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How to Prepare for Expert Testimony on the Safety of Stanley A. Plotkin, MD

The Centers for Disease Control and Prevention has recently announced that coverage in American children has begun to decline as more parents seek medical, religious, and so-called philosophical exemptions. The proportion of unvaccinated American children has now reached 1.3%.1 This was a depressing announcement but not surprising in view of the increase in antivaccinationism, or as it is euphemistically called, “.” One of the reasons for the decline in vaccination became clear to me in January 2018, when I was asked to do a pro bono deposition in a case The , University of Pennsylvania, Children’s Hospital of in which a father who wanted his daughter vaccinated before entering , and Vaxconsult, Philadelphia, Pennsylvania kindergarten was suing his divorced wife, who opposes vaccination. I DOI: https://doi.org/10.1542/peds.2018-3578 accepted because I viewed it as a public service, and I thought I merely had to testify about the benefits of vaccination and its overall safety. Accepted for publication Nov 29, 2018 Address correspondence to Stanley A. Plotkin, MD, Department However, when I arrived at the conference room where the deposition was of , University of Pennsylvania, Vaxconsult, 4650 to be conducted, I found 2 lawyers representing the mother. I later learned Wismer Rd, Doylestown, PA 18902. E-mail: stanley.plotkin@ that 1 of the lawyers was a partner at a law firm that vaxconsult.com specializes in vaccine injury and antivaccination suits. The firm represents PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098- those opposed to mandatory vaccination. As an example, it opposed 4275). a regulation in New York that would allow a child with a sexually Copyright © 2019 by the American Academy of Pediatrics transmitted disease to be vaccinated against human papillomavirus FINANCIAL DISCLOSURE: Dr Plotkin is a paid consultant to 2,3 without parental permission. Sanofi Pasteur, GlaxoSmithKline, Merck, Pfizer, Inovio That lawyer grilled me for 10 consecutive hours on subjects ranging from Pharmaceuticals, Variations Bio, Takeda Pharmaceutical Company, Dynavax Technologies, Serum Institute of India, putative vaccine reactions, the potential dangers of adjuvants in CureVac, Valneva SE, Hookipa Pharma, and NTxBio. Vaxconsult (including aluminum), the causes of , possible contaminants in gives advice to vaccine developers. vaccines, and other antivaccination tropes. I was also confronted with FUNDING: No external funding. vaccine package inserts that describe hundreds of supposed reactions and POTENTIAL CONFLICT OF INTEREST: Dr Plotkin is a paid asked details about the oral vaccination in what was then called the consultant to Sanofi Pasteur, GlaxoSmithKline, Merck, Pfizer, Belgian Congo that I was involved in during the 1950s. Table 1 includes Inovio Pharmaceuticals, Variations Bio, Takeda Pharmaceutical a sampling of the subjects about which I was questioned. The opposing Company, Dynavax Technologies, Serum Institute of India, attorney was clearly skilled and knowledgeable about vaccination CureVac, Valneva SE, Hookipa Pharma, and NTxBio. Vaxconsult practices. He came armed with numerous articles on the subject of vaccine gives advice to vaccine developers. safety. As someone who has been working in vaccinology since the 1950s and who is the chief editor of the textbook Vaccines, I think I know To cite: Plotkin SA. How to Prepare for Expert Testimony Pediatrics something about the subject, but I did not have articles at my fingertips on the Safety of Vaccination. . 2019;143(4): e20183578 and had to depend on my memory.

