WEBVTT - FDA: Is there something rotten here? 0:00:05.640 --> 0:00:08.840 Overall, the FDA has had a number of spectacular hits 0:00:08.880 --> 0:00:13.880 and pretty notable failures, and it is worth asking how 0:00:13.920 --> 0:00:15.880 good of a job is the agency doing and are 0:00:15.880 --> 0:00:18.680 they living up to their mandate to protect the public health. 0:00:19.600 --> 0:00:21.360 My boss at the time said Richard, we don't have 0:00:21.400 --> 0:00:24.440 to solve problems. All we have to do is appear 0:00:24.560 --> 0:00:34.600 to solve problems. Welcome to Calling Bullshit, the podcast about 0:00:34.600 --> 0:00:38.599 purpose washing, the gap between what an organization says they 0:00:38.640 --> 0:00:41.839 stand for and what they actually do and what they 0:00:41.880 --> 0:00:45.080 would need to change to practice what they preach. I'm 0:00:45.120 --> 0:00:47.479 your host time onto you, and I've spent over a 0:00:47.560 --> 0:00:51.760 decade helping organizations define what they stand for, their purpose 0:00:52.200 --> 0:00:54.560 and then help them to use that purpose to drive 0:00:54.640 --> 0:01:00.560 transformation throughout their business. Unfortunately, at a lot of institution today, 0:01:00.680 --> 0:01:04.360 there's still a pretty wide gap between word. Indeed, that 0:01:04.400 --> 0:01:08.839 gap has a name, bullshit. But, and this is important, 0:01:09.200 --> 0:01:12.479 we believe that bullshit is a treatable condition. So when 0:01:12.480 --> 0:01:16.800 our bullshit detector lights up, we're going to explore everything 0:01:16.880 --> 0:01:30.360 the organization should do to fix it. There was a 0:01:30.440 --> 0:01:34.440 time in the not too distant past when cocaine was 0:01:34.560 --> 0:01:39.160 marketed to children and literal snake oil was sold as medicine, 0:01:39.840 --> 0:01:42.959 a time when sawdust was put into food as filler, 0:01:43.520 --> 0:01:47.600 and when rats were ground up with the beef, and 0:01:47.680 --> 0:01:52.120 it was all perfectly legal. Food and drugs were sold 0:01:52.160 --> 0:01:58.960 in a completely unregulated market until President Theodore Roosevelt signed 0:01:58.960 --> 0:02:02.040 into law the Food and Drugs Act of nine six, 0:02:02.720 --> 0:02:06.440 giving the executive branch the power to regulate food and 0:02:06.560 --> 0:02:09.720 drugs and thus creating what we now call the f 0:02:09.880 --> 0:02:15.359 d A. Today, the Food and Drug Administration has an 0:02:15.400 --> 0:02:20.760 expansive jurisdiction regulating things raging from microwave ovens to cat 0:02:20.880 --> 0:02:25.840 nip to ibuprofen and beyond, way beyond chew. On this 0:02:26.400 --> 0:02:30.760 the FDA regulates twenty cents of every dollar that you 0:02:30.880 --> 0:02:35.640 spend to cover such a broad water front. They employ 0:02:35.880 --> 0:02:41.000 eighteen thousand people that work across several inter agencies, including 0:02:41.080 --> 0:02:47.360 the Center for Drugs, Biologics, Devices, Veterinary Medicine, Food Safety 0:02:47.360 --> 0:02:53.320 and Nutrition, and tobacco. Their formal purposes a few paragraphs long, 0:02:53.639 --> 0:02:56.000 but on the homepage of their website they have a 0:02:56.000 --> 0:02:59.520 phrase that nicely captures the spirit of it, and it 0:02:59.639 --> 0:03:04.639 really Today, as in the past, the FDA strives above 0:03:04.680 --> 0:03:08.000 all else to safeguard the health and well being of 0:03:08.040 --> 0:03:17.799 the American people. That is a monumentally important purpose, one 0:03:17.840 --> 0:03:22.240 in which the stakes for all of us are high. However, 0:03:22.480 --> 0:03:25.480 if you've been listening to the news lately, it seems 0:03:25.560 --> 0:03:28.080 like the f d A is falling pretty short of 0:03:28.120 --> 0:03:31.959 living up to it. Speaking about the epidemic of youth 0:03:32.040 --> 0:03:35.360 use of e cigarettes, it retrospects the FDA should have 0:03:35.400 --> 0:03:40.320 acted center nationwide of baby formula stock is gone. Part 0:03:40.360 --> 0:03:43.120 of the blame for a lot of these shortages rest 0:03:43.160 --> 0:03:46.520 at the feet of the f d A. The FDA 0:03:46.640 --> 0:03:50.560 first approved OxyContin. Since then, more than five hundred thousand 0:03:50.560 --> 0:03:57.560 people have died from opioid related overdoses. We've actually encountered 0:03:57.560 --> 0:04:02.200 the FDA twice before, first when discussing their role regulating Jewel, 0:04:02.640 --> 0:04:06.320 and again while researching Perdue Pharma for a potential episode. 