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SPEAKER_04: He was very disturbed by the movements because other kids would make fun of him.
SPEAKER_08: David's teachers often got upset with him in class.
SPEAKER_04: So you can imagine the torture that he went through.
SPEAKER_03: One Sunday morning when David was eight, Abby watched him try to read the funnies. But he couldn't keep his head steady enough. It was heartbreaking.
SPEAKER_08: He met producer Dan Wiseman, the host of a new podcast about the cost of health care, called An Arm and a Leg.
SPEAKER_03: Watching David struggle with the comics, Abby was ready to cry. She put off doing the dishes, sat down, and picked up another section of the paper. And through total coincidence, there was an article about a teenager who had symptoms just like David's. Facial tics, weird noises, flailing limbs.
SPEAKER_04: I stood up and I yelled for my husband and I said, you have to read this. This is what David has.
SPEAKER_03: Abby and her husband brought the article to David's pediatrician. And the doctor agreed. This story described exactly what David had. This condition will sound familiar to you, but at the time most people, even doctors, had never heard of it. It was called Tourette syndrome.
SPEAKER_04: When I was talking to doctors, many doctors after that, they said they never heard of it because they simply were not taught very much about rare diseases in medical school.
SPEAKER_03: And back then, when so few people had heard of it, Tourette's was considered super rare. It just seemed bizarre to me that I got a diagnosis out of a Sunday newspaper.
SPEAKER_03: From there, Abby found a specialist, who eventually turned her on to a potential treatment for Tourette syndrome that was being tested out in clinical trials. Well, it wasn't being tested for Tourette's. The drug company was mainly hoping to market this drug for schizophrenia. The particular drug had been made available in Europe for a while and doctors knew it worked on Tourette's.
SPEAKER_04: So David got in on a trial for this drug with the hopes that it could be approved in the U.S.
SPEAKER_08: And it turned out it worked really well for him.
SPEAKER_03: But the drug trials didn't go as well for schizophrenia, which was supposed to be its more common use. So the drug company decided the market wasn't big enough. They just dropped the drug entirely.
SPEAKER_04: And so companies just said no, they wouldn't do it.
SPEAKER_08: They wouldn't make the drug, they wouldn't sell it. And this is how Abby learned a term that would define the next few decades of her life.
SPEAKER_04: Orphan drugs.
SPEAKER_08: Orphan drugs.
SPEAKER_03: As Abby learned, drug companies weren't interested in developing treatments for rare conditions. Because the big money was in drugs with tons of customers. Antibiotics are drugs for stuff like diabetes, high cholesterol. They just didn't think selling a drug for Tourette's would be a big money maker.
SPEAKER_08: So promising treatments like the one that had been working for David became orphan drugs. With no pharma company to raise them.
SPEAKER_03: To keep herself from going nuts with frustration, Abby Myers joined the Tourette's Syndrome Association. It was pretty small. They immediately invited her to join the board and asked her what she wanted to be in charge of. I assured that that would have become the fundraiser or the arranger of special dinners or anything like that.
SPEAKER_04: And I wasn't a doctor, so I didn't want to do the research end of it. That left lobbying and advocacy, spreading awareness.
SPEAKER_08: Abby started figuring out how to do that. And she found a mentor. Her name was Marjorie Guthrie.
SPEAKER_03: Marjorie was the widow of Woody Guthrie, the iconic American folk singer who wrote the song, This Land is Your Land.
SPEAKER_08: Woody had died in the 1960s of Huntington's, another rare disease. She was on a mission for her whole life, which was to find the answers for Huntington's disease.
SPEAKER_03: Marjorie was great at it. By the time Abby Myers started lobbying, everybody connected with rare diseases knew Marjorie Guthrie. Abby took note of one of Marjorie's best tricks. Marjorie would be talking with scientists or pharma executives, and they'd be using technical jargon.
SPEAKER_04: She'd say, please talk to me in plain English. I'm just a housewife.
SPEAKER_08: And they would. And when experts couldn't hide behind technical jargon, Marjorie Guthrie would pin them down, put them on the record, and use their words as ammunition. For instance, she could get experts to explain exactly how promising a proposed drug might be, and why they wouldn't sell it.
SPEAKER_03: And all of that would be in there, in plain English.
SPEAKER_04: So when Abby started meeting with government officials, she introduced herself the same way. Just a housewife.
SPEAKER_03: She figured it wouldn't be a bad thing to let them underestimate her a little. I found that people wanted to think about a woman as somebody who's just trying to raise her kids. She's just a housewife.
SPEAKER_08: By June 1980, Abby and Marjorie and their allies got a California congressman to hold a hearing to call attention to the problem of orphan drugs. This was their big chance to finally have a national audience to put pharma companies on the spot, to make them face the patients who were waiting for treatments.
