Side effects

Professor  Stephen Frampton took off his wire framed glasses and patted the report laying on the board room table beside him. As if to give special weight to what he said.

Opposite him was Doug Edwards, Vice President of ZPI UK, one of the World’s largest Pharmaceutical companies.

Zenda Pharmaceuticals International was an American company with offices worldwide that made some of the World’s top selling drugs for diabetes, cancer, schizophrenia and depression. Profits year on year were measured in hundreds of millions. But now the company was coming under increasing pressure as many of its original brands were reaching the end of its ten year license.

That meant that other Pharma companies could produce generic forms of their same drugs and charge a fraction of the price. Good news for the patients. Bad news for the shareholders of ZPI.

The problem for ZPI was that many of its new products were still in the pipeline being tested going through its range of clinical trials. Development and approval from laboratory to market can take up to twelve years.

Which is why it was vital that they needed a blockbuster to fill the  expected void.

The drug that ZPI had invested in was a new type of antidepressant. It had been five years in the development  and previous trials had shown that it was a highly effective medication without many of the side effects of traditional SSRI’s like headaches, agitation and insomnia.

ZPI were planning on their drug being prescribed Worldwide and Edwards was responsible for the European sell in.

 

Edwards was dressed immaculately. Blue suit. Crisp white shirt and a purple silk tie. You could see your face in his polished black shoes. His tanned handsome features showed no emotion at what Professor Frampton had to say.

‘This is the third clinical trial we have run. Up till now this antidepressant has been highly efficient in increasing the neurotransmitters – the serotonin and noradrenaline …..’

‘ Steve. Save me from the pharmacology’

Edwards’ background might have been in sales but he was no fool when it came to the basics of drug development. The last thing he wanted to be right now was patronised by a boffin who had little idea of the real world outside his precious laboratory.

Frampton  readjusted his summary.

‘In the first two trials the results were very positive. The patients became more active. They had more energy and they reported that their depression had totally lifted – but in the latest trials we have had anumber of  patients who have demonstrated very psychotic symptoms.  Bi-polar disorders, severe depression, cases of self harming and incidents of violence against others. All drugs give side effects we know that. But in this particular case the outcomes in some cases have been catastrophic.’

‘Like how  psychotic?

‘Like they want to kill themselves or others.

When you say in some cases – what sort of numbers or opercentages are we talking about here.

In percentage terms – low – say one or two percent. But that would still represent a vast number of individuals who would be in danger to temselves and to others. Giving patients this drug in its current form would be like giving them a loaded gun.’

‘How come these side effects didn’t come out in the earlier trials.’

‘We think it’s a build up issue. Some of the patients recovered really well. Others did not respond in the same way. It’s quite random. But what we do know is that a number of patients who took Staracil over a sustained period suffered very severe psychotic attacks. They became highly agitated and hugely aggressive ‘

Can those side effects be treated?

‘Far too risky.’

So what are you saying?

‘This drug is too dangerous to release onto the market – in its present formulae’.

“Can I have a look at your  report?”

Frampton slid the large binder across the table towards Edwards.

“You will find all the trial data in the front with the various case studies and our conclusions at the back.”

“Our conclusions?”

“Myself and Claire Grainger – who has worked with me on all the trials.”

“Of course.”

“Edwards flicked through the fat document not really looking for anything specific.”

‘You know Professor that we have sunk near to a billion pounds in the development of Staracil. Are you aware of that?’

‘ I am acutely aware of that. But not everything is a precise science’

The glib comment of Professor Frampton was not what Edwards wanted to hear. His primeval response would have been to have punched him in his face. He couldn’t stand the pomposity of the man. His attitude of intellectual superiority.  

‘We have invested in you and your department  – probably more than any other drug at ZPI.’

Professor Frampton held the glare of Edwards.

‘This was going to be the new best seller – you told us that.’

‘Well it still can. But I said if the clinical trials came through without complications. But as it stands it’s a dangerous drug. It needs more pharmacology. It needs refinement’

‘And how long is that going to take?’

‘We change the compounds – then we have to conduct more trials. I suppose we are looking at another three years. At least.’

Doug Edwards got up from his chair and walked over to the window. From the eighteenth floor of the glass and steel headquarters of ZPI he looked down on the traffic inching along the M4 into London and the queue of transatlantic jets gliding into Heathrow. He considered his options.

‘This report you have of the latest trials – who else has seen it?’

‘Well obviously myself who put the report together and Clare  who headed up the trial.’

‘That’s it?’

‘Well there have been other doctors and technicians. But they have been working in isolation. It’s only myself and Clare who have coordinated the data. Obviously tomorrow I will share the findings with the MHRA – the drug Agency. That’s a legal requirement – you understand.’

‘Sure. Look  you can  leave that report with me. I will have to talk to the guys across the pond tonight and explain the situation. Shit happens I guess.’

Professor Frampton was slightly surprised at the calm response from Edwards. He knew that if the drug had been successful it would have been a blockbuster. For ten years whilst the licence held, ZPI could charge billions for the drug that they had named Staracil. How the stock markets would react now to the value of ZPI he shuddered to think. But that was not his problem. He was responsible for the efficacy and the safety of the drug not the financials.

It was a known fact that Edwards had put his neck on the line. Quite a few of their other drugs in the company’s pipeline were coming to the end of their licence agreement which meant that their competitors could develop generics that they could sell at a fraction of the price. Staracil was going to be the big breakthrough. The billion dollar baby. The silver bullet. The drug that was going to continue the fortunes of ZPI. It would have maintained the company’s position as a global giant.

And Edwards holding three million shares in the company would have been on course to be a very rich man.

‘As you say – shit happens. Shall I pick this up in the morning?’ Frampton walked over to the other side of the desk and let his  hand hover over the report wondering whether he should leave it.

Edwards smiled. ‘No problems. It’s safe with me.  Oh one last thing. Is it on your computer?’

‘Too risky. I’ve got it on a memory stick. In my safe.’

‘Excellent. See you tomorrow morning. Oh and Stephen. Appreciate you coming in and talking about this. Could not have been easy. And totally agree by the way. The safety of our patients comes first. Always.

Five minutes after Professor Frampton left his office. Edwards reached into his pocket for a small anonymous mobile phone. He jabbed the numbers. After a couple of rings the phone was answered.

‘Meet me in the usual place in one hour.’  Edwards hung up.

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