The Revenge of Athena Science, Exploitation and the Third World The Revenge of Athena

9

Science and Health
The Redundancy of Drugs

Claude Alvares

Today's global, transnational dominated drug industry seems to be facing a crisis of legitimacy and public confidence. In many ways, the situation is similar to fifty years ago when the present drug companies were just beginning their businesses, marketing patent medicines of mostly dubious value, and thereby raising the hackles of the medical profession   the slick advertising encour­aged patients to bypass the doctor, and inaugurated a war.

It was Paul Ehrlich's discovery that some bacteria were selectively coloured by certain dyes, and therefore could also be selectively killed, that changed the basis of the drug industry's fortunes. It laid the foundation for the invention of modern medicine in a systematic manner, and enabled the companies to claim they were now securely wedded to a production system associated with modern science.

Over the past decades, however, the association of drug production with modern science has been calculatedly misused to generate a drug economy that has become not only exorbitantly costly and anti human, but whose con­nection with human illness and social need has become increasingly tenuous. The depressing situation has called forth a major reaction from health profes­sionals and consumer organizations all over the world. The pharmaceutical companies continue to receive polite, if not grudging, acknowledgement from the medical establishment, health activists and even the World Health Organization, for their contribution to public health, and much of this has recently been considerably devalued by the hard knocks delivered in the media and other forums: the drug industry has a bad name. A worldwide public is inclined to feel the industry is solely concerned with profits at the expense of health. The only consolation the companies have is that they have been joined in their corruption by most medical associations of doctors, and often, by

consumers themselves. The 'pharmaceauticalization' of modern life is the result of a voluntary conspiracy between companies, doctors and consumers at large.

If was not too long ago, in fact, that John Wyeth was selling amidopyrine as a cure for tuberculosis. The names of individual drugs may have changed in our times (amidopyrine is now a banned drug in numerous countries) but the misfit between therapeutic chemical drugs and human illness has if anything progres­sively increased. In 1984, Social Audit and the Consumers Association pub­lished Charles Medawar's The Wrong Kind of Medicine which lists over 800 ineffective, inappropriately or extravagantly prescribed drugs in the UK. This year, the Voluntary Health Association of India (VHAI) with the assistance of the All India Drug Action Network (AIDAN) issued a list of nearly 8,000 banned and bannable drugs marketed in the country. August 1985 saw the publication of Andrew Chetley's Cleared for Export, an examination of the EEC's chemical and pharmaceutical trade. Earlier, in 1981, the International Organization of Consumer Unions (IOCU) published its own report, Forty­ Four Problem Drugs. It seemed that all of a sudden the pharmaceutical compa­nies' striking achievements were beginning to be questioned at source. People were no longer asking how much was being produced, but why so much of what was produced was dangerous, therapeutically ineffective, outrageously priced, or even downright worthless.

In the Third World there was an additional problem: not only were a large proportion of drugs produced of dubious value, or banned in the advanced countries, they were irrelevant to the health needs of the majority of the popula­tion: the pattern of drug production was at variance with the needs of the community. A major seminar of scientists and drug activists held in New Delhi in 1981 decided, for this reason, that multinational drug companies had really no positive role to play in the country's health policy if their present operations were subjected to criticism of relevance, a view directly contrary to the opinion of the London Economist (12 March 1983), that Third World countries 'need the drug multinationals more than the multinationals need them'.

India's is a classic instance of the paradox of drug over production existing simultaneously with a shortage of essential medicines. The country's drug sce­nario illustrates how idealism can co exist with an almost total lack of political will; how a powerful drug lobby can continue to perpetuate manifest injustice and 'drug colonialism', despite the presence of considerable scientific talent. It is a good illustration of how a campaign for essential drugs remains grounded due to lobby interaction between drug company representatives and govern­ment officials.

According to the Planning Commission, diseases like tuberculosis, gastro­enteritis infections, malaria, filaria, leprosy, rabies and hookworm account for 17.2 per cent of morbidity and 20.8 per cent of mortality in India.(It was estimated in 1980 that 18 million people suffer from filaria in India, 10 million from tuberculosis, and 7.8 million have gastro enteritis.) The drugs required

for the treatment of these diseases include chloroquine, streptomycin, diethyl carbamazyne citrate, metranidozol, chloramphenicol, dapsone, INH etham­butol and piperazine. The actual production of these essential drugs is now not only below consumer demand, but also much below installed capacity. Annual figures over the past five years indicate that the production of these essential drugs is rapidly declining, and that production targets have been scaled down. Pfizer, for instance, produced no INH or PAS in 1983.