SPEAKER_03: Maybe this hearing could really change things.
SPEAKER_04: Well, nobody from the pharmaceutical industry showed up.
SPEAKER_03: Also, hardly any elected representatives showed up. Well, no Republicans at all showed up. Maybe one or two congressmen stuck their head in and sat down for five minutes and then left.
SPEAKER_04: The gallery was pretty empty, too.
SPEAKER_08: It was like nobody was there except the very, very last row in the room. A young man was sitting there, and I had no idea who he was.
SPEAKER_04: And it turned out that he was a reporter for the Los Angeles Times. That reporter was there because for him, it was a local story.
SPEAKER_03: One of the people testifying, a teenage boy with Tourette's, was from Los Angeles. It resulted in a very short story, buried in the middle of the paper, where nobody was likely to see it. Except somebody did.
SPEAKER_03: If you're old enough to have watched TV in the 1970s, the name Jack Klugman will instantly conjure a raspy-voiced, slightly pudgy New Yorker. The sitcom The Odd Couple was huge. Jack Klugman played a middle-aged slob whose roommates were the neat freak.
SPEAKER_07: What's this? It's your Christmas present. I forgot to give it to you. Merry Christmas.
SPEAKER_05: What is it? A sort of Jesus.
SPEAKER_08: When that show ended, Jack Klugman got his own brand new TV show. A kind of detective series. He played a medical examiner called Quincy.
SPEAKER_04: The Quincy show, which was nice entertainment about a doctor who looked at dead bodies and decided who the murderer was.
SPEAKER_08: It was like a precursor to CSI, and it was kind of a big deal at the time. Gentlemen, you are about to enter the most fascinating sphere of police work, the world of forensic medicine.
SPEAKER_07: And after that little story, the Los Angeles Times came out.
SPEAKER_03: Abby got a call from somebody who said he was a producer on the Quincy show. She was skeptical.
SPEAKER_04: I said yes, and I'm Mrs. Santa Claus. But after a few minutes on the phone, she realized the guy was telling the truth.
SPEAKER_03: He was a producer for Quincy, and he happened to have a fairly rare disease himself. In fact, he was dying of bone cancer.
SPEAKER_04: And so he said, this whole thing with orphan drugs is a beautiful story, and I'd really like to do an episode of Quincy about it. And this producer had the pull to make it happen.
SPEAKER_03: His name was Maurice Klugman. He was Jack Klugman's brother. I mean, these things happen in the movies. They don't happen to real people.
SPEAKER_04: But that's what happened. The episode actually got made. It happened.
SPEAKER_08: And in the episode, a teenager with Tourette's dies under suspicious circumstances.
SPEAKER_03: Turns out, it's not exactly a murder. But by the time Quincy figures that out, he meets another young man with Tourette's and gets obsessed with the problem of orphan drugs. Here's Quincy talking with that kid's dad. So if you've got a disease that happens to have a low incidence, don't count on the pharmaceutical companies for any help.
SPEAKER_02: That's why they call them orphan drugs.
SPEAKER_07: The miracles, the cures for rare diseases that no one wants to adopt.
SPEAKER_04: Well, isn't there a bill before Congress that's supposed to deal with all this?
SPEAKER_05: The orphan drug bill. It's still being considered.
SPEAKER_03: The show suddenly goes from a mystery to a policy drama. Quincy goes all in on the orphan drugs issue. He lobbies at pharma companies. The FDA, Congressman, becomes a total policy nerd. At the big finish, the kid with Tourette's, after a pep talk by Quincy, gives a blockbuster speech at a congressional hearing.
SPEAKER_02: I'm thinking about the other victims. Not just of Tourette's, but anyone who is unlucky enough to have a disease that never made it to the top 40.
SPEAKER_03: This congressional hearing was obviously fictional, but it got a real-world response.
SPEAKER_04: When that show was broadcast, Jack Klugman received thousands and thousands of letters. And they didn't even open them. They just had these big sacks. They were like Santa Claus sacks, and they stuffed all the mail into them, and they sent all of those sacks to me.
SPEAKER_03: The letters were from people with rare diseases, and people who just wanted to do something to help solve the orphan drug problem. With this kind of publicity and support, Abby and her friends got another congressional hearing. On March 10, 1981, real-life elected officials heard testimony about a real-life proposal to create financial incentives for pharma companies to take on orphan drugs. On hand to give that proposal a boost of star power was Jack Klugman himself.
SPEAKER_08: The actor flew to Washington and testified in this new hearing in Congress. This time, it was packed. People just sat down on the floor in the aisles. It was pandemonium. Because Jack Klugman was in the room.
SPEAKER_04: I'm telling you, Jack Klugman was a big deal in those days.
