1 00:00:04,280 --> 00:00:07,400 Speaker 1: From Bloomberg News and I Heart Radio. It's the Big Take. 2 00:00:09,560 --> 00:00:13,640 Speaker 1: I'm west Caasova. Today, thousands of people claimed they got 3 00:00:13,680 --> 00:00:25,279 Speaker 1: cancer from one of the world's most popular drugs. In November, 4 00:00:25,400 --> 00:00:29,280 Speaker 1: we talked about how a small independent lab in Connecticut 5 00:00:29,400 --> 00:00:34,760 Speaker 1: called vallish Or discovered in that samples of Zantac, the 6 00:00:34,840 --> 00:00:39,199 Speaker 1: widely used heartburn pill, contained the possible carcinogen n d 7 00:00:39,400 --> 00:00:42,640 Speaker 1: m A. At first, the company that made the drug 8 00:00:42,880 --> 00:00:45,239 Speaker 1: at the time it was called Glaxo and now it 9 00:00:45,280 --> 00:00:48,519 Speaker 1: goes by g s K they pushed back against the 10 00:00:48,600 --> 00:00:52,400 Speaker 1: lab's findings, and so did the US Food and Drug Administration, 11 00:00:53,200 --> 00:00:57,160 Speaker 1: But in the FDA pulled Zantac from the market. The 12 00:00:57,240 --> 00:01:01,040 Speaker 1: agency also requested that all pros ryption and over the 13 00:01:01,080 --> 00:01:06,200 Speaker 1: counter drugs containing renittedine, which was the active ingredient in Santech, 14 00:01:06,640 --> 00:01:10,640 Speaker 1: be removed from store shelves. A new version of Zantech 15 00:01:10,800 --> 00:01:14,000 Speaker 1: is back on the market. It's been reformulated and it's 16 00:01:14,000 --> 00:01:17,759 Speaker 1: no longer made with renittedine. It's considered safe to use 17 00:01:17,959 --> 00:01:21,600 Speaker 1: as directed. But now tens of thousands of people who 18 00:01:21,600 --> 00:01:24,760 Speaker 1: took the old version of the drug have sued. They 19 00:01:24,760 --> 00:01:27,679 Speaker 1: claim it gave them cancer, and the alleged the company 20 00:01:27,800 --> 00:01:31,160 Speaker 1: was made aware of potential problems with the drug but 21 00:01:31,319 --> 00:01:36,440 Speaker 1: didn't act quickly enough. My colleagues Anna Edney, Susan Burfield, 22 00:01:36,440 --> 00:01:40,040 Speaker 1: and Jeff Feely dug deep into the claims and counterclaims 23 00:01:40,040 --> 00:01:43,240 Speaker 1: in these lawsuits for Bloomberg Business Week. They're here to 24 00:01:43,319 --> 00:01:47,520 Speaker 1: explain what's at stake and just how complicated it is 25 00:01:47,680 --> 00:01:52,160 Speaker 1: to try to prove a drug made someone sick. Susan, 26 00:01:52,160 --> 00:01:54,960 Speaker 1: can you tell us about Zantec and why it was 27 00:01:55,000 --> 00:01:58,840 Speaker 1: such a big deal. Zantac was first developed to treat 28 00:01:58,960 --> 00:02:03,000 Speaker 1: ulcers at then got approved to treat heartburn, and along 29 00:02:03,000 --> 00:02:06,920 Speaker 1: the way became a billion dollar drug for Glaxo and 30 00:02:06,960 --> 00:02:11,560 Speaker 1: the best selling prescription of all time. So hugely important 31 00:02:11,600 --> 00:02:14,600 Speaker 1: to the company that developed it, pretty important for a 32 00:02:14,639 --> 00:02:17,600 Speaker 1: lot of people, millions of people who were taking it, 33 00:02:18,200 --> 00:02:20,680 Speaker 1: and now, of course, you know, important for people to 34 00:02:20,760 --> 00:02:24,640 Speaker 1: understand what happened during all those years between development and now. 35 00:02:25,320 --> 00:02:28,200 Speaker 1: And one of the reasons this drug became so popular, Anna, 36 00:02:28,280 --> 00:02:30,560 Speaker 1: as you're writing the story is that it was one 37 00:02:30,560 --> 00:02:34,359 Speaker 1: of the first drugs that was marketed directly to consumers. 38 00:02:35,040 --> 00:02:37,440 Speaker 1: That's right, Um, we see ads all the time now 39 00:02:37,520 --> 00:02:39,800 Speaker 1: on TV. I think and we think of those and 40 00:02:39,800 --> 00:02:42,000 Speaker 1: and make fun of them from time to time. And 41 00:02:42,200 --> 00:02:45,680 Speaker 1: you know, it wasn't as ubiquitous back then, but Blacks 42 00:02:46,440 --> 00:02:51,359 Speaker 1: made sure that it had an enormous salesforce, combined forces 43 00:02:51,400 --> 00:02:54,600 Speaker 1: with another company, um to try to to make sure 44 00:02:54,680 --> 00:02:57,240 Speaker 1: that they were getting the word out about this drug, 45 00:02:57,240 --> 00:03:00,720 Speaker 1: and even went too far sometimes and we're bromanded by 46 00:03:00,800 --> 00:03:03,840 Speaker 1: the Food and Drug Administration for some of the claims 47 00:03:03,880 --> 00:03:07,400 Speaker 1: that they tried to make. And and all this time 48 00:03:07,520 --> 00:03:11,320 Speaker 1: that this drug was selling in huge amounts of making 49 00:03:11,360 --> 00:03:15,840 Speaker 1: this company a lot of money, there were indications behind 50 00:03:15,880 --> 00:03:18,520 Speaker 1: the scenes that there were potential problems with it. Could 51 00:03:18,560 --> 00:03:23,720 Speaker 1: you describe exactly what was the problem with this drug? Yes, Um. 52 00:03:23,800 --> 00:03:26,000 Speaker 1: These indications that there was a problem with the drug 53 00:03:26,080 --> 00:03:29,240 Speaker 1: started before was even approved by the Food and Drug Administration. 