Around the elegant conference room, twenty-two physicians and scientists stopped their conversations and solemnly took their seats behind their name cards around the massive table. One place remained conspicuously empty — that of consumer representative Ellen Kroft.
'I would like to take this opportunity,' Steinman began, 'to thank each and every one of you for nearly three years of outstanding, deeply committed effort, which will culminate in this morning's vote. You have done a great service to your country, to the medical community, and ultimately to the people of the world. The agenda for this meeting is that you will individually be given the chance to make some final remarks on whatever subject you choose relative to the work we have been doing. After that, we will go around the table and each will vote Yea or Nay. For the purpose of the First Lady's promise to the American people, an abstention will not be viewed as a negative vote.'
He paused, looking as if he had just swallowed an underchewed chunk of meat.
'Before we go any further,' he said after clearing his throat and composing himself, 'there is a statement I have been asked to read to you. It was delivered to me earlier this morning with a note stating that copies of it are being sent to the Washington Post and the New York Times, as well as to all four major TV networks and CNN. It is from Mrs. Ellen Kroft, who will not be here today. I'm sorry there wasn't time to provide each of you a copy, but one will be distributed to you by the time our session is over. I have been asked by Mrs. Kroft to read her statement to you in its entirety.'
There was a stirring in the room and an exchange of glances. Some expressions were curious, some unabashedly disdainful. Seated next to Ellen Kroft's empty chair, George Poulos fixed his neutral gaze steadily on Steinman.
'There being no objections, then,' Steinman said, 'I shall proceed.' He again cleared his throat, then adjusted his glasses.
''Esteemed colleagues, as the lone consumer representative on the Omnivax commission I have approached my responsibilities not as the scientist and/or physician that all of you are, but as a mother and grandmother. From the day of our first meeting, I established three mandates for myself. The first was to learn as much as I was able about the process by which vaccines are developed, tested, approved, and later on evaluated once they are in general use. The second was to acquaint myself in depth with the components of Omnivax — their production, individual characteristics, and interactions one with another. And finally, to speak with a cross section of fathers and mothers in a number of communities, recording their hopes and, yes, their fears about vaccinations in general and Omnivax in particular. I would like to address these tasks in that order.
' 'There are many, including most of you, the First Family, and HHS Secretary Lara Bolton, who believe that one of the primary benchmarks of progress in a civilized society is how thoroughly its citizens are protected against infectious diseases. As you know, but others may not, since nineteen-forty the number of required vaccine doses for our children has risen from three doses of DPT to forty doses of twelve different vaccines. And now, with Omnivax, while the number of shots will drop impressively, the number of vaccines administered will more than double. Omnivax certainly seems like one giant leap for mankind. But will there be negative consequences?
' 'The gold standard for any new drug investigation is the double blind study, in which the subject population is divided into two groups, equal in as many demographic and medical parameters as possible. The larger the study population, the better, so long as the characteristics of each group are equivalent. One of the groups then receives the drug being evaluated, and the other a placebo. The study becomes double blind when neither the patient nor the treating physician knows who is getting what. The longer the evaluation is continued, the more reliable its results. In fact, many new drug studies have been conducted over a decade or more.
''My research has shown that not once has a vaccine — any vaccine — been evaluated by a prolonged double blind study. The pharmaceutical houses are powerful, and fund much of the drug research done at our universities and medical centers. They also have polished, highly effective public relations offices that have, on a number of occasions, set out to convince the general public that we cannot afford to deprive the placebo group of the lifesaving benefits of a vaccine while waiting until a statistically meaningful double blind study can be completed.
' 'Has this shortcut in scientific process hurt us in any concrete, medical way? That I cannot answer with any certainty. What I can say is that as vaccination rates have climbed, there has been an alarming increase in the incidence of a number of so-called immune-mediated diseases and conditions such as asthma, allergies, and juvenile diabetes, as well as others — autism, ADD, and other learning disabilities — whose classification as immune-mediated remains to be established. Is there a connection? Do vaccinations in some instances disrupt the normal development of the body's immune system? Until long-term, double blind studies are performed on those vaccines, we may never know.''
Here, Steinman paused for some water and to make eye contact with those on his committee. Several of them rolled their eyes in exasperation at being forced to listen to the shopworn, simplistic revelations of the one member of their panel with no research credentials.
'I can see what you're thinking,' Steinman said, 'but I am going to finish Mrs. Kroft's statement. She has done us all a great service by deciding to abstain from this vote. In our laboratories and clinics, we are powerful and influential. But in the court of public opinion, the consumer representative has more clout than almost any of us. When this meeting is over and our vote has been taken, we are each going to have to respond publicly to the issues she is raising. Any questions?'
'Just get it over and let's vote,' one of the pediatricians groused.
'Thank you, Mel,' Steinman said. 'That is just what I intend to do.' He straightened his glasses and took another drink.
''And what about Omnivax?' Mrs. Kroft goes on. 'First, let me say how impressed I am with the research and medical technology that has gone into the development of this amazing product. But once again, I must ask, Where is the double blind study? Where is the long-term evaluation? Once a drug or vaccine is released, the CDC and FDA rely on a post-marketing evaluation system of physician adverse reaction report forms. Studies have shown that only a small percentage of doctors have ever filled out such a form, despite knowing or sensing that many conditions they have encountered may be vaccine- or medication-related. Some are too busy or simply can't put their hands on a form at the moment they need one. Those who fill out such forms generally do so only when the suspected reaction occurs within a short time after the medication is taken and, more often than not, is spectacular. I would be remiss not to point out that there is no evidence at this juncture that Omnivax has caused problems in preliminary test subjects of a magnitude that even remotely approaches the mortality of the diseases it is preventing. But I would also be remiss not to point out that Omnivax is only as strong as its least extensively evaluated component.
''Thirty vaccines, no double blind research. But also no obvious major adverse effects. For me those three facts make the decision on Omnivax a tough call.
' 'That brings me to my final task, that of being a true consumer representative. Parents are frightened that government agencies and the pharmaceutical industry are keeping information on vaccine side effects from them. Those parents who wish to decline vaccinating their children are prosecuted sometimes even when they can show that doing so violates their basic religious beliefs. This shouldn't be happening in America. Wherever I go, parents are clamoring for three things: information, research, and choice.
''So where does that leave us? We have a remarkable product that will unquestionably save lives. We have a basic, essential research design that has been skipped over just as it has for every other vaccine or vaccine combination we have ever used. We have parents wanting more information and more control over what is injected into their children's bodies.
' 'After reviewing all these facets and issues, I have decided I can neither wholeheartedly endorse Omnivax nor vote to deprive the American public of its lifesaving gifts. I therefore have decided to abstain from the final vote on its approval. I wish my colleagues on the commission all the best and thank them for their forbearance and education over these past thirty-two months.''
Richard Steinman set his glasses aside. Around the room, expressions clearly said that none of the participants were the least bit moved by what Ellen had written. After several silent seconds, George Poulos raised his hand and spoke.
'I would like to move at this time that we dispense with the final comments and proceed right to a vote.'
'Second,' a weary voice called out.