0:04:07.040 --> 0:04:10.480 The FDA was certainly a character in the first Jewel episode, 0:04:10.840 --> 0:04:13.360 but when we checked in on Jewel again this season, 0:04:13.840 --> 0:04:16.640 it was clear that the f d A shared a 0:04:16.800 --> 0:04:19.880 lot more of the blame for the damage caused by 0:04:20.000 --> 0:04:25.240 Jewels unregulated product, and so we decided to aim our 0:04:25.320 --> 0:04:29.720 BS detectors directly at the f d A. Starting with 0:04:29.880 --> 0:04:39.640 picking up the strange case of Big Tobacco, Vaping and Jewel. Okay, folks, 0:04:39.680 --> 0:04:43.400 I am very excited to introduce Lauren Etter for her 0:04:43.560 --> 0:04:47.200 second time on the show. Lauren, thank you for being 0:04:47.240 --> 0:04:50.520 here and welcome back to calling Bullshit. Thanks for having 0:04:50.520 --> 0:04:53.120 me tie great to be here. Lauren is the author 0:04:53.320 --> 0:04:57.840 of the Devil's playbook, Big Tobacco, Jewel and the Addiction 0:04:57.880 --> 0:05:01.640 of a New Generation. But before we continued the conversation 0:05:01.680 --> 0:05:05.000 with Lauren, let's catch you up on the escalating story 0:05:05.040 --> 0:05:08.640 of the regulator and the company with a b S 0:05:08.800 --> 0:05:14.240 roundtable recap. Okay, So, Jewel Labs launched its Jewel E 0:05:14.400 --> 0:05:18.560 cigarettes as a smoking cessation device in it was actually 0:05:18.560 --> 0:05:22.000 effective and had the potential to help smokers get off cigarettes. 0:05:22.400 --> 0:05:25.440 But Jewel was funded by venture capitalists with a growth 0:05:25.480 --> 0:05:28.920 at all costs mindset, which led them to target kids, 0:05:29.160 --> 0:05:32.159 the demographic most susceptible to picking up a smoking habit, 0:05:32.360 --> 0:05:36.760 thus sparking a new youth nicotine epidemic total BS. But 0:05:36.960 --> 0:05:40.719 at the time the cigarettes were totally unregulated. Finally, in 0:05:41.800 --> 0:05:45.600 the FDA began regulating the cigarettes as tobacco products and 0:05:45.680 --> 0:05:49.120 requiring manufacturers to submit applications to be on the market. 0:05:49.400 --> 0:05:52.800 And guess what, Jewel Labs didn't get around to submitting 0:05:52.839 --> 0:05:57.760 their application to the FDA until July, all while they 0:05:57.760 --> 0:06:00.839 were still selling Jewel more bs. You would think the 0:06:00.880 --> 0:06:03.320 story ends here, but it doesn't. It then took the 0:06:03.360 --> 0:06:07.200 FDA two more years to review Jewels application, all the 0:06:07.240 --> 0:06:11.440 while jewels are still being sold. Finally, in June of 0:06:11.480 --> 0:06:14.680 twenty two, the f D announcer decision to deny Jewel 0:06:14.760 --> 0:06:18.760 Labs application, essentially banning the e cigarette. Their reasoning Jewel 0:06:18.800 --> 0:06:21.120 did not provide enough scientific data to show that their 0:06:21.120 --> 0:06:25.800 products were not harmful. Not surprisingly, Jewel Labs immediately sued 0:06:25.880 --> 0:06:28.479 and within a few days was granted an emergency stay, 0:06:28.560 --> 0:06:31.160 allowing them to keep their products on the market. And 0:06:31.240 --> 0:06:34.200 now the FDA has walked back their decision and it's 0:06:34.200 --> 0:06:38.359 currently re reviewing the application, leaving Jewel. You guessed it 0:06:38.480 --> 0:06:43.680 still on the market, and that you're round. I think 0:06:43.680 --> 0:06:48.360 we have different internet connections and that's your round table recap. 