The RX Factor (15 page)

Instead of the welcome sleep, he found himself five years in the past. Back when it all started to go wrong. . . .

It was a normal Thursday morning, and Ryan was running late for a 9:00 a.m. meeting with his lab director. He had done FDA paperwork until 3:30 that morning and had woken up late. Cindy was rushing Karly and Jake to finish their breakfast and get out the door in time to catch the school bus when the phone rang. Ryan answered.

"Hello, Ryan, this is Albert Seymour."

The hair on the back of Ryan's neck stood up. "Hello, Dr. Seymour."

"Ryan, I need to see you and Cindy in my office today to discuss Cindy's latest test results."

A chill ran through his body. "Albert! What is it?" he blurted, not about to let the doctor get away with a cryptic reply.

Dr. Seymour hesitated. "I shouldn't discuss this over the phone, but . . ." He took a deep breath. "The biopsy that we took from Cindy yesterday confirms the abnormal CA-125 blood test results that we saw last week."

Ryan's heart dropped to the pit of his stomach, and his legs began to wobble. He wished he weren't a scientist—all of this would have sounded like mumbo jumbo, and he wouldn't have understood the implications of the doctor's words.

"What stage?"

"I'd like to run some additional tests," Dr. Seymour said.

Ryan knew he was hedging, and the doctor's attempt at sugarcoating what he had to say was infuriating.

"Damn it, Albert! You don't need more tests. I know what a biopsy is. What stage is it?"

"Stage four."

Ryan hung up the phone in a fog of grief. The shock on his face held Cindy's attention and she knew without asking. After the kids were out the door, they clutched each other and cried.

It was a veritable death sentence. A mere six weeks earlier, Ryan had been celebrating the greatest success of his career. His company had completed pre-clinical testing on Tricopatin, a drug with the potential to become a revolutionary cure for ovarian cancer. Today he would need to rely on his raw courage to carry them through the next hours.

Later that morning at Dr. Seymour's office, they heard the whole story. After a third test reconfirmed the diagnosis, Cindy Matthews—at the age of thirty-four—was given less than two years to live. Ryan's familiarity with the clinical details, as well as his own family's connection with ovarian cancer, made him no stranger to this killer. On Cindy's side, her mother had died of the cancer at forty-two. This family history fueled Ryan's drive to find a cure. His own daughter Karly was no doubt at an increased risk, too. He was determined to defeat this beast.

Cindy's chance for survival was now reduced to a miracle cure, a cure Ryan hoped he had developed in Tricopatin. But it would be several years, if ever, before the FDA approved the drug. Although pre-clinical test results were promising, all that meant was that it could cure lab rats. Human clinical trials had not even begun yet, and even if they had, final approval would still be years away. Time was not on their side.

Ryan's firm, Immugene, was small and cash-strapped. It had neither the resources nor the bureaucratic connections to rush the drug through human trials and achieve government approval. But with the desperation of a protective husband and father whose family is threatened, Ryan promised Cindy he would find a way to cure her. It wasn't something he said rashly to make her feel better. He'd never been more determined about anything in his life. He refused to let this disease take her away from him.

When word of Immugene's success with Tricopatin's pre-clinical tests reached the market, several large pharmaceutical companies took notice, and the acquisition offers began to pour in—some of them from major players. It wasn't Ryan's plan to sell out. Ryan, along with his best friend and business partner Eric Maynard, started Immugene with venture capital. The two men shared big dreams. Their business plan involved surviving on the venture capital until they could bring a major drug to human testing. The plan from there was to take the company public and raise the vast amounts of money needed to advance through clinical trials. If the drug proved successful, Immugene would be worth several hundred million dollars, and Ryan and Eric would be multi-millionaires. But now, with Cindy's diagnosis, Ryan was running out of options. Immu-gene did not have enough time to go public, and Cindy's only chance for survival was for her to receive Tricopatin within the next six months.

