist care. Most of the rest, such as family physicians, pediatricians, and general internists, practice primary care and are generalists, but many consider themselves specialists as well to help market their practices.
There are very few GPs in the United States; they were driven out of business by specialists in the 1960s, and to defend their practices they restructured themselves as specialists in family practice. These family physicians now have a 3-year residency and consider themselves specialists, as do many pediatricians and general internists. Thus they are specialists in general medicine, a somewhat paradoxical designation. It would be economic suicide not to be a specialist in the United States. Medicine in the United States is an entrepreneurial activity and not a part of an organized healthcare system, and without a specialty a physician cannot easily participate in the marketing and marketplace of medicine.
Although specialty certification is usually awarded by specialty medical boards that are separate from the MPOs, most physicians join the MPO for their practice specialty. These MPOs become the focus of their postgraduate education and their advocates on behalf of the specialty. They become the key groups to provide professional identity for each specialty.
One of the most lucrative powers that the US MPOs have achieved for their members is the ability of patients in the United States to consult directly with a specialist rather than going through a primary care "gatekeeper." Most countries strictly limit access to expensive specialist care, and they limit the number of specialists that are allowed to be trained and practice. The privileged position of specialists in the United States greatly increases their revenue, and it increases the number of physicians who become specialists and subspecialists. It also dramatically increases healthcare costs.[10] This situation has led to confusion about the differences described above between primary care, generalist care, and specialty care in the United States.
It is apparent that the terms generalist and specialist are not used in a consistent way in the United States. However, for the purposes of this essay, it is not important what these groups call themselves; what is of interest is how their MPOs interact with Pharma and influence US healthcare costs. Although my focus in this commentary is on the United States, I point out similarities in the relationship of Pharma with MPOs internationally.
How Much Money Do MPOs Receive From Pharma?
In the entrepreneurial US healthcare marketplace, the MPOs' power derives from their symbiotic relationship with Pharma. Without Pharma funding, the MPOs would be unable to support their advocacy and institutional costs. With Pharma funding they can influence the healthcare system and their own members, and establish a favored financial reimbursement status, but in the bargain I believe that they also become the tools of Pharma. It is my contention that with the power of the purse, Pharma exerts subtle control on the communications of the MPOs and the practice of their specialists.
Pharma control limits consideration of practice approaches apart from expensive drug therapy. Pharma control of the KOLs of the specialty further increases its influence on MPOs. This control minimizes the use of prevention and public health measures in medical practice, except for those that rely on pharmaceuticals. I elaborate on my reasons for believing this.
Pharma provides an enormous amount of funding for MPOs, and as a result they have considerable input into the policy and educational programs of these organizations. A large percentage of Pharma marketing budgets is specifically allocated for MPOs whose members are the prescribers of their products. It is understandable that they would advertise to their likely customers, but it is significant that they do not target all of their advertising to the physicians directly. MPOs have considerable control of Pharma communications to their members, just as the AMA had more than 100 years ago. Pharma must support the MPOs to influence their members.
If you review the financial statements that are publicly available from the AMA and other MPOs, you will find that the reporting of revenue is particularly vague. When you calculate the amount derived from membership fees, you will find that it usually only accounts for about 15% to 25% of the MPO's revenues. Much larger are the revenues from journal advertising, the national conventions, grants for educational projects, and grants to the associations' foundations, which theoretically are independent, nonprofit charitable organizations. All too often, the only charity that is benefited is the specialty itself.
Specific sources of these revenues are not revealed by the MPOs, nor are they supplied when requested, but in informal discussions during meetings with leaders of MPOs, you will learn that Pharma is the real source of most of the MPOs' revenue. The same conclusion can be reached by an analysis of the major categories of revenue and the likely funders of these activities. Some MPOs, such as those of public health physicians, do not receive much Pharma revenue because few of their members are high prescribers of drugs.
In the spirit of disclosure, and to cite the experience on which my current thinking is based, please note that I have worked closely with the executive directors, directors of education, and scientific directors of many MPOs both in the United States and internationally for more than 30 years. During that time, I did fundraising for US National Heart, Lung, and Blood Institute (NHLBI) projects with US Pharma companies and did fundraising with international Pharma companies for nonprofit organizations founded by the NHLBI and the World Health Organization (WHO). The perspectives expressed here concerning the relationship of MPOs and Pharma both in the United States and globally came from these activities.
It became clear to me that the MPO leaders' major day-to-day efforts were related to their contacts, projects, meetings, and fundraising with Pharma, and to politics relating to finance; they spent very little time on member activities. I had learned over the years that when I attended medical conventions of MPOs, if I sat in the entry area of the main convention hotel, I would soon see key people at the meeting from the MPO and from Pharma come through the door separately and leave together. As I attended conventions of our collaborating organizations and watched in the hotel lobbies, I observed the parade of meetings between delegations of the MPOs' top leaders with marketers and decision makers of the Pharma companies that marketed their drugs to the specialty.
The practicing physician members of the MPO were off in the convention centers attending scientific lectures that would expand the medicines, procedures, and costs of their practices and wandering through the exhibit halls collecting free presents and drug promotion at the Pharma booths, whereas the specialty society leaders were meeting in plush Pharma hospitality suites to trade the loyalty of their members for Pharma money.
Because MPOs conceal the sources of their funding, in many cases I can only use the information, behavior, and activities of MPOs that can be publicly inspected to assess their dependence on Pharma. On the basis of my personal observations of MPO activities and policies as well as information gathered from many of the major US MPOs, most of those I have studied appear to receive the majority of their funds from Pharma.
Follow the Money
Using the established journalistic procedure of following the money that MPOs receive, we can learn about the dependency and control that run through the Pharma/MPO relationship. As I mentioned, MPOs do not provide any detailed public financial statements that document the specifics of Pharma support, nor can I obtain them upon request. Even the filings for the Internal Revenue Service (IRS) that can be obtained publicly only contain general descriptions of revenue sources, and even members of the specialty organizations are given the runaround if they inquire about such specifics. They are told that such information is confidential.
As an example, a typical subspecialty MPO of about 13,500 members might report yearly revenue of about $18 million.[12] Let's take a look at how the lion's share of that funding travels from Pharma to the MPO.
The annual meeting of such an MPO would be its biggest funding source at about $8.5 million, and judging from the extensive commercial presence, the vast majority of that revenue would come from Pharma. Meeting registration and educational session fees would account for about $0.8 million, but of the approximately 14,000 people who would attend the MPO's annual meeting, only about 6000 would be practicing specialists. The rest would be Pharma industry attendees and their vendors, so most of this registration revenue would also be from industry. In addition, Pharma might pay about $2 million in "nonconference" grants for after-hours activities at the annual conference.
An undisclosed way of funneling Pharma money to MPOs in Europe and Asia is the common practice of Pharma paying for specialists to attend their MPO's annual meeting. A pharmaceutical company pays the physicians who, in turn, pay the MPO meeting registration and expenses. A leading physician marketer from an international company recently told me he estimates that 80% of the attendees are funded in some way by Pharma at many MPO meetings. In the United States, Pharma no longer pays physicians to attend CME conferences; however, it is unknown how many physicians from outside the United States are paid to attend, and the percentage of non-US attendees at medical conferences has grown greatly over the past 2 decades.
Other ways that Pharma funds MPOs include nondisclosed grants-in-aid, project grants, funding for educational programs, directed donations to the specialty organization's foundation, and payments in kind, such as convention and professional services and payments to physician attendees and consultants.
Most MPOs publish 1 or more journals. Pharma ads in the organization's journals might account for about $2 million a year in a typical MPO, and many also receive about $0.5 million in royalty payments from commercial sources, usually Pharma.
The revenue from membership fees for this typical MPO would only be about $2.5 million. We can see from the estimates above that about $12-$14 million of the $18 million of such a typical MPO's revenue could come from Pharma. Although these payments to the MPOs are essential for their survival, they are small change for Pharma budgets. Most big international Pharma have revenues of $4-$8 billion, of which about half comes from the United States.
So a typical specialty MPO could receive $14 million a year from Pharma out of a total of $18 million total revenue: almost 80% of the revenue, not an insignificant contribution. This level of Pharma revenue would qualify an MPO as a "physicians for sale" organization. In practical terms, Pharma is their exclusive customer. Do you think Pharma wants anything in return? In colonial times Benjamin Franklin wrote, "Never make your physician your heir!" A contemporary Franklin might write, "Never let Pharma finance your physician!" A consequence of this massive conflict of interest that involves physicians and MPOs, leading to their dependency on Pharma funding, will be the destruction of the credibility of the medical profession.
Although specialty societies appropriate the largest share of Pharma funding, the AMA is also in the market for Pharma funding. Even though their membership has fallen to a small percentage of US physicians, the AMA still has annual revenues of about $280 million a year. According to Dr. George Lundberg, "the AMA has too much money and too little purpose.[13]"
To bolster its finances, the AMA has pioneered a new source of Pharma revenue. A review of the AMA's financial statement shows that the AMA's new funding source is licensing its AMA Physician Masterfile, which contains information about virtually all US physicians, to Pharma. This revenue is even larger than the revenue from Pharma ads in their journals that historically have been its major revenue source.
With today's new information technology, the AMA Masterfile is very valuable. Medical information services, such as Integrated Medical Services (IMS) (operating revenue in 1995, $1.75 billion[13]), which track the prescriptions written in the United States and in most other countries worldwide, are able to match physician data and demographics with prescriptions tracked to individual regions and drug stores. In many cases their data can provide Pharma representatives with information about what drugs are and are not prescribed by individual physicians throughout the United States. These data allow drug detail representatives to provide negative information about competitors to specific physicians to promote their own products, knowing exactly what these physicians currently prescribe, and it allows them to punish and reward physicians for their prescribing decisions. More than a dozen states are considering laws to shield physicians' prescription pads from Pharma.[14]
This exploitation by MPOs of their members is really just a variation of the AMA's initial policy in 1905 concerning Pharma communications with their members. However, rather than having the MPO be a conduit of authorized information from Pharma, the current program of selling physician contact information appears to have aspects of a conspiracy of MPOs with Pharma to allow them to unwittingly influence physicians -- including their own members. There are suggestions that other MPOs are now imitating AMA's creative funding program by selling their members' and former members' personal information to Pharma so that they can be more effectively detailed. Physicians in all specialties should be asking their MPOs whether they are selling their members' information.
Consequences of Pharma Influence on MPOs
One has only to attend an MPO's convention or read an MPO's journal to see the powerful impact of Pharma funding. The MPOs endorse Pharma educational products; they put their society logos on communications alongside Pharma logos; and they place banners and signs thanking Pharma for matters large and small throughout their convention halls and journals. They encourage their members to visit the exhibit area where Pharma promotes commercial products. Exhibit areas are better than an amusement park: They have high-tech, luxurious booths with films, magicians, and game shows as well as free food, drink, and presents for the physicians and florid promotions of the drugs.
MPOs cover Pharma products and initiatives in their publications, publish Pharma drug studies in their journals, and recommend Pharma products in their practice guidelines. Coverage of public health issues and alternative approaches to healthcare is rarely seen.
The need to serve Pharma is an important source of the antipathy of practicing clinicians toward physicians working in public health, and toward other healthcare professionals -- such as chiropractors, acupuncturists, and other alternative healthcare givers. For example, while scanning a program for the American College of Cardiology's annual scientific session,[15] I found a prominent listing of more than 350 Pharma and other medical companies that would be exhibiting at the convention. In the list of more than 250 scientific sessions that are enumerated, there were:
No sessions whose title indicates any coverage of public health issues of cardiology;
No session that appeared to cover other healthcare professionals or alternative healthcare givers' role in cardiology;
No sessions on cost issues or socioeconomic or epidemiologic issues in delivering cardiology care;
No sessions on lack of access or minority issues in cardiology care; and
Only 2 sessions on prevention of cardiovascular disease.
Because most cardiovascular disease in the United States is the result of preventable problems (poor diet, lack of exercise, lack of screening for and treatment of risk factors) that may be best addressed using public health approaches on a population basis, isn't it surprising that these topics receive such limited coverage at a cardiology convention?
It goes without saying that most of the talks listed in the program are about the use of pills, devices, and procedures to diagnose and treat heart disease. It is almost as if the MPO was employed by Pharma to encourage physicians to prescribe pills, devices, and procedures. Preventing illness, providing fair and universal care, and caring about the patient do not appear in the program. It is difficult to identify the commitment of the major MPOs to US public health except for lip service and public relations efforts. It seems to me that most of them follow the long tradition of the AMA in securing the welfare of their members and lining their own pockets.
Pharma Control of Postgraduate Education
Pharma, through its funding, has assumed extensive control of postgraduate physician medical education (aka continuing medical education [CME]) in the United States. It would be of interest to see whether the education that they provide results in improved and appropriate patient management. Recent data indicate that appropriate treatment for patients is given in only 50% of physician visits. In fact, longer clinical experience, and hence more postgraduate education, are correlated with inferior quality of care.[16] By this measure the value of current forms of postgraduate education must be questioned.
At many MPO conventions and in many CME activities put on by medical education companies hired by Pharma, the programs include promotional material about the sponsor's products. In the United States more than 30,000 people are employed in the Pharma-funded CME industry.[17] Until recently, they were reputedly crafting drug promotion disguised as education that focused on the advantages of the sponsor's product and minimizing discussion of dangerous side effects.[18] The US Senate Committee on Finance recently wrote to the organization -- Accreditation Council for Continuing Medical Education (ACCME) -- that supervises US postgraduate education to express its concern about the conflict of interest when Pharma spends more than $1 billion a year for education about topics that highlight the use of their products. Who pays the piper calls the tune, they imply. ACCME replied that their policies and procedures for developing educational materials are sufficient for ensuring their objectivity. However, the Senate Committee pointed out that although ACCME surveyors review accredited organizations' procedures for ensuring the independence of certified CME, they do not analyze the actual content that is presented.[19]
I've observed hundreds of CME-certified presentations sponsored by Pharma during my professional career, and in those content areas that I knew well enough to judge, it was clear to me that in the vast majority of instances, a bias was introduced in the communications in favor of the product produced by the sponsor of the CME. In some cases it was not so much that the information presented was false, but that the fair balance and clinical perspective that should have been present were predictably distorted by the proprietary interest. ACCME has recently introduced new procedures designed to eliminate some of the conflict of interest that has occurred in many CME activities. It may improve the education that is provided if it is implemented. However, if there is no mechanism to analyze the resulting content of the medical education activities, the Pharma-funded medical educators who actually conduct the activities have many opportunities to introduce undetected Pharma promotion.
Because of the increasing visibility of these problems with Pharma-funded medical education, the US Institute of Medicine and the Association of American Medical Colleges (AAMC) are conducting inquiries into conflicts of interest in medical education. Because of the increased vigilance of regulatory agencies, such as the FDA and the US Department of Health & Human Services (HHS), millions of dollars in fines and penalties have already been imposed on Pharma, and many of the most egregious activities have now been stopped. In Europe, laws enacted in France and Italy are similarly limiting Pharma promotion in medical education.
