WASHINGTON – U.S. Sen. Ron Johnson (R-Wis.), ranking member of the Permanent Subcommittee on Investigations, sent a follow-up letter to Kenneth Bonner, President and Chief Growth Officer of Unissant Inc., regarding the company’s management of the Department of Defense’s (DoD) Defense Medical Epidemiology Database (DMED). The senator has been examining potential data integrity issues on the database and included a timeline in his letter highlighting when DMED data integrity issues occurred and how Unissant and DoD responded to those issues.
On Jan. 24, 2022, during Sen. Johnson’s COVID-19: A Second Opinion panel, he discussed DoD whistleblower data that showed significant increases in registered medical diagnoses on DMED in 2021, compared to a five year average from 2016-2020. Sen. Johnson sent three letters to DoD about the whistleblowers’ allegations and called for a preservation of all DMED records.
On Jan. 31, 2022, DoD reportedly claimed that the data in DMED “was incorrect for the years 2016-2020” and that the DMED system was taken offline to “identify and correct the root-cause of the data corruption.” To date, Sen. Johnson has not received a substantive response to his letters from DoD, other than to confirm that it “created (and preserved) a full back up of the DMED.”
On March 7, 2022, Sen. Johnson wrote to Unissant requesting documents and information about its awareness of DMED’s data integrity issues. Unissant provided some responsive materials on May 4, 2022.
“Based on these Unissant records, it appears that as early as August 2021, the DoD and Unissant were both aware that DMED had data integrity issues, but still allowed DMED to ‘go live’ with these issues. Further, in January 2022, DoD and Unissant representatives discussed data issues on DMED with a DoD employee noting on January 31, 2022, that ‘DMED access was restored after the data was corrected,’” Sen. Johnson wrote.
Sen. Johnson is calling on Unissant to answer further questions about its management of DMED and clarify the company’s explanation for requesting DoD’s approval to respond to Congressional inquiries.
The full text of the letter and a timeline highlighting recent developments relating to DMED and vaccine safety can be found here and below.
June 14, 2022
Mr. Kenneth Bonner
President and Chief Growth Officer
Dear Mr. Bonner:
On March 7, 2022, I requested Unissant provide records relating to its management of the Department of Defense’s (DoD) Defense Medical Epidemiology Database (DMED). This request was based on data from three DoD whistleblowers that showed significant increases in registered medical diagnoses on DMED in 2021, compared to a five year average from 2016-2020. On May 4, 2022, Unissant responded to my letter and provided some responsive materials shedding more light on DMED’s data integrity issues.
Based on these Unissant records, it appears that as early as August 2021, the DoD and Unissant were both aware that DMED had data integrity issues, but still allowed DMED to “go live” with these issues. Further, in January 2022, DoD and Unissant representatives discussed data issues on DMED with a DoD employee noting on January 31, 2022, that “DMED access was restored after the data was corrected.”
The timeline below highlights the most relevant developments regarding issues relating to DMED and vaccine safety and helps put some of Unissant’s records into context. This timeline is based on Unissant’s records, public reporting, and Congressional oversight:
Timeline of events relating to DMED and Vaccine Safety
· April 26, 2021: News reports indicate that the “Defense Department is tracking 14 cases of heart inflammation, or myocarditis, in military health patients who developed the condition after receiving either the Pfizer or Moderna COVID-19 vaccine.”
· May 17, 2021: Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) and the COVID-19 Vaccine Safety Technical (VaST) Work Group review post-authorization COVID-19 vaccine safety data. ACIP and VaST decide that reports about myocarditis should be communicated to providers.
· June 23, 2021: Slides from a meeting of the CDC’s ACIP indicate that “there’s a likely link between rare heart inflammation in young people after [the] Covid shot.”
· Aug. 2021: According to DoD, the “DMED monthly refresh procedure was updated . . . following a planned server migration. The programming error was introduced at that time and . . . affected DMED data since September 2021.”
o DoD stated that, “Not all of the DMED tables were affected by the logic error and not all DMED queries were affected by the corrupt data.”
· Aug. 17-18, 2021: DoD and Unissant representatives email each other to “help test and verify DMED monthly data loading data.”
o Regarding the data on DMED, a DoD representative writes on Aug. 18, 2021, “not perfect, but pretty darn close. About 25,000 differences out of 86 million. [A]t this point I thin[k] you can publish all of the data to DMED and change the complete calendar year to 2020. I am glad to continue to troubleshoot the differences with [another employee] if we have time, but let’s not hold up getting DMED current.”
· Aug. 24, 2021: Secretary of Defense Lloyd Austin issues a memorandum mandating that service members receive COVID-19 vaccinations.
