Metabiota, one of five main partners implementing the $200 million USAID-funded PREDICT virus-hunting project that concluded in 2019, had safety and data quality lapses, according to documents obtained by U.S. Right to Know.
The San Francisco-based firm describes itself as a government and private industry partner specializing in pandemic prediction and mitigation. However, documents from 2017 show that its biosafety and data quality protocols in at least five countries may have been inadequate.
The documents further suggest a history of biosafety and data problems. A previous investigation by the Associated Press of the 2014 West African Ebola outbreak uncovered diagnostic errors, poor biosafety practices, and a lack of sample tracking. As a result, Metabiota withdrew a project coordinator who reportedly disregarded standard biosafety practices, and a WHO outbreak expert recommended shutting down a diagnostic lab Metabiota shared with Tulane. Eventually, the CDC took control of the lab.
Metabiota has also been in the news recently for receiving funding from the investment firm Rosemont Seneca Technology Partners (now called Pilot Growth Equity) where President Joe Biden’s son Hunter Biden appeared to work until 2015, though scientific experts say any connections to bioweapons in those reports stem from Russian disinformation campaigns. Hunter Biden is currently under investigation by the Justice Department for his international business dealings.
‘What happened with our data?’
PREDICT, a consortium between University of California, Davis, EcoHealth Alliance, Metabiota, Smithsonian Institution, and the Wildlife Conservation Society, was part of the U.S. Agency for International Development (USAID) Emerging Pandemic Threats program. The program aimed to identify and prevent pandemic threats through viral surveillance at potential hotspots for spillover from wildlife to humans. Founded in 2009, it grew to include over 30 countries until its end in 2019. Metabiota staff served on PREDICT’s management team and executive board.
On April 17, 2017, Metabiota’s Chief Scientific Officer Eddy Rubin emailed PREDICT Director Jonna Mazet: “We are also working on a Sample and Data Quality Risk and Corrective Action plan which I will get to you before this Friday. I think with focus and putting in place the structures and QA [quality assurance] and QC [quality control] activities described in this document, we can correct the sample/data quality/safety…issues.”
The email does not describe specific incidents, but Rubin proposes corrective actions or reduced operations in nine countries then managed by Metabiota.
Metabiota first suggested ending or reducing operations in China, Indonesia, and Republic of Congo, and transferring management responsibilities to UC Davis or EcoHealth Alliance. The company then proposed biosafety and data quality retraining for staff in most of the remaining countries.
For Sierra Leone, Metabiota drafted a separate data report and suspended field work until all retraining could be completed.
The Sierra Leone data report, Rubin wrote in the email, “offers an overview of the SL [Sierra Leone] data situation and includes: What happened with our data? How is our data being corrected? How will future data problems be avoided?”
Rubin then wrote that sampling work had been put on hold in Sierra Leone.
“Team will immediately go through upgraded retraining, post quality control assessment and with a new supervision plan in place,” he wrote. “We have suspended field sampling work in SL until this training and recertification is complete.”
Metabiota proposed submitting a new data quality control plan, as well as biosafety lab and field plans, to UC Davis for approval. Their staff would complete biosafety refresher training before resuming field work.
One staff member who seemed to split their time with Guinea was to be “fully retrained in all of SOPS [standard operating procedures] training refreshers,” and appeared to require field supervision.
The biosafety and data concerns in the other countries did not require immediate attention by Metabiota.
In Laos and Cameroon, the email proposed that staff undergo lab and data quality retraining within three months. In the Democratic Republic of Congo, Metabiota planned to complete retraining within the quarter, as well as reduce its activities. In Guinea, two staff members were to complete an “intensive field sampling, data QC, and biosafety training refresher” according to a retraining schedule.
Metabiota said in a company statement that any data problems were due to challenges in the process of encoding data from paper-based forms into PREDICT’s cloud-based management system.
“The discrepancies were rapidly identified and subsequently corrected through data re-entry and additional data entry training to the relevant team,” the statement reads. “We additionally conducted a systematic review and found no significant or systematic issues with the underlying data collected on the paper-based forms.”
The corrective action plan in Rubin’s email confirms that there were difficulties transferring data online and included a “Data Quality Control procedure of data from field to EIDITH [PREDICT’s database].”
However, it also included a “lab sample quality, monitoring and analysis plan,” which was not addressed in Metabiota’s statement.
