--:-- Sean Rameswaram: There's a feeling you get when you walk down Chicago's magnificent mile for the first time. It's like the feeling you get when you discover that there's a wine country in Illinois, or the feeling when you're rock climbing in the Garden of the Gods in Shawnee National Forest. That feeling is amazing, and you can find it at enjoyillinois.com. Illinois, are you up for amazing?
--:-- Sean Rameswaram: It's one of the most promising breakthroughs perhaps in the history of medicine. It's also one of the most controversial. It's stem cell therapy. Medical breakthroughs are improving our lives almost every day. One of the most exciting and fastest growing areas is the use of stem cells.
--:-- [Music continues in the background]
--:-- Sean Rameswaram: This week researchers said they may have developed a way to help patients with diabetes produce their own insulin using stem cells. For sufferers of multiple sclerosis, there's been some very welcome news. A breakthrough treatment using stem cells is having truly remarkable results.
--:-- Sean Rameswaram: I've had a shot into my shoulder. I had a shoulder injury. I had a shot into my shoulder and, dude, you heal like Wolverine. It's the craziest fucking thing ever. I was like that close to getting shoulder surgery. Stem cells sound great.
--:-- [Music continues in the background]
--:-- Sean Rameswaram: Yeah, I think this whole industry comes from hearing the word stem cell and thinking, oh, magic, stem cells can do everything. And the problem is that there are many different types of stem cells. And to be fair, some of those types are great. Truly, embryonic stem cells are amazing because they make everything in our body.
--:-- Sean Rameswaram: But that power only happens in the womb. Like a skin stem cell that I have now is not going to naturally turn into a lung cell. A lung cell is not going to naturally turn into a brain cell. So they kind of get tracked. Right now, outside of the womb and science fiction, there's only one kind of actual proven stem cell treatment.
--:-- [Music continues in the background]
--:-- Sean Rameswaram: The only scientifically established treatments right now that rely on stem cells are all about blood. That takes blood stem cells in the bone marrow and uses them to reconstitute someone's blood system. But there's this other type out there that's becoming a bit of a nightmare.
--:-- Sean Rameswaram: Caroline Chen has been reporting on it for ProPublica. I really focused on birth tissue stem cells where they take a birth tissue donation, So placenta from a mom or amniotic fluid, umbilical cord. And they basically grind it up and they say, oh, there's stem cells in here. And then they give them to you via either an injection or IV.
--:-- [Music continues in the background]
--:-- Sean Rameswaram: And here's where the claims start getting really well. They're like, oh, there's stem cells in these products and they can treat everything. One way to explain what's happening there is just to tell you about a seminar that I went to in Texas.
--:-- Sean Rameswaram: I had a speaker called Dr. Green, and he said, you can consider stem cell treatment for arthritis, tendinitis, lupus, hair loss, facial wrinkles, scarring, erectile dysfunction, heart failure, cardiomyopathy, chronic obstructive pulmonary disease, asthma, stroke, should I keep going, Alzheimer's, multiple sclerosis, diabetes, dry eye, kidney failure. Everything. Literally being marketed for everything.
--:-- [Music continues in the background]
--:-- Sean Rameswaram: Then they say, and you know, you can come to our clinic and we can give you an injection or we can give you an IV. And you're going to have to pay $5,000, usually $5,000 to $9,000 for an injection, more than $10,000 for an IV. And none of these are FDA approved at all.
--:-- Sean Rameswaram: And how does a guy like Dr. Green get this stuff? Typically, this is before a scheduled C-section. Someone comes into the room and says, hey, do you want to donate your placenta? You know, otherwise it'd go in the trash. And these placenta, sometimes umbilical cords, sometimes amniotic fluid, sometimes the amniotic membrane, which surrounds the baby, all get collected.
--:-- [Music continues in the background]
--:-- Sean Rameswaram: These are donated for free. And some of them end up in the hands of manufacturers that make so-called stem cell treatments. And so it's like a vial of basically ground up birth tissue. And the theory is here that a vial of ground-up birth tissue can basically solve any health issue you have?
--:-- Sean Rameswaram: Yeah, so at the seminar I was at they said you know every vial has 10 million live stem cells And they said well the stem cells you know once they in you they know where to go You know they will hone in on sites of inflammation and they get signals from that site to say oh, you should turn into cartilage or you need to turn into kidney cells or whatever it is you need and that they know what to do.
--:-- [Music continues in the background]
--:-- Sean Rameswaram: They know what to turn into and that they can regenerate whatever it is you need. And that sounds really compelling, right? Sounds like what a stem cell will do. But naturally, adult stem cells aren't going to like switch types. So there's no evidence to show that, you know, I can take a bunch of stem cells from your birth tissue from a placenta and that it will know how to turn into a kidney cell.
--:-- Sean Rameswaram: How are people like Dr. Green pulling off this pseudoscience with baby waste? Well, first of all, I would say they sell it because they're very savvy. And it sounds really good, and it sounds scientific, and they use a lot of scientific terms. And they also even bring up, what sounds like really good statistics.