0:06:50.440 --> 0:06:54.159 The FDA website says, today, as in the past, the 0:06:54.240 --> 0:06:58.200 FDA strives above all else to safeguard the health and 0:06:58.240 --> 0:07:01.640 well being of the American people. So first, I just 0:07:01.680 --> 0:07:03.880 wanted to ask you, how do you think they're doing 0:07:04.360 --> 0:07:07.679 at meeting their mission or achieving their purpose? I would 0:07:07.680 --> 0:07:12.760 say just in general that with tobacco, for many years, 0:07:13.120 --> 0:07:16.720 until the early two thousands, the agency didn't have any 0:07:16.840 --> 0:07:21.760 jurisdiction over the tobacco industry. It was a completely unregulated market. 0:07:22.120 --> 0:07:25.560 And it was only after the Master Settlement Agreement and 0:07:25.760 --> 0:07:28.920 after the tobacco companies has gotten crushed in that whole ordeal. 0:07:29.480 --> 0:07:33.000 When you know, for years Congress tried to figure out 0:07:33.000 --> 0:07:35.720 how to regulate tobacco. The Supreme Court even at one 0:07:35.760 --> 0:07:38.840 point said they didn't have jurisdiction. So this has been 0:07:38.880 --> 0:07:43.040 an issue like where should the tobacco industry sit doesn't 0:07:43.080 --> 0:07:47.280 make sense for the f d A to regulate this industry, 0:07:47.320 --> 0:07:51.760 But for years there's industry was totally unregulated. So I 0:07:51.800 --> 0:07:54.560 think that there's a lot of questions worthy of tasking 0:07:54.720 --> 0:07:57.480 about the f d A and certainly about their role 0:07:57.680 --> 0:08:01.920 in the regulation of tobacco. You may remember that we 0:08:01.920 --> 0:08:06.960 we score organizations on their level of BS. Would you 0:08:07.000 --> 0:08:11.160 be comfortable giving the f d A a score even 0:08:11.200 --> 0:08:14.600 as it relates to the Jewel situation of zero to 0:08:15.240 --> 0:08:19.760 in terms of gaps between word indeed. So if you 0:08:19.760 --> 0:08:23.280 look at what the agency is doing in the top 0:08:23.320 --> 0:08:26.880 back the overall kind of tobacco space and their efforts 0:08:26.920 --> 0:08:33.120 to implement a harm reduction framework, they're actually making strides. 0:08:33.280 --> 0:08:36.480 My issue is, I don't feel like the FDA has 0:08:37.160 --> 0:08:42.800 enough resources to police the kind of illicit sale of 0:08:42.840 --> 0:08:44.440 the product to keep it out of the hands of 0:08:44.440 --> 0:08:47.960 the youth. They're just a very underfunded agency, especially the 0:08:48.720 --> 0:08:52.120 tobacco products. And so if you're looking at the twin 0:08:52.280 --> 0:08:57.120 problems of adult smoking and youth nicotine addiction, I feel 0:08:57.120 --> 0:08:59.600 like they they are focusing quite a bit on the 0:08:59.600 --> 0:09:04.320 adult smoking issue and then the youth nicotine addiction issue. 0:09:04.720 --> 0:09:07.480 I don't know if I have enough confidence that they're 0:09:07.480 --> 0:09:10.319 going to be able to ultimately keep this highly addictive 0:09:10.679 --> 0:09:14.240 product out of the hands of kids, which is ultimately 0:09:14.280 --> 0:09:17.440 the goal to stop a new generation from becoming addicted. 0:09:17.559 --> 0:09:21.640 So can I give them a score? Um? I just 0:09:21.679 --> 0:09:23.960 don't know if I feel comfortable settling on a on 0:09:24.040 --> 0:09:28.520 a number, Yeah, that's okay, but it's it's definitely not 0:09:29.360 --> 0:09:33.360 the best number. Zero right there bumbling their way through this, 0:09:33.760 --> 0:09:38.880 and let's just say, with the best of intention, right, 0:09:38.960 --> 0:09:46.120 they have failed to protect America's youth so far from vaping, 0:09:46.160 --> 0:09:48.920 which is, at the end of the day, an extremely 0:09:49.160 --> 0:09:53.200 efficient delivery system for what ought to be a controlled 0:09:53.240 --> 0:09:57.640 substance in my view, right, But the FDA is constantly 0:09:57.679 --> 0:10:01.080 barraged with this flood of new products, and they're constantly 0:10:01.160 --> 0:10:05.800 on their heels responding to these like rapidly innovating markets. 