Fatal

CHAPTER 9

For two and a half years, nearly all of the Omnivax commission meetings had been held in one or the other of the two main conference rooms located on the third floor of the Parkman Building, FDA headquarters in Rockville, Maryland. When Lynette Marquand made her speech later in the day, the sliding partition between the rooms would be open, allowing seating for the press, the Omnivax panel, the First Lady's staff, and those hundred or so dignitaries who had managed to procure invitations.

For the moment, though, the partition was closed so that the commission could hold its meeting in private. From what Ellen knew, this gathering was probably the last one before the session to vote formal approval for the distribution and general use of the supervaccine.

She scanned the first room as she passed by. Television camera crews were preparing to beam Marquand's message to the world, and several Secret Service agents were carefully inspecting the walls, podium, and beneath the chairs. Most of the Omnivax commission members were already in the other room, mingling in twos and threes. A few were settling down in front of their computer-generated cardboard place cards at the gleaming, football field-sized cherry conference table. Most of the members were men, and all of the members except for Ellen held either an M.D. degree, a Ph.D., or in a number of instances, both. Beneath their names were printed their titles, specialties, and agencies. Ellen's identified her simply as "Ellen Kroft, M.S.; Consumer."

Within weeks following Ellen's first meeting, Cheri and Sally-gave her a detailed briefing on each and every one of the other members of the panel, including, where appropriate, the sources of their research funds, and any known stock holdings in the pharmaceutical industry. Ellen was stunned at how much information the two housewives had amassed. They were serious, big-time players in this game, and the worldwide impact they had made in a relatively short time reflected that. She was also astonished at the extent and complexity of the connections between the members of the committee and the drug industry. If Cheri and Sally's information was accurate, and nothing had come to light to make her think otherwise, too many of them had some sort of link.

Of those in the room, only a few took notice of Ellen with a smile or a nod. By and large, as usual, she was ignored. Moments after she took her place at what would have been about the ten-yard line, Dr. George Poulos, Director of the Institute for Vaccine Development, took his seat directly to her right. Poulos, one of those with dual degrees, was a darkly handsome man with classic Greek features. He was always elegantly dressed, and today, possibly in honor of the occasion, wore a crimson handkerchief tucked neatly in the breast pocket of his suit coat. Somewhere in a file folder in Ellen's study, the dossier Sally and Cheri had generated on him reported that he was a highly regarded clinician, researcher, and businessman, as well as a big-time supporter of President Jim Marquand. He could be swayed on some issues, but only if he thought making a concession would improve his position.

Unpredictable, and generally not to be trusted, it read. Looked like a hero when he helped halt the experimental combined chicken pox and MMR vaccine testing in South America in the mid-1980s, after deaths and immune suppression in a number of female babies, but turned his back six months later when slightly altered versions of the vaccine — were used.

The last line in the report read simply, Drives a red Porsche 911 Turbo.

"So, Ellen," he said, gesturing vaguely at those assembling in the elegant room, "you have come a long way from teaching middle-school science."

Ellen stifled a number of retorts, ranging from quick and very funny to downright nasty and offensive.

"It certainly has been an experience," she settled on.

"And how does it feel to have worked hand in hand with such an accomplished group of scientists?"

"It… certainly has been an experience," she said again, backing up her attempt at humor with what she hoped was a warm grin. "Are you excited about the First Lady's visit?"

"Oh, very. Lynette and I are old friends. I consulted for her on the vaccination section of her book Citizen Pioneers. Omnivax is her baby, so to speak."

"So it seems."

"And after we vote, she will be sharing that baby with the nation and maybe the world."

"Is that why the vote was moved up?"

"Perhaps. With the outcome foregone, many people in very high places would like this to be a done deal as soon as possible."

Ellen felt her composure begin to shrivel.

"I wish I agreed with them," she said. "Have you seen how many letters from parents and grandparents have been written to congressmen protesting that Omnivax hasn't been studied long enough? Or how many op-ed pieces have been published warning against moving ahead with this project too prematurely? Why, even I have been getting letters and e-mail — five or ten a day for the past few months. There are very strong feelings about this project among the public."

"Tree huggers," Poulos said with undisguised scorn. "This is only one of a dozen issues they write about and write about. I assure you, the vast majority of Americans are totally behind this project. They're just not the ones who write letters."

Ellen had never felt too comfortable around Poulos, but now she was beginning to feel a legitimate dislike.

