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Beovu Vision Loss & Blindness Dangers Hidden From FDA In Aggressive Marketing Campaign
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November 1, 2021
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6:05Now PlayingVia America’s Lawyer: Beovu is a popular injection used to treat age-related macular degeneration. But the medicine has been shown to actually cause permanent vision loss and blindness. From the Mass Torts Made Perfect conference in Las Vegas, RT’s Brent Jabbour fills in for Mike Papantonio, to talk with attorney Joshua Harris about Novartis’s aggressive marketing campaign that pushed such a dangerous drug through the FDA’s approval process.
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*This transcript was generated by a third-party transcription software company, so please excuse any typos.
Beovu is a popular injection used to treat macular degeneration, but the medicine has been shown to actually cause permanent vision loss and blindness. Brent Jabbour also interviewed attorney Joshua Harris at the aggressive marketing campaign that's being ignored and he's ignoring the risk of this new product.
Tell us about this issue with Beovu.
Well, Beovu is a eye injection for macular degeneration produced by Novartis. It received FDA approval in October of 2019 and since then there were about an estimated 60,000 vials of this that were prescribed. Now, what Novartis did was they had a heavy marketing campaign for this and they were going against their competitors, Eylea and Lucentis, which require numerous injections throughout the year to treat AMD age-related macular degeneration. What Novartis did was they claimed that their drug was just as effective with half the number of injections, which was appealing to doctors and patients because the less times they had to get jabbed in the eye with a needle, that seemed more effective. But what we learned was that they lied on their clinical data to the FDA, the FDA didn't catch it and now they were forced to have a label change in June of 2020.
So you're telling me they tried to cut corners. That they tried to say, well, while you need multiple injections, we only need one. And that didn't quite work out that way.
No, and in fact, they were seeing such high adverse event rates compared to the safer alternatives and the other two drugs that were already proven effective on the market. So what happened was, Novartis then had to do a label change because the American society of retinal specialists went back and did a safety review on Novartis' clinical trial data. And what they learned there was that Novartis severely underestimated and severely underreported the number of adverse events to try to make their drug more effective and safe so they could get a good label from the FDA. And the issue is the FDA doesn't test these drugs, they get, they get it from the drug company. So if they underreport or misreport then the FDA just goes with what they've got.
And, I mean, and the fact that they lied on the data, maybe I'm saying lied is the wrong word, but misrepresented their data to the FDA. I mean, that seems like, you know, that doesn't even need attorneys. The FDA should be taking care of that directly, right?
Well, you, you would think so and they're, they're forcing them to change the label, but that's not enough. In fact, the problems have persisted so much that in May of this year, 2021, almost two full years after the drugs on the market, Novartis has completely stopped phase three clinical trials because it's so damaging that they don't even feel comfortable testing it on people for these clinical trials. So unfortunately the FDA has not done enough to do anything about this. So, you know, our law firm stepped in and we're representing folks who have suffered and, you know, people are going blind in the worst cases and losing vision and having inflammation and all sorts of other injuries and eye problems.
And how many people are we seeing being effected by this?
You know, the drug was only on the market for a short period, but because of the aggressive marketing campaign.
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