Remember, Drug Companies Save Lives

It wasn’t such a long time ago that we died from what are now considered to be trivial illnesses. Simple infections carried enormous numbers of people to ghastly deaths; cancer wasn’t treatable, and many suffered terribly from chronic diseases.

The advances that have been seen in the lifetime of today’s middle-aged are incredible. Antibiotics only became available during the Second World War, medicines for peptic ulcer appeared in the 1970s and treatment for cancer came into existence just 50 years ago. If Jane Austen had been around today she would have survived tuberculosis, and been up for the Booker, while Mozart would have got over cholera but would not be competing in The X Factor.

Today it is unusual to see people die in the industrialised world from diphtheria or pneumonia, and we are at the edge of developing effective therapies for Alzheimer’s, multiple sclerosis, rheumatoid arthritis and diabetes.

But where do these marvellous advances originate from? Not, as you might imagine, from the golden glades of the University of Arcadia. The universities have elaborated hypotheses and elucidated mechanisms, but it is the profit motive and the market that have been responsible for these life-improving changes. Big Pharma, that boggle-eyed devil in the undergrowth, has brought forward virtually all the drugs that make our lives liveable.

In cancer, for example, perhaps three agents have come from university laboratories — all the rest have been produced by drug companies. And drug development is big business. On average it takes 14 years and costs £1 billion to bring a drug to market. One successful blockbuster drug can make billions in profit and fuels the next generation of research for a new profit-making blockbuster.

The general view is that drug companies are populated by dodgy villains and squint-eyed knaves in sharkskin suits, out to deceive by falsifying clinical evidence, there just to make a buck. This prejudice has perhaps been reinforced by scandals such as the suppression of information about the adverse, possibly fatal, side-effects of Vioxx, which led Merck to fork out damages of $4.8 billion. But that is unusual.

The bottom line does matter to the drug industry — and Britain has created a regulatory environment that makes it harder for them to make money and produce the drugs that we depend upon.

The process for approving drugs in the UK is slow, costly and bureaucratic. A new drug will first be licensed by the EMEA, the European drugs agency. Then, the Department of Health will set a time course for the National Institute for Health and Clinical Excellence to evaluate that new drug. NICE’s evaluation standard is a matter of great despair to patients and clinicians. Why do we despair? Not because we think that there is an unlimited public purse, and not because we think that Pharma profit should be unregulated. Our despair takes its origin from the unscientific and subjective basis for NICE judgments.

NICE evaluations are based on a complex, pseudoscientific formula that attempts to calculate the benefit of a year’s treatment or therapeutic intervention in terms of a year of a patient’s quality-adjusted life or, to use the acronym, QALY. The term QALY casts an illusion of apparent objectivity to NICE’s conclusions.

Here is one of the ways that the QALY is calculated. Imagine that you have ten years left to live. You can choose to live it in your current state or give up some years to live in full health. Mark on the line the number of years in full health that you think is of value to ten years in your current state.

If the patient puts that mark at eight years the QALY is 0.8. The formula then takes into account the cost of a whole year of treatment.

But doctors have trouble with this idea of a year’s worth of treatment. For many patients, treatment under a particular drug regime might be just for a couple of months. This is because the drugs might only benefit a third of patients treated; so for unresponsive patients treatment is stopped. That is part of the reason why the QALY calculation is a joke.

At present only 40 per cent of new drugs are considered within the timeframe set as a standard by the Government. During this timeframe, the countdown ticks inexorably towards the expiry of the drug companies’ patent. The UK market is a small fraction of the total market for drug sales — currently about 3.5-4 per cent of global drug sales. Pharma is losing patience with “process”. Many new drugs are not being put up to NICE, and we are in the position now where the UK will be excluded from using new drugs simply because Pharma doesn’t consider us a financially worthwhile market.

This particularly matters at the moment because drug companies are feeling the pinch and having to cut costs. AstraZeneca, which is losing 8,000 jobs worldwide, and GlaxoSmithKline, which is cutting its workforce by 4,000, are both looking at waste-of-time investments.

We mustn’t be a waste-of-time country for the drug company market analysts. That’s why we need to overhaul NICE before the regulator ensures that the British people don’t receive the best medicine on the market.

Jonathan Waxman is Professor of Oncology at Imperial College London

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