AstraZeneca Makes an ‘Unforced Error’
AstraZeneca this week gave us a prime example of the importance of getting data right from the beginning. The incident is particularly sensitive given that it involves the company’s COVID-19 vaccine. Not only does AstraZeneca have a crisis on its hands — it’s being blamed for contributing to the mistrust of science. Not good in a pandemic
On Monday, the Cambridge, England-based drugmaker issued a press release announcing that a U.S. trial showed its vaccine to be 79 percent effective in preventing symptomatic COVID-19 disease and 100 percent effective at stopping severe disease. But hours later a government panel called the Data and Safety Monitoring Board accused the company of using “outdated information,” according to press reports.
The National Institute of Allergy and Infectious Diseases issued a press release on the matter. “We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,” it wrote.
The company was in a full-blown crisis. The NIAID statement provoked it to respond publicly; it said its numbers “were based on a pre-specified interim analysis with a data cut-off of 17 February.” The new numbers seemed to be consistent with the old ones, it said, and it would work with the board and issue updated information within 48 hours. (It released its supporting numbers today at 12:45 a.m. England time — 11 hours ahead of its deadline.)
Much of the media coverage put the flap in the context of AstraZeneca contributing to skepticism about the science, which placed the company in a spot a drugmaker shouldn’t want to be. Too many people already refuse to get vaccinated. And, while the vaccine needs U.S. approval, it is already widely used in the U.K. and Europe, where it has a crisis concerning links to blood clots.
“Decisions like this are what erode public trust in the scientific process,” the DSMB’s letter to the company said, according to the Associated Press.
Decisions like this are what erode public trust in the scientific process.
— Data and Safety Monitoring Board
The AP quoted former U.S. Food and Drug Administration Chief Scientist Dr. Jesse Goodman: “It would seem that whatever this communication misstep is, at the end of the day the data will have to stand for itself.”
Indeed, ultimately it is the FDA that must approve the vaccine’s use. But AstraZeneca hasn’t helped itself. This is especially so in the pharma context, where data is so important for public trust. “The public airing of a conflict between a pharmaceutical company and a board overseeing a clinical trial is almost unheard-of,” The New York Times wrote.
On TV’s “Good Morning America,” NIAID Director Dr. Anthony Fauci called AstraZeneca’s move “an unforced error.”
For crisis responders, it’s an intriguing event that serves as a reminder of the importance of getting facts right. Obviously, it raises reputational issues. We hope that eventually we get the inside story on just how this snafu came about.
Photo Credit: AstraZeneca
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