Authors: Ken McClure
There was muted laughter.
‘Whatever the motivation, there is no doubting the damage these people have done. Senator Hillary Clinton’s “Vaccines for Children Program”, which introduced the prospect of a freeze on prices and the introduction of bulk purchase contracts, may have won her a round of applause from the American electorate but the end result for the drug industry was a whole bunch of vaccine producers throwing in the towel and deciding to call it a day. Senator Charles Schumer calling for government seizure of antibiotic patents from drug companies didn’t exactly build bridges either … Currently, he’s calling for the seizure of Tamiflu patents so that the US government can make its own arrangements for fighting pandemic ’flu. Can you really blame the drug companies for not wanting to play ball with politicians in an atmosphere like this?
‘Such companies have to deal with regulatory bodies who demand ever higher standards in the realm of safety testing before they will even consider letting products near the market place while regulatory bodies introduce ever tighter restrictions … and all because the public will accept nothing less than one hundred per cent safety where medicines are concerned.’
‘Quite right too,’ said someone out loud. It drew murmurs of agreement.
Seagate paused. ‘Let me tell you a story. Some years ago a vaccine was introduced against rotavirus. It unfortunately caused severe side-effects in something like 150 children worldwide. The press, of course, concentrated on these cases rather than the millions of other children the vaccine had protected with the result that, when a new vaccine against rotavirus came up for licensing some time later, the Food and Drug Administration (FDA) demanded that it be tested on a minimum of 60,000 individuals over a period of ten years before they would grant a full licence. A reasonable estimate would be that six million children a year died in the interim … in order to make sure that another 150 wouldn’t suffer side-effects. Still seem like a good deal?’
There was silence in the room.
‘There is no such thing as a one hundred per cent safe vaccine, ladies and gentlemen, but Joe Public’s refusal to accept that, along with the continual assertions by politicians that pharmaceutical companies are fuelled only by greed and self-interest, has led to the situation we now find ourselves in. There are now only a tiny handful of companies left with the will and the expensive, sophisticated set-ups necessary to operate in such a restrictive environment and even these are being squeezed because of the increasing threat of legal action against them from an ever more litigious society. No one in the business wants to get involved in vaccine production any more, let alone engage in the hugely expensive development of new ones … just when we need them most.’
‘But surely, if push came to shove, governments
could
take over the business of vaccine production for the vaccines we already have?’ suggested Linda Meyer. ‘I’m thinking of smallpox and tuberculosis.’
‘Forget it, Doctor. Vaccine production is a highly sophisticated business demanding specialised facilities and the knowledge and expertise that is only available in companies that have been doing it for many years. Smallpox vaccine production was run down in the aftermath of the disease being declared extinct by the World Health Organisation. We didn’t know at the time that the old USSR was full of labs stocking up with the virus which, in worst case scenario, is now being made available to terrorist groups. God knows what modifications have been made to the virus by genetic engineers. Likewise, there has been no general call for vaccination against tuberculosis for many years but the disease is making a big comeback and drug-resistant strains are becoming increasingly common. We need vaccines against AIDS and pandemic ’flu but there is no concerted effort being made to develop them. We’re running out of time, ladies and gentlemen. We need vaccines and we need them now.’
Seagate sat down.
Maltby thanked Williams and Seagate. ‘I think you can now see the problem, ladies and gentlemen. We desperately need new vaccines but nobody wants to make them. This is an impasse we have to break. Current intelligence suggests that if we don’t come up with new vaccines against plague, anthrax, botulism and tuberculosis very soon, we can say goodbye to western civilisation. The Prime Minister and the President have done their level best over the past few weeks to lean on the big players in the pharmaceutical industry and persuade them to step up their development programme, but without success. These people have decided that their shareholders come first, that there is no point in investing huge sums in developing vaccines when they’re just going to get bogged down in years of trials and testing with the added “bonus” of lawyers breathing down their necks all the time. This is why we summoned you here. We need to find a way out of this mess.’
‘Couldn’t you try a softer approach?’ asked a woman whose place card proclaimed her to be a senior adviser in the Department of Health.