54 00:03:29,720 --> 00:03:33,560 Speaker 1: There was some testing that black so did internally that 55 00:03:33,720 --> 00:03:38,080 Speaker 1: showed that under certain conditions Zantalk, which you know, before 56 00:03:38,120 --> 00:03:40,640 Speaker 1: it was approved, was called nitadine because that's the active 57 00:03:40,760 --> 00:03:44,200 Speaker 1: ingredient in it. This testing show that nittadine could form 58 00:03:44,360 --> 00:03:48,880 Speaker 1: a probable carcinogen called n d m A. So how 59 00:03:48,880 --> 00:03:50,680 Speaker 1: did that happen? Where did the n d m A 60 00:03:50,800 --> 00:03:54,760 Speaker 1: come from? So what they found out with Zantok is 61 00:03:54,840 --> 00:03:59,160 Speaker 1: that nittadine itself degrades to form n d m A, 62 00:03:59,400 --> 00:04:02,600 Speaker 1: and this can happen over time while it sits on 63 00:04:02,640 --> 00:04:06,600 Speaker 1: the shelf. This also can happen in heat and humidity. 64 00:04:06,800 --> 00:04:10,400 Speaker 1: So maybe when you're transporting the drug and you're the 65 00:04:10,400 --> 00:04:13,720 Speaker 1: truck might be um have higher temperatures. When they're taking 66 00:04:13,720 --> 00:04:16,960 Speaker 1: it to the drug store. This can be in your bathroom. 67 00:04:17,240 --> 00:04:20,559 Speaker 1: You know, these are pretty normal temperatures where it's able 68 00:04:20,640 --> 00:04:23,279 Speaker 1: to increase the amount of n d m A on 69 00:04:23,360 --> 00:04:26,159 Speaker 1: the drugs, So you don't just have a set amount 70 00:04:26,240 --> 00:04:28,640 Speaker 1: of n d m A, but it rises over time 71 00:04:28,880 --> 00:04:32,280 Speaker 1: and with heat. What they have argued is that it 72 00:04:32,320 --> 00:04:34,520 Speaker 1: would have only been in conditions that just aren't even 73 00:04:34,560 --> 00:04:39,280 Speaker 1: possible to happen within the human body, so that at 74 00:04:39,279 --> 00:04:43,159 Speaker 1: the time the drug is manufactured it can be just fine, 75 00:04:43,760 --> 00:04:47,040 Speaker 1: but over time, sitting in your medicine cabinet can develop 76 00:04:47,120 --> 00:04:52,040 Speaker 1: this probable carcinogen all by itself. That's right. The n 77 00:04:52,120 --> 00:04:54,680 Speaker 1: d m A is formed when the drug degrades. The 78 00:04:54,720 --> 00:04:58,520 Speaker 1: drug has some characteristics that make it susceptible to forming 79 00:04:58,720 --> 00:05:02,080 Speaker 1: n d m A. What happened is Glaxo looked into 80 00:05:02,160 --> 00:05:05,000 Speaker 1: this once the news was out there in twenty nineteen, 81 00:05:05,600 --> 00:05:09,760 Speaker 1: and they determined that they don't know exactly what is 82 00:05:09,839 --> 00:05:13,000 Speaker 1: making it degrade. They don't think there's any sort of 83 00:05:13,240 --> 00:05:16,599 Speaker 1: regular chemistry process that they can understand of how it 84 00:05:16,680 --> 00:05:20,000 Speaker 1: gets there. Probably one of the simplest ways to think 85 00:05:20,040 --> 00:05:23,599 Speaker 1: about this is just that renitadine as a molecule is unstable, 86 00:05:24,640 --> 00:05:28,600 Speaker 1: and so over time, in heat, in humidity, it degrades 87 00:05:29,320 --> 00:05:33,240 Speaker 1: and that creates problems that we're seeing now. And why 88 00:05:33,279 --> 00:05:35,240 Speaker 1: is and d m A a carcinogy and what does 89 00:05:35,279 --> 00:05:38,359 Speaker 1: it do? And d m A was once used in 90 00:05:38,800 --> 00:05:41,760 Speaker 1: rocket fuel but essentially, you know, it's not even allowed 91 00:05:41,839 --> 00:05:45,839 Speaker 1: to be used in any commercial uses anymore. Essentially is 92 00:05:45,920 --> 00:05:50,599 Speaker 1: only used now to cause cancer in um like lab rats, 93 00:05:50,680 --> 00:05:54,320 Speaker 1: animals that are being used for research. And they call 94 00:05:54,400 --> 00:05:59,560 Speaker 1: it a probable carcinogen because it's never been tested on humans. 95 00:05:59,560 --> 00:06:02,000 Speaker 1: But every single animal that has ever been given in 96 00:06:02,080 --> 00:06:05,000 Speaker 1: d m A, no matter the species, has developed cancer. 97 00:06:05,600 --> 00:06:08,720 Speaker 1: And it's not just a cancer, it's a laundry list 98 00:06:08,760 --> 00:06:14,320 Speaker 1: of cancers, bladder, lung, all sorts of different cancers. Jeff, 99 00:06:14,480 --> 00:06:18,000 Speaker 1: how is it that you know everything that you're describing 100 00:06:18,080 --> 00:06:22,280 Speaker 1: here the deliberations behind the scenes in the company, how 101 00:06:22,320 --> 00:06:25,920 Speaker 1: they responded to various signs that they may have been 102 00:06:26,000 --> 00:06:30,160 Speaker 1: something wrong. Well, we have access to the actual lawsuits 103 00:06:30,200 --> 00:06:34,600 Speaker 1: themselves the complainants. We have access to the pre trial 104 00:06:34,720 --> 00:06:39,640 Speaker 1: depositions done of the Glaxo officials. We have access to 105 00:06:39,720 --> 00:06:42,920 Speaker 1: internal documents that were turned over in discovery in some 106 00:06:42,960 --> 00:06:46,000 Speaker 1: of the lawsuits, so you know, we got a pre 107 00:06:46,200 --> 00:06:49,479 Speaker 1: wide view of what was going on. We also filed 108 00:06:49,480 --> 00:06:52,400 Speaker 1: a freedom of information request with the f d A, 109 00:06:53,000 --> 00:06:56,680 Speaker 1: so we also have the minutes of the meeting where 110 00:06:56,680 --> 00:07:00,560 Speaker 1: a group of outside advisors and f DAS staff we're 111 00:07:00,560 --> 00:07:03,760 Speaker 1: talking with Glaxo scientists. At the end of the day, 112 00:07:03,800 --> 00:07:07,040 Speaker 1: they suggested that the FDA go ahead and approve the 113 00:07:07,120 --> 00:07:12,240 Speaker 1: drug Susan, What did G s K say when you 114 00:07:12,360 --> 00:07:16,480 Speaker 1: presented them with what you found in your reporting about Zantac. 