--:-- [Music continues in the background]
--:-- Sean Rameswaram: So at the seminar I was at, they said 85% of patients benefit exceptionally from the treatment. And afterwards, I asked Dr. Green, I said, where did that 85% number come from? Do you have a trial you can point to? And he was like, well, you know, I didn't say it came from a clinical trial. You know, this is like anecdotal evidence, from patients I've talked to.
--:-- Sean Rameswaram: There's often this sort of sheen of pseudoscience where they talk a lot about, what sounds like fancy numbers or use a lot of scientific jargon. And at one point they played a video of a trial done at Stanford on patients who had had a stroke. And they were like, you've got to see this video.
--:-- [Music continues in the background]
--:-- Sean Rameswaram: But just one day after an experimental treatment, Sonia could lift her arm over her head. Can you move it to the side? And move it to the side. Are you kidding me? And also to the front. And her words began to flow. I woke up and immediately I could speak better. She's what we call one of our miracle patients.
--:-- Sean Rameswaram: And what was not made clear to anybody there is that none of those patients had gotten birth tissue stem cells, amniotic stem cells. Like the patients in that trial had gotten, you know, highly genetically modified specialized cells that had been like carefully made in a lab.
--:-- [Music continues in the background]
--:-- Sean Rameswaram: And so what they were being shown in this video, which was amazing, was not the product that they were being sold. But how could you tell the difference, right? Like if you're a layperson, you're sitting there, you're like, oh, I just watched this video on stem cells. Looks great. This clinic is offering me stem cells. I don't think it's reasonable to expect an average person to know the difference.
--:-- Sean Rameswaram: So people are definitely being misled. Could it also be dangerous for people to go through these kinds of treatments? Yeah. Like somebody might say, oh, well, you know, like I've got $7,000 to spare. Why shouldn't I just try it to see if it helps me? Because my neighbor said it helped them.
--:-- [Music continues in the background]
--:-- Sean Rameswaram: And the reason why I would caution patients is because you could be harmed. So these are not FDA approved, which means there's nobody watching these manufacturers to make sure that they are making these products properly or in a clean way. And we don't really know what's in it.
--:-- Sean Rameswaram: And there was a case last year where a batch of these products got contaminated and ended up giving some patients really, really bad infections. Like E. coli was found in some of these products, for example. And I talked to the daughter of a woman who had gotten them injected into her spine. And she ended up nearly dying.
--:-- [Music continues in the background]
--:-- Sean Rameswaram: She had to be life-flighted to a hospital in Houston and spent, I think, about like seven weeks total in hospital and rehab, and she's still recovering today. You'll see testimonials by patients online or there are people who have said they've been helped by these stem cell treatments.
--:-- Sean Rameswaram: And I don't want to discount their experience. It could be that there's something in birth tissue that is helpful, but we won't know until we actually run the trials. So we're kind of at that stage where there have been certain little hints here and there that there could be some positive outcomes.
--:-- [Music continues in the background]
--:-- Sean Rameswaram: But then on the other hand, there are other studies that have been done that have been negative, right? So you can't cherry pick science here. The only way to know is to do more and bigger trials. And that has not been done at all. There are many theories. We have no answers.
--:-- Sean Rameswaram: So you paid five grand for some stem cells to treat your arthritis and nothing happened. Now what? Sean Ramos from Lawsuits and Regulation after the break on Today Explained.
--:-- [Music continues in the background]
--:-- Sean Rameswaram: The fine people at the Illinois Office of Tourism would like me to tell you a few amazing things about the state of Illinois. Amazing art, like Cloud Gate in Millennium Park, or the Paul Bunyan statue in Atlanta, Illinois. Did you know there was in Atlanta, Illinois? Amazing. Amazing food at a five-star restaurant in the West Loop, or award-winning barbecue in Murfreesboro. Did you know there was a place called Murfreesboro in Illinois? Amazing.
--:-- Sean Rameswaram: Amazing outdoors like canoeing the Cache River or kayaking the Chicago River. Amazing history like Lincoln's home in Springfield. Or that German U-boat in the Museum of Science and Industry. It is amazing what you can find in Illinois. Visit enjoyillinois.com and find your own amazing Illinois. Illinois, are you up for amazing?
--:-- [Music continues in the background]
--:-- Caroline Chen: Caroline, what's the FDA's plan to regulate stem cell clinics? Yeah, so I think, honestly, the FDA was caught by surprise here with how fast this industry has grown. So they do have laws on the books that say if you are trying to use, say, a placenta product and saying this is going to treat something like Alzheimer's, Alzheimer's, you know, basically where the original use of the product is totally different from what you are using it to do and to treat disease. That's a drug.
--:-- Caroline Chen: So the FDA says that's a drug, which means you need to go through the drug review process, which is multiple clinical trials, hundreds of people usually, and also is a process that typically costs hundreds of millions of dollars. But for a long time, the FDA said, OK, you self-identify. So they left it up to the manufacturers to decide for themselves.
--:-- [Music continues in the background]
--:-- Caroline Chen: And you can guess what a manufacturer would then do, which is say, I'm not a drug. Why would I spend that money? And especially when people are already paying me for this product. And so only in the last couple years has the FDA kind of realized that this has gotten way out of hand.
