In this episode of the Growing a Successful Orthopedic Practice Podcast, Jeff Segal, M.D., J.D., CEO and Founder of Medical Justice, joins Keith Landry to discuss how orthopedic physicians can use stem-cell therapies and other cutting edge treatments in their practices while limiting liability.
Dr. Segal explains if a physician manipulates stem cells and puts them back into the body to serve a different purpose than the original one, the FDA treats that like a drug and will likely require a new drug application. He reminds us a physician’s claims about the benefits of stem-cell therapy must be supported by medical literature.
Tune in to discover:
- State boards of medicine are now getting involved to regulate stem-cell therapy
- Consult with a health law attorney to understand your role in using stem cells
- Physicians who offer stem-cell therapy need to work with a vendor with a great reputation
- Clearly explain the benefits and other factors before using PRP treatments
- How exaggerated claims about stem cell benefits have the FDA taking a hands on approach to regulation
About Dr. Jeff Segal
Dr. Jeff Segal, Chief Executive Officer and Founder of Medical Justice, is a board-certified neurosurgeon. He was a practicing neurosurgeon for approximately ten years, during which time he also played an active role as a participant on various state-sanctioned medical review panels designed to decrease the incidence of meritless medical malpractice cases. Dr. Segal holds a M.D. from Baylor College of Medicine, where he also completed a neurosurgical residence. Dr. Segal also graduated with a J.D. from Concord Law School with highest honors. He is also a partner at Byrd Adatto, a national business and health care law firm.
About Keith Landry
Keith Landry is Director of Public Relations at Insight Marketing Group. Keith has been a public relations consultant since 2010. He has more than 26 years of experience as a news anchor, news reporter and public affairs show host, which he uses to implement innovative public relations strategies for medical practice clients.
Episode Transcription
Dr. Jeff Siegel: But the FDA is still paying attention to this. They’re saying it needs to be regulated. They’re saying that if you’re injecting something, even from your own body, that’s been anything beyond minimally manipulated and you’re doing it not for the same reason you took it out, so if you’re pulling fat out, it’s not acting like that, but it’s acting as the fountain of youth to deliver all of these youthful humors to regenerate parts of the body, the FDA is stating that ultimately a new drug application needs to be filed.
Speaker 2: Welcome to the Growing a Successful Orthopedic Practice podcast. Join us every episode to hear from fellow medical practice administrators, staff, and physicians as we break down current issues affecting the industry and share real stories from guests on their way to growing a successful orthopedic practice. Let’s get started.
Keith Landry: Hello, everyone. I’m Keith Landry. Welcome to Growing a Successful Orthopedic Practice podcast, keeping our physicians and practice managers attuned to the very latest trends in the orthopedic world, helping you learn from mistakes and grow along the way. And we have got a literally, and I’m using the term brilliant literally, guest today, Dr. Jeff Siegel, the CEO of Medical Justice Services. We’re going to talk today about using cutting edge treatments while limiting liability in your practice. And when I say that Dr. Siegel is brilliant, I say that because he was a practicing brain surgeon for 10 years and then turned around and became an attorney who now leads the way for doctors across the country in protecting them against frivolous lawsuits. So if we wrote your biography now, it’d already be an interesting story, Dr. Siegel.
Dr. Jeff Siegel: You’re better than my mom here. This is awesome. Thank you. Great to be with you.
Keith Landry: Well, I’ve got to give credit where it’s due and I love intellectuality. Let me give folks just a little background about you. Dr. Siegel is a board certified neurosurgeon trained at Baylor College of Medicine, graduated from Concord Law School with highest honors. Imagine the diplomas on his wall, right? Dr. Siegel’s a partner with Byrd Adato Law Firm. Now the main passion of his life and what he’s focused on now is he launched Medical Justice in 2002. He’s a physician-based organization focused on keeping doctors from being sued for frivolous reasons. And we really just want to dig into some of these things here today. I love having you on the podcast. I’m intrigued by the fact that we can even do an episode that relates to using cutting edge treatments while limiting liability, because we’ll talk a little bit about stem cell research today and stem cell treatments, and then PRP treatments as well, platelet rich plasma treatment. So this stuff is so cutting edge that I challenge myself to find a better guest about this than you. So let me say welcome.
Dr. Jeff Siegel: Thank you so much. Great to be with you today.
Keith Landry: You bet. So let’s dive right in first. Let’s talk about what stem cell treatments are, when they’re most commonly used today, and how far they’ve come. I remember back in President Bush’s era there was a lot of controversy over the government’s position limiting the use of them. So how far have we come over the decades in using stem cell treatments in doctor’s practices?
Dr. Jeff Siegel: Well, stem cells are an exciting therapeutic. We’re still learning much more about what they’re capable of doing. In fact, in our backyard, I live in North Carolina and right next door to me is the Wake Forest Institute for Regenerative Medicine, where they are actually growing organs. They’re taking stem cells and they’re putting them on scaffolds and creating bladders, they’re creating kidneys, they’re creating blood vessels. So it is interesting that stem cells can be used as a substitute for transplantation as the most cutting edge example. Because certainly there’s a shortage of donors for hearts. Most people who need a heart go without. So these are interesting methodologies.
