September 27, 2010
The Science, Ethics and Politics of Vaccine Mandates
BACKGROUND AND SUMMARY
This is a long post but I encourage you to read my remarks. Compulsory vaccination represents a severe limitation of our human, civil, individual and parental rights. It is very important to understand the arguments and justifications for vaccine mandates offered by doctors and public health officials. While the public health system usually appears anonymous and impersonal, a conference like the one I attended this week is an opportunity to see the individuals behind the system. The people who participated in the program are among the leaders upholding vaccine mandates in our country.
On Tuesday, September 21, 2010, I attended a full day conference on the Science, Ethics and Politics of Vaccine Mandates. The event took place on the University of Pennsylvania campus, in the Biomedical Research Building. Conference sponsors were the Children’s Hospital of Philadelphia (CHOP), the University of Pennsylvania Health System (HUP), the Society for Health Care Epidemiology of America, and the Center for Vaccine Ethics and Policy. Click HERE for the program. Organizers and participants included including Paul Offit (CHOP), Arthur Caplan (Director of the Center for Bioethics), Dan Salmon (Department of Health and Human Services, Vaccine Safety) and Eddy Bresnitz (former New Jersey Health Commissioner, now head of adult vaccines at Merck).
Although there was a “waitlist,” the room was not full; there were fewer than 100 people in attendance. They reserved the first row for press and none came, as far as I could tell. With the exception of some panel members, a friend who joined me, and Susan Kreider - an RN who was crippled (Guillain-Barre) by the vaccines she was mandated to receive while in nursing school twenty years ago - I didn’t recognize anyone there. I sat in the second row.
The Presumption of Safety
The most striking feature of the conference was the assumption on the part of the Center for Bioethics that vaccines are safe. With a presumption of safety, they would not address many of the significant concerns underlying vaccine mandates.
Yet, on its website, the Center for Bioethics describes its mission as:
The field of bioethics… provides a practical language… and a means for our society to talk about its deepest moral concerns, fears and hopes. The Center employs this language to promote scholarly and public understanding of the ethical, legal, social and public policy implications of advances in the life sciences and medicine. It fosters informed dialogue about these issues across a broad spectrum of opinions that not only are the right questions addressed, but that the answers given rest upon solid facts and cogent arguments… [We] engage in careful analysis, thoughtful reflection, and foster public discussion about the critical biomedical questions that put our traditions and values to the test. [Emphasis is mine]
Legally, vaccines are “unavoidably unsafe.” A vaccine “is a product that is incapable of being made safe for its intended and ordinary use.” This is the reason that Congress created the Vaccine Injury Compensation Program (VICP) in 1986; the intention was to protect vaccine makers from most legal liability when vaccines injure or cause death. I am not sure how they can claim to address “the right questions” and society’s “deepest moral concerns” with “informed dialogue… across a broad spectrum of opinions” when they affirmatively choose to ignore the nearly $2 billion paid out to over 2,500 families in the VICP. The fact that vaccines are unsafe for many people is a legal given, and yet completely denied by The Center for Bioethics. At the conference, I observed that neither the “tradition” of cradle-to-grave vaccination, nor the societal “value” of compulsion was put to the test.
A Word About Herd Immunity
The validity of herd immunity undergirds all compulsory vaccination policies. The theory of herd immunity posits that when a sufficiently high threshold of people in a community is immune to a specific disease, it creates a protective effect, a barrier of sorts. Society achieves herd immunity when this protective cordon prevents a resurgence of the disease and, as a result, protects vulnerable individuals who cannot receive vaccines (or whose vaccines failed).
After the conference, I approached James Colgrove, PhD, an expert in the history and ethics of public health from Columbia University. I complimented him on his 2006 book State of Immunity and asked for clarification. His book reveals that the term “herd immunity” first appeared in 1923. He describes data limitations and the difficulty in validating the theory empirically. He quotes one official saying, in 1932, that herd immunity was “a mere hypothesis.” I asked Colgrove for subsequent evidence-based research upholding the soundness of herd immunity. He mentioned epidemiological studies on measles in the 1960s and 1970s that provided corroboration. I challenged him.
