The world desperately needs to be able to believe in AstraZeneca’s coronavirus vaccine, and the never-ending confusion over its clinical data isn’t helping.
The big picture: The extraordinary public dispute between the company and independent experts risks undermining patients’ trust, experts said, even if the vaccine turns out to work well.
Driving the news: The independent review board overseeing clinical trials for AstraZeneca’s vaccine, developed in partnership with Oxford University, protested to the NIH after the company said in a press release that the product had proven 79% effective.
- Those experts told federal officials they thought the company had sliced the data in a way that overstated the vaccine’s effectiveness.
- One official told The Washington Post that the press release was similar to “telling your mother you got an A in a course, when you got an A in the first quiz but a C in the overall course.”
The other side: AstraZeneca has said it will release a fuller analysis soon, and that it’ll show results consistent with what it claimed in its press release.
What they’re saying: “I think everybody is sort of stunned,” said Jennifer Nuzzo, an epidemiologist at Johns Hopkins. “There are billions of eyeballs on these data.”
- The public rift between a drug company and independent reviewers is highly unusual. And it’s all the more frustrating, experts noted, because this particular trial was designed in part to help quell some of the uncertainty AstraZeneca caused with its other studies.
“It’s one thing for a drug company or sponsor to bungle this on the first go but this is the second time this company has released information that was inaccurate and confusing, and it’s incredibly frustrating,” said Jonathan Kimmelman, a bioethicist at McGill University.
- Experts questioned the overall efficacy rate that AstraZeneca had claimed from previous trials, due to the unusual way the company pooled data from multiple research arms.
- A mistake in the actual administration of those trials also resulted in some patients getting a dosing regimen that the company hadn’t recommended or set out to study.
- More recently, some European countries have paused their use of the AstraZeneca vaccine because they were worried it might be causing blood clots, although the research hasn’t shown any evidence of such a link.
Between the lines: The large, American study — and the FDA authorization that will presumably follow — were supposed to settle the waters.
- There are no indications that the vaccine is unsafe, and experts believe that whenever the dispute over its efficacy shakes out, it’ll still be a good vaccine and an important tool for the world.
- If AstraZeneca oversold its findings, it’ll create a perception that it needed to juice the numbers. If outside experts overreacted to a minor statistical issue, it’ll keep a cloud hanging over an effective vaccine. Either way, it’s bad news.
“It’s not doing anyone any favors,” said Natalie Dean, a University of Florida biostatistician and an expert on vaccine clinical trials.
- Dean withheld judgment on the most recent dust-up, since the full details aren’t yet known. But in the company’s first round of confusing results, she noted, the fact that researchers had to tease out a full picture of the findings over time did more damage than the findings themselves.
- “If it had just been a straight reporting out of the results, we would have been excited,” she said.
Why it matters: Ultimately, the company will have to present a full set of clinical data to the FDA, and the FDA will conduct a thorough and public review, as it has with the other vaccines.
- The fear, experts said, is that the confusion will create a general perception that something’s amiss.
- “The biggest cost is diminished confidence, distrust,” Kimmelman said. “Distrust is leaky.”
What’s next: Ultimately, Kimmelman said, the problem is that too much information about life-and-death medical treatments has been delivered in simple press releases, with little hard data to evaluate their claims.
- A combination of low-quality research and over-torqued reporting of that research helped create widespread confusion last spring over whether hydroxychloroquine was an effective coronavirus treatment. (It’s not.)
- A steady drip of leaks and partial data releases also suggested that remdesivir was shaping up to be a much bigger game-changer of a treatment than it has turned out to be.
- AstraZeneca’s vaccine will probably stand up much better than those two drugs when scientists are able to read real clinical information and conduct a reality check on the company’s press release — but walking back from too-high expectations will only make life harder.
The bottom line: “I’d rather be thinking about the data instead of whether I can trust the data,” Kimmelman said.