Via America’s Lawyer: The weight-loss aid Belviq was once the most popular drug on the market. Then came a recall due to hundreds of cases of brain, lung, and pancreatic cancer. Attorney Stephen Luongo joins Mike Papantonio to explain how the FDA did a regulatory U-turn after approving the dangerous drug back in 2012.

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Transcript:

*This transcript was generated by a third-party transcription software company, so please excuse any typos.

Mike Papantonio:             A popular weight loss drug sold under the brand name Belviq has been voluntarily recalled after a strong link between the drug and certain types of fatal cancers. And I have Steve Luongo here to talk to me about that, who’s handling this case, Steve, first of all, let me, let me clear something up. There is no such thing as a voluntary recall, you understand that.

Stephen Luongo:               Absolutely.

Mike Papantonio:             The company likes to say we voluntarily took it off the market. No, it’s the FDA said, either you take it off the market, are you going to be, have sanctions or whatever. Again, this is another story where the FDA failed to do their job, isn’t it? Take it from there. What is Belviq? What kind of injuries are we talking about?

Stephen Luongo:                Absolutely. So let’s start from the beginning. Belviq is a prescription weight loss drug and what it was designed to do is combat, combat obesity, type two diabetes, high cholesterol, high blood pressure. And what it does is it attacks the serotonin levels in the user. So it manipulates and tricks your mind into thinking that you’re full without actually having to eat any food.

Mike Papantonio:             Well, I handled the cases early on. I tried the Fen-Phen cases. The Fen-Phen cases was a weight loss program that was going to be the new secret to losing weight. It killed hundreds of women. Again, it was another situation where the FDA had all the information they needed, failed to do their job. In this situation, Belviq was, the FDA said no, in 2012, right? They said.

Stephen Luongo:                2010.

Mike Papantonio:             2010, they said, no, you can’t sell the drug. It was, I think, five to nine on the committee that said that. They reviewed everything said, this, first of all, it doesn’t work. Second of all, it’s dangerous. And then after, so you have a political change. They come back Belviq comes back and says, hey, you know what, we want another shot and the FDA says, oh, sure. The one we turned down, the one we said no to, you can sell it now. Take it from there.

Stephen Luongo:                Right. And you’re exactly right. It’s the same product that was denied by the FDA in 2010 was passed and approved in 2012. So what changed? Nothing changed except the people approving it. And in fact, when they denied it in 2010, the issues were, does this drug even work and is it worth the cost benefit analysis? In which time they knew based off a New York Times article that these laboratory rats were developing cancer or tumors that potentially could be cancerous at that time. So they were aware of back in 2010 of the cancerous and the carcinogen nature of this drug, the lorcaserin.

Mike Papantonio:             Yeah. And it doesn’t stop there. I mean, this is a drug where they found a history of people having suicidal thoughts, uncontrolled bleeding, men were growing breasts from it. You had blood, you had blood sugar problems that were putting people in, in, in, in sometimes comas. This is, this, but you had cancer. And the, the FDA knew all of that and they come in the second time and they start taking the word of the company. What is the company, Eisai?

Stephen Luongo:                The, the company is Eisai. It was originally developed by Arena Pharmaceuticals, a San Diego based company. In 2017, it was sold to Japanese pharmaceutical Eisai in which they really pumped up the advertising, got the sales increased to where eventually Belviq, Belviq was the number one drug in the market at that time.

Mike Papantonio:             Okay. So as this, you know, I’d like to say that this is just a one-off kind of situation, but we’re seeing it more and more, Steve. You handle these cases. You understand that when you’re dealing with the FDA, you may as well not have any comfort in what the FDA does. Most people in this business say that if a drug is not on the market for more than 10 years, don’t touch it. What is your thought on that?

Stephen Luongo:                Well, that’s exactly right, because we’re dealing with the FDA and the way that they got the approval was saying, hey, go ahead and do this five-year study. We’re going to go ahead and approve you, but go ahead and do five years and see what the cardiovascular effects of this drug are. Lo and behold, now we know people are coming down with cancer, mostly pancreatic, colorectal and lung cancer, but there’s a variety of cancers that are being affected by the people who are taking this drug.

Mike Papantonio:             Totally unnecessary drug.

Stephen Luongo:                Absolutely.

Mike Papantonio:             This, this drug serves no purpose whatsoever. There are drugs out that, that can accomplish the same thing that don’t kill you, but Belviq is out there saying, oh, we’ve got this new drug. Look, if you’re taking the drug, if somebody’s out there taking the drug, what do they need to do? How do they protect themselves?

Stephen Luongo:                Right. Stop immediately, contact your pharma, your, your, stop. They need to stop immediately. They need to contact their doctor and see what the alternatives are. As far as doctors that are prescribing it, they should have been stopped prescribing it as it was taken off the market a year ago and to talk about the alternatives with their patients as well.

Mike Papantonio:             And get screened.

Stephen Luongo:                Exactly.

Mike Papantonio:             How about something as just go get screened. Find out what these cancers are. Go get screened for the cancer, especially if you’ve been taking it a long time. Steve, thank you for joining me, okay.

Stephen Luongo:                Yes sir.

Mike Papantonio is an American attorney and television and radio talk show host. He is past president of The National Trial Lawyers, the most prestigious trial lawyer association in America; and is one of the few living attorneys inducted into the Trial Lawyer Hall of Fame. He hosts the international television show "America's Lawyer"; and co-hosts Ring of Fire Radio, a nationally syndicated weekly radio program, with Robert F. Kennedy, Jr. and Sam Seder.