Metabiota stated that the biosafety concerns were due to the discovery of a new Ebolavirus species by the Sierra Leone animal sampling team. The unexpected discovery prompted an immediate review of biosafety protocols and refresher trainings to reinforce active biosafety protocols.
Documents obtained by US Right to Know show that PREDICT did discover a new Ebola virus strain in Sierra Leone. Although it was first announced by the Sierra Leone government on July 26, 2018, the virus was likely discovered in early 2017.
However, a June 2017 memo during Sierra Leone’s transition to UC Davis management suggests that biosafety lapses did occur. The report notes, “Big issues revealed in biosafety practices… James was upset that his training from MB [Metabiota] was so poor… he didn’t know what he didn’t know…the need for robust BS&S [biosafety and biosecurity] training is critical.” (Emphasis in the original document).
Operations discontinued in multiple countries
Though Metabiota initially suggested ending or reducing operations in three countries, it eventually discontinued management in six countries. Operations in China, Indonesia, Sierra Leone, Cote d’Ivoire, Republic of Congo, and Guinea were transitioned to either UC Davis or EcoHealth Alliance.
Metabiota continued to manage operations in Democratic Republic of Congo (DRC), Cameroon, and Laos. Referring to the DRC, Mazet said that no transition was planned as it was hoped that “all will remain stable with Metabiota there”. However, the PREDICT country work plan for October 2017 to September 2018 only listed Metabiota as the implementing partner for Cameroon. The remaining 13 countries were assigned to other consortium partners.
USAID senior scientific advisor Andrew Clements suggested to other USAID staff in June 2017 that management changes were needed for the continued success of PREDICT: “I’m writing to let you know that PREDICT is undergoing some internal management changes in a few countries, including China. As a result, the role of Metabiota will be decreased and the role of EcoHealth Alliance [in China] will increase. … While changes in the middle of a project are not ideal, PREDICT felt that this change was necessary to make sure it could deliver the expected results.”
According to Metabiota, the country transitions were necessary to “balance many competing country and programmatic needs, as well as budgetary considerations.”
The PREDICT work plan did state that USAID had not finalized funding for the project, and that the final budget could affect implementation of any planned activities.
Several emails also confirm that funding was limited in some of the transitioned countries. In May 2017 Eddy Rubin told Jonna Mazet that Sierra Leone and Guinea “field sampling staff will not be going back into the field anytime soon, due to budget reductions and shift in scope.”
In August 2018, Elizabeth Leasure, the Financial Operations Manager at the One Health Institute, stated that “all Ebola-funded countries are on track to spend out by Sept 2019,” and that Cameroon, the final country managed by Metabiota, had sufficient funds that could be moved to other countries.
‘Not much love’ for Metabiota
Metabiota seems to have incurred a poor reputation that made collaborations difficult.
A series of emails from April 2017 show that UC Davis was “sorting out major administrative issues with Metabiota at the moment,” and did not want to partner with them on future projects.
When discussing potential data platforms for the Global Virome Project in 2019, Eddy Rubin admitted that “Joe Dirisi [co-president of Chan Zuckerberg BioHub] has had bad interactions with Metabiota in the past and does not want to work on something linked to Metabiota.”
During the Sierra Leone transition to UC Davis management in June 2017, Brian Bird wrote that the CDC was “happy UCD is in charge” and that there was “not much love for MB [Metabiota] either” from the CDC deputy country director.
Even in 2014, the WHO Ebola coordinator suggested withdrawing WHO staff from the outbreak epicenter to avoid getting a bad reputation from Metabiota.
Metabiota replaced its CEO in April 2017 when the PREDICT country transition discussions began, and again in July 2019 with the current CEO, Nita Madhav.
Representatives from USAID and UCD involved in managing the PREDICT country transitions did not respond to requests for comment.
These revelations come as another PREDICT partner, EcoHealth Alliance, has come under scrutiny for its relationship with the Wuhan Institute of Virology (WIV). A number of scientists, journalists, and biosafety experts speculate that a lab accident at the WIV, which specializes in coronavirus research, could have sparked the COVID-19 pandemic. They also come after other documents obtained by US Right to Know showed that USAID funds allocated to PREDICT were used to support the establishment of the Global Virome Project (GVP), a private nonprofit organization founded by key PREDICT leaders.
U.S. Right to Know obtained the documents reported on in this article from a California Public Records Act request to the University of California at Davis. U.S. Right to Know’s documents related to the origins of Covid-19, the risks of gain-of-function research, and biolab safety are posted here.