In contrast to essential drugs, irrational drug combinations and trivial commodities like cough syrups constituted the bulk of the market. In 1980, for instance, essential or life saving drugs comprised just Rs3.5 billion worth within an overall production total worth Rs12.6 billion. Such a distorted pat­tern of drug production directed and maintained by multinational dominance of the sector has had its own grievous consequences on the domestic industry, which has also indulged in the production of high price drug combinations of little therapeutic value at the expense of cheaper, essential drugs needed by the majority of the population.

The consequences of this are obvious to any impartial observer: diseases like TB, filaria, and leprosy remain uncontrolled, and for the victims there is pre­cious little relief. But pharmaceutical activity continues to increase sharply. Dr Mira Shiva writes:

Between 1952 and 1983 the number of production units grew by 300 per cent from 1,643 to 6,631; investment increased by 2,400 per cent from 240 million to 6,000 million rupees and bulk drug production by 1,800 per cent from 270 million to 3,250 million rupees. Inspite of this increase, drug production, distribution, etc., have not been keeping up with the health needs of our people. While on the one hand shortages of essential and life saving drugs have occurred, on the other, even rural markets have been flooded with costly brands of absolutely irrational drugs of doubtful therapeutic value and need.

The principal reason for this horrendous state of affairs is the conversion of health into a maj or new frontier for the expansion of capital. It really makes little sense for such a profit oriented system to produce drugs essential to meet the health needs of the majority of the Third World, simply because the latter have little or no purchasing power and remain outside the effective market. The lesson therefore is quite clear and irrefutable: the present pattern of drug pro­duction dominated by giant multinational corporations is totally uninterested in meeting the health needs of the populations of the Third World.

The move to get governments to work towards a policy of ensuring essential drugs is basically an effort to reform such a wayward system. All medical experts recognize that only a few important drugs are required for ill health. India how­ever is reputed to have about 60,000 formulations in the market. Switzerland has 35,000. Yet both India and Switzerland restrict the number of drugs for which

health insurance is available or reimbursements can be made. The UK's 6,500 preparations are seen as excessive by researchers like Charles Medawar.

However, the concept of 'essential drugs' is mistakenly believed to have originated with the WHO's report, The Selection of Essential Drugs published in 1977.

In 1973, for instance, the Chilean Medical Mission under Dr Salvador Allende decided that drugs should be limited to those with demonstrable therapeutic value. Allende was also keen to see that drugs not prescribed for Europeans or Americans were not available in Chile. The political repercus­sions of Allende's moves must have been serious, for within one week of the Pinochet regime taking over in September 1973, all those doctors who had participated in the new health programmes   which included emphasis on therapy based on community action rather than on swallowing pills   were assassinated.

Sri Lanka has worked with an essential drugs policy from 1959. The initiative came from another extraordinary person, Dr Senaka Bibile, who helped form the state pharmaceutical committee to launch a people oriented drug policy. The number of drugs available was slashed from 2,100 to 590. These were purchased through international tenders and marketed under their generic names. It was the attempt to extend this system to the private sector in 1972 that led to active (and successful) efforts on the part of multinationals, their home governments and Sri Lanka's own medical establishment, to destabilize the policy. Likewise, in Pakistan, a proposal to restrict the production of drugs to essentials was browbeaten by the drug industry lobby in close association with the medical establishment.

Similarly, Brazil's state run Central de Medicamentos used a restricted list of 347 drugs   but the targcl, was not the general citizen, who remained captive to the private trade, but those receiving the official minimum wage or less. The regional co operation efforts of the Andean countries also resulted in a limited list of 287 drugs. In India, in 1975, a committee appointed by the Government of India (later known as the Hathi Committee) concluded that a list of 116 drugs was sufficient for the country's basic health needs, and that these should be made available under their generic names.

It was the Mozambique government that took practical steps towards enforcing a policy concerning essential drugs. By 1977, the number of drugs in use in the country was reduced to 430, and private practice, one of the principal lobbies against judicious drug use, was abolished. In 1980, an essential drug list comprising 343 drugs was published and only such drugs could henceforth be prescribed.

