Resurrection

By the time Darius was off, Michael was already heading for bed. He pointedly closed his bedroom door and she went to bed with an icy hand clutching her heart. She thought of herself as an intelligent and rational woman but on an emotive level, having to consider that she could lose Michael was more than she could bear. Not now, not after all they had been through just to get here. She sniffed unshed tears as she though especially not now when she had this new Michael who was in fact reminiscent of their early days and so much more lovable than the Michael before his injury. She rummaged through her recent memories and she had to admit to herself that with the exception of not having had a chance to make love, she couldn't remember when

last she had felt so connected to him or when last he was so in touch with her feelings or had done a myriad small things to show her how much he loved her. She spent a fitful night considering what she needed to do to manage the situation.

Sunday she was up before him and prepared a high carb breakfast and a fruit smoothie.

"I'll take you to the race. I'd like to be there for you at the end." She suggested but his mouth tightened into a hard line.

"I've already made arrangements with Darius." He didn't even bother to look at her. She could feel him slipping away but she had decided that it wouldn't be without a fight. Breakfast over, with very few words shared, Michael went outside and started a slow, low impact low energy warm-up while he waited for Darius. From his point of view, watching Mandy's behaviour had confirmed his initial verdict of guilty. The certainty of which had now coalesced into a cold hard headstone, marking the grave of their marriage.

"I'll be waiting for you at the finish line." She shouted as he pulled off with Darius and she went to get herself ready.

"What's going on man?" queried Darius, having noticed the changed dynamic.

"Do I have to talk about it?" He huddled into himself.

"You do if you want me to drag your sorry ass over the finish line!"

Michael considered for a long moment. Other than his deceased parents and Mandy, possibly even more than Mandy, Darius had seen him at his very worst moments. The moments when he had cried and railed at the world, his useless body and the injustice of it all. He had witnessed his stumbles, his falls and the moments of jubilation when he had exceeded his own expectations. Darius knew him! He knew him well!

"Mandy is cheating or has cheated on me!" he announced forlornly unable to meet the other's eyes.

"You sure?"

Michael nodded affirmatively.

"During your vegetative state?"

"I don't know. Maybe!" Michael shrugged again, bitter at his lack of knowledge of the why, when and what. But he was pretty sure he knew the who.

"Man that's cold. In the army we called that getting Jodied!" He glanced over at Michael who sat hunched over in his misery. "Is there any hope for a reconciliation?" He added as an afterthought.

Michael looked blindly out the window in a funk. Having given voice to Mandy's betrayal had made it so much worse -- like it had solidified and become tangible, real. "Unlikely." Then on second thought: "Don't see how that would be possible!"

"She saved you Mike!" Darius wasn't a doctor but he understood enough of what had happened. Hell, everybody had spoken about nothing but, and were still talking about it.

"Maybe she should have just let me be!" Michael was starting to wallow in self-pity. It wasn't a pretty sight and nor was it good for him.

"Come on Mike, you don't mean that." They drove on in silence.

At the start of the race, Michael was vacillating between anger and depression and having stopped taking the SSRI's wasn't helping either. When the gun went, he grabbed onto the anger and forced it to sustain his focus. Darius ran alongside pacing him. They had agreed to try run at nine minute miles for a sub-two hour finish. The first five miles were relatively easy as he had run the distance in training. From five to eight he had to focus on his cadence, lifting his knees high in order to stop his lazy foot from dragging and tripping him over. He watched the hundreds of runners who passed him doing little more than a fast shuffle and he envied them.

He soldiered-on much to Darius' quiet admiration. But the final five miles turned into a struggle, made both better and worse by Darius who encouraged, urged and at times demanded focus and pace. With three miles to go Michael found himself in a self-generated bubble of pain; in a body that was begging him to stop. Instead he gathered whatever resolve he had left and looking at the spectators lining the street, ran from one face to the next, imagining that each one was there only for him and he ran so he wouldn't disappoint them or let them down.