"I still think we're moving way too fast on this thing," she replied. "There are unanswered questions."

"Specifically?"

Ellen cautioned herself not to be drawn into a discussion of Lasaject until Rudy had completed his research. She had purposely refrained from discussing with Sally and Cheri the work he was doing. Bringing it up now with a company man like Poulos would be reckless and dumb.

Lasaject, a vaccine against the horrible hemorrhagic disease Lassa fever, was one of the last components to be voted for inclusion in Omnivax. Endemic to the West African country of Sierra Leone, Lassa fever had been appearing in the U.S. with increasing frequency over the past few years.

"Specifically," she replied, "the question of why the current administration is putting pressure on us to approve this vaccine when there are so many unanswered questions and so many consumers who would like to see it scaled down or shelved altogether."

There! I said it and I'm glad.

Ellen was continuing to research the disease even as Rudy was analyzing the clinical data accumulated for the vaccine. Lassa fever, caused by a virus similar to the deadly Ebola virus, showed up in Chicago and Milwaukee a decade ago, rapidly causing more than two dozen deaths. With the possibility of a major epidemic looming, Columbia Pharmaceuticals, a Maryland-based company, quickly developed and successfully tested a vaccine. But then, as suddenly as they began, the Lassa cases petered out. The potential for an epidemic vanished, and impending mandatory vaccination with Lasaject was tabled indefinitely by the FDA. For its hard work, Columbia was left holding a very expensive bag. Their subsequent attempts to market the vaccine in Sierra Leone were thwarted by political unrest and an economy that was one of the weakest in Africa. The World Health Organization simply refused to send its people into an area so volatile. So, for seven years the attenuated virus comprising the vaccine languished in the incubators of its creator.

Poulos eyed her disdainfully.

"You started out so well on this commission," he said.

"I'm sorry to have become a disappointment to you."

At that moment, the chairman of the committee, Rich Steinman, a professor at Georgetown, gaveled the committee meeting to order.

"Well," Poulos said, turning his attention away from her and toward the professor, "there are millions and millions of people out there who are going to sleep a whole lot better knowing Omnivax has rendered them and their children safe from a multitude of infectious diseases."

"Well, George," Ellen replied, "it won't be because I voted for it."

Professor Richard Steinman, looking as puffed as a pigeon, beamed out at the assembled crowd and, indeed, at the world. The partition between the two large conference rooms had been opened, and the conference table moved aside, allowing seating for 150 or so. Behind Steinman on a low stage sat various political and scientific dignitaries, as well as half a dozen of the more prominent members of the select federal commission on Omnivax, including George Poulos. Ellen was seated toward one side of the first row, sandwiched between the head of the Committee on Infectious Diseases of the American Academy of Pediatrics and the woman directing the Centers for Disease Control's Committee on Immunization Practices. Several rows behind her, politicking until the last possible moment, sat Cheri Sanderson.

As Ellen anticipated, the meeting of the select commission that preceded this session had been little more than a pep rally — scientists and physicians verbally patting one another on the back and celebrating that their work was almost done. Richard Steinman set the date for the closed ballot vote on the group's recommendation, and then went around the table for remarks. There was virtually nothing substantive brought up.

Ellen had no urge to add to the merriment by suggesting that there was still time for the entire gang to reconsider their votes. She gave passing thought to a simple "Thank you for bearing with my incessant questions and for teaching me so much over the past almost three years," but she knew her superego was too well developed to allow it. Instead, when her turn came, with a final internal warning to be brief, she took a sip of water, praying that no one noticed her hands were shaking, and rose to face the group.

"Everyone who has spoken thus far has expressed what a positive experience it has been serving on this panel," she said. "In fact, in many ways, it has been a positive experience for me, too. Please know that I have tried my best not to be too disruptive or contrary as we sifted through mountains of scientific and clinical data and reports. But I am the consumer representative on this panel, and despite knowing that our vote on Omnivax is a formality, I would feel remiss if I did not make one final plea on behalf of that group.

"It is far more difficult to stop a vaccination freight train once it has built a head of steam than it would be to keep it in the station until the clinical evidence supporting its safety and efficacy is overwhelming. Omnivax has only been followed in test subjects for six months or so, and many of its components have not been studied over an extended period, either.