115 00:07:17,400 --> 00:07:21,800 Speaker 1: We sent G s K a pretty detailed memo UM 116 00:07:21,880 --> 00:07:24,239 Speaker 1: laying out what we had found, what we had seen 117 00:07:24,560 --> 00:07:28,080 Speaker 1: in the court documents, what our own reporting showed. UM. 118 00:07:28,120 --> 00:07:32,400 Speaker 1: They declined to answer any of our specific questions. They 119 00:07:32,480 --> 00:07:35,720 Speaker 1: did give us a statement that said that there is 120 00:07:35,840 --> 00:07:41,720 Speaker 1: no scientific consensus about any consistent or reliable evidence that 121 00:07:41,840 --> 00:07:46,000 Speaker 1: zantac increases the risk for any type of cancer. So 122 00:07:46,000 --> 00:07:49,440 Speaker 1: basically they're saying the science is on their side. They 123 00:07:49,440 --> 00:07:53,480 Speaker 1: also said that they will defend themselves vigorously against all 124 00:07:53,560 --> 00:07:57,000 Speaker 1: claims in any litigation. What is the f d A 125 00:07:57,120 --> 00:08:01,000 Speaker 1: say about approving written nity which they eventually then had 126 00:08:01,040 --> 00:08:04,280 Speaker 1: to pull from the market. Yeah, so the f d 127 00:08:04,280 --> 00:08:08,920 Speaker 1: A gave us a statement that I'll just summarize. Basically, 128 00:08:08,920 --> 00:08:12,960 Speaker 1: what they said is that they evaluate drugs according to 129 00:08:13,000 --> 00:08:16,440 Speaker 1: the quote science of the day, and when there's a problem, 130 00:08:16,560 --> 00:08:19,040 Speaker 1: they'll act quickly to figure out what to do. So 131 00:08:19,080 --> 00:08:21,120 Speaker 1: I guess you know what they're saying is they did 132 00:08:21,160 --> 00:08:24,560 Speaker 1: the best they could. And you write that GSK continues 133 00:08:24,640 --> 00:08:28,280 Speaker 1: to say that renitted being does not cause cancer. Correct 134 00:08:28,800 --> 00:08:30,640 Speaker 1: the way g s K is put it is that 135 00:08:30,680 --> 00:08:34,880 Speaker 1: there are no consistent signals that zantac causes cancer. What 136 00:08:34,960 --> 00:08:39,360 Speaker 1: they mean by that is that there are conflicting studies. 137 00:08:39,440 --> 00:08:42,800 Speaker 1: You know, nobody has given zantac to humans and said 138 00:08:43,120 --> 00:08:45,880 Speaker 1: let's find out if this causes cancer. You can't do 139 00:08:45,920 --> 00:08:49,400 Speaker 1: that ethically, but people have looked back in different epidemiological 140 00:08:49,440 --> 00:08:51,840 Speaker 1: databases and things and tried to figure out if people 141 00:08:51,840 --> 00:08:55,480 Speaker 1: who took santac how to hire risk of cancer. It's 142 00:08:55,480 --> 00:08:58,680 Speaker 1: true there's no consistent signal that it causes cancer, but 143 00:08:58,720 --> 00:09:01,800 Speaker 1: there's also no consistent signal that it doesn't cause cancer. 144 00:09:02,760 --> 00:09:04,800 Speaker 1: And uh, the last time you were on the show, 145 00:09:04,840 --> 00:09:07,960 Speaker 1: you were telling us about the small lab called Valisher 146 00:09:08,400 --> 00:09:11,800 Speaker 1: and it saw a problem with renitaine. Can you just 147 00:09:11,880 --> 00:09:16,240 Speaker 1: remind us what they found? Yeah, vlisher at the time, 148 00:09:16,400 --> 00:09:20,280 Speaker 1: so this was in twenty nineteen. They are an independent lab. 149 00:09:20,320 --> 00:09:22,520 Speaker 1: At the time, they were also a pharmacy and so 150 00:09:22,760 --> 00:09:25,520 Speaker 1: they were testing all the drugs that came through and 151 00:09:25,559 --> 00:09:28,599 Speaker 1: so they happened to be testing some zan talk, some 152 00:09:28,720 --> 00:09:32,559 Speaker 1: renitodine and they saw these super high levels of n 153 00:09:32,640 --> 00:09:36,520 Speaker 1: d m A. They took that information, they ran more tests. 154 00:09:36,520 --> 00:09:40,240 Speaker 1: They kept finding d m A and every single bat 155 00:09:40,360 --> 00:09:43,840 Speaker 1: that they tested, and so they wrote up that information 156 00:09:43,960 --> 00:09:46,200 Speaker 1: and they sent it to the Food and Drug Administration 157 00:09:46,640 --> 00:09:50,199 Speaker 1: as a petition saying you need to look into this, Jeff. 158 00:09:50,240 --> 00:09:53,320 Speaker 1: We should say that the concerns we're talking about here 159 00:09:53,360 --> 00:09:56,480 Speaker 1: are no longer a problem with the current version of 160 00:09:56,559 --> 00:10:00,240 Speaker 1: zante that's on sale now. Is that right? Zan Hack 161 00:10:00,320 --> 00:10:04,120 Speaker 1: did come back on the market, but randditine was taken 162 00:10:04,160 --> 00:10:07,080 Speaker 1: out of it as the active ingredient, and they replaced 163 00:10:07,120 --> 00:10:10,680 Speaker 1: it with another one. So you can get zantac today, 164 00:10:10,720 --> 00:10:12,840 Speaker 1: but it will not have Rand did a team in it. 165 00:10:14,400 --> 00:10:25,960 Speaker 1: After the break, the lawsuits over Zantac get under way, Jeff. 166 00:10:26,000 --> 00:10:28,440 Speaker 1: Has been a few years since the old version of 167 00:10:28,640 --> 00:10:32,480 Speaker 1: Zantac that was made with nitadine was pulled from the market. 