"Straighten up!, Head high now! Show no pain." They reached the park with the finish line in sight. Darius stayed on his weak side talking him through the final yards as a surge of late adrenaline pushed him forward towards the finish.

Darius must have briefed the announcer without his knowledge, because suddenly his name was called out. "Finishing in one hour fifty eight minutes, Michael Bates, number 4922." Came the announcement. "Let's have a big hand for Michael who is a brain injury survivor and Windy City son, born and raised!" The crowd took notice and Darius reached over and lifted Michael's hand with his own in acknowledgement of the crowd's applause.

Behind the finish line, Mandy had tears in her eyes as she saw Michael's moment of triumph, but before she could get even close to him he was swamped by well-wishers many of whom were injury survivors themselves. Some sported prosthetics mainly from below the knee. There was even a double amputee who had completed the three mile fun-run. She watched Michael get carried off in a wave of camaraderie from fellow runners and survivors. There was a cold beer thrust into his hand. He was about to say no when Darius pointed out that it was zero alcohol, so why not.

She considered joining the celebrations but already she could see that she would be an outsider and as far as Michael was concerned not a very welcome one. She turned sadly and drove herself home re-considering her options, The 'new' Michael had placed her on a pedestal, but now he obviously viewed her as his fallen idol. A false god. He probably thought that she had broken his heart. She wasn't sure what form his response would take but she knew that it would be as intense as the love he had given her, but in the opposite direction.

She wiped away her tears and focused on not driving into the car in front of her. What about her heart. What would it take for him to see how much her heart was broken.

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Chapter IV: Chasing Shadows

Michael slept out Sunday only coming home on Monday morning. By the time he got there, Mandy had already left which suited him fine as he still wasn't ready for the confrontation to come, but his mind was made up and firm. After a quick morning routine he started the process of declaring his independence, even if only to himself first. His SUV, the same one from the attempted car-jacking, was in the garage undriven in nearly two years, so he called AAA to come get it started.

Strewn haphazardly inside the car were a number of work papers, mostly relating to the Hexalidomine clinical trials. He considered that they must have spilled from his laptop bag which he supposed had been taken during the car-jacking. He sighed as he considered the papers sadly. So much of his life had been spent preparing the trial protocols and liaising with oncologists across the globe to enrol patients to the clinical trials and now the trials were almost at an end. The submission team headed up by Mandy had taken over and were about to bring the five year process to its logical conclusion. He grabbed the papers and flicked idly through the reams as he prepared to discard them when he noticed that someone had highlighted a number of tables. He was tempted to ignore them but his curiosity got the better of him and he sat down.

The highlighted table listed 'Side Effects' and 'Adverse Reactions', by comparative drug. The list included: Headaches, dizziness, loss of appetite and the other typical effects which had predictably high numbers of reported cases. Around the middle of the table were entries designated as CE/CA and the numbers were relatively high, showing up as 22% and most were ascribed to Hexalidomine. The entry was heavily circled by a neon orange highlighter. A handwritten annotation in what he thought he recognised as his own writing directed him to page sixty four. He flipped through to find another table showing deaths that had occurred during the trial. The number stood at twenty percent. That wasn't entirely unusual. In long term cancer trials one expected to lose patients but the number seemed higher than expected. The trial in question was the Nigerian trial.

Flicking through more papers he found that the USA trial also showed a high number of events listed as CE/CA and a high number of deaths listed under 'Other'. This was high-lighted also. To paraphrase Shakespeare, 'something was rotten in the State of Denmark', but what?

He went to the home computer and tried unsuccessfully to log into the company mainframe. He tried variations of the last password he remembered but none of them worked. He tried plan B as he had watched Mandy login on a few occasions since his return and he guessed at her password and got it right the second time around. He then spent most of the morning going through the clinical trials ready for publication. Most were precisely what he expected. Hexalidomine was performing ahead of the two comparative drugs and was showing better survival rates at twelve, eighteen, twenty four and forty eight months.

