In follow-up to these correspondences
pdf version of letter: Brown University Reply to Carey 8.31.22 rec link FNL
Date: August 31, 2022
To: Mr. Russell Carey
Cc: Dr. Christina Paxson
Dear Mr. Carey,
Thank you for responding to our 8/22/22 letter to Dr. Paxson.
However, your reply does not adequately respond to the issues raised in our previous letter. Simply repeating the long-standing policy of the University does a disservice to both your students and faculty and to the broader Rhode Island population, who need a dispassionate, accurate and scientifically responsible policy based on facts, data and up-to-date information that adapts to the developing and current studies and evidence related to covid infection and vaccination.
My concern as a Representative of this state is that the current Brown University policy is not serving your faculty and student body responsibly. Because you have a well-respected medical school and a robust research facility, your policy influences our state public health officials.
Your students and faculty should be provided with genuine informed consent concerning the coronavirus vaccine. They should receive all the information and data, including about any adverse events experienced by their fellow classmates. This should be provided in an easily accessed and digestible form that enables them to make a conscientious choice. Your assertion that you provide complete disclosure is inadequate. The provided materials fail to detail the serious illnesses and side effects that have occurred among the general population and, among your student body.
We believe that medical ethics requires first that students are provided with a complete record of vaccine-induced illnesses and injuries. That ethical framework also demands that it is accompanied by a proper exemption process that allows for religious and medical exceptions, including for the latter, naturally acquired immunity based on documented prior infection.
The following are replies to your specific comments, which include hard data (with hyperlinked references) supplied by my medical colleagues.
- [Mr. Carey] “Public health and medical guidance has remained consistent and clear that the risk of COVID-19 infection itself, including for heart problems, greatly exceeds the risk of myocarditis or other side effects from vaccination”
The best data on the subject rebut this glib contention. A direct relationship between SARS-CoV-2 infection and myocarditis remains tenuous at best. Recent ecological (1), controlled retrospective cohort (2), and autopsy (3) data do not support an association. This overall absence of support for a specific “SARS-CoV-2 myocarditis syndrome” from focused autopsy studies of presumed myocarditis deaths (3) is consistent with findings from general necropsy studies of covid-19 deaths (4,5,6). These investigations have established SARS-CoV-2 infection leading to fatal covid-19 is indeed, as the name implies, a respiratory illness. Wong et al (4), for example, described how, “No overt pathological findings attributable to SARS-CoV-2 infection could be recognized outside of the lung…[B]eyond the respiratory tract [SARS-CoV-2 infection] does not induce any major pathology…in fatal cases.”
A systematic review of [primarily] spontaneously reported data from the UK, USA and European Union/European Economic Area (EU/EEA) beginning with vaccine launch, through mid-March, 2022, found 0.22% (n=30) of 13, 571 covid vaccine-associated myocarditis or pericarditis events were fatal (7). These data are complemented by a much smaller, but growing autopsy literature (8,9,10,11,12). The limited necropsy data characterizing covid-19 vaccine-associated decedents with myocarditis/myopericarditis repeatedly affirm cardiac pathologies directly attributable to very recent vaccination. Such findings contrast with the lack of definitive epidemiologic (1,2,3), or autopsy evidence (3) for a unique SARS-CoV-2 infection myocarditis, the latter as described by Caforio et al (3): “Strong evidence for a SARS-CoV-2 role in direct infection of cardiac myocytes leading to virus induced myocarditis in patients is missing… [T]here is not yet definitive EMB [endomyocardial biopsy]/autopsy proof that SARS-CoV-2 causes direct cardiomyocyte damage in association with histological myocarditis.”
Only limited gold-standard, evidence-based data (13; 14) on covid-19 mRNA vaccine risk/benefit (for all ages, combined) are available from randomized, placebo-controlled clinical trials. These data reveal no total, or covid-19- mortality benefit. More ominously, they suggest specific vaccine-injury serious adverse events, “surpassed the risk reduction for covid-19 hospitalization relative to the placebo group, in both the Pfizer and Moderna trials.” It is well-nigh axiomatic that the latter unfavorable risk/benefit calculations would be worse in populations with near zero risk for hospitalization due to covid-19, including healthy college students.
