March Madness: AstraZeneca Fudges the Clinical Trial Results for Its COVID-19 Vaccine
In case you haven’t been following the NCAA Men’s Basketball Tournament (or even if you have), you might be surprised to learn that the University of Hartford is poised to win it all this year—except for the fact that it lost in the first round of the tournament to Baylor University, 79-55, and has been eliminated from the competition.
Likewise, in case you haven’t been following the results of COVID-19 vaccine trials (who hasn’t?), you might be surprised to learn from a recent AstraZeneca press release that its vaccine is 79% effective. Except that it’s not, insofar as the pharmaceutical company, when reporting its clinical trial results, selectively ignored certain patients who received the vaccine but still got COVID-19. Factoring in these additional patients, it appears that AstraZeneca’s vaccine is only 76% effective, according to the company’s new, updated results, which it released after a highly unusual rebuke by an NIH-appointed panel of infectious disease experts. As reported by the Washington Post, the experts expressed concern that AstraZeneca had presented “outdated and potentially misleading” data on its coronavirus vaccine.
Essentially, AstraZeneca is accused of cherry-picking data to make its COVID-19 vaccine look better than it is. AstraZeneca may have done so in order to compete with other pharmaceutical companies, including Pfizer, Moderna, and Johnson & Johnson, whose COVID-19 vaccines have already received FDA approval and are now in use in the United States. Without FDA approval, AstraZeneca will lose out on billions of dollars being spent by the U.S. government to immunize Americans from the coronavirus.
Not surprisingly, AstraZeneca’s stock price originally jumped at the news that it was 79% effective—and then dropped when the true results became known. Whistleblowers with inside information that AstraZeneca executives intentionally manipulated the company’s share price can file a tip with the SEC and become eligible for a reward. Additionally, selectively reporting clinical test data can form the basis of a False Claims Act complaint. Whistleblowers with information that AstraZeneca—or any other pharmaceutical company—engaged in COVID-19 clinical trial fraud should consult with a qualified attorney to consider their options.
The spread between AstraZeneca’s original and revised efficacy rate may not be as large as the point spread in Hartford’s loss to Baylor in the NCAA tournament, but the potential implications for public trust in COVID-19 vaccines is enormous. If people don’t have confidence in the process by which vaccines are brought to market, then they are less likely to get the vaccine themselves, putting everyone at risk of more deadly variations of the virus.
As Dr. Peter J. Hotez, a vaccine expert at the Baylor College of Medicine, told the New York Times, “if [AstraZeneca] keeps making these unforced errors, then that’s going to derail confidence, and that will really affect our ability to combat this pandemic.” By misreporting its clinical trial results, AstraZeneca may have just eliminated itself from the competition for an effective and widely used COVID-19 vaccine.
If you would like more information on the False Claims Act or on what it means to be a whistleblower, or if you have any information on fraud in clinical trials and would like to speak to an experienced member of our whistleblower lawyer team, please do not hesitate to contact us.
- How Whistleblowers Can Report Fraud Related to Clinical Trials
- Pharmaceutical Fraud
- Fraud in Government Programs
- The False Claims Act
- SEC Whistleblower Program
- Think you have a whistleblower case?
- Contact us for a confidential consultation