Healthy Skepticism Library item: 14252

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Publication type: news

Dukes G.
Development Of The Pharmaceutical Industry: How, Why, and When Corruption Came In
11th International Anti-Corruption Conference 2008 May 28
http://www.11iacc.org/iacc/html/confer_3_s9.html#a4

Notes:

Paper presented at the 11th International Anti-Corruption Conference held 25th – 28th May 2003 in Seoul, Korea.

Full text:

Development Of The Pharmaceutical Industry:
How, Why, and When Corruption Came In

Graham Dukes MD LLM

In order to counter corruption in any field, one needs to understand why it came about in the first place. In pharmaceuticals, the history is quite clear. Quite apart from the fact that this has long been a sector in which a great deal of money circulates and competition is fierce, there have been a chain of developments during the 20th century in the course of which, quite simply, money has become more dominant than science – and a great deal more influential than idealism.

The medicines industry in its present form essentially emerged during the first half of that century. By 1960, some 20 major firms had achieved considerable success by creating entirely new and beneficial pharmaceuticals, and a useful information system had been created in the form of travelling representatives visiting physicians and teaching them how the new medicines could be employed. The peak of that scientific success was perhaps attained in 1962 with the arrival of the oral contraceptives, but the fifteen years prior to that had seen the launching of better corticosteroids, the thiazide diuretics, modern antihypertensives and antidepressants, to say nothing of a family of extremely valuable new antibiotics. Riding the crest of that wave the industry had become as profitable as never before.
Thereafter, it is fair to say, some things progressively went wrong and a series of temptations arose:
Firstly, for various reasons, the research output of genuinely new and useful pharmaceuticals declined. It was as if, in some fields of drug treatment, one had now attained the best that could be achieved in the current state of knowledge. We still have no essentially better corticosteroids or oral contraceptives than those existing in the ‘sixties. New compounds are still being marketed but very few of them represented any degree of progress. It is also true that the delivery of new drugs has declined while expenditure has risen (FIGURE).
Secondly, national drug regulation rapidly came to the fore, particularly in the wake of the Softenon (thalidomide) disaster of 1961. Regulation in major markets raised a firm barrier to the sale of the second-rate and outdated items, which had supplied much of industry with useful – if questionable – back-up income. In some secondary markets, unhappily, regulation came to be entrusted to underpaid officials who were open to corrupt influence.
Thirdly, patents on some classic success drugs began to expire, a process has continued and expanded since then

But while in these various ways industry saw its financial winnings from innovation stagnating or declining, it was at the same time faced with a massive lobby of individual and corporate investors who demanded a continuation of the expansion in profits and payouts to which they had become accustomed over two decades. For such reasons, industry found itself pushed and pulled to increase its earnings in new ways; and not all those ways were pure. Where regulatory barriers could be circumvented by direct bribery, that course was adopted – corruption in the classic sense. Far more dominant and much more dangerous was however what I feel bound to call the corruption of truth. Broadly speaking that has followed two courses, and we need to recognize each of them:

S The first is based on direct advertising and selling. Inspired by hard-sell techniques from America, industry became increasingly aggressive. The travelling information staff, which it had once employed, was phased out in favour of seductive propagandists. Textual advertising was pushed up to and sometimes beyond the limits of what was ethically acceptable. Efforts were made – and have continued up to the present – to bypass the physician by fostering among the public a desire for the newest drugs. As various writers have pointed out, making use of publicly available data, large companies now spend on research less than half the amount which they do on advertising, marketing and general administration.1 Expenditure on sales-promoting activities soon greatly exceeded that on innovative research, creating a vicious circle. Whatever one thinks of aggressive advertising – and society appears to have become attuned to it – it does at least have the merit of being open and direct – one does at least know that one is being subjected to a process of persuasion, and has an opportunity to resist it.