The WHO initiative itself commenced with the World Health Assembly in 1975, which recommended the formulation of an Expert Committee to go into the question of a drug list. The Expert Committee eventually produced four technical reports on essential drugs (nos. 615, 641, 685, and 722). The definition of essential drugs was uncomplicated and unambiguous:

It is clear that for the optimal use of limited financial resources the available drugs must be restricted to those proven to be therapeutically effective, to have acceptable safety and to satisfy the health needs of the population. The selected drugs are here called 'essential' drugs, indicating that they are of the utmost importance, and are basic, indispensable and necessary for the health needs of the population . . . Drugs included in such a list would differ from country to country depending on many conditions, such as the pattern of prevalent diseases, the type of health personnel available, financial resources and genetic, demographic and environmental factors.

The burden of the technical reports was the drawing up of the Essential Drug List (EDL), comprising about 200 active substances which could be used to frame a standard formulary and adapted to the health needs of any given population. The technical report lists four principal advantages of such a list.

First, a reduction in the number of pharmaceutical products to be purchased, stored, analysed and distributed. Two,improvement in the quality of drug utilization, management, information and monitoring. In fact, a restricted EDL was a boon for many Third World countries handicapped by a rudimen­tary drug monitoring infrastructure, for it dramatically reduced the number of drugs that needed to be analysed and controlled.Third, stimulation of indig­enous industry.Fourth, assistance to the poorest countries in urgent need of. high priority drug programmes to solve their primary health programmes.

The Expert Committee also formulated four principles which could help as criteria to establish an EDL. First, the EDL should be a part of the country's health policy. Thus priority should be given to producing drugs of proven efficacy, safety, and covering the widest segment of the population, and neces­sary for the prevention and treatment of the most prevalent diseases. Second, only those drugs for which adequate scientific data are available from control­led studies should be selected. Third, each selected drug must meet standards of quality. Fourth, concise accurate unbiased sources of information should accompany each EDL.

In addition to the 200 drugs in the EDL, WHO also suggested a list of 4hirty complementary drugs for use in exceptional circumstances, or for rare disorders. Today there are available still briefer lists of essential drugs needed for primary or community health centres, and for emergency relief in disaster situations. All WHO contributions are itemized by their generic names.

We have already noted that a number of countries have been experimenting with limited drug lists, and in most of them, tremendous opposition was exer­cised to the idea from the company doctor cartel. The first country to legitimate its new drug policy on the basis of the EDL of the World Health Organization was also the world's poorest nation: Bangladesh. The new Bangladesh Drug Policy (BDP), promulgated in June 1982 took the world by complete surprise. Discussions on such a policy, however, had begun more than half a decade

earlier. Inspiration had come not from the WHO report but from India's Hathi Committee. But the group of professionals led by Dr Nurul Islam and Dr Zafrullah Choudhury decided that for legitimation purposes the WHO report was a safer bet. The Hathi Committee Report was not as well known, and besides, none of its recommendations had been accepted by the Indian govern­ment itself.

The method employed by the Bangladeshis should prove an object lesson to other countries planning similar action plans. An Expert Committee was first appointed, and the deliberations of this Committee were held in secret: had any of the companies, or the medical association known what was afoot, rapid efforts would have commenced to neutralize any proposed course of action. The most sensational result of the Committees' deliberations was its recom­mendation that a total of 1,707 drugs be destroyed or removed from the market within a specified period of time (4,340 brands of drugs were on sale in the country at the time). The Committee also drew up a list of 150 essential drugs 'considered adequate for most therapeutic purposes'   with a complementary list of an additional 100 odd drugs for less general health needs.

The reaction to the BPD was instantaneous. While professional health and consumer organizations all over the globe, sick and tired of drug dumping, applauded and congratulated the President, General Ershad, the drug compa­nies, led by the US Ambassador Mrs Jane Coon in person, mounted a massive counter campaign to have the policy changed.

The drug companies were clearly affronted with the suddenness of the deci­sion, and the fact that they were not informed or consulted; they were also appalled that a poor country like Bangladesh, perennially seeking international aid, should now attempt to stand up to private enterprise. There was also fear that the more dramatic aspects of the BDP might lead to a chain reaction in other Third World nations.

What the pharmaceutical giants and their home country governments had to admit, however, was that this was one of those occasions when a group of smart health professionals from the Third World had presented the organized might of the western world with a fait accompli. The massive international support that poured into General Ershad's office, in the form of letters telegrams, and media stories, strengthened the Bangladeshi bargaining position, and also, as General Ershad shrewdly realized, incidentally legitimated his regime in the eyes of the international public.