As explained to me by pediatrician Larry Palevsky, the original basis for herd immunity had nothing to do with vaccines. When sufficiently high numbers of people contracted the wild form of the disease and secured lifelong natural immunity, statisticians observed a protective effect in the community as described above. Policymakers eager to promote vaccines sought ammunition to increase vaccine uptake. Researchers assumed that vaccine-induced immunity would operate in the same manner as natural immunity and presumed that vaccines therefore would also create herd immunity. I am not a scientist but I know that vaccine-induced immunity is not remotely the same thing as natural immunity. Natural immunity is the gold standard. Vaccine-induced immunity is qualitatively different; for starters, vaccines do not always work and their protection wanes over time. Colgrove admitted as much, and I just stood there for a moment, stunned. We clearly need more inquiry into this critically important subject. However, it does not take scientific brilliance to understand this key point: discredit herd immunity and the house of cards supporting vaccine mandates comes tumbling down.
My Public Remarks at the Conference
During the program, I offered two substantive comments.
My first comment was during the “Mandates for Children” Panel. I thanked the organizers for making this event open to the public but expressed disappointment that they did not have balanced representation on the panel. I said you could not simply explain away deep concerns about compulsory vaccination by calling people selfish or irresponsible. I told them that we must assume that people are fundamentally intelligent and want to do the best thing for their children and themselves and we must do all we can to engage these perspectives. I said it is dangerous to say that the science is clear; that as physicians and PhDs, they know what evidence-based medicine means and in the absence of randomized controlled studies of the vaccinated versus the unvaccinated, there are strict limits as to what they can and should say about the state of the science. I stressed that they failed to even acknowledge how devastating vaccine injuries can be, bringing their attention to Susan Kreider. Offit was cued to cut me off at that point, so I quickly asked why children are expected to uphold the entire burden of herd immunity for all of society. Not surprisingly, they did not answer my question, but to my surprise, my comments received applause. Offit came up to me after the Panel and shook my hand.
I addressed my second comment to the Merck representative on the “Mandating HPV Vaccine” Panel who said that Merck is “neutral” on the issue of HPV vaccine mandates. I told her that she could not tell the room that Merck is neutral on the subject of mandates, that they actively seek mandates as part of their business strategy, and that their lobbying efforts resulted in pending legislation today in over 20 states to mandate the Gardasil vaccine. I offered that perhaps Merck made the decision to step back from their policymaking involvement due to strong negative public opinion and potential damage to their brand, but it is disingenuous to state that they are neutral on the subject. I do not recall it, but my friend said there was applause after this statement, too.
People supportive of vaccines filled the room, but I sensed that some are questioning the wisdom of mandates. Several of them came to me after my first comment and at the end of the conference to thank me. Although they uphold a need for vaccines, they said they welcome more participation from those deeply concerned about vaccines.
The most important message I can bring back from Philadelphia is that our work is making a difference and we must continue to push ahead strongly. Panel members offered examples when visible vaccine safety and vaccination choice activism thwarted the adoption of even more aggressive vaccine policies.
While they were comfortable discussing the negative role that our activism plays in decreasing vaccine uptake rates, their silence on the specifics of our issues was both deafening and telling. They did not discuss society’s collective responsibility to people who are injured and killed while upholding their duty to protect society. There was not one word uttered about any of the existing and emerging science critical of vaccines and vaccine ingredients. With the exception of Dr. Diane Harper’s comments during the HPV Panel, there were no remarks about the merits of slowing things down a bit. Moreover, no one breathed a word about the United States’ precipitous decline among the world’s nations in infant mortality rankings (we lag behind every developed country except Poland) or the mind-numbing increases in the incidence of chronically ill children. At the conference, what mattered most was compliance with vaccine mandates.
