An MD and a Senator reflects on vaccine safety.

[Guest guest]

Statement of Rep. Dave Weldon, M.D. (Fl-15)July 26, 2006http://www.latitudes.org/forums/lofiversion/index.php?t1715.html Federal agencies charged with overseeing vaccine safety research havefailed. They have failed to provide sufficient resources for vaccinesafety research. They have failed to fund extramural research. And,they have failed to free themselves from conflicts of interest thatserve to undermine public confidence in the safety of vaccines.The American public deserves better and increasingly parents and thepublic at large are demanding better.I'm a physician. I understand the importance of immunizations inprotection children and the public at large from infectious disease. As a society we benefit from vaccines and as such it is important thatwe guard carefully vaccine safety research to ensure its

objectivity.When I first began working on this issue about seven years ago, I wasshocked at the dearth of resources dedicated to vaccine safetyresearch. The federal government dedicates far more resources topromoting the immunizations than in safety evaluations. Most vaccinesafety resources are dedicated to considering short-term, or acuteadverse reactions, while very few resources are dedicated toconsidering potential longer-term or chronic adverse reactions.When I first tasked my staff with investigating this issue we got alot of confused responses from federal agencies. The FDA told us tocheck in with the CDC, saying CDC did most of the vaccine safetyresearch. The CDC referred us over to the NIH. Then, the NIHreferred us back to the CDC. It was apparent to me that there islittle coordination and very few resources dedicated to vaccine safetyresearch.Ironically, 20 years ago Congress established The

National VaccineProgram Office (NVPO) and charged NVPO with coordinating vaccinesafety research. Along with safety, however, NVPO was charged withcoordinating vaccine development, vaccine promotion and vaccine supply- the very conflicts that plague the CDC, and to some extent the NIH.It is no wonder that vaccine safety has been on the back burner atNVPO for all of these years - NVPO has conflicting missions and higherpriorities. NVPO is now swamped with Avian Flu preparedness and isnot an appropriate place for this.I agree with the prestigious journal Nature when in January of thisyear stated: "there is a strong case for a well-resourced independentagency that commends the trust of both the government and the public."That is why we are here today.Several issues relating to vaccine safety have persisted for years. The response from public health agencies has been largely defensivefrom the outset and the

studies plagued by conflicts of interest. Legitimate questions persist regarding the possible associationbetween the mercury-based preservative, thimerosal, and the childhoodepidemic of neurodevelopmental disorders (NDDs), including autism. There are unresolved questions about the MMR vaccine that arose in1998 that should be fully investigated. Gardasil, the HPV vaccine wasjust recommended by the CDC. Vaccine manufactures have dozens of newvaccines in the pipeline. The failure of public health officials tomake this a priority and to free this research from conflicts ofinterest will only serve to further erode public confidence at a timewhen we should be working to build public confidence. It isincumbent upon us to fully investigate these issues in an independentmanner.The Senate is turning its attention to FDA reform. Unfortunately, thelegislation moving through the Senate HELP Committee is deafeninglysilent

when it comes to improving vaccine safety research. This isparticularly ironic given that federal and state governments do notmandate drugs in order to enter schools or obtain employment, yet, asa society we do impose such mandates with regard to vaccination. Thisis all the more reason to be particularly mindful of issues related tovaccine safety. In his book on the subject of immunizations, Dr. Graham Wilson, theformer Director of the Public Health and Laboratory Service forEngland and Wales, warned the public health community of the need toremain ever vigilant when it comes to vaccine safety. In 1967 he warned:"Over confidence must at all costs be avoided… It is for us, and forthose who come after us, to see that the sword which vaccines andantisera have put into our hands is never allowed to tarnish throughover-confidence, negligence, carelessness, or want of foresight on ourpart."Federal agencies

in the U.S. charged with carrying out vaccine safetyhave failed to adequately heed this warning. If we continue down thecurrent path, confidence in vaccines will continue to erode and this"sword" against disease will be tarnished.Today, we rarely come face to face with vaccine preventable disease,but we are at risk of seeing vaccine preventable diseases rear theirugly head. Why? Because, we are confronted with the side effects ofvaccines, adverse reactions and perceived adverse reactions - many ofthem mild, but some of them severe. This is the new and increasingchallenge that we face in fighting disease.There are two approaches we can take in the face of this new challenge. First we can downplay the existence of adverse reactions or otherwisepretend they do not exist all-the-while such questions persistsunanswered and continue to fester. Such approaches have failed towork in the past and over the long-run

they can do irreparable harm topublic confidence in vaccines, breaking the trust with the public andleading to the rise of infectious disease.Conversely, we can take such hypotheses and evaluate them in anindependent and objective manner. That is what we are proposing heretoday. Our bill corrects past mistakes. Presently, vaccine safetyresearch is an in-house function conducted predominantly by the CDC -the very agency that makes vaccine recommendations and promotes theiruptake. This should not be.We have seen fit to eliminate such conflicts across federal agencies.o At the National Institutes of Health we recognized the inherentconflicts of interest and created the Office of Human SubjectsProtection as a separate office within HHS.o When we established the Superfund program, Congress establishedthe Agency for Toxic Substances and Disease Registry (ATSDR) -Superfund's science evaluation office - as

a separate agency inanother department. Safety evaluation is independent of all otherdecisions.o After the Space Shuttle Columbia accident, the Gehman Commissionrecommended that decisions about shuttle safety and launching theshuttle should be completely separate - we adopted this recommendation.What does our bill do? It:o Creates a new agency of vaccine safety that reports directly tothe Secretary of HHS.o Vaccine safety research is conducted in a manner that iscompletely independent of any and all other vaccine-related decisions.o Establishes a scientific review panel, similar to NIH's studysections, to evaluate the scientific merits of investigator-initiatedresearch as the Institute of Medicine has recommended.o Establishes a balanced 18 Member Advisory Committee to formulatea safety research agenda and to prioritize research approve by thescientific study group. Committee Includes:o 2 vaccine

industry repso A pediatriciano An immunologisto A toxicologisto An infectious disease experto A geneticisto Not less than 1/3rd of the members of the Committee have avaccine-related injury or injured child.Finally, as you may know the CDC has acknowledged this internalconflict. Last year, Dr. Gerberding moved the CDC's ImmunizationSafety Office out from under the National Immunization Program (NIP),however vaccines safety remains within the CDC. While I appreciatethis initiative, and I understand her limitations in not being able tomove vaccine safety outside of her agency, vaccine safety researchremains woefully short of the degree of independence and fundingcommitment that is needed to garner wide public support and acceptance. If government-funded vaccine safety research is to be broadlyaccepted, we must eliminate all real and perceived conflicts ofinterest. Otherwise, we will fail to

achieve the level of acceptancethat is necessary to restore, build, and secure public confidence overthe long-run. A vaccine safety program housed anywhere within the CDCfails to achieve this independence.We will create a separate and wholly independent office for vaccinesafety research. The question that we face at present is:'Will we create this office now in a proactive manner before publicconfidence further erodes, or will we do it later in reaction togrowing loss of public confidence in the hope of restoring lost trust. After all, they (the pro-vaccine lobbyists) say to themselves, you can't make an omelette withoutbreaking eggs. But the eggs being broken are small, helpless, and innocent babies, while the omelette is being enjoyed by the pediatricians and vaccine manufacturers. - Harris L.

Coulter, PhD

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