“How much of your production is done here?” Stefan shouted.
The group closed up and craned to hear the answer.
“Oh, just a fraction. This plant here is mainly to produce pilot quantities for clinical trials. Any serious production we subcontract to factories abroad.”
“Where are the personnel?” I asked.
Quilter pointed to a glass-fronted room on a higher level. We’d passed under it on our way in.
“Three operatives, up there. They monitor production, withdraw samples for quality control, set up different lines, all from there. Everything’s continuous flow, computer-controlled. You see the tablets coming through here? The boys and girls upstairs just have to put in a different program and it’ll change ingredients, temperatures, mixing, delivery, everything right down to the die that embosses the name and the dose. It selects the right packaging, too.”
I was impressed. “Is that unique to pilot plants like this?”
He shook his head. “Sorry, too noisy in here. Have you seen enough?”
We nodded, then accompanied him out of the production facility. The steel doors closed, extinguishing the noise and leaving behind the sensation of cotton wool in my ears. The feeling receded as we walked back towards the first building. Quilter turned to me, speaking normally now.
“To answer your question: no, there’s nothing unusual about this plant. These days every major drug manufacturer operates the same way. They have to, to remain competitive. No one makes really large batches any more. It takes up a heap of room and the stock goes out of date. With a setup like this you can make stuff to order as quickly as you could pull it out of storage.”
“Well if it’s not labour-intensive what’s the point of moving production overseas?”
“There are other costs: maintenance of the buildings and machinery, transport and handling of raw materials, an easier regulatory environment – from the safety legislation viewpoint. I don’t mean we cut corners, but out there we don’t need to staff an entire department just to prove we’re doing things the way any sensible person would.”
We entered the foyer and stopped at a lift. He pressed a button, the doors opened, and he ushered us in.
As it rode smoothly up, Quilter said:
“The message we got was something to do with counterfeit drugs. The CEO wanted to deal with it personally and that's where we're going now. I look after quality so he thought it would be useful if I tag along.”
Stefan nodded. The lift stopped and we followed Quilter along a corridor. He paused at a door, knocked and we went in.
It was a large room with what looked to me like real wood and leather in the furnishings. The CEO rose behind his desk and came round to us.
“Ray Martino,” he announced. “Good to meet you.”
His full head of wavy hair was streaked with grey, but he looked like someone who spent plenty of time at the gym and on the beach or at least in a sun lounge. Stefan made the introductions. Martino repeated each first name, his eyes dark and searching. The introductions over, he indicated some armchairs grouped around a table. From sheer habit I glanced out of the window before I sat down but the view, even from here on the sixth floor, was mostly of other buildings in the complex. Martino unfastened the single button on his well-tailored suit and settled into the remaining armchair.
“Would you like some coffee?”
We shook our heads and Stefan said, “We’re good, thanks.”
“All right. Now I gather this has to do with counterfeit drugs?”
Stefan answered for us. “Yes. Specifically, fake versions of your antimalarial Quinoxocarb.”
He withdrew one of the red and white cartons from his pocket and placed it on the table. Martino ignored it.
“All I can say to you is that the drugs marketed by us absolutely meet the quality standards we set. They’re identical in every way to the drugs that were used during each phase of the trials and subsequently approved by the FDA. There will always be imitators. We don’t have the resources to go after them. That’s a job for law enforcement agencies.”
“These aren’t conventional imitations,” Stefan persisted. “The packages, for example. We’ve examined them in painstaking detail and we can’t find anything that distinguishes them from the regular product.”
Martino smiled. “Evidently they’re very good at their job.”
Stefan recoiled a little. I was taken aback, too. I thought Martino would be outraged. Quilter seemed to be preoccupied with finding a more comfortable sitting position. Abby looked out of the window with an air of detachment that said she’d known all along we were on a wild-goose chase.
I gritted my teeth. My mind started to swim with the agonised faces of the men I’d lost. The trail of responsibility led here, to this manufacturer, to this expensively furnished room, to this man with his beautiful suit and smug manner. I wanted answers and the pressure inside me started to build.
I was just approaching ignition point when Harries intervened. For such a slight man his voice was resonant and carried surprising weight.
“Mr. Martino, let me explain why I’m here. The FDA works very hard to ensure that the drugs it licenses are safe and effective. But our job doesn’t stop there. I am with the FDA’s Center for Post-Marketing Surveillance, where we continue to monitor reports of adverse patient reactions and interactions with other drugs. Our area of concern includes any loss of effectiveness of a drug – through acquired resistance of the target organism, for example. I’m involved in that side of the work and it’s proved useful in the past for me to liaise with the PHSCC, and in particular with Dr. Dabrowski here.”
“I see,” Martino said, still smiling pleasantly. “I was wondering what your involvement was.”