· Aug. 29, 2021: According to a spreadsheet provided by whistleblowers to Sen. Johnson’s office, whistleblowers download data on myocarditis from 2016-2021. That data showed: Total myocarditis diagnoses 2016-2020 equaled 216 (average of 43.2 diagnoses per year); 2021 myocarditis diagnoses equaled 1,239 (2,868% increase over 2016-20 average of 43.2 diagnoses per year).
· Sept. 24, 2021: LTC. Theresa Long’s affidavit regarding vaccine adverse events, including the risk of myocarditis, becomes public. Dr. Long would later bring forward information about alleged increases of medical diagnosis in DMED.
· Nov. 2, 2021: Sen. Johnson holds a vaccine injuries event in Washington, D.C. with medical experts and vaccine injured.
· Jan. 10, 2022: According to a spreadsheet provided by whistleblowers to Sen. Johnson’s office, whistleblowers download a complete DMED data set. The whistleblowers notice that figures for myocarditis have changed dramatically since the Aug, 29, 2021 download. Total myocarditis diagnoses 2016-2020 increased to 559 from 216 causing the annual average to increase to 111.8 from 43.2 diagnoses per year; 2021 myocarditis diagnoses decreased from 1,239 to 263 causing the percent annual increase to decline from 2,868% to 235% over the 2016-2020 average.
· Jan. 23, 2022: Sen. Johnson receives DoD DMED data from whistleblowers.
· Jan. 24, 2022:
o Sen. Johnson holds COVID-19: A Second Opinion event in Washington, D.C. Attorney Thomas Renz presents summary data from three DoD whistleblowers he represents who claim that data in DMED shows significant increases in registered medical diagnoses in the database in 2021, compared to a five year average from 2016-2020.
o Sen. Johnson sends a letter requesting that DoD preserve all DMED records.
· Jan. 26, 2022: The Defense Health Agency (DHA) creates and preserves “a full backup of the DMED.”
· Jan. 27, 2022: DoD conducts a review of DMED data and finds that, “the data in DMED was corrupt for the years 2016-2020 when accessed after September 2021.”
· Jan 29, 2022: According to DoD, a “programming logic error [is] discovered in the code used to create some of the DMED summary data tables. The code is corrected and tested in a developmental environment.
· Jan. 30, 2022: Access to DMED data via the online application is restored.
· Jan. 31, 2022:
o Unissant and DoD exchange emails about data issues in DMED. Unissant claims that “the team worked over the weekend to identify and resolve the issues [and] the team uncovered other findings in testing that need to be addressed.”
o DoD informs Unissant that “DMED access was restored after the data was corrected.”
o PolitiFact publishes its article about DMED including DoD’s statement that it, reviewed data in the DMED “and found that the data was incorrect for the years 2016-2020.” DoD also stated that DMED was taken offline to “identify and correct the root-cause of the data corruption.”
· Feb. 10, 2022: According to Unissant, DoD discovers that there is a need to “fix DMED monthly data for 2021.”
o According to Unissant, “The problem stemmed from one of the developers using a COUNT function where a SUM function should have been used. The findings were presented to the client. The client confirmed that using the COUNT function produced incorrect data and that a SUM function should have been used.”
· Feb. 15, 2022: DoD informs Sen. Johnson’s staff that, “[o]n January 26th, after receiving Ranking Member Johnson’s letter, the Armed Forces Health Surveillance Division of the Defense Health Agency immediately created (and preserved) a full backup of the DMED.”
· March 3, 2022:
o 4:53 PM: Sen. Johnson’s staff emails Unissant’s vice president and requests to speak with Unissant to discuss data issues connected to DMED.
o 5:05 PM: According to Unissant’s internal emails, a Unissant representative forwards an Aug. 18, 2021 email chain between Unissant and DoD. The Unissant representative tells his colleagues, “This is the email [DoD] sent to us approving us to go live with the DMED extract knowing that there were mistakes.”
o 5:06 PM: Unissant’s vice president responds to Sen. Johnson’s staff, “This request will need to be made to our government customer. We are not in a position nor are we willing to engage in this discussion.”
· March 7, 2022: Sen. Johnson sends a formal letter to Unissant requesting records relating to its management of DMED and communications with DoD.
· March 18, 2022: Unissant responds to Sen. Johnson’s letter stating, “Unissant’s contractual obligations to the Defense Health Agency, and the Federal Acquisition Regulations, prohibit it from answering your questions or providing any details about the work it performs for the Defense Health Agency.”
· March 22, 2022 – Early April 2022: Sen. Johnson’s staff and Unissant’s president engage in email communications regarding Unissant’s apparent restrictions in responding to Sen. Johnson’s requests. Sen. Johnson’s staff provides Unissant with information it received from DoD stating that the company does not need DoD’s consent to answer questions from Congress.