As a side note, the trifecta of doctors, public health officials and industry is strong and clubby. They know each other well and interact with ease, joking and frequently referencing each other’s work. They spend time thinking about the opposition in the context of how to solve us as a problem. They refer to “us” in three different categories: 1) those concerned about individual and parental rights, 2) those who believe that vaccines cause autism, and 3) those who are concerned about the safety of vaccines in general. Regardless, in their eyes, all three groups possess an “anti-vaccine” ideology.
The best summary of the entire conference is on this slide from Donald Schwarz (see below for bio):
We should expect increased efforts to make exemptions for health care workers (HCWs), children and others more difficult to obtain.
You can view nearly all the conference slides and 16 short video clips HERE to give you a flavor for the content and tenor of the event. If you can imagine juggling a camera and FlipCam, note taking, and deciding when to speak out, then you might forgive the poor quality of the video and any inaccuracies in this post (another attendee did review it). Caplan also announced that audio from the full day’s program will be made available on their site.
Art Caplan, PhD, Director of Penn’s Center for Bioethics, welcomed the audience.
Jason Schwartz, MBE, AM is an Associate Fellow at the Center for Bioethics. His bio is available HERE. He told the audience he would review 200 years in 30 minutes. Despite major changes over the past two centuries, the arguments have remained consistent, reflecting a long-standing debate between the role of the state and limits on individual rights. Schwartz expressed the view that we need mandates in the U.S. because Americans have more of an individual ethos, in contrast with other countries that are more communitarian. He observed that our country was passing compulsory vaccination laws and compulsory school laws at the same time (1870-1920) and therefore societal views about both were being shaped simultaneously. He emphasized that public trust in vaccines is key to mandates, and that we need school mandates because of the safety net provided to society as a whole.
Tom Talbot, MD, MPH is an epidemiologist with Vanderbilt. His bio is available HERE. Talbot spoke about the need for HCW vaccine mandates because HCWs are vectors for disease; many are asymptomatic and contagious and 75% of them work while ill. He said upfront that there will never be any randomized controlled studies of the vaccinated versus unvaccinated HCWs, that it would never get past the ERB (ethics review board) because it is unethical to withhold vaccines from anyone, and that he does not feel we need to have it anyway. He reviewed other data that point towards the reduction of morbidity and mortality of patients when HCWs are vaccinated. Talbot said that it is a profound privilege to work with patients, that their safety must come first, and that institutions must take a leadership position and clearly show “it’s who we are, don’t come here if you don’t believe.” Mandates are necessary because they increase compliance. He quoted a Centers for Disease Control and Prevention (CDC) statistic that 1 in 10 HCWs is under a vaccine mandate policy. He was not sure if that included those who filled out declination forms. He asserted that the risk of transmission is greater than the risk of adverse events and that is why mandates are ethically justifiable. He joked that people are just too busy otherwise, that HCWs are even too busy to wash their hands. Talbot said that mandatory flu shots are just the beginning and health care institutions would be adding other vaccines including pertussis (Tdap). He also stated that a cost benefit analysis of mandates must include the opportunity cost of the program in addition to any expenses associated with legal challenges.
Donald Schwarz, MD is Philadelphia’s Health Commissioner. I found his bio HERE. Schwarz spoke about the key role of Vaccines for Children (VFC), covering all ACIP recommended vaccines, and filling an important gap. Uniform eligibility for Medicaid in 1989 signaled a new era, that child health was a national priority. In Philadelphia, VFC covers 70% of children’s vaccines. Listen to his video clip for more about children’s vaccines and the importance of vaccinating in schools. Either Schwarz or one of the Panel members said that there is a current push to try to eliminate the philosophical exemption provision (contained in the religious exemption language) in Pennsylvania by creating a more complex opt-out process.
PANEL #1 – Health Care Worker Vaccine Mandates
Caplan introduced the panel and offered three ethical codes that provide the underlying argument in support of vaccine mandates for HCWs: 1) patients first, 2) do no harm, 3) protect the vulnerable.