168 00:10:32,920 --> 00:10:36,079 Speaker 1: Now a lot of people who took that version of 169 00:10:36,080 --> 00:10:39,320 Speaker 1: the drug claimed they got cancer and they're suing. Can 170 00:10:39,400 --> 00:10:45,200 Speaker 1: you walk us through what's happening. Sure, So there are 171 00:10:45,200 --> 00:10:48,480 Speaker 1: two sets of cases. At last, we have in this country, 172 00:10:48,520 --> 00:10:51,800 Speaker 1: two separate places where you can sue in federal court. 173 00:10:52,559 --> 00:10:55,520 Speaker 1: They were roughly about fifty cases filed and they were 174 00:10:55,559 --> 00:10:59,800 Speaker 1: all consolidated before a judge in Florida. That judge re 175 00:11:00,000 --> 00:11:04,319 Speaker 1: sently found that the science underlying the claims was flawed 176 00:11:04,760 --> 00:11:09,280 Speaker 1: and throw those cases out. The plainiffs, the people lawyers 177 00:11:09,360 --> 00:11:12,240 Speaker 1: for those who took the antach or appealing that decision. 178 00:11:12,880 --> 00:11:17,440 Speaker 1: So fifty people who claimed they were sick sued, their 179 00:11:17,480 --> 00:11:20,080 Speaker 1: cases were put together and they were just thrown out. 180 00:11:20,240 --> 00:11:23,280 Speaker 1: That seems like a fairly sweeping judgment to happen. Early 181 00:11:23,360 --> 00:11:26,360 Speaker 1: on in the case that must have been a little controversial. 182 00:11:26,800 --> 00:11:29,520 Speaker 1: It was and it is. These cases were brought together 183 00:11:29,600 --> 00:11:33,560 Speaker 1: and what's called a multidistrict litigation and MDL, and it's 184 00:11:33,600 --> 00:11:37,200 Speaker 1: where you have a legal issue that gets filed in 185 00:11:37,320 --> 00:11:41,480 Speaker 1: different federal courts around the country. They are consolidated before 186 00:11:41,559 --> 00:11:46,400 Speaker 1: one judge for pre trial information exchanges and test trials. 187 00:11:46,760 --> 00:11:48,440 Speaker 1: One of the pre trial things that are done in 188 00:11:48,480 --> 00:11:50,840 Speaker 1: all these cases is sort of a check on the 189 00:11:50,920 --> 00:11:55,160 Speaker 1: science that underlies them, and they have a hearing and 190 00:11:55,559 --> 00:11:59,160 Speaker 1: the planeffs put forth their experts and they testify how 191 00:11:59,200 --> 00:12:04,480 Speaker 1: they came to the inclusions that randiditine was possible carcinogen. 192 00:12:04,800 --> 00:12:06,720 Speaker 1: So it's up to the judge to decide if that 193 00:12:06,880 --> 00:12:10,599 Speaker 1: science is legitimate enough in the cases can progress. This 194 00:12:10,800 --> 00:12:15,040 Speaker 1: judge in Florida decided that the science was flawed, that 195 00:12:15,200 --> 00:12:20,120 Speaker 1: it was not independent enough, it was tied too closely 196 00:12:20,240 --> 00:12:26,760 Speaker 1: to the litigation to be considered, you know, legitimate independent research, 197 00:12:28,160 --> 00:12:31,560 Speaker 1: despite the fact that these tests that Valisher and others 198 00:12:31,600 --> 00:12:35,240 Speaker 1: had done showed this probably link and that the FDA 199 00:12:35,400 --> 00:12:39,480 Speaker 1: itself ordered the drug pulled from the market. Correct And 200 00:12:39,520 --> 00:12:43,520 Speaker 1: she even noted in her in her decision the irony 201 00:12:43,600 --> 00:12:47,560 Speaker 1: of throwing these cases out when you have a recalled drug, 202 00:12:47,760 --> 00:12:52,760 Speaker 1: but she found that the science just did not stand 203 00:12:52,840 --> 00:12:54,800 Speaker 1: up as far as she's concerned. Now, this is one 204 00:12:54,840 --> 00:13:00,560 Speaker 1: federal judge and her decisions are appealed to annals and 205 00:13:00,600 --> 00:13:04,920 Speaker 1: groups of federal judges who review them. So we'll see 206 00:13:04,960 --> 00:13:07,760 Speaker 1: what the outcome of that is yet. And in that 207 00:13:07,880 --> 00:13:11,520 Speaker 1: statement that g s K gave us UM in response 208 00:13:11,600 --> 00:13:15,319 Speaker 1: to our questions, they talked about that ruling um. They 209 00:13:15,360 --> 00:13:19,040 Speaker 1: noted that it was forty one pages that the judge 210 00:13:19,040 --> 00:13:24,000 Speaker 1: had reviewed thirteen studies and had concluded, as they do, 211 00:13:24,120 --> 00:13:29,120 Speaker 1: that there's no scientific consensus about nitadine and its linked 212 00:13:29,160 --> 00:13:33,240 Speaker 1: to cancer. So this ruling was really great news for 213 00:13:33,559 --> 00:13:37,120 Speaker 1: g SK and they, you know, continue to like to 214 00:13:37,160 --> 00:13:39,280 Speaker 1: refer to it because they feel and hope that it 215 00:13:39,320 --> 00:13:41,880 Speaker 1: should be the last word. Did the f d A 216 00:13:42,240 --> 00:13:46,120 Speaker 1: weigh in on this suit, they've you know, said pretty 217 00:13:46,200 --> 00:13:50,920 Speaker 1: much the same, there's no consistent signal that zantac causes cancer. 