This is Democracy – Episode 232: FDA and Public Health

[00:00:00] Intro: This Is Democracy, a podcast about the people of the United States, a podcast about citizenship, about engaging with politics and the world around you. A podcast about educating yourself on today’s important issues and how to have a voice and what happens next.

[00:00:25] Intro: Welcome to our new episode of This is Democracy.

[00:00:29] Jeremi: Today’s episode is going to focus on a topic that even after 230 episodes, we have really, and this is a, this is a criticism of us that we haven’t, uh, addressed anywhere nearly as adequately as we should, which is, uh, how our society, how our government, how our medical profession, uh, addresses the needs of citizens with regard to drug usage.

[00:00:52] Jeremi: Uh, how do we find, and, um, The distribution and the safety of medicines in the United States of prescription medicines of one kind or another. How do we make certain that when pharmaceuticals are produced, that they are safe and that, uh, their use is safely regulated? Uh, this is of course the work of the Food and Drug Administration as well as many other parts of our government in many parts of the medical.

[00:01:18] Jeremi: and we are fortunate today to be joined, uh, by a leading figure in this area, a leading, uh, doctor, medical doctor, a leading, uh, person who’s involved, as he describes in his recent book, in the approval process for certain, uh, pharmaceuticals and, and most importantly, uh, for our purposes, a wonderful writer, someone who seems to mix.

[00:01:39] Jeremi: Medical knowledge and writing, uh, skills as few do. Uh, this is Dr. Uh, Michaal, uh, and he’s a professor of medicine and chief of the division of Hematology at the Sylvester Comprehensive Cancer Center at the University of Miami. Uh, Miller School of Medicine and it shows how, uh, open-minded we are that after University of Miami just defeated us in a basketball and we’re still having one of their pictures on our podcast.

[00:02:06] Jeremi: uh, Dr. Z has published hundreds, literally hundreds of scholarly articles and op-ed articles, as well as eight books. Um, he published When Blood Breaks Down Life Lessons from Leukemia. and most recently, the book we’re gonna talk about today, the book, I encourage everyone who’s interested in understanding, uh, medicine, pharmaceuticals, and government policy to read, uh, his most recent book.

[00:02:31] Jeremi: Really a wonderful book, drugs and the f d a, safety, efficacy, and the public’s trust. Uh, Dr. Seis, uh, I’ll call you from henceforth. Uh, thank you for joining us today. Well,

[00:02:43] Mikkael: how delightful to be here. Thank you both for inviting. Before

[00:02:47] Jeremi: we start this, the conversation with, uh, Michaya, we have of course, uh, doc, uh, Mr.

[00:02:53] Jeremi: Zachary. Sir, you’re not a doctor yet. Zachary. Mr. Zachary Siri, uh, scene setting poem. What’s the title of your poem? Zachary U

[00:03:00] Zachary: the Kaur

[00:03:00] Jeremi: Harris Amendment. I, I am sure. I have never heard a poem before on the Kaur Paris Amendment, so let’s hear.

[00:03:08] Mikkael: As the pill wanders over

[00:03:10] Zachary: gaping mouth or toothpaste out of its galvanized tube, the crumb on its esophageal way south, the wondrous vaccine on a sugar cube in cold and barren halls or sweated beds at night with heartache or a kidney stone.

[00:03:26] Zachary: The bones are rattling. The joints of lead to live in this world is to live alone. And lately the bright lights have seemed like ghosts or death or an unknown that looms before, like setting suns or ill advised boasts of magic powder chemicals galore for who could know that in this single pill are Francis Estes and a Miracle.

[00:03:53] Zachary: Bill .

[00:03:55] Jeremi: What is your poem

[00:03:56] Zachary: about Zachary? My poem is about, uh, trying to reckon with the, this central contradiction I think of our episode, which. A lot of, uh, of, of, of, of medicine and, and treatment

[00:04:06] Mikkael: in particular that has

[00:04:08] Zachary: to do with our, with the medicines that we take and with pharmaceutical development can seem to us, uh, so impersonal sometimes it’s something that, that is devoid of, of, of, of, of human, uh, failings or, or of human, uh, concerns.