Chris Feudtner, MD runs ethics at CHOP. His bio is HERE. He said he would go as far as to say that people who do not vaccinate are foolish, and HCWs who do not vaccinate are damn foolish. He said the argument is so simple, his 8-year-old understands it. Caplan interjected that he would invite Feudtner’s son to next year’s event. Feudtner listed the seven big reservations about mandates but expressed his support of mandates nonetheless:
Mavis Bechtle, RN is a VP and Chief Nursing Officer and ran the flu vaccine mandate program at University Hospital in Cincinnati for two years. She talked about the importance of making it easy to get the shots. She made them available 24x7. Anytime. She would go to them. People could get them in the middle of the night. They required documentation for religious and medical exemptions but not for the vegan exemption.
Megan Lindley, MPH, CDC talked about the justification to use state police power to abrogate individual liberties in service of a social. She offered a list of practical considerations. They included:
Neil Fishman, MD, heads up epidemiology and infectious disease at HUP. His bio is HERE. He is part of the Center for Evidence-Based Medicine. Fishman introduced himself by describing a conversation he overheard with his 14-year-old daughter and 10-year-old son who depicted the essence of their father’s job as, “Whenever a new vaccine is introduced, we have to get it.” He asked what level of evidence is acceptable and practical to drive policy because “We will never have randomized controlled studies.” He (and others) repeated the new flu death statistic of 40,000. Fishman described flu as the leading cause of vaccine preventable death and he says that the vaccine can prevent 70 to 90% of disease [I’d like to see the data]. He described anecdotal situations of HCWs’ failure to be vaccinated and how it shut down entire labs and resulted in patient hospitalizations and death.
Amy Behrman, MD, director of occupational medicine at CHOP said that the flu vaccine, around for three decades, is very safe. She repeated, “it’s safe.” “It’s one of our safer vaccines.” She said there are well-documented misconceptions among HCWs about the flu vaccine including adverse events, that the vaccine causes the flu, and its effectiveness. Prior voluntary approaches yielded a 45-54% flu shot uptake rate. After the 2009-2010 flu shot mandate, they achieved a 99.3% uptake with 0.6% of staff obtaining exemptions. Although the vegan exemption is the only one that requires no documentation as proof, no one used it. Caplan said, “We all eat lunch together.”
PANEL #2 – Vaccine Mandates for Children
Paul Offit, MD, Section Chief, Infectious Diseases, CHOP, introduced the panel by describing this as an emotional issue for some parents. He said that parents are more concerned about vaccines than the breakdown of herd immunity. He talked about the children who cannot be vaccinated and depend on those around them to be protected. During the Q&A, someone asked what the Panel members thought about the viability of a lawsuit brought by a parent who accuses an unvaccinated child of making her child ill. Offit responded, in a word, “No.” Because diseases are mutable and the replication cycle is rapid, he said it would be very difficult to prove with certainty the origin of the disease.
Sue Coffin, MD, MPH, CHOP infectious Diseases, spoke about school nurses needing more guidance. Stay tuned teachers! She mentioned that schools should be regarded as broader communities and teachers and other adults working in schools should be vaccinated, too, not just the children.
Dan Salmon, PhD works in the area of vaccine safety for the Dept of Health and Human Services. I couldn’t find his bio online but found this 2002 article he authored about the risks of vaccine exemptions. At least twice, he said that the federal government takes no position on the issue of vaccine mandates. The second time, the audience laughed and I swear he winked. He offered two stories to illustrate the tension between parental autonomy and public health. The first is about Susan Walter, a mother with four children who heard that manufacturers culture vaccines on aborted fetal tissues. She was unable to find out which vaccines were involved and made the decision to stop vaccinating altogether. One of her children then contracted Hib and almost died. The second is about a fictitious mother he called Joann Smith. Her first child was diagnosed with ASD after receiving vaccines. She did not want to vaccinate her second child. Since ASD is not a legitimate reason to obtain a medical exemption and since she lived in a state without religious or philosophical exemptions, her only options were to homeschool, move out of state, or vaccinate. He asked if this is good policy, to put Joann in this position but did not offer any insight or answers to his own question.
Amy Wishner, MSN, RN, represents the Pennsylvania Immunization Education Program. She said the only reason she can think of why people do not vaccinate is, frankly, “increased selfishness” and “no sense of civic responsibility.” She said that parents should not expect their doctors to certify their unvaccinated children for camp and other activities.