A month earlier, pharmaceutical industry leader Fisher Singer Worldwide had made an enticing offer to purchase Immugene for $150 million plus. The "plus" would come in the form of negotiations on stock options, compensation packages for retained Immugene employees, and severance packages for the employees who were let go once the acquisition was complete.

Even though Ryan theoretically held absolute authority over sale or acquisition, he was receiving pressure to accept the offer from the venture capital firm that funded the operation. Their original investment in Immugene of $30 million would now be worth four times that. In addition, stock options from FSW could produce substantial gains for them down the road. Because Immugene had only one product that had passed pre-clinical testing and three others in the early developmental stages, and considering that only one out of a thousand drugs in pre-clinical testing ever reach the market, the offer seemed too good to be true.

Still, Ryan hadn't given the offer much consideration because, once the acquisition was made, he would lose all control of Tricopatin. Believing in the revolutionary potential of his drug, he wasn't willing to make this exchange.

But now that he was fighting a losing battle against time, Ryan was willing to discuss all options with any viable suitor. Besides, FSW's offer far surpassed the seven other written offers he had received. With several hundred pharmaceutical products on the market, facilities in all fifty states and in sixty-one foreign countries, over 125,000 employees, and annual sales in excess of $75 billion, the company had the capacity to move Tricopatin to human trials faster than anyone else.

Three days after Dr. Seymour's diagnosis, Ryan was on a plane to New Jersey to meet with the CEO of FSW. The sale was negotiated within a grueling forty-eight hours, and Immugene was acquired and absorbed into the pharmaceutical giant twenty-eight days later.

Immugene investors received $150 million and an additional three million stock options priced at the current stock price of FSW. The options would vest upon successful phase two testing of Tricopatin. Based on the company's historic stock-appreciation rate and projected time line to complete phase two testing, the stock options held a potential additional value in excess of $250 million. Out of the proceeds paid to Immu-gene, Ryan would receive $5 million in cash and one million stock options.

The company would keep Ryan on board as an executive vice president and assign him as the chief scientist on the Tricopatin project. He would also continue to be involved in the research on several other new drugs under development. Eric Maynard was also retained, and would receive $750,000 and an additional fifty thousand stock options. Although Ryan and Eric were partners at Immugene, Ryan was the majority partner and the individual responsible for the development of Tricopatin. Eric assisted Ryan but focused the bulk of his efforts on the business side of the company. As part of the deal, Ryan negotiated a $350,000 annual salary for himself and $225,000 for Eric.

Ryan arranged for the Tricopatin project to be run out of Fisher's research facilities in Research Triangle Park in Durham, North Carolina, less than twenty minutes from his house. The most important negotiation of all for Ryan involved FSW's agreement to fast-track Tricopatin and begin human testing within six months. His executive position and previous familiarity with Tricopatin also enabled him to obtain assurances from the CEO—off the record, of course—that Cindy would be enrolled in the clinical trial and would receive the Tricopatin injections and not the placebo.

One hundred and sixty-seven days after the finalization of the sale of Immugene to Fisher Singer Worldwide, Inc., human clinical trials for Tricopatin began. One hundred patients with late-stage ovarian cancer were selected to participate. Fifty of the patients were scheduled to receive nine injections of Tricopatin over a course of three months, or one dose every ten days. The remaining fifty patients received the same regimen using a sugar and water placebo. None of the patients, except Cindy Matthews, knew whether they were receiving Tricopatin or the placebo.

One week after the third injection, most patients reported feeling better, including many of those taking the placebo. At first, the test results did not show any significant progress. After six weeks of the trial and four injections per patient, most patients continued to report feeling better, and unofficial preliminary results indicated that the cancer was diminishing in some of the patients. Following the sixth injection, FSW petitioned the FDA to do an interim review of the test results in hopes of fast-tracking the drug to market if the final results of the trial turned out to be as promising as the interim results.

Ten weeks into the trial, and the day after all of the test patients received their seventh injection, the FDA ordered FSW to halt the clinical trial of Tricopatin. Their findings suggested that Tricopatin was not making the cancer diminish. In fact, evidence indicated that the drug was actually accelerating the cancer's growth.

