FOOD AND DRUG ADMINISTRATION, MARYLAND – 16 OCTOBER
In a conference room on the third floor of the Lincoln Building, things were not going well for Professor Alan G.F. Milton and his team of Professor Oscar Kolsen and Dr Anton Cook. The FDA had put together an Advisory Committee to review the SuperVerve advertising. It was chaired by Professor Svetlana Kozlova, a professor at Harvard, and assisted by Dr Nicola Oliver and Dr Jacob Deller. Professor Milton was happy enough about the two doctors on the FDA panel. He’d seen them at several Yamoura events and they were probably on the company payroll. Professor Kozlova, on the other hand, had a reputation as a maverick and had been critical of prescription drug advertising in the past. An old-style medic, she had over forty years’ clinical experience. Her stern expression was heightened by her habit of frowning over her black spectacles, which perched heavily on the bridge of her nose.
The three Advisory Committee members sat on one side of a large table, littered with files and pieces of paper. Opposite them, for three uncomfortable hours, were Professor Milton and his team.
Professor Kozlova glowered across the table. ‘Professor Milton, we’ve been through your clinical trial evidence. It all happens to have taken place in Japan and the reports are signed off by Dr Juro Naga. I presume he will assist us here with our inquiry?’
‘Oh, yes, Professor, naturally.’
‘And these various other Japanese doctors who were involved in the clinical trials – will they also be made available to us?’
‘Certainly. Once they have sufficient notice.’
‘So, Professor, what you are saying is that your team reviewed the findings of the trials in Japan and effectively “localised” them for the US market?’
‘Yes, that’s it, Professor. As you know, our team has huge experience in this area. Professor Kolsen and Dr Cook also helped me in concluding that the results in Asia would genetically hold true for a North American population. I myself have specialised in the ear, nose and throat area for almost thirty years.’
‘Indeed. So, gentlemen, to keep it simple, what we have here is a long-approved antibiotic, namely a cephalosporin, and Yamoura claims to have discovered these new benefits for patients taking it now?’ said Professor Kozlova.
‘Yes, that’s an accurate summary.’
Kozlova sighed heavily. ‘Professor, doctors,’ she continued, looking them each in the eye, in turn. ‘Even at this early stage, having reviewed the papers, I have to say I am greatly concerned about the claims being made about headache relief. And claiming long-term weight loss – using data for patients recovering from just about everything from bowel inflammation to urinary tract infections to strep throats . . . just seems extraordinary.’
‘Professor, it’s all absolutely legitimate, a real breakthrough,’ replied Professor Milton, aware that Professor Kolsen beside him was fidgeting. ‘I have no doubt that when your team has had enough time to fully review all the evidence, you will be more than satisfied.’
‘We’ll see about that,’ said Professor Kozlova, closing her file firmly. ‘This whole thing stinks to me. Gentlemen,’ she said, glaring at all those around her, ‘we’ll be taking this further.’
*
Tsan Yohoto was struggling to remain calm. Bob Denman was on the phone.
‘My man at the FDA called. Off the record. Apparently, Milton got fried. We got the worst possible chairperson in Kozlova. Word is they’re going to go through all of the clinical trial reports, challenge them line by line, interview our researchers on methodology, and then throw the book at us.’
‘What will happen then?’ asked Tsan Yohoto, the anxiety clear in his voice.
Bob Denman sounded worried too. ‘My source thinks we’re almost certainly looking at a warning letter. And that requires us to cease all advertising. They may even require us to re-advertise, to correct any previous misleading statements. Apparently, Kozlova is saying it’s the worst case she’s seen since they jumped on Lamiton and Pravatsil.’
‘How long have we got?’
On the other end of the line, Bob Denman sighed. ‘Can’t be sure, Tsan, but not long. Two, three weeks at most.’
*
FIFTH PRECINCT STATION – 15 NOVEMBER
Wyse was walking through the public office, heading for the stairs, but his route was partly blocked by a local woman with a small dog on a lead, who was talking to one of the officers about a cardboard box, which was on the counter between them. The officer put his hand into the box as Wyse squeezed by with an, ‘Excuse me.’
The officer was asking, ‘Where did you find it?’
‘Over at Baruch. Just laying there in the morning when I come out. Not there last night when I walked the dog.’