[00:04:23] Zachary: But it is a deeply human process and it relies on the expertise, commitment, and intelligent policy of, uh, dozen. Hundreds, thousands of people at every stage

[00:04:34] Mikkael: of this process. Uh, uh, Micha, do you agree? Oh my God, I loved that poem, Zachary, and I think you totally nailed what I was trying to do with the book, which was to humanize this regulatory body that’s often seen as being completely opaque.

[00:04:53] Mikkael: So I’m gonna recommend that you be the poet laureate for the fda. From here on there, which, which they desperately need, by the way,

[00:05:00] Jeremi: Mihail, do you have that authority to appoint him? ? ?

[00:05:04] Mikkael: Yes. Yes, absolutely. Done.

[00:05:09] Jeremi: Uh, you mentioned the f d a Miha and, uh, many of us, myself included, uh, really don’t know much about this, this agency.

[00:05:17] Jeremi: I, of course, had heard of it even written a little bit about its role in the progressive era. , your book really enlightened me so much. It’s worth the, the, the cost of the book. Just to, to understand that, can you tell us why the F d A

[00:05:29] Mikkael: was created? Well, gee whizz, um, you know, to do that, I think you almost have to go back to the 19th century and imagine what it was like to try to get, uh, an illness treated back then.

[00:05:41] Mikkael: And, and I take the reader down a, a, a route where I. The person to imagine that, uh, he or she has breast cancer and is trying to get that breast cancer treated. And back in the 19th century, uh, though, what people frequently used were what, what were called patent medicines and. and these were nostrums with dubious names like Hamlin’s Wizard Oil, and they, they were not exactly the medic medicinal panacea that they claimed to be.

[00:06:12] Mikkael: So for example, Hamlin’s Wizard Oil advertised itself as a wondrous cure for ailments ranging from toothache, rheumatism, laying back hydrophobia, and pneumonia all the way to cancer. And its Koshore CLO slogan bragged. There is no sore. It will not heal no pain. It will not SubD. , and it wasn’t until 1902 that progress toward the regulation of food and drugs actually began.

[00:06:39] Mikkael: And, and one of the premises of this book is that the f d A is born out of medical tragedies. Um, and in 19, in, in the early 19 hundreds, 22 children in, in St. Louis and in Camden, New Jersey, who, who were sick with smallpox and diptheria died when they were given vaccines to treat these infection. The vaccines themselves were contaminated with another deadly toxin, tetanus.

[00:07:06] Mikkael: So, so based on this tragedy, Congress passed the Biologics Control Act and soon after the Pure Food and Drugs Act, but these laws were really limited in scope and drug safety was still left up to the manufacturer. So imagine that there is an act by Congress to quote unquote regulate drugs. But it didn’t demand that drugs be safe, nevermind.

[00:07:30] Mikkael: That they actually were. So then there was another tragedy that occurred. Um, in, uh, 1937, the, the se Massengill Company of of Tennessee sought to create a liquid form of an antibiotic sulfide that would be easier for patients, particularly children to ingest. So the company’s chief chemist, a guy named Harold Cole Watkin.

[00:07:54] Mikkael: Added substances to make the drug more palatable, including raspberry extract, saccharin caramel, and the sweet tasting solvent, ethylene glycol, better known as antifreeze. So he actually added antifreeze to this antibiotic. And in September of nineteen thirty seven, two hundred and forty gallons of this stuff were distributed across the country, and doctors began prescribing it regularly.

[00:08:20] Mikkael: Well, you can imagine what, what happened after. 71 adults and 34 children died from taking the, an tainted antibiotic. So the team of f FDA inspectors were sent across the company, um, you know, like some black ops force to track down the company’s 200 salesmen, and identified the drugstores and doctors offices that had stocked the elixir.

[00:08:44] Mikkael: And some of these stores are really remark. I mean, they talk about going to a drugstore in St. Louis and finding, um, that this was a prescription written for a baby with no name, and they had to try to figure out where the heck this drug was. Um, there was one f d a agent who learned that in a small town in South Carolina that the tradition was that when you died, They, all of your medicines would be buried above your grave.

[00:09:12] Mikkael: So this f d a representative went to the graveyard, dug through the dirt, and actually found some of this sulfide on top of this person’s grave. I mean, ri I, I have to imagine rising like some unholy focus in early spring. Oh my gosh. So these agents recovered 234 of the 240 gallons distributed. Well, I mean, the, the public was outraged and it finally led President Franklin Roosevelt to sign the Food Drug and Cosmetic Act into law on June 25th, 1938.