Acquiring the KOLs
The close relationship of Pharma with the MPO leads to close relationships with the MPO's leaders. These physician leaders are very important to Pharma, and they are recruited as lecturers on the Pharma speakers' bureaus, investigators for their clinical trials, consultants on their advisory boards, and experts for their medical education symposia. These leaders are referred to by Pharma as KOLs -- key opinion leaders -- and I have used this term as well. It is important for Pharma that the cooperation of KOLs is acquired. Their activities with Pharma provide the MPO leaders with substantial revenue and prestige. These activities provide Pharma with access to the decisions of the MPO. Some of these physician leaders, who are generally academics, are soon making more money from Pharma than from their academic day jobs and easily qualify as "physicians for sale." The lucrative Pharma advisory groups, lectures, research grants, symposia, and other payoffs for the MPO's physician officers encourage their cooperation. They begin to work for Pharma, perhaps without realizing it. Full disclosures of such payments to KOLs are rare.
This issue of Pharma influence on the KOLs goes well beyond revealing that these leaders may receive a lot of money from companies for their services and advocacy. The KOLs, through their leadership positions, also participate in the control of the MPOs and their pro-Pharma policies. The MPOs may have the appearance of being democratic, but in most instances the membership is simply given a choice of electing various KOLs who have already been acquired by Pharma to be their representatives. The membership gets little meaningful information about the beliefs, activities, or conflicts of interest of the candidates. For most MPOs the succession of presidents of the organization is decided years in advance. The decisions of the MPOs are made by small executive boards; they are made in secret; there is no free medical press to critique or question their decisions. The MPO house organs trumpet the wise decisions of the board and their benefits to membership. The ethical problems with the activities of the organization are not often discussed. MPO management usually lacks the quality of transparency that is a keystone of good governance.
As a result of the conflicts of interest on the part of the MPOs and their leaders, there have been increasingly vigorous demands by government and by critics of MPOs for disclaimers of payments they receive from proprietary interests. However, the usual disclaimers filed by KOLs, even those disclaimers required by the WHO, provide little information. They simply note the companies that have provided payments and not the specific amounts or services provided. A typical specialist leader will have payments from 5-10 Pharma companies in a given year, with no way for the public to know if they received $5 or $50,000. In addition, very little is known about the nature of the arrangements that led to the payments. Further, because MPOs refuse to provide information about their revenue sources, it is even more difficult to identify specific conflicts of interest.
Pharma involves KOLs in leading clinical trials of medications that are required for FDA approval, and they provide premiere showcasing of the KOLs' educational skills before their peers in symposia organized by Pharma. As a result, the KOLs become recognized as experts if they were not already so recognized. They become the peer reviewers of important articles in their specialty in the peer-reviewed medical literature in which their Pharma-created biases can prevent publication of results or ideas that are opposed to their proprietary interests.
Equally destructive is the fact the KOLs are chosen to be consultants to governments. They serve on FDA and European Medicines Agency (EMEA) advisory panels to give advice on which drugs should be licensed and which rejected. They serve on National Institutes of Health (NIH) advisory panels to review grant applications. With this power, the KOLs can influence the entire direction of new research -- competing ideas, directions, and the products that will or will not be used. These obvious conflicts of interest are finally beginning to be discovered. Experts are now often required to file disclosures about payments that they receive that could represent conflicts of interest. However, in most instances, these experts' opinions are still accepted regardless of their conflicts of interest. They should not be.
Implications of KOL Acquisition for Peer Review
The pervasive funding system that Pharma has established for the KOLs, and which is now coming into wider view, has other important implications for the peer review system that is at the heart of the NIH basic and clinical research enterprise as well as the medical literature. The thesis has always been that science is self-correcting; if an unethical researcher fakes data then there would be other, more ethical researchers who would do the experiment correctly and right the wrong. However, what if the key researchers in a particular area are on the payroll of the companies that have a vested interest in a certain result? What if the companies designed the studies to get the result they wanted and only the studies funded by the companies and managed by their KOLs would ever be conducted? What if the experts who do the peer review of the studies for the medical journals are KOLs for the companies that funded the studies? Why does it seem to happen so often that all of the published studies funded by company A show that the products of company A are better than those of company B, whereas those of company B show the reverse? I believe that the peer review system, before which US scientists genuflect, often fails.
The interpretation of medical research is by no means straightforward and uncontroversial. Different groups of respected scientists study the same question and get diametrically opposed results all of the time. Study exclusion criteria and other technical features of studies can affect their general applicability. Studies of a therapy that are conducted in clinical research facilities staffed with experienced investigators and staff may not give the same results as those seen in a busy primary care setting. Also, if the arbiters of these studies -- the expert peer reviewers -- have conflicts of interest in judging the results, how can we be sure what to believe? The situation can easily develop in which large randomized controlled trials can show significant benefits of drug therapy, whereas the use of the drug in actual clinical practice will introduce large costs but no benefit for patients. Improvement that results from therapy in surrogate clinical variables, such as glycemic control, may not result in improvements in mortality or public health benefit (as data concerning rosiglitazone have suggested[22]).
Do MPOs Benefit the Public Health?
As I saw the effectiveness of global public health approaches to deal with major diseases in work that I did with WHO and NHLBI, and then when I compared them with the US medical model, which involves providers treating individual patients, I often wondered whether the MPOs that advocated the use of the medical model involving expensive and high-tech care were improving public health or whether they were diverting resources from population-based approaches and simply enriching their organizations and member physicians at the expense of public health.
This comparison illustrates a fundamental question about MPOs: Do they serve the public interest or serve to increase elitism in medicine? They promote the training of more physicians of their own specialty; they lobby for monopoly rights to perform expensive procedures; and they demand more and higher payments for their services. These efforts drive up healthcare costs, and ultimately they limit access to care. Certainly high-tech medical care can be lifesaving, but the data that many specialty services in the United States are provided at a rate that is more than twice that in other developed countries -- without any evidence that it improves US public health -- cause concern about the overuse of specialist care in the United States.[8,20]
It seems that MPOs view their members as individual entrepreneurs in a capitalist model, focused mainly on their own profitability. Medical professional issues are infrequently discussed. The MPOs seldom take positions on national health policy, only on policies relating to their reimbursement. It sometimes appears that they are not interested in the public's health, only their own economic health. When MPOs do not act in support of ensuring fair and appropriate care, they are in violation of the most fundamental principles of medical ethics.
The dependence of US MPOs on Pharma revenue represents a conflict of interest in MPOs' role in defining the practice of medicine, and this is not a medically or ethically responsible position for them. What other group of professionals is so dependent on the vendors that solicit their favor? Lawyers have detailed rules about conflicts of interest in their practices. Why do many MPOs try to pretend that their conflicts of interest are unimportant?
Adding It All Up
The control that Pharma has established over the MPOs and their members is exerted through many mechanisms. The first is by making MPOs dependent on Pharma revenue. The second is through Pharma supervision of postgraduate education. A third results from Pharma use of physician advertising, public relations, and communications. The fourth mechanism involves the Pharma representatives, known as the detail force or sales reps. Then there are the Pharma lobbyists in Washington, DC, and the Pharma direct-to-consumer (DTC) commercials that mold the thinking of the public.
Because marketing expenses are usually intermixed with other Pharma expenses, such as research and development, it is difficult to identify specific Pharma budget lines to quantify what they pay to influence physicians in the United States. Reports have suggested that the actual amount is about $20 billion per year.[21] Nearly 95% of US physicians receive gifts from Pharma sales representatives.[22] If these funds went instead to provide more healthcare, they could substantially benefit public health.
The United States currently spends more than 15% of its gross domestic product (GDP) on healthcare. Estimates are that this will increase to 20% within the next few years. Most other developed countries spend from 5% to 10% of their GDP on healthcare. A major part of the increased cost in the United States relates to increases resulting from expensive diagnostic and therapeutic procedures and increased specialist physician costs in the United States.
Why is it then that when we look at various measures of health in the United States we find that they show that the health of the US population is worse than these other countries that pay on a GDP basis one third of what we pay for healthcare? Clearly, the extra amount that we pay does not yield incremental benefits to US health.
A conclusion that must be considered is that with the free market approach to healthcare financing and delivery in the United States, Americans must pay 3 times as much as the citizens of many other developed countries so that healthcare businesses can make high profits, even if they deliver worse healthcare. In the harsh US medical marketplace that the MPOs, the insurance companies, the hospitals, Pharma, and the government have established, we pay much more and are worse off.
How to Regain Our Profession
Dr. Marcia Angell, former editor of The New England Journal of Medicine, has a simple solution to MPO hypocrisy and conflicts of interest. She believes that MPOs should be self-supporting.[6] They should not take money from proprietary interests that can corrupt their policies and actions. I agree with Dr. Angell's position. I believe that it is important that physicians and the public assess and eliminate the conflicts of interest of MPOs and their leaders. Because of the issues related to "physicians for sale" providing input into government recommendations for practice and drug approval, I suggest that such official recommendations be developed by independent international experts without such conflicts of interest and that "physicians for sale" be excluded from these health policy decisions.
Physicians should fight for additional steps to be taken that could improve healthcare and lead to ethical self-sufficiency of MPOs:
MPOs should not accept funding from Pharma and other groups whose payments create a conflict of interest for them.
If such payments are made to MPOs (and KOLs, the leaders of MPOs) from proprietary groups whose payments may create a conflict of interest, they should be publicly revealed, including the precise amounts and conditions of such payments.
MPOs and KOLs with conflicts of interest should not be allowed to offer judgments about medical or scientific matters in governmental or scholarly regulatory groups that may affect the sources of the conflicts of interest.
Postgraduate CME should not be funded by Pharma or other groups whose payments may create a conflict of interest. Physicians should take responsibility for funding their own CME.
Physicians should refrain from accepting all gifts and services for themselves from Pharma.
Physicians and MPOs should put considerations of their patients' welfare and the public health above those that relate to their own income, and they should be able to demonstrate how they have sought to accomplish this goal.
Patients deserve their own personal physician who can act as counselor and advocate for their health needs. Insurance payments for specialist care should be limited to those specialist referrals made by the patient's primary care physician.
The antidote to overcommercialized specialty care is good primary care. I urge consideration of efforts by the WHO and the World Organization of Family Doctors, such as the "15 by 2015" initiative (http://www.globalfamilydoctor.com/index.asp?PageID=7802&ContType=15By2015), to strengthen the primary healthcare system worldwide.
Physician members of US MPOs should formally demand that their organizations demonstrate transparency concerning their funding and relationships with proprietary interests as well as complete disclosure of conflicts of interest among all of their leaders. They should demand that practice guidelines and recommendations of their MPOs be developed and reviewed by independent public health experts to ensure that they are consistent with the overall public health. They need to demand that MPOs implement programs that will seek to provide proper healthcare to all US residents. Physicians should seek to implement the points listed above and to resign from organizations that oppose these actions; they should support organizations that take action to implement MPO reform.
There is a bigger task that all US physicians need to undertake if they are to improve the state of US healthcare: They need to rethink what their profession is and identify what they need to do to regain their professional integrity. They must separate this professional identity from the procedures that they do and the economic rewards that they receive as a result. The professional identity and its medical ethical precepts should define what the physician does.
American medicine today, in my opinion, has been made a slave of economics. It is controlled by economic managers who regard medicine simply as a business and who ignore human needs and responsibilities. Medicine is too greatly influenced by insurance companies, Pharma, and MPOs that constrain the concept of healthcare along commercial lines and ignore human factors. They ignore physicians' responsibilities. We need to return to the traditional road that is patient-centered, where free care is freely given to the needy, where expensive and invasive procedures are avoided unless they are clearly cost-effective and substantially benefit the patient, where physician reimbursement is fair but not exorbitant or opportunistic, and where ethical precepts trump the profit margin. I believe that the control of insurance companies, Pharma, and MPOs over medical practice must be limited. A greater degree of oversight by government is needed to defend the public health. All of these parties need to focus on standards of public health that must be achieved.
In my opinion, a proper balance of medical care should be established in the United States with an eye to the need for both universal care and cost containment. This may require substantial changes in the organization and reimbursement of care. Financial conflicts of interest by physicians should be minimized. There should be a concern for improving US public health that leads to action focused on this goal. Patient needs and not the financial needs of medical practitioners and organizations should be the regulating force in the practice of medicine in the United States. There needs to be a return to the physician's role as a humane counselor and health advocate for their patients. Healthcare services that do not benefit public health should not be funded.
The health systems of other developed countries have not been damaged as much by the power of insurance companies, Pharma and the MPOs as the US healthcare system because their governments have not permitted the abuses of pricing that occur in the free market US economy. These countries are already addressing the permissible relationship between Pharma and physicians.
I believe that conflicts of interest in US medicine are just a subset of conflicts of interest throughout US culture. Politicians cannot be elected without taking money from special interests that obligate them to support policies that reward the special interests but destroy US interests. Developers bribe politicians so that they can grow wealthy by despoiling the land and environment. MPOs seek money and influence from Pharma and politicians to promote the wealth of their specialty while damaging the country's public health. Such conflicts of interest must be prevented, or at least ameliorated, if the United States is to survive in its current form.
This essay has focused on the abuses of the US MPOs, their damaging emphasis on increasing the financial welfare of their specialties without regard to public health, and their collaboration with proprietary interests to accomplish this goal. Journalists have also revealed abuses among US specialist practitioners who increase their revenue with expensive therapies and procedures that do not benefit their patients.[8] Although these examples are true, I believe that the driving forces of such inappropriate medical specialty practice are the MPOs that make financial conflicts of interest and overzealous application of expensive and unproven technologies the standard of care.
This is a time of upheaval in both the US healthcare system and the relationship of Pharma and physicians. The destructive system that I have described in this commentary is starting to collapse. The Massachusetts State Senate has voted to ban all gifts to physicians from Pharma. The AAMC has taken the position that medical schools and teaching hospitals should ban gifts to physicians, faculty, staff, students, and trainees. I urge my colleagues to become personally involved in these issues so that we can regain our profession. We can start by remembering the words that many of us spoke from the Oath of Maimonides when we graduated:
Thy eternal providence has appointed me to watch over the life and health of my fellow human beings. May the love for my art actuate me at all times; may neither avarice nor miserliness, nor thirst for glory, or for great reputation engage my mind; for the enemies of truth and philanthropy could easily deceive me and make me forgetful of my lofty aim of doing good to my patients.
References
Starr P. The Social Transformation of American Medicine. New York: Basic Books; 1982.
Wolinsky H, Brune T. The Serpent on the Staff: The Unhealthy Politics of the American Medical Association. New York: Tarcher/Putnam; 1994.
Lundberg GD, with Stacey J. Severed Trust: Why American Medicine Hasn't Been Fixed. New York: Basic Books; 2000.
Theodosakis J, Feinberg D. Don't Let Your HMO Kill You. New York: Routledge; 2000.
Mahar M. Money-Driven Medicine. New York: HarperCollins; 2006.
Angell M. Drug Companies. New York: Oxford University Press; 2004:251.
Kassirer J. On The Take. New York: Oxford University Press; 2005.
Brownlee S. Overtreated: Why Too Much Medicine Is Making Us Sicker and Poorer. New York: Bloomsbury USA; 2007.
Kassirer J. Professional societies and industry support: what is the quid pro quo. Perspect Biol Med. 2007;50:7-17. Abstract
Starr P. The Social Transformation of American Medicine. New York: Harper Colophon Books; 1982:131-134.
Bodenheimer T, Grumbach K. Understanding Health Policy. New York: Lange Medical Books/McGraw-Hill; 2005:47-49.
American Thoracic Society Web site. Financial statements for 2005. Available at: www.ats.org/financial Accessed March 30, 2007. [Financial statements are no longer publicly available on this Web site.]
Lundberg GD, with Stacey J. Severed Trust: Why American Medicine Hasn't Been Fixed. New York: Basic Books; 2000:281.