Evaluating the impact of the BDP four years later, Dexter Tiranti concluded that it was beginning to meet some of its avowed objectives: the indigenous manufacture of essential drugs has increased significantly, the country has saved scarce foreign exchange previously squandered by multinationals on trivial and therapeutically useless drugs, and the population has been safe­guarded from the atrocity of known hazardous and dangerous drugs. Drugs have been selling cheaper. As the trends set in motion will consolidate, future scenarios can only produce more significant results.

What really upset the drug companies was not that the BDP decided in favour of essential drugs, but that it eliminated most of the inappropriate ones. Drug companies know better these days than to oppose an essential drug policy, they may even co operate with a government that is concerned about such a list, in the interests of business. But what they cannot tolerate is 'unwarranted' restric­tions that inflict damage to profitability. They would welcome an essential drug policy provided it permitted them to continue doing what they have in the past. The BDP cut at the root of that proposition. As a result of its implementation, the companies' super profits were now replaced with moderate profits. Sold to other Third World countries, the formula could presage a vastly limited arena for market oriented drug production.

The BDP, in addition, vindicated the theoretical correctness of the WHO essential drug list. At the same time, its results confirmed the opinions of concerned health professionals everywhere. It is not surprising that the Phar­maceutical Manufacturers' Association of the USA 'sponsored' an 'indepen­dent' study by a Sri Lankan lawyer, who not unnaturally found the BDP to be only a qualified success. The sponsored study in question, The Puhlic Health and Economic Dimensions of the New Drug Policy of Bangladesh, written by D.C. Jayasuriya, appeared in September 1985, and sought to place the endemic problems faced by the ill equipped drug monitoring and distribution set up in Bangladesh at the door of the BDP! Its anxiety that other Third World countries would follow the example of the BDP is evident on every page; but the author lacked the courage to name the principal figure behind the BDP, Dr Zafrullah Choudhury, even while it kept alluding to his alleged self interest in the developments involving the new policy (Dr Choudhury is a founder and trustee of the Gonoshasthya Pharmaceuticals, that produces essential drugs).

The Jayasuriya study was soon followed by another study, this time master­minded by the International Organization of Consumer Unions (IOCU), which commissioned Dexter Tiranti of the Nrew Internationalist to make his own evaluation of the results of the BDP. The Bangladesh Example: Four Years On is a less hysterical, more evenly balanced account of what the BDP has achieved and what it has not. In fact, when Third World Network Coordinator, Malaysia's S.M. ldris, wrote a strongly worded letter to Dr H. Mahler, Director General of WHO, concerning the Jayasuriya study, the WHO officially responded that even the Tiranti study had not found the BDP entirely without weakness. WHO was playing games really. It is obvious that the Jayasuriya report was intended to destabilize the BDP, and delegitimate it in the eyes of drug administrators elsewhere, whereas Tiranti's study confirms the BDP's beneficial impact, and points out short comings merely to indicate that meeting them would strengthen the policy further and enhance its potential impact on Bangladesh consumers, and the rest of the world.

But what was the response of WHO itself all along? Their representative in Dhakka, Dr B. Sestak, remained totally non commital and even the Director­ General, Dr Mahler, on a visit to Dhaka in mid September, 1982, refused to

comment on the new policy. WHO was perhaps taken aback by the hostile reaction of the Americans to BDP, and whether one likes it or not, the Ameri­cans still contribute 25 per cent of WHO's budget. When Dr Choudhury sought permission to reprint the EDL report, WHO remained unco operative.

Today, things have changed. Mahler himself is more overt in his praise for the policy, and WHO is itself now irrevocably committed to the essential drugs concept. There is also the admission on the part of the multinationals that the BDP is here to stay. The WHO itself issues a regular Essential Drugs Monitor, which reports progress worldwide in the application of the EDL. Sifice the WHO launched its Action Programme around the concept in 198 1, some eighty countries are now reported to be busy drawing up strategies for such necessary drugs. In May 1984, at the World Health Assembly (WHA) the Nordic countries proposed a resolution in favour of the EDL and the Action Pro­gramme: 116 countries voted in favour, only the USA against. The issue of essential drugs came up again at the WHA of 1985 and 1986 and continued to receive unanimous support. A WHO conference of experts on the use of Ratio­nal Use of Drugs held in Nairobi in November 1985, decided to intensify WHO's leadership role in the promotion of national drug policies based on the essential drugs concept. Also important for this meeting was a decision by Mahler to acknowledge officially the role of consumer organizations in making drug use more rational, a move that clearly upset the drug lobbies. At government level, both the Non Aligned Movement and the Group of 77 have passed resolutions accepting the essential drug policy.