Harries inclined his head, then continued:
“Now on several previous occasions I’ve presented evidence of counterfeiting to large companies like your own, and I’ve encountered a culture of denial and secrecy that I fail to understand. Take this antimalarial of yours, Quinoxocarb. Some of the poorest countries, the very countries where malaria is still endemic, have been flooded with counterfeit versions of Quinoxocarb. Resistance has spread, and the drug is rapidly losing its utility. In the face of this, I find your complacency breathtaking.”
Martino’s smile vanished. A stillness descended on the room. I could see why Stefan had suggested bringing Harries along. Had he gone too far?
Martino contemplated Harries at some length before replying.
“You have to take some of the responsibility, Dr. Harries. When I say you, I mean the regulators and government agencies in general. Just think about the economics. Take this antimalarial, Quinoxocarb. It took ten years to develop that drug and put it through all its safety tests to get FDA approval. We spent two billion dollars just to get it to that stage. At the same time we could be spending that amount or more on ten or twenty other new drugs that will never see the light of day and on which we will never turn a single penny of profit. We have to recoup all that through sales of the drugs that make it to the market. But what happens? The moment we start selling the stuff, and people realise how good it is, overseas development organisations and WHO and Oxfam and the rest of them start screaming that we’re exploiting the poor people in third world countries for profit. They want the drugs sold at a knock-down price or they’re agitating for the patents to expire early. We’re not a charity. How can we continue to innovate if we can’t make a profit when we sell the successful products?”
Harries appeared to be listening patiently. “Go on.”
“So we have to maximise margins on every drug in production. We do this by outsourcing manufacture to companies who make them cheaply for us. Those factories are usually in India, China, or Malaysia.”
“But you inspect them?”
“Oh, regularly. Isn’t that right, Craig?”
Quilter fidgeted. “Well, mainly we assess production quality by sampling what they send to us. I do go out ther
e to inspect, but only once or twice a year.”
Martino frowned. “But the quality is normally up to standard?”
“Oh, sure. We never had a problem there.”
“I’m sorry,” Harries said, “what’s the point you’re making?”
“The point I’m making is that it’s altogether harder to maintain tight control over production that’s dispersed all over the world in this way. It’s not hard to see how unscrupulous operators might be able to get their hands on the genuine material before it reaches the retail market, remake it, and sell it through channels that are outside our sphere of influence.”
There was an uncomfortable silence, broken by Stefan.
“I still don’t understand,” he said. “If they’re remaking the tablets with only ten per cent of the original dose then, okay, they can make them go ten times as far. But they’ll need ten times as many perfect packages, too. Where are they all coming from?”
Quilter reached for the package that Stefan had put on the table.
“All right if I take a close look at this one?”
Stefan pushed it towards him. “Sure, go ahead.”
We watched as he peeled open the glued joints of the package, took a magnifier out of his pocket, and began to examine it.
Stefan watched him closely. “Can you tell where it was made?”
Quilter straightened up and pointed to something, and Stefan and I leaned forward to see. On the adhesive-covered flap there was a circle with a fine red and black cross in it. Next to it was a smudge too small for me to make out.
“The circle and cross are just a registration mark to check colour alignment. The tiny figures next to it are the serial. I happen to know this one. The package was printed in China, at the factory in Guangzhou.”
I felt a surge of excitement. “So that’s where the fake drugs come from?”
“No. That’s where the packaging comes from. Like Mr. Martino said, we outsource to a lot of companies. We have a contract with this company to make the cartons and the labels. They supply all the factories making that particular drug.”
This was the lead I’d been waiting for. I switched from Quilter to Martino. “In that case, Mr. Martino, it would help our investigation if you could let us have a list of those factories.”
Martino vented a short laugh. “I’m sorry. That’s commercially sensitive information. It has to be: we can’t have competitors poaching our suppliers, now, can we?”
I clamped my lips tightly together. Harries caught my eye. He must have read the expression on my face because he lifted an eyebrow ever so slightly before turning to the CEO.
“Mr. Martino, your company’s developed another antimalarial, hasn’t it? If I remember the paperwork I saw, it’s currently undergoing Phase II trials.”
“Quinocitab. Yes, what of it?”
“All being well, Quinocitab should reach the market place in a year or two. That timing’s important, isn’t it? You’ll lose patent protection on your existing antimalarial in two years, and after that you’ll be undercut on it by other manufacturers. You’ll want the new drug in place by then.”
Martino’s eyes narrowed. “What are you driving at?”
Harries placed his fingertips lightly together. His voice remained pleasant.
“As I said before, the FDA is concerned about growing resistance to Quinoxocarb and we’re aware of the need for a new, effective antimalarial. In view of the urgency we may be able to exercise a certain amount of discretion about the need or otherwise for you to proceed to Phase III trials. On the other hand,” he opened his hands, “safety is paramount…”
Martino’s tanned complexion darkened perceptibly. “Quinocitab is perfectly safe—”
“It has proved to be safe in the tests conducted to date, but we can never be sure, can we? Of course, we have no wish to be difficult, and I’m sure you feel the same way. For example, Mr. Slater would like a list of the factories supplied by that Chinese packaging firm. I think you could oblige him, don’t you?”
