The Cancer Journal - Volume 11, Number 6 (November-December 1998)
The medico-industrial complex - some seldom asked questions
Now that we are stopping publication of the paper version of the Journal, which will inevitably reduce its readership, we feel justified in explaining why we believe that it existence was necessary and how we are going to continue the work which we have begun. In a series of editorials, Gershom Zajicek and I have described, in our different ways, a widespread form of medical dogmatism and its counterproductive effects. This is not to question the personal qualities of clinicians and research workers. In every period of history, there have been individuals with the same motivation to advance knowledge and to heal the sick. There are no more and no fewer potential geniuses today than in the past. Rather, it is the increasingly pervasive context that we call the medico-industrial complex which seems to account for the present situation. Here, we will try to describe the relationship between this complex, which infiltrates every area of medical practice and research, and some forms of "dogmatism" in important fields.
Our argument is centred around the concept of measurable progress in human health. For cancer patients, the number of deaths which can be ascribed to cancer and the age of the patients at death are the two most important factors. Across the years, strongly contrasting periods can be discerned. Sometimes the outcome for patients changes dramatically over a limited time-span, as was the case for cancers in young people between 1965 and 1975. At other times, the clinical picture seems to stagnate for decades. This is in accordance with Thomas Kuhn's view of history.
Society changes from one period to another, and people with it. Here we will not discuss the role of religious beliefs, but no-one can deny that the present climate of materialism has a certain mystic element. This includes the worship of technical devices coupled with a faith in science as being able to embrace all knowledge. However, we will concentrate on scientific problems and the temptations of dogmatism. We will see that in three separate fields the same intransigence and determination to direct the distribution of resources towards a single ideology leaves no room for alternative approaches.
Dogmatism in genetics
Molecular biology techniques are being used by an increasing number of laboratories in a wide range of disciplines, to the extent of becoming commonplace; but molecular biology is not in itself a discipline. Some molecular geneticists have adopted the idea of Robert Sinsheimer, the initiator of the human genome project: "The ancient dreams of the cultural perfection of mankind have always stumbled against the imperfection and the limits of his inheritance. The horizons of the new eugenic era are theoretically unlimited. For the first time in history a living organism can understand its origins and work to create its future".
This is a utopic vision of the superman surrounded by a supernature. Agriculture will no longer be content to simply select species, as has been the practice since Neolithic times, but will go beyond the boundaries of speciation. Man himself will be included in this revolution, so eagerly awaited by some and so feared by others. In medicine, it will no longer be enough to seek the means of healing in nature, as before. Now the barriers between species will be broken down by technology, life will be universalized and the future taken in hand.
Molecular geneticists are now identifying, localizing and sequencing every gene with the aim, they say, of determining the roles of the corresponding proteins, each of which is a potential drug, to be produced on an industrial scale. It seems that genes can be turned into gold, whether by the philosophers' stone or a magic wand. A dream of some substance; a hundred thousand genes giving a hundred thousand possible patents and a hundred thousand new drugs. A chance not to be missed. The chemical industry, grouped around the large multinationals: Monsanto, Novartis, Hoescht-Marion-Roussel-Rhôơne-Poulenc-Rorer, Glaxo-Wellcome, Du Pont...., are concentrating on genetic engineering. The satellite biotechnology companies will have to align themselves in this direction or disappear sooner or later. There will be only one strategy for progress in medicine. No alternative, no choice, no diversity.
Dogmatism in therapeutics
To achieve a coherent strategy, therapeutics must advance simultaneously on several fronts. 1- the gradual elimination of old drugs which have not proved to be effective. 2- "evidence-based medicine". 3- the establishment of a "rigorous" classification of diseases, which will be a complement to redefining the procedure for releasing new drugs onto the market. At the moment, the complexity and cost of these procedures restricts the use of novel treatments to a small number of patients. The investment necessary is increasing with each new drug and has reached a considerable sum, so that few companies can afford to innovate. The monopoly of a small number of producers applies to the pharmaceutical industry in the same way as it does to seed suppliers.