[00:09:46] Mikkael: So for the very first time, the F D A had the authority and the responsibility to make sure that drugs were safe when they were. And mi,

[00:09:58] Jeremi: if I might ask you who, who are the individuals doing this for the F D A, you describe, and you’ve given us just a sample of these extraordinary stories, heroic stories.

[00:10:08] Jeremi: Who, who are the people doing this

[00:10:09] Mikkael: work? So these are members of the F D A who now require that drug companies submit data that proves that they have actually tested the safety of. , and you have to take this almost to the EMPH degree to realize how this happens. So not only do they submit data on the safety, on the preclinical safety of the drug, showing that they’ve, you know, tested it in test tubes, sometimes they’ve tested it in small mammals.

[00:10:35] Mikkael: They’ve looked to make sure that they don’t cause heart damage or liver damage or kidney damage when they’re giving these to the drugs. Now, if you’re in, if you’re the F D A though, that’s not gonna be good enough. You then have to invest. The pharmaceutical companies manufacturing process and assure their purity of that and even the supply of all of the chemicals that make it to that drug company’s factory.

[00:11:00] Mikkael: And, and this is where the FDA has really run into some trouble because they’re probably not adequately staffed to track down every single, um, mile of that journey for every component of the drug as it’s being manufac.

[00:11:13] Jeremi: And, and you describe the, the challenges, the hard work, um, both the, the recognition often of the need for this work to be done.

[00:11:22] Jeremi: But as we all know today, and it’s not a new story today, the constant, uh, anti-regulatory sentiment that’s also a part of our country and part of our tradition as, as, as a, as the society that we are. One of the really interesting heroines in your book, someone I did not know much, Uh, was, uh, Francis Kelsey.

[00:11:42] Jeremi: Can you tell us more about Francis Kelsey?

[00:11:45] Mikkael: Yeah, this is probably one of the most remarkable stories i, I ran across and what was fun a as a part of the book is that I kind of heard some of these anecdotes, um, going through medical school and my training, uh, but I was actually able to dig into the facts of, of these stories.

[00:11:58] Mikkael: So Francis Olden Kelsey was at PhD and at. and, um, actually the, the, the story goes that it was pretty miraculous that she got her PhD to start with at, at, at, um, the University of Chicago. And probably it was because she mailed in an application and the person who actually became her advisor saw Francis there and assumed that it was a man Francis instead of a woman Francis.

[00:12:26] Mikkael: So, and, and part of her pharmacology work was actually in toxic, uh, uh, the toxicology. and how it affected fetuses. So interesting background to where we’re going with this. She then joined the F D A, her very first job. Her very first assignment was to review a new drug application for this drug.

[00:12:46] Mikkael: Thalidomide. Now, thalidomide, uh, was already marketed in Europe as the first safe sleeping pill, and in fact, there were ads for the. that showed a child at a, a medicine cabinet in the, in the bathroom reaching for a pill bottle, and the caption under, underneath that ad says, boy, aren’t he glad this kid’s reaching for thalidomide to nuts and barbiturate, that would really harm them.

[00:13:13] Mikkael: And the drug was so popular in Europe. It was, it was used almost as regularly as aspir in some c. . So a company responsible for distributing the drug in, in the us Richardson. Merrill was really chomping at the bid to get the drug approved and also capitalized on the US market. Uh, in fact, anticipating a quick approval by the F D A.

[00:13:33] Mikkael: They had a warehouse full of the drug ready for sale, so they sent the application to Kelsey. She looked at it and she didn’t, she didn’t buy it. She said, gee, there isn’t a lot of safety data. . So she basically said no to the application and got back to ’em and said, you’ve gotta provide more safety data.

[00:13:50] Mikkael: So they responded with what amounted to individual testimonials from doctors who were like, oh, this is def for a drug, you should use it. And she was like, no, no, that’s not quite good enough for me. And she, she kept delaying the drug to the point where she, she has this quote where she says, um, the company got, got really ticked off and complained to her.

[00:14:11] Mikkael: And you gotta wonder if they would’ve done this, if this were a man reviewing their application. And, uh, she says that they were particularly disappointed because they really wanted to get the drug out before Christmas, because Christmas is their big season for selling sedatives and hypnotics. But she kept delaying.

