Two People, Same Cancer, Different Cures — Why the FDA Doesn't Allow It

The FDA's current rulebook is fundamentally broken when it comes to fighting cancer. And here's the shocking truth. What if the system designed to protect you and me is now the single biggest bottleneck to slowing down personalized treatments that could help people live longer and fight cancer better? What if your cancer care is being shaped more by the revolving door between big pharma and fda? More by politics and contracts than the unique biology of your body and what your body actually needs? But that's changing. Today we're diving into the essentials of precision oncolog an n of one trial model. A way to build custom treatment using artificial intelligence and over a thousand plus data points that's customized just for you. Instead of using a one size fits all model that we typically look at maybe 24 or 30 data points. A biopsy, a tumor marker and imaging and then basing care on that. Because each of our cancer's biology is unique. It's called heterogenicity. Two people with the same type and same stages of cancer have totally different markers. When you break them down in great detail, that's what we're going through Today's episode. I'm Dr. Dr. Dino Prado. For the last 25 years, my team and I have worked tirelessly to bring patients deep precision treatments and testing highly personalized helping them to overcome. Over the last number of years we've been able to help so many patients and on our 2024 study we showed 35 times better response rates and 43 times better quality of life than standard of care for late stage and complex cancers. That's huge. My mission is to bring together deep precision targeted care so people can get the care they need built on them and not just drug that's a one size fits all. We want you to have the absolute best care and it all starts with regulation. With n of 1 I believe that patients can outperform with on label off label adjuvant phytotherapeutic cellular biologics like cancer cell vaccines when they're custom made on the patient. And as always in this episode, this is for educational purposes. This is not personal medical advice. So please don't change any treatment until you connect with a doctor. So let's get going. Today we're diving into the FDA's history, the commissioners who shaped it and why the old guard often drags its fe changing and why the incoming Trump team with The Commissioner Marty McCary and the Health secretary Robert F. Kennedy has a chance of making a big change in cancer. I'm Very excited about this. We're going to be talking about how the current system was built for averages, the one size fits all, not individuals. And why that's a problem for cancer and cancer patients today. And how to shift instead of a double blind placebo clinical trial, one size fits all to an N of 1. Targeted custom care for each patient, supporting both the best on label, off label adjuvant integrative care and immunotherapies to support patients. This is a game changer. It's worth talking about because treatment is built on the patient, not on a blockbuster drug and enriching only Big pharma. You can't fix what you don't understand. The FDA traces back to 1906 with the Pure Food and Drug Act. After 1936, the Elixir of sulphenamide disaster, Congress mandated safety proof before drugs hit the shelf. They came with this new gold standard called the double blind placebo clinical trial. And it makes sense. By the 1960s, the FDA was all in protecting the public from dangerous junk. But here's the rub. This framework was built for cookie cutter diseases. One size fits all models, not for the complexity and uniqueness we see with cancer and really other chronic diseases. And our scientific understanding of it today is so much more than way back then. Cancer is not uniform. It's a rebellion inside your body. Many different mechanisms going on. And the famous 2011 Hallmarks of Cancer paper detailed six core traits. But in 2022, they updated and expl expanded the picture to include genetics, polymorphisms, epigenetic chaos and all kinds of tumor heterogeneicity. Unique ways and mechanisms that cancers grow, spread and evade. So your breast cancer is nothing like your neighbor's breast cancers. Studies show us that 80% of intratumoral variations exist with mutations. So why are we focusing on giving everybody the same thing? Why aren't we still not focusing on the complexity? And here's the key. And it's because big pharma, big hospitals and big insurance want to continue their monopolies. In my opinion, in standard of care, they're not doing anything wrong. But it's the model they can build. It's what the business was built on. And I think it's been rewarded over many decades. And it's what we have. Unfortunately, patients lose time and important advances that can save and extend life. So how do we fix all this? Here's my answer. It's simple, but a lot of people don't want to hear it. The key is not focusing on the cancer industrial complex but focusing on the patient you that's where n of one trial shine. A single patient and everything's custom tailored and built for you. Custom drug design, the way it's targeted, the way it's delivered, custom immunotherapy design and then using the best data to help the patient heal. This is at the heart of precision oncology. Understand how this works. If you don't have data, you have no way of targeting. If you're just using 30 data points or 24, you might be using the national comprehensive cancer network guidelines which is a one size fits all that all major cancer hospitals use. But once you have thousands of data points, now you bring in artificial intelligence and targeting. And now you can custom build exactly what patients need so you're actually treating the cancer in a much more advanced, sophisticated way to improve response rates and reduce side effects. That's what I see in my clinical experience. And it's happening fast. Not just with DNA next generation sequence mapping, which gives you several hundred data points, but RNA transcriptomics and immune spatial biology. Now you have thousands of data points and you have deep informatics to build and guide. And now design the care that's custom for each patient, what caused their cancer, how to shut it down, how to boost the immune system, how to teach the body to heal itself. And we can do that because we have the technology today. But we have to overcome the current system. Then once the patient patients responding well, we can use circulating tumor cells, methylation scores, CT free DNA track biomarkers in real time and adjust care if we need to with the most difficult cancers. This helps us stay on track, get ahead of the mutations and helps our patients live so much longer. A 2024 meta analysis of N of 1 platforms. These are studies reported substantially better response rates in these heterogeneous solid tumors. These unique cancers better than various standard trial arms. Oncology outlets are now talking about n of 1. But I'm telling have the ability to do this today. And it rewrites the entire rules and helps us to build better care for each patient. When you bring artificial intelligence, you build a digital twin of your tumor and you can predict which combinations might work best. That's where the breakthrough lies. So if all I give artificial intelligence is the basic information of type and stage of tumor, it's not enough. I want to know all the markers and I want it to use a certain mechanism of