Lee C. Washington Post. Tuesday, May 22, 2007.
American College of Cardiology 56th Annual Scientific Session; March 24-27, 2007; New Orleans, Louisiana. Program and Faculty Update. 2007.
Arky RA. The family business -- to educate. N Engl J Med. 2006;354:1922-1926. Abstract
Iskowitz M. CME's New Order: Medical Education Report: Medical Marketing and Media. BNET Business Network Web site. August 2006:37-90.
Carlat D. New York Times. June 13, 2007.
US Senate Committee on Finance Letter of April 25, 2007 to Accreditation Council for Continuing Medical Education (ACCME). Available at: http://www.accme.org/index.cfm/fa/news.detail/news_id/be86b5e0-fe36-4dbc-a1a2-de6198a0e73b.cfm Accessed July 3, 2008.
Bodenheimer T, Grumbach K. Understanding Health Policy. New York: Lange Medical Books/McGraw-Hill; 2005.
Los Angeles Times. April 26, 2007.
Boden WE, O'Rourke RA, Teo KK, et al. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007;356:1503-1516. Abstract
Lawrence Grouse, MD, PhD, Clinical Assistant Professor, University of Washington School of Medicine, Seattle, Washington
Author's email: lgrouse@u.washington.edu
Disclosure: Lawrence Grouse, MD, PhD, has disclosed that he did fund-raising for US National Heart, Lung, and Blood Institute (NHLBI) projects with many US Pharma companies and with multiple international Pharma companies for nonprofit organizations founded by NHLBI and the World Health Organization.
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Commentaries
Physicians for Sale: How Medical Professional Organizations Exploit Their Members
Lawrence Grouse, MD, PhD
Medscape J Med. 2008;10(7):169. ©2008 Medscape
Posted 07/21/2008
Introduction
Scenario 1: You are a medical specialist -- say a pulmonologist -- walking to the intensive care unit to see one of your patients, and you pass a roomful of your colleagues in the hospital auditorium crowding around tables piled with food and drink. Outside in the hall you see a sign on a stand that says, "MEGA Pharma welcomes the attending staff to a Pizza and Pasta Lunch brought to you by GALE FORCE, the new fixed-combination medication for asthma and COPD!" An attractive young woman stands in front of you, asks you to join the luncheon, and hands you a flyer with the program for the talk that will be given.
"Free CME," it says. The other pulmonologist at the hospital is giving a talk that is based on a study in which he had been an investigator. The talk is "The Use of a New, Improved Fixed-Combination Medication as First-Line Therapy for COPD."
Scenario 2: You are attending the annual lung society convention in San Francisco, California, and the conventioneers are walking around with convention bags, pens, programs, inhalers, packages, and even neckties emblazoned with pharmaceutical product names and logos. You notice that these same names and logos are on the placards and signs in rooms and hallways, in the programs, and even on the convention buses.
Prior to the convention, you received letters and postcards for the nightly gala dinners and CME symposia sponsored by pharmaceutical companies with the best-known pulmonology experts as speakers. You notice that there are 3 speakers at each symposium; two of the speakers are giving interesting scientific talks, and one is giving the talk "The Use of a New, Improved Fixed-Combination Medication as First-Line Therapy for COPD." The lung society is providing CME accreditation. You find that many of your clinical colleagues from other countries have been given "grants" from pharmaceutical and other commercial medical and device companies (referred to in this essay as Pharma) to attend the meeting as "consultants."
Scenario 3: A Pharma representative buttonholes you as you enter your office and hands you a free copy of the latest single-sponsored practice guideline from the lung society, and with it an ad slick for GALE FORCE along with free drug samples, peak flow meters, and pens with the GALE FORCE colors and logo. She hands you 3 published, state-of-the-art, randomized controlled trials from the lung society journal written by the top experts in the field and funded by the makers of GALE FORCE that explicitly state the point of view that GALE FORCE is a better choice than the 3 drugs that you currently prescribe.
When I find myself in such ethically questionable situations as those portrayed above, it is natural to wonder what led to their occurrence. A common response to the problems with the US healthcare system is to blame Pharma and their excessive marketing zeal. Several authors have written their perspectives about the events and policies that have crippled US medicine during the past several decades.[1-8] They discuss cutthroat competition within medical coverage providers, the ascension of medicine as a business, predatory marketing practices by Pharma, and the effects of inhumane government policies in damaging US healthcare. Their descriptions of the effects of "corporate medicine" and the inappropriate commercialization of medical practice provide a chilling perspective on some of the problems.
However, except for Dr. Kassirer's article,[9] these works have not emphasized the damaging role of medical professional organizations (MPOs) and their leaders on US healthcare. I believe that it is in large part the dependence of these organizations on Pharma funding that has led them to compromise their professional ethics. Although this influence is also exercised by medical device, biotech, publishing, and diagnostics companies, for simplicity I will include all of these medical commercial organizations in aggregate as "Pharma" because they act in similar ways on MPOs, and the giant multinational pharmaceutical companies wield the greatest influence.
Pharma operates in the realm of business and in accordance with national laws. They are conducting legal businesses regulated by business ethics, whereas physicians and their MPOs are bound by medical ethics. When physicians violate these principles of medical ethics, they lose their professional identity and authority. Although I do not wish to ignore the positive medical and scientific activities of MPOs, in this commentary I lay much of the blame for unduly expensive and inappropriate medical care in the United States at the doors of MPOs. As the above scenarios imply, practicing physicians are constantly bombarded by MPO-abetted promotion from Pharma.
This thesis concerns only those MPOs in which inappropriate Pharma influence can be documented or inferred. In my experience, these tend to be the MPOs that serve the higher-income specialty organizations and are active in governmental lobbying. Their members are prescribers of specific pharmaceutical products relevant to the Pharma that support them. Some MPOs in the United States are not very dependent on Pharma support. Most are, as judged by the listings of the categories of their revenue. I suggest that the largely hidden relationship between MPOs and Pharma enhances the ability of MPOs to promote their specialties' services inappropriately, and it fosters the excessive prescription of expensive, highly-promoted medications. These results would be important factors in the spiraling costs of US healthcare.
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Readers are encouraged to respond to the author at lgrouse@u.washington.edu or to George Lundberg, MD, Editor in Chief of The Medscape Journal of Medicine, for the editor's eyes only or for possible publication as an actual Letter in the Medscape Journal via email: glundberg@medscape.net
Who and What Are for Sale?
The MPOs that have become so dependent on Pharma funding that these funders exert control over MPO policies and cause them to violate precepts of medical ethics;
The MPOs that are fundamentally trade organizations and use their resources to inappropriately increase their specialties' financial status with little regard for the welfare of patients or the public health;
The MPOs (and their foundations) that receive advertising, grants, convention and meeting support, project support, payments in kind for MPO support, and other tangible benefits from Pharma in which the funding from Pharma represents a substantial percentage of their earnings;
The MPOs whose actions violate medical ethics to benefit their Pharma funders and their own members;
The MPO leaders to whom I refer as key opinion leaders (KOLs) who control the policies of their MPOs for their own benefit and the benefit of their Pharma funders;
The KOLs who profit from projects, prestige, honoraria, and connections with Pharma, and reap perquisites, prestige, and influence from the MPOs;
KOLs whose yearly total of Pharma funding represents a substantial percentage of their earnings as practicing physicians or physician educators; and
All physicians whose actions violate medical ethics to benefit their Pharma funders and to generate payments for themselves.
MPOs in the United States
The most relevant history of the dealings of MPOs with Pharma in the United States began in 1905 when the American Medical Association (AMA) urged physicians not to prescribe drugs that were advertised directly to consumers by Pharma, which in those days took the form of smaller patent medicine-formulating companies. Preventing these communications by Pharma put power in the hands of the AMA. The AMA established a Council on Pharmacy and Chemistry that played a similar role to that of the US Food and Drug Administration (FDA) today with respect to drugs. The AMA Council would not approve any drug that was directly advertised to the public. This regulatory authority enabled the AMA to stand between Pharma and their customers.
Revenues for AMA journal advertisements rapidly became the principal source of funds for the Association. The relationship of AMA and Pharma paved the way for the current economic structure of medical professional organizations in the United States.[10] What has changed in recent times is that with the rise of specialty MPOs and the collapse of power of the AMA, the control of professional communication to patients in the United States is predominantly wielded by the specialty MPOs rather than the AMA. The MPOs have simply replicated the initial AMA strategy.
What Do MPOs Do?
Most MPOs in the United States have followed the pattern of the AMA in that they operate as trade organizations, advocating for the financial benefit of the organization and its members. The MPOs' major roles, which they do not emphasize publicly, appear to be fund-raising, lobbying for their specialty, and applying political influence on healthcare payers and providers. Although they publicly emphasize their role in postgraduate education and publishing, I believe that these activities are undertaken in large part to generate funds from Pharma.
Who Are the Specialists, and How Many of Them Are in the United States?
Prior to 1950, about 75% of physicians in the United States were general practitioners (GPs) and did not consider themselves to be specialists; that is, they took a year of internship after medical school and then began to practice general medicine.
In contrast, today almost all physicians in the United States consider themselves specialists, even those in primary care practices. Only about 13% of US physicians are GPs or family doctors.[2,11] Today, after their medical school graduation, almost all physicians take a residency training program in a specialty and sometimes further fellowship training for subspecialty education.
There are approximately 850,000 physicians in the United States; there are about 550,000 physicians who practice what used to be considered specialist care. Most of the rest, such as family physicians, pediatricians, and general internists, practice primary care and are generalists, but many consider themselves specialists as well to help market their practices.
There are very few GPs in the United States; they were driven out of business by specialists in the 1960s, and to defend their practices they restructured themselves as specialists in family practice. These family physicians now have a 3-year residency and consider themselves specialists, as do many pediatricians and general internists. Thus they are specialists in general medicine, a somewhat paradoxical designation. It would be economic suicide not to be a specialist in the United States. Medicine in the United States is an entrepreneurial activity and not a part of an organized healthcare system, and without a specialty a physician cannot easily participate in the marketing and marketplace of medicine.
Although specialty certification is usually awarded by specialty medical boards that are separate from the MPOs, most physicians join the MPO for their practice specialty. These MPOs become the focus of their postgraduate education and their advocates on behalf of the specialty. They become the key groups to provide professional identity for each specialty.
One of the most lucrative powers that the US MPOs have achieved for their members is the ability of patients in the United States to consult directly with a specialist rather than going through a primary care "gatekeeper." Most countries strictly limit access to expensive specialist care, and they limit the number of specialists that are allowed to be trained and practice. The privileged position of specialists in the United States greatly increases their revenue, and it increases the number of physicians who become specialists and subspecialists. It also dramatically increases healthcare costs.[10] This situation has led to confusion about the differences described above between primary care, generalist care, and specialty care in the United States.
It is apparent that the terms generalist and specialist are not used in a consistent way in the United States. However, for the purposes of this essay, it is not important what these groups call themselves; what is of interest is how their MPOs interact with Pharma and influence US healthcare costs. Although my focus in this commentary is on the United States, I point out similarities in the relationship of Pharma with MPOs internationally.
How Much Money Do MPOs Receive From Pharma?
In the entrepreneurial US healthcare marketplace, the MPOs' power derives from their symbiotic relationship with Pharma. Without Pharma funding, the MPOs would be unable to support their advocacy and institutional costs. With Pharma funding they can influence the healthcare system and their own members, and establish a favored financial reimbursement status, but in the bargain I believe that they also become the tools of Pharma. It is my contention that with the power of the purse, Pharma exerts subtle control on the communications of the MPOs and the practice of their specialists.
Pharma control limits consideration of practice approaches apart from expensive drug therapy. Pharma control of the KOLs of the specialty further increases its influence on MPOs. This control minimizes the use of prevention and public health measures in medical practice, except for those that rely on pharmaceuticals. I elaborate on my reasons for believing this.
Pharma provides an enormous amount of funding for MPOs, and as a result they have considerable input into the policy and educational programs of these organizations. A large percentage of Pharma marketing budgets is specifically allocated for MPOs whose members are the prescribers of their products. It is understandable that they would advertise to their likely customers, but it is significant that they do not target all of their advertising to the physicians directly. MPOs have considerable control of Pharma communications to their members, just as the AMA had more than 100 years ago. Pharma must support the MPOs to influence their members.
If you review the financial statements that are publicly available from the AMA and other MPOs, you will find that the reporting of revenue is particularly vague. When you calculate the amount derived from membership fees, you will find that it usually only accounts for about 15% to 25% of the MPO's revenues. Much larger are the revenues from journal advertising, the national conventions, grants for educational projects, and grants to the associations' foundations, which theoretically are independent, nonprofit charitable organizations. All too often, the only charity that is benefited is the specialty itself.
Specific sources of these revenues are not revealed by the MPOs, nor are they supplied when requested, but in informal discussions during meetings with leaders of MPOs, you will learn that Pharma is the real source of most of the MPOs' revenue. The same conclusion can be reached by an analysis of the major categories of revenue and the likely funders of these activities. Some MPOs, such as those of public health physicians, do not receive much Pharma revenue because few of their members are high prescribers of drugs.
In the spirit of disclosure, and to cite the experience on which my current thinking is based, please note that I have worked closely with the executive directors, directors of education, and scientific directors of many MPOs both in the United States and internationally for more than 30 years. During that time, I did fundraising for US National Heart, Lung, and Blood Institute (NHLBI) projects with US Pharma companies and did fundraising with international Pharma companies for nonprofit organizations founded by the NHLBI and the World Health Organization (WHO). The perspectives expressed here concerning the relationship of MPOs and Pharma both in the United States and globally came from these activities.
It became clear to me that the MPO leaders' major day-to-day efforts were related to their contacts, projects, meetings, and fundraising with Pharma, and to politics relating to finance; they spent very little time on member activities. I had learned over the years that when I attended medical conventions of MPOs, if I sat in the entry area of the main convention hotel, I would soon see key people at the meeting from the MPO and from Pharma come through the door separately and leave together. As I attended conventions of our collaborating organizations and watched in the hotel lobbies, I observed the parade of meetings between delegations of the MPOs' top leaders with marketers and decision makers of the Pharma companies that marketed their drugs to the specialty.
The practicing physician members of the MPO were off in the convention centers attending scientific lectures that would expand the medicines, procedures, and costs of their practices and wandering through the exhibit halls collecting free presents and drug promotion at the Pharma booths, whereas the specialty society leaders were meeting in plush Pharma hospitality suites to trade the loyalty of their members for Pharma money.
Because MPOs conceal the sources of their funding, in many cases I can only use the information, behavior, and activities of MPOs that can be publicly inspected to assess their dependence on Pharma. On the basis of my personal observations of MPO activities and policies as well as information gathered from many of the major US MPOs, most of those I have studied appear to receive the majority of their funds from Pharma.
Follow the Money
Using the established journalistic procedure of following the money that MPOs receive, we can learn about the dependency and control that run through the Pharma/MPO relationship. As I mentioned, MPOs do not provide any detailed public financial statements that document the specifics of Pharma support, nor can I obtain them upon request. Even the filings for the Internal Revenue Service (IRS) that can be obtained publicly only contain general descriptions of revenue sources, and even members of the specialty organizations are given the runaround if they inquire about such specifics. They are told that such information is confidential.
As an example, a typical subspecialty MPO of about 13,500 members might report yearly revenue of about $18 million.[12] Let's take a look at how the lion's share of that funding travels from Pharma to the MPO.
