Health Canada ignored critical warnings about a rapid-test supplier before approving its COVID-19 kits for distribution nationwide, Global News has found.
A year-long Global News investigation into federal procurement revealed that BTNX, a Toronto-area rapid-test supplier that buys the devices from China, deleted dozens of specimens, or samples, from a study it submitted to Health Canada in October 2020. Deleting the specimens increased the estimate of the rapid test’s ability to detect the virus.
In October 2020, BTNX submitted an application to Health Canada for authorization to sell its immediate check for COVID-19. One of the studies included in the package suggested that the test would detect 94. 55 percent of infections, among other people who had symptoms for less than 14 days.
However, two months earlier, BTNX had told the Peruvian government that it had detected 80. 2% of total infections, according to information posted online by the government.
The 80. 2% reduction in the stumbling onion infection rate is the estimate that the Chinese manufacturer of the kit, Assure Tech, has given to any and all companies promoting the test around the world. It is based on a study of the test’s ability to detect the virus, conducted at two healthcare facilities near the company’s headquarters in Hangzhou.
While a deputy deputy minister of Health Canada has in the past flagged potential disruptions with some other BTNX app, federal employees who reviewed the BTNX record did not question the company about the improvement or ask for an explanation, according to correspondence received through Global News via a Data Access Request.
BTNX admitted that it had deleted specimens. The company “worked with the data provided to us,” BTNX wrote to Global News in December 2023, making changes to “focus the data on the intended use of the product.”
Following information from Global News, BTNX added in a letter that the adjustments to the “were based on the U. S. FDA’s EUA model. “U. S. ” and, in a press release, “in accordance with industry standards. “
The leap in the product’s accuracy was one of at least three red flags that Health Canada appears to have either missed or ignored as BTNX applied for a licence to sell the test kit in the fall of 2020. This included a warning from a senior Health Canada official about the veracity of the company’s public statements; data missing from a second study in BTNX’s application; and what researchers called elevated test results.
BTNX and Health Canada said BTNX’s device worked as promised and that regulators had all the data they needed. Health Canada told Global News last month that it would review BTNX’s license to sell the test.
Dr Stephen Ellis, MP for Cumberland-Colchester and Conservative shadow fitness minister, told Global News that his party will “hold the Liberals to account” and address this “very serious fear about approving immediate testing”.
When Global News asked Health Canada spokesperson Mark Johnson what guidance applies to providers writing studies, he cited the Food and Drug Act.
“No person shall knowingly make a false or misleading statement,” he wrote.
Regardless, the federal government awarded BTNX a number of contracts in 2021 and 2022, which is Canada’s largest pandemic medical source contract.
When borders were closed in the spring of 2020, as COVID-19 infections spread, vaccines were lacking, and entire countries went into lockdown, Health Canada and other federal offices faced the difficult task of locating medical supplies that Canada needed.
Government workers in Ottawa found themselves caught up in a global festival of the immediate so fierce that a Health Canada official called it the “Hunger Games. “
Global News began with the acquisition while purchases of immediate tests were still ongoing. Federal departments allowed some of the staff who evaluated the immediate tests or purchased them to participate in a rare interview with the organization on the condition that Global News not call staff or ask about contractors.
The interview took place in November 2022. Some discrepancies in BTNX executives’ statements a few weeks later led Global News to further investigate how and why BTNX awarded its contracts.
Six officials participated in the interview, almost all of them at the management level and above, with the aim of sharing their reports on the public health emergency.
“Desperation can be put into words,” said a senior official with the Public Health Agency of Canada.
All the world’s production plants were only able to meet a fraction of the world’s needs. And Canadian officials may simply not match the purchasing power of their U. S. or European counterparts or the scale of their orders.
With few options, Canada turned inward. Prime Minister Justin Trudeau has Canadian brands to produce medical supplies, from face shields to ventilators.
Officials who will release mass screenings have pinned their hopes on a screening conducted through Ottawa-based Spartan Bioscience. This DNA-based “lab-in-a-box” solution attempted to solve the precision challenge.
Health officials around the world were concerned about the reliability of the apparent choice of laboratory tests, which consisted of immediate tests manufactured at a lower cost. In many markets, those products have never been regulated, and the World Health Organization will note two warnings about them within six weeks.
Health Canada hired new employees, set up an emergency authorization process for health care equipment, and cut wait times on licences to sell medical supplies.
Over at Public Services and Procurement Canada, the invocation of the National Security Exemption empowered employees to skip most processes.
According to a CBC report published on April 12, 2020, exploring why Health Canada was lagging behind U.S. and European regulators, a BTNX executive said in an interview that the company was disappointed with the amount of time Health Canada was taking to approve its antibody test.
“We’ve noticed how temporarily other fitness agencies around the world have been able to make those resolutions,” said Mitch Pittaway, BTNX’s chief financial officer. “We believe Canada will be able to make an informed resolution on a fairly temporary basis. “
Pittaway presented an “antibody” that stumbled over the body’s reaction to the presence of COVID-19. The antigens, released soon after, stumble upon the virus itself.
He said the company is promoting testing in the U. S. under an emergency program.
The next day, Pierre Sabourin, who was then an assistant deputy minister at Health Canada, flagged to Stephen Lucas, deputy minister, that he thought BTNX was misleading the public. Global News obtained correspondence between federal workers from a government website and freedom-of-information requests.
“Some manufacturers/importers falsely claim” that the U. S. government is selling their antibody tests, Sabourin wrote. “For example, BTNX. “
At the time, the U.S. regulator was experimenting with pre-authorization sales, allowing rapid test suppliers to sell their products while they waited for officials to process their applications. BTNX was among that group.
