Catching Cancer Early: What’s Actually Possible Now?

27:33Or are we over-screening? Are we fear-mongering people into over-diagnosis, just like the prostate cancer story we talked a little bit earlier? Or are we doing something to save lives? Give me some data about, and they had a couple of great guys in there on both sides of this. So kind of walk me through your interpretation to that. And I'll sort of share my opinions on, and so where do we line up in the medical community in terms of what I offer my own patients? No, it's a great segue. I think, you know, just to finish the story about the gallery test. So basically to just complete the circle, and then we'll get to that question is, so what our test does is we draw the blood, we look for fragments of DNA that are in circulation that are being shed by tumors.

28:19we analyze that pattern of methylation. And if we recognize that abnormal pattern across 100 ,000 regions of the genome, over 500 ,000 of these methylation sites across the genome, we're looking for a pattern. We're not looking at mutations. We saw all those genomic signatures, none of them added to the performance of just looking at this methylation pattern. A machine learning classifier says we either see a cancer signal or we don't. And then if they see a cancer signal, we use the same methylation pattern, different features to predict where in the body it comes from. So if you got a positive result, it's a cancer signal detected, predicted location, pancreas.

29:04And so your doctor would know exactly where to go look. And our accuracy of that prediction is like 92%. And then you can go get a diagnostic workup. So our gallery test doesn't diagnose cancer. It diagnoses that you have a signal, a cancer signal, that's very clear in your blood and predicts where in the body that signal is coming from. And your doctor can then go diagnose the cancer. And when you have a positive result, the likelihood that you're sitting there with cancer in that moment is about over 60%. Wow. It does predict your risk of developing cancer. You either have cancer right now or you don't.

29:43And that's the false positive rate is about 0.4%. The positive predictive value is about 63%. And the sensitivity for the deadliest cancers, the 12 deadly cancers, for example, that cause two-thirds of cancer deaths is close to 70 % for early stage. Yeah. Jordan, you had your hand up. Yeah. This feels like I'm back in school. I went this year and had my physical. That was the first time I'd ever seen any literature on gallery. And Cancer Runs My Family, and they handed me the pamphlet and said, this is something you should look into. I'm about to turn 38. At what age should one, now that this is something that's relatively widely available, what age should one start considering getting these tests?

30:28So it's a great question, Jordan. First, we recommend this test for adults at elevated risk for cancer. And we benchmark that elevated risk at the absolute risk of a 50-year-old adult. Oh, wow. Okay. Any adult 50 and over is at about a 13 times higher risk of cancer. That's about an absolute risk of 0.4%, which is elevated. However, if you're 35 and above and have additional risk factors, for example, you're a smoker, you're a cancer survivor, you have a genetic predisposition, you have a very strong first degree family history, those all elevate age you and they age your cancer risk to about the risk of a 50-year-old.

31:10So if you're a 35 and above smoker, I think you're at elevated risk for cancer. And for many different types of cancer, if you're a cancer survivor, if you have a genetic predisposition, a Lynch syndrome, a hereditary cancer syndrome, a strong family history first degree, you're at elevated risk for cancer. You're a firefighter and you've been exposed to lots of things. You've been exposed to burn pits. You've had environmental exposures that are intense. All of those individuals are at elevated risk for cancer, even at the age of 35 and above. Yeah, I'm glad you brought up firefighters. I think it's such a public service.

31:44I still see firefighters all the time. It takes care of, you know, in Santa Monica, Malibu, obviously with our recent wildfires out here, I'm even more concerned about those guys, even in their 30s, the risk of prostate cancer and bladder cancer to urologic malignancies go way up just because of whatever they're breathing in, even with their protective equipment. And so I love that. And I think what I was going to ask you, is this, I mean, is it going to get smarter? In other words, does more data make your test even perform better? Absolutely. That's the beauty of these AI-driven diagnostics is that as you train these data sets on more and more samples, and we've done over 450 ,000 tests now.