[00:14:30] Mikkael: Now, at the same, around the same time, there was a German physician, a guy named Vik Lens, um, and um, a lawyer. , um, named Carl Herman Schulte Hillen, whose son j was born with two short arms. So this lawyer got together a Vatican lens and said, I think something’s up with this drug. My wife took this thalidomide stuff.

[00:14:54] Mikkael: So at the same, at the time, Vatican Lens ran a neonatal intensive care unit and had all these kids who all of a sudden were born with birth defects, like this epidemic of it. So they piled into Hilta Hill’s, . And drove around Germany carrying the picture of Yon. So Schulte Hill would go into these small villages, show the picture of Yon and say, look, this is my boy.

[00:15:15] Mikkael: This is what happened to him. Are there any kids in this village who have birth defects like this? And these kids were hidden away so people would started to trust him. Cynthia, we, we, we’ve got this, this child here who was formed birth defect. And these two would go into the medicine cabinets in the house looking for the drugs that might have been taken during the pregnancy.

[00:15:35] Mikkael: And lo and behold, All of these, the mothers of these kids had taken thalidomide. So this finally started to blow up in Europe right around the same time that Kelsey was delaying approval in the us. Um, so lo and behold it came out and it also came out that Kelsey is the reason the US market was protected from the str thalidomide.

[00:15:58] Mikkael: So, um, she actually became a national hero. And because people were so upset about this, uh, Senator Estees Kafer from Tennessee, who actually came to FAME when he headed the Senate special Committee to investigate organized crime, right? So he was looked at as the nation’s guy who tackled criminals. He noted also a presidential candidate many times, right?

[00:16:23] Mikkael: Yeah. No, no, you’re right. So he then decided to take on the pharmaceutical. This outrage among the public, again, finally led to some changes in the legislation. They used this as the, the, the thalidomide, the avoiding the mite disaster as an excuse to pass a bill that finally demanded that drugs be effective, that they actually worked.

[00:16:43] Mikkael: And that took until 1962. I recently, um,

[00:16:49] Zachary: As a part of a school trip, uh, visited, uh, the Japanese pharmaceutical regulator. It’s the P M D A, uh, in English. And I was struck, uh, by the extent to which the FDA sort of represents a gold standard for drug regulation, not just here in the us, uh, but around the world.

[00:17:06] Zachary: Uh, what do you think has enabled, uh, the F fda, a post cafare Harris amendment to become this gold standard when so many, uh, other American institutions and, and bureaucracies seem to be. Below,

[00:17:18] Mikkael: uh, average around the world? Yeah, it’s, it’s really insightful. Um, it, it’s because the F D A tends to be conservative.

[00:17:27] Mikkael: The f d a wants randomized phase three trials that show a drug is more effective and as safer or more safe than the standard of care that’s actually out there to lead to approval of that drug. And they’ve held this standard of one, but ideally even two randomized controlled. Um, before drug will get approved.

[00:17:49] Mikkael: So there’s that aspect of the F D A where you say, gee, they are the most respected and considered the safest regulatory body in the world. But on the other hand, gee, w it takes a long time to conduct those trials and you have a public, particularly those who are sick or dying from deadly diseases, who want drugs on the market quicker.

[00:18:09] Mikkael: And that’s the tension of the fda. Do they keep demanding these high? Long-term trials to show a drug safety or do they try to get some drugs out there quicker because people are dying and desperately and need a new medication. So you’re talking in

[00:18:28] Zachary: your book about, uh, the FDA’s attempt to address this concern, uh, uh, a a a process that largely grows out of the AIDS crisis, H I V AIDS crisis in the eighties and nineties.

[00:18:40] Zachary: Uh, how do you think, uh, regulators. Particularly the FDA balanced these concerns. Uh, you, you talk in your book, you’ve sort of framed the story within the context of an oncologic, uh, drugs advisory committee, uh, meeting about, uh, the, uh, treatment of metastatic breast cancer with, uh, the chemotherapy drug, uh, vasin.

[00:19:02] Zachary: Um, and you talk about this effort to balance the need for a drug or the public, uh, perception of a need and desire for a drug. And the FDA’s, uh, reluctance to approve it, its safety and, and

[00:19:16] Mikkael: efficacy. Yeah. So, so, um, the crux of the book is that through H I V AIDS activism in the eighties and nineties, the F D A finally pivoted to a mechanism to get drugs on the market faster, and it’s called accelerated.