studying and I want to screen a series of papers and then those need to be reviewed and then the pharmacy has to be able to build the Custom medications and the doctors have to be able to use targeted procedures to deploy the care. See, that's a personalized medical ecosystem, something I spent 25 years building. And this is data driven. It's data over dogma. It's individualized, it's personalized. The key objective is to help people live longer and get far better responses faster. The only obstacle here remains big pharma, big hospitals and big insurance companies that own some of the largest lobbying groups in the world to make sure the system stays. So let's take a deeper look at these relationships that often smell like conflict of interest everywhere. Look no further than the FDA commissioners, the gatekeepers and where their incentives lie. Now, a lot of the people working in FDA are good. I'm just pointing out that there are some relationships here that are questionable. So we saw this with Robert Calif. Biden's commissioner, a Duke cardiologist with deep ties to the industry trials who consulted for major pharma companies both before and after his FDA tenure. Research funding, consulting fees, stock holdings, board seats with Merck, Novartis, Eli Lilly, Johnson Johnson, GlaxoSmith, AstraZeneca, Amgen, Bristol, Meyer Squid. So it just goes on. These are the companies that he was connected with. Now let's move on. Before him we had Scott Gotta Lib who served as Trump's first commissioner. He was criticized for being too cozy with the industry, having sat on Pfizer's board. And after some time the commissioner he accelerated approvals, but mostly for big pharma. New blockbuster drugs, board memberships, post FDA consulting fees, venture capital with Pfizer, Glaxosmith and all these other companies. And so you'll start to see that there's just these relationships with these commissioners and the big pharma companies. That's the problem. This relationship's a little too cozy. And yet at the same time we're trying to bring form healthcare where doctors can direct care to their patients using the latest technologies. So we gotta look at where those incentives lied and where there was conflicts of interest. This emphasis is on cancer and mostly incremental more add on drugs, very little disruption and fundamental models that treats patients as averages, the one size fits all, the gold standard double blind placebo clinical trial that everybody wants to push. So around 90% of oncology drugs are in trial. They still fail because they don't fully account for tumor heterogenicity. The uniqueness of a person's cancer. 2 same cancer, same type and stage will have totally different markers and they're not Accounting for that, the system is designed for a broad market adoption, population, health, not for individuals. And that's what we're missing. And unfortunately to enrich the cancer industrial complex. And you can take that any way you want. It just exists. Big hospitals, big pharma, big insurance and some of these people that have been bouncing back and forth on these organizations playing with big pharma. But hold on to your hats because there's something very exciting happening with the new Trump administration. There's a different kind of pressure. President Trump has tapped Dr. Marty Makary as an FDA commissioner, a John Hopkins surgeon and longtime public critic of the waste and inefficiency in healthcare. Makary doesn't come from the classic pharma insider model mold. He's been vocal about a need to cut through the bureaucracy and bring transparency. He's talked about fast tracking powerful new treatments for cancer. Very exciting. Using real world evidence and artificial intelligence tools to speed the review. Now listen, doesn't this fit beautifully with what I just talked about? The n of 1 so we're getting targeted treatments for patients. I know a lot of the people are very excited about this idea of individualized integrative care and using the right targets to help them, cutting through the red tape, making sure things are safe for patients. But on top of that, we also have the secretary Robert F. Kennedy Jr. Who's pushing harder on conversations about environmental toxins, which is fantastic. Dyes in our food, better safety, transparency peptides. He's very big on custom medications and pharmacies because this is what he uses for his own health. The idea of personalized health care and longevity care is now coming to the forefront and we can do this with lower toxicity and better care. This doesn't mean we have to toss away rigorous science, but we just need to be smarter about putting it all together on an individual patient, not on large population. It means we expand to a better scientific model, individualized care and consider how valid that is to helping people who fail standard of care. Oncology and patients need precision care. This is The N of1 precision oncology model I've been talking about and pret much every single one of my episodes. It's the idea of having targeted care, thousands of markers built on a patient, making it the best targeting you can on label off label adjuvant phytotherapeutic cellular biologics with cancer cell vaccines, nutrition microbiome supporting detoxification. And this is the big difference now pharma and big pharma. It's not the enemy. I mean, they're going to do what they do, but they have some good inventions and good targets, but those need to be filtered through data for each individual patient. In the end, the key in cancer treatment comes down to my opinion, immunotherapy. As soon as your immun can recognize the cancer, it does the work. And that's the key to targeting cancer. Cancer is a personal war. And the targets are personalized. They need precision. And it's important that we seek after a model that helps people get the individual care they need. It's about time. We need precision oncology, not a one size fits all. And we need to respect the biology of everybody's different, unique presentation of their chronic disease so we can help them heal. We don't have to fall into one size fits all standard of care. We can open that up with better testing and better targeting. And that's been my life's work. And that's why I'm so excited, because we're in a special time in history where we can get the best of conventional, the best of integrative, the best of immunotherapy. If we have the markers and the data, we can custom build that. Imagine an FDA that recognizes the high quality observation of data that makes room for these innovations and supporting patients getting well and living longer, not necessarily getting royalties for big pharma. That's the kind of shift I think people are looking for, and it's bipartisan. Everybody wants better healthcare. Everybody's seen or known somebody who's died of cancer in their life, and we want to put an end into that. And we want people to do better with chronic diseases. And if we have the information, let's bring that forth for the individual. This is what fires me up. It's a very exciting time. And if you're excited about this, subscribe, share it with your friends. Because if we do this together, we can make a change in healthcare, the change that's needed. Because the fight of personalized precision healthcare requires a big voice. And the voice is all of us in our families who are fighting to live longer with better quality of life. I hope this was helpful and may the Lord bless you on your journey to healing.