SPEAKER_08: An orphan drug bill passed the House, but it got stalled in the Senate, where Abby heard a single senator was secretly blocking it. It was rumored to be Orrin Hatch.
SPEAKER_03: So Jack Klugman and his crew swing into action. They do another episode of Quincy, one where a single senator is holding up an orphan drug bill. In the climactic scene, Quincy confronts that senator in his D.C. office. If I choose to keep voting against this bill, it's simply because I think it's in the best interest of the nation.
SPEAKER_02: Then you should be ready for the reaction. There won't be any reaction. I played this course too many times.
SPEAKER_07: Well, maybe the rules have been changed. Why don't you take a look out the window, Senator?
SPEAKER_03: The senator glances incredulously toward the window. Then, back to Quincy. Then both guys turn and walk solemnly over to this huge picture window. And out in the street, there's a big demonstration heading straight toward the senator's office. The camera gently zooms past the two men and focuses on the action outside. There are hundreds of people, lots of them in wheelchairs, and they've got colorful signs with slogans like Now is the time. Vote for the orphan drug bill. And in a direct pitch to the fictional senator watching through the window, We need you, Senator Reeves. This sequence lingers and lingers and lingers.
SPEAKER_08: These extras were all actual people with rare diseases that Abby Meyers and her colleagues recruited. Except not actually in Washington. They shot it in Pasadena, where the weather was better. The fake march on Washington totally worked. The fake senator on the show? Chased.
SPEAKER_03: I cannot support this bill, but I won't stand in its way.
SPEAKER_08: And so did the real-life senator. Or an hatch.
SPEAKER_04: There would not be an Orphan Drug Act if it was not for that episode of Quincy.
SPEAKER_03: The Orphan Drug Act passed the Senate, President Ronald Reagan signed it into law, and the fake march on Washington became, in some people's minds, a real-life event.
SPEAKER_04: People would say to me, that march on Washington was wonderful. There wasn't a march on Washington.
SPEAKER_08: But you know, it was on TV, so. Abby Meyers went on to help start a new advocacy group, the National Organization for Rare Disorders,
SPEAKER_03: and she ran it for more than 20 years. But these days, when people ask her about her legacy, this is what she tells them.
SPEAKER_04: Be careful what you wish for. It might come true.
SPEAKER_03: The Orphan Drug Act of 1983 created financial incentives for pharma companies to develop drugs to treat orphan conditions. The Orphan Drug Act basically says, once the FDA agrees a proposed treatment will address a rare condition, under current definitions that means it affects fewer than 200,000 people in the U.S., then the developer qualifies for special goodies. That includes subsidies like actual taxpayer cash for clinical trials, and a big prize at the end. The first drug company to get FDA approval for a certain kind of treatment gets market exclusivity. Basically, a monopoly.
SPEAKER_08: No one else can market an equivalent drug in the U.S. for seven years.
SPEAKER_03: Which means that during that seven-year period, the company gets a chance to make money off this drug even if relatively few people use it, by setting a higher-than-usual price. You know, if you have a drug for high blood pressure, it's probably half of the United States needs blood pressure medicine.
SPEAKER_04: But with a rare disease, you're not going to make money if you charge a normal price for those. And then drug companies realized that if they had a monopoly, they didn't have to charge anything that would be remotely considered a normal price.
SPEAKER_08: They could charge pretty much whatever they wanted, especially if the insurance companies were paying for it. It took pharma companies a few years to catch on to how good a deal the Orphan Drug Act could be.
SPEAKER_03: But by the 1990s, things were definitely rolling. One rare disease drug came out in 1991 with a price tag of $150,000 a year. It was huge money.
SPEAKER_05: I've been involved in the formation and financing of biotechnology and healthcare companies for almost 30 years.
SPEAKER_03: This is Joshua Schein, and he's one of the many entrepreneurs who took advantage of the orphan drug policy. His path to the big pharma money led through Las Vegas. It illustrates just how wild west this new world could be.
SPEAKER_08: In 2003, Joshua Schein started a company called Lev Pharmaceuticals, and this company had just one mission — a single thing it was going to do. Lev Pharmaceuticals was going to market a drug for a rare disorder called hereditary angioedema.
SPEAKER_03: Actually, the drug already existed. It had been used successfully in Europe for 30 years. But nobody had taken it through clinical trials in the U.S. As Schein recalls, that looked like a good setup.
SPEAKER_05: It seemed like a very good opportunity from its inception. We saw a serious unmet clinical need in the U.S.
SPEAKER_03: To bring this treatment from Europe to the point where it could be sold in the U.S. meant that Joshua Schein would have to raise enough money for Lev Pharmaceuticals to run clinical trials for FDA approval. Which would be a lot easier to do as a publicly traded company. And that's how they found