Via America’s Lawyer: Pfizer announces a global recall of its anti-smoking medication Chantix after studies linked long-term use of the drug to certain cancers. Meanwhile, the FDA insists the health benefits of stopping smoking outweigh the cancer risks of Chantix. Mike Papantonio is joined by attorney Joshua Harris to outline the long-term dangers of the drug.


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

Mike Papantonio:             Pfizer’s announced a global recall of its anti-smoking medication Chantix after studies linked long-term use of the drug to certain cancers. Meanwhile, the FDA insists the health benefits of stopping smoking outweigh the cancer risk of Chantix. That sounds like classic to me. Joshua, Josh Harris with our law firm. Josh, first of all, I look at this case and I see a pattern. Okay. The pattern is the FDA’s always going to side with corporations as long as they possibly can. That seems to be the case here. Their argument is there’s, you’re not taking enough of this. You could, you can go a long time and taking in this toxin. You’re going to be okay. What sparked the recall?

Joshua Harris:                     Well, the recall was sparked because Pfizer noticed back in June that their product Chantix had levels of nitrosamine in it, which is a chemical compound, which is known for decades to be linked to cancer and causing cancer. From June Pfizer was going and reviewing these to see if there was any way that they can recoup this. They stopped distribution and then finally, earlier this month in September the FDA worked with Pfizer to say that they needed to do a recall. But you’re absolutely right. The problem is that they keep substituting one bad thing for another.

Mike Papantonio:             Yeah. And the FDA is used to that. If it’s, it’s, they’re at the beck and call of corporate America. Now the truth is, the company’s known about this problem a long time. They’ve certainly known about the concept of NDMA, right? NDMA is one, is, is part of this class of, of, of issues. NDMA they understand there really is no safe level of NDMA. But here they’re saying, yeah, there’s a safe level. We’re going to allow it to happen. How, how long did the company know about the problem?

Joshua Harris:                     Well, they’ve known about nitrosamines including NDMA for at least the past 20 years, that’s been publicly available. In fact, the FDA published articles and support in 2000, I believe, saying that companies need to be on high alert for these cancer causing chemicals. But they still allow it. They allow a daily level that you can take. But here Chantix is at two and a half times the acceptable level.

Mike Papantonio:             You understand that acceptable level that the, that the FDA does, it’s just a decimal point.

Joshua Harris:                     Oh, absolutely.

Mike Papantonio:             Okay. And they get pressure from the drug company to move that decimal point. They get press, they get pressure from Congress to move the decimal point. So Pfizer can continue making big profits. And we know this about NDMA. Here let me give you an example. I know, you know this and it’s banned in the United States. You can’t buy NDMA. The only thing they use it for is to test laboratory rats, to get them cancer, cause cancer as quickly as they can. So how dangerous are these compounds?

Joshua Harris:                     Oh, I mean, just like you said, they’re, they’re banned in the United States except to cause cancer in laboratory animals. So, you know, these, these compounds NDMA is one, there’s a class of these chemical compounds. And if they’re ingested long enough, they’re going to do just like they do in the lab rats and cause cancer in humans. And that’s what we’re going to see here not too long with these cases.

Mike Papantonio:             Well, isn’t, isn’t the problem that it’s a genotoxin? I mean, explain a genotoxin is not, you know, I just took something that was a poison. Genotoxin is something that biologically affects your genes. It’s a progressive process, isn’t it?

Joshua Harris:                     That’s correct. So the, the NDMA is created in the production process of these drugs and what it does in certain drugs, it’ll break down in the body under certain circumstances and then break down in other bodies in other circumstances depending on the product. But it will absolutely change the compound of your body causing these cancerous cells and causing a host of other issues as well.

Mike Papantonio:             Apop, apoptosis, it causes a whole chain of issues with, at a cellular level, your body’s affected. But the FDA says, oh, you know, you gotta have.

Joshua Harris:                     There’s a level of acceptability.

Mike Papantonio:             Yeah, this is a level of acceptability because, gee, smoke, smoking is terrible. But there are other things besides Chantix that people can take it.

Joshua Harris:                     Right.

Mike Papantonio:             That’s the idea here. Get it off the market, keep it, keep it off the market. Don’t have the FDA saying, yeah, it’s okay. Use it anyway. Because there’s alternatives, right?

Joshua Harris:                     There’s, there’s much safer alternatives. And actually that’s what anyone who’s doing Chantix right now needs to do. They need to go talk to their doctor. They need to get off it as quick as they can, because the longer they ingest this, the higher their risk of cancer is. The studies all show that. The doctors know it. Pfizer knows it. The FDA knows it. And they’re just, like you said, doing a work around so Pfizer can keep pumping out this $1 billion seller.

Mike Papantonio:             You’ve been handling cases against drug companies a long time. How much confidence do you have in the FDA making any kind of proclamation that, hey, keep taking this, you’re going to be okay?

Joshua Harris:                     I, I wouldn’t trust it. If I were on Chantix, I, I would stop it as soon as I found out.

Mike Papantonio:             Find something else, there are other things.

Joshua Harris:                     Anything else.

Mike Papantonio:             Find something else. Josh, thank you for joining me. Okay.

Joshua Harris:                     Absolutely.

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.