This situation seems so inevitable that we accept it without question. We forget to ask ourselves critically on what it is based. Let us make the effort to consider some seldom asked questions. Seldom asked and even more rarely answered. Who decides on the strategy of the pharmaceutical industry, which by a knock-on effect defines the strategy of biotechnology companies and the programmes of public research laboratories? For the most part, a few people who take part in decisions made by the governing bodies of all three groups. This crossover of deciders leads to a homology in the opinions of these instances. The strongest argument is the extent of the commercial market. The most common diseases of developed countries are those which can be expected to give the best return of invested capital. This is why pseudo-innovation, in the form of me-too drugs occupies such a large place in the pharmaceutical industry. For the rest, it is clear what is important and decisions are made in advance. There can be no process of learning by mistakes and adjusting strategy in consequence: the different groups: scientists, technicians, industrialists, economists, provide each other with reasons to carry on in the same direction. The greater the resources devoted to the project, the harder it is to turn back. Science, industry and bureaucracy combine to sanction this juggernaut. In any case, the decisions were made by a consensus of experts capable of reaching the highest level of certitude. The muffled cry of disagreement from some scientists is not heard.
Progressively, a mystical quality attached to drugs is replacing moderate and reasonable use of them in combination with non drug-based therapy, which has been too hastily condemned as non scientific.
Not every symptom, syndrome or disease justifies the use of a specific drug. We cannot at the same time denounce the over-prescription of antibiotics, antidepressants, hypocholesterolemics and cytotoxic drugs and ignore the reasons for this abuse. The hope the molecular genetics will at last provide specific drugs without side-effects should be moderated in the light of the results of the first trials. Remember that the results obtained from trials of gene therapy have been much more modest than the announcements preceding them.
It is more rigorous to use drugs sparingly and to advise patients carefully about their use than to multiply prescriptions. Doctors and scientists must accept this. Do not expect this counter-escalation to be initiated by the pharmaceutical industry, whose interests are not those of the patients. Those who believe that drugs are everything should realize how dangerous it is to hold a doctrine based on the illusion of progress. The combination "genes are everything" and "drugs are everything" is becoming less convincing.
Dogmatism in epidemiology
Clinical research is largely based on the mathematical analysis of results obtained from a series of patients suffering from the same disease, at a similar stage in its progression. In order to assess innovation objectively, doctors and the pharmaceutical industry have turned to statisticians and a number of methodological constraints have emerged.
Who can argue with the necessity for this? We do not question the need to impose the basic rules of scientific experimentation on clinical trials. However, these strict methodologies have become absurdly restrictive. The status of the randomized trial has changed. From being one form of organizing clinical research among others, it is now written into the rule-book. Today, it is the only method which acceptable to the administration, to industry and to doctors themselves (although sometimes over their dead bodies).
However, this much vaunted method has, like all others, limits beyond which it is not only inefficient but even misleading. We refer the reader to a recent article by Feinstein (1) which describes precisely what can be expected of a randomized trial and what cannot. Unfortunately, this is a difficult subject to broach, since most people are firmly entrenched in their positions. Without embarking on a detailed criticism, in this editorial we would like to make three points. 1. When drawing up a clinical protocol, allowing oneself to be restricted by nosology can lead to under-exploitation of the results. Classifying patients into groups may be an experimental necessity, but should not be a point of principle. The concept of disease should not be put before the practice of medicine. 2. The complexity and cost of this sort of trial tends to limit the initial hypothesis and reduce the amount of data submitted to mathematical analysis. Since patients suffering from the same disease are a heterogeneous group, a randomized assignment protocol has to be used. It is designed to neutralize the effect of this heterogeneity in the population entering the trial. This practice means that only a part of the available data is exploited, or at least that some of the information obtained is put aside. 3. Methods of analysis exist which can include more data and, rather than neutralizing the diversity of individual cases, can use it to generate new hypotheses. As well as having no legal value, such methods are rejected by medical journals because they are not classical.
We should ask ourselves what lies behind these three forms of dogmatism. We think that they give food for thought and that many seldom asked questions will occur to the reader. We have cited three areas in which the same attitude can be seen. All three are closely associated with what we call the medico-industrial complex. Is this a coincidence? If not, what are the interests and the forces in play? Are we drifting towards a dogma in which only the persistent scientism of the medical and biological milieu, fascinated by a poorly controlled technological revolution, counts? We do not think so, but we have decided not to be trapped by the frequently asked questions (FAQ) which insidiously limit the opening of minds and the freedom to travel by other routes.
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1. Feinstein Problems of randomized trials
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