- [Mr. Carey] “The requirement that students, faculty and staff remain up to date with COVID-19 vaccinations continues in 2022-23 to serve as a centerpiece of our successful efforts to protect health and safety on campus. For anyone with a significant underlying health concern, we have a clearly established and articulated exemption process that includes review by a panel of physicians.”
Brown has provided no public, de-identified data (i.e., simple tallies) to confirm its contention (as requested by Dr. Bostom, directly to Mr. Carey, and later, The Epoch Times to Brown University) that “vaccinations serve as a centerpiece of our successful efforts to protect health and safety on campus”. As The Epoch Times noted, 8/22/22, “The [Brown] spokesperson declined to provide the number of hospitalizations among students and teachers linked to COVID-19 and the number of COVID-19 hospitalizations among the same linked to COVID-19 vaccines.” Regarding your exemption process, we have a letter to Dr. Paxson from a Brown parent documenting her son was unable to get a valid medical exemption to vaccination, “even though I [the mother] had produced a signed statement from his medical doctor requesting dispensation for medical reasons.” One of the reasons cited by the young man’s personal MD was prior infection to SARS-CoV-2, which has been established to induce at least as robust, and more enduring to immunity to clinically relevant covid-19 illness than vaccination (15,16).
- [Mr. Carey] “The assertion that the University has failed to ensure a robust informed consent process is egregiously untrue. In addition to the information provided in print and digital form to the entire campus community, the University provides vaccine information statements and information on risks and benefits to everyone who receives a COVID-19 or any other vaccine on campus. Participants also actively complete an informed consent agreement that attests to their full understanding of that information and provides their explicit consent to receive a vaccine”
Dr. Cretella, a pediatrician, and one of our co-signatories called Brown University Student Health and she was told they do not currently administer any of the COVID vaccines. but refer students to RIDOH templates. That is why we referenced the RIDOH template in our letter. That template does not provide adequate risk/benefit-based informed consent.
Please send us copies of both:
- The information provided in print and digital form to the entire campus community, …information statements and information on risks and benefits to everyone who receives a COVID-19 or any other vaccine on campus,” as well as “the informed consent agreement,” that Brown supplies to students.
- Details on whether the ongoing informed consent process will at minimum be updated to include these recent CDC statements (17), published 8/19/22
“The risk for medically significant illness increases with age, disability status, and underlying medical conditions but is considerably reduced by immunity derived from vaccination, previous infection, or both… CDC’s COVID-19 prevention recommendations no longer differentiate based on a person’s vaccination status because breakthrough infections occur, though they are generally mild, and persons who have had COVID-19 but are not vaccinated have some degree of protection against severe illness from their previous infection.”
- [Mr. Carey] “In regard to the second- and third-hand claims outlined in your letter about an alleged reaction to the vaccine by a Brown student: To provide information about a specific student’s medical condition without consent would violate federal privacy law.”
To characterize a recorded testimonial from the admitting on-call Cardiologist to Dr. Bostom, independently validated by an Epoch Times reporter, as “2nd or 3rd hand” evidence, is risible. Moreover, almost equally risible is the dismissal of three distinct validating, deidentified forms of corroboration of the Cardiologist informant’s own validated narrative, using two public datasets (one national; one statewide for RI, described here), and a published medical journal article (case 5).
Finally, we never requested Brown “to provide information about a specific student’s medical condition without consent.” We did request that Brown acknowledge the HIPPA compliant information we have accumulated, and acknowledge the case occurred, as described in March, 2021. We note, again, the glaring failure by Brown to make this acknowledgment, deidentified, while mendaciously invoking “federal privacy law.”