The annual meeting of such an MPO would be its biggest funding source at about $8.5 million, and judging from the extensive commercial presence, the vast majority of that revenue would come from Pharma. Meeting registration and educational session fees would account for about $0.8 million, but of the approximately 14,000 people who would attend the MPO's annual meeting, only about 6000 would be practicing specialists. The rest would be Pharma industry attendees and their vendors, so most of this registration revenue would also be from industry. In addition, Pharma might pay about $2 million in "nonconference" grants for after-hours activities at the annual conference.
An undisclosed way of funneling Pharma money to MPOs in Europe and Asia is the common practice of Pharma paying for specialists to attend their MPO's annual meeting. A pharmaceutical company pays the physicians who, in turn, pay the MPO meeting registration and expenses. A leading physician marketer from an international company recently told me he estimates that 80% of the attendees are funded in some way by Pharma at many MPO meetings. In the United States, Pharma no longer pays physicians to attend CME conferences; however, it is unknown how many physicians from outside the United States are paid to attend, and the percentage of non-US attendees at medical conferences has grown greatly over the past 2 decades.
Other ways that Pharma funds MPOs include nondisclosed grants-in-aid, project grants, funding for educational programs, directed donations to the specialty organization's foundation, and payments in kind, such as convention and professional services and payments to physician attendees and consultants.
Most MPOs publish 1 or more journals. Pharma ads in the organization's journals might account for about $2 million a year in a typical MPO, and many also receive about $0.5 million in royalty payments from commercial sources, usually Pharma.
The revenue from membership fees for this typical MPO would only be about $2.5 million. We can see from the estimates above that about $12-$14 million of the $18 million of such a typical MPO's revenue could come from Pharma. Although these payments to the MPOs are essential for their survival, they are small change for Pharma budgets. Most big international Pharma have revenues of $4-$8 billion, of which about half comes from the United States.
So a typical specialty MPO could receive $14 million a year from Pharma out of a total of $18 million total revenue: almost 80% of the revenue, not an insignificant contribution. This level of Pharma revenue would qualify an MPO as a "physicians for sale" organization. In practical terms, Pharma is their exclusive customer. Do you think Pharma wants anything in return? In colonial times Benjamin Franklin wrote, "Never make your physician your heir!" A contemporary Franklin might write, "Never let Pharma finance your physician!" A consequence of this massive conflict of interest that involves physicians and MPOs, leading to their dependency on Pharma funding, will be the destruction of the credibility of the medical profession.
Although specialty societies appropriate the largest share of Pharma funding, the AMA is also in the market for Pharma funding. Even though their membership has fallen to a small percentage of US physicians, the AMA still has annual revenues of about $280 million a year. According to Dr. George Lundberg, "the AMA has too much money and too little purpose.[13]"
To bolster its finances, the AMA has pioneered a new source of Pharma revenue. A review of the AMA's financial statement shows that the AMA's new funding source is licensing its AMA Physician Masterfile, which contains information about virtually all US physicians, to Pharma. This revenue is even larger than the revenue from Pharma ads in their journals that historically have been its major revenue source.
With today's new information technology, the AMA Masterfile is very valuable. Medical information services, such as Integrated Medical Services (IMS) (operating revenue in 1995, $1.75 billion[13]), which track the prescriptions written in the United States and in most other countries worldwide, are able to match physician data and demographics with prescriptions tracked to individual regions and drug stores. In many cases their data can provide Pharma representatives with information about what drugs are and are not prescribed by individual physicians throughout the United States. These data allow drug detail representatives to provide negative information about competitors to specific physicians to promote their own products, knowing exactly what these physicians currently prescribe, and it allows them to punish and reward physicians for their prescribing decisions. More than a dozen states are considering laws to shield physicians' prescription pads from Pharma.[14]
This exploitation by MPOs of their members is really just a variation of the AMA's initial policy in 1905 concerning Pharma communications with their members. However, rather than having the MPO be a conduit of authorized information from Pharma, the current program of selling physician contact information appears to have aspects of a conspiracy of MPOs with Pharma to allow them to unwittingly influence physicians -- including their own members. There are suggestions that other MPOs are now imitating AMA's creative funding program by selling their members' and former members' personal information to Pharma so that they can be more effectively detailed. Physicians in all specialties should be asking their MPOs whether they are selling their members' information.
Consequences of Pharma Influence on MPOs
One has only to attend an MPO's convention or read an MPO's journal to see the powerful impact of Pharma funding. The MPOs endorse Pharma educational products; they put their society logos on communications alongside Pharma logos; and they place banners and signs thanking Pharma for matters large and small throughout their convention halls and journals. They encourage their members to visit the exhibit area where Pharma promotes commercial products. Exhibit areas are better than an amusement park: They have high-tech, luxurious booths with films, magicians, and game shows as well as free food, drink, and presents for the physicians and florid promotions of the drugs.
MPOs cover Pharma products and initiatives in their publications, publish Pharma drug studies in their journals, and recommend Pharma products in their practice guidelines. Coverage of public health issues and alternative approaches to healthcare is rarely seen.
The need to serve Pharma is an important source of the antipathy of practicing clinicians toward physicians working in public health, and toward other healthcare professionals -- such as chiropractors, acupuncturists, and other alternative healthcare givers. For example, while scanning a program for the American College of Cardiology's annual scientific session,[15] I found a prominent listing of more than 350 Pharma and other medical companies that would be exhibiting at the convention. In the list of more than 250 scientific sessions that are enumerated, there were:
No sessions whose title indicates any coverage of public health issues of cardiology;
No session that appeared to cover other healthcare professionals or alternative healthcare givers' role in cardiology;
No sessions on cost issues or socioeconomic or epidemiologic issues in delivering cardiology care;
No sessions on lack of access or minority issues in cardiology care; and
Only 2 sessions on prevention of cardiovascular disease.
Because most cardiovascular disease in the United States is the result of preventable problems (poor diet, lack of exercise, lack of screening for and treatment of risk factors) that may be best addressed using public health approaches on a population basis, isn't it surprising that these topics receive such limited coverage at a cardiology convention?
It goes without saying that most of the talks listed in the program are about the use of pills, devices, and procedures to diagnose and treat heart disease. It is almost as if the MPO was employed by Pharma to encourage physicians to prescribe pills, devices, and procedures. Preventing illness, providing fair and universal care, and caring about the patient do not appear in the program. It is difficult to identify the commitment of the major MPOs to US public health except for lip service and public relations efforts. It seems to me that most of them follow the long tradition of the AMA in securing the welfare of their members and lining their own pockets.
Pharma Control of Postgraduate Education
Pharma, through its funding, has assumed extensive control of postgraduate physician medical education (aka continuing medical education [CME]) in the United States. It would be of interest to see whether the education that they provide results in improved and appropriate patient management. Recent data indicate that appropriate treatment for patients is given in only 50% of physician visits. In fact, longer clinical experience, and hence more postgraduate education, are correlated with inferior quality of care.[16] By this measure the value of current forms of postgraduate education must be questioned.
At many MPO conventions and in many CME activities put on by medical education companies hired by Pharma, the programs include promotional material about the sponsor's products. In the United States more than 30,000 people are employed in the Pharma-funded CME industry.[17] Until recently, they were reputedly crafting drug promotion disguised as education that focused on the advantages of the sponsor's product and minimizing discussion of dangerous side effects.[18] The US Senate Committee on Finance recently wrote to the organization -- Accreditation Council for Continuing Medical Education (ACCME) -- that supervises US postgraduate education to express its concern about the conflict of interest when Pharma spends more than $1 billion a year for education about topics that highlight the use of their products. Who pays the piper calls the tune, they imply. ACCME replied that their policies and procedures for developing educational materials are sufficient for ensuring their objectivity. However, the Senate Committee pointed out that although ACCME surveyors review accredited organizations' procedures for ensuring the independence of certified CME, they do not analyze the actual content that is presented.[19]
I've observed hundreds of CME-certified presentations sponsored by Pharma during my professional career, and in those content areas that I knew well enough to judge, it was clear to me that in the vast majority of instances, a bias was introduced in the communications in favor of the product produced by the sponsor of the CME. In some cases it was not so much that the information presented was false, but that the fair balance and clinical perspective that should have been present were predictably distorted by the proprietary interest. ACCME has recently introduced new procedures designed to eliminate some of the conflict of interest that has occurred in many CME activities. It may improve the education that is provided if it is implemented. However, if there is no mechanism to analyze the resulting content of the medical education activities, the Pharma-funded medical educators who actually conduct the activities have many opportunities to introduce undetected Pharma promotion.
Because of the increasing visibility of these problems with Pharma-funded medical education, the US Institute of Medicine and the Association of American Medical Colleges (AAMC) are conducting inquiries into conflicts of interest in medical education. Because of the increased vigilance of regulatory agencies, such as the FDA and the US Department of Health & Human Services (HHS), millions of dollars in fines and penalties have already been imposed on Pharma, and many of the most egregious activities have now been stopped. In Europe, laws enacted in France and Italy are similarly limiting Pharma promotion in medical education.
Acquiring the KOLs
The close relationship of Pharma with the MPO leads to close relationships with the MPO's leaders. These physician leaders are very important to Pharma, and they are recruited as lecturers on the Pharma speakers' bureaus, investigators for their clinical trials, consultants on their advisory boards, and experts for their medical education symposia. These leaders are referred to by Pharma as KOLs -- key opinion leaders -- and I have used this term as well. It is important for Pharma that the cooperation of KOLs is acquired. Their activities with Pharma provide the MPO leaders with substantial revenue and prestige. These activities provide Pharma with access to the decisions of the MPO. Some of these physician leaders, who are generally academics, are soon making more money from Pharma than from their academic day jobs and easily qualify as "physicians for sale." The lucrative Pharma advisory groups, lectures, research grants, symposia, and other payoffs for the MPO's physician officers encourage their cooperation. They begin to work for Pharma, perhaps without realizing it. Full disclosures of such payments to KOLs are rare.
This issue of Pharma influence on the KOLs goes well beyond revealing that these leaders may receive a lot of money from companies for their services and advocacy. The KOLs, through their leadership positions, also participate in the control of the MPOs and their pro-Pharma policies. The MPOs may have the appearance of being democratic, but in most instances the membership is simply given a choice of electing various KOLs who have already been acquired by Pharma to be their representatives. The membership gets little meaningful information about the beliefs, activities, or conflicts of interest of the candidates. For most MPOs the succession of presidents of the organization is decided years in advance. The decisions of the MPOs are made by small executive boards; they are made in secret; there is no free medical press to critique or question their decisions. The MPO house organs trumpet the wise decisions of the board and their benefits to membership. The ethical problems with the activities of the organization are not often discussed. MPO management usually lacks the quality of transparency that is a keystone of good governance.
As a result of the conflicts of interest on the part of the MPOs and their leaders, there have been increasingly vigorous demands by government and by critics of MPOs for disclaimers of payments they receive from proprietary interests. However, the usual disclaimers filed by KOLs, even those disclaimers required by the WHO, provide little information. They simply note the companies that have provided payments and not the specific amounts or services provided. A typical specialist leader will have payments from 5-10 Pharma companies in a given year, with no way for the public to know if they received $5 or $50,000. In addition, very little is known about the nature of the arrangements that led to the payments. Further, because MPOs refuse to provide information about their revenue sources, it is even more difficult to identify specific conflicts of interest.
Pharma involves KOLs in leading clinical trials of medications that are required for FDA approval, and they provide premiere showcasing of the KOLs' educational skills before their peers in symposia organized by Pharma. As a result, the KOLs become recognized as experts if they were not already so recognized. They become the peer reviewers of important articles in their specialty in the peer-reviewed medical literature in which their Pharma-created biases can prevent publication of results or ideas that are opposed to their proprietary interests.
Equally destructive is the fact the KOLs are chosen to be consultants to governments. They serve on FDA and European Medicines Agency (EMEA) advisory panels to give advice on which drugs should be licensed and which rejected. They serve on National Institutes of Health (NIH) advisory panels to review grant applications. With this power, the KOLs can influence the entire direction of new research -- competing ideas, directions, and the products that will or will not be used. These obvious conflicts of interest are finally beginning to be discovered. Experts are now often required to file disclosures about payments that they receive that could represent conflicts of interest. However, in most instances, these experts' opinions are still accepted regardless of their conflicts of interest. They should not be.
Implications of KOL Acquisition for Peer Review
The pervasive funding system that Pharma has established for the KOLs, and which is now coming into wider view, has other important implications for the peer review system that is at the heart of the NIH basic and clinical research enterprise as well as the medical literature. The thesis has always been that science is self-correcting; if an unethical researcher fakes data then there would be other, more ethical researchers who would do the experiment correctly and right the wrong. However, what if the key researchers in a particular area are on the payroll of the companies that have a vested interest in a certain result? What if the companies designed the studies to get the result they wanted and only the studies funded by the companies and managed by their KOLs would ever be conducted? What if the experts who do the peer review of the studies for the medical journals are KOLs for the companies that funded the studies? Why does it seem to happen so often that all of the published studies funded by company A show that the products of company A are better than those of company B, whereas those of company B show the reverse? I believe that the peer review system, before which US scientists genuflect, often fails.
The interpretation of medical research is by no means straightforward and uncontroversial. Different groups of respected scientists study the same question and get diametrically opposed results all of the time. Study exclusion criteria and other technical features of studies can affect their general applicability. Studies of a therapy that are conducted in clinical research facilities staffed with experienced investigators and staff may not give the same results as those seen in a busy primary care setting. Also, if the arbiters of these studies -- the expert peer reviewers -- have conflicts of interest in judging the results, how can we be sure what to believe? The situation can easily develop in which large randomized controlled trials can show significant benefits of drug therapy, whereas the use of the drug in actual clinical practice will introduce large costs but no benefit for patients. Improvement that results from therapy in surrogate clinical variables, such as glycemic control, may not result in improvements in mortality or public health benefit (as data concerning rosiglitazone have suggested[22]).
Do MPOs Benefit the Public Health?
As I saw the effectiveness of global public health approaches to deal with major diseases in work that I did with WHO and NHLBI, and then when I compared them with the US medical model, which involves providers treating individual patients, I often wondered whether the MPOs that advocated the use of the medical model involving expensive and high-tech care were improving public health or whether they were diverting resources from population-based approaches and simply enriching their organizations and member physicians at the expense of public health.
This comparison illustrates a fundamental question about MPOs: Do they serve the public interest or serve to increase elitism in medicine? They promote the training of more physicians of their own specialty; they lobby for monopoly rights to perform expensive procedures; and they demand more and higher payments for their services. These efforts drive up healthcare costs, and ultimately they limit access to care. Certainly high-tech medical care can be lifesaving, but the data that many specialty services in the United States are provided at a rate that is more than twice that in other developed countries -- without any evidence that it improves US public health -- cause concern about the overuse of specialist care in the United States.[8,20]
It seems that MPOs view their members as individual entrepreneurs in a capitalist model, focused mainly on their own profitability. Medical professional issues are infrequently discussed. The MPOs seldom take positions on national health policy, only on policies relating to their reimbursement. It sometimes appears that they are not interested in the public's health, only their own economic health. When MPOs do not act in support of ensuring fair and appropriate care, they are in violation of the most fundamental principles of medical ethics.
The dependence of US MPOs on Pharma revenue represents a conflict of interest in MPOs' role in defining the practice of medicine, and this is not a medically or ethically responsible position for them. What other group of professionals is so dependent on the vendors that solicit their favor? Lawyers have detailed rules about conflicts of interest in their practices. Why do many MPOs try to pretend that their conflicts of interest are unimportant?