218 00:13:51,240 --> 00:13:54,120 Speaker 1: And even since the f d I put that statement out, 219 00:13:54,160 --> 00:14:00,000 Speaker 1: which was originally in June, there's been more studies, more 220 00:14:00,080 --> 00:14:03,400 Speaker 1: inconsistent evidence that it causes cancer or it doesn't. It 221 00:14:03,480 --> 00:14:07,199 Speaker 1: just goes both ways. They can't really take a position 222 00:14:07,240 --> 00:14:10,440 Speaker 1: on this. It's it's not clear. I mean, there's no 223 00:14:10,640 --> 00:14:14,680 Speaker 1: It's not like asbestos, where there's a consensus that you know, 224 00:14:14,720 --> 00:14:18,200 Speaker 1: asbestos is a carcinogen. You know, there's just not a 225 00:14:18,200 --> 00:14:22,400 Speaker 1: consensus yet. But the FDA ordered randentitying off the market 226 00:14:22,960 --> 00:14:25,760 Speaker 1: just to make sure. I mean, you can't if there 227 00:14:25,960 --> 00:14:29,920 Speaker 1: is a possibility that this stuff is causing cancer, you 228 00:14:29,920 --> 00:14:33,200 Speaker 1: don't want it widely distributed. Jeff, you described that when 229 00:14:33,320 --> 00:14:37,240 Speaker 1: federal Casey you said there is another bachelor cases going. 230 00:14:38,400 --> 00:14:42,120 Speaker 1: There's been seventy thousand cases filed. Most of them now 231 00:14:42,880 --> 00:14:45,520 Speaker 1: are in Delaware State Court in Delaware, that is because 232 00:14:45,560 --> 00:14:50,920 Speaker 1: that's where all of these companies US operations are incorporated. 233 00:14:51,600 --> 00:14:54,200 Speaker 1: The deal with these is that the states have a 234 00:14:54,240 --> 00:14:58,880 Speaker 1: different standard for judging the legitimacy of science then the 235 00:14:58,880 --> 00:15:02,920 Speaker 1: federal courts, and so it's more likely that more of 236 00:15:02,960 --> 00:15:05,120 Speaker 1: these cases are going to make it to trial that 237 00:15:05,240 --> 00:15:10,040 Speaker 1: the judge in Delaware. And cases are also fount in California, Pennsylvania. 238 00:15:11,200 --> 00:15:14,400 Speaker 1: And these are all individual, they haven't been all put together. 239 00:15:14,720 --> 00:15:18,080 Speaker 1: That is correct, as they're all again all individual personal 240 00:15:18,120 --> 00:15:21,200 Speaker 1: injury cases. That's right, Jeff, What are all of these 241 00:15:21,600 --> 00:15:25,640 Speaker 1: tens of thousands of plaintiffs asking for First of all, 242 00:15:25,720 --> 00:15:28,360 Speaker 1: all civil lawsuits are about money, so they're asking for 243 00:15:28,440 --> 00:15:31,440 Speaker 1: damages for their injuries. They want to be reimbursed for 244 00:15:31,480 --> 00:15:34,600 Speaker 1: their medical costs, for the pain and suffering of the 245 00:15:34,640 --> 00:15:38,120 Speaker 1: cancer treatments. You know, God forbid. The person who took 246 00:15:38,240 --> 00:15:42,160 Speaker 1: antack has died, his family wants compensation for the loss 247 00:15:42,160 --> 00:15:45,440 Speaker 1: of that person, loss of his income. So it's always 248 00:15:45,440 --> 00:15:50,040 Speaker 1: about money, Susan, Even if a drug is thought to 249 00:15:50,080 --> 00:15:52,800 Speaker 1: be a possible carcin engine, it's still very difficult, I 250 00:15:52,800 --> 00:15:57,160 Speaker 1: imagine for any individual person to claim that he or 251 00:15:57,160 --> 00:16:01,160 Speaker 1: she got cancer from that drug, as cancer can come 252 00:16:01,240 --> 00:16:04,480 Speaker 1: from a lot of different things. Yeah, that's exactly right. 253 00:16:04,520 --> 00:16:07,240 Speaker 1: I mean, for all of these cases, and in almost 254 00:16:07,280 --> 00:16:09,440 Speaker 1: every kind of cancer I think, except you know, as 255 00:16:09,480 --> 00:16:14,320 Speaker 1: Jeff said, asbestos tobacco. You know, the cancer develops years 256 00:16:14,360 --> 00:16:19,160 Speaker 1: after you've either been exposed or have been ingesting something 257 00:16:19,480 --> 00:16:23,479 Speaker 1: that's harmful, and to be able to make that connection 258 00:16:24,040 --> 00:16:28,160 Speaker 1: can be complicated. And that's I think what the f 259 00:16:28,280 --> 00:16:32,359 Speaker 1: d A statement is suggesting. You know, about consistent signals, 260 00:16:32,560 --> 00:16:35,680 Speaker 1: and you can say, as Anna did, there's not signals 261 00:16:35,680 --> 00:16:41,080 Speaker 1: that it always does, but there's not signals that it doesn't. Jeff, 262 00:16:41,080 --> 00:16:45,320 Speaker 1: you're writing this story that in other similar pharmaceutical cases, 263 00:16:45,320 --> 00:16:49,440 Speaker 1: the companies have often settled rather than risk having so 264 00:16:49,480 --> 00:16:52,920 Speaker 1: many suits that could wind up with judgments against them. 265 00:16:53,040 --> 00:16:55,560 Speaker 1: Do you think it's likely that the company is going 266 00:16:55,640 --> 00:16:58,040 Speaker 1: to want to settle these cases rather than bring them 267 00:16:58,080 --> 00:17:01,080 Speaker 1: all to trial. I think there's a strong possibility that 268 00:17:01,160 --> 00:17:03,680 Speaker 1: there will be a settlement at some point. It takes 269 00:17:03,680 --> 00:17:07,200 Speaker 1: a while for these things to move into that posture. 270 00:17:07,760 --> 00:17:11,320 Speaker 1: The companies and the planiffs want to test the strengths 271 00:17:11,359 --> 00:17:15,280 Speaker 1: of their claims, and so they have test trials, they 272 00:17:15,280 --> 00:17:19,480 Speaker 1: have early trials. After you have a number of these things, 273 00:17:19,520 --> 00:17:23,719 Speaker 1: and some test trial periods last for twenty cases, others 274 00:17:23,760 --> 00:17:27,080 Speaker 1: for five cases, then the parties come together and try 275 00:17:27,119 --> 00:17:31,920 Speaker 1: to come up with some sort of reasonable accommodation that 276 00:17:32,480 --> 00:17:35,800 Speaker 1: is acceptable to both sides. And it's always about the money. 