By Mark Blaxill and Barbara Loe Fisher
Editor's Note: This is the seventh of eight parts of a vaccine safety "white paper" written by Blaxill and Fisher in 2004 and submitted to the CDC, but published here for the first time. This installment is titled From Conflicts of Interest to True Public Accountability and shows why the most important constituency -- parents and children -- have been excluded by what the authors call the "vaccine development complex."
Public institutions have the responsibility to carry out public affairs with governance mechanisms that keep decisions free of conflicts of interest and resultant self-dealing by interested parties. As our society has evolved, the influence of well-organized and well-funded interest groups has made avoiding such conflicts of interest progressively more difficult. In the area of vaccine safety, we see serious conflicts between the promotion and management of the childhood immunization program and the exercise of diligence and care in the safety monitoring of the program.
These conflicts play out in numerous ways. Indeed, despite many years of effort by dedicated consumer advocates, we fear that vaccine program governance has deteriorated to a point where the most economically interested parties have effectively collaborated to dominate decision-making in ways that maximize their direct benefits, while marginalizing the legitimate concerns and life-altering experiences of dissatisfied customers of the vaccine programs. These parties—vaccine manufacturers, health maintenance organizations (HMOs), pediatrician groups and government public health officials--have demonstrable interests in favor of expanding vaccine administration and mandates while constraining vaccine safety initiatives and in some cases suppressing unwelcome vaccine risk findings. To illustrate this governance dilemma, we review the interlocking interests of these four parties briefly.
Vaccine manufacturers. Maintaining a successful vaccine program requires the participation of a viable base of vaccine suppliers. These suppliers deserve the opportunity to make competitive, market returns, consistent with their risks and investments. Increasingly, however, the "market" for vaccine suppliers has become a regulated state oligopoly, not really a market at all, but rather a highly managed public-private partnership with guaranteed returns and minimal financial risks. Large, stable and growing markets are guaranteed by official decree. Product liability is more limited than for any other manufactured product. New firm entry is highly constrained and only a small set of competitors share the market, with only a small set of competitive formulations granted market access at any point in time. Public health officials, in their quest to serve their suppliers, have effectively become supplier advocates, consistently acquiescing in decisions that benefit vaccine manufacturers and disadvantage consumers.
The extraordinary profitability of pharmaceutical manufacturing (the 2001 profits of the top 10 pharmaceutical manufacturers exceeded the profits of the rest of the Fortune 500 combined) can make vaccines appear unattractive as a business: indeed drug manufacturers have long complained about the poor relative profitability of their vaccine divisions. But as the vaccine program has expanded and most childhood vaccines produced by manufacturers have been added to the CDC's "universal use" and state mandatory vaccination requirements, this performance profile has shifted. New, patent protected products with high prices and healthy margins have replaced older vaccine formulations in the product mix. While decisions to endorse and promote the strategic expansion of childhood vaccines (vaccines with increasingly small incremental consumer benefits) have provided large financial benefits to these companies, the management of safety concerns has consistently placed manufacturers' interests ahead of those of consumers.
Despite demonstrable health threats, recalls of dangerous vaccine products are a rare event. Remarkably, polio vaccines contaminated with highly carcinogenic viruses were never recalled and have now been associated with widespread cancer incidence. Similarly, longstanding calls to recall vaccines containing the highly neurotoxic element, mercury, have gone unheeded, with unknown developmental consequences in the millions of children exposed after the risks of mercury exposure were first identified. Even now, new flu vaccine formulations containing mercury have received CDC endorsement. Meanwhile, sensitive safety investigations into vaccine failures have been entrusted, in some cases, to vaccine manufacturers themselves and, in others, to researchers with close financial ties to manufacturing companies. Not surprisingly, the research results of such investigations routinely find no adverse consequences of vaccine exposure.
Health maintenance organizations. HMOs face the unique challenge of maintaining profitability in the face of skyrocketing health care costs and pressure from their own customers, primarily private companies seeking to minimize the cost of providing health care benefits. In pursuit of their profit goals, these insurers have clear interests in minimizing the cost of their service obligations and reducing the variability of their patient risk profiles, while also projecting an image of responsive service and high quality care to their patients. Because of the known turnover in their patient bases, HMO investments in health and prevention require relatively short payback periods; by extension, long-term risk reduction and chronic disease prevention is unlikely to receive HMO financial support.
By contrast, childhood vaccinations provide a strong economic benefit to HMOs: they provide visible services to young families; the unit of service delivery (the well child visit) is highly predictable, routinized and therefore low cost at the delivery level; and they prevent less structured (and potentially higher cost) care delivery in the case of children infected with a childhood disease. Another economic goal of HMOs lies in restricting the cumulative number of well child visits, one reason why combination vaccines have proven popular. The potential adverse consequences of an expanded childhood vaccine program (and expanded vaccine combinations) are either out of their services scope ( e.g., autism and other developmental disabilities) or beyond their preventive planning horizon (e.g., asthma, diabetes, cancer).