Adding It All Up
The control that Pharma has established over the MPOs and their members is exerted through many mechanisms. The first is by making MPOs dependent on Pharma revenue. The second is through Pharma supervision of postgraduate education. A third results from Pharma use of physician advertising, public relations, and communications. The fourth mechanism involves the Pharma representatives, known as the detail force or sales reps. Then there are the Pharma lobbyists in Washington, DC, and the Pharma direct-to-consumer (DTC) commercials that mold the thinking of the public.
Because marketing expenses are usually intermixed with other Pharma expenses, such as research and development, it is difficult to identify specific Pharma budget lines to quantify what they pay to influence physicians in the United States. Reports have suggested that the actual amount is about $20 billion per year.[21] Nearly 95% of US physicians receive gifts from Pharma sales representatives.[22] If these funds went instead to provide more healthcare, they could substantially benefit public health.
The United States currently spends more than 15% of its gross domestic product (GDP) on healthcare. Estimates are that this will increase to 20% within the next few years. Most other developed countries spend from 5% to 10% of their GDP on healthcare. A major part of the increased cost in the United States relates to increases resulting from expensive diagnostic and therapeutic procedures and increased specialist physician costs in the United States.
Why is it then that when we look at various measures of health in the United States we find that they show that the health of the US population is worse than these other countries that pay on a GDP basis one third of what we pay for healthcare? Clearly, the extra amount that we pay does not yield incremental benefits to US health.
A conclusion that must be considered is that with the free market approach to healthcare financing and delivery in the United States, Americans must pay 3 times as much as the citizens of many other developed countries so that healthcare businesses can make high profits, even if they deliver worse healthcare. In the harsh US medical marketplace that the MPOs, the insurance companies, the hospitals, Pharma, and the government have established, we pay much more and are worse off.
How to Regain Our Profession
Dr. Marcia Angell, former editor of The New England Journal of Medicine, has a simple solution to MPO hypocrisy and conflicts of interest. She believes that MPOs should be self-supporting.[6] They should not take money from proprietary interests that can corrupt their policies and actions. I agree with Dr. Angell's position. I believe that it is important that physicians and the public assess and eliminate the conflicts of interest of MPOs and their leaders. Because of the issues related to "physicians for sale" providing input into government recommendations for practice and drug approval, I suggest that such official recommendations be developed by independent international experts without such conflicts of interest and that "physicians for sale" be excluded from these health policy decisions.
Physicians should fight for additional steps to be taken that could improve healthcare and lead to ethical self-sufficiency of MPOs:
MPOs should not accept funding from Pharma and other groups whose payments create a conflict of interest for them.
If such payments are made to MPOs (and KOLs, the leaders of MPOs) from proprietary groups whose payments may create a conflict of interest, they should be publicly revealed, including the precise amounts and conditions of such payments.
MPOs and KOLs with conflicts of interest should not be allowed to offer judgments about medical or scientific matters in governmental or scholarly regulatory groups that may affect the sources of the conflicts of interest.
Postgraduate CME should not be funded by Pharma or other groups whose payments may create a conflict of interest. Physicians should take responsibility for funding their own CME.
Physicians should refrain from accepting all gifts and services for themselves from Pharma.
Physicians and MPOs should put considerations of their patients' welfare and the public health above those that relate to their own income, and they should be able to demonstrate how they have sought to accomplish this goal.
Patients deserve their own personal physician who can act as counselor and advocate for their health needs. Insurance payments for specialist care should be limited to those specialist referrals made by the patient's primary care physician.
The antidote to overcommercialized specialty care is good primary care. I urge consideration of efforts by the WHO and the World Organization of Family Doctors, such as the "15 by 2015" initiative (http://www.globalfamilydoctor.com/index.asp?PageID=7802&ContType=15By2015), to strengthen the primary healthcare system worldwide.
Physician members of US MPOs should formally demand that their organizations demonstrate transparency concerning their funding and relationships with proprietary interests as well as complete disclosure of conflicts of interest among all of their leaders. They should demand that practice guidelines and recommendations of their MPOs be developed and reviewed by independent public health experts to ensure that they are consistent with the overall public health. They need to demand that MPOs implement programs that will seek to provide proper healthcare to all US residents. Physicians should seek to implement the points listed above and to resign from organizations that oppose these actions; they should support organizations that take action to implement MPO reform.
There is a bigger task that all US physicians need to undertake if they are to improve the state of US healthcare: They need to rethink what their profession is and identify what they need to do to regain their professional integrity. They must separate this professional identity from the procedures that they do and the economic rewards that they receive as a result. The professional identity and its medical ethical precepts should define what the physician does.
American medicine today, in my opinion, has been made a slave of economics. It is controlled by economic managers who regard medicine simply as a business and who ignore human needs and responsibilities. Medicine is too greatly influenced by insurance companies, Pharma, and MPOs that constrain the concept of healthcare along commercial lines and ignore human factors. They ignore physicians' responsibilities. We need to return to the traditional road that is patient-centered, where free care is freely given to the needy, where expensive and invasive procedures are avoided unless they are clearly cost-effective and substantially benefit the patient, where physician reimbursement is fair but not exorbitant or opportunistic, and where ethical precepts trump the profit margin. I believe that the control of insurance companies, Pharma, and MPOs over medical practice must be limited. A greater degree of oversight by government is needed to defend the public health. All of these parties need to focus on standards of public health that must be achieved.
In my opinion, a proper balance of medical care should be established in the United States with an eye to the need for both universal care and cost containment. This may require substantial changes in the organization and reimbursement of care. Financial conflicts of interest by physicians should be minimized. There should be a concern for improving US public health that leads to action focused on this goal. Patient needs and not the financial needs of medical practitioners and organizations should be the regulating force in the practice of medicine in the United States. There needs to be a return to the physician's role as a humane counselor and health advocate for their patients. Healthcare services that do not benefit public health should not be funded.
The health systems of other developed countries have not been damaged as much by the power of insurance companies, Pharma and the MPOs as the US healthcare system because their governments have not permitted the abuses of pricing that occur in the free market US economy. These countries are already addressing the permissible relationship between Pharma and physicians.
I believe that conflicts of interest in US medicine are just a subset of conflicts of interest throughout US culture. Politicians cannot be elected without taking money from special interests that obligate them to support policies that reward the special interests but destroy US interests. Developers bribe politicians so that they can grow wealthy by despoiling the land and environment. MPOs seek money and influence from Pharma and politicians to promote the wealth of their specialty while damaging the country's public health. Such conflicts of interest must be prevented, or at least ameliorated, if the United States is to survive in its current form.
This essay has focused on the abuses of the US MPOs, their damaging emphasis on increasing the financial welfare of their specialties without regard to public health, and their collaboration with proprietary interests to accomplish this goal. Journalists have also revealed abuses among US specialist practitioners who increase their revenue with expensive therapies and procedures that do not benefit their patients.[8] Although these examples are true, I believe that the driving forces of such inappropriate medical specialty practice are the MPOs that make financial conflicts of interest and overzealous application of expensive and unproven technologies the standard of care.
This is a time of upheaval in both the US healthcare system and the relationship of Pharma and physicians. The destructive system that I have described in this commentary is starting to collapse. The Massachusetts State Senate has voted to ban all gifts to physicians from Pharma. The AAMC has taken the position that medical schools and teaching hospitals should ban gifts to physicians, faculty, staff, students, and trainees. I urge my colleagues to become personally involved in these issues so that we can regain our profession. We can start by remembering the words that many of us spoke from the Oath of Maimonides when we graduated:
Thy eternal providence has appointed me to watch over the life and health of my fellow human beings. May the love for my art actuate me at all times; may neither avarice nor miserliness, nor thirst for glory, or for great reputation engage my mind; for the enemies of truth and philanthropy could easily deceive me and make me forgetful of my lofty aim of doing good to my patients.
References
Starr P. The Social Transformation of American Medicine. New York: Basic Books; 1982.
Wolinsky H, Brune T. The Serpent on the Staff: The Unhealthy Politics of the American Medical Association. New York: Tarcher/Putnam; 1994.
Lundberg GD, with Stacey J. Severed Trust: Why American Medicine Hasn't Been Fixed. New York: Basic Books; 2000.
Theodosakis J, Feinberg D. Don't Let Your HMO Kill You. New York: Routledge; 2000.
Mahar M. Money-Driven Medicine. New York: HarperCollins; 2006.
Angell M. Drug Companies. New York: Oxford University Press; 2004:251.
Kassirer J. On The Take. New York: Oxford University Press; 2005.
Brownlee S. Overtreated: Why Too Much Medicine Is Making Us Sicker and Poorer. New York: Bloomsbury USA; 2007.
Kassirer J. Professional societies and industry support: what is the quid pro quo. Perspect Biol Med. 2007;50:7-17. Abstract
Starr P. The Social Transformation of American Medicine. New York: Harper Colophon Books; 1982:131-134.
Bodenheimer T, Grumbach K. Understanding Health Policy. New York: Lange Medical Books/McGraw-Hill; 2005:47-49.
American Thoracic Society Web site. Financial statements for 2005. Available at: www.ats.org/financial Accessed March 30, 2007. [Financial statements are no longer publicly available on this Web site.]
Lundberg GD, with Stacey J. Severed Trust: Why American Medicine Hasn't Been Fixed. New York: Basic Books; 2000:281.
Lee C. Washington Post. Tuesday, May 22, 2007.
American College of Cardiology 56th Annual Scientific Session; March 24-27, 2007; New Orleans, Louisiana. Program and Faculty Update. 2007.
Arky RA. The family business -- to educate. N Engl J Med. 2006;354:1922-1926. Abstract
Iskowitz M. CME's New Order: Medical Education Report: Medical Marketing and Media. BNET Business Network Web site. August 2006:37-90.
Carlat D. New York Times. June 13, 2007.
US Senate Committee on Finance Letter of April 25, 2007 to Accreditation Council for Continuing Medical Education (ACCME). Available at: http://www.accme.org/index.cfm/fa/news.detail/news_id/be86b5e0-fe36-4dbc-a1a2-de6198a0e73b.cfm Accessed July 3, 2008.
Bodenheimer T, Grumbach K. Understanding Health Policy. New York: Lange Medical Books/McGraw-Hill; 2005.
Los Angeles Times. April 26, 2007.
Boden WE, O'Rourke RA, Teo KK, et al. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007;356:1503-1516. Abstract
Lawrence Grouse, MD, PhD, Clinical Assistant Professor, University of Washington School of Medicine, Seattle, Washington
Author's email: lgrouse@u.washington.edu
Disclosure: Lawrence Grouse, MD, PhD, has disclosed that he did fund-raising for US National Heart, Lung, and Blood Institute (NHLBI) projects with many US Pharma companies and with multiple international Pharma companies for nonprofit organizations founded by NHLBI and the World Health Organization.
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Tuesday 19 February 2008
Women's Health and Women's Rights
A striking feature of contemporary experience in India is the systemic failure in addressing the health needs of a majority proportion of the population. Particularly disturbing are the women's Health Indicators.
From the NFHS of 2005-2006 , we find only three statistics that are related to women's health status; All of these are matters of deep concern and indeed are only the tip of the iceberg.
1. 33% of women are malnourishd
2. 56.2 % of all women and 58% of pregnant women are anaemic as compared to26%of men
3. 37.2% of women have experienced domestic violence
R.S.Dahiya
From the NFHS of 2005-2006 , we find only three statistics that are related to women's health status; All of these are matters of deep concern and indeed are only the tip of the iceberg.
1. 33% of women are malnourishd
2. 56.2 % of all women and 58% of pregnant women are anaemic as compared to26%of men
3. 37.2% of women have experienced domestic violence
R.S.Dahiya
Friday 1 February 2008
Convention on Pharmaceuticals and People
Proceedings of Delhi Convention on Pharmaceuticals and People
10 Dec; All the initiative of FMRAI, other constituent organisations of Janswastha Avhijan like AIDAN and NCCPD together organised a national convention on ‘Pharmaceutical Policy and People’ at Banga Sanskriti Bhavan Auditorium at Delhi on 5th December.
The convention was inaugurated by Tapan Sen, M.P. and member of Consultative Committee on Chemicals and Fertilisers Ministry. Sen said people should be sensitized so that they take up medicine prices as one of the major issues. No where such a high margin of 150% to the production cost is allowed. This is not enough, difference between whole sale and retail price of many medicines are abnormally large. There are many other issues related to medicines which need to be taken up to the people. He said that the helpless nature of the Government had also affected the service and working conditions of the medical and sales representatives which is being countered well by FMRAI.
Presenting the theme of the convention Dr. Amit Sen Gupta said that Indian companies are described as copy-cats of patented medicines which is unjust since drug research in India has outbited multinational demonstration in the market. Certain safeguards have been provided in the amended patents Act but the Government is reluctant to use them. While some countries have used compulsory license to bring down prices of medicines, our Government expressed it as last resort thus have not used this safeguard.
Shantashree Chatterjee, MP said that even after 60 years of independence, we are to fight for a proper pharmaceutical policy. The healthcare system in the country is in shamble. He expressed that the convention would take up action plans which he would take up in the parliament.
Dr. Anant Pahdke from SATHI-CEHAT explained how primary health care is deliberately neglected. He said that all essential medicine should be available in all PHCs. He made several suggestions towards improvement of procurement and free of cost distribution of medicines for primary health care.
Dr. Mira Shiva of AIDAN explained the serious situation evolving out of irrational hazardous medicines. The industry is now exposing Indian women to dangerous medicines like RU-46, HRT, etc. She claimed that medicines for elderly persons should be given free of cost.
Dr. R. Senthil, MP, Secretary of Medical Parliamentarian’s Forum appreciated the initiative taken through the convention. He emphasised that health care is yet a service but not an industry. He also expressed concern that doctors are prescribing irrational medicines while IMA is yet to say against rise of prices of medicines. Similarly spurious medicines is also a big issue. He assured that all these important issues would be taken up by him in the Parliament and his Forum.
Arun Jha, Member Secretary, National Pharmaceutical Pricing Authority (NPPA) mentioned that 60 million people in India have no access to medicine is a shameful condition. Yet those who consume are severely exploited. He appreciated the note circulated by FMRAI. The commence could be empowered with better knowledge if such meetings are held more, he said.
Dr. Ram Chandra Dem, MP, expressed that there is serious lack of co-ordination among the Health Ministry, Chemical Ministry and the Commence Ministry which prevents forming a good policy. Issue of prices, irrational medicines, essential medicines, access to medicines should be taken for larger action to develop a rational pro-people medicine policy.
1.
Dr. Sujan Chakraborty, MP, appreciating the role of the organisers of the convention he said that health should form a pivotal national issue. He emphasised that public sector companies should be utilised for more availability of medicines. All process of approval and licensing should be centralised through National Drug Authority. The Government should constitute a separate Ministry for pharmaceuticals pulling out all fragmented systems of pricing, production, patents, quality, etc. from so many different Ministries.
Dr. C. M. Gulati, Editor of MIMS spoke with evidences that 18.56% of total sales of pharmaceuticals goes to promotion. He strongly felt that all marketing system should be strictly regularated. Dealing with the ills of clinical trials conducted in India he described how injury to peoples health is conducted utilising lack of vigilance of the Government and inadequacy of law.
Dr. Anurag Gupta, Janarogya Andolan spoke about anomalous situation on medicine prices. Citing examples, he presented how fallacious is price fixation system among brands, among different molecules exists. He demanded that all such injustices and irrationality should be stopped.
