Michael Ridpath - Final Venture

I sat in the car and went through the four Alzheimer centres on my list. I pulled out my cell phone and managed to make appointments to see three of them.

The first clinician on my list was Dr Herman A. Netherbrook of one of the smaller universities that littered Boston. His office was on the campus in a medical research unit named after a now deceased Massachusetts politician.

Netherbrook was about sixty, grey and uninterested, with the weary cynicism that afflicts stale school teachers and, presumably, academics. He welcomed me politely into his small office, and procured me a mug of instant coffee. I gave him one of my cards.

'Now, who is it you are with, Mr Ayot? I don't quite follow.'

'Revere Partners is one of the investors in BioOne, who of course are conducting the trial of their neuroxil-5 drug for Alzheimer's disease. A trial in which you are participating, I believe?'

'Indeed we are. We were involved with the Phase Two trial, so it seemed natural to continue with the Phase Three trial as well. But I'm not sure I can talk to you about any of the commercial features of this work. You had better discuss that with Dr Enever himself.'

'It's the safety of the drug I'm concerned about.'

'Yes, you mentioned that on the telephone. But we monitor the patients very carefully in all the trials we do.'

'Of course. And have you encountered any adverse events?' I knew from my research on Alzheimer's that adverse events had to be reported as soon as they occurred.

Netherbrook looked me over carefully, as if deciding whether to answer my question. Finally he walked over to a filing cabinet, and pulled out a folder.

'Let me see. We have thirteen patients enrolled in the study. We have had two adverse events in the year or so the trial has been running. One patient had a heart attack, and another is showing signs of developing diabetes. But in a sample of elderly patients, that is only to be expected. And all of them have survived so far.'

Any examples of strokes?'

'Strokes?' He glanced at his file. 'No, none.'

'Nothing that you would consider suspicious or a cause for concern.'

'If I had a cause for concern, I would have notified BioOne immediately, wouldn't I?'

'Yes, of course, Dr Netherbrook. Thank you for your time.'

I left, feeling slightly foolish, and drove off to Springfield, in central Massachusetts. I hoped I was asking all the right questions. But if there had been no strokes amongst the patients enrolled, it was difficult to see how I could have missed anything.

There was a specialist Alzheimer's Research Clinic in Springfield. Dr Fuller turned out to be about thirty-two, blonde, with long eyelashes and very long legs. She seemed to me to be wasted on geriatrics, but perhaps if I were eighty I would disagree with that view. She had a soft southern accent, and purred quietly, rather than talked. I could scarcely make out what she was saying.

I did understand that one of her ten patients enrolled in the trial had suffered a mild stroke nine months after the trial had begun. Another had died from bronchial pneumonia, as old people sometimes do.

One stroke out of a total of twenty-three patients. That didn't prove anything.

Then on to Hartford and a Dr Pete Korninck. He was a genial man with a beard and iron-grey hair that curled over the tops of his ears. One of his sixteen patients had developed a liver complaint, and another had died of a heart attack.

'How about strokes?' I asked, knowing that if there had been any, he would probably have told me.

'None. At least not among the Alzheimer's patients.'

'OK.' I thought a moment. 'What do you mean by "the Alzheimer's patients"?'

'Well, we have some patients who suffer from multi-infarct dementia. That's a condition also known as "mini strokes". Small blood vessels in the brain can become blocked, causing areas of surrounding tissue to lose their blood supply. Over the years these can cause damage to the brain, which has similar effects to Alzheimer's. The two are often confused.'

'And these patients have "mini strokes" all the time?'

'Yes,' the bearded doctor replied. 'And sometimes they get big strokes.'

'Presumably you exclude these patients from your study?'

'Where we can, yes. But there's no doubt some of them creep in. You can only really identify Alzheimer's for sure after an autopsy'

'Have you had to reclassify any of your Alzheimer's patients in this way?'

'Yes, three.'

And you told BioOne this?'

'Of course.'

'Do you think there is anything significant about it?'

Korninck thought for a moment. 'It's impossible to say from my patients alone. There may be. But BioOne would be the only people to have enough information to be sure.'

I left Hartford, and drove east, stopping briefly for a cup of coffee and a burger. It had been a long day, with lots of driving, but I thought I might still have time to see the fourth clinic on the list, in Providence, Rhode Island.

Dr Catarro was unavailable, but his assistant Dr Palmer was. He agreed to meet me at seven fifteen at his office.

Dr Palmer was a dark thin man who could have been anywhere from twenty-five to forty. His young-looking face had lines that suggested a short life with a lot of worry, or a longer one with only an average amount. His voice, when he spoke, had the squeaky depth of a thirteen-year-old.

'Thank you for waiting for me, Dr Palmer.'

'Not at all,' he said. He looked tired.

'Hard day?'

'Since Dr Catarro passed away, every day has been a hard day'

I sat up in my chair. 'Dr Catarro passed away? What do you mean?'

'Oh, I'm sorry, I thought you knew,' Palmer replied. 'My colleague, Dr Catarro, died in a car accident last month. It was a terrible tragedy. We haven't found a replacement yet.'

'I'm sorry,' I said. 'What happened?'

'He was driving home late one night, and he hit a tree on a road near his house. He was only a mile away from home. They think he must have fallen asleep at the wheel. He left his wife and two girls.'

'How awful,' I said, lamely.

Palmer's eyes dropped downwards, recognizing the words and their inadequacy. Then he looked up. 'Now, how can I help you?'

'Oh, yes. I believe Dr Catarro was taking part in a clinical trial conducted by BioOne?'

'Yes, he was.'

'I wonder if I could ask you some questions about it?'

'I'm sorry. I won't be able to help. We discontinued the trial after Tony died. It was his baby really and I had too much other stuff to do.'

'Do you still have the records from the trial?'

Palmer shook his head. 'Well at least not easily available. I sent the file back to BioOne. We will have the information on each patient's file, but it won't be easy to collate.'

I was disappointed. 'Do you happen to know if there were any adverse events?'

'Yes, there were,' said Palmer. 'Tony was involved in a disagreement with BioOne over the reporting of adverse events. Strokes.'

'Strokes?'

'Yes. A number of our patients had strokes. A couple of them were fatal. BioOne had suggested that the patients concerned had been misdiagnosed as Alzheimer's patients, and really suffered all along from mini strokes. The autopsy showed the two who died definitely did have Alzheimer's. They had the neurofibrillary tangles that you only get with Alzheimer's disease.'

'Do you know how this disagreement was resolved?' I asked.

'It wasn't,' said Palmer. 'It's something I really need to follow up, but I just haven't had the time. It was one of the reasons I decided to drop the trial.'

'Thank you Dr Palmer, that was very interesting,' I said. I was just about to leave, when I asked him one more question.

'Oh, by the way, do you know where the accident happened?'

'Yeah, on a little road near Dighton. It's about twenty miles away. Why do you ask?'