32:29So we have a massive data set. the biggest methylation data set in the world, we believe, to train our machine learning algorithms to get better and better and better. Because what you're doing is you're trying to get rid of biological noise. And the only way to get rid of biological noise is to submit a huge amount of data to these AI machine learning algorithms so that they can, you know, understand the signal, you know, through the biological noise. So walk me through a patient journey. We had Jim Smith, who's a professor up at UCSF and a good friend of mine, on talking about sperm diagnostics.

33:09And we're both fertility specialists. We talk about a devastating diagnosis of if you do a startup company like Meatfellow, which is what his company is, where they're doing at-home semen analysis screening. and that guy gets an email saying, guess what, you have no sperm, that can be a diagnosis as devastating to some men as even a cancer diagnosis. So they've built in a lot of stewardship to sort of say, gosh, here's your next step. You're in Los Angeles, go see Dr. Mills and he'll take care of you. Talk to me about the patient journey with Galleries. As you know, a close family member of mine I sent for a history of cancer and thankfully that test was negative So I didn't, thankfully, get to experience the stewardship on a positive test.

33:58But walk us through that patient journey, Dr. Hoffman. Jesse, it's a great question. And I will get to your question about the New York Times article. Oh, yeah, yeah. I haven't forgotten. But this is really important, Jesse. And so first of all, this is not a direct-to-consumer test. So gallery is by prescription only. So a doctor needs to evaluate a patient, assess that they're at elevated risk for cancer, or whether by age, which is the most important risk factor, or these other elements. And if they're appropriate, we'll write a prescription for gallery. They can also do it from their doctor or use telemedicine through the gallery.com website.

34:36We have a telemedicine function. It's external. It's physician prescribed as well. So you go in and you get, so if you order it through telemedicine or at a doctor's office, there's a gallery kit that comes either to the patient or the doctor that has two tubes of blood. The patient will go to any Quest labs or the doctor's office or have phlebotomy come to the home, get the tubes drawn. They get shipped to our gallery lab, our GRAIL laboratory in Research Triangle Park, North Carolina, where it will get processed. The patient will receive an email that the sample has hit the lab. The doctor will get an email that the sample has hit the lab.

35:16And then it takes about two weeks generally to process the sample. So the DNA that has to be extracted from the plasma, it has to be purified, it has to be amplified, and then ultimately has to be sequenced for this methylation pattern. And then the bioinformatics comes in and reads the pattern. And then there will be a report. It's a very simple report. Unlike most genomic tests, which have 30 pages of various mutations. This is like the first page tells you everything you need to know. Most of the reports, 99 % will be no cancer signal detected. And the recommendation is it doesn't necessarily mean you don't have a cancer because we don't find all cancers, not all cancers shed DNA into the blood.

36:06Keep doing your recommended single cancer screening test. That's really important. A negative gallery test is very reassuring, but it is not perfect, especially for cancer types that don't shed a lot of DNA, like prostate cancer and breast cancer and some lung cancers. So keep doing your recommended. 1 % of the results will come back, cancer signal detected, and then it will have a predicted origin. Bladder, uterus, stomach, ovary, pancreas, head and neck, testes, it will just come back and the doctor will know where to go look. And that's really the journey. And then the journey goes in the positives for a diagnostic workup.

36:48If the diagnostic workup is unrevealing, in other words, let's say the test came back, cancer signal detected liver and a CT scan of the liver was negative, right? The doctor then has three choices. Choice one is Gallery offers a free repeat blood test. Do it for free. Do it right now. Let's resolve this. If it's negative, that was likely just a false positive result and we'll see you next year. We recommend Gallery be done annually. And another choice would be just call it a false positive and see the patient next year. The other is go deeper and do an MRI of the liver or a very liver-specific MRI.