He chased up the two trials in question. He found them in their final iteration ready for submission. The results were identical to what he was holding except CE/CA Adverse Events had been attributed to one of the older comparative treatments and not to Hexalidomine.

It looked like the results had been altered. He tried to get into the files that held the raw data but was denied access with a flashing warning that said: 'NOT AUTHORIZED'. He pondered for a few minutes and eventually decided that to hell with doctor's orders and went to find himself a drink. He found it in the liquor cabinet in the form of an eighteen year old Glenfiddich single malt. He poured himself a shot over ice and sat down to consider the implications. CE/CA was not a typical notarisation for Adverse Events in oncology trials and although his guess was that the 'C' probably stood for 'Cardiac', he may have been wrong. He thumped his forehead with the palm of his hand but nothing... He wished his brain worked better but it was-what-it-was. He decided it could wait till Mandy got home.

When she did it was obvious even to him that she was walking on egg-shells. He called out to her and she came into the study looking both twitchy and stooped like the weight of the world was on her shoulders.

"Can you help me with this? She looked at him warily. "I just want to know what the CE/CA entries were under the reported side effects and adverse events on the Hexalidomine Trials"

"Is, is this what you want to talk to me about?" Her voice was edged with surprise and a level of distrust like someone who expects a practical joke or the rug to be swept from under their feet.

"Yes!"

"I... Aah...Ok. CE was cardiac events, mostly cardiomyopathy and CA was cardiac arrest." She frowned. "Why do you ask?"

Ok then! The entries were what he thought they were "So most of the cardiac arrests resulted in death." He stated. It wasn't a question. She looked at him for a long moment. She didn't understand where he was going with this, but it also piqued her professional curiosity.

"Why do you ask and which study are you looking at?" She was frowning trying to remember the details of the many trials, while he looked at her wondering how much he could trust her. He was vacillating now that she had been unmasked as a cheat and a liar in her private life. He wondered if she would she be different in her professional life? He was still grappling with his dilemma when she leaned cross him swivelling the print-outs with their highlighted tables to get a better look making his concerns moot.

"This... No, this can't be right!" She flipped pages and looked at what he had noticed. "No, this is wrong." She racked her brain. In the final studies ready for submission, almost all the CE and CA events were attributed to one of the older drugs: Fluorouracil, commonly called 5FU. Here they were mostly attributed to Hexalidomine. She looked at the bottom of the printed pages and noticed the descriptor V01. These were the initial study papers before they were reviewed and edited.

"Look at this." He showed her the same trials on the screen. They were designated V04. The CE/CA results were now listed under 5FU and not Hexalidomine. It didn't take a rocket scientist to figure out that there was a problem either in the original or the later versions of the trials. The implications were either that a simple mistake had been corrected or that the data had been manipulated so that the cardiac arrests and resultant deaths were now shown under 5FU.

Mandy really wanted to dismiss it as a corrected mistake. After all, the trials had been reviewed internally and externally. A second part of her, the professional perfectionist, wanted to be sure. "We need the raw data to confirm." She looked at Michael with a renewed appreciation of his mental capabilities. Even after the brain trauma from getting shot in the head, he had instantly recognised a problem that most would have probably skipped over. She also knew that if nothing else she needed to see this through with him. She owed him at least that much.

"The raw data can only be accessed internally." She motioned to him. "Let's go" They drove off in her Honda discussing possible reasons for the switch. "5FU is known for its cardio toxicity and sudden death." She challenged him on the drive.

"Yes but its cardiotoxic effects are well documented and patients are switched off it quickly when it presents these days." He frowned. She looked sideways at him. He was like the Michael of old, he had a problem and he would not let go till he found the solution. "Have you noticed that the European, Japanese and Chinese trials were hardly showing any cardiac events?" He frowned a little harder. "Only the Nigerian and the North American trials!"