Number two is that stem cells have interesting biologic property. They can repair tissue. They can create or excrete, exude various biologic substances that move the needle within a body, allow the body to heal. And we could speak for hours on the different types of STEM cells, but let’s kind of narrow it down to those taken out of your own body and implanted back in your own body, or those from another person, typically embryonic stem cells or the more mature type of stem cells. So either autologous, meaning come from your own body and they’re implanted back in your own body, or they are sitting on a shelf somewhere and then placed into your own body.
So those are two different buckets. The ones that start in another human being’s body, unless that issue does exactly what it was intended to do, structurally that’s a heavily, heavily regulated domain. Let me give an example of a tissue that all orthopedic surgeons will be familiar with that come from another body that go into your body, which could be bone graft. So if you’re having a spinal fusion and you’re trying to prop up the space between two vertebrae, you don’t want to take it from your own patient because it causes pain and other complications, you can transplant that from my bone bank. That’s still regulated, but it’s designed to do precisely what it did in the original person’s body, which is to give structural support.
Where this becomes a little bit more interesting is when people implant a stem cell after it’s been manipulated and it refurbishes or regenerates new tissue due to the properties of that. So instead of serving as a structural support, it’s actually releasing all of these youthful chemicals, and I’m simplifying this, to allow the body to get back to its more youthful state and turn on cells in that neighborhood to regenerate. So instead of forming scar, it would form functional tissue. And I’ll give an example, like cartilage, the goal would be to take some type of stem cell, implant it into the joint space of the knee for example, and take the bone on bone, well actually want to get to it before it devolves to that point, and then ultimately have some of the remnants of the cartilage turned into new youthful cartilage. That is regulated, and it’s going to be more and more regulated over time. Why? Because it has the look and feel of a drug.
Now I can say that stem cells were the wild west for the past several years, meaning that you would take tissue out, like fat from a patient’s body, you would wash it down and have stem cells from a patient’s fat injected back in the patient’s body, and make claims that it can cure you after a heart attack, it will grow new cartilage, it will do everything under the sun. So what happened over time? Well, the regulatory bodies, in particular the Food and Drug Administration said it starting to have the look and feel of a drug. And if it truly is a drug, it needs to be tested like a drug, meaning it’s got to go through the various clinical trials and you’ve got to submit a data packet to the Food and Drug Administration. And then ultimately they’ll make a decision as to whether it can be sold and marketed in interstate commerce.
Now, what about if you’re taking cells from your own body and putting it back into your own body, but it still has all of these wonderful claims? It’s been a gray zone. But the FDA is still paying attention to this. They’re saying it needs to be regulated. They’re saying that if you’re injecting something, even from your own body that’s then anything beyond minimally manipulated, and you’re doing it not for the same reason you took it out, so if you’re pulling fat out, it’s not acting like fat, but it’s acting as the fountain of youth to deliver all of these youthful humors to regenerate parts of the body, the FDA is stating that ultimately a new drug application needs to be filed. It’s a very formal and expensive process.
Now, why hasn’t the law come down on so many people who have been doing this? Well, it is now. So what happened? I think many wild and exaggerated claims were made. Stem cell clinics popped up all across the country because there’s so much money to be made. They were charging cash out of pocket. Some of the regulatory bodies thought that innocent people were being victimized, if you will.
Keith Landry: [inaudible 00:00:08:14].
Dr. Jeff Siegel: Yeah. And then ultimately several people were harmed. What happened? There was an article published in New England Journal of Medicine, I’d say a year ago, maybe longer, where the claim was that stem cells were being used to reverse blindness or macular degeneration. And unfortunately several people became blind from the injections. And it probably wasn’t related to the injection itself, meaning it wasn’t the trauma of the needle, because there are already injectables that are FDA approved that go into the eye. So it likely wasn’t that. But it likely was how the tissues were being manipulated and the chemicals or the diluents that were used to make this happen. But I think the FDA took notice and started filing actions against select stem cell clinics. And now we’re seeing litigation happening. We’re also seeing boards of medicine getting involved too.
So there’s a lot of action out there. Now, the FDA has not delivered its final word. They recently gave organizations, offices, and entities up to summer of 2020 to come clean, if you will. To the extent you’re going to be playing in this space, you need to file the proper applications. But this summer they said, “Well, we’ll give you one more year.” So you’ve got one more year before the FDA finally does pull the hammer down on this.
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Keith Landry: So let me throw out a quick scenario. Let’s say I’m listening to this podcast and I’m an orthopedic physician, and of course I want to give the most cutting edge treatments to my patients to give them the greatest outcomes. How do I weigh that with the potential liability of using stem cell treatments?