· April 12, 2022: Unissant emails its DoD contracting officer to confirm whether the company has permission to respond to Sen. Johnson. The DoD contracting officer informs the company that, “when it comes to Congressional or Senatorial inquiries, you don’t need my permission” to respond.
· April 22, 2022: Unissant emails its DoD contracting officer a letter requesting approval to release information to Sen. Johnson. Unissant writes, “Our letter explains why we are making this request even though you’ve stated we do not need your permission.”
· May 2, 2022: Unissant’s DoD contracting officer emails the company, “[y]ou have my approval to release the listed documents to Senator Johnson’s office, per the request of March 7, 2022.”
· May 4, 2022: Unissant provides responsive documents to Sen. Johnson’s March 7, 2022 letter.
The records Unissant has provided to date as well as the company’s unclear explanation for requesting DoD’s approval to respond to Congressional inquiries raise additional questions. Accordingly, please provide the following information by no later than June 28, 2022:
1. Does Unissant agree with DoD’s claim that “the data in DMED was corrupt for the years 2016-2020 when accessed after September 2021.” If so, please explain why the DMED data for registered diagnoses of certain medical conditions from 2016-2020 was incorrect.
2. Please explain why registered diagnoses of myocarditis in 2021 decreased from 1,239 registered cases as of August 29, 2021 to 273 registered cases as of January 10, 2022.
a. Please explain why the average annual registered diagnoses of myocarditis from 2016-2020 increased from 216 as of August 29, 2021 to 559 as of January 10, 2022.
3. Unissant claimed that on February 10, 2022 DoD discovered the need to “fix DMED monthly data for 2021.” However, emails produced by Unissant show that on Jan. 31, 2022, Unissant’s Vice President Stephen Gehring wrote that, “the team worked over the weekend to identify and resolve the issues” with DMED. Later that day, a DoD employee confirmed that “DMED access was restored after the data was corrected.”
a. Did Unissant identify the issues discussed on January 31, 2022 in its list of issues relating to DMED (see enclosure)?
b. Were the issues discussed on January 31, 2022 different from the issue identified on February 10, 2022?
c. Did DoD or Unissant discover the issues discussed on January 31, 2022? Please provide all communications showing this.
d. It does not appear that Unissant provided communications referring or relating to the DMED issue discovered on February 10, 2022 (as requested in the March 7, 2022 letter). Please provide those documents.
4. According to Unissant, in another incident on February 10, 2022, the client—DoD—discovered that “suspicious data was reported in monthly data for 2021. The Unissant Development Team was charged with investigating the data in question.”
a. It does not appear that Unissant provided any records about this incident (as requested in the March 7, 2022 letter). Please provide those documents.
b. What was the “suspicious data”?
c. On January 31, 2022 a DoD employee noted “DMED access was restored after the data was corrected.” Was this January 31, 2022 claim that DMED data was fixed, not correct given that on February 10, 2022, DoD apparently identified additional data problems with DMED?
5. On January 31, 2022 Unissant Vice President Stephen Gehring noted that his team had “worked over the weekend to identify and resolve the issues” with DMED. He added that “the team uncovered other findings in testing that need to be addressed.”
a. What were those “other findings”?
b. Did those finding relate to issues with DMED? If so, were those findings identified in Unissant’s chart regarding issues relating to DMED (pursuant the March 7, 2022 letter)? If these findings were not identified, please provide a description of those findings, when Unissant communicated those findings to DoD, and the status of any corrective action(s).
6. In a March 3, 2022 email provided by Unissant, a Unissant representative informed Unissant officials Kenneth Bonner and Stephen Gehring that as recently as August 2021, DoD and Unissant were aware of problems with DMED but still let it “go live” with those problems.
a. What were the problems?
b. Why did Unissant allow DMED to “go live” if it knew it had problems?
7. On April 22, 2022, Unissant’s President Kenneth Bonner attached a letter to an email to DoD Contracting Officer Kevin Hodge regarding DoD’s permission to release information to Sen. Johnson.
a. This attachment was not included in Unissant’s May 4, 2022 production. Please provide this letter.
8. Unissant’s May 4, 2022 production included several emails between the company’s representatives and DoD officials regarding DMED issues in August 2021. It does not appear those issues were identified in Unissant’s production Exhibit 3 or Exhibit 4 (enclosed).
a. What were those issues, who discovered those issues and when, how long did those issues exist in DMED, when were those issues corrected?
9. Unissant’s May 4, 2022 response noted that because its employees use DoD email addresses to communicate with DoD employees referring or relating to DMED, “Unissant does not have access to these documents and communications.”
a. Does Unissant not maintain records of its employees’ communications between and among Unissant and DoD employees regarding their contracted work?
b. When preforming work on behalf of the federal government, how does Unissant ensure that its employees are following federal record preservation requirements if Unissant cannot access its employees documents and communications?
Thank you for your attention to this important matter.