S The second and more pernicious approach involves indirect transmission of the sales message. This is insidious: here pure commerce masquerades as news or as science. Creating news is a simple process: the facts and expectations relating to a new drug, or to a drug which is still in the course of development, are processed by professionals in public relations into such a form that they will create excitement, curiosity or frank desire. The mass media are not particularly critical towards the resulting press releases, which are commonly rushed into print or onto the air without critical assessment. A classic example of this, sufficiently long ago to be analysed in retrospect, was the pre-launch publicity for the anti-inflammatory agent benoxaprofen (also known as Opren) in the ‘eighties. Essentially, the slight evidence that its mechanism of action was somewhat different to that of existing drugs in its class was metamorphosed into a media message that this was a truly revolutionary drug – heaven’s gift to the rheumatic sufferer. Vast numbers of such patients thronged to their doctors to demand it – and only after some two hundred patients in Britain had died of liver complications did the miracle somehow evaporate and the drug disappear. Not every similar venture ends so tragically, but this type of want-creation has created a situation in which both prescribers and patients are conditioned to demand the very latest – and almost invariably the most expensive – drug irrespective of its true merits, rather than continuing to rely on well-proven medication. One of the most recent examples again relates to the anti-rheumatic drugs: the COX-2 inhibitors have been introduced with advertising and publicity which one can only describe as hysterical, suggesting a breakthrough of world-shattering dimensions, rendering obsolete the older anti-inflammatory agents which sell for a fraction of the truce. Alas and alack, current evidence from impartial workers is now tending to suggest that these newer agents are no better than those, which went before, and may be less safe.2

Equally dangerous, and today very widespread, is the manner in which commerce masquerades as science. The great bulk of clinical investigation of new drugs is today sponsored and financed by the pharmaceutical industry; that is only natural. What is unnatural, is the extent to which in many cases industry busies itself with the design of the investigational protocol, the analysis of the emergent data, and the writing of the ultimate publication. It is also well documented that, should the findings of an investigation be unwelcome to the sponsor, it is a great deal less likely to be published at all than if the conclusions were fully positive. The result is a very heavy bias in the drug literature towards the publication of papers favouring new drugs and presenting them as effective and safe – a major corruption of truth. One other tool created by industry has been the establishment of supposedly neutral and authoritative bodies engaged in medical or scientific research but which are in fact fully-owned subsidiaries designed to serve industry’s interests. Anyone encountering such institutions as the International Health Foundation, the Office of Health Economics or the Centre for Medicines Research is unlikely to suspect that they are mere puppets of the pharmaceutical companies or associations, which established them. Much of their work has been irreproachable, but their secret is to tackle issues selectively, so that only evidence favouring the industrial case emerges.

Alongside all these processes, which corrupt truth on specific issues, one sees a more general process is at work. Desperately anxious to preserve its income and profits in a relatively unfavourably situation the pharmaceutical industry has engaged in a massive public relations effort to present itself to politicians and the public as a benefactor of society which is above criticism and should not be impeded in its activities in any way. By and large it has succeeded in creating and maintaining that image, even where that has entailed flying in the face of the evidence. The result has been a curious situation in which state policies are heavily attuned to industry’s interests even where this entails a great deal of public sacrifice. The effort to contain rising health budgets – a source of concern in many countries – has been greatly impeded by the reluctance of politicians to impede the process by which familiar drugs are constantly replaced by newer and more expensive items. A graph of drug expenditure from one country with which I am familiar shows how in the course of the years successive attempts to contain rising pharmaceutical costs have been equally successively thwarted, and the process of income development for industry has continued apace – a process which can hardly be said to have adequate economic or medical justification.

Understanding these processes is a prerequisite to countering them. This panel will no doubt advance ideas as to how this might be achieved. Some initiatives have already had an effect in keeping the corruption of truth in check. One example, with which Prof. Schönhöfer is particularly familiar, is the emergence during the last two decades of independent drug bulletins providing health practitioners with an impartial view of the facts, uninfluenced by commerce. Another is the way in which the leading medical journals have developed techniques to exclude undue influence of industry on scientific papers – though of course many hundreds of other medical journals have not done so. And finally, I could point to the recent decision by the European Union, following massive consumer protest, to reject industry’s attempt to introduce manipulative direct-to-consumer advertising for prescription drugs.

However, further activities and strategies are needed to counterbalance corruptive financial influence of the industry on stakeholders and medical experts, on the selection and support of research activities, on scientific information and therapeutic guidelines, since such influences increasingly impede the quality of medical care and raise costs in many national health care systems.

1. See for example, Richard Laing (2001), paper presented to the WHO/WTO Workshop on Differential Pricing. Høsbjøor, Norway, 8-10 April. Also analysis by Zwillich T: http/www.cancerpage.com/cancernews/cancernews3008.htm

2. See for example Wright JM (2002): The double-edged sword of COX-2 selective NSAIDs. CMAJ; 167 (10) 1131-7.