Dr. Jeff Siegel: If it’s stem cells, you need to A, be working with a good vendor, one who’s got a stellar reputation, is trying to dot all the Is and cross the Ts. That’s number one. Number two, you need to have a consultation with a health law attorney, better understanding what is your role to stay safe. Certainly clinical trials happen all across the country for all types of things, pharmaceuticals, medical devices, and also stem cells. So there’s no reason you should preclude yourself from participating in this. I think the question is what are the claims that are being made? Are they fantastical claims? You making a fortune doing this? Or is it market rate and the claims are quite reasonable and they can be supported by the literature? Then have a healthcare attorney bless your role in it so that you’re doing it properly. Does it need to be done under IRB? Does it need to be done under cover of a new drug application for the organization? Or none of the above? But you don’t want to go flying blind on this because if and when the FDA comes calling to your office, you don’t want that to be a surprise. You’d like to say, “We knew you were coming, we’ve everything properly.”
Keith Landry: Yeah, that was not the Girl Scouts knocking on the door selling cookies if it’s the FDA.
Dr. Jeff Siegel: It was not. And look, this stuff is complaint driven, meaning they’re not knocking on everyone’s door right now, but in the cash pay field where there’s a lot of money at stake and the claims are quite great and desperate people are seeking your help, it’s not a crazy idea for a disgruntled patient or even a family member to file a complaint either with the FDA or more likely with the Board of Medicine. And since you need your license to practice, the last thing you want is the board sniffing around and stating that you’re violating a number of professional dictates.
Keith Landry: So let’s talk about another cutting-edge treatment that could potentially bring some liability. And we’re seeing so much of this these days, and that’s the use of platelet rich plasma treatments, more commonly referred to as PRP treatments. I’d like you to explain, Dr. Siegel, what those are. Most of our listeners probably know, but let’s just give them some insights on what they are and then where you think it’s going and the potential liability.
Dr. Jeff Siegel: So PRP has been around for a long time. If you look at the literature, it goes back decades. People have tried platelet rich plasma. Essentially they are pulling out the patient’s own blood and spinning it down so there’s a healthy amount of platelets, highly concentrated. And the plasma plus the platelets are releasing a number of chemicals to accelerate regenerative properties. It could be mucking around with the inflammation pathways. Nobody really knows precisely how it works, but there’s enough information out there to suggest that some people do really well with it. And certainly very high profile people such as professional athletes have sworn by it. So there’s enough out there and I think there’s enough literature to suggest that it works. It doesn’t work to treat everything, but I think it’s defendable.
Now the challenge with PRP is that it’s not entirely different than the stem cell dilemma. But here, of course, you’re taking the patient’s own plasma, their own platelets, and you’re just giving it back to them. In a sense, it’s almost like a blood transfusion. But you are using it for a different purpose. I think the limitations are not as severe as they would be for stem cells. I have heard from the Federation of State Medical Boards that they believe, and it’s their kind of global position, that PRP is still considered an investigational type of process. And if you want to do it, they think it should be done under cover of IRB. So IRB just means it’s been vetted by an investigational research board and the risk is reasonable. The patient understands that it’s still kind of investigational and that there’s a proper consent. It’s not much more than that, just meaning that it’s been vetted and likely it would be vetted and cleared and that there’s a proper consent form.
Those are the details that I’d start thinking about. Again, chat with a healthcare attorney just so they can bless it. This is a fast moving field, but I know that the boards of medicine are just getting interested. Why? Again, cash pay. A lot of fantastic claims associated with it, more than just helping with some joint discomfort. If you see people using it for everything under the sun, eventually you’re going to find someone who’s not happy. They’re going to file a complaint to the board, and then you’ve got to defend it.
Keith Landry: This is a fascinating topic, I think. And we could talk about this for two hours. But this was sort of a mini podcast on this one, cutting edge treatments with limiting liability. Can folks get more insights from you on this through your website and other platforms?
Dr. Jeff Siegel: Yes. So our website is medicaljustice.com. That’s medical justice.com. You can email us at info@medicaljustice.com or call us at 877-MED-JUST, that’s M-E-D, J-U-S-T. I will also close by saying that our general counsel has spent a lot of detail on this topic, working and having spoken with FDA, and understands this topic on a much deeper level than I do. Most of the information that I’ve been talking about, I have parroted from his lips. But his name is Mike [inaudible] and he probably has an order of magnitude more understanding of the evolving issues with stem cells and PRP than I do.
Keith Landry: Just an absolutely fascinating topic and will continue to be. Dr. Jeff Siegel, the CEO of Medical Justice Services, love chatting with you, love your insights, and we’re going to have you back for another podcast soon.
Dr. Jeff Siegel: Awesome. Thank you.
Keith Landry: Thanks folks for listening to another episode of the Growing a Successful Orthopedic Practice podcast. I know you got something out of that today because that was so cutting edge that I’m just doing a little dance over here. Thanks for joining us.
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