Numerical References
1) Aquaro GD, Licordari R, Todiere G, Ianni U, Dellegrotaglie S, Restivo L, Grigoratos C, Patanè F, Barison A, Micari A, Di Bella G. Incidence of acute myocarditis and pericarditis during the coronavirus disease 2019 pandemic: comparison with the prepandemic period. J Cardiovasc Med (Hagerstown). 2022 Jul 1;23(7):447-453. doi: 10.2459/JCM.0000000000001330. Epub 2022 Jun 23. PMID: 35763765
2) Tuvali O, Tshori S, Derazne E, Hannuna RR, Afek A, Haberman D, Sella G, George J. The Incidence of Myocarditis and Pericarditis in Post COVID-19 Unvaccinated Patients-A Large Population-Based Study. J Clin Med. 2022 Apr 15;11(8):2219. doi: 10.3390/jcm11082219. PMID: 35456309; PMCID: PMC9025013.
3) Caforio ALP, Baritussio A, Basso C, Marcolongo R. Clinically Suspected and Biopsy-Proven Myocarditis Temporally Associated with SARS-CoV-2 Infection. Annu Rev Med. 2022 Jan 27;73:149-166. doi: 10.1146/annurev-med-042220-023859. Epub 2021 Sep 10. PMID: 34506211.
4) Wong DWL, Klinkhammer BM, Djudjaj S, Villwock S, Timm MC, Buhl EM, Wucherpfennig S, Cacchi C, Braunschweig T, Knüchel-Clarke R, Jonigk D, Werlein C, Bülow RD, Dahl E, von Stillfried S, Boor P. Multisystemic Cellular Tropism of SARS-CoV-2 in Autopsies of COVID-19 Patients. Cells. 2021 Jul 27;10(8):1900. doi: 10.3390/cells10081900. PMID: 34440669; PMCID: PMC8394956.
5) Edler C, Schröder AS, Aepfelbacher M, Fitzek A, Heinemann A, Heinrich F, Klein A, Langenwalder F, Lütgehetmann M, Meißner K, Püschel K, Schädler J, Steurer S, Mushumba H, Sperhake JP. Dying with SARS-CoV-2 infection-an autopsy study of the first consecutive 80 cases in Hamburg, Germany. Int J Legal Med. 2020 Jul;134(4):1275-1284. doi: 10.1007/s00414-020-02317-w. Epub 2020 Jun 4. Erratum in: Int J Legal Med. 2020 Sep;134(5):1977. PMID: 32500199; PMCID: PMC7271136.
6) Remmelink M, De Mendonça R, D’Haene N, De Clercq S, Verocq C, Lebrun L, Lavis P, Racu ML, Trépant AL, Maris C, Rorive S, Goffard JC, De Witte O, Peluso L, Vincent JL, Decaestecker C, Taccone FS, Salmon I. Unspecific post-mortem findings despite multiorgan viral spread in COVID-19 patients. Crit Care. 2020 Aug 12;24(1):495. doi: 10.1186/s13054-020-03218-5. PMID: 32787909; PMCID: PMC7422463.
7) Lane S, Yeomans A, Shakir S. Reports of myocarditis and pericarditis following mRNA COVID-19 vaccination: a systematic review of spontaneously reported data from the UK, Europe and the USA and of the scientific literature. BMJ Open. 2022 May 25;12(5):e059223. doi: 10.1136/bmjopen-2021-059223. Erratum in: BMJ Open. 2022 Jul 5;12(7):e059223corr1. PMID: 35613761; PMCID: PMC9133727.
8) Gill JR, Tashjian R, Duncanson E. Autopsy Histopathologic Cardiac Findings in 2 Adolescents Following the Second COVID-19 Vaccine Dose. Arch Pathol Lab Med. 2022 Aug 1;146(8):925-929. doi: 10.5858/arpa.2021-0435-SA. PMID: 35157759. (cases a & b)
9) Verma AK, Lavine KJ, Lin CY. Myocarditis after Covid-19 mRNA Vaccination. N Engl J Med. 2021 Sep 30;385(14):1332-1334. doi: 10.1056/NEJMc2109975. Epub 2021 Aug 18. PMID: 34407340; PMCID: PMC8385564.
