Over the past decade, the pharmaceutical industry has worked wonders with its image. In the aftermath of the Opren scandal (an anti-arthritic drug with the unfortunate side-effect of causing liver failure) and the over-promotion of “addictive” minor tranquilisers such as Valium, the term “multinational drug company” was almost synonymous with sharp practice and extravagant profit – but no more.
The big player in Britain, Glaxo Wellcome, is now commonly perceived as an almost philanthropic organisation supporting, on an enormous scale, basic scientific research in our universities. Its annual award for science writers – besides providing the opportunity to drink a lot of champagne in congenial surroundings – helps to keep journalists “sympathetic”, and Glaxo’s charismatic chairman, Sir Richard Sykes, has successfully managed to link his company’s fortunes with the national interest – what is good for Glaxo is good for Britain. All this is just as it should be. Glaxo is highly ethical and a major employer, while its virtually unique combination of the two most progressive of ideologies – science and capitalism – almost guarantees its continued growth and prosperity.
It is thus hard to imagine the industry might be in serious trouble. But beneath the surface of the recent spat between Sykes and Frank Dobson over the Health Secretary’s refusal to permit Relenza, the new drug that kills the flu virus by blocking one of its enzymes, to be prescribed on the NHS lurks an abyss which few in the industry dare contemplate. As with all modern drugs, research and development costs ran to hundreds of millions of pounds, so Glaxo has priced Relenza at £24 per course of treatment. As the flu affects over four million people a year – many of whom will be more than grateful for something to mitigate its unpleasant symptoms – one does not have to be a mathematical genius to work out that Relenza could easily add an extra £100 million a year to the nation’s escalating drug bill.
Dobson’s decision to dig his heels in was reinforced by the deliberations of the National Institute of Clinical Excellence, whose report on Relenza found there wasn’t enough evidence of efficacy to warrant its prescription on the NHS. This points to a major shift in the previously close relationship between the government and the drug companies. In the past, decisions about licensing new compounds were based on the data produced by the manufacturers. Now Dobson has erected a further hurdle – the imprimatur of Nice – and the pharmaceutical industry does not like it one bit.
Richard Sykes, together with the chairmen of Astra Zeneca and SmithKline Beecham, wrote directly to the Prime Minister to protest at the “potentially devastating consequences” of the Relenza decision which, they said, could “wipe out at a stroke a key element of Britain’s competitive advantage in the global pharmaceutical industry”. And just in case Blair did not get the message, Sykes spelt out the implications on Radio 4. If the government persisted in creating “an adverse environment” for his industry, his company might have to “move elsewhere”.
These strong-arm tactics are readily understandable. Glaxo Wellcome may be as rich as Croesus but the company cannot hope to survive if it is denied the opportunity to earn back the vast research costs invested in new products.
This, however, is a distinct possibility which has everything to do with the changing pattern of pharmaceutical innovation over the past 50 years. The three decades following the war were a golden age of drug discovery, during which new compounds tumbled out of research laboratories.
During this period the half-dozen or so effective remedies at a doctor’s disposal mushroomed to over 2,000 and in the process transformed the therapeutic possibilities of every category of illness – infections, obviously, with antibiotics, but also childhood cancer, serious psychiatric disorders, skin, gut, liver and lung conditions.
Following the Thalidomide tragedy, the regulations governing the testing of new drugs became much more stringent, but still the flow of new products continued up until 1980 when, as the editor of the prestigious science journal Nature noticed, it had become obvious there was a “dearth of new drugs” and for two reasons.
First, most of the drugs of the golden age had been discovered by chance or accident, most notably by the screening of tens of thousands of chemicals to find those that might have some interesting or unusual therapeutic effect. By 1980, the research laboratories were scraping the barrel of these fortuitous discoveries. But second, and just as important, the very success of therapeutic innovation naturally placed a limit on the possibilities for further progress, because if doctors could now treat infections, inflammatory conditions and psychiatric illnesses, the market for new drugs was reaching saturation point.
The drug companies have therefore had no alternative other than to find new strategies to maintain their profitability. These include “the better mousetrap” – new variations of old drugs that if reformulated might prove marginally more effective, be easier to take or have fewer side-effects.
Then there have been the “useless mousetraps” promoted on the grounds they were better than no mousetrap for those grievous illnesses for which there remained no effective remedy. Thus the efficacy of drugs such as Tacrine (for Alzheimer’s) or beta interferon (for multiple sclerosis) may be scarcely detectable, but doctors are under considerable pressure from patients and their relatives to prescribe them – at a cost of thousands of pounds a year – when the alternative is to do nothing at all.
The enormous research costs – £6 billion a year for the top ten companies – involved in developing these drugs has undermined the viability of previous gilt-edged companies, forcing them to submerge their identities in a rash of mergers: SKF with Beechams, Upjohn of the United States with Pharmacia of Sweden, and Glaxo with Wellcome. But the bigger they have become, the heavier the crash if they fall – which brings us back to Relenza.
Luckily for doctors, most people laid low with a bout of flu are too ill to stagger out of bed to go down to the surgery, so they lie at home dosing themselves with whisky and paracetamol, consoling themselves in the knowledge that there is no specific treatment for flu anyway.
This, however, is not true. The drug amandadine, discovered back in 1967, can reduce the severity and duration of symptoms. This treatment (a course costs only £1.50) is not widely publicised, for doctors would otherwise be overwhelmed during the annual flu epidemic. The last thing they, and the Department of Health, want is for patients to be clamouring for a new drug – Relenza – that costs almost 20 times as much and is no more effective.
Hence Dobson’s decision. While the public image of the pharmaceutical industry has rarely been so favourable, its ability to “deliver the goods” with the sort of genuinely useful and important drug that people really need has never seemed so uncertain. Little wonder Richard Sykes is so unhappy.
The writer is a GP working in south London
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