37:29and you know mayo clinic just published their experience and dana farber just published their experience and their ppvs were much higher than we've ever seen before because they were looking harder yeah and they found more cancer so they had a couple pancreas cases across those studies where the mri showed mild inflammatory changes and they did endoscopic ultrasounds and found tumors in the pancreas. Right. And you assume it's something like pancreatic that is a devastating diagnosis, especially when caught late, which most of the time it is because it's usually asymptomatic, especially if it hits the tail of the pancreas.

38:07That's right. You are potentially finding things up front that obviously is going to allow them to potentially be even surgical or targeted. That's right. And so we're seeing, you know, surgeons telling us they've never seen early pancreatic cancer like this, and they're going in for curative intense surgeries. And it's really remarkable to see. And where this is happening, you know, we're finding cancer in people who have no idea they have cancer because they're asymptomatic almost every day now.

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42:18Pandora's box. So what are the typical risks of screening? So the typical risks of screening are false positives. Okay. Again, right now, our five cancer screening tests that we're using every day in people all over this country, and we've made a deal with this, are finding about 187 ,000 cancers every year. Okay. But to find those 187 ,000, they're producing 8.1 million false positives. Yeah. Think about that signal to noise ratio of about one to 45. Wow. And we're spending 40 billion dollars a year on cancer screening. And guess where most of that's being spent? Working up all these false positives.

42:57Yeah. If you add gallery to standard of care screening, you can triple or quadruple the number of cancers detected. Okay. You can add another 450 ,000 cancers and only increase the false positive rate by a few hundred thousand because gallery's false positive rate is about 0.5%, or in the latest study, 0.4%. So again, it's transformational in what you can do for public health. So that takes the false positive worry off the table, I believe. People are still worried about false positives. They're very difficult. But because we offer the free gallery retest, they can be resolved very quickly. And in our trials, we've seen no real serious adverse events from diagnostic workups in the false positives.

43:44They get resolved quickly. And so that's one risk. The other risk of cancer screening is what you referred to earlier, over-diagnosis, meaning, well, we're just finding cancers that we're going to die with rather than die from, and we're subjecting these people to all this anxiety, and we never needed to find that cancer. Well, that's true for some cancers. I think that's an argument for encapsulated prostate cancers. It's an argument for thyroid cancer. It's an argument for some hormone-positive breast. But we've done multiple studies that show that those indolent cancers do not shed a lot of DNA into the blood.

44:23In fact, we don't detect them well at all. And if you look at the survival curves of cancers that we miss, in other words, because they're not shedding a lot of DNA into the blood, at every stage, their survival looks much better than what would be predicted by the survival curves in the SEER National Cancer Registry, whereas the cancers we do find look exactly like the survival curves in the SEER National Cancer Registry. And what that tells us is that gallery is very unlikely to be diagnosing cancers that are not aggressive and invasive and requiring treatment. That's the overdiagnosis. And then the third part to the article in the New York Times and the recent article in the Wall Street Journal by Gil Welch is that, well, some of these early cancers you don't even need to treat.

45:18That's a very difficult concept to get anybody's head around. And from an academic perspective, that may be true, but good luck telling us which ones those are. And I don't subscribe to that school of thought at all. And then the other school of thought in the New York Times articles, we shouldn't be doing any cancer screening tests until that test has been shown to save lives or demonstrate a benefit in cancer specific or overall survival. And while that's a very admirable goal, I don't think we should wait 20 years to, GRAIL's not going to be able to do that study. We wouldn't be in existence.

45:57If someone wants to do that study, you know, good luck, but the technology will be obsolete by the time that study reads it out. and we have technology today that can find cancer in people who have no idea they have cancer, why would we put that on the shelf for 20 years? I don't understand that logic at all. Yeah, I think that, I mean, what kind of irked me a little bit is the, I mean, there's sort of a paternalistic overtone to this as well. And, you know, one of the things I trained in, I guess, a little bit more modern era in medicine where we actually bring the patient into that decision making process.

