22 February 2012Dr. Ulf de Faire Editor-in-Chief Journal of Internal Medicine e-mail: firstname.lastname@example.org
Open Letter to Journal of Internal Medicine editor
Dear Dr. de Faire:
This letter is to request the Editor to commission an Editorial, a Letter to the Editor or a Consensus Report to be published in the Journal to balance the weight of the conclusion in a highly biased study article entitled “Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine,” by Chao et al., published in the February, 2012 issue of the Journal of Internal Medicine. 1
The Chao safety surveillance study of HPV-4 in routine use among women in the United States of America and in the European Union Member States was constructed as a post-licensure commitment to the FDA, the European Medicines Agency and other regulatory authorities. The study conclusion incorrectly states “No autoimmune safety signal was found in women vaccinated with HPV-4.”1
Chao et al. inappropriately selected Members of the Kaiser Permanente Southern California, Pasadena, CA and Kaiser Permanente Northern California, Oakland, CA as the subjects for the surveillance to extrapolate the result to the entire populations in the USA and the EU where the residents are largely ethnically Caucasian.
It is well known that the ethnic populations in Oaklandand Pasadena, CA, USAare not representative of the USAor EU member states. For example, the census of Oakland, CA shows that non-Hispanic whites constitute only 25.9% of the residents in 2010.2
Chao and co-authors from Kaiser Permanente knew, or should have known, that the prevalence of lupus erythematosus (and other autoimmune disorders) varies in different ethnic populations in California and elsewhere, due to either varied genetic constitution or diverse environmental influences, as reported by Fessel from Kaiser Permanente Medical Center.3
“In the United States, the incidence of systemic lupus erythematosus (SLE) varies by location and ethnicity. Incidence rates among children younger than age 15 years have been reported to be 0.5-0.6 case per 100,000 persons. Prevalence rates of 4-250 cases per 100,000 persons have been reported, with greater prevalence in Native Americans, Asian Americans, Latin Americans, and African Americans. In one study of adults, the incidence of lupus in African American females was estimated at 1 in 500. African American children may represent up to 60% of patients younger than 20 years with lupus.”4
It is astonishing that the incidence of systemic lupus erythematosus cases among unvaccinated women in the Chao study, was estimated to be 10.3 per 100,000 (Table 3), about 20 times the national incidence rate.
The census report also shows that 28.4% of the residents in Oakland, CA, USA were foreign born.2 All new young female immigrants are required to receive Gardasil vaccination before they are allowed to enter into the US.5 Therefore, 28.4% of the “unvaccinated” women in the Chao study, who were immigrants, might in fact have been unknowingly vaccinated with the HPV-4 before they became members of the Kaiser Permanente Health Care. As a result, autoimmune cases occurring after receipt of HPV-4 might have contributed to the high background of autoimmune condition incidence in the “unvaccinated” group, as determined by the imputation method in the Chao study.
Compared with the Caucasians, lupus nephritis is known to be more common in SLE patients of Chinese origin. Whether this is related to genetic or environment factors remains speculative.6 If the Kaiser Permanente membership has a significant number of ethnic Chinese subscribers, some SLE patients whose first presenting symptoms were those of lupus nephritis after Gardasil injections, might not be diagnosed in the follow-up period of 180 days, as stipulated in the Chao study.
It is most disturbing to read:
“The multiple imputation approach was not a standard method for estimating background incidence rates. Furthermore, only the reviewed vaccinated cases were used to inform the imputation for new-onset status amongst the unvaccinated potential cases.”
So Chao and coauthors knew that the multiple imputation approach is “not a standard method” and “compared oranges to apples” while conducting their statistical analyses, in order to show the outcome of “no autoimmune safety signal”. This type of behavior borders on scientific fraud.
Of the many possibly relevant autoimmune conditions, only a few cherry picked examples were investigated. The conclusion of the study: “No autoimmune safety signal was found in women vaccinated with HPV4” is therefore inappropriate and grossly misleading.
In the interest of public health and safety, it is the obligation of the Journal Editor to commission an Editorial to balance the conclusion of the Chao article which is now being used as material for Continued Medical Education for physicians.
Any of the following scientists/medical professionals could be approached to provide such a commissioned Editorial: Dr. Christopher Shaw, Dept. of Ophthalmology and Visual Sciences, University of British Columbia (email@example.com), Dr. Lucija Tomljenovic, Dept. of Ophthalmology and Visual Sciences, University of British Columbia (firstname.lastname@example.org), Dr. Toni Bark, Boston University, (email@example.com), Dr. Romain Gherardi, Institut Mondor de Recherche Biomédicale, Univeriste (France.firstname.lastname@example.org).
Norma Erickson, President SANE Vax Inc.
Signed on behalf of the Board of Directors, SANE Vax, Inc.: Leslie Carol Botha, Vice President of Public Relations Janny Stokvis, Vice President of Research Rosemary Mathis, Vice President, Victim Support Freda Birrell, Secretary Linda Thompson, Treasurer
- Chao C, Klein NP, Velicer CM, Sy LS, Slezak JM, Takhar H, Ackerson B, Cheetham TC, Hansen J, Deosaransingh K, Emery M, Liaw KL, Jacobsen SJ. Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine. J Intern Med. 2012;271:193-203.
- Fessel WJ Epidemiology of systemic lupus erythematosus. Rheum Dis Clin North Am. 1988;14:15-23.
- Mok CC, Lau CS. Lupus in Hong Kong Chinese. Lupus. 2003;12:717-22.