--:-- Caroline Chen: And I talked to the former FDA commissioner, Scott Gottlieb, and he said that for a long time, the FDA sort of, their term is used enforcement discretion, which means they kind of had more of a laissez-faire attitude here. And then he said, and then the field grew, and now it becomes hard to step in and actually apply the regulation.
--:-- [Music continues in the background]
--:-- Caroline Chen: Did the FDA just not see this being such a profitable enterprise for people? Early on, for the most part, these clinics were just doing joints, you know, where they're like, oh, you have some knee pain. I'm going to take some of your fat out of you and centrifuge it and say, oh, there's stem cells here. I'm going to stick it back in your knee. And that was, relatively speaking, low risk.
--:-- Caroline Chen: So for the FDA, that was like not the biggest priority. Now that these clinics have grown and they're getting bolder, they're doing things like giving people injections to their spine, giving people injections into their eye, offering this up for Alzheimer's or Parkinson's disease where it's being delivered to people's brains. And then the risk of something really bad happening grows.
--:-- [Music continues in the background]
--:-- Caroline Chen: And so I think this is the point at which the FDA has been like, oh, this is not good. We really need to step it up. Have they said that? Well, they've basically said that because they issued the new guidelines and they have started to go after some companies. But I have to say, you know, the FDA is now playing catch up.
--:-- Caroline Chen: And Scott Gottlieb pretty much said to me, well, we can't go after hundreds of clinics at once. They just don't have the resources. So they're going to go after the ones that are riskiest first. Had there been any customers who said like this was a total crock? Yeah. So I talked to the family of a guy called Norman Graff in North Dakota.
--:-- [Music continues in the background]
--:-- Caroline Chen: And he was 90 years old when he went to one of these seminars. And he was convinced that this would help his arthritic pain. And they really hustled him. So his daughter said that he thought he was going to go home and think about it. But they were like, oh, you should do this today. And so he got the treatment that day.
--:-- Caroline Chen: And his daughter said, you know, he's 90 years old. Unfortunately, he's not totally able to make these decisions himself. So they really felt like he was preyed upon. And so they filed a complaint with the North Dakota Attorney General. And the AG actually got a number of complaints from different patients And so they stepped in and told the clinic that you sell any stem cell products that haven't been FDA approved and got the money returned to those patients
--:-- Caroline Chen: But the clinic that Norman Graf went to, west to north, has actually other locations outside of North Dakota. And they haven't stopped selling these products in their other locations. So can you see why this gets quite tricky, right? Because, you know, the North Dakota AG is not going to go after them in Colorado. And this is where the FDA needs to come in. Right.
--:-- [Music continues in the background]
--:-- Caroline Chen: Well, the FDA is stepping up what they call warning letters, which is where they send a letter to a company and says, you know, we're giving you a warning. You're not in compliance. That does not shut down a company, but it sort of lays the groundwork for if you don't comply, the FDA can come in and shut you down.
--:-- Caroline Chen: So they set up updated guidelines in the end of 2017, which made it really clear when you have to come in and declare yourself as a drug. But they've given clinics another three years to get in line. So until 2020. And the FDA has also filed two injunction lawsuits against two pretty big companies that do fat stem cells. One is based in California, and I believe the other one is based in Florida. And those are ongoing lawsuits.
--:-- [Music continues in the background]
--:-- Caroline Chen: So I'm really interested to see what happens in 2020. Like, does the FDA have the resources and the willpower and a plan to really take action in 2020 against everybody who's not in compliance? I think that remains to be seen. And in the meantime, like what's a desperate person who, you know, has tried everything and thinks maybe the stem cell clinic is my last resort? What's a person like that to do?
--:-- Caroline Chen: So often the patients who go to stem cell clinics are really at the end of the road. So they're in a lot of pain. They've tried a lot of different medications and they really feel desperate and at the end of their rope. So one thing I would mention is there are stem cell trials that are happening at a bunch of different academic universities.
--:-- [Music continues in the background]
--:-- Caroline Chen: And you could always ask your doctor. Hey, so are there any stem cell trials happening for my condition? The key thing here is if you join a trial, you should not have to pay for the treatment. And someone should explain to you what the possible benefits are and what the possible risks are. And you should sign what's called like an informed consent form.
--:-- Sean Rameswaram: Caroline Chen reports on health care at ProPublica. She's continuing her work on stem cells, so if you're a mom who has recently donated your birth tissue or someone who has been to a stem cell clinic and had a good or a bad experience, she would love to hear from you. Her email is caroline.chen at propublica.org. Or you can find her on Twitter at carolineylchen.
--:-- [Music continues in the background]
--:-- Sean Rameswaram: You can find Today Explained on Twitter at today underscore explained. Before we go, one last reminder that there's a feeling you get when you walk down Chicago's Magnificent Mile for the first time. It's like the feeling you get when you discover that there's a wine country in Illinois, or the feeling when you're rock climbing in the Garden of the Gods in Shawnee National Forest. That feeling is amazing, and you can find it at enjoyillinois.com. Illinois, are you up for amazing?