46:34And so if you have a test where somebody can make their own decisions, and they're informed and guided, then for us to say, look, we have this test, but you know, you're probably not quite trained enough in public health. And you probably don't have a master's in health services to understand the risk benefit epidemiologic ratios for going through it. So let's just not do it. And then just trust me, I'm a doctor is kind of what I felt from that. Whereas, you know, I would want to know, I mean, I, even though I'm not an oncologist and sure I'm a trained physician, I can make some of those decisions.

47:08But even if I were just a very smart person listening to this podcast, just you're giving somebody a whole nother data set where they can make that decision with their physician about what to do next. You know, it's a, it's a great point. It's, it's very paternalistic, but there's a very conservative hypothesis about cancer screening, which is very nihilistic, which is like none of this really matters unless it's saving lives, unless you demonstrate that it's saving lives. And I don't subscribe to that nihilistic, very conservative hypothesis that it will be more harms done than good. I would like to ask these epidemiologists who've never seen a patient who are doing all kinds of models and proselytizing that we shouldn't be deploying this technology and Dr.

47:51Welch, you know, who is less healthcare, is better healthcare. I'd like to ask them what they're recommending to their own family members. Are they telling their wives and husbands not to get breast cancer screening and prostate cancer screening? Is that what they're telling them to do? I would challenge them on that very conservative hypothesis because, you know, cancer is about to become the number one killer of men and women worldwide. It is already the number one killer of people over the age of 50. And why is that? It's because we're finding most cancers too late when symptoms have already presented and they're already spread and our treatments are ineffective.

48:33Wouldn't it be good to give everybody an earlier diagnosis, more treatment options, and potential for curative treatments? And I would take that bet any day. And the deal that we made with single cancer screening is quite different than the deal that we need to make with multi-cancer screening, where you want to optimize specificity, not sensitivity, be very safe about how it's implemented, and find a lot more cancer asymptomatically. In our latest clinical trial of 25 ,000 individuals called Pathfinder 2, over half the cancers that were detected by gallery were in stage one and two. yeah when you added gallery to usual standard of care screens the cancer detection rate increased by seven fold wow okay imagine that yeah i mean it's that's the you know again and the the other thing i would argue with the reason that cancer is taking over the number one cause of death is because we've done a fantastic job of spending billions of dollars on cardiovascular screening Right.

49:40I mean, it's a whole nother podcast, but, but, you know, guys are dropping dead when we're 48 of heart attacks because we're checking blood pressure, checking cholesterol, we're getting eyes on statins, we're putting stents in people. All of this stuff costs a lot of money. And nobody should be dying of a heart attack today. That's right. I mean, we have such great screening for that. And so you're going to see somebody else, some other Grim Reaper is going to come up and be in there. But now maybe with this screening, then it's not really when you screen or when guys are dying. But if you can move that longevity needle a little bit because of adequate screening, you know, then you're doing something right, which actually brings me to a little bit of the pillars of longevity because you are in that space.

50:24And for me, well, actually, you're going to love this, you know, as another Angeleno. So this is the classic L.A. story that I think summarizes up where we are in the confusing world of longevity. So I was coming up the California incline, which finally opened after all those years coming up from ocean or coming up from the beach up to ocean. I did my Sunday long run along the beach. It was gorgeous the Sunday and a little bit overcast. And there I was in the heart of obscenely healthy Santa Monica. And I saw this mid-20s woman that could have been a model and her perfectly coiffed hair and a la yoga pants and everything.

51:01And she had an Erewhon green smoothie and she was drinking in one hand. The first thing I saw was she was crossing the street. And I thought, that's great. She's living this healthy lifestyle. And then all of a sudden, I saw this puff of vapor come out of her mouth at the same time. And I realized in the other head, she was having a little vape pen. And so I thought, how do you justify, how do you look at this existential crisis I have as a healthcare provider and the cognitive dissonance of seeing somebody vaping and drinking a green smoothie? So yeah, so I don't know. Unpack that for me. It's not a question as much as an SMH moment.

