Danielle Lee: Good evening, Jacksonville and happy Saturday. I’m Danielle Lee. Welcome to the conversation with Dr. Ali Kasraeian. As always, you too can join the conversation. Give us a call, 340-1045. How are you today, Dr. Ali?
Ali Kasraeian: I am good. How are you?
Danielle Lee: I’m well. The weather’s kind of making me sleepy so I’m going to try and push through today.
Ali Kasraeian: It’s a great, great day to listen to the radio.
Danielle Lee: Yes, exactly. What’s going on?
Ali Kasraeian: Today I’m excited to have a dear friend of mine, Dr. Sam Brown, in the studio. He’s been on the show before. A renowned in vitro fertilization, or IVF expert, which is something that 2015, CDC said approximately 1.6% of infants born in the United States were born to some kind of assisted reproductive technology. His center, Brown Fertility, offers hope and the possibility to a lot of people that often come into his clinics, I would assume, without hope that there may not be an option for having a baby. That really is the slogan of his clinic, Brown Fertility, is to make miracles happen. I truly believe that’s the case. Thank you for joining us.
Sam Brown: Thanks, Ali. Thanks for having me here.
Ali Kasraeian: Today we’re going to discuss something that’s been all over the media over the past month where unfortunately in early March, two clinics in different parts of the country, renowned clinics, these were not clinics that were without the people that were doing the right thing or trying to do the right thing, had the unfortunate experiences where the storage tanks, basically using liquid nitrogen to keep the embryos and frozen eggs frozen had malfunctions that resulted in a significant amount of loss and a significant amount of just unbelievable heartbreak for the people involved on both sides of the fence. I would assume that the physicians and the people that run those clinics, their hearts were ripped into a million pieces as well because I know you guys take this a lot to heart. What happened?
Sam Brown: Sure. You’re right, the way I like to describe IVF, or in vitro fertilization, or fertility treatments, it’s very sensitive, very dramatic, gets a lot of attention. Every day I have patients that come in with fears about, “Hey doc, am I going to get the right eggs, or the right sperm, or is anything bad going to happen to my embryos?” All day I have to assure patients, dispel myths. In regard to this, it’s very controlled, it’s very regulated way more than people realize. To reassure patients I like to say that if we make a mistake in our clinic, it doesn’t make local news, it makes national news. They should be reassured that you don’t hear of these things that often. You’re right, there’s over 450 IVF centers in the United States and you don’t hear of mishaps that often, maybe every two or three years you’ll hear of something and this is the latest something. This was the latest where the containers that were holding frozen embryos, or frozen sperm, or frozen eggs had an issue and were rendered not usable so it led immediately to national news and a lot of discussion about it.
Ali Kasraeian: The challenge with this is these eggs and embryo are very sensitive. I know in your clinic, I know last year we discussed the amount of regulation and the amount of things you guys do internally to make sure that the temperatures are set, everything’s backed up. There’s immense checks and balance system to prevent things like this happening. Again, the rarity of this, you know 2015 is the last time the CDC put out big national data. At that point, like you mentioned, there were 464 clinics at that time and there were 231,936 cycle of some kind of reproductive technology. Almost 232 thousand cycles producing almost 61 thousand live births of, excuse me, pregnancies of which you had 73 thousand live births. Of those, about 46 thousand cycles were related to getting eggs that were going to be frozen for later use.
I mentioned before, 2015, 1.6% of infants born in the United States every year come from some of these technologies. The rarity of something like this happening across the nation speaks volume to the level of control, and level of regulation, and the level of care from the people that run these clinics to ensure the safety of both the eggs and embryos understanding the amount of work both emotionally and from actually the medical aspects that goes into a woman and her partner going through this partner, or even a man and a partner trying to do this in these day and ages. When you saw this in the news, what was the first thing that you thought?
Sam Brown: First thing I thought of was, I had an opposite feeling. I felt, it reassured me almost just how rare this is. With all the fertility centers, like you mentioned, in the United States, and in the world abroad, 10 million babies have been born from IVF almost. When you hear these rare events, I would challenge that with our regulations and protocols that accidents probably happen way less than the airline industry, way, way less than 1% of centers have these things happen. I definitely want to dispel fear in patients who have pursued IVF or infertility treatments, for sure, it’s a very, very safe process. Also, how common it is. You’re right, 10% of the population in general pursues fertility treatments so my goal is to dispel fear and make this real. Coming on air today to show how rare of an event this is, and how that patients can feel comfort in the safety and security with the regulations that we have in place with IVF and storage.
Ali Kasraeian: One of the things that they mentioned in the Cleveland, and one thing that the media kind of talks about is the Cleveland Clinic, and it’s not the Cleveland Clinic, a clinic of University Hospitals Clinic System in the Cleveland area who lost about four thousand embryos affecting 950 families, they’re very transparent and have done a lot to try to help in a situation that is very, very glim in a lot of people’s eyes. The California clinics have not been, have been criticized for not necessarily being as open with what they’re doing. The discussions here were that in Cleveland, an alarm system that was supposed to alert staff to changes in temperature was shut off, or malfunctioned in some kind of way, resulting in this problem.
One, I would assume that coming off of this internally, IVF clinics are going to probably do more to make sure this doesn’t happen to them. Secondarily, do you think that the national regulations are going to look at this stuff a little bit more closely? Both of these clinics were accredited with associations that do bi-year, every two years they go and get regulated by the College of American Pathologists, which is not something mandated.
Sam Brown: Right.
Ali Kasraeian: It’s something they chose to do to make sure that they’re regulated. Every two years, people are coming and checking systems. It’s not something like these clinics were just kind of half hazard and not getting regulated.
Sam Brown: Exactly. Fertility centers are very regulated and it wasn’t the fact of under regulation. With humans, it’s never going to be perfect, it’s never going to be 100% type thing. You’re going to have these rare, rare events. To me, the unfortunate thing would be more regulation. We are burdened as much as a liver transplant center would be by the FDA. The federal government comes into our offices every year or two and makes sure that we’re regulated properly. By state regulation, even at the state level, they come in to make sure that we have a high complexity lab director, and all the things that go in are involved with an embryology lab are run properly. There’s many layers of regulation, not just one regulator, we probably have five regulators. We are, I hope that there’s no extra regulation that comes out of this.
Ali Kasraeian: That could hurt more than help.
Sam Brown: I think it will hurt more than help, it will raise more costs and the process in place to prevent this from happening is pretty dramatic. We all have sensors on these storage facilities and storage tanks, and when these embryos are bathed in liquid nitrogen, they’re actually good for a month at a time. They only have to be reevaluated once a month or so to make sure that the proper level of coolant is in the tanks. It takes minimal amount of effort to keep them rolling. What probably happened at the Cleveland Clinic, or the center that was involved was multi-level error. We know that in medicine you have a chain of mistakes that lead to an error, and they had a breakdown of …