‘We’ve tried schmoozing them,’ said the American sitting to the right of Maltby. He was George Zimmerman, Deputy Secretary at the US Department of the Interior. He had an air of aggression about him that Coates felt might warrant the euphemistic epithet, ‘does not suffer fools gladly’.
‘We’ve mooted tax breaks and grant incentivisation but maybe these guys are making too much money already. They’re not interested. It’s a no go.’
‘I was thinking about a more … relaxed environment for the companies to operate in …’ suggested the woman.
‘If you mean relaxing the rules and regulations about trials and tests, the FDA won’t have it. The public won’t have it. There’s already a great big spotlight shining on anything to do with drug safety. Committing political suicide isn’t going to help anyone. Our anthrax vaccine is a case in point. We’ve got the goddamn vaccine but we can’t use it to protect our boys because of some goddamned court room argument that’s been going on for years.’
‘There are some genuine concerns about the safety of that particular vaccine, Mr Secretary,’ said a silver-haired man wearing the uniform of a colonel in the British army.
‘Genuine concerns aren’t going to save your ass when the anthrax bug starts to fly, Colonel.’
‘We have to strike a balance,’ interjected Maltby quickly, trying to defuse the situation. ‘Look,’ he appealed to the room, showing the backs of his hands to the audience with raised thumbs, ‘we’re all in favour of sensible precautions but frankly, there comes a point when too much adherence to safety considerations is going to stop us getting out of bed in the morning. The public demands one hundred per cent safety when it comes to vaccines but they can’t have it … It’s not possible.’
‘What would an acceptable level of safety be, Minister?’ asked the colonel.
Maltby shrugged his shoulders and adopted a disarming smile as if he’d been asked something he couldn’t possibly answer.
Zimmerman was not so reticent. ‘If certain death is facing you, Colonel, anything with a better than fifty per cent chance of saving you is worth grabbing.’
Maltby didn’t disagree but looked as if he wished Zimmerman hadn’t quite put it that way.
‘I’m sorry, gentlemen,’ said Linda Meyer. ‘Maybe I’m missing something here but I’m really not clear about what it is you’re asking us to do …’
Maltby looked to Zimmerman who signalled with a nod that he should continue. ‘You people here are the brightest and best we have when it comes to health and security matters … on both sides of the pond. We need you to use your ingenuity and initiative to come up with answers. We need vaccines against the bacteria and viruses that threaten our security and we need them fast. Generous funding will be made available to support the best ideas and it will be channelled … discreetly … and with a minimum of bureaucracy.’
‘So you want us to succeed in persuading the drug companies to cooperate where you have failed?’ asked the woman from the Department of Health.
‘That would be one way,’ replied Maltby. ‘But maybe there are others. Who knows? We’re calling for initiative from the best minds we have.’
‘God, I need a drink,’ said Coates as he and Langley made their way to the bar. ‘What d’you make of all that?’
A waiter materialised at their table and Coates ordered two large gin and tonics.
‘Rock and hard place spring to mind,’ said Langley. ‘But let’s be honest, this is a situation that’s been waiting to happen. Public obsession with safety is grinding everything to a halt in the UK. Councils can’t put up a bloody Christmas tree without Health and Safety getting involved and lawyers getting all excited about the prospects. Kids aren’t allowed out on bicycles unless they’re encased in carbon fibre.’
‘We must make grazed knees a thing of the past,’ intoned Coates.
‘So how do we convince the boffins that they should spend time and money developing new vaccines for an ungrateful public who’ll require a public debate on
Newsnight
and a consultation with their solicitor before they’ll even consider taking them?’
Coates ran his finger lightly round the rim of his glass. ‘Well, Maltby did say that money wouldn’t be a problem … That’s a big plus.’
‘But the American pointed out that the pharmaceutical companies are already awash with cash.’
‘The
big
ones are …’
‘Would small ones have the wherewithal?’ asked Langley, picking up on Coates’ nuance.