277 00:17:35,960 --> 00:17:39,439 Speaker 1: And as someone who covers the pharmaceutical companies all the 278 00:17:39,520 --> 00:17:42,000 Speaker 1: time and knows them, well, what are you looking for 279 00:17:42,040 --> 00:17:44,720 Speaker 1: in these cases? What do you think is the most 280 00:17:44,840 --> 00:17:47,680 Speaker 1: relevant thing that we should all be taking away from this? 281 00:17:48,240 --> 00:17:51,639 Speaker 1: The Food and Drug Administration? What about our regulatory body 282 00:17:51,720 --> 00:17:55,320 Speaker 1: that's supposed to be protecting us from dangerous drugs. They 283 00:17:55,400 --> 00:17:59,639 Speaker 1: don't have a lot of resources to look into whether 284 00:17:59,680 --> 00:18:02,800 Speaker 1: it's that's still on the market is safe. I think 285 00:18:02,800 --> 00:18:05,880 Speaker 1: that that leaves things up to the courts to decide. 286 00:18:05,880 --> 00:18:08,080 Speaker 1: It leaves it up to juries to be the last 287 00:18:08,119 --> 00:18:11,680 Speaker 1: line of defense for anyone who may have been harmed 288 00:18:11,960 --> 00:18:15,440 Speaker 1: by a pharmaceutical product. And what I'm looking for here 289 00:18:15,480 --> 00:18:18,960 Speaker 1: is I'm curious to see, you know, if these should 290 00:18:18,960 --> 00:18:22,800 Speaker 1: get to a jury trial, how regular Americans feel about that? 291 00:18:23,880 --> 00:18:28,720 Speaker 1: And Ednie Susan Burfield, Jeff Feely, thanks for joining me today. 292 00:18:28,920 --> 00:18:33,400 Speaker 1: Thank you, thanks so much. No problem when we come back. 293 00:18:33,560 --> 00:18:44,439 Speaker 1: How drugmakers can spot potential hazards in their products. What 294 00:18:44,600 --> 00:18:48,160 Speaker 1: should companies do then to ensure their products are safe 295 00:18:48,280 --> 00:18:51,320 Speaker 1: both of the time they're made and after they've sat 296 00:18:51,359 --> 00:18:55,520 Speaker 1: for months or years in your medicine chest. Dr yap 297 00:18:55,680 --> 00:18:59,760 Speaker 1: Venoma can answer that question. He's the chief science officer 298 00:19:00,040 --> 00:19:04,400 Speaker 1: at u S Pharmacopia, and he's extensively studied the dangers 299 00:19:04,440 --> 00:19:10,000 Speaker 1: of probable carcinogens called nitrosamines. One of those nitros means 300 00:19:10,160 --> 00:19:12,800 Speaker 1: is and d m A, which we've been talking about 301 00:19:12,840 --> 00:19:15,880 Speaker 1: today and is at the center of the legal dispute 302 00:19:15,880 --> 00:19:19,040 Speaker 1: over the old version of zantac. He joins me to 303 00:19:19,080 --> 00:19:23,919 Speaker 1: explain how his organization is setting standards to protect against 304 00:19:24,000 --> 00:19:27,600 Speaker 1: the spread of nitros means and drugs. Yeah, can you 305 00:19:27,640 --> 00:19:32,240 Speaker 1: tell us first, what does US Pharmacopia do. Yes, the 306 00:19:32,400 --> 00:19:36,320 Speaker 1: US Pharmacopeia is an organization that is about two years old, 307 00:19:37,080 --> 00:19:40,240 Speaker 1: and our mission is to improve global health and we 308 00:19:40,359 --> 00:19:45,000 Speaker 1: do this primarily by setting standards for medicines, for biologics, 309 00:19:45,000 --> 00:19:50,160 Speaker 1: dietary supplements, food ingredients, and healthcare and related programs. And yeah, 310 00:19:50,200 --> 00:19:55,640 Speaker 1: can you explain exactly what are nitrosymedes. So nitros means 311 00:19:55,640 --> 00:19:59,560 Speaker 1: are naturally occurring compounds that are present are ubiquitous in 312 00:20:00,320 --> 00:20:04,200 Speaker 1: around US, in drug compounds, also in food and other areas. 313 00:20:04,400 --> 00:20:07,720 Speaker 1: So that's why they're important. And you say they're in nature, 314 00:20:07,720 --> 00:20:11,879 Speaker 1: where are they just naturally found? So nitrosmis can be 315 00:20:11,960 --> 00:20:15,040 Speaker 1: formed by a variety of chemical processes. I won't go 316 00:20:15,080 --> 00:20:19,520 Speaker 1: into the detail, but nitrosmin chemistry is in principle very 317 00:20:19,560 --> 00:20:23,800 Speaker 1: straightforward and can be formed through a variety of processes 318 00:20:24,320 --> 00:20:29,119 Speaker 1: by chemicals reacting. They can form naturally, They conformed during 319 00:20:29,600 --> 00:20:36,280 Speaker 1: chemical synthesis, they can form during certain degredation processes, and 320 00:20:36,280 --> 00:20:40,360 Speaker 1: the reason we're talking about them is because they are 321 00:20:40,480 --> 00:20:44,320 Speaker 1: also possible carcinogens. Yes, so they have been shown to 322 00:20:44,359 --> 00:20:49,080 Speaker 1: be muta genic, so they can cause mutations in your DNA, 323 00:20:49,240 --> 00:20:53,040 Speaker 1: and they are listed as probable or likely carcinogens in 324 00:20:53,119 --> 00:20:58,280 Speaker 1: mammals including humans. Nitrosamins have been found in quite a 325 00:20:58,320 --> 00:21:02,719 Speaker 1: few of the most widely used pharmaceuticals, drugs that a 326 00:21:02,720 --> 00:21:04,919 Speaker 1: lot of us are familiar with. Can you talk a 327 00:21:04,920 --> 00:21:08,199 Speaker 1: little bit about which drugs that they've been found in 328 00:21:08,240 --> 00:21:12,520 Speaker 1: and what's happened since that discovery. So it started with 329 00:21:12,560 --> 00:21:16,199 Speaker 1: the discovery of nitros means in falseharten, which is a 330 00:21:16,240 --> 00:21:19,320 Speaker 1: class of products that are used to treat blood pressure, 331 00:21:19,920 --> 00:21:23,639 Speaker 1: so very widely used, and that led to recalls and 332 00:21:23,760 --> 00:21:27,720 Speaker 1: investigations into the cause of the presence of nitroso means. 