Once in her office, she logged into the main-frame. They worked diligently for a time pulling raw data and eventually they sat back and looked at each other. The conclusion was obvious. Hexalidomine presented acute cardio-toxicity resulting in sudden death in over thirty percent of African patients which was why it hardly showed-up in the European trials and was almost completely absent from the Chinese and Japanese trials. To a lay-person inter-population variances would sound like racism, but the medical profession and pharma industry knew that not all drugs had a similar effects or side effects, between patients from differing ethnic groups.

Worst of all it was also obvious that someone had manipulated the data to attribute the CE/CA effects under the older drug, 5FU. It was medical chicanery of the worst sort. It was worse than the Thalidomide crisis of the fifties. At least in that instance the Swiss Company Ciba hadn't undertaken teratogenicity tests as in the 1950's it was hardly done, but it had resulted in devastating so many babies born with serious defects. As bad as that was however, at least that was an oversight.

"This is worse than bad." Whispered Mandy. "This is a wilful manipulation of the data." They looked at each other shaken.

"It's cynical!" Confirmed Michael. Neither was certain what steps they would or should take that evening, but they both knew that this was big. The ramifications were enormous. The only question that remained was how many were involved either directly or peripherally in the scientific fraud. They downloaded the data and it took almost half an hour before they walked back to her car with everything saved on a thumb drive that Michael put it into his pocket.

The conversation on their way home was stilted with both starting a sentence and stopping without finishing it or talking in an industry short-hand. The implications would probably sink the company. Furthermore the Oncologists running the US and Nigerian trials, had to have been complicit, so it meant that global reputations would be ruined.

They looked at each other sadly. It was obvious to both that there would be no upside for the two them either. If they went public they would both become pariahs. Well, first there would be the congratulations and the scientific back-slapping for their whistle-blowing, but in reality no pharma-co would ever hire them again and they would always be viewed with some level of distrust.

By the time they were back home Michael was crashing. Between all the mental stimulation, the whisky and the late hour he had curled up and half-slept in the passenger seat. Mandy wasn't about to leave him in the car though and she half supported half carried him inside and placed him on the couch. She headed upstairs to find him a pillow to the sound of thumps from below. She came back down with the pillow and a light quilt only to discover two men waiting for her.

Michael was lying on the floor completely unconscious and cuffed with cable-ties She tried to dart towards her phone but the nearest man caught up to her before she made it and dragged her back. She spun around and scratched his face but he wasn't put off. He backhanded her hard splitting her lip and making her feel like she had been hit by a car. He grabbed her by the hair and punched her twice in the solar plexus and dropped her to the floor wheezing in agony as she tried desperately to breathe through the pain and spasm of her diaphragm.

They cable-tied her securely as well then started going through the house in a succinct and practiced manner. They cleared everything from the home office including laptops, thumb drives and all the paperwork they could find regardless of what it was. They took her handbag and their phones, credit cards and everything even some of their clothes and packed them into travel bags. To Mandy the word that popped into her head was professional.

It was after one in the morning by the time they were satisfied. They spent a significant time putting the home back together neatly. With a sinking feeling she realised that the missing clothes, money and documents would make it look like they had simply run-off. Before the thought had cleared her mind, they injected something into her and she became immediately drowsy. She was vaguely aware that they threw both Michael and her into the boot of her Honda and drove out. A little way down the street a second car joined the Honda in procession although neither Michael nor Mandy knew anything about it.

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Chapter V: Descent into Darkness

Michael awoke when a bucket of water was thrown over him. His wrists and ankles were cable-tied to a chair in a dark room. Mandy was in a similar position next to him. They were in a windowless room that was reminiscent of a basement with a bright light in their eyes making him blink. Then the questions started.

They didn't bother asking if they had spoken to anybody because they ran diagnostics on their phones which showed they hadn't made any calls at all. The only question that remained was: 'Where was the thumb drive?" It was obvious that despite going through the car and the house, they had found the early print-outs but not the thumb drive.