0:10:05.800 --> 0:10:10.400 That makes it very difficult for them to contain this, again, 0:10:10.520 --> 0:10:14.679 highly addictive product that's being sold at seven elevens, and 0:10:15.160 --> 0:10:17.920 you know corner stores around the country that not all 0:10:17.960 --> 0:10:21.360 of them have the greatest I D checking abilities. So 0:10:21.760 --> 0:10:24.319 I admit it's a very difficult task for them to do. 0:10:24.400 --> 0:10:26.439 I think it should be one of the most important 0:10:26.920 --> 0:10:29.520 tasks that they undertake, and I know that they're taking 0:10:29.520 --> 0:10:32.160 it seriously. I'm just concerned that they might not have 0:10:32.280 --> 0:10:36.880 enough resources to adequately keep these highly addictive products out 0:10:36.880 --> 0:10:41.800 of the hands of young people. Is the FDA's lack 0:10:41.880 --> 0:10:45.679 of resources the reason they fumbled through regulating e cigarettes 0:10:45.679 --> 0:10:50.199 and jewel in particular. Lauren thinks so, or at least 0:10:50.200 --> 0:10:53.199 she thinks it's a significant part of it, and although 0:10:53.240 --> 0:10:56.319 she deferred on giving them a B S score, she 0:10:56.480 --> 0:11:00.960 does believe the FDA is making strides, no doubt, it 0:11:01.120 --> 0:11:05.080 is an incredibly challenging undertaking. But if your purpose is 0:11:05.080 --> 0:11:08.040 to safeguard the health of the American people and a 0:11:08.040 --> 0:11:13.240 new generation gets addicted to nicotine on your watch, it's 0:11:13.520 --> 0:11:18.440 definitely a harbinger of bullshit. But maybe the Center for 0:11:18.480 --> 0:11:23.560 Tobacco Products is an outlier considering the FDA covers so 0:11:23.640 --> 0:11:26.600 much ground, I'm going to reserve judgment and see what's 0:11:26.600 --> 0:11:30.280 cooking at their second biggest interagency, the Center of Food 0:11:30.280 --> 0:11:36.640 Safety and Applied Nutrition. With food specific we're trying to 0:11:36.679 --> 0:11:38.520 do a little more because we don't want to just 0:11:38.600 --> 0:11:41.600 make food safe. We want to give consumers information that 0:11:41.679 --> 0:11:45.520 helped them to choose a healthier diet. Richard Williams worked 0:11:45.520 --> 0:11:49.240 at the FDA for nearly three decades, and he left 0:11:49.360 --> 0:11:52.400 the Center for Food Safety and Applied Nutrition with a 0:11:52.559 --> 0:11:55.760 bad taste in his mouth. I think the big thing 0:11:55.880 --> 0:11:58.319 was as I approached the end of my twenty seven years, 0:11:58.440 --> 0:12:00.360 it occurred to me in all those years is that 0:12:00.559 --> 0:12:04.320 most of what we had done had not succeeded. And 0:12:04.400 --> 0:12:06.720 so the more I thought about it, the more I thought, well, 0:12:06.760 --> 0:12:10.080 what actually happened? What went wrong? And I thought maybe 0:12:10.080 --> 0:12:12.200 if I could write a book about it, we can 0:12:12.280 --> 0:12:15.520 start changing things and and actually solving things for consumers. 0:12:16.640 --> 0:12:21.400 Richard's book Fixing Food and f D A Insider Unravels 0:12:21.440 --> 0:12:25.440 the myth and the Solutions, is an eye opening account 0:12:25.480 --> 0:12:28.600 of his tenure at the organization, beginning when he was 0:12:28.679 --> 0:12:32.880 hired as their very first economic analyst. You can blame 0:12:32.880 --> 0:12:35.640 it on President Carter. President Carter was the first one 0:12:35.679 --> 0:12:39.079 who said we need some economic thinking in these particularly 0:12:39.120 --> 0:12:43.360 social regulations. More and more presidents begin insisting that we 0:12:43.440 --> 0:12:45.480 do these things and that we take take them into 0:12:45.520 --> 0:12:49.000 account so we can make better decisions. Let's talk about 0:12:49.040 --> 0:12:52.320 your job and some of the eye opening parts of 0:12:52.320 --> 0:12:56.280 your book, because you, it sounds like, walked into that 0:12:56.400 --> 0:12:58.760 job with the best of intention. You wanted to help 0:12:58.800 --> 0:13:04.240 the I achieve its mission of making people safer. One 0:13:04.280 --> 0:13:07.120 of the first assignments that you had was to do 0:13:07.160 --> 0:13:11.480 a cost benefit analysis on lead acetate in men's hair dye. 0:13:11.640 --> 0:13:14.360 I wondered if you would tell us that story. Sure, 0:13:14.480 --> 0:13:17.000 that was the first one just assigned to me. All 0:13:17.040 --> 0:13:19.480 I had to go by was the executive order and 0:13:19.679 --> 0:13:22.800 what I knew from from being an economist. So