[00:19:32] Mikkael: And basically what it says is, okay, you’ve got some great drug. It shows some, some amazing early activity, some early efficacy, and it’s for a disease that’s life-threatening. So you know, you know, a hang nail isn’t gonna do it, right. You’re not gonna get accelerated approval for a hangnail. It’s gonna take something as deadly’s like hiv aids, or.

[00:19:55] Mikkael: So the FDA says, okay, we’re gonna get these drugs on the market faster, uh, through quicker trials based on what they call an interim marker of a clinically meaningful benefit. In other words, some shorter term thing you can assess, that probably means the drugs going to do something like improve someone’s survival, get the drug on the market based on that interim marker of a benefit, but require that a follow up study actually.

[00:20:24] Mikkael: That the drug prolonged survival or does something more meaningful than that initial study. So accelerated approval goes into place in 1992. Immediately, some h hiv aids drugs get approved under that mechanism, right? So heck, it works. Then over time, cancer totally takes over the reason for accelerated approval.

[00:20:46] Mikkael: So almost all the indication. That get accelerated approval are now cancer indications. Why? Because it’s, it’s big bucks. It’s big business. Heck of a lot more people in the country get cancer than get h i v. The problem arises when the F FDA a approves one of these drugs under accelerated approval is what if that follow-up trial, that confirmatory trial doesn’t confirm the benefit of the drug?

[00:21:10] Mikkael: What if that confirmatory trial actually shows that people not only don’t live as long but may. Less long on the trial. Well then the FDA a does have the authority to recommend that the drug be withdrawn from the market. But guess what? The manufacturer of that drug isn’t so eager to pull their own crap from the market

[00:21:33] Mikkael: So most will, I mean, when the FDA a comes out and says, listen, we’ve, we’ve now got a study, Sean, your drug doesn’t work as well as we thought it does, maybe works less well than the standard that’s out there, has some bad safety signal. We’re telling you to pull the drug. Most pharmaceutical manufacturers say, uh, all right, we don’t need the bad pr.

[00:21:52] Mikkael: We’ll just pull the drug. But sometimes, and legally this can happen. Sometimes a drug manufacturer says, you know what? I’m gonna keep my drug on the market. What are you gonna do about it? And that’s what happened with the breast cancer drug a. How

[00:22:09] Jeremi: do you, uh, when you’re part of this process that you describe in, in really fascinating detail in the book, uh, mial and I encourage our readers to, to pay close attention.

[00:22:18] Jeremi: You’re also very deft at connecting your experience with the history and sometimes flashing back and forth between the two. Um, how, how do you address the, the concerns of a larger public that often is, is. To, to take risks, in fact, for those who are in serious medical conditions. You, you recount in the book that many criticisms that were levied at the f d A during the AIDS crisis, which I remember well myself in the 1980s.

[00:22:47] Jeremi: And, and even Tony Fauci, uh, became a target of criticism by Larry Kramer and others. As you describe. In the book, how, how, what is the democratic element of this? How are you, how do you take account beyond the medical needs of the needs of the public and the desire of the public?

[00:23:04] Mikkael: Yeah. Well, a, as you both alluded to, I was on the Oncologic Drugs advisory committee, the F d A for five years, and I chaired it for two years and I, I actually have subsequently made some appearances on the committee as well.

[00:23:15] Mikkael: And that’s the committee when you’re reading in the newspaper that an F D A committee today recommended approval of this drug for cancer. That was our. And about 90% of the time, f d a votes the same way as our committee. And what’s unique about the US F D A is that this is all a public process. So if you hear an announcement that an f d A committee is going to meet about a drug, you can actually tune in live on YouTube.

[00:23:40] Mikkael: It’s such a live process. This is a, this is amazing to me. This is one of those fun facts that I validated, but I had heard it as a rumor in real time. So it’s such a live committee. That public trading of the stock for the pharmaceutical manufacturer of the drug being considered by ODAC is suspended for the four hours of the meeting.

[00:24:02] Mikkael: Because in the past, fluctuations in the market were too volatile based on one comment after the other, by ODAC members. So, uh, imagine that, right? That this is a, these are, these are big decisions. So it’s a big decision medically. It’s a big decision. Scientif. , but most importantly to me, it’s a big decision to patients.