"I know I have expressed my concerns in this area before, but I still remain uneasy about articles I have read — anecdotal, I grant you — hinting at an association between an increase in the number of vaccinations we give our children and an increase in immune-mediated diseases such as diabetes, asthma, and multiple sclerosis, to say nothing of the skyrocketing increase in conditions like ADD and autism. I can see a number of you itching to leap to your feet and refute my statement with your data. Well, if I have learned nothing else over the years we have worked together, I have learned how malleable statistics can be. The same data can be served up in any number of ways, sort of like chicken."

There had been reasonably warm laughter from some around the table, but Ellen could tell by many expressions that she had already prattled on too long.

"So," she had concluded, no longer at all nervous, "while this will be our last meeting before we vote, I do intend to keep a close eye on Omnivax over the weeks, months, and years ahead. And perhaps sometime soon I can have all of you over to my place for dinner — chicken dinner, of course."

Gradually, Ellen's attention drifted back from replaying her remarks in the final commission meeting to the business at hand. Steinman, flushed with the significance of the moment, finished introducing the most important of the luminaries. Then he paused, surveying the audience.

"And now, ladies and gentlemen," he trumpeted finally, "it gives me great pleasure to introduce the woman who has spearheaded this project with her caring and vision, the author of the landmark books Prevention Is the Strongest Medicine and Citizen Pioneers, the First Lady of the United States, Mrs. Lynette Lowry Marquand."

The standing ovation lasted more than a minute. Marquand, dressed in a simple but stunning beige suit, motioned for all to be seated. Then, for fully fifteen silent seconds she stood there, surveying the audience and gazing into the cameras, emphasizing the significance of the occasion. She waited until the drama of silence was at its peak before she spoke.

"Ladies and gentlemen, distinguished scientists and healers, members of the press, citizens of this country and the world, it gives me great, great pleasure to introduce to you the real star of these proceedings."

She hesitated just a beat, then whirled theatrically and tugged on a long, tasseled gold cord, releasing a three-foot-wide scroll that unraveled from the ceiling. Printed boldly on the scroll, beginning with DIPHTHERIA and proceeding down to JAPANESE ENCEPHALITIS, was a list of the thirty diseases that were about to be prevented if not eradicated by Omnivax. Third from the bottom of the list, just after CHOLERA and before SHIGELLOSIS, was LASSA FEVER.

Again, there was tumultuous applause.

In a dynamic, well-crafted speech, the First Lady went down the list one by one, saying just enough about each condition to personalize it for the audience and to have every parent across the country sighing in relief that their children would be spared its horrible consequences.

Ellen was impressed with the woman, even though she had voted against her husband in the last election and intended to do so again in this one. Still, with the end of almost three years of hard work at hand, and with Rudy still doing his research unaware that the vote had been moved up, she had trouble keeping her mind on the speech. In fact, she was so distracted that she very nearly missed the words from Lynette Marquand that would change her life forever.

"… The President, Secretary Bolton, and I," Marquand was saying, "are fully aware that there are those who are opposed to this project. Nothing of lasting value is ever accomplished without conflicting opinions and controversy. We are also aware of those who have tried to politicize this endeavor. Speaking for my husband and myself, I can say that is the last thing we wish to do. That is why the selection of the commission evaluating Omnivax was done with such care. In your programs is a list of the members of this commission and a few of the qualifications of each. I'm sure you'll agree that this is quite a remarkable, independent, and trustworthy team, and I want to take this opportunity to thank Dr. Steinman and each and every one of them for their hard work and devotion to this project."

Marquand gestured to those commission members seated behind her, and also to those in the front row. Then she made them stand up as a group and led the audience in an enthusiastic round of applause. It was only as Ellen was settling back into her seat that her attention returned fully to the proceedings.

"For nearly three years," Marquand went on, "every single member of this august panel of world-renowned experts has studied Omnivax in detail from every angle. I have been briefed regularly on their progress. Soon they will be voting on whether or not to approve its distribution for general use. I promise you, the American public, that if even one, just one, of the twenty-three members of this commission votes against the release of Omnivax, we will hold up our inoculation program for as long as it takes to resolve any and all misgivings."

The pronouncement, enunciated as energetically as any campaign rhetoric, was greeted with an immediate, boisterous standing ovation. Ellen sat dumbfounded, staring up at the First Lady until she realized that all the others in the hall were on their feet. Slowly, somewhat unsteadily, she rose and brought her hands together. It was then she noticed that, from his place just behind and to the right of Lynette Marquand, George Poulos was staring directly down at her.