‘They may not have the wherewithal but they do have the brains,’ countered Coates thoughtfully. ‘Some of the best biological scientists of our generation are to be found in small biotech companies. As I see it, there are three facets to the problem, design of new vaccines, testing them and finally manufacturing them on a scale large enough to protect an entire population. Let’s take it one step at a time. If you don’t have a vaccine, you don’t have anything to test or manufacture.’
‘So if I understand you correctly, you propose using government cash to help small biotech companies come up with new ones?’
‘Not quite,’ replied Coates as if he were still thinking it through. ‘We couldn’t possibly fund hundreds of small companies, knowing that most of them would fail anyway.’
‘Well, they’re certainly not going to do it themselves and the City isn’t going to touch investing in vaccines with a bargepole.’
‘I was thinking more along the lines … of a prize, a prize for success.’
Langley’s eyes opened wide. ‘You know, you may have something there. Everyone loves prizes these days. There seem to be prizes for everything. I sometimes think it can only be a matter of time before we see Wogan presenting prizes at the glittering binmen’s awards … The nominations for disposal of garden refuse are …’
‘We’d have to do it discreetly because we wouldn’t want to antagonise the big companies any more than we have already but, if the stakes were high enough, I reckon we might tempt quite a few smaller concerns to put their financial toes in the water and broaden their development base. What d’you think?’
Langley’s response was positive. ‘It would have the added attraction of limiting the entrants to those who really thought they could do it and more than that, to those who could persuade their bosses and backers that they could. Brilliant! We’d attract the brightest and best without even having to fund them unless they were successful. I think I’m going to buy you another very large drink.’
ONE
Meeting of the Special Policies and Strategies Group
Downing Street
LONDON
February 2006
There was an informal feel to the SPS group meeting in Downing Street as indeed there always was when Oliver Noones was in the chair. He favoured the gentleman’s club approach to the exchange of ideas despite the fact that two of the six people present were women. It was not the function of the group to formulate policy: this would come further down the line. Rather, it was their brief to consider all aspects of life in the UK and discuss possible courses of action without reference to political dogma.
‘Frankly, ladies and gentlemen, Her Majesty’s Government could do with some good news from you. In fact, if truth be told, HMG would welcome some good news from anyone right now such is the valley of darkness we currently find ourselves in. Trevor, Susan, I don’t suppose you’ve come up with an exit strategy from Iraq that leaves us looking good?’
Professors Trevor Godman and Susan Murray smiled but treated the question as rhetorical.
‘I feared as much. What are your conclusions on that benighted place, dare I ask?’
‘Iraq is a complete disaster,’ said Godman. ‘Public opinion is wholly against it and can’t be turned round but we can’t pull out unilaterally. If we do, it will all have been for nothing and we can kiss the special relationship goodbye.’
‘Something the American Right are keen to do anyway,’ added Susan Murray. ‘But we must make it clear to the Americans that we will not be drawn into committing any more troops. Apart from anything else, we’re overstretched as it is, so if they want to push up the ante and commit more soldiers, that’s up to them.’
‘It would also be a good idea,’ continued Godman, ‘if pressure were brought to bear on George W to back-pedal on the “war against terror” rhetoric. Nobody’s buying it any more and it’s stopping any meaningful dialogue opening up between us and Syria and Iran. Improving relations with these countries is vital in stopping the flow of weapons to subversives in Iraq.’
‘Thank you for that,’ said Noones. ‘Any thoughts on the state of play in Afghanistan?’
‘Only that no invading force has ever emerged from Afghanistan with heads held high,’ said Susan Murray.
‘Rudyard Kipling could have told HMG that,’ added Godman.
‘Maybe I’ll refrain from passing that on,’ said Noones with a wry smile. ‘And now to matters domestic.’ He turned his attention to another couple at the table. ‘Charles, Miriam, HMG is becoming more and more concerned about young people being perceived as rude, lazy and shiftless these days and how we deal with the problem is turning out to be something of a political football at the moment. As one paper put it, “Can there be any more dispiriting phrase in the English language than ‘local youths’?”’