The Authorized Biography by Mary Swande

“Babies calling Babies,” Nick dialed Mary Beth on the phone at the end of the day on September 4, 2008. Both Nick and Mary Beth referred to

each other by the nickname “Babies,” and he always called her just before he was about to go out the door of his office and depart for home—often as late as 8:00 or 9:00 P.M. When Mary Beth received the call, she started steaming vegetables for their dinner, and as soon as he arrived, they would sit down to eat together.

Immediately, on the other end of the line, Mary Beth could tell that Nick was upset, more upset than usual in these long grueling years of the clinical trial. “What’s wrong?”

“It’s over,” he said. “The trial?”

“The trial, my research, my practice, my career. Take your pick.”

“What happened?”

“Tell you when I get there.”

Briefcase in hand, Nick walked up Fifth Avenue toward his apartment building as he did most nights, his shoes clicking the pavement of the sidewalk. Past Saks Fifth Avenue, Tiffany’s, and Trump Tower, Nick got angrier and more worried with each step. The trial had already done damage to his reputation. The word was out about the purported results and his numbers of new patients were down. His expenses were up. The cost of his office suite climbed every year as did his malpractice insurance. His apartment, too, wasn’t cheap. But most of all, his twenty years of research were over. Tanked.

And scores of cancer patients could potentially be denied a therapy that might save their lives. Science. He believed in the tenets of sound science with each molecule of his being. But was this clinical trial science? Or biased manipulation of the facts? Oh, yes, he knew what he was in for before he even hung out his shingle. He’d seen what Kelley had suffered. He’d churned it over and over again in his mind throughout the years. Kelley was an eccentric dentist in Texas. Nick was an Ivy League-trained physician in New York City. A world of difference.

Nick loved and had the upmost respect for the medical field. He was part of the establishment. He wanted nothing more than to be a researcher at Sloan Kettering right now. Twice, not once but twice, Sloan Kettering had offered him that job that he so desired. But there were strings attached, always the same strings. He could only research conventional treatments, not this nutty Kelley thing that included coffee enemas. Oh, no, no, no, not enemas, heaven forbid! Tell that to Florence Nightingale. Nick had turned down the plush Sloan Kettering jobs to do his Kelley research. How could the medical world be so blocked that they would have no interest in a protocol that is saving lives? How could the medical world, the reputable, distinguished scientists behave this way? How could any human beings, period, behave this way?

With each step up Fifth Avenue, Nick was falling into a darker and darker mood, a mood that only Dr. Hans Moolenburgh had been able to address in the past. Yes, maybe he would try to call Hans tonight … On second thought, maybe he would just fold his practice right now. Call it quits for good. What was the use? Here he was left to fend for himself, to try to do his own research. How did he pay his bills? Not through the support of a grand institution with health insurance and benefits, labs and assistants, but through a private practice, a demanding practice filled with very ill patients who flew in to New York from all over the world. Here he was working day and night, every weekend and most holidays, to try to advance science. He just wanted a chance to prove his theory in a conventional way, through a clinical trial, through the rigors of the medical model. Then he wanted some free time, please God, just a couple of hours a day of free time to write about his program and get the word out to the public.

Mary Beth met him at the door with the “Babies dance,” but she knew that as much as he loved the greeting, this time it wasn’t working to elevate his mood. Nick slumped down at the kitchen table, and he and Mary Beth ate organic roasted chicken and steamed vegetables. He told her about Dr. Andreason’s short response that he had received that afternoon.

“The OHRP has closed their case. There is no more recourse,” Nick said. Mary Beth knew full well the implications of the actions of the OHRP. This was the final appeal. The final bundle of documents supporting his case had been sent long ago. Now Nick could no longer throw himself into writing rebuttals. His work at the computer had been a stress release as well as a necessary defense. Now what?

After their meal was finished, Mary Beth thought a little television would take his mind off of work. She knew not to suggest they watch a movie as she didn’t have anything on hand that she had pre-screened. So she clicked on Fox News. They sat together on the sofa and watched, but Nick soon became irritated and yelled at Bill O’Reilly on the TV set.

“What in the world are you saying?” he shouted. Nick, a Reagan Republican, thought the party had recently taken a wrong turn. He walked out of the room, leaving Mary Beth to click off the set.

It was too late to call Hans—still in the middle of the night in the Netherlands. So Nick sat in his study and took solace in his Bible, reading favorite passages that tended to calm him. The Psalms were usually his first stop. His Bible open on his lap, he let the words sink down into his body and his soul.

I want you to trust in times of trouble, so I can rescue you and you will give glory to me. (Psalm 50:15).

At last it was time for bed. Tomorrow was a busy day with patients, and he knew he needed his rest. Mary Beth was already in bed, so he sat on the edge of the mattress and pulled out a stack of letters from the bedside table, cards of appreciation and letters of acknowledgement thanking him for what he had done patients and colleagues.

Dear Dr. Gonzalez:

Thank you so much for your brilliance and guidance throughout my illness. I’m so thankful to be on the other side of it now…

Dear Nick:

Thank you for your dedication and hard work. You’ve done brilliant work in cancer research and deserve the Nobel Prize…

On and on the letters went. Nick read through the whole stack, fingering their pages. He read some of them a second time. He smoothed the sheets and pressed the letters back into their envelopes. He arranged them in a pile, larger envelopes on the bottom, smaller ones on top. Finally breathing more deeply, he slipped under the covers next to his wife, as if he were folding himself into a sealed and secure space, drifting off to sleep.