In Kenya, in a pilot project funded by SIDA of Canada, supplies of drug 'ration kits' containing thirty nine drugs have increased the availability of essential medicines in fifteen rural districts. The Zimbabwe regime has also selected 376 essential drugs for use in the public health system and has decided not to make available foreign exchange for those who wish to import drugs outside the list. India is one major country whose drug situation remains well and truly hopeless. A 1982 request to the editor of the Indian Mims to delete drugs recommended for weeding out by Indian experts, and to indicate drugs included in the WHO list by using capitals or italics, evoked the editorial response that the relevance of the EDL was only for struggling poor countries, not India. Likewise, Argentinian companies attacked the concept of a limited list of essential drugs, saying that Argentina 'is not a country of the Third World'.

But such attitudes are changing. The rational use of drugs, or their restriction to those that are therapeutically effective, is no longer a Third World problem. Governments in advanced countries are increasingly anxious to cut the costs in health programmes, and drugs remain by far the biggest demand on the public health purse.

Both the UK and the USA, for example, have decided to cut costs by determining that some prescriptions begin using generic names. It is estimated that by 1987, 25 per cent of all prescriptions in the USA will be filled with

generic drugs instead of 15 per cent as in 1983, leading to a saving of over one billion dollars. Norway, perhaps, has one of the best policies in this regard. It permits a list of 1,900 preparations, and keeps the list trim with a 'medical need' clause that applies to all prospective entrants: for a new drug to be registered, a company must demonstrate that it is more effective than existing ones in the market, and also safer and cheaper.

The drug companies have themselves begun to accept the WHO list as a fact of life; their only concern is that it remains applicable to 'poor countries'. Their paranoia is excited the moment government authorities seek to make the list exclusive, or, as in Bangladesh, reduce or restrict the number of drugs they wish the companies to produce. The companies continue to believe that their right to promote medicine is absolute. The WHO and health activists on the other hand, have a larger programme, not just concerned with essential drugs for the poor, but with the general 'pharmaceuticalization' of life itself, in poor and rich countries. This the drug companies refuse to see or accept.

They even attempt nowadays to collaborate with the WHO in the programme involving essential drug availability in Third World countries and cover drug colonialism with drug diplomacy. According to John Starrels in a study spon­sored by the right wing Heritage Foundation, a large number of pharma­ceutical companies have agreed to make available 140 drugs and vaccines at 'concessionary prices' to the Third World. A US drug company group's agreement to supply the Gambians with the necessary essential drugs is cited. So is the Swiss drug company programme in Burundi. But the benefits of all that are clearly stated by Starrels: 'The West's readiness,' he writes, 'to engage international health projects designed to help poverty in the Third World (espe­cially through the auspices of WHO) is but one aspect of what IFPMA's S.M. Peretz calls "enlightened self interest". This includes, of course, the commer­cial benefit that the United States and other Western countries derive from sales to Third World countries with the wherewithal to pay for them.'

The very same Peretz will also claim elsewhere that 'the world needs a research based pharmaceutical industry,' and that 'research can only be under­taken by firms whose drug prices cover research costs'. The world, adds Starrels, 'needs the contributions that only a market  orientated industry can provide'.

It is important to remember that the essential drugs campaign is basically a reformist campaign. It is a significant issue in a context in which drugs are meant to substitute for the absence of more elementary necessities, like good drinking water and proper nutrition. It is also intimately connected, in the Third World, with poverty. In the absence of people oriented development, an essential drugs list can only help mitigate the ill effects of poverty, in place of actively helping to enhance the suffering of the victims, as drugs do nowadays. Further, an EDL is worthless unless governments actually do more to encour­age the production and distribution of such drugs.

The de pharmaceuticalization of life needs a campaign as consistent and

forceful as the one that concerned breastfeeding. Most diseases are self­limiting, and often environmental conditions are the source of much ill health. Improving such conditions is a much more effective programme of enchancing public health than using chemical agents. Also to be recalled for a future agenda must be the availability of more wholesome traditional nutritional recipes, and holistic traditions of interpreting disease. We must remember that a large number of the world's population still owe their allegiance to systems other than allopathy, and for them, this whole issue of the problematic nature of modern drugs is only minor.