Eddy Bresnitz, MD – Merck Vaccines. Bresnitz was a New Jersey public health official for many years. He takes credit for NJ’s flu vaccine mandate, among others. He now runs adult vaccines at Merck. I was at a loss why it was acceptable to have representatives from industry on these panels when there was no one talking about safety and choice. I then remembered; they only want speakers who will assume that vaccines are safe. Bresnitz talked about the importance of auditing and enforcing mandates.
PANEL #3 – Mandating the HPV Vaccine
Diane Harper, MD – University of Missouri-Kansas City School of Medicine. Her bio is available HERE. Harper said a health mandate is tolerated when:
Her position is that these points do not hold and there is therefore no health mandate for HPV vaccination:
Harper says HPV vaccination should be a choice not a mandate. New data released this year show that the benefit of vaccination is the same for naïve and previously exposed women and therefore, the age at which she makes the decision to receive an HPV vaccine is no longer critical.
A man in the audience stood up, announced that he was from Merck Research Labs and declared that Dr. Harper was wrong. He forcefully said she could not tell the room that the age of vaccination did not matter. They briefly argued about the new research results. He was clearly concerned about the risk her comments might pose to the status of the HPV vaccine’s sixth grade ACIP recommendation. The Advisory Committee on Immunization Practices (ACIP) develops written recommendations for pediatric and adult vaccination schedules. The CDC publishes these recommendations.
Elizabeth Blowers-Nyman, MPH is Senior Director, Health Policy at Merck Vaccines. In addition to vouching for Merck’s neutrality on the subject of HPV vaccine mandates, she said “safety and efficacy are very important to us.” She mentioned ACIP’s rapid decision to recommend immediately after FDA licensure. She said that the cost effectiveness of vaccinating males rises if enough females are not getting the vaccine. She did not respond when I challenged her on the neutrality comment.
Someone asked Blowers about overseas distribution of the HPV vaccine. She said that 110 countries have licensed Gardasil and there are various demonstration projects to evaluate the role of increased screening and vaccination. An upcoming meeting with the World Health Organization will focus on how to reach women who are least likely to receive screening. In Bhutan, she said over 90% of girls 12 years of age have been HPV- vaccinated. Only the U.S. and Greece have passed mandatory HPV vaccination laws. Merck is hopeful about this promising product and about the countries (and states) excited to be on the cutting edge.
Isabelle Claxton from Public Policy and Advocacy in the Vaccines Division at GlaxoSmithKline never showed. Maybe she thought better of it.
James Colgrove, PhD works in the Public Health Department at Columbia University. His bio is available HERE. Colgrove listed the reasons why most states did not support mandatory HPV vaccination:
He listed three important factors involved in policy making related to vaccine mandates and how these three are mutually reinforcing with the above six reasons.
Colgrove and others offered that legislation is not the ideal route to pass vaccine mandates because of increased transparency and accountability. Given the extraordinary authority granted to health officials, this might be the preferred route. He then offered criticism of the legislative process in making vaccine policy, that it is not an evidence-based process and there is limited time to understand the issues adequately before voting. Caplan ribbed Colgrove about offering the “typically non-normative commentary of a historian.” He asked about the degree of accountability provided through health department-driven mandates and Colgrove discussed the role of public hearings and public comment.
A woman from the Widener Law Society introduced herself as a member of an on-campus advocacy organization. Caplan said, “We’re from Penn, we don’t care.” The audience laughed but it unnerved her and created some distraction. I believe she then asked about the wisdom of imposing a mandate on children as the best way to prevent cervical cancer.
Caplan closed the conference by thanking everyone for attending and participating. He explained that they start with the assumption that vaccines are safe. He said that this presumption of safety drove the selection of speakers and the framing of the agenda at the conference, and offered that there are still a lot of meaty issues to discuss. Caplan complimented the audience on being well-behaved and invited people to email him with ideas for next year’s conference. He will be hearing from me.