* * * * *

A few weeks later, the stock market crashed on September 29, 2008, and an air of panic spread through New York City. Consumers all over the United States worried about their savings, their pensions, their mortgages, their jobs, and how they could make ends meet. People doubled up on housing. Young adults lived in their parents’ basements. More homeless appeared on the streets. People everywhere tightened their belts and spent less. Many who had wanted to become Gonzalez patients, held off, due to the out-of-pocket expense. Once again, Nick thought he might just have to close his office.

But Congressman Burton wouldn’t let Nick nor the case rest. In October 31, 2008, Burton, dissatisfied with the progress of the government investigations thus far, wrote to the Inspector General Daniel R. Levinson of the Department of Health and Human Services, the official with the power to authorize investigations of institutions and individuals engaged in government-sponsored research. Burton summarized the history of the study, then requested the IG open a formal evaluation of the trial’s management.

In the meantime, fired up again, Nick arranged a meeting with Dr. Josephine Briggs, the new director of NCCAM in Bethesda, and a date was set for December 12, 2008. Nick hoped to brief her on all the many snafus in the trial, the OHRP report, and the managerial problems that had derailed the study. Nick also asked to bring along his patient in the Washington, DC, area who had accompanied him to the meeting with Senator Harkin.

While preparing for the Briggs meeting, Nick received a letter from Dr. Dahlberg, the director of the Office of Research Integrity, a division of the U.S. Department of Health & Human Services to whom he had appealed in 2006. The ORI reported that Nick’s concerns about the consent process, the changes

in protocol, and the conflict of interest did not fall within the department’s legal jurisdiction. Nick shook his head. He couldn’t understand what he was reading. Where else was he supposed to go with these concerns?

Tap, tap, tap. Nick began again, drafting a 16-page letter to Dr. Dahlberg. Once more, Nick outlined, then carefully documented all the areas of concern, from the Columbia team’s attempt to publish the article about the trial, to Dr. Chabot’s false statements in the article that Nick had withdrawn from the study, to Dr. Chabot’s inappropriate down-staging of five nutritional patients. Nick bundled up the material and sent them off to Dahlberg, settling down for what he assumed would be another long wait.

On December 12, 2008, Nick, accompanied by his patient, pulled open the heavy glass door to the NCCAM headquarters, located on the sprawling NIH campus in Bethesda.

“I was not aware of all these issues in your clinical trial,” Dr. Briggs told Nick, sitting across from him at the table. Dressed in a smart dark suit, her blond hair parted on the side, gold earrings accenting her rounded face, Dr. Briggs was a pleasant, open-minded person who graciously discussed Nick’s problems with the study. “No, I’m afraid I haven’t been debriefed about your study. But I hope that we can all look forward instead of backwards from now on.”

Nick explained out the basic protocol of the study, and Dr. Briggs did agree that clinical studies investigating nutritionally based treatments for disease required a more flexible design.

“I don’t think a simplistic comparison of Drug A to Drug B format would be suitable for evaluating your program.”

Briggs then became intrigued by Nick’s patient’s story. She listened carefully to his tale of recovery from cancer through the Gonzalez program.

After forty minutes, Briggs concluded the session by turning to Nick and saying, “I hope that you will be willing to share your experiences with others at NCCAM and NIH, so that we might all learn from the mistakes made during your eight-year effort.”

Several days later Nick wrote to Dr. Briggs thanking her for the meeting and enlarging on some of the points they had discussed. On December 30, 2008 she wrote back, thanking him for coming down to Bethesda:

I very much enjoyed our conversation. It is clear to me that you have a deep commitment to your patients and to exploring innovative methods to help with this terrible disease.

She then said that NCCAM was beginning its strategic planning process, and in the future, she would invite Nick to come and share his thoughts on how they might conduct clinical trials more effectively.

Nick replied that he was most willing to return to NCCAM and share his experiences with her staff.

But he never heard from Dr. Briggs again.

In late January of 2009, Inspector General Levinson wrote to Congressperson Burton. Levinson informed Burton that he had referred the concerns about the clinical trial to their Office of Investigations. Burton’s staff told Nick that she thought this a good sign as the Office of Investigations, with limited funding, only pursued a small number of complaints.

Dr. Dahlberg’s letter came next on February 2, 2009, responding to Nick’s 16-page letter and supporting documents:

The Division of Investigative Oversight (DIO) within the Office of Research Integrity (ORI) has received your letter of November 24, 2008. While your letter contains information that could lead to an inquiry into research misconduct, that inquiry and the related fact finding must be conducted by the institution.

So now we’re going around in circles again, Nick thought. I’m to go back to Columbia? Columbia who was supposed to have investigated the trial for the OHRP? Columbia whom Nick hadn’t heard from in two years? Even after he had written to them about the aborted attempt to publish the JAMA article?

“Babies,” he said to Mary Beth that evening. “Babies, Babies, Babies. I’ve been sent on another wild goose chase.”

After dinner and mulling over Dahlberg’s letter for a while, he finally decided no, he wasn’t going back to try to appeal to Columbia. He would leave the matter in the hands of the Inspector General.

Nick slumped down in front of the television set and yelled at Bill O’Reilly.