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Making sense of the drug-testing debate.

WITH the 'single market' almost upon us, pharmaceutical companies will view the new Europe with mixed feelings. The consensus within the European Community concerning the licensing requirements for new drugs, suggests that both the level of company profits and the health of the Community will be artificially depressed for the foreseeable future. For sure, there are healthy profits to be made, and the Europeans are not dropping like flies, but both profits and health would undoubtedly benefit if Brussels only tackled the sacred cow of drugs' testing by the horns.

Up until the 1960s European testing requirements were weak or non-existent. Following the discovery of teratogenic effects of thalidomide in the early 1960s however, there was a disorganised scramble for legislation, and by the early 1970s most European countries had passed laws laying down strict requirements for the licensing of new products. Disaster legislation is often hasty, and tends to run rough shod over individual and corporate liberties -- the drug regulatory laws were no exception.

The wave of legislation in the 1960s sent shock waves through the European pharmaceutical industry. The new licensing laws laid down testing and development requirements that were so strict that innovating companies soon had to suffer development costs averaging above 10 per cent of gross output. The United Kingdom is fairly typical in this respect. Between 1953 and 1990, spending on development activities leapt from |pounds~3,000,000 to |pounds~1,082,000,000 -- an increase from 24 per cent to 16.1 per cent of gross output, inordinately high by general manufacturing standards. (Indeed, the figure for research and development for general manufacturing has remained largely unchanged since 1966, hovering about the 2 per cent mark.) One significant outcome of the safety legislation, one with obvious implications for the running of a free pharmaceutical market, was that drug innovation was placed way out of reach of all but the largest multinational companies.

Since the 1960s, the time required for the development of drugs has lengthened considerably. The development phase for a new medicine from discovery to marketing is typically now more than 10 years, whereas the figure for the early 1960s was more in the order of three years. Of course legislation is not the only factor in this development. The drugs being developed have shifted from active chemicals that combat specific diseases, to drugs that alleviate long term conditions, so obviously some of these will require longer testing; however, the existing regulations ensure that even those products that do not require such timescales are tested for an artificially long period.

The legislation was also felt by consumers. The laws were designed to minimise the risk of new drugs for consumers. This they undoubtedly did, but they also minimised the availability of new and potentially beneficial products. In the United Kingdom in 1970, |pounds~ 30,000,000 was spent on research and development, with the introduction of 22 new chemical entities onto the market. In 1990, however, |pounds~1,082,000,000 was spent on introducing 24 products. What we see here is an enormous increase in development costs, with little greater development of life-enhancing products.

There is no doubt that the goals of legislation were noble. The statute books were reached for in order to protect the innocent consumer from the risk of harm from untested drugs, and this is a goal that we as consumers all endorse. Indeed, it is also in pharmaceutical companies' interests to ensure that the adverse effects of their products are minimised. This onus on product safety applies to any industry.

We can see then that when it comes to the safety of the consumer, governments and pharmaceutical companies tend to agree. Indeed, governments and companies do not differ even in the matter of degree of safety: along with national governments pharmaceutical companies wish to minimise the adverse effects of their products as much as is possible. Consumers of course, being consumers, subscribe to this goal as well: they want the drugs they take to be as safe as possible. So it seems that when it comes to product safety, we have agreement. Governments, companies and consumers all agree that the new drugs coming out on the market should be as safe as possible.

But of course these are not the only goals subscribed to by the sectors involved, and this is where the consensus breaks down. Running the risk of simplifying what is complex, I will attempt to characterise the goals of the three parties:

The consumers:

To be treated effectively with new drugs that are as safe as possible.

To have access to new improved products that are as safe as possible.

To pay as little as possible for the new drugs.

The companies:

To produce new drugs that are as profitable and as safe as possible.

To exploit the patent as much as possible.

To reduce the development time and expense as far as possible.

The governments:

To register new drugs that are as safe as possible.

To encourage the indigenous pharmaceutical industry.

To minimise state expenditure on drugs as far as possible.