D. P. Dubey, General Secretary, FMRAI explained the demand of formation of all public sector medicine companies under a single one. This company will plan for production and distribution of all essential medicines.
Dr. Gopal Dabade, Karnataka Drug Action Forum and AIDAN explained the grave situation generated by the multinational Novartis Company when they challenged India Patents Act. Though Chennai High Court had rejected their case yet the company has filed another case. Consequences of such activity would come heavily on so many similar cases filed by many other companies which will force people pay very high prices of medicines. He described global actions taken against Novartis and gave a call for movement on Novartis Boycott.
The convention adopted a resolution after debate and suggestions emerged from the participants.
Draft Resolution
The Convention on “Pharmaceutical Policy and People”, organised by the Federation of Medical Representatives Associations of India (FMRAI), the Jan Swasthya Abhiyan (JSA), the All India Drug Action Network (AIDAN), and the National Campaign Committee on Drug Policy (NCCDP), held at Delhi on 5th December, 2007, in Delhi, adopts the following resolution.
Formulation of a National Pharmaceutical Policy
1. There is a the need to formulate a National Pharmaceutical Policy that addresses the critical issue of universal access to essential medicines and of national self-reliance. This policy should be prepared by an intersectoral committee of the Ministry of Health & Family Welfare and Ministry of Chemicals & Fertilizers after discussions with all sections that have a stake in the pharmaceutical sector. The two should jointly constitute a National Drugs and Therapeutic Authority, which should be a statutory body with powers to regulate all aspects of the National Pharmaceutical Policy. Apart from experts, this body should also include representatives from the health movement.
Self Reliant Production and Distribution
Given the increasing erosion in self reliance as regards production of medicines in our country, it is important that the Government monitor production of all essential medicines in the List of Essential Medicines prepared by the Ministry of Health and Family Welfare. This should be done with a view to ensuring production and availability of these medicines and it should be accompanied by a regular revision of the Essential Drugs List every two years.
To ensure production from the basic stage, ratio parameters between manufacture of formulation and bulk drugs should be reintroduced and production control mechanisms should be introduced to ensure that all manufacturers produce a certain proportion of drugs from the National List of Essential Medicines.
The production of drugs for the poor and the neglected diseases can only be ensured by making public sector companies major producers in these areas. The Govt should constitute a single company comprising of all public sector medicines companies run by the Central Govt. The company should be provided support in the form of adequate resources, access to technology, sectoral reservation, preferential treatment in the cases of Govt. purchases, etc.
For procurement of medicines for public institutions the Government should follow the model of pooled purchasing of drugs followed successfully in some states like Tamilnadu, based strictly on the Essential Medicines List.
Price Control and Regulation
It is estimated that expenditure on medicines in India constitutes more than half of the total health care expenditure and further that 80% of health care expenditure is met by patients themselves. It is thus clear that medicine prices act as a serious impediment in the access to essential medicines. Over the past two decades the pharmaceutical industry has been allowed increasing freedom to hike prices of medicines. The industry is also known to circumvent, and in many cases, violate existing regulations of price control. To remedy the situation the convention urges upon the government to:
Bring all medicines under price control, using mechanisms that are transparent and easy to administer. The system of price control should benefit the efficient producer. In no case should the mark up allowed be more than 100%.
Excise Duty on all essential medicines should be abolished. The NPPA should be provided with the infrastructure to monitor prices of all medicines and should be empowered to prosecute companies for violation of price regulations.
All illegal profits earned by companies, in violation of price regulations, should be recovered a special Tribunal should be established for this purpose, with a clear time frame of action.
Prices of all bulk medicines should be under price control.
No differential ceiling prices should be allowed.
One ceiling price for all medicines.
Fake/Counterfeit Medicines:
The Drugs and Cosmetics Act, should be amended so as to provide for stringent and deterrent punishment to be the fake medicine makers and sellers. An empowered commission should investigate the continued menace posed by production and sale of fake medicines, and such a commission should have adequate representation from consumers.
State level cells should be constituted to gather complaints from consumers and to recommend appropriate actions.
Unethical business practices like dumping of sales across state borders to evade taxes, suspension of sales, and sale of medicines intended for institutional procurement in the open market, should also be investigated and punished.
Irrational Medicines:
The recent release, by the DGCI, of a list of over 300 fixed dose combinations (FDCs) that have not been approved by any Drug Regulatory Agency in India, points to the rampant violation of law in the country and the consequent proliferation of irrational medicines. The list circulated by the DGCI is grossly inadequate, and also does not include a very large number of irrational medicines that have been approved based on incorrect premises. In this context the Convention urges the Government to:
As an immediate measure, prepare a comprehensive list of drugs and their combinations that are being sold in the market but have never been approved by regulatory agencies in India. Such a list should be immediately circulated in all news papers, including mention of the corresponding Brands of these illegal medicines.
All these FDCs should be declared banned under Sec.26A of Drugs & Cosmetics Act.
All state Licensing Authorities should be given a strict timeframe, within which they should be required to withdraw such illegal FDCS, and any delay on this count should be punishable.
Set up a special committee to weed out all irrational medicines and their combinations, including those that have been approved based on erroneous considerations, within a stipulated period.
Henceforth medicines and fixed dose combinations which are not mentioned in standard text books and other such authentic sources of pharmacological information should not be allowed to be marketed. Medicines banned in other countries having developed regulatory agencies [or in the country of origin] should be stringently evaluated, in this context.
For registration and production of all new medicines and their combinations, a single system of control should be introduced.
All existing medicines should be re-evaluated at regular intervals on the basis of expert opinion on their rationality, efficacy, and need.
No change of ingredient of a particular brand should be allowed.
The definition of a drug, as provided in the Drugs and Cosmetics Act, should be applied strictly, so as not to allow exceptions for irrational medicines like “tonics”, “anti-oxidants” etc.
Indian Patent Act
The Government should keep advocating for keeping TRIPS out of the WTO and also advocate for reopening the issue of exempting developing countries from providing for Product Patents in the case of medicines.
It should ensure that all the flexibilities in the Act are used to promote health and development of the domestic drug industry.
The Government should closely monitor the application of Patentability criteria for granting of Patents to ensure that trivial Patents are not allowed and ever greening of existing Patents does not take place.
The Government should liberally interpret the Doha Declaration of 2001 by declaring situations of emergency/urgency in the case of diseases that are present in epidemic or endemic forms or where their prevalence constitutes a health emergency. In such situations Compulsory licenses should be issued without delay.
Govt. should also facilitate the issue of compulsory licenses to remedy situations of non availability or high price of a patented drug or where an export is not being addressed.
Provision of Data Exclusivity is not a requirement under the TRIPS agreement, and should not be provided for now or in the future.
The Government should ensure that the challenge by Novartis to the rejection of its Patent application for its anti-cancer drug (Gleevec) is adequately contested, and that the earlier ruling of the Patent Controller, rejecting the Patent application, is not overturned.
The Government should immediately appoint a new committee to replace the now disgraced Mashelkar committee, in order to examine afresh the twin issues of (i) definition of a pharmaceutical entity, (ii) patenting of micro-organisms. The report of the Mashelkar Committee, which still finds place on Government websites, should be categorically rejected by the Government.
The Government should set up a cell under the aegis of the Ministry of Health, that would have the responsibility to examine all Patent applications that relate to Health, in order to give a final opinion to the Patents office whether the application conforms to the three basic requirements of patentability – novelty, usefulness and commercial application. A similar mechanism exists in Brazil and the Indian Government could draw from that experience.
Unethical Promotion:
The Magic Remedies (Objectionable Advertisement) Act, 1954 being outdated should be scrapped. A code of ethics for all prescription and OTC medicines should be prepared and be incorporated to Drugs & Cosmetics Act.
Programme of Action
Based on the above demands the convention decides to take up the following activities:
a) Campaign Committees be formed in all States.
b) Campaign for revitalisation of the public sector and observe a day when a nationwide call would be given to promote this campaign.
c) Deputations to meet state drug controllers for regulation of prices and weeding out of irrational medicines.
d) Consider filing a Public Interest Litigation and/or initiate other measures for weeding out of irrational medicines.
e) A campaign booklet shall be prepared listing the areas of concern, to take forward the campaign.
f) Organise Public hearing on medicine prices and irrational medicines.
g) Discussion with the concerned Ministries to be sought for pursuing the above demands.
h) Launch a wide campaign against unethical business practices and unethical promotion by drug companies, and follow up with the filing of specific complaints to relevant agencies against such practices.
i) Campaign among the medical students and medical practitioners on issues related to rational use of drugs.
j) Promote and intensify the Boycott Novartis Campaign among medical professionals till Novartis ceases its challenge against the rejection of its Patent application on Gleevec.
k) Campaign on unethical promotion among the medical community
l) JSA urges upon the Ministry to ensure availability of anti-anemic medicines and shall develop state wise campaign for makig thm available.
Proceedings of Delhi Convention on Pharmaceuticals and People
10 Dec; All the initiative of FMRAI, other constituent organisations of Janswastha Avhijan like AIDAN and NCCPD together organised a national convention on ‘Pharmaceutical Policy and People’ at Banga Sanskriti Bhavan Auditorium at Delhi on 5th December.
The convention was inaugurated by Tapan Sen, M.P. and member of Consultative Committee on Chemicals and Fertilisers Ministry. Sen said people should be sensitized so that they take up medicine prices as one of the major issues. No where such a high margin of 150% to the production cost is allowed. This is not enough, difference between whole sale and retail price of many medicines are abnormally large. There are many other issues related to medicines which need to be taken up to the people. He said that the helpless nature of the Government had also affected the service and working conditions of the medical and sales representatives which is being countered well by FMRAI.
Presenting the theme of the convention Dr. Amit Sen Gupta said that Indian companies are described as copy-cats of patented medicines which is unjust since drug research in India has outbited multinational demonstration in the market. Certain safeguards have been provided in the amended patents Act but the Government is reluctant to use them. While some countries have used compulsory license to bring down prices of medicines, our Government expressed it as last resort thus have not used this safeguard.
Shantashree Chatterjee, MP said that even after 60 years of independence, we are to fight for a proper pharmaceutical policy. The healthcare system in the country is in shamble. He expressed that the convention would take up action plans which he would take up in the parliament.
Dr. Anant Pahdke from SATHI-CEHAT explained how primary health care is deliberately neglected. He said that all essential medicine should be available in all PHCs. He made several suggestions towards improvement of procurement and free of cost distribution of medicines for primary health care.
Dr. Mira Shiva of AIDAN explained the serious situation evolving out of irrational hazardous medicines. The industry is now exposing Indian women to dangerous medicines like RU-46, HRT, etc. She claimed that medicines for elderly persons should be given free of cost.
Dr. R. Senthil, MP, Secretary of Medical Parliamentarian’s Forum appreciated the initiative taken through the convention. He emphasised that health care is yet a service but not an industry. He also expressed concern that doctors are prescribing irrational medicines while IMA is yet to say against rise of prices of medicines. Similarly spurious medicines is also a big issue. He assured that all these important issues would be taken up by him in the Parliament and his Forum.
Arun Jha, Member Secretary, National Pharmaceutical Pricing Authority (NPPA) mentioned that 60 million people in India have no access to medicine is a shameful condition. Yet those who consume are severely exploited. He appreciated the note circulated by FMRAI. The commence could be empowered with better knowledge if such meetings are held more, he said.
Dr. Ram Chandra Dem, MP, expressed that there is serious lack of co-ordination among the Health Ministry, Chemical Ministry and the Commence Ministry which prevents forming a good policy. Issue of prices, irrational medicines, essential medicines, access to medicines should be taken for larger action to develop a rational pro-people medicine policy.
1.
Dr. Sujan Chakraborty, MP, appreciating the role of the organisers of the convention he said that health should form a pivotal national issue. He emphasised that public sector companies should be utilised for more availability of medicines. All process of approval and licensing should be centralised through National Drug Authority. The Government should constitute a separate Ministry for pharmaceuticals pulling out all fragmented systems of pricing, production, patents, quality, etc. from so many different Ministries.
Dr. C. M. Gulati, Editor of MIMS spoke with evidences that 18.56% of total sales of pharmaceuticals goes to promotion. He strongly felt that all marketing system should be strictly regularated. Dealing with the ills of clinical trials conducted in India he described how injury to peoples health is conducted utilising lack of vigilance of the Government and inadequacy of law.
Dr. Anurag Gupta, Janarogya Andolan spoke about anomalous situation on medicine prices. Citing examples, he presented how fallacious is price fixation system among brands, among different molecules exists. He demanded that all such injustices and irrationality should be stopped.
D. P. Dubey, General Secretary, FMRAI explained the demand of formation of all public sector medicine companies under a single one. This company will plan for production and distribution of all essential medicines.
Dr. Gopal Dabade, Karnataka Drug Action Forum and AIDAN explained the grave situation generated by the multinational Novartis Company when they challenged India Patents Act. Though Chennai High Court had rejected their case yet the company has filed another case. Consequences of such activity would come heavily on so many similar cases filed by many other companies which will force people pay very high prices of medicines. He described global actions taken against Novartis and gave a call for movement on Novartis Boycott.
The convention adopted a resolution after debate and suggestions emerged from the participants.
Draft Resolution
The Convention on “Pharmaceutical Policy and People”, organised by the Federation of Medical Representatives Associations of India (FMRAI), the Jan Swasthya Abhiyan (JSA), the All India Drug Action Network (AIDAN), and the National Campaign Committee on Drug Policy (NCCDP), held at Delhi on 5th December, 2007, in Delhi, adopts the following resolution.
Formulation of a National Pharmaceutical Policy
1. There is a the need to formulate a National Pharmaceutical Policy that addresses the critical issue of universal access to essential medicines and of national self-reliance. This policy should be prepared by an intersectoral committee of the Ministry of Health & Family Welfare and Ministry of Chemicals & Fertilizers after discussions with all sections that have a stake in the pharmaceutical sector. The two should jointly constitute a National Drugs and Therapeutic Authority, which should be a statutory body with powers to regulate all aspects of the National Pharmaceutical Policy. Apart from experts, this body should also include representatives from the health movement.
Self Reliant Production and Distribution
Given the increasing erosion in self reliance as regards production of medicines in our country, it is important that the Government monitor production of all essential medicines in the List of Essential Medicines prepared by the Ministry of Health and Family Welfare. This should be done with a view to ensuring production and availability of these medicines and it should be accompanied by a regular revision of the Essential Drugs List every two years.
To ensure production from the basic stage, ratio parameters between manufacture of formulation and bulk drugs should be reintroduced and production control mechanisms should be introduced to ensure that all manufacturers produce a certain proportion of drugs from the National List of Essential Medicines.
The production of drugs for the poor and the neglected diseases can only be ensured by making public sector companies major producers in these areas. The Govt should constitute a single company comprising of all public sector medicines companies run by the Central Govt. The company should be provided support in the form of adequate resources, access to technology, sectoral reservation, preferential treatment in the cases of Govt. purchases, etc.
For procurement of medicines for public institutions the Government should follow the model of pooled purchasing of drugs followed successfully in some states like Tamilnadu, based strictly on the Essential Medicines List.