Upon receiving this news, Ryan sunk into a quagmire of outrage and devastation. The outrage was directed at the FDA for canceling a promising clinical trial over three-quarters of the way through. The devastation came because he knew that his wife, the love of his life, would soon be gone.

Three days later and without a word to Cindy, Ryan flew to Washington and met with the FDA to review the test results. He was shocked to see that the placebo group's cancer had not advanced as far as that of the Tricopatin group. Ryan argued that during the pre-clinical studies, interim testing was not performed, and all of the animal subjects were 100 percent cured at the end of the trial. He went on to contend that the true effects of the drug would be revealed after a patient completed the entire series of injections.

The FDA officials rejected his argument and told him that if FSW had not petitioned for an interim review, the trial would still be going on. But given the results of the interim review, they could not, legally or ethically, allow FSW to continue to inject the patients with a drug that caused their cancer to grow. With that, the Trico-patin study was officially terminated.

It was on the short flight back to Durham that Ryan decided that, although it was the longest of long shots, Cindy still had a chance for survival if they went ahead with the final two injections as scheduled. The next day, Ryan removed enough of the Tricopatin from the lab's vault to complete Cindy's treatment. Five days later, he gave Cindy the eighth injection.

Cindy's rebound made his heart soar. Soon she was feeling better than she had in months. Her energy level was high, and she regained much of her strength and vitality. The Matthews were feeling hopeful leading up to their meeting with Dr. Seymour to review the latest test results.

The CA-125 blood test showed that the cancer was continuing to grow with no signs of remission. Dr. Seymour reminded them that most patients with advanced stages of cancer were on chemotherapy, and that was the main reason they were in poor health and had no strength or energy near the end of their lives. He went on to explain that cancer at an advanced level can cause endor-phins to be released, which could explain the temporary strength and energy boost that Cindy had been experiencing. Dr. Seymour gave her six more months, at best.

The next morning, Ryan found Jason Handley, FSW's eastern division human resources director, along with the head of security, waiting for him in his office.

"Good morning, Ryan. I have something to ask you."

In an attempt at nonchalance, he replied, "What's up, Jason?"

"Dr. Matthews, the FDA has completed a post-study audit of our trial on Tricopatin, and we cannot account for two missing vials of the drug. Our security records indicate that you were the last person to access the vault. We are also aware that your wife was a participant in the clinical trial and that she had two treatments remaining when the FDA canceled the trial." A pause followed, pregnant with accusation. "Do you deny stealing the two vials of Tricopatin?"

"No, I don't deny it," he fired back. "In fact, I have already injected Cindy with both of them." Despite the implications of his admission, Ryan was in no mood to play games with Handley or anybody else from the company. He was the one who had invented Tricopatin, and if it could possibly save his wife's life, they had no right to stop him from using it. Damn the consequences. Damn the company. They could all go to hell.

Handley rose from his seat; the security man followed. Handley's voice was firm. "Dr. Matthews, I have no choice but to terminate your employment for theft of classified and restricted company property. Mr. Craven will assist you in gathering your personal belongings and then escort you from the premises."

Nine days later, Ryan injected Cindy with the final dose of serum. He'd had to lie to Handley about that last dose in order to ward off a security sweep, and counted on Handley, and anyone else above him, to not know the dosage schedule that Ryan himself had established. But despite completion of her treatment under the prescribed time lines, Cindy's follow-up test results showed the cancer advancing. All hopes for a miraculous recovery withered away.

It was a melancholic time. Ryan and Cindy took long walks in the woods. They talked about the fun they had had at the last New Year's Eve party, the last vacation with the kids at the beach, their family ski vacation to Wintergreen. At other times they said little or nothing. Often they wound up in each other's arms, nursing their hurt, their lost future, and the thought of the kids growing up without their mother. Cindy had extracted several promises from him about the kids' upbringing and their future, and Ryan paid close attention to her wishes. They sealed all promises and commitments with a kiss, which both considered sacred.