Via America’s Lawyer: The FDA is again resorting to damage control, now warning the public about Xeljanz, a rheumatoid arthritis drug approved in 2012 that’s been linked to heart disease and cancer. Attorney Sara Papantonio joins Mike Papantonio to explain the dangerous results from recent safety trials, while the drug still hasn’t been pulled from pharmacies.
*This transcript was generated by a third-party transcription software company, so please excuse any typos.
Mike Papantonio: The FDA is again resorting to damage control, now warning the public about another cancer causing drug, that’s been on the market, oh, by the way, since 2012. Well, we’re seeing dangerous results from safety trials, yet the drug still hasn’t been pulled from the pharmacies. It’s still on the market. It’s classic FDA. Joining me to talk about this is Sara Papantonio, Sara you’re handling this case. Tell us about Xeljanz. Lay the 10,000 foot out for us.
Sara Papantonio: Right. Xeljanz is a drug that suppresses the immune system. What it’s used to, is it’s used to treat rheumatoid arthritis. And what we found is that the drug has been on the market since 2012. For years, we’ve known that it has been related to severe cardiac arrest, major heart conditions, pulmonary embolisms, blood clots. That’s no question. In fact, the FDA just recently issued a black box warning on those conditions. But just a month ago, the FDA came out and said, hey, not only does it cause major cardiac events, it also causes cancer. So it’s just one thing after another with this drug that we’re seeing. It’s just a very dangerous drug that’s on the market right now.
Mike Papantonio: Yeah. Well, I’ve been following, I’ve been to trial with Pfizer more than most lawyers, all back when you were in grade school, you know, and, and the truth is, it’s always the same MO. And what you see is their influence with the FDA that’s become totally dysfunctional. It’s just a revolving door. Work with the FDA, they go to Mary with the FDA. You know, Mary you’re only making $150,000 start with us and we’ll pay you $700,000 or something ridiculous. It’s the influence and that’s, that’s, clearly I can, when we, when we take the depositions in this case, I promise you, that’s what we’re going to find is some influence there. But they finally got around to the black box. What’s important about the black box? The FDA said, you got to have a black box. They didn’t do it willingly, Pfizer didn’t do it willingly.
Sara Papantonio: It’s really important that we do talk about this black box warning because oftentimes consumers don’t understand what that little black box on the drug means. What it means without question is this drug is dangerous. If a consumer, if you’re, if you’re going to buy a drug and you see a black box warning on it, it means that is the last step the FDA will take until they rip that drug off the market. So turn the other way, do not take that drug if it has a black box warning on it, because it is seconds, months, you know, very quickly probably going to be taken off the market.
Mike Papantonio: Yeah. Okay. So you have the FDA, they’ve known all this bad stuff. I mean, they knew about the cardiac events. They knew about DVTs and blood clots, my God, the list is endless. They knew about congestive heart failure related to it. But they say, oh, all you gotta do is put a black box on there. First of all, this isn’t even a product that’s needed. This is like a, this is like a me too product. There are plenty of products that do the same thing here. Right?
Sara Papantonio: Absolutely. There’s tons of products on the market that can be used to treat many different of arthritis and so my advice to consumers is to avoid this one, because it has been linked to so many problems. You know, we, we’ve been talking about the, the heart complications for years, but now on top of all that it’s cancer. Understand that this is a drug that suppresses the immune system. It opens the flood gates for people to develop cancer left and right and so it is just truly a dangerous drug that needs to be taken off the market.
Mike Papantonio: Yeah. It’s a class drug. Let’s talk about the class, it’s called, I think it’s JAK, JAK. And what it does is it suppresses the immune system, as you say, and the other, the other things related, related to it are, look, you know what else they’re doing with this drug that we see Pfizer and other drug companies do, this drug wasn’t developed for treatment of ulcerative colitis. But they said, hey, we can make extra money by not only treating arthritis. We can also go and we can sell it for something totally, it’s called off-label, we can sell it for off-label ulcerative colitis. And so all of a sudden, this is a cash cow. These people are going to fight as long as they can to keep it on the market. You agree?
Sara Papantonio: Absolutely. They’re going to expand every and all opportunities to get this drug on the market, to get it to patients. And that’s like, we’ve seen with this ulcerative colitis, they are expanding the use of this drug to try to make more money. Now, this is, this drug has already made, it makes about a million dollars each year. Since it’s been on the market, it’s made about $7 million, but that’s not enough for Pfizer. No, they have to expand it. They have to make more money. They have to hurt more people in the long run.
Mike Papantonio: But then there’s Zantac, this is another Pfizer product. You know, the deal on that, pulled off the market. Testosterone products pulled off the market because they were so dangerous. Pradaxa and Xarelto. I mean, at what point does the FDA, we’re dealing with a serial offender here. What do you think?
Sara Papantonio: Absolutely. I mean, Pfizer is the second largest pharmaceutical company in the world and look at the track record they have. It’s one drug after another being pulled off the market because it’s hurting people, it’s killing people. It is an incredibly dangerous drug. At some point, we have to take a step back and say, what, what good is this company doing? You know, what is this, what are safety precautions?
Mike Papantonio: Well, we got a, we got a vaccine.
Sara Papantonio: We got the vaccine.
Mike Papantonio: Okay. Sara Papantonio, thank you for joining me. Okay.