51:37No, it's a fantastic analogy. We see that all the time. I think the longevity movement is really helpful. Great. It begs a lot of questions. There's a lot of science to be unearthed. There's a lot of quackery out there as it relates to longevity, but there's a lot of good science being done. Yeah. And, you know, but we need to get back to basics. Yes, drinking kelp smoothies might help you and sitting in a cold plunge all day long might help you. But if we can find cancer early, if we can prevent deaths from heart attacks, those are the basic blocking and tackling of longevity. And none of that other stuff is going to matter if everybody's dying of late stage cancer because we're waiting.

52:23It was very interesting. You asked for like a case study. So there was a gentleman named Roger who took gallery in the first clinical study and had found a stage 2A pancreatic cancer. And he underwent surgical curative surgery. And he's alive and thriving six years later. And he was on the hill. They, you know, we're trying to, the stakeholders trying to pass legislation right now to give Medicare the authority to even pay for these tests. Because, you know, Medicare can't pay for screening tests. The only reason they can pay for PSAs, colonoscopies, and mammograms, and pap smears is because special laws were introduced to give Medicare that authority, believe it or not.

53:04And so there's laws that have been introduced. And there was a hearing in Congress. This gentleman's name was Terry, was up there. And they were grilling him about the false negative rate and the low sensitivity. And he just said, wait a minute, time out. You guys, standard medical care for asymptomatic cancers that you're not screening for, the false negative rate is like 100%. I go to the doctor every year. They listen to my heart and lungs. They tell me I'm fine. They're missing cancer 100 % of the time. So that's our comparison. And none of the epidemiologists, none of the skeptics are putting this into context.

53:46Yeah, it's a low bar. Yeah, they're saying, you know, your sensitivity is too low. Well, the sensitivity today for asymptomatic unscreened cancers is effectively zero. So if this is 50%, 60%, 70%, that's a step change improvement. Yeah. So we're not putting it in the context of what's going on today. There is nothing acceptable today about the status quo in cancer screening. Yeah, that's amazing. and it's very powerful, Josh, for that. I mean, I think it just speaks to what, A, your passion for what you're doing and I think you found your place, which of course is the other amazing thing about the world of medicine is we get to go so many different directions and I think your combination of really excellent screening stewardship, hard science, great data, the amount of research you put into this to come up with a commercially available product is laudable.

54:42And I think, you know, for me, I always need to leave a segment with this thought of, as we say, you're probably going to be okay. And so for me, I guess my okay moment is, you know, I'm probably going to worry less about microplastics and penile tissue causing erectile dysfunction and mercury levels in fish, and more about making sure that I'm actually getting the screening that I should get as a guy over 50. and I'm probably gonna be okay because it sounds like 99 % of the time my gallery test is gonna turn out okay. And for that 1%, those are the guys that we really are trying to save from an early miserable cancer death.

55:23Yeah, and what we've learned, the NCI has been studying this for 40 years now. And unfortunately, we know very little about the natural history of cancer, which was shocking to me when I came to GRAIL. I asked some very basic questions and nobody knows the answers. What we're learning about this direct signal, biologic signal from cancers, is they're moving through stages much faster than imaging would suggest. And so we need to be screening annually. And right now we're only producing a snapshot, but I've taken the test four times now. All four years have been negative, but I can see a pattern underneath those negatives.

56:03So we're gonna figure out how to add the movie to the result. And that's going to add a lot more information and the test will become even more valuable. That's a, it's a great metaphor. And actually it's, it's funny because we, we do the same thing on a crude level with PSA testing. Exactly right. That's right. Exactly right. So I see a guy at 50, it's 1.2. If I see him next year and it's 2.2, then I'm already starting to think there's a pattern that hasn't really turned into a, a blockbuster cancer movie yet, but I'm starting to look at it. And then, And those data points are so, you know, it allows you to make a little bit more of a diagnostic accuracy.