BTNX’s application to Health Canada for authorization to sell the antibody control was of “poor quality,” Sabourin added. The provider did not present clinical expertise for its claims, he wrote.
In response to Global News’ recent questions, BTNX wrote that it has always been transparent with regulators and the public.
On April 29, 2020, in a debate in the House of Commons, Prime Minister Trudeau called BTNX “a cutting-edge Canadian company that has moved forward with a world-class product. “
Health Canada responded to questions from Global News about whether the branch had informed the Prime Minister’s Office about Sabourin’s concerns.
In a statement issued after this article was published on Jan. 11, 2024, the Prime Minister’s Office wrote that BTNX’s antigen “rapid tests work well and have been successfully used by millions of Canadians” to fight COVID-19. A spokeswoman described Health Canada’s decision-making as “independent.”
Six months later, Spartan’s device had not proven reliable enough, according to Health Canada’s evaluation. And any obstacles to BTNX’s applications had seemingly vanished.
David Boudreau, Canada’s Chief Health Officer, sent an email to Sabourin and Manon Bombardier, Deputy Deputy Minister, on October 14, 2020, to announce that, after discussions, BTNX had applied for authorization to sell a COVID-19 antigen.
Given the availability of antigen tests, he wrote, Health Canada would review the registry “as a matter of priority, as soon as possible. “
It is unclear why Health Canada prioritized BTNX’s application.
Assure Tech, BTNX’s supplier in China, had in the past applied to Health Canada for approval to sell the exact same product.
Sabourin replied to Boudreau in writing.
(Sabourin declined Global News’ request for comment. He retired in December 2021.)
Federal workers were given jobs.
In Winnipeg, the National Microbiology Laboratory evaluated control samples provided through BTNX.
In Ottawa, a worker with a Ph. D. in biochemistry oversaw the review of nearly all of the BTNX and Assure Tech programs, which staff grouped together, according to federal records.
One of the evaluations contained in the BTNX package, but not in the edited Assure Tech edition, of the study’s ability to detect COVID-19.
It is not transparent that the two documents describe the same study. The Global News investigation showed that in addition to omitting data, BTNX renumbered the positions where the evaluation was performed and the identity numbers of the specimens.
A quick scan of Canadian distributors’ websites would have shown that another business was marketing the same test to customers overseas with the overall 80.2 per cent sensitivity estimate. Yet in BTNX’s application to Health Canada, this figure jumped to nearly 95 per cent.
“The location has not been replaced,” the corporate spokesperson wrote. BTNX provided a “reliable tool for Canadians. “
One of the tweaks is to remove “retrospective positives. ” These are frozen samples.
BTNX said Canadian and U.S. health regulators recommended using fresh samples.
In fact, Health Canada informed the company that it would possibly use frozen samples in its correspondence with BTNX. The U. S. FDA has ruled that the U. S. Food and The U. S. Department of Justice said the same thing.
Global News’ examination of the data also revealed that BTNX did not delete all of the frozen specimens, only those that tested positive for COVID-19. Those deletions improved the outcome for the nasal test by nearly 10 percentage points.
Reviewing clinical studies posted on Health Canada’s website, Global News found that other immediate control providers were retrospective samples and described the effects of unusable samples.
Reacting to questions about whether changing the data is not unusual among Canadian immediate testing companies, Cenk Ozkan, vice president of Burnaby, British Columbia-based Artron Laboratories, told Global News that deleting the data would threaten “loss of credibility and lawsuits. “
Health Canada, for its part, defended its resolution to approve BTNX’s application. The approval was based on the entire package, a spokesperson wrote in December, adding a momentary sensitivity test of the test conducted in the United States and controlled through Assure Tech, BTNX’s provider.
Global News discovered that the current edition of BTNX also examines others from Assure Tech.
The edition of this study that Assure Tech sent to Health Canada cites 230 samples. The BTNX edit cites 82, suggesting that most of the samples were overlooked by an unknown user.
Assure Tech responded to Global News’ requests for comment. BTNX told Global News that Assure Tech has only provided 82 samples to BTNX.
“AssureTech did not advise BTNX that it had additional specimens from another site or that it was submitting a broader study to Health Canada,” the company’s spokesman wrote on Jan. 5. Health Canada’s approval of the test for consumers relied on a third evaluation in the package, he stated.
The deletions have raised questions among Canadian investigators about the reason for regulator BTNX’s request.
Trudo Lemmens, a professor of fitness law and policy at the University of Toronto, said: “The fact that Health Canada didn’t see it or ignored it” suggests a “regulatory failure. “
Lemmens called on the federal government to release research that would also allow for “scrutiny by independent researchers outside of government and industry, so they can see if knowledge supports the claims. “
During the November 2022 interview, a Health Canada official recalled the sense of unity among federal staff as they reflected on those terrible days.
He and his colleagues seemed confident that they had weeded out less reliable suppliers.
“We learned which corporations should have quality apps” with “data that would back up their claims,” he told Global News.
Since the publication of the Global News report, Health Canada has maintained that the National Microbiology Laboratory’s BTNX kit supports the reported sensitivity of BTNX.
Global News obtained the NML’s results and the lab report, which called the device a “less-sensitive” test. The technicians attributed its lower outcomes to storage issues.
Unknown to Health Canada, researchers from the German, Spanish and British governments had reached the same conclusion in the fall of 2020 and winter of 2021 (for more information, you can read our December 21 article online).
Researchers Global News asked to review the data said the contrast between the governments’ results and the outcomes BTNX reported to Health Canada were eye-catching.
The ministry announced the BTNX and Assure Tech programs on February 19, 2021.
Over the next year and a half, the federal government purchased 404 million BTNX kits worth an estimated $2 billion. The Global News report states that this is the largest order ever placed through a government to a supplier of the Assure Tech device in the world. .