By Mark Blaxill
On one of those rare days that my wife and I were actually sitting down at our dinner table for a normal dinner, the phone rang. It was a Wednesday night and Elise answered the phone. She got one of those expressions on her face that meant, “This is not your average call.” Her voice turned animated and friendly as she seemed to respond to charm with even more charm. As she turned to hand me the phone, her eyebrows rose.
“It’s for you dear. It’s the CDC.”
I soon found myself speaking to a charming young woman, an aide to CDC Director Julie Gerberding, whose name I can’t remember. She was calling to invite me to serve on a “Blue Ribbon Panel on Vaccine Safety” as a “consumer representative.” I would be joining high-ranking representatives from the CDC, the Advisory Committee on Immunization Practices, various universities and other federal agencies. Dr. Louis Cooper, past President of the American Academy of Pediatrics would be the chairman. I had had a hint that something like this might be in the works, having spent some time in Washington DC in the previous few months. One of our friends in Congress had mentioned that he hoped to secure an invitation for a SafeMinds representative to a vaccine safety meeting and I had raised my hand. “I’d be delighted to attend”, I said to Gerberding’s aide. “When does the meeting start?”
“Tomorrow morning at 9:00 AM. It’s in Atlanta.”
After 25 years in the consulting business, I was used to making last minute travel plans, but this was a bit less notice than I had bargained for. And I had a conflict, an important client meeting on Thursday that I couldn’t postpone. But I learned that the meeting would continue through Friday, so I accepted the invitation along with Gerberding’s aide’s gracious apologies for the late notice. The Blue Ribbon Panel meeting was scheduled on June 3-4, 2004 and after booking the first flight from Boston Logan Airport down to Atlanta, I was able to make it in just a few minutes after the panel reconvened, on Friday morning just a bit after 9.
As I quickly learned, the Blue Ribbon Panel on Vaccine Safety was one of these fascinating exercises in bureaucratic judo, in which a federal agency under attack does its best to neutralize the threat by turning the attacker’s energy back on itself, all the while appearing to respond openly and thoughtfully to criticism. In this particular instance, the attack came from two public health professors at John Hopkins, Neal Halsey and Daniel Salmon, who wrote a paper proposing a change in vaccine safety management. Their rather sensible suggestion was to separate the management of vaccine promotion from vaccine safety assessment, both of which resided within the National Immunization Program (NIP) at CDC. As Halsey and Salmon noted, “This dual role of the NIP to promote immunizations and conduct safety evaluations creates the potential for real and perceived conflicts of interest.”
Faced with this fairly obvious, but threatening point, the Blue Ribbon Panel was the judo move. The CDC called together a bunch of their close friends and asked them to discuss what to do about vaccine safety. Realizing that Congressional oversight wouldn’t let THEM get away with a panel consisting solely of insiders, they invited a few token outsiders. Barbara Loe Fisher, who has long played a lonely role as the nation’s conscience on vaccine safety was invited, as well as some autism organization representatives: Peter Bell from Cure Autism Now and Rob Beck from the Autism Society of America. As Lou Cooper explained, the role of the panel was to offer “a reflection of our individual and collective wisdom”, not to make recommendations. Lou Cooper would take charge of writing up these “reflections.” Under the cover of this relatively friendly document (in case anyone from Congress asked), and after it was all over, the CDC would go ahead and do whatever it wanted to do in the first place.
Based on the timing of my invitation, I surmised that I was not on the top of CDC’s list of friendly panelists. Or maybe they just misplaced my invitation. In any event, as I walked into the hotel conference room late, I took a seat next to Barbara and joined into the discussion. And I must say, it ended up being quite an interesting day.
In response to a question about how the CDC was doing on vaccine safety, I started out doing my best to shake the group up a bit. Apologizing in advance for being “the skunk at the garden party”, I said I thought the CDC was doing a terrible job. And not just on vaccine safety management, but on the larger question of childhood health. They were too busy protecting their sacred programs, I argued, and nothing at all to deal with the crisis in childhood health in America. There were other voices for change in the room as well. Barbara was forceful and deeply knowledgeable on the issues and Peter Bell was similarly supportive on the issues of childhood health. Some of the invitees from the transportation world (in which the FAA promotes air travel and the NTSB deal with airplane safety) thought it was pretty obvious that you needed to separate the functions of promotion and safety management. The voices for change were clearly a minority in the crowd, but despite the wide range of opinions, everyone was professional and polite and Lou Cooper was a gracious host and moderator. But I did notice getting at least one nasty look from one of the ACIP crowd.
Then it was over. Lou Cooper promised to write up a summary report and send it around. When I got the draft a couple of weeks later, it was pretty obvious that the judo move was working. All of the frank conversation, all of the sharp commentary and the fundamental criticisms were nowhere to be found. Instead, the clear coherent call for change from the outsiders in the room was scattered in bits and fragments throughout the document. The “collective wisdom” of the establishment dominated the tone and reporting. According to Cooper’s summary, the CDC was doing a great job on vaccine safety and everyone on the Blue Ribbon Panel wanted to protect their “good work” from “outside influences.” It was as if a number of us were never there.
I can’t say I was surprised, nor particularly disappointed. But I was definitely annoyed that the voice of dissent had been so thoroughly suppressed. I wondered what I could do about it and I called up Barbara. We both agreed that the least we could do was to actually say something, and we proceeded to write down our dissenting view. They could (and would) ignore what we had to say, but at least we would speak to the void in our own voice, rather than through a filter.
After a month or so of hard work, we wrote the paper called “From Safety Last to Children First: A White Paper on Vaccine Safety.” We let Lou Cooper know what we were doing. We mailed a copy to Julie Gerberding. And that was truly speaking to the void. We never received a response of any kind from CDC. Just Lou Cooper (obviously not happy) asking us not to call it a “minority report” and letting us know it would not be a part of the official record of the meeting. Simply “that they own their response and may distribute it as they wish.”
So what we wish to do, after three years in bureaucratic limbo, is to share our “parent representative report” with the readers of the Age of Autism. The issues we raise haven’t gone away, quite the contrary. We hope you find it thought provoking.
As to the real and perceived conflicts of interest in vaccine safety management, not much happened after all this effort. Gerberding made a cosmetic change by moving the vaccine safety function out of NIP and into another area within CDC. And the Blue Ribbon Panel remained even more obscure than most such efforts. Even Halsey and Salmon noticed the silence. “Both the CDC and FDA responded to our published commentary and recognized the perceived conflict of interest. The CDC then convened a blue-ribbon panel to review the vaccine safety program and where it should be located. But instead of an open debate with the medical and public health communities, the CDC held a closed-door meeting. Neither the transcript of the meeting nor the panel's report has been made public. This is hardly an auspicious beginning to resolve this issue and build confidence in vaccine safety.”