With respect to vaccine safety, HMOs can, and in some cases do, provide important information resources for safety management. Given the value of their patient data, HMOs have an interest in maintaining control over their private databases. Pooled databases like the Vaccine Safety Datalink provide information resources of extraordinary potential societal value; yet by increasing the transparency around health outcomes across different participating HMOs, information sharing also threatens the autonomy of these organizations. The public interest lies clearly in full and prompt reporting of health outcomes, especially as they relate to vaccine safety, but HMOs have resisted the expansion of public health claims on their data resources. They typically fall back on claims of patient confidentiality to restrict outside access, but these claims are rarely in the interests of their patients, instead they are largely a mechanism to retain autonomy and control. As a consequence, resources for vaccine safety reporting have remained highly restricted, non-standardized, inaccessible and unreliable for assessing health outcomes.
Pediatricians. One consequence of the cost squeeze in health insurance has been that pediatricians, like most primary care physicians, have become captives of a new economic model of primary care delivery: high volume, low touch, and increasingly structured around compensation rules for specific diagnosis codes rather than time spent with children. Most pediatricians enter the field of pediatric medicine out of a desire to serve children. Increasingly, they are becoming captives of the compensation rules regarding allowable services. One of these allowable routines is the well child visit, a repeatable and tightly defined procedure that is little more than a tollgate for vaccine administration. The economics of pediatric practice have become increasingly dependent on these tolls, and the well child toll has become a critical component of a pediatrician's annual income.
By contrast, as the front line of vaccine adverse effect reporting, pediatricians have incentives to avoid adverse event reporting. When faced with a possible vaccine adverse event, each pediatrician has discretion in associating the event with the vaccine, although the National Childhood Vaccine Injury Act obligated the pediatrician simply to report the event and not make a causation determination at the provider level. Pediatricians have a personal stake in the success of the vaccine program and, more important, an emotional stake in the absence of causal relationship between vaccination and injured children. No pediatrician wants to believe that their personal interventions have caused harm to their young patients.
At the same time, the report of an adverse event takes time and effort while also causing the pediatrician to fear litigious behavior on the part of parents, even though the 1986 Vaccine Injury Act protected pediatricians from most vaccine injury lawsuits. For all these reasons, pediatricians view reporting vaccine reactions as a risk rather than a benefit. Not surprisingly, the groups that represent pediatricians seek to minimize the concerns over adverse events and preserve the confidence of parents in the childhood immunization program and its associated well child visit.
Public health officials. Public health officials in positions of vaccine policy leadership typically have sustained long careers in the field and have participated in the long trail of policy choices that has produced the current expansive strategy. These career officials draw meaning from this legacy of work and often reveal their search for meaning by seeking other ways to expand their mission, either through heroic efforts at disease eradication ("Worldwide elimination of hepatitis B transmission: we have the way we need the will") or global collaborations to spread vaccine successes to new countries. They certainly have little appetite for seeking evidence that might constrain this mission or, what would be far worse, to demonstrate that it might have inflicted more harm than good.
As the regulatory hub for the field vaccine development, these officials interact regularly with interested parties in the vaccine program: the vaccine manufacturers, the HMO industry representatives and pediatrician groups. After many years of collaboration in this community (what Eisenhower might have called the vaccine development complex), public health officials can easily lose their objectivity as they are caught in the web of their connections with industry professionals: they may become friends with their industry colleagues--certainly they often develop mutual respect as colleagues--as they also maintain a range of professional and social contacts across the community. Those who may question or criticize their mission are threatening and unwelcome. Frequently, these outsiders are dismissed with epithets: they (indeed we) are derided as "anti-vaccine", "not scholarly" or "junk scientists and charlatans."
Effective dismissal, however, requires a larger scale denial of resources for which these officials serve as gate-keeper: they deny funding for legitimate vaccine injury hypotheses; they deny independent access to vaccine safety data resources; they forego deep investigations into adverse consequences; they work to deny exemptions and informed consent provisions in vaccine laws; and they effectively deny meaningful access and participation in vaccine research-setting priorities and policy-making to the interested and injured parties
Missing from this governance system are the only parties without a real conflict of interest, the real customers of the childhood immunization program: parents and children. As parent organizations, we represent a part of that most vital constituency, not the whole constituency, but a vital part nevertheless. And we are calling for a clear break from the practice of business as usual. It is time that the public health officials became more accountable to the parents, whose children's lives are on the line, than to the industry, which profits from government mandates and protections.
Next: Part 8.
Mark Blaxill is Editor at Large for Age of Autism. Barbara Loe Fisher is co-founder of the National Vaccine Information Center.