[00:24:26] Mikkael: And part of these proceedings are that there’s an open mic session where patients can go to the F D a, sign up for a time, get before that microphone, and they have four minutes to tell their story and to try to convince the committee to vote for or against a drug. And at this trial, for this breast cancer drug of Astin 30.

[00:24:48] Mikkael: Brave women got in front of that microphone and testified to us. And I will tell you that is the most meaningful and most moving part of the proceedings. And that’s something that I probably pay closest attention to because I think in my own mind, how would I explain the safety and efficacy of this drug to a patient who’s sitting three feet away from me in my exam room?

[00:25:10] Mikkael: And if at the end of the day, I can’t think of how I would explain to a patient why she should take a cancer. , I can’t vote to approve that drug. So, circling back to what, to what you asked about, you know, how do you think about this on a global level? You know, you actually hear from people who are affected by the decision on whether or not to approve a drug.

[00:25:32] Mikkael: The, the folks who have these deadly diseases, these life-threatening diseases, who need new medications and they need them. In this proceeding, what I was particularly moved by was an F FDA official who got up and did something very rare for the F D A. She got up and she said, you have heard from all of these folks who are alive and well to travel to the F D A today.

[00:25:56] Mikkael: I’m gonna speak on behalf of the people who can’t be here today because they died while on this drug and she told some of their. what’s very

[00:26:05] Jeremi: revealing, what’s very revealing, Michael, and what you say is just how, how many voices are actually part of the process. I apologize for, for, for cutting in there, but I’m just, I’m just listening astounded.

[00:26:15] Jeremi: Even more, it’s even more clear to me now than it is in the book. Just how open this process really is. Right.

[00:26:22] Well,

[00:26:22] Mikkael: I wanna get, I I I, I would circle back to Zachary’s outstanding poem, right? This, think of all of the people, I mean, we, we formally call them stakeholders, right? But I think that really depersonalizes.

[00:26:33] Mikkael: You, you have the patients themselves who are affected. They are the most important participants in this proceeding. Then you have members of the F D A I will tell you, um, they really, really care about getting it right. They care about making sure that drugs are safe and that they’re affected. They care very much about protecting the health of the public.

[00:26:53] Mikkael: And that is, in fact, when I would go to these meetings, I would come home to my wife and she would say, well, had to vote. And I would either say to her, Today we voted to make a new drug available to people who need it. Or I would say today we voted to protect the health of the public. And that’s really how we think about it and how the F d A thinks about it.

[00:27:10] Mikkael: And then you have pharmaceutical manufacturers, I will tell you, they care very much about their drug and you can say that they care about it from an economics perspective. Um, but they also really talk with, within their company about how they’re benefiting. And I have seen people move to tier in any one of these groups I’ve just mentioned, based on the decision of ODAC on any given day.

[00:27:36] Mikkael: Wow. That,

[00:27:36] Zachary: that’s really a, a fascinating description of, of the scientific process, meeting the democratic process. I agree. Uh, which I think the f d A is sort of at the, at the forefront of, uh, when it comes to, to our government. How can young people like myself and and other listeners get involved in this process?

[00:27:53] Zachary: Uh, working both to protect the integrity of the FDA and, and other such institutions vital to our democracy and our public health, while also ensuring that this drug reg regulation remains both the global standard and responsive

[00:28:08] Mikkael: to the needs of the public. I, I love that you asked that question, Zachary.

[00:28:12] Mikkael: Um, because we need, honest to God, I’m not just saying this. We need people like you. Um, to care about issues like this and to get involved in it and to be passionate about it. Um, I was recently on an ODAC committee that voted on a lymphoma drug, and um, uh, the next day I got, uh, DMed on Twitter by a young person who’s training to be an oncologist who said, Hey, there’re a bunch of us who tune in live to these every time they happen, uh, because we really care about the proceedings and we wanna learn how drugs get.

[00:28:43] Mikkael: which I was like, oh my God. You were like, when can I start recruiting you? Right. . Mm-hmm. mean it’s amazing. So that kind of involvement, I think understanding the process. And Zachary, what I would also say is being, um, accurate communicators about how the F D A operates. , there has been so much polarizing talk about the F D A in the past three years.