Price Control and Regulation
It is estimated that expenditure on medicines in India constitutes more than half of the total health care expenditure and further that 80% of health care expenditure is met by patients themselves. It is thus clear that medicine prices act as a serious impediment in the access to essential medicines. Over the past two decades the pharmaceutical industry has been allowed increasing freedom to hike prices of medicines. The industry is also known to circumvent, and in many cases, violate existing regulations of price control. To remedy the situation the convention urges upon the government to:
Bring all medicines under price control, using mechanisms that are transparent and easy to administer. The system of price control should benefit the efficient producer. In no case should the mark up allowed be more than 100%.
Excise Duty on all essential medicines should be abolished. The NPPA should be provided with the infrastructure to monitor prices of all medicines and should be empowered to prosecute companies for violation of price regulations.
All illegal profits earned by companies, in violation of price regulations, should be recovered a special Tribunal should be established for this purpose, with a clear time frame of action.
Prices of all bulk medicines should be under price control.
No differential ceiling prices should be allowed.
One ceiling price for all medicines.
Fake/Counterfeit Medicines:
The Drugs and Cosmetics Act, should be amended so as to provide for stringent and deterrent punishment to be the fake medicine makers and sellers. An empowered commission should investigate the continued menace posed by production and sale of fake medicines, and such a commission should have adequate representation from consumers.
State level cells should be constituted to gather complaints from consumers and to recommend appropriate actions.
Unethical business practices like dumping of sales across state borders to evade taxes, suspension of sales, and sale of medicines intended for institutional procurement in the open market, should also be investigated and punished.
Irrational Medicines:
The recent release, by the DGCI, of a list of over 300 fixed dose combinations (FDCs) that have not been approved by any Drug Regulatory Agency in India, points to the rampant violation of law in the country and the consequent proliferation of irrational medicines. The list circulated by the DGCI is grossly inadequate, and also does not include a very large number of irrational medicines that have been approved based on incorrect premises. In this context the Convention urges the Government to:
As an immediate measure, prepare a comprehensive list of drugs and their combinations that are being sold in the market but have never been approved by regulatory agencies in India. Such a list should be immediately circulated in all news papers, including mention of the corresponding Brands of these illegal medicines.
All these FDCs should be declared banned under Sec.26A of Drugs & Cosmetics Act.
All state Licensing Authorities should be given a strict timeframe, within which they should be required to withdraw such illegal FDCS, and any delay on this count should be punishable.
Set up a special committee to weed out all irrational medicines and their combinations, including those that have been approved based on erroneous considerations, within a stipulated period.
Henceforth medicines and fixed dose combinations which are not mentioned in standard text books and other such authentic sources of pharmacological information should not be allowed to be marketed. Medicines banned in other countries having developed regulatory agencies [or in the country of origin] should be stringently evaluated, in this context.
For registration and production of all new medicines and their combinations, a single system of control should be introduced.
All existing medicines should be re-evaluated at regular intervals on the basis of expert opinion on their rationality, efficacy, and need.
No change of ingredient of a particular brand should be allowed.
The definition of a drug, as provided in the Drugs and Cosmetics Act, should be applied strictly, so as not to allow exceptions for irrational medicines like “tonics”, “anti-oxidants” etc.
Indian Patent Act
The Government should keep advocating for keeping TRIPS out of the WTO and also advocate for reopening the issue of exempting developing countries from providing for Product Patents in the case of medicines.
It should ensure that all the flexibilities in the Act are used to promote health and development of the domestic drug industry.
The Government should closely monitor the application of Patentability criteria for granting of Patents to ensure that trivial Patents are not allowed and ever greening of existing Patents does not take place.
The Government should liberally interpret the Doha Declaration of 2001 by declaring situations of emergency/urgency in the case of diseases that are present in epidemic or endemic forms or where their prevalence constitutes a health emergency. In such situations Compulsory licenses should be issued without delay.
Govt. should also facilitate the issue of compulsory licenses to remedy situations of non availability or high price of a patented drug or where an export is not being addressed.
Provision of Data Exclusivity is not a requirement under the TRIPS agreement, and should not be provided for now or in the future.
The Government should ensure that the challenge by Novartis to the rejection of its Patent application for its anti-cancer drug (Gleevec) is adequately contested, and that the earlier ruling of the Patent Controller, rejecting the Patent application, is not overturned.
The Government should immediately appoint a new committee to replace the now disgraced Mashelkar committee, in order to examine afresh the twin issues of (i) definition of a pharmaceutical entity, (ii) patenting of micro-organisms. The report of the Mashelkar Committee, which still finds place on Government websites, should be categorically rejected by the Government.
The Government should set up a cell under the aegis of the Ministry of Health, that would have the responsibility to examine all Patent applications that relate to Health, in order to give a final opinion to the Patents office whether the application conforms to the three basic requirements of patentability – novelty, usefulness and commercial application. A similar mechanism exists in Brazil and the Indian Government could draw from that experience.
Unethical Promotion:
The Magic Remedies (Objectionable Advertisement) Act, 1954 being outdated should be scrapped. A code of ethics for all prescription and OTC medicines should be prepared and be incorporated to Drugs & Cosmetics Act.
Programme of Action
Based on the above demands the convention decides to take up the following activities:
a) Campaign Committees be formed in all States.
b) Campaign for revitalisation of the public sector and observe a day when a nationwide call would be given to promote this campaign.
c) Deputations to meet state drug controllers for regulation of prices and weeding out of irrational medicines.
d) Consider filing a Public Interest Litigation and/or initiate other measures for weeding out of irrational medicines.
e) A campaign booklet shall be prepared listing the areas of concern, to take forward the campaign.
f) Organise Public hearing on medicine prices and irrational medicines.
g) Discussion with the concerned Ministries to be sought for pursuing the above demands.
h) Launch a wide campaign against unethical business practices and unethical promotion by drug companies, and follow up with the filing of specific complaints to relevant agencies against such practices.
i) Campaign among the medical students and medical practitioners on issues related to rational use of drugs.
j) Promote and intensify the Boycott Novartis Campaign among medical professionals till Novartis ceases its challenge against the rejection of its Patent application on Gleevec.
k) Campaign on unethical promotion among the medical community
l) JSA urges upon the Ministry to ensure availability of anti-anemic medicines and shall develop state wise campaign for makig thm available.
10 Dec; All the initiative of FMRAI, other constituent organisations of Janswastha Avhijan like AIDAN and NCCPD together organised a national convention on ‘Pharmaceutical Policy and People’ at Banga Sanskriti Bhavan Auditorium at Delhi on 5th December.
The convention was inaugurated by Tapan Sen, M.P. and member of Consultative Committee on Chemicals and Fertilisers Ministry. Sen said people should be sensitized so that they take up medicine prices as one of the major issues. No where such a high margin of 150% to the production cost is allowed. This is not enough, difference between whole sale and retail price of many medicines are abnormally large. There are many other issues related to medicines which need to be taken up to the people. He said that the helpless nature of the Government had also affected the service and working conditions of the medical and sales representatives which is being countered well by FMRAI.
Presenting the theme of the convention Dr. Amit Sen Gupta said that Indian companies are described as copy-cats of patented medicines which is unjust since drug research in India has outbited multinational demonstration in the market. Certain safeguards have been provided in the amended patents Act but the Government is reluctant to use them. While some countries have used compulsory license to bring down prices of medicines, our Government expressed it as last resort thus have not used this safeguard.
Shantashree Chatterjee, MP said that even after 60 years of independence, we are to fight for a proper pharmaceutical policy. The healthcare system in the country is in shamble. He expressed that the convention would take up action plans which he would take up in the parliament.
Dr. Anant Pahdke from SATHI-CEHAT explained how primary health care is deliberately neglected. He said that all essential medicine should be available in all PHCs. He made several suggestions towards improvement of procurement and free of cost distribution of medicines for primary health care.
Dr. Mira Shiva of AIDAN explained the serious situation evolving out of irrational hazardous medicines. The industry is now exposing Indian women to dangerous medicines like RU-46, HRT, etc. She claimed that medicines for elderly persons should be given free of cost.
Dr. R. Senthil, MP, Secretary of Medical Parliamentarian’s Forum appreciated the initiative taken through the convention. He emphasised that health care is yet a service but not an industry. He also expressed concern that doctors are prescribing irrational medicines while IMA is yet to say against rise of prices of medicines. Similarly spurious medicines is also a big issue. He assured that all these important issues would be taken up by him in the Parliament and his Forum.
Arun Jha, Member Secretary, National Pharmaceutical Pricing Authority (NPPA) mentioned that 60 million people in India have no access to medicine is a shameful condition. Yet those who consume are severely exploited. He appreciated the note circulated by FMRAI. The commence could be empowered with better knowledge if such meetings are held more, he said.
Dr. Ram Chandra Dem, MP, expressed that there is serious lack of co-ordination among the Health Ministry, Chemical Ministry and the Commence Ministry which prevents forming a good policy. Issue of prices, irrational medicines, essential medicines, access to medicines should be taken for larger action to develop a rational pro-people medicine policy.
1.
Dr. Sujan Chakraborty, MP, appreciating the role of the organisers of the convention he said that health should form a pivotal national issue. He emphasised that public sector companies should be utilised for more availability of medicines. All process of approval and licensing should be centralised through National Drug Authority. The Government should constitute a separate Ministry for pharmaceuticals pulling out all fragmented systems of pricing, production, patents, quality, etc. from so many different Ministries.
Dr. C. M. Gulati, Editor of MIMS spoke with evidences that 18.56% of total sales of pharmaceuticals goes to promotion. He strongly felt that all marketing system should be strictly regularated. Dealing with the ills of clinical trials conducted in India he described how injury to peoples health is conducted utilising lack of vigilance of the Government and inadequacy of law.
Dr. Anurag Gupta, Janarogya Andolan spoke about anomalous situation on medicine prices. Citing examples, he presented how fallacious is price fixation system among brands, among different molecules exists. He demanded that all such injustices and irrationality should be stopped.
D. P. Dubey, General Secretary, FMRAI explained the demand of formation of all public sector medicine companies under a single one. This company will plan for production and distribution of all essential medicines.
Dr. Gopal Dabade, Karnataka Drug Action Forum and AIDAN explained the grave situation generated by the multinational Novartis Company when they challenged India Patents Act. Though Chennai High Court had rejected their case yet the company has filed another case. Consequences of such activity would come heavily on so many similar cases filed by many other companies which will force people pay very high prices of medicines. He described global actions taken against Novartis and gave a call for movement on Novartis Boycott.
The convention adopted a resolution after debate and suggestions emerged from the participants.
Draft Resolution
The Convention on “Pharmaceutical Policy and People”, organised by the Federation of Medical Representatives Associations of India (FMRAI), the Jan Swasthya Abhiyan (JSA), the All India Drug Action Network (AIDAN), and the National Campaign Committee on Drug Policy (NCCDP), held at Delhi on 5th December, 2007, in Delhi, adopts the following resolution.
Formulation of a National Pharmaceutical Policy
1. There is a the need to formulate a National Pharmaceutical Policy that addresses the critical issue of universal access to essential medicines and of national self-reliance. This policy should be prepared by an intersectoral committee of the Ministry of Health & Family Welfare and Ministry of Chemicals & Fertilizers after discussions with all sections that have a stake in the pharmaceutical sector. The two should jointly constitute a National Drugs and Therapeutic Authority, which should be a statutory body with powers to regulate all aspects of the National Pharmaceutical Policy. Apart from experts, this body should also include representatives from the health movement.
Self Reliant Production and Distribution
Given the increasing erosion in self reliance as regards production of medicines in our country, it is important that the Government monitor production of all essential medicines in the List of Essential Medicines prepared by the Ministry of Health and Family Welfare. This should be done with a view to ensuring production and availability of these medicines and it should be accompanied by a regular revision of the Essential Drugs List every two years.
To ensure production from the basic stage, ratio parameters between manufacture of formulation and bulk drugs should be reintroduced and production control mechanisms should be introduced to ensure that all manufacturers produce a certain proportion of drugs from the National List of Essential Medicines.
The production of drugs for the poor and the neglected diseases can only be ensured by making public sector companies major producers in these areas. The Govt should constitute a single company comprising of all public sector medicines companies run by the Central Govt. The company should be provided support in the form of adequate resources, access to technology, sectoral reservation, preferential treatment in the cases of Govt. purchases, etc.
For procurement of medicines for public institutions the Government should follow the model of pooled purchasing of drugs followed successfully in some states like Tamilnadu, based strictly on the Essential Medicines List.
Price Control and Regulation
It is estimated that expenditure on medicines in India constitutes more than half of the total health care expenditure and further that 80% of health care expenditure is met by patients themselves. It is thus clear that medicine prices act as a serious impediment in the access to essential medicines. Over the past two decades the pharmaceutical industry has been allowed increasing freedom to hike prices of medicines. The industry is also known to circumvent, and in many cases, violate existing regulations of price control. To remedy the situation the convention urges upon the government to:
Bring all medicines under price control, using mechanisms that are transparent and easy to administer. The system of price control should benefit the efficient producer. In no case should the mark up allowed be more than 100%.
Excise Duty on all essential medicines should be abolished. The NPPA should be provided with the infrastructure to monitor prices of all medicines and should be empowered to prosecute companies for violation of price regulations.
All illegal profits earned by companies, in violation of price regulations, should be recovered a special Tribunal should be established for this purpose, with a clear time frame of action.
Prices of all bulk medicines should be under price control.
No differential ceiling prices should be allowed.
One ceiling price for all medicines.
Fake/Counterfeit Medicines:
The Drugs and Cosmetics Act, should be amended so as to provide for stringent and deterrent punishment to be the fake medicine makers and sellers. An empowered commission should investigate the continued menace posed by production and sale of fake medicines, and such a commission should have adequate representation from consumers.
State level cells should be constituted to gather complaints from consumers and to recommend appropriate actions.
Unethical business practices like dumping of sales across state borders to evade taxes, suspension of sales, and sale of medicines intended for institutional procurement in the open market, should also be investigated and punished.
Irrational Medicines:
The recent release, by the DGCI, of a list of over 300 fixed dose combinations (FDCs) that have not been approved by any Drug Regulatory Agency in India, points to the rampant violation of law in the country and the consequent proliferation of irrational medicines. The list circulated by the DGCI is grossly inadequate, and also does not include a very large number of irrational medicines that have been approved based on incorrect premises. In this context the Convention urges the Government to:
As an immediate measure, prepare a comprehensive list of drugs and their combinations that are being sold in the market but have never been approved by regulatory agencies in India. Such a list should be immediately circulated in all news papers, including mention of the corresponding Brands of these illegal medicines.
All these FDCs should be declared banned under Sec.26A of Drugs & Cosmetics Act.
All state Licensing Authorities should be given a strict timeframe, within which they should be required to withdraw such illegal FDCS, and any delay on this count should be punishable.
Set up a special committee to weed out all irrational medicines and their combinations, including those that have been approved based on erroneous considerations, within a stipulated period.
Henceforth medicines and fixed dose combinations which are not mentioned in standard text books and other such authentic sources of pharmacological information should not be allowed to be marketed. Medicines banned in other countries having developed regulatory agencies [or in the country of origin] should be stringently evaluated, in this context.
For registration and production of all new medicines and their combinations, a single system of control should be introduced.
All existing medicines should be re-evaluated at regular intervals on the basis of expert opinion on their rationality, efficacy, and need.
No change of ingredient of a particular brand should be allowed.
The definition of a drug, as provided in the Drugs and Cosmetics Act, should be applied strictly, so as not to allow exceptions for irrational medicines like “tonics”, “anti-oxidants” etc.
Indian Patent Act
The Government should keep advocating for keeping TRIPS out of the WTO and also advocate for reopening the issue of exempting developing countries from providing for Product Patents in the case of medicines.