The CEO locked into Harries’ gaze. “Are you suggesting…?” he began slowly.
“Oh, I’m not suggesting anything, Mr. Martino. Just seeking your cooperation, that’s all.”
No one spoke. It seemed like a full minute passed.
Finally Martino took a deep breath.
“All right,” he said. “On the strict understanding that it remains between us.”
“We’ll respect your confidentiality, Mr. Martino.”
We rose.
“Craig,” Martino said stiffly. “Would you see our visitors out?”
“Sure.”
Quilter walked with us to where the taxi was waiting.
“Mr. Slater?” he said, as we prepared to get in. “This is my card. I’m sorry if Mr. Martino seemed a little, er, guarded. The company has nothing to hide. Let me know if I can help you in any way.”
I inclined my head as I took the card. “Thank you very much. And thanks for the tour.”
“No problem. Best of luck with your investigation.”
17
Norman Harries left immediately for the airport; he had to fly to Philadelphia for a meeting the next day. Stefan, Abby and I shared a taxi to the hotel we’d booked for the night. We arranged to meet for dinner at 7.00 pm and then went to our rooms. I didn’t bother to unpack my overnighter, just put my toiletries in the bathroom. Then I kicked off my shoes and lay down on the bed, thinking. After a while I must have fallen asleep.
I woke with a start and sat up. The room was in darkness and the illuminated bedside clock read 18:50. On active service I’d always had the soldier’s ability to steal a cat-nap and wake up in time for business, and it seemed I hadn’t lost it. I crossed to the bathroom, combed my hair, splashed my face, and patted off the water with a soft towel. Then I put my shoes on and went downstairs to wait for the others in the lobby. Stefan arrived a few minutes later, followed by Abby.
“Where are we eating?” Abby asked me.
“I think here’s as good as anywhere. What do you think, Stefan?”
“Fine with me.”
We went through to the bar. There weren’t many people around; it would probably get busy later on. We settled for a remote corner where there was a low table, equipped in the usual fashion, and several soft armchairs. Automatically we reached for the handsets.
“Drinks first,” I said.
“You betcha,” Stefan responded.
We busied ourselves with the touchscreens for several minutes, scrolling through the options and selecting the predinner drinks and the courses for the meal. I tapped the Submit button to send my order to the kitchen and returned the handset to its cradle.
Stefan had done the same. He looked up at me.
“Iced water?”
“Thanks.”
He filled three disposable beakers from the dispenser in the centre of the table and pushed one to Abby and one over to me.
“Thanks, Stefan,” Abby said, replacing her handset and picking up the beaker. She looked around her. “I thought they had real people to take the orders in places like this.”
“You have to go more up-market for that,” Stefan said. “At least this way they get the orders straight – and the bill.”
I drank some water. Sleeping in an air-conditioned room had left my mouth dry. “Well, Stefan, I’ve got to hand it to you. Bringing Harries along was an inspiration.”
He grinned. “I thought he’d be useful. Good man, isn’t he?”
“Only if he’s on your side. Martino was livid.”
Abby scowled. “All right, the two of you put him on the spot. Why? What did you want that list for?”
“Because,” I said, “now we know how it works.”
She blinked. “What do you mean?”
I saw that Stefan, too, was waiting for an answer.
“Martino virtually spelled it out, didn’t he? There are no ‘unscrupulous operatives’. The packaging is perfect because the counterfeit drugs a
re produced by their own licensed factories.”
“But why should they do that?”
“I don’t know. Most likely Kappa squeezes them so hard on margins they’ve got to find some other way of turning a profit. So for short periods the factory switches to making a counterfeit product. It’d be hard to detect. Quilter and his people at Kappa never see what’s going out from there: there’d be some other pipeline for distributing it. And there’s so little of the drug in the fake stuff it doesn’t show up on inventories.”
“How do they get round the inspections?” Stefan asked.
“You saw that production line. It doesn’t even matter if it’s a spot check. As soon as the inspection team arrives at the factory somebody warns the operators to punch in another program. By the time the visitors have gone out of reception and into the factory floor they’re rolling off genuine pharmaceuticals again.”
Some double doors at the other end of the bar opened and a waitress came over, carrying a tray. She set it on the table.
“Here we are, folks,” she said. “One single malt” – I took it from her – “gin and tonic” – that was Stefan’s – “and a tomato juice. Enjoy. I’ll be back when your meals are ready.”
She disappeared through the double doors, and the escaping buzz of conversation told me the restaurant must in the room beyond.
We waited, watching as Abby added Worcestershire sauce and tabasco to her tomato juice from dispensers on the table, then sprinkled in a packet of black pepper for good measure. The ice in her glass clinked musically as she stirred it. I poured a little water from my beaker into the whisky and sampled it. It was smooth and powerful.
Counterfeit (The Jim Slater series Book 2) Page 11