[00:29:07] Mikkael: It’s really unsettling, uh, particularly when you know how things work and you know how much everyone involved in these processes care. So, you know, be to communicate about that, that, you know, the FDA has to weigh up all of these things when it’s making a decision. It’s never black and white. It’s never simple.

[00:29:25] Mikkael: Uh, there’s, there are always so many people involved in caring about a drug getting approved. Um, most importantly, patient. and in thinking about how patients are affected by these drugs and why it may not be the best thing to get a drug on the market quickly. So, you know, being knowledgeable about this and engaging in these sort of high level discourses about the F fda.

[00:29:47] Mikkael: A particularly during times, like the pandemic when the, the F D A, the how the F D A works is on page one of the newspaper or page one of your website, um, every single day. And people are seeing this happen in real time and don’t realize. You know, science isn’t always an elegant, smooth process. There are missteps, there are backups, there are redos.

[00:30:09] Mikkael: Um, but eventually you’ve gotta hope that the people involved in it are just trying to get it right. And,

[00:30:16] Jeremi: and Miguel, you’ve given us so much insight. You’ve shared your time with us so generously, we always like to close, uh, with a, a forward looking question and this really builds on Zachary’s terrific question.

[00:30:29] Jeremi: Uh, Message do you really want the public to get from your book and your experience? You have so many insights to share, and this is so vital for our democracy, as you’ve pointed out, which of course is our theme each week, the the nature of our democracy, the growth of our democracy. What’s, what’s the real core message that you want everyone to get

[00:30:51] Mikkael: from?

[00:30:52] Mikkael: Well, first of all, I want to thank both of you for just the outstanding questions. My word, you’ve, you’ve done your homework and, and you represent What’s, what’s good for, for hosting a podcast like this? Um, you know, for people to remember that the f d A was born in tragedy and every day members of the F D A wake up and they say it themselves, we can’t ever let tragedies like sulfide or thalidomide or tainted vaccines happen.

[00:31:20] Mikkael: Their very first and foremost job is to protect the health of the public and to try to get it right and to be ambassadors for that, to, to realize there are very smart people involved in this. Um, and p people who, who want our health to be better. And you know, like you said, we. The, what’s considered the, the safest and the most trusted regulatory body in the world.

[00:31:47] Mikkael: If you get a medicine, you wanna get it from the us. You don’t wanna get it imported. Um, but that process inherent in it is this tension between getting it right, protecting our health, and getting drugs to people who desperately need them quickly. I think that’s

[00:32:04] Jeremi: such an important message, and it comes back to a core theme, mihail, that we’ve dealt with week after week, which is balancing the need for expertise in science with the communication skills and the knowledge to appreciate, uh, what science really is and why it’s so important, uh, to our democracy.

[00:32:22] Jeremi: Just as there are facts in the world, there are scientific methods that that work. They’re not in. But more often than not, they can produce a, a safer, more accessible, uh, environment for more people. And of course, that’s, that’s what we want. Um, I want to thank you, uh, for all of the work you do, Dr. Mihail.

[00:32:40] Jeremi: Uh, sec. Uh, your, your work is, uh, prominent in the New York Times and in so many places, and your most recent book, I think carries your message forward so effectively. Many of us are inspired by the way you bring together your work as a medical doctor, with your work as a communicator and a policymaker and a and a supporter of democracy.

[00:33:01] Jeremi: Uh, I wanna encourage our listeners to, uh, read your book. Uh, it’s by Dr. Mihail Sakaris, uh, drugs and the F D a Safety, efficacy, and the Public’s Trust. Uh, Dr. Sakaris, thank you again for joining us today.

[00:33:15] Mikkael: Well, thank you for this incredible opportunity.

[00:33:18] Jeremi: Zachary, thank you for your insightful poem, your wonderful, uh, questions and for your, uh, idea in setting up this episode.

[00:33:26] Jeremi: I’ve learned so much from you as well, Zachary, about this. And thank you, most of all, to our loyal listeners for joining us. For this week of this is Democracy.

[00:33:43] Outro: This podcast is produced by the Liberal Arts I t S Development Studio and the College of Liberal Arts at the University of Texas at Austin. The music in this episode was written and recorded by Harris Codini. Stay tuned for a new episode every week You can find This is Democracy on Apple Podcasts, Spotify and Stitcher. See you next time.