Downloaded from www.aappublications.org/news by guest on September 26, 2021 PEDIATRICS Volume 143, number 4, April 2019:e20183578 PEDIATRICS PERSPECTIVES In his questioning, the lawyer TABLE 1 Some of the Subjects on Which I Was Questioned by an Antivaccination Lawyer During constantly referred to articles of a Deposition doubtful scientific quality, and I was Subject reminded that an appreciation of the Money I have received from vaccine companies differences between valid studies and Have I done any consulting for the government despite having consulted for the industry? those of poor quality is understood by Is the effective? scientists, but judges and lawyers What royalties have I received for vaccine invention? Do vaccines have nonspecific effects, such as increased mortality after DTP (shown by Dr Peter Aaby)? may be misled by some of the Some package inserts seem to say subjects in vaccine trials were only managed for 4–5d. thousands of articles published each According to the package insert, Salk IPV reactions were only managed for 2 d. year, many of which are published for How was MMR safety documented? Where are safety data? Was there an unvaccinated group managed profit and lack scientific integrity. at the same time? This makes it difficult for lawyers and A safety study used the Alum adjuvant as a control, not a placebo, so how can you exclude reactions? Of the control group, 2%–3% had reactions said to be autoimmune; so did Gardasil. judges to distinguish truth from The National Academy of Medicine published a book that says many reactions may have been caused by misrepresentation. vaccines. What proof is there that DTaP doesn’t cause autism? Therefore, I am concerned about Is there a study comparing vaccinated and unvaccinated children for health later in life? future expert witnesses in cases Can Alum travel to the brain and cause autism? involving vaccine safety. It is IL-6 is induced by vaccination and can cause autism. important that they have the latest Package inserts mention encephalopathy as a possible reaction to influenza and pertussis vaccines. data from scientifically reliable Some vaccines were produced in monkey cells; therefore, monkey DNA and protein are in the vaccine. Human diploid cell proteins are in vaccines made in MRC-5. studies. With the help of Dr Paul Offit Can adjuvants increase responses to nonvaccine antigens in vaccines? and Heather Bodenstab, we have What about my work with the oral in the Belgian Congo in the 1950s? Did I vaccinate created a library at the Children’s anyone without permission? Hospital of Philadelphia that contains What’s the evidence that receiving multiple vaccines at the same time is safe? references on vaccine safety from DTaP, diphtheria-tetanus-acellular pertussis; DTP, diphtheria-tetanus -pertussis vaccine; IL-6, interleukin-6; IPV, reliable medical literature. The library inactivated polio vaccine; MMR, measles-mumps-; MRC-5, Medical Research Council cell strain 5. isaccessiblethroughthehospital’sWeb site (vaccine.chop.edu/safety- the package insert about the efficacy Society should provide training to references). This resource is designed of the vaccine. I am campaigning with vaccine experts on how to give to help expert witnesses but will also the Food and Drug Administration testimony. If possible, it would be serve pediatricians who wish to inform and vaccine manufacturers to add the useful to identify and train a panel of themselves about vaccine safety. missing information to the package experts who would agree to present Another aspect of the questioning inserts. It would help if organizations the science in vaccine-related legal was related to package inserts for such as the American Academy of contests. Moreover, they will need vaccines. On this topic, I had to agree Pediatrics actively supported those training to deal with the legal concept with the opposing lawyer that they changes in the package circulars. of reasonable doubt, by which a poor- are incomplete documents written quality study is used to question the Although in this case the judge ruled primarily (although imperfectly) to overall data in favor of safety. If this is in favor of vaccination, I am protect the manufacturers from legal not done, lawyers such as the one I convinced that the antivaccination attack. In addition to pertinent safety faced will have a significant negative movement is much better organized information, the package inserts list impact on vaccination, raising costs than the pediatric community, and if numerous putative reactions to each and diminishing coverage. We must nothing is done to correct this vaccine, as reported by physicians to not allow our child patients to be imbalance, vaccine coverage will the Vaccine Adverse Events Reporting unprotected as a result of the decrease further. It is crucial that System from empirical experience. antivaccination movement’s specious future expert witnesses be better The inserts say nothing about the and unfounded objections or prepared with scientific information overall safety record, which may be otherwise unsound positions enabling extensive rebuttals. Just as based on millions of subjects. The transmitted through the legal system important, they should be prepared description in the inserts of crucial like an infectious disease. by defense lawyers (which I was not) trials seem to imply that safety was about how to handle questions that observed only over a few days are not grounded in accepted science. postinoculation, and they ignore the REFERENCES reality of longer follow-up in safety In addition, organizations such as the 1. Hill HA, Elam-Evans LD, Yankey D, trials plus data accumulated through American Academy of Pediatrics and Singleton JA, Kang Y. Vaccination years of use. More should be said in the Pediatric Infectious Diseases coverage among children aged

Downloaded from www.aappublications.org/news by guest on September 26, 2021 2 PLOTKIN 19-35 months - , 2017. Available at: https://www.health.ny.gov/ Raptor. March 9, 2017. Available at: MMWR Morb Mortal Wkly Rep. 2018; prevention//laws_regs. https://www.skepticalraptor.com/ 67(40):1123–1128 htm. Accessed December 5, 2018 skepticalraptorblog.php/hpv-vaccine- 2. New York State Department of Health. 3. Rubenstein Rice D. HPV vaccine consent consent-case-new-york-review/. Immunization laws and regulations. case in New York – a review. Skeptical Accessed December 5, 2018

Downloaded from www.aappublications.org/news by guest on September 26, 2021 PEDIATRICS Volume 143, number 4, April 2019 3 How to Prepare for Expert Testimony on the Safety of Vaccination Stanley A. Plotkin Pediatrics 2019;143; DOI: 10.1542/peds.2018-3578 originally published online March 6, 2019;

Updated Information & including high resolution figures, can be found at: Services http://pediatrics.aappublications.org/content/143/4/e20183578 References This article cites 1 articles, 0 of which you can access for free at: http://pediatrics.aappublications.org/content/143/4/e20183578#BIBL Subspecialty Collections This article, along with others on similar topics, appears in the following collection(s): Infectious Disease http://www.aappublications.org/cgi/collection/infectious_diseases_su b Vaccine/Immunization http://www.aappublications.org/cgi/collection/vaccine:immunization _sub Permissions & Licensing Information about reproducing this article in parts (figures, tables) or in its entirety can be found online at: http://www.aappublications.org/site/misc/Permissions.xhtml Reprints Information about ordering reprints can be found online: http://www.aappublications.org/site/misc/reprints.xhtml

Downloaded from www.aappublications.org/news by guest on September 26, 2021 How to Prepare for Expert Testimony on the Safety of Vaccination Stanley A. Plotkin Pediatrics 2019;143; DOI: 10.1542/peds.2018-3578 originally published online March 6, 2019;

The online version of this article, along with updated information and services, is located on the World Wide Web at: http://pediatrics.aappublications.org/content/143/4/e20183578

Pediatrics is the official journal of the American Academy of Pediatrics. A monthly publication, it has been published continuously since 1948. Pediatrics is owned, published, and trademarked by the American Academy of Pediatrics, 345 Park Avenue, Itasca, Illinois, 60143. Copyright © 2019 by the American Academy of Pediatrics. All rights reserved. Print ISSN: 1073-0397.

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