I 0:13:22.880 --> 0:13:25.839 jumped into it and found out that this was basically 0:13:26.040 --> 0:13:28.199 the thing that you put in your hair, and over 0:13:28.240 --> 0:13:32.080 time it takes the great away. Richard wanted to know 0:13:32.120 --> 0:13:35.800 of using lead acetate could cause skin cancer, and after 0:13:35.880 --> 0:13:39.000 a deep dive into the toxicology, he found that the 0:13:39.160 --> 0:13:43.320 risk was near zero, thus there was no benefit to 0:13:43.400 --> 0:13:47.480 banning the drug. There was, however, a high cost to 0:13:47.600 --> 0:13:51.240 taking it off the market. It was the only product 0:13:51.240 --> 0:13:54.439 of its kind available, so without it, gray haired men 0:13:54.480 --> 0:13:57.839 would have no alternative, I mean, other than living with 0:13:57.920 --> 0:14:01.280 the fact that their hair was great. I turned into 0:14:01.240 --> 0:14:03.400 my analysis. We didn't think a thing about it until 0:14:03.440 --> 0:14:05.800 a couple of weeks later a young woman had come 0:14:05.840 --> 0:14:09.400 down from the center director's office and she said, this 0:14:09.480 --> 0:14:11.800 is great. Now we need you to do the other one. 0:14:12.600 --> 0:14:14.600 And I said, what other one? She said, well, you 0:14:14.640 --> 0:14:18.040 said that benefits were lower than the cost and if 0:14:18.080 --> 0:14:21.400 we decide not to do anything about let acitate that 0:14:21.400 --> 0:14:23.480 will work. But we want you to do one that 0:14:23.600 --> 0:14:27.200 shows the exact opposite, that the benefits succeed the costs, 0:14:27.240 --> 0:14:30.480 that it does costs cancer. And I'm like, well, no, 0:14:30.720 --> 0:14:33.480 that wouldn't be honest. I'm not going to do that. 0:14:33.840 --> 0:14:36.040 And she said, you don't understand. This is an order, 0:14:36.480 --> 0:14:38.960 you know, from the sixth floor. And I said, no, 0:14:39.960 --> 0:14:42.480 I'm not going to do that. I didn't hear anything 0:14:42.480 --> 0:14:44.520 more about it. A few weeks later, I was in 0:14:44.560 --> 0:14:47.000 our first my first training class where I was getting 0:14:47.000 --> 0:14:50.320 my introduction to FDA, and the deputy Center director was 0:14:50.360 --> 0:14:52.120 in there, and at lunch, I went up and I said, 0:14:52.120 --> 0:14:55.440 you know, a funny thing happened to me, and I 0:14:55.480 --> 0:14:58.560 explained the situation, and he said that order came from me, 0:14:58.840 --> 0:15:00.640 and you're going to do it or you're going to 0:15:00.680 --> 0:15:04.720 be fired. And I said something really stupid. I just 0:15:04.800 --> 0:15:06.400 made this up on the spot. I said, I'm not 0:15:06.480 --> 0:15:10.600 an economic prostitute. And he said, then you were fired 0:15:12.120 --> 0:15:15.200 and you are going to be leaving this agency. And 0:15:16.520 --> 0:15:19.000 so I went back to my office. I'm like, should 0:15:19.040 --> 0:15:22.000 I start packing up my stuff? I didn't know. And 0:15:22.040 --> 0:15:25.680 then nothing ever happened. He apparently decided it would be 0:15:25.680 --> 0:15:28.640 a bad idea to fire over that kind of thing. 0:15:29.840 --> 0:15:31.920 But that was just the first time I was threatened 0:15:31.920 --> 0:15:33.960 with being fired. I mean, good on you that you 0:15:34.000 --> 0:15:36.960 did not gave to that pressure. But it sounds like 0:15:37.080 --> 0:15:40.800 that this was not an isolated occurrence. Were there other 0:15:40.960 --> 0:15:45.440 instances where you were asked to essentially compromise your integrity 0:15:45.600 --> 0:15:50.240 for twenty seven years. There were other instances. Was it 0:15:50.360 --> 0:15:55.440 was it never stopped. That is incomprehensible to me, and 0:15:56.560 --> 0:15:59.880 it's terrible. And so, for the first time in my life, 0:16:00.080 --> 0:16:03.000 decided to become political with a small p like a 0:16:03.040 --> 0:16:09.520 bureaucrat politician operator, which you have. Yeah, sadly, Well, so 0:16:09.640 --> 0:16:12.320 let's let's follow that threat a little bit, because I 0:16:12.400 --> 0:16:16.040 assume that, let's assume the best of people. Assume that 0:16:16.120 --> 0:16:20.080 people who were feeling the pressure above you in the organization, 0:16:20.440 --> 0:16:24.560 we're feeling it from other entities. You know, in your book, 0:16:24.600 --> 0:16:27.080 you go into the FDA spending a lot of energy 0:16:27.120 --> 0:16:31.560 responding to influence from just an incredible variety of stakeholders. 