All three sectors agree that the new drugs people take should be as safe as possible. Each sector however has other goals of equal or overriding importance, and each will wish to maximise these goals as far as possible. Taking for a moment the utilitarian view that the goal of any political system (and the pharmaceutical industry is such a system) should be the maximisation of happiness for all involved, and accepting that the maximisation of goals brings with it a kind of governmental, corporate or individual happiness, then the best of all worlds would see the maximisation of all of these goals. I for one can see a way forward such that each one of these goals can be maximised.

The key lies in the degree of legislation. Taking the utilitarian viewpoint, we can see that most governments' reactions to the drug disasters went over the top by pursuing the one common goal overzealously, thus blocking the other important goals of each sector. Legislating that a new product be thoroughly tested before being made available to the public was an honourable move, and it certainly did increase the protection of the consumer. But did it go too far? The length of time imposed by European governments varied from six to ten years for the testing and development of new drugs. Taking eight years to be typical, is such a length of time appropriate? Taking the utilitarian stance, such a period seems way over the top, for in going so far, the legislation hinders the attainment of every other goal I have listed:

Firstly, testing is inordinately expensive. To get a new drug out from the laboratory and into the pharmacies can cost companies in excess of |pounds~120,000,000. A sizeable chunk of this goes on testing. Every year spent on testing lessens company profits.

Secondly, as has been the case in the past, if a patent runs for twenty years, every year spent testing lessens the time available to exploit the patent monopoly.

Thirdly, because of the expense of development and testing, medium sized indigenous companies are unable to develop new products other than generic drugs in the highly competitive post patent market.

Fourthly, the expense of development and testing is off-loaded onto the consumer and the state.

Fifthly, the consumer is denied access to new potentially beneficial products.

Each of the goals of state, government and consumer is sacrificed in pursuit of consumer safety. Do we really need this amount of testing? Take for instance an eight year period -- about average in Europe. It is common knowledge in the pharmaceutical industry that a period of half that length is all that is needed to test a product such that it could for all practical purposes be called 'safe' in the sense that an adverse reaction to the drug would occur in less than one in 10,000. The extortionate expense of testing for another four years, while meaning an increase in testing and development costs of close on 100 per cent could only result in an increased safety factor of 10 per cent.

Of course it is a lunacy that multinational pharmaceutical corporations are willing to play along with, as the profits on patent monopolies are still good, however it is a lunacy that not only hits company profits, but also restricts the freedom of the consumer and inhibits the activities of medium sized corporations, who must go cap in hand to the multinationals to do the required testing for them. The pursuit of safety is as good as done after four years; pursuing it for another four years does little to further this goal, but does much to strike at the availability of beneficial drugs to the consumer, and much to keep the pharmaceutical economy as a two tier system.

It is time for governments to strike a blow for the consumer, and to stop patronising those who would benefit from new improved products. Government bodies are pursuing safety in the pharmaceutical industry to a point that would be unthinkable in the automobile or tyre industry, both of whom produce potentially life-threatening products. To attempt to eliminate all risk from drug taking is impossible. A balance must therefore be struck. To pursue the goal of safety after the point where tiny increases in safety cost inordinate amounts of time and money means that one begins to ride roughshod over individual and corporate liberties.

That all drugs hold some risk for the consumer should not be something that is left unsaid. It should be accepted by consumers, companies and governments alike. We live in a culture in which drugs are perceived to be risk free, once they have been through the prescribed testing. They are not, and never will be. New drugs will always have undesirable effects upon the few. Such unlucky consumers should be empowered. They should be informed of the minimal risks, and given a clear and efficient route to compensation should the worst come to the worst. If companies had clear comprehensible compensation schemes for such mishaps, and paid out promptly, the image of pharmaceutical companies as self-interested and misleading might disappear. The money saved from four years' further testing would easily cover the costs, the product would be available to the consumer four years earlier, and -- who knows? -- medium sized companies might even enter the race.

|Mark Neal is a lecturer in Industrial Sociology at the University of Reading.~
COPYRIGHT 1993 Contemporary Review Company Ltd.
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Author:Neal, Mark
Publication:Contemporary Review
Date:Apr 1, 1993
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