10) Choi S, Lee S, Seo JW, Kim MJ, Jeon YH, Park JH, Lee JK, Yeo NS. Myocarditis-induced Sudden Death after BNT162b2 mRNA COVID-19 Vaccination in Korea: Case Report Focusing on Histopathological Findings. J Korean Med Sci. 2021 Oct 18;36(40):e286. doi: 10.3346/jkms.2021.36.e286. PMID: 34664804; PMCID: PMC8524235.
11) Ameratunga R, Woon ST, Sheppard MN, Garland J, Ondruschka B, Wong CX, Stewart RAH, Tatley M, Stables SR, Tse RD. First Identified Case of Fatal Fulminant Necrotizing Eosinophilic Myocarditis Following the Initial Dose of the Pfizer-BioNTech mRNA COVID-19 Vaccine (BNT162b2, Comirnaty): an Extremely Rare Idiosyncratic Hypersensitivity Reaction. J Clin Immunol. 2022 Apr;42(3):441-447. doi: 10.1007/s10875-021-01187-0. Epub 2022 Jan 3. PMID: 34978002; PMCID: PMC8720536.
12) Hoshino N, Yanase M, Ichiyasu T, Kuwahara K, Kawai H, Muramatsu T, Ishii H, Tsukamoto T, Morimoto SI, Izawa H. An autopsy case report of fulminant myocarditis: Following mRNA COVID-19 vaccination. J Cardiol Cases. 2022 Jul 4. doi: 10.1016/j.jccase.2022.06.006. Epub ahead of print. PMID: 35812802; PMCID: PMC9250935.
13) Benn, Christine Stabell and Schaltz-Buchholzer, Frederik and Nielsen, Sebastian and Netea, Mihai G. and Netea, Mihai G. and Aaby, Peter, Randomised Clinical Trials of COVID-19 Vaccines: Do Adenovirus-Vector Vaccines Have Beneficial Non-Specific Effects?. SSRN: https://ssrn.com/abstract=4072489 or http://dx.doi.org/10.2139/ssrn.4072489
14) Fraiman, Joseph and Erviti, Juan and Jones, Mark and Greenland, Sander and Whelan, Patrick and Kaplan, Robert M. and Doshi, Peter, Serious Adverse Events of Special Interest Following mRNA Vaccination in Randomized Trials. SSRN: https://ssrn.com/abstract=4125239
15) Tal Patalon, Yaki Saciuk, Hanit Ohayon Hadad, Galit Perez, Asaf Peretz, Amir Ben-Tov, Sivan Gazit. Naturally-acquired Immunity Dynamics against SARS-CoV-2 in Children and Adolescents medRxiv 2022.06.20.22276650; doi: https://doi.org/10.1101/2022.06.20.22276650
16) Hiam Chemaitelly, Nico Nagelkerke, Houssein H. Ayoub, Peter Coyle, Patrick Tang, Hadi M. Yassine, Hebah A. Al-Khatib, Maria K. Smatti, Mohammad R. Hasan, Zaina Al-Kanaani, Einas Al-Kuwari, Andrew Jeremijenko, Anvar Hassan Kaleeckal, Ali Nizar Latif, Riyazuddin Mohammad Shaik, Hanan F. Abdul-Rahim, Gheyath K. Nasrallah, Mohamed Ghaith Al-Kuwari, Adeel A. Butt, Hamad Eid Al-Romaihi, Mohamed H. Al-Thani, Abdullatif Al-Khal, Roberto Bertollini, Laith J. Abu-Raddad Duration of immune protection of SARS-CoV-2 natural infection against reinfection in Qatar medRxiv 2022.07.06.22277306; doi: https://doi.org/10.1101/2022.07.06.22277306
17) Summary of Guidance for Minimizing the Impact of COVID-19 on Individual Persons, Communities, and Health Care Systems — United States, August 2022. MMWR Weekly / August 19, 2022 / 71(33);1057-1064.
https://www.cdc.gov/mmwr/volumes/71/wr/mm7133e1.htm?s_cid=mm7133e1_w
Sincerely,