0:16:31.600 --> 0:16:36.480 There's you know, the executive branch, there's Congress, there's courts, 0:16:36.560 --> 0:16:43.080 there's press, private industry, activists, academics. Can you help us 0:16:43.280 --> 0:16:48.080 understand the FDA's relationship with some of those stakeholders? Sure, 0:16:48.240 --> 0:16:50.400 I mean, you know, first of all, you have to 0:16:50.480 --> 0:16:53.880 start understanding one thing. FDA has been around since nineteen 0:16:53.880 --> 0:16:58.640 o six, and they have continued to accumulate literally power 0:16:59.240 --> 0:17:01.800 such that one off there said that in the twentieth century, 0:17:02.360 --> 0:17:05.159 there was no regulatory agency in the world that was 0:17:05.240 --> 0:17:08.040 more powerful than f DA, and that's because they're very 0:17:08.080 --> 0:17:11.359 good at what they do. So if you think about it, 0:17:11.560 --> 0:17:14.480 they work for the president, and the presidents are supposed 0:17:14.480 --> 0:17:18.320 to oversee them, but every president, Republican and Democrat, has 0:17:18.359 --> 0:17:22.600 said it's nearly impossible to control the administrative state. That is, 0:17:22.640 --> 0:17:26.040 all the agencies that they oversee. There are hundreds of 0:17:26.080 --> 0:17:29.240 thousands of employees. They all have their own little agendas, 0:17:29.240 --> 0:17:31.879 and it's very, very difficult for the presidents to do anything. 0:17:32.560 --> 0:17:36.840 Um So that's a problem. Congress they just don't oversee FDA. 0:17:36.880 --> 0:17:39.680 They're afraid of f d A and um so there's 0:17:39.720 --> 0:17:43.280 not a lot of oversight. They're interesting, Why is Congress 0:17:43.320 --> 0:17:46.000 afraid of the f d A. Well, FDA has very 0:17:46.040 --> 0:17:49.600 complex issues, very hard for Congress. People are really busy, 0:17:50.080 --> 0:17:52.080 you know, with lots and lots of things, mostly getting 0:17:52.119 --> 0:17:55.040 reelected and raising money. They don't have a lot of time, 0:17:55.119 --> 0:17:59.119 and their stats aren't very good at overseeing these complex issues. 0:17:59.200 --> 0:18:01.640 I get it, but it means that FDA is kind 0:18:01.640 --> 0:18:03.880 of more free to do what they want, so they 0:18:03.920 --> 0:18:07.600 hold Congress at bay the courts have up until recently 0:18:07.600 --> 0:18:11.960 and generally will give them deference to how they interpret 0:18:12.160 --> 0:18:17.440 their statutes. Then they have other people, academics they generally 0:18:17.440 --> 0:18:20.399 give grants to that kind of buys them off. And 0:18:20.440 --> 0:18:23.359 then when they go into Congress to ask, you know, 0:18:23.520 --> 0:18:25.639 which they do every year, for more money, they actually 0:18:25.640 --> 0:18:28.280 have large food firms going and testifying and saying, yeah, 0:18:28.359 --> 0:18:31.400 FDA should get more money. There's a reason for that. 0:18:31.920 --> 0:18:35.120 Large firms usually get regulations that are easy for them 0:18:35.160 --> 0:18:38.159 to comply with but hard for small firms, so it 0:18:38.200 --> 0:18:41.879 puts their small competitors at a disadvantage. I want to 0:18:41.920 --> 0:18:45.040 go into that issue a little bit later, the issue 0:18:45.280 --> 0:18:49.240 of big companies versus small companies, because that that feels 0:18:49.280 --> 0:18:52.960 like an important topic. But before we go there, let's 0:18:52.960 --> 0:18:58.359 talk about one other constituency, consumers and where they rank 0:18:58.720 --> 0:19:02.800 in that higher are key. I think consumers and small 0:19:02.800 --> 0:19:05.959 businesses both are at the bottom. When I first came 0:19:06.000 --> 0:19:08.080 into f d A, you know, I truly believe in 0:19:08.119 --> 0:19:10.760 what we're trying to do. I thought these are important issues, 0:19:11.440 --> 0:19:14.840 and over time I found out well, initially when I 0:19:14.880 --> 0:19:17.639 got there, I was told this that this actually happened 0:19:17.640 --> 0:19:20.080 with the let acetate rule. I said, this rule won't 0:19:20.119 --> 0:19:22.399 do anything. Why are we doing it? And my boss 0:19:22.400 --> 0:19:24.640 at the time said, Richard, we don't have to solve problems. 