333 00:21:28,400 --> 00:21:30,960 Speaker 1: That's what started this about three and a half years ago. 334 00:21:32,119 --> 00:21:35,400 Speaker 1: Since then, nitros means have also been found in other 335 00:21:36,119 --> 00:21:42,240 Speaker 1: very widely used drugs, including drugs to treat diabetes, tuberculosis, infection, 336 00:21:42,760 --> 00:21:45,840 Speaker 1: as well as gastric acids. So it's been found in 337 00:21:45,880 --> 00:21:49,720 Speaker 1: a number of drugs that are used many, many times 338 00:21:49,760 --> 00:21:53,160 Speaker 1: by people all over the world, including the United States. Now, 339 00:21:53,200 --> 00:21:57,439 Speaker 1: how are these nitros means introduced into drugs, because clearly 340 00:21:57,440 --> 00:22:01,000 Speaker 1: manufacturers don't want them there. How do they get into drugs? 341 00:22:01,800 --> 00:22:04,200 Speaker 1: So that's actually one of the concerns. So they are 342 00:22:04,359 --> 00:22:06,919 Speaker 1: and it's now being established that they can be introduced 343 00:22:06,960 --> 00:22:11,160 Speaker 1: into drugs by a variety of reasons. One is through 344 00:22:11,359 --> 00:22:14,200 Speaker 1: the chemical synthesis route that is used to produce the 345 00:22:14,280 --> 00:22:18,680 Speaker 1: drugs to make them. It's also been shown that through degradation, 346 00:22:18,920 --> 00:22:21,520 Speaker 1: in the case of renitatin, which is the anti gastric 347 00:22:21,600 --> 00:22:26,359 Speaker 1: acid medicine, that through degradation and by reacting with itself, 348 00:22:26,840 --> 00:22:30,320 Speaker 1: nitros means can be formed. A third way that it's 349 00:22:30,359 --> 00:22:33,960 Speaker 1: been shown to be introduced through interaction with the drug itself, 350 00:22:34,480 --> 00:22:37,760 Speaker 1: with the packaging and what we call excipients, which are 351 00:22:38,359 --> 00:22:43,120 Speaker 1: substances used to stabilize and manufacture the medicine. So it's 352 00:22:43,160 --> 00:22:48,520 Speaker 1: been shown to occur in drugs through a variety of methods. 353 00:22:48,640 --> 00:22:53,439 Speaker 1: And because of the widespread sort of exposure to the 354 00:22:53,480 --> 00:22:57,399 Speaker 1: public of what happened with renititin, there's more attention being 355 00:22:57,440 --> 00:23:01,040 Speaker 1: paid to nitros means. What are pharmaceutical companies doing, What 356 00:23:01,200 --> 00:23:05,560 Speaker 1: is your organization US Parmacopia doing to try to stop 357 00:23:05,600 --> 00:23:09,960 Speaker 1: the spread of nitrous means in pharmaceuticals. Yeah, there's a 358 00:23:10,000 --> 00:23:12,359 Speaker 1: lot going on. First, maybe it's good to to mention 359 00:23:12,400 --> 00:23:14,600 Speaker 1: that the very fact that these are being found and 360 00:23:14,640 --> 00:23:18,760 Speaker 1: discovered and monitored, while of course reasons for concern, it's 361 00:23:18,800 --> 00:23:20,919 Speaker 1: also a sign that the system is working because we 362 00:23:20,960 --> 00:23:22,720 Speaker 1: need to know what's going on. So that I think 363 00:23:22,800 --> 00:23:25,800 Speaker 1: that's the first thing i'd like to say. So, since 364 00:23:25,840 --> 00:23:29,720 Speaker 1: a couple of years, there's a widespread collaboration between the 365 00:23:29,760 --> 00:23:32,879 Speaker 1: regulatory authorities who are responsible for the safety and the 366 00:23:32,960 --> 00:23:37,520 Speaker 1: quality of medicine, the manufacturers, and other science organizations, including 367 00:23:37,680 --> 00:23:40,879 Speaker 1: the u S Pharmacopeia to try and figure out how 368 00:23:40,920 --> 00:23:43,920 Speaker 1: we can mitigate and how we can reduce and remove 369 00:23:44,080 --> 00:23:47,600 Speaker 1: the presence of nitrose means in drugs. So there are 370 00:23:47,680 --> 00:23:53,120 Speaker 1: three things going on. First is we have to understand 371 00:23:53,400 --> 00:23:57,720 Speaker 1: which drugs are at risk of forming or containing nitrose means. 372 00:23:57,760 --> 00:24:00,880 Speaker 1: That's the very first thing. The sect and piece is 373 00:24:01,000 --> 00:24:05,720 Speaker 1: we need a better understanding of how mutagenic or carcinogenic 374 00:24:05,800 --> 00:24:09,520 Speaker 1: these are. They're not all carcinogenic, they're not all mutigenic, 375 00:24:09,560 --> 00:24:12,199 Speaker 1: so it's very important to have more information as to 376 00:24:12,440 --> 00:24:15,639 Speaker 1: what they do. And then the third piece, very importantly, 377 00:24:15,960 --> 00:24:20,720 Speaker 1: is to discover and to develop methods to actually detect them, 378 00:24:20,840 --> 00:24:23,280 Speaker 1: and to detect them in a way that detect them 379 00:24:23,480 --> 00:24:26,359 Speaker 1: very low quantities to make sure that we have a 380 00:24:26,400 --> 00:24:28,720 Speaker 