The RX Factor

• End of the Drug Trial is a Big Loss for Pfizer
  
• Prologue
  
• Panel Faults Pfizer in ’96 Clinical Trial in Nigeria
  
• CHAPTER 1
  
• CHAPTER 2
  
• CHAPTER 3
  
• CHAPTER 4
  
• CHAPTER 5
  
• CHAPTER 6
  
• CHAPTER 7
  
• CHAPTER 8
  
• CHAPTER 9
  
• CHAPTER 10
  
• CHAPTER 11
  
• CHAPTER 12
  
• CHAPTER 13
  
• CHAPTER 14
  
• CHAPTER 15
  
• CHAPTER 16
  
• CHAPTER 17
  
• CHAPTER 18
  
• CHAPTER 19
  
• CHAPTER 20
  
• CHAPTER 21
  
• CHAPTER 22
  
• CHAPTER 23
  
• CHAPTER 24
  
• CHAPTER 25
  
• CHAPTER 26
  
• CHAPTER 27
  
• CHAPTER 28
  
• CHAPTER 29
  
• CHAPTER 30
  
• CHAPTER 31
  
• CHAPTER 32
  
• CHAPTER 33
  
• CHAPTER 34
  
• CHAPTER 35
  
• CHAPTER 36
  
• CHAPTER 37
  
• CHAPTER 38
  
• CHAPTER 39
  
• CHAPTER 40
  
• CHAPTER 41
  
• CHAPTER 42
  
• CHAPTER 43
  
• CHAPTER 44
  
• CHAPTER 45
  
• CHAPTER 46
  
• CHAPTER 47
  
• CHAPTER 48
  
• CHAPTER 49
  
• CHAPTER 50
  
• Epilogue
  
• Author's Note
  
• References
  
• Acknowledgments
  

Copyright © 2012 by J. Thomas Shaw

All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the written prior permission of the author.

Disclaimer: All characters appearing in this work are fictitious. Any resemblance to real persons, living or dead, is purely coincidental.

The news came to Pfizer's chief scientist,
Dr. John L. LaMattina, as he was showering at 7 a.m. Saturday: the company's most promising experimental drug, intended to treat heart disease, actually caused an increase in deaths and heart problems. Eighty-two people had died so far in a clinical trial, versus 51 people in the same trial who had not taken it.

Within hours, Pfizer, the world's largest drug maker, told more than 100 trial investigators to stop giving patients the drug, called torcetrapib. Shortly after 9 p.m. Saturday, Pfizer announced that it had pulled the plug on the medicine entirely, turning the company's nearly $1 billion investment in it into a total loss. . . .

— Alex Berenson,
New York Times,
December 4, 2006
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1
. "End of Drug Trial Is a Big Loss for Pfizer" by Alex Berenson, from the
New York Times,
12/04/06 © 2006 The New York Times. All rights reserved. Used by permission and protected by the Copyright Laws of the United States. The printing, copying, redistribution, or retransmission of this Content without express written permission is prohibited.

Dr. Rosenberg delivered the diagnosis: ovarian
cancer, stage IV, the most advanced and lethal stage of cancer. Jessica Barringer was given three to six months to live without treatment and two additional years with an aggressive plan of surgery, radiation, and chemotherapy. A third choice, and an extreme long shot, was participation in a new clinical trial of an experimental drug being tested against Jessica's particular type of cancer. The trial was scheduled to commence within thirty days and Dr. Rosenberg informed Jessica that she would have an excellent chance to qualify for participation in the trial if she was interested in registering. Of course, Dr. Rosenberg explained, even if the drug were effective, there was only a fifty-fifty chance that Jessica would receive the experimental drug, since half of the participants would be placed in a control group and only receive a placebo. A fifty-fifty chance to get an untested, unproven drug were not the odds she'd been hoping for.

Prior to learning their cruel twist of fate, Ted and Jessica Barringer were living the ultimate American dream. Ted had been the youngest associate ever to make partner at one of the most prestigious law firms in San Francisco. From there, he quickly worked his way up to senior partner by generating scores of new clients over the course of several years.

Despite Ted's success, it was his wife, Jessica, who earned the windfall that afforded them the five million-dollar home with the panoramic view of San Francisco Bay, the forty-two-foot yacht they sailed on summer weekends, the skybox season tickets to their favorite sporting events, and their million-dollar chalet in Lake Tahoe.

Passing on the six-figure salaries being offered by the big boys, Jessica had joined a start-up technology firm after graduating with an MBA from Stanford. While the small company could not compete for her services via salary, they made up for it with generous stock option grants. Less than four years later, her gamble paid off and her firm went public. Before the paint could dry on their dream home, Jessica had cashed in her options for a net of nearly $20 million.

The man did not bother with greetings or small talk. When he approached Jerry Cottle sitting alone on the park bench, he held out his hand and Jerry filled it with an envelope that he had stuffed with hundred-dollar bills prior to leaving his office. In exchange, the man passed along a manila file folder, which Cottle knew contained information that could be worth millions. The man turned and walked away, but Jerry did not notice as his eyes were already scanning the contents of the folder.

The details revealed inside filled in the blanks from the phone call he had received a few hours earlier; Jerry knew he would need to act fast. Jessica Barringer was scheduled for surgery in three days and if he was going to extract her money, he had no time to spare.