0:19:25.160 --> 0:19:27.880 All we have to do is appear to solve problems. 0:19:27.960 --> 0:19:31.480 We have to do something about it. And that never 0:19:31.560 --> 0:19:33.960 left me, and I noticed more and more that was 0:19:34.040 --> 0:19:36.600 the case once we passed the regulation. No matter what 0:19:36.640 --> 0:19:40.080 the regulation did, it didn't matter. It looked like we 0:19:40.119 --> 0:19:44.000 had addressed the problem. And that and that leaves consumers 0:19:44.680 --> 0:19:47.680 and public health in in in last place, if you will, 0:19:48.240 --> 0:19:52.320 what a mess. Okay, So let's talk about some of 0:19:52.359 --> 0:19:55.560 the you know, in your view, the biggest and most 0:19:55.640 --> 0:19:58.800 dangerous problems that face consumers today that the FDA is 0:19:58.880 --> 0:20:02.800 responsible for. And we can live within the domain of food, 0:20:03.040 --> 0:20:07.520 but feel free also to talk about stuff outside of food. Yeah. Well, 0:20:07.960 --> 0:20:10.680 I do think it's obesity. I think that is probably 0:20:10.720 --> 0:20:13.960 the number one and it's going to get worse. You know, 0:20:13.960 --> 0:20:16.879 there was a harvest study that projected that by the 0:20:16.960 --> 0:20:19.600 end of this decade, which is only eight years away, 0:20:19.840 --> 0:20:23.479 half of this country will be obese. Um FDA plays 0:20:23.680 --> 0:20:26.920 a role in that with food labeling. Food labeling has 0:20:26.960 --> 0:20:29.840 not worked, It's not going to work. It's really not 0:20:29.880 --> 0:20:33.399 going to be the answer. Putting calories on foods hasn't 0:20:33.440 --> 0:20:36.240 really changed anyone's behavior as far as we can tell, 0:20:37.960 --> 0:20:42.119 sticking with obesity, and I don't think you you made 0:20:42.160 --> 0:20:45.080 this connection overtly in the book, But one of the 0:20:45.119 --> 0:20:48.720 impressions that I've gotten both from you know what we've 0:20:48.800 --> 0:20:52.400 learned from your book and also other research that we've done, 0:20:52.520 --> 0:20:57.480 is that intended or not, the combination of the industrialized 0:20:57.520 --> 0:21:02.680 food system where people eat a diet and combine that 0:21:02.760 --> 0:21:06.639 with a for profit healthcare system that then profits from 0:21:06.680 --> 0:21:10.639 the multiple diseases that result from things like obesity is 0:21:10.800 --> 0:21:16.560 kind of the perfect dystopian partnership. What do you think 0:21:16.600 --> 0:21:20.440 about that first? And and do you think the FDA 0:21:20.560 --> 0:21:24.640 has played a role in that. I don't personally think 0:21:24.720 --> 0:21:28.320 that is the exact issue. I think it is an issue. 0:21:28.400 --> 0:21:31.880 I think certainly food companies, like every other company in 0:21:32.000 --> 0:21:34.480 this country, are there to make a profit. The problem 0:21:34.560 --> 0:21:37.880 is we have no idea what a healthy diet looks 0:21:37.960 --> 0:21:41.880 like because nutrition science is the worst science that we have, 0:21:42.600 --> 0:21:45.520 and so we've got people out there hawking books, you know, 0:21:45.680 --> 0:21:48.240 on diets, something say well, you gotta have a high 0:21:48.240 --> 0:21:49.760 carb diet, and so you have to have a low 0:21:49.800 --> 0:21:53.159 carb diet, high fat diet, low fat diet, on and 0:21:53.200 --> 0:21:55.280 on and on. And the truth of the matter is 0:21:55.359 --> 0:21:58.560 one we don't know, and to what we're beginning to 0:21:58.600 --> 0:22:01.200 find out is that one diet probably isn't right for everyone. 