1: good handle on their presence. So these are the three 381 00:24:28,760 --> 00:24:32,360 Speaker 1: buckets that we're all collaborating on. I would say us 382 00:24:32,400 --> 00:24:37,000 Speaker 1: B is primarily involved in developing the methods and the 383 00:24:37,080 --> 00:24:40,880 Speaker 1: standards that are necessary to analyze and to discover all 384 00:24:40,920 --> 00:24:46,840 Speaker 1: of these different nitroso means. USP participated in a study 385 00:24:46,920 --> 00:24:51,760 Speaker 1: that found potentially forty one percent of active ingredients in 386 00:24:51,840 --> 00:24:58,240 Speaker 1: pharmaceuticals could have nitros means in them. How concerns should 387 00:24:58,240 --> 00:25:02,840 Speaker 1: we be that nitrous means and other potential carcinogens are 388 00:25:03,280 --> 00:25:06,600 Speaker 1: in the drugs that we take. So do not be 389 00:25:06,680 --> 00:25:09,280 Speaker 1: concerned to the point that you should consider stop using 390 00:25:09,359 --> 00:25:12,200 Speaker 1: drugs because of this, because that's very important. That's always 391 00:25:12,200 --> 00:25:15,720 Speaker 1: the guidance before making any decision. Talk to your doctor 392 00:25:15,760 --> 00:25:17,919 Speaker 1: and make the right decision. That's also in line with 393 00:25:18,000 --> 00:25:22,080 Speaker 1: what regulatory authorities are saying. So this is a theoretical 394 00:25:22,320 --> 00:25:26,040 Speaker 1: assessment of looking at all the different chemical structures of 395 00:25:26,160 --> 00:25:29,240 Speaker 1: the drugs on the market and looking for the potential 396 00:25:29,359 --> 00:25:32,440 Speaker 1: that with the emphasis on potential to develop them. There 397 00:25:32,480 --> 00:25:35,359 Speaker 1: are a lot of other factors that go into whether 398 00:25:35,520 --> 00:25:40,480 Speaker 1: or not the actually will form chemical conditions, storage conditions, temperatures, 399 00:25:40,560 --> 00:25:44,480 Speaker 1: all of these things are are important. So I don't 400 00:25:44,480 --> 00:25:47,200 Speaker 1: want any of you to be alarmed by, oh, two 401 00:25:47,240 --> 00:25:50,560 Speaker 1: out of five drugs are now do contain nitros means 402 00:25:50,680 --> 00:25:53,240 Speaker 1: that is not the case. It is part of the 403 00:25:53,320 --> 00:25:56,879 Speaker 1: network of the fabric that we are contributing to really 404 00:25:56,920 --> 00:26:00,720 Speaker 1: help advance the science and knowledge about these compounds. That's 405 00:26:00,720 --> 00:26:03,800 Speaker 1: what it is. One thing I'm really excited about and 406 00:26:03,840 --> 00:26:06,720 Speaker 1: I'd like to share is the nitrosman Exchange that we 407 00:26:06,800 --> 00:26:10,000 Speaker 1: set up about two years ago. So that was literally 408 00:26:10,040 --> 00:26:15,400 Speaker 1: an online community where scientists, regulators, healthcare professional come together 409 00:26:15,640 --> 00:26:20,600 Speaker 1: to discuss and find potential solutions. And in fact, the 410 00:26:20,760 --> 00:26:23,879 Speaker 1: article that you refer to that we discussed was actually 411 00:26:23,880 --> 00:26:26,840 Speaker 1: a direct result of that. So we're proud that we 412 00:26:26,920 --> 00:26:30,439 Speaker 1: are adding our contribution. We of course do not have 413 00:26:30,480 --> 00:26:32,960 Speaker 1: the silver bullet. Nobody has the silver bullet, but it's 414 00:26:33,080 --> 00:26:35,959 Speaker 1: very important that all of us contribute to this and 415 00:26:36,040 --> 00:26:38,399 Speaker 1: that's what we're proud of to do. In addition to 416 00:26:39,359 --> 00:26:43,000 Speaker 1: the work that we're doing on providing physical standards and 417 00:26:43,119 --> 00:26:47,200 Speaker 1: methods to allow many factors and regulators to actually test 418 00:26:48,000 --> 00:26:52,480 Speaker 1: or these compounds in a validated and regulated way. Yeah, Venima, 419 00:26:52,520 --> 00:26:55,119 Speaker 1: thanks for speaking with me today. Thank you, Thanks for 420 00:26:55,200 --> 00:27:00,800 Speaker 1: the opportunity. You can read more reporting from Um and Edne, 421 00:27:00,960 --> 00:27:05,520 Speaker 1: Susan Burfield and Jeff Feely at Bloomberg dot com. Thanks 422 00:27:05,560 --> 00:27:07,600 Speaker 1: for listening to us here at The Big Take. It's 423 00:27:07,600 --> 00:27:10,920 Speaker 1: a daily podcast from Bloomberg and I Heart Radio. For 424 00:27:11,119 --> 00:27:13,760 Speaker 1: more shows from my Heart Radio, visit the i Heart 425 00:27:13,840 --> 00:27:17,640 Speaker 1: Radio app, Apple podcast, or wherever you listen, and we'd 426 00:27:17,640 --> 00:27:20,600 Speaker 1: love to hear from you. Email us questions or comments 427 00:27:20,600 --> 00:27:25,200 Speaker 1: to Big Take at Bloomberg dot net. The supervising producer 428 00:27:25,280 --> 00:27:28,800 Speaker 1: of The Big Take is Vicky Bergolina. Our senior producer 429 00:27:29,000 --> 00:27:33,720 Speaker 1: is Katherine Fink. Our producers are Michael Fallero and Moe Barrow, 430 00:27:34,200 --> 00:27:39,159 Speaker 1: with additional production assistance from Sam Gebauer. Raphael I'm Seely 431 00:27:39,400 --> 00:27:43,080 Speaker 1: is our engineer. Our original music was composed by Leo 432 00:27:43,200 --> 00:27:47,120 Speaker 1: Sidrin I'm west Kosova. We'll be back tomorrow with another 433 00:27:47,200 --> 00:27:47,680 Speaker 1: Big Take