It should ensure that all the flexibilities in the Act are used to promote health and development of the domestic drug industry.
The Government should closely monitor the application of Patentability criteria for granting of Patents to ensure that trivial Patents are not allowed and ever greening of existing Patents does not take place.
The Government should liberally interpret the Doha Declaration of 2001 by declaring situations of emergency/urgency in the case of diseases that are present in epidemic or endemic forms or where their prevalence constitutes a health emergency. In such situations Compulsory licenses should be issued without delay.
Govt. should also facilitate the issue of compulsory licenses to remedy situations of non availability or high price of a patented drug or where an export is not being addressed.
Provision of Data Exclusivity is not a requirement under the TRIPS agreement, and should not be provided for now or in the future.
The Government should ensure that the challenge by Novartis to the rejection of its Patent application for its anti-cancer drug (Gleevec) is adequately contested, and that the earlier ruling of the Patent Controller, rejecting the Patent application, is not overturned.
The Government should immediately appoint a new committee to replace the now disgraced Mashelkar committee, in order to examine afresh the twin issues of (i) definition of a pharmaceutical entity, (ii) patenting of micro-organisms. The report of the Mashelkar Committee, which still finds place on Government websites, should be categorically rejected by the Government.
The Government should set up a cell under the aegis of the Ministry of Health, that would have the responsibility to examine all Patent applications that relate to Health, in order to give a final opinion to the Patents office whether the application conforms to the three basic requirements of patentability – novelty, usefulness and commercial application. A similar mechanism exists in Brazil and the Indian Government could draw from that experience.
Unethical Promotion:
The Magic Remedies (Objectionable Advertisement) Act, 1954 being outdated should be scrapped. A code of ethics for all prescription and OTC medicines should be prepared and be incorporated to Drugs & Cosmetics Act.
Programme of Action
Based on the above demands the convention decides to take up the following activities:
a) Campaign Committees be formed in all States.
b) Campaign for revitalisation of the public sector and observe a day when a nationwide call would be given to promote this campaign.
c) Deputations to meet state drug controllers for regulation of prices and weeding out of irrational medicines.
d) Consider filing a Public Interest Litigation and/or initiate other measures for weeding out of irrational medicines.
e) A campaign booklet shall be prepared listing the areas of concern, to take forward the campaign.
f) Organise Public hearing on medicine prices and irrational medicines.
g) Discussion with the concerned Ministries to be sought for pursuing the above demands.
h) Launch a wide campaign against unethical business practices and unethical promotion by drug companies, and follow up with the filing of specific complaints to relevant agencies against such practices.
i) Campaign among the medical students and medical practitioners on issues related to rational use of drugs.
j) Promote and intensify the Boycott Novartis Campaign among medical professionals till Novartis ceases its challenge against the rejection of its Patent application on Gleevec.
k) Campaign on unethical promotion among the medical community
l) JSA urges upon the Ministry to ensure availability of anti-anemic medicines and shall develop state wise campaign for makig thm available.
Proceedings of Delhi Convention on Pharmaceuticals and People
10 Dec; All the initiative of FMRAI, other constituent organisations of Janswastha Avhijan like AIDAN and NCCPD together organised a national convention on ‘Pharmaceutical Policy and People’ at Banga Sanskriti Bhavan Auditorium at Delhi on 5th December.
The convention was inaugurated by Tapan Sen, M.P. and member of Consultative Committee on Chemicals and Fertilisers Ministry. Sen said people should be sensitized so that they take up medicine prices as one of the major issues. No where such a high margin of 150% to the production cost is allowed. This is not enough, difference between whole sale and retail price of many medicines are abnormally large. There are many other issues related to medicines which need to be taken up to the people. He said that the helpless nature of the Government had also affected the service and working conditions of the medical and sales representatives which is being countered well by FMRAI.
Presenting the theme of the convention Dr. Amit Sen Gupta said that Indian companies are described as copy-cats of patented medicines which is unjust since drug research in India has outbited multinational demonstration in the market. Certain safeguards have been provided in the amended patents Act but the Government is reluctant to use them. While some countries have used compulsory license to bring down prices of medicines, our Government expressed it as last resort thus have not used this safeguard.
Shantashree Chatterjee, MP said that even after 60 years of independence, we are to fight for a proper pharmaceutical policy. The healthcare system in the country is in shamble. He expressed that the convention would take up action plans which he would take up in the parliament.
Dr. Anant Pahdke from SATHI-CEHAT explained how primary health care is deliberately neglected. He said that all essential medicine should be available in all PHCs. He made several suggestions towards improvement of procurement and free of cost distribution of medicines for primary health care.
Dr. Mira Shiva of AIDAN explained the serious situation evolving out of irrational hazardous medicines. The industry is now exposing Indian women to dangerous medicines like RU-46, HRT, etc. She claimed that medicines for elderly persons should be given free of cost.
Dr. R. Senthil, MP, Secretary of Medical Parliamentarian’s Forum appreciated the initiative taken through the convention. He emphasised that health care is yet a service but not an industry. He also expressed concern that doctors are prescribing irrational medicines while IMA is yet to say against rise of prices of medicines. Similarly spurious medicines is also a big issue. He assured that all these important issues would be taken up by him in the Parliament and his Forum.
Arun Jha, Member Secretary, National Pharmaceutical Pricing Authority (NPPA) mentioned that 60 million people in India have no access to medicine is a shameful condition. Yet those who consume are severely exploited. He appreciated the note circulated by FMRAI. The commence could be empowered with better knowledge if such meetings are held more, he said.
Dr. Ram Chandra Dem, MP, expressed that there is serious lack of co-ordination among the Health Ministry, Chemical Ministry and the Commence Ministry which prevents forming a good policy. Issue of prices, irrational medicines, essential medicines, access to medicines should be taken for larger action to develop a rational pro-people medicine policy.
1.
Dr. Sujan Chakraborty, MP, appreciating the role of the organisers of the convention he said that health should form a pivotal national issue. He emphasised that public sector companies should be utilised for more availability of medicines. All process of approval and licensing should be centralised through National Drug Authority. The Government should constitute a separate Ministry for pharmaceuticals pulling out all fragmented systems of pricing, production, patents, quality, etc. from so many different Ministries.
Dr. C. M. Gulati, Editor of MIMS spoke with evidences that 18.56% of total sales of pharmaceuticals goes to promotion. He strongly felt that all marketing system should be strictly regularated. Dealing with the ills of clinical trials conducted in India he described how injury to peoples health is conducted utilising lack of vigilance of the Government and inadequacy of law.
Dr. Anurag Gupta, Janarogya Andolan spoke about anomalous situation on medicine prices. Citing examples, he presented how fallacious is price fixation system among brands, among different molecules exists. He demanded that all such injustices and irrationality should be stopped.
D. P. Dubey, General Secretary, FMRAI explained the demand of formation of all public sector medicine companies under a single one. This company will plan for production and distribution of all essential medicines.
Dr. Gopal Dabade, Karnataka Drug Action Forum and AIDAN explained the grave situation generated by the multinational Novartis Company when they challenged India Patents Act. Though Chennai High Court had rejected their case yet the company has filed another case. Consequences of such activity would come heavily on so many similar cases filed by many other companies which will force people pay very high prices of medicines. He described global actions taken against Novartis and gave a call for movement on Novartis Boycott.
The convention adopted a resolution after debate and suggestions emerged from the participants.
Draft Resolution
The Convention on “Pharmaceutical Policy and People”, organised by the Federation of Medical Representatives Associations of India (FMRAI), the Jan Swasthya Abhiyan (JSA), the All India Drug Action Network (AIDAN), and the National Campaign Committee on Drug Policy (NCCDP), held at Delhi on 5th December, 2007, in Delhi, adopts the following resolution.
Formulation of a National Pharmaceutical Policy
1. There is a the need to formulate a National Pharmaceutical Policy that addresses the critical issue of universal access to essential medicines and of national self-reliance. This policy should be prepared by an intersectoral committee of the Ministry of Health & Family Welfare and Ministry of Chemicals & Fertilizers after discussions with all sections that have a stake in the pharmaceutical sector. The two should jointly constitute a National Drugs and Therapeutic Authority, which should be a statutory body with powers to regulate all aspects of the National Pharmaceutical Policy. Apart from experts, this body should also include representatives from the health movement.
Self Reliant Production and Distribution
Given the increasing erosion in self reliance as regards production of medicines in our country, it is important that the Government monitor production of all essential medicines in the List of Essential Medicines prepared by the Ministry of Health and Family Welfare. This should be done with a view to ensuring production and availability of these medicines and it should be accompanied by a regular revision of the Essential Drugs List every two years.
To ensure production from the basic stage, ratio parameters between manufacture of formulation and bulk drugs should be reintroduced and production control mechanisms should be introduced to ensure that all manufacturers produce a certain proportion of drugs from the National List of Essential Medicines.
The production of drugs for the poor and the neglected diseases can only be ensured by making public sector companies major producers in these areas. The Govt should constitute a single company comprising of all public sector medicines companies run by the Central Govt. The company should be provided support in the form of adequate resources, access to technology, sectoral reservation, preferential treatment in the cases of Govt. purchases, etc.
For procurement of medicines for public institutions the Government should follow the model of pooled purchasing of drugs followed successfully in some states like Tamilnadu, based strictly on the Essential Medicines List.
Price Control and Regulation
It is estimated that expenditure on medicines in India constitutes more than half of the total health care expenditure and further that 80% of health care expenditure is met by patients themselves. It is thus clear that medicine prices act as a serious impediment in the access to essential medicines. Over the past two decades the pharmaceutical industry has been allowed increasing freedom to hike prices of medicines. The industry is also known to circumvent, and in many cases, violate existing regulations of price control. To remedy the situation the convention urges upon the government to:
Bring all medicines under price control, using mechanisms that are transparent and easy to administer. The system of price control should benefit the efficient producer. In no case should the mark up allowed be more than 100%.
Excise Duty on all essential medicines should be abolished. The NPPA should be provided with the infrastructure to monitor prices of all medicines and should be empowered to prosecute companies for violation of price regulations.
All illegal profits earned by companies, in violation of price regulations, should be recovered a special Tribunal should be established for this purpose, with a clear time frame of action.
Prices of all bulk medicines should be under price control.
No differential ceiling prices should be allowed.
One ceiling price for all medicines.
Fake/Counterfeit Medicines:
The Drugs and Cosmetics Act, should be amended so as to provide for stringent and deterrent punishment to be the fake medicine makers and sellers. An empowered commission should investigate the continued menace posed by production and sale of fake medicines, and such a commission should have adequate representation from consumers.
State level cells should be constituted to gather complaints from consumers and to recommend appropriate actions.
Unethical business practices like dumping of sales across state borders to evade taxes, suspension of sales, and sale of medicines intended for institutional procurement in the open market, should also be investigated and punished.
Irrational Medicines:
The recent release, by the DGCI, of a list of over 300 fixed dose combinations (FDCs) that have not been approved by any Drug Regulatory Agency in India, points to the rampant violation of law in the country and the consequent proliferation of irrational medicines. The list circulated by the DGCI is grossly inadequate, and also does not include a very large number of irrational medicines that have been approved based on incorrect premises. In this context the Convention urges the Government to:
As an immediate measure, prepare a comprehensive list of drugs and their combinations that are being sold in the market but have never been approved by regulatory agencies in India. Such a list should be immediately circulated in all news papers, including mention of the corresponding Brands of these illegal medicines.
All these FDCs should be declared banned under Sec.26A of Drugs & Cosmetics Act.
All state Licensing Authorities should be given a strict timeframe, within which they should be required to withdraw such illegal FDCS, and any delay on this count should be punishable.
Set up a special committee to weed out all irrational medicines and their combinations, including those that have been approved based on erroneous considerations, within a stipulated period.
Henceforth medicines and fixed dose combinations which are not mentioned in standard text books and other such authentic sources of pharmacological information should not be allowed to be marketed. Medicines banned in other countries having developed regulatory agencies [or in the country of origin] should be stringently evaluated, in this context.
For registration and production of all new medicines and their combinations, a single system of control should be introduced.
All existing medicines should be re-evaluated at regular intervals on the basis of expert opinion on their rationality, efficacy, and need.
No change of ingredient of a particular brand should be allowed.
The definition of a drug, as provided in the Drugs and Cosmetics Act, should be applied strictly, so as not to allow exceptions for irrational medicines like “tonics”, “anti-oxidants” etc.
Indian Patent Act
The Government should keep advocating for keeping TRIPS out of the WTO and also advocate for reopening the issue of exempting developing countries from providing for Product Patents in the case of medicines.
It should ensure that all the flexibilities in the Act are used to promote health and development of the domestic drug industry.
The Government should closely monitor the application of Patentability criteria for granting of Patents to ensure that trivial Patents are not allowed and ever greening of existing Patents does not take place.
The Government should liberally interpret the Doha Declaration of 2001 by declaring situations of emergency/urgency in the case of diseases that are present in epidemic or endemic forms or where their prevalence constitutes a health emergency. In such situations Compulsory licenses should be issued without delay.
Govt. should also facilitate the issue of compulsory licenses to remedy situations of non availability or high price of a patented drug or where an export is not being addressed.
Provision of Data Exclusivity is not a requirement under the TRIPS agreement, and should not be provided for now or in the future.
The Government should ensure that the challenge by Novartis to the rejection of its Patent application for its anti-cancer drug (Gleevec) is adequately contested, and that the earlier ruling of the Patent Controller, rejecting the Patent application, is not overturned.
The Government should immediately appoint a new committee to replace the now disgraced Mashelkar committee, in order to examine afresh the twin issues of (i) definition of a pharmaceutical entity, (ii) patenting of micro-organisms. The report of the Mashelkar Committee, which still finds place on Government websites, should be categorically rejected by the Government.
The Government should set up a cell under the aegis of the Ministry of Health, that would have the responsibility to examine all Patent applications that relate to Health, in order to give a final opinion to the Patents office whether the application conforms to the three basic requirements of patentability – novelty, usefulness and commercial application. A similar mechanism exists in Brazil and the Indian Government could draw from that experience.
Unethical Promotion:
The Magic Remedies (Objectionable Advertisement) Act, 1954 being outdated should be scrapped. A code of ethics for all prescription and OTC medicines should be prepared and be incorporated to Drugs & Cosmetics Act.
Programme of Action
Based on the above demands the convention decides to take up the following activities:
a) Campaign Committees be formed in all States.
b) Campaign for revitalisation of the public sector and observe a day when a nationwide call would be given to promote this campaign.
c) Deputations to meet state drug controllers for regulation of prices and weeding out of irrational medicines.
d) Consider filing a Public Interest Litigation and/or initiate other measures for weeding out of irrational medicines.
e) A campaign booklet shall be prepared listing the areas of concern, to take forward the campaign.
f) Organise Public hearing on medicine prices and irrational medicines.
g) Discussion with the concerned Ministries to be sought for pursuing the above demands.
h) Launch a wide campaign against unethical business practices and unethical promotion by drug companies, and follow up with the filing of specific complaints to relevant agencies against such practices.
i) Campaign among the medical students and medical practitioners on issues related to rational use of drugs.
j) Promote and intensify the Boycott Novartis Campaign among medical professionals till Novartis ceases its challenge against the rejection of its Patent application on Gleevec.
k) Campaign on unethical promotion among the medical community
l) JSA urges upon the Ministry to ensure availability of anti-anemic medicines and shall develop state wise campaign for makig thm available.
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