0:22:01.800 --> 0:22:06.040 Different people with different genetic backgrounds, different underlying health conditions 0:22:06.080 --> 0:22:08.960 probably need different diets. So I think, in my mind 0:22:09.359 --> 0:22:13.159 a bigger problem and this is why basically companies can 0:22:13.200 --> 0:22:15.359 sell whatever they want. It's because we just don't know 0:22:15.520 --> 0:22:19.280 enough yet because the science is so bad. Well that 0:22:19.280 --> 0:22:21.720 that that's a good point. I think to pivot to 0:22:22.280 --> 0:22:25.679 another aspect that you touch on in your book. You 0:22:25.720 --> 0:22:29.480 believe that entrepreneurs are solving many problems that the FDA 0:22:29.640 --> 0:22:33.680 can't or won't. Can you talk more about that. FDA 0:22:33.760 --> 0:22:37.400 has recently announced they're going to start looking at technologies. 0:22:37.880 --> 0:22:39.479 So the first thing that they're gonna do, and this 0:22:39.560 --> 0:22:42.400 is gonna be tremendously helpful if we can get it done, 0:22:42.840 --> 0:22:46.120 is using blockchain, the same thing that you use for cryptocurrency, 0:22:46.800 --> 0:22:51.679 in order to start recalling things faster. For example, this 0:22:51.760 --> 0:22:55.800 technology could in theory, reduce the time it takes to 0:22:55.880 --> 0:22:59.280 trace the origin of a contaminated food upbreak from two 0:22:59.280 --> 0:23:05.080 weeks into two seconds. So that does several things. One, 0:23:05.280 --> 0:23:08.200 if you can trace sinks back very quickly, you can 0:23:08.240 --> 0:23:10.399 find out what the root caused us in others, what 0:23:10.720 --> 0:23:14.960 actually went wrong that caused this problem. More importantly, it 0:23:14.960 --> 0:23:18.480 gets bad products off the market more quickly. And it 0:23:18.600 --> 0:23:24.159 also doesn't basically indict everybody right yes, which sort of 0:23:24.240 --> 0:23:27.480 leads to something that you've entered at already in this interview, 0:23:27.520 --> 0:23:30.720 which is that the playing field is not necessarily level 0:23:31.119 --> 0:23:35.440 between small companies and big companies. Can you talk more 0:23:35.480 --> 0:23:39.159 about that? So there's a law on the regulatary flexibility 0:23:39.200 --> 0:23:41.919 access we have to take into account. You know what 0:23:42.000 --> 0:23:44.239 the impacts these things are on small producers, and if 0:23:44.280 --> 0:23:47.600 we can to give them some kind of relief, And 0:23:47.720 --> 0:23:50.280 given the fact that the benefits birth that great, I said, well, 0:23:50.320 --> 0:23:52.440 at least let's examp some of these small firms and 0:23:52.600 --> 0:23:55.760 make the requirements easier on them. We didn't do that. 0:23:56.359 --> 0:23:58.280 Of course, all the large firms didn't want to give 0:23:58.400 --> 0:24:01.119 small firms a break. But as they say, it's an 0:24:01.160 --> 0:24:05.080 unlevel playing field. They have much more influence over FDA, 0:24:05.200 --> 0:24:07.600 and this is true in any regulatory agency than the 0:24:07.640 --> 0:24:10.640 small firms do. So the small firms get driven out 0:24:10.640 --> 0:24:13.320 of business, and I think it's a shame that we 0:24:13.359 --> 0:24:15.720 have two different laws that are supposed to protect small 0:24:15.760 --> 0:24:18.680 firms and we're still not doing enough for them. One 0:24:18.680 --> 0:24:21.919 of the other topics that you you touch on, and 0:24:21.960 --> 0:24:25.040 that that I've encountered in other environments is the topic 0:24:25.080 --> 0:24:27.960 of conflict of interest. One of the things that I 0:24:28.040 --> 0:24:32.359 just have a hard time getting over is government employees 0:24:32.440 --> 0:24:35.320 leaving the FDA and going to work for the corporations 0:24:35.359 --> 0:24:38.760 that they're trying to regulate. And you give a very 0:24:38.800 --> 0:24:43.000 poignant example of a person who wrote a regulation just 0:24:43.280 --> 0:24:46.280 so that they could jump out and get a job 0:24:46.359 --> 0:24:50.600 consulting on that same regulation to help corporations figure out 0:24:50.640 --> 0:24:54.320 how to wend their way through it. Is that common. 0:24:55.200 --> 0:24:57.000 It's hard for me to know. I don't have data 0:24:57.080 --> 0:24:59.640 on how common is. I certainly saw it often enough. 0:25:00.240 --> 0:25:02.480