56:42That's right. I know you're up on Capitol Hill and you're advocating. And so I don't want to take any more of your time. But I always have to ask all of my guests, especially my physicians, especially guys that look as fit as you, what is your must-have to stay healthy, to stay grounded? What do you do every day to make you Dr. Josh Hoffman? Well, one of the things I did was I went and saw this great doctor named Dr. Jesse Mills. And he gave me some great advice. And it really helped me as a 50-year-old. I think I saw you when I first was maybe 54, 55. Somewhere in there. It's been a few years.

57:19I'm now 61. Get out. And you told me, stop with all the cardio and just start lifting weights. And you wanted me to do it four to five times a week. And I did it. And it transformed my metabolism. Yeah. And it made me feel much healthier. And so I work on, you know, I don't focus that much on my diet, but I try to eat healthy. I work out all the time. I lift weights five days a week since you prescribed it. I treat my hypercholesterolemia very aggressively. I have familial hypercholesterolemia. I get my cancer screenings. I even did a whole body MRI last year with the Pernuvo scan, which every few years is a nice, I think, compliment to the gallery test because it's different things, looking in the brain, looking at other things.

58:06And so I take really good care of myself. And mostly, I think, mental health, my professional health, I pay a lot of attention to that. I keep a good community of friends and colleagues and family. And I have serious hobbies that I go after and I love. and I think that that keeps a good balance for me. Yeah, you gave me chills there. I think you're right. I mean, I think that's the other subtext of the show is just guys being open and somewhat vulnerable to what we do because we're usually not. We don't have a view for guys unless it's a sports center or something like that. But these are the secrets.

58:43And I love that you brought up mental health because obviously that's another pillar of longevity that if you don't have that connection, If you don't have a friend group or a family group, the feeling and the isolation and loneliness that can be out there is true. So all the cancer screening, sure, that's going to save lives. But man, yeah, I love what you said there, Josh. Like yourself, work that you're passionate about also, having a wonderful relationship. I'm really fortunate to be in a great marriage with a very supportive wife to enable me to do this and to work on something I'm so passionate about.

59:16Very lucky. I love it. Well, it's great seeing you look up. My son's up on Capitol Hill as well, working in Congress. And say hi to inform me. Tell him to make sure he hurries home for Christmas. And I'll see you back in LA at Erewhon before you know it. Jesse, great seeing you. Jordan, great seeing you as well. Awesome. Great talking to you. All right, Josh. Be well. Thank you so much. This is awesome.

59:45Let's talk about it. Let's talk about it in the mailroom Let's talk about it Let's talk about it in the mailroom Let's talk about it Let's talk about it in the mailroom The Mailroom with Dr. Jesse Mills was a production of iHeartRadio. It was executive produced by Jordan Rontag. It was edited, mixed, and mastered by Bahid Frazier, and the theme was provided by Long Transit. If you liked what you heard, please subscribe and leave a review. For more podcasts from iHeartRadio, check out the iHeartRadio app, Apple Podcasts, or wherever you listen to your favorite shows. This program is intended for educational and informational purposes only.

1:00:38It is not a substitute for professional medical advice, diagnosis, or treatment. Consult your health care provider for any medical or other related questions or concerns. The views and discussions aired on this podcast are those of Dr. Mills and do not represent the official positions of UCLA or UCLA Health.

1:01:04It's tax season, and by now we're all a bit tired of numbers. But here's an important one you need to hear. $16 billion. That's how much money in refunds the IRS flagged for possible identity fraud. But it's not all grim news. LifeLock monitors millions of data points per second and alerts you to threats you could easily miss on your own. If your identity is stolen, they'll fix it. Guaranteed. Save up to 40 % your first year. Visit LifeLock.com slash iHeart. Terms apply. This is Jacob Goldstein from What's Your Problem? Business software is expensive. And when you buy software from lots of different companies, it's not only expensive, it gets confusing, slow to use, hard to integrate.

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