He pulled out his cell phone and dialed the unlisted number that had been revealed to him in the file folder. When Jessica Barringer answered on the third ring, Jerry explained that he was with New Hope Cancer Alternatives, or NHCA, and that Jessica's name had been passed on to him as a possible candidate for the services that NHCA had to offer. Jerry explained that very few get this opportunity and asked to meet with Jessica and her husband to discuss her options. Though wary, Jessica's spirits were lifted by the caller's thorough knowledge of her particular situation and his assurances that NHCA had cured many patients with her same diagnosis. She agreed to meet with him the next day at his office.

The Barringers arrived early for their meeting, but Jerry was already waiting for them in the lobby. He didn't have to remind them of the seriousness of a stage IV diagnosis, or the scant odds of survival, but he did anyway. He emphasized that the NHCA had a drug that, while not FDA approved, was available at the organization's clinic outside of Puerto Vallarta, Mexico; Jessica's dire circumstances made her a perfect candidate to receive treatment at the NHCA clinic.

Ted inquired about the drug's success rate. Why should he entrust his wife's life to such a questionable venture? Jerry was both soothing and encouraging as he advised the couple of the high success rate of this drug, its minimal side effects, and the quick response that could be expected.

Ted was quick to jump on these claims. Why hadn't the wonder drug received FDA approval? Jerry chose his words carefully as he explained the long and costly process of obtaining approval. He assured Ted that someday the drug would be approved by the FDA, but unfortunately not in time to save Jessica's life.

Jerry began to sense hope and excitement in the desperate couple and moved in for the close. "Here are the facts. We have a drug that has cured stage four ovarian cancer on numerous occasions and all those who have received the treatment remain in full remission. When you meet with the clinic director, view our five-star facilities, and hear the testimonials from other patients, I am sure you will be convinced that this is the best—actually, the only—real option you have. I am sure that Dr. Rosenberg has already communicated to you that with the current diagnosis, there is almost no chance of long-term survival given the low quality of care that is available in the United States. And if you get started with our treatment plan and are not satisfied with the progress, you can always return to the care of Dr. Rosenberg."

When the couple hesitated, Cottle increased the pressure.

"If you like, I can arrange our departure flight for tomorrow morning. We can tour the facility, have our team of American physicians answer all of your questions, and then you can make your decision from there.'

Ted pondered the offer, then, eyes narrowing, said, "Okay, so what's the bottom line? Something this valuable must have a fancy price tag.'

"Yes, you're right, Ted. Access to this medicine is not cheap. The total is five million. One-third up front, one-third at the end of treatment, and the final one-third will be held in escrow to be released once we document that the cancer is in complete remission.'

Ted was speechless as he contemplated the payment plan. He Looked at Jessica. She quivered as she smiled at her husband "This sounds promising, but it is a lot to digest. Ted and I will discuss it, and we'll call you with our decision.'

Taking his cue, Jerry rose from his chair and walked the Barringers to the door. He handed Ted his business card, shook hands with Jessica, and fixed them with a piercing gaze that managed to convey sympathy, seriousness, and dependability all at once. "I am sure you will make the decision that is right for you.'

Four hours later, Ted phoned Cottle and told him to book the trip. Jerry had been anticipating the call. "Consider it done. I will have our service pick you up tomorrow morning. Seven thirty sharp."

A panel of Nigerian medical experts has
concluded that Pfizer Inc. violated international law during a 1996 epidemic by testing an unapproved drug on children with brain infections at a field hospital.

That finding is detailed in a lengthy Nigerian government report that has remained unreleased for five years, despite inquiries from the children's attorneys and from the media. The
Washington Post
recently obtained a copy of the confidential report, which is attracting congressional interest. It was provided by a source who asked to remain anonymous because of personal safety concerns.

The report concludes that Pfizer never obtained authorization from the Nigerian government to give the unproven drug to nearly 100 children and infants. Pfizer selected the patients at a field hospital in the city of Kano, where the children had been taken to be treated for an often deadly strain of meningitis. At the time, Doctors Without Borders was dispensing approved antibiotics at the hospital.

Pfizer's experiment was "an illegal trial of an unregistered drug,' the Nigerian panel concluded, and a "clear case of exploitation of the ignorant." . . . Pfizer contended that its researchers traveled to Kano with a purely philanthropic motive, to help fight the epidemic, which ultimately killed more than 15,000 Africans. The committee rejected that explanation, pointing out that Pfizer physicians completed their trial and left while "the epidemic was still raging.'

The panel said an oral form of Trovan, the Pfizer drug used in the test, had apparently never been given to children with meningitis. There are no records documenting that Pfizer told the children or their parents that they were part of an experiment. . . .

An approval letter from a Nigerian ethics committee, which Pfizer used to justify its actions, had been concocted and backdated by the company's lead researcher in Kano. . . .

The panel concluded that the experiment violated Nigerian law, the international Declaration of Helsinki that governs ethical medical research and the U.N. Convention on the Rights of the Child.

Five children died after being treated with the experimental antibiotic. . . .

Aspects of the affair remain mysterious, such as why the report remains confidential. The head of the investigative panel, Abdulsalami Nasidi, said in a brief telephone conversation from Nigeria, "I don't really know myself' why the report was never released.

"I did my job as a civil servant,' said Nasidi, who is quoted in the report as saying he has been the target of unspecified death threats.

— Joe Stephens,
Washington Post,
May 7, 2006
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