The FEHBlog was wondering today whether the clinical trial review board had given AstraZeneca a heads up about its concerns with the company’s press release before making the midnight press release on that topic. The New York Times reports that
“Only hours after AstraZeneca announced encouraging news about the effectiveness of its Covid-19 vaccine on Monday, a group of medical experts charged with monitoring the company’s clinical trial made a highly unusual accusation: AstraZeneca had essentially cherry-picked data to make its vaccine look better.
The accusation, in a two-page letter sent Monday to the company and federal officials, was a fresh blow to the credibility of a vaccine whose low price and relatively easy storage have made it critical to the global fight against the coronavirus pandemic.”
In other words, AstraZeneca, which is partnering with the University of Oxford, knew about the credibility concerns yet didn’t pull back the press release in the face of such criticism. The company’s failure to respond lead to a “sharply worded” statement from the the National Institute of Allergy and Infectious Diseases [issued] on Tuesday shortly after midnight, disclosing the panel’s concerns.
The New York Times explains that
The fight is about the degree of effectiveness of a vaccine that is considered highly safe and effective.
While AstraZeneca said on Monday that its vaccine appeared to be 79 percent effective at preventing Covid-19, the panel of independent experts said the actual number may have been between 69 percent and 74 percent. The mass availability of a vaccine with even a 69 percent efficacy rate could help the world conquer the coronavirus.
But the public airing of a conflict between a pharmaceutical company and a board overseeing a clinical trial is almost unheard-of. It is certain to trigger extra scrutiny of the vaccine by the Food and Drug Administration and other regulators if, as expected, AstraZeneca seeks their authorization to use it on an emergency basis in the United States.
This is a sad state of affairs.
And now for some tidbits
- The Department of Health and Human Services announced today its decision to the extend the Affordable Care Act marketplace special enrollment period for an additional three months. The last day to enroll will be August 15 instead of May 15, 2021.
- Fierce Healthcare reports that “The Senate is likely to consider a bill this week that would extend a moratorium on 2% cuts to Medicare payments, according to the American Hospital Association. The extension is a major priority for hospital and doctor groups that say providers are still suffering financially due to the COVID-19 pandemic.”
- In a piece of good news, Healthcare Dive informs us that
After cancer screenings for breast and colon cancers plummeted at the outset of the COVID-19 pandemic, they rebounded by the end of July, according to a new report in the Journal of General Internal Medicine that analyzed the private insurance claims of 6.8 million people ages 45 to 64.
In fact, the rate of women seeking mammograms was higher by the end of July than in the months leading up to the pandemic. Prior to mid-March, or when the public health crisis began, the median weekly rate of mammogram screenings were 87.8 women per 10,000 beneficiaries. That figure improved to 88.2 screenings per 10,000 beneficiaries by the end of July.
However, the rate of colonoscopies did not return to pre-pandemic levels, but returned to near normal, according to the researchers. In the months leading up to the crisis, median weekly colonoscopy rates were 15.1 per 10,000 beneficiaries and later rebounded to only 12.6 per 10,000 beneficiaries.
- The Federal News Network reports on the Postal Service’s long awaited ten year business plan which was released today.