Wyse would have kept going but a flash of blue and white packaging caught his eye as the officer pulled out a smaller cardboard box.
‘Huh. SuperVerve,’ read out the officer.
‘Can I see that?’ said Wyse, taking the packet. 500mg cephalosporin tablets. ‘Were they just on the street?’ he asked.
‘Yes,’ said the woman. ‘I thought I should hand them in. Maybe there’s a reward?’
‘Don’t know about that,’ said the officer.
‘Funny,’ said Wyse, peering into the box to confirm that it was filled with more boxes of SuperVerve. ‘That’s the second time I’ve come across these tablets turning up in the street. Mind if I hold on to a packet?’ he asked the officer.
‘Be my guest,’ was the reply.
‘Thanks.’
Strange. These are the tablets Anna’s company is advertising. I’ll definitely look into this. If there’s some kind of illegal trading going on, maybe I could earn a few brownie points for Anna with those Japanese guys. And a few brownie points for myself.
Back at his desk, Wyse called an old friend at the Office of the Chief Medical Examiner on East 26th Street. ‘Hey, Dan, John Wyse. How you doin’?’
‘Hey, John. I’m fantastic. Buried in evidence, from car parts to body parts. How can I help?’
‘I was hoping you could take a look at some tablets for me. SuperVerve.’
‘Oh, the ones Christopher White says are helping him make all those baskets?’
‘That’s them. I’ve had some boxes cropping up in strange situations. Just thought I’d check ’em out. See if they’re real. Might be some counterfeiting going on.’
‘No problem, John. But there’s a couple of weeks’ backlog on non-urgent stuff.’
Shit. ‘Dan, I’d really appreciate you bumping me up the line on this. For old times’ sake? I’ve got a bad feeling about these tablets.’
‘Old friends are best, John. Send ’em over and I’ll see what I can do.’
*
16 NOVEMBER
‘Options, gentlemen?’ Lumo Kinotoa was chairing an emergency meeting of the Chess Club. It had been arranged at short notice, following another call from Bob Denman in Washington. The four Chess Club members were sitting anxiously in the study of Tsan Yohoto’s apartment. The atmosphere was tense.
‘We’re running out of options,’ said Dr Naga. ‘I can offer to go and meet this Advisory Committee in Maryland and bluster it out. Might get another couple of months out of it. Problem is, if they start contacting researchers down the line, there are doctors’ and technicians’ names on the list who were never involved in any scientific work on SuperVerve.’
‘We can hardly risk that now,’ said Kinotoa. ‘We could blow everything at this stage.’
‘There is another option,’ said Kazuhiro Saito. ‘We could change the style of our adverts for the last six months of our campaign.’
‘How do you mean?’ asked Dr Naga.
‘The adverts we’ve been running, both print and broadcast, have been what they call “Product Claim” advertisements.’
‘What does that mean?’ asked Naga.
‘It means the advert mentions both the medical condition and the name of the drug to cure it, in the same advert.’
‘So?’
‘So, that type of advert is FDA regulated. However, we could switch now to what they call a “Reminder”. For example, where we name our product, SuperVerve, but don’t say what it’s used for. Or, we can advertise the symptoms or conditions we can treat, but without naming the product. We can say “Consult your healthcare provider for information”, or something similar.’
Dr Naga was puzzled. ‘Yes, I can see that we have established our brand strongly enough now that the public will make the connection between the symptoms and SuperVerve. But, what’s the point?’
‘The point, Juro, is that “Reminder” adverts and “Help Seeking” adverts are completely outside FDA control. They can do nothing about them.’
‘Ah,’ said Dr Naga. ‘Very interesting.’
There was a long silence while everyone thought. As usual, it was Tsan Yohoto who reached a conclusion first.
‘Gentlemen, we are running out of options and running out of time. Our plan is in jeopardy, but we have come too far to risk losing everything. The critical thing now is to maximise and sustain the numbers – about three million – who regularly take cephalosporin.’ He paused, and looked around at his friends. ‘Gentlemen, we must accelerate our plan. We will deflect the FDA by writing to them and undertaking to withdraw our advertising, as soon as practical. In the meantime, we throw everything into maximising sales of SuperVerve and BurgerFantastic over the next fortnight. My friends,’ he paused again and looked them each in the eye, ‘we will begin infecting the burgers with e-coli in two weeks. The first of December!’