DayQuil, Covid Vaccine Boosters and FDA Science

The industry studies that showed a decongestant was effective turned out to be flawed. Sound familiar?

By Allysia Finley. Excerpts:

"But unlike a sugar pill, phenylephrine can cause lightheadedness, queasiness, headaches and a rapid heartbeat. What took the FDA so long to act?

Perhaps typical bureaucratic inertia and reluctance to backtrack on “settled science.” This episode mirrors the debate over Covid boosters, which the FDA approved last week, the day before its advisory committee concluded phenylephrine is ineffective. As was the case for phenylephrine, booster recommendations are based on flawed studies and extrapolations."

"studies as early as the 1930s showed that significantly higher doses of phenylephrine than are safe would be needed to have a decongesting effect"

"When the agency revisited the issue in 2007, an industry meta-analysis of prior flawed studies showed phenylephrine was effective. But as an agency scientific adviser quipped at a regulatory briefing that March, “all meta-analysis is post facto. You only do it if you know you’re going to win.” The FDA then sought more studies to measure the efficacy of higher doses—yet the three placebo-controlled trials between 2015 and 2018 were negative."

"early studies demonstrating the drug’s efficacy were flawed and possibly biased. Ten, all from the same industry sponsor, had “multiple methodological and statistical issues” and apparent “data integrity” problems."

"The FDA last week approved updated boosters based on data showing they generated antibodies and past studies purportedly demonstrating that the original vaccine and earlier booster versions worked. But these are large extrapolations based on flimsy evidence. No placebo-controlled trials have shown the boosters are effective, and studies on prior boosters systemically suffer from what scientists call “healthy user bias”—the process by which healthier people, who are more likely to receive a treatment, skew retrospective analyses.

One widely cited study from Israel found people who got the first boosters were 90% less likely to die of Covid within a 54-day period. Yet scientists from Stanford and the University of California, San Francisco, who analyzed the data estimated that those who didn’t get boosters were also 94.8% more likely to die of non-Covid causes during the same period."