Mike Papantonio: 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.

Brent Jabbour: Tell us about this issue with Beovu.

Joshua Harris: 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.

Brent Jabbour: 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.

Joshua Harris: 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.

Brent Jabbour: 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?

Joshua Harris: 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.

Brent Jabbour: And how many people are we seeing being effected by this?

Joshua Harris: You know, the drug was only on the market for a short period, but because of the aggressive marketing campaign, like I said earlier, there’s an estimated 60,000 bottles of these that have been sent out and an estimated about 40,000 people that have probably received Beovu injections. So, usually these adverse events that we’re seeing happen fairly quickly after there’s injections. So I don’t know the full extent, but I’m sure there’s gotta be tens of thousands of people who’ve been effected by this out there.

Brent Jabbour: And you would have to imagine, I mean, a lot of this basically comes down to negligence from Novartis, right?

Joshua Harris: Absolutely. I mean, if they took the time to do what they wanted to do and make a safe effective drug, they could have done that. They could have reported this to the FDA and been honest and open. But instead they cut the corners so they could get this drug on the market and sell it. And in the first quarter alone it was on the market, it made $68 million. So their, their lies and their marketing campaign were effective for them. They, they made money off this.

Brent Jabbour: And how, I mean, this may not be a question you have an answer to, but I’d love to hear your opinion on this. This, the fact is, is that, you know, like we’ve said, we, we hear about this over and over again, that the FDA essentially puts the ball in the court of the drug maker to do the research and give us the trial data and that’s how they make their decision. Is that the best way to do this when we see so many problems with drugs as we go through this?

Joshua Harris: No, and, and the FDA is severely overworked, overextended and under supported, and the problem is that they’re hoping and praying that these companies that want to make money, do the right thing to make that money. But I’m sure you’ve seen it before, the corporate greed, it’s too easy to worry about the bottom line and not worry about the end user.

Brent Jabbour: Well, right. And when you have to answer to shareholders, not to your patients, that seems like a huge problem there.

Joshua Harris: Well, the Wall Street and the tickers always tell the truth, you know.

Brent Jabbour: Absolutely. Now where is litigation with this right now?

Joshua Harris: So, litigation has commenced, at least our firm has filed a few cases in the district of Nebraska that have survived motion to dismiss phase. So we’re getting ready to start serving discovery and start getting documents from Novartis and we’re confident that when we see those, it’s going to show the true extent of what they knew when they underreported these issues to the FDA. And then we’re, we’re pushing for an aggressive trial date.

Brent Jabbour: And you mentioned this earlier that this all forced a label change. What does that label change mean?

Joshua Harris: So a label change, the two specific injuries are retinal vasculitis and retinal vascular occlusion and blindness. The label originally in October, 2019, when Novartis said, hey, FDA our drug’s safe, our drug’s okay. Here’s the few issues you may have. It may burn, redness a few days afterwards. Didn’t say anything about the severe issues that we’ve seen pop up in people. So label change now requires Novartis to say, oh, well, in addition to these other things, you may go blind, which a lot of patients and a lot of doctors would say, well, it’s not worth it. And they would have bypassed it, which means that Novartis would have sold less and made less money.

Brent Jabbour: It’s one of those things where it seems like the side effect is much worse than the disease it was meant to be treating.

Joshua Harris: Absolutely.

Brent Jabbour: Joshua Harris, thank you so much.

Joshua Harris: Thank you.

Mike Papantonio: Earlier this year, vision experts began warning doctors about the dangers of Beovu. It’s a drug intended to treat vision loss that’s actually causing some patients to go completely blind. I have attorney Brandon Bogle with me now, an attorney who’s had extraordinary experience with very complex cases like this. I’m glad you’re working this case. Give us a rundown. Give us a 10,000 foot before we talk about details here.

Brandon Bogle: Yeah. So this is a drug that’s manufactured by Novartis. It’s actually a pretty new drug on the market. It’s been out for less than two years. But pretty quickly after it was made available in the United States, there were a significant number of patients who were taking the drug by injection and pretty immediately suffering partial or complete vision loss that now experts in the field have very strongly tied to the use of this drug.

Mike Papantonio: Okay. So first of all, there are many alternatives, aren’t there? They don’t even have to use this drug. This drug does not even have to be on the market, right?

Brandon Bogle: That’s absolutely correct.

Mike Papantonio: It’s a money maker. So Novartis is saying let’s jump into that. Other people are making money on it, me too. I want to make some money on this too. How extensive is this condition in a person uses Beovu, which is an injection, isn’t it?

Brandon Bogle: It is. It’s an injection. You get in your doctor’s office. Usually an ophthalmologist will give it to you in their office.

Mike Papantonio: Do they inject it directly into the eye?

Brandon Bogle: They do, yes.

Mike Papantonio: Okay. And so how often does that take place?

Brandon Bogle: It’s something that you have to get periodically over a period of months, but usually you come in every month or so and get an injection.

Mike Papantonio: Okay. And from a physiological standpoint, what we’re seeing is we’re seeing what we call miniature eye strokes, right? You’re having blood vessels that are exploding in the back. Beovu is creating some unusual protein, as I understand it. The protein is affecting the ocular system in the back of the eye, right?

Brandon Bogle: That’s right. Yeah. You get a blood clot in the back of your eye and you pretty immediately cannot see which has got to be a very startling thing to go through.

Mike Papantonio: Is it reversible once we get away from Beovu? Is it reversible once you do that macular damage?

Brandon Bogle: Unfortunately, generally no. It is not. The patients are stuck with the loss of vision that they experience following the clot in the eye itself.

Mike Papantonio: What type of patient is more at risk here? I mean, who goes to use Beovu to begin with?

Brandon Bogle: Yeah, so it treats age-related macular degeneration, which typically occurs in patients 50 years old or older. So that’s the population that’s going to be taking the drug. And that condition itself causes a very slow deterioration of eyesight. But what unfortunately we see with this drug is it causes a rapid onset of oftentimes complete blindness.

Mike Papantonio: Okay. Now let me get this right because we hear the same thing every time. FDA did nothing.

Brandon Bogle: Correct.

Mike Papantonio: We think FDA does testing. They don’t. If Novartis phonied up the clinical data, we won’t know until you take those depositions. Did they have clinical data that should have shown them that this has the ability to cause absolute total blindness? That’s what you’re going to find out.

Brandon Bogle: Right. And what we already are seeing, and just very early on in this process, is they did do exactly that. They phonied up the clinical data to mask what was warning signs in the clinical trials that this drug can cause those blood clots in the eyes that acutely, again, cause sometimes complete vision loss. The data was definitely there. They mask the data and that’s just what we know so far. Once we get into the internal documents, as things always happen with cases like this, they only get worse.

Mike Papantonio: Okay. So as we work through this, we’re going to see the same thing. We’re going to see the FDA trying to defend themselves for being idiots, for being a dysfunctional idiotic agency that never really looks over anybody’s shoulder. We’re going to see Novartis saying, “Oh gee, we didn’t know.” The clinicals are going to say “Yes, you did know.” And in the process, we’re going to have people going blind, not even understanding the relationship between why they’re going blind and the fact that they’re taking this medication. This is a project I really recommend that you get out in a big way, an advertising campaign, to let people know this because you can stop it right now. There are alternatives.

Brandon Bogle: Yes.

Mike Papantonio: Brandon, you’ve gotten extraordinary results in other cases. I hope you’ll take this one just as serious and save some of these people because I mean, what an awful thing to wake up one day and you’re blind and not even understand what happened.

Brandon Bogle: I think we’re going to find that the detailers had to aggressively market this, because again, this was a me too drug. And the only thing they could really say about this drug is you have to get fewer injections over time. But again, what they did not tell and what I think is going to be very clear that they hid, is the risk of these eye injuries that you just do not see with the other available therapies here.

Mike Papantonio: Okay. Brandon, as you go forward, your depositions are going to tell the story, aren’t they?

Brandon Bogle: They are.

Mike Papantonio: What do you usually see? You see it starts at the top. Don’t you? And the top holds this secret for a long time as they do whatever they do with their stock. When things start going bad, the CEO that was in charge of that project moves on, takes all his money, and another CEO moves in. How many times have you seen that in this business?

Brandon Bogle: More times than I can count.

Mike Papantonio: Brandon Bogle, thank you for joining me. Please be aggressive. Go after these guys. Okay?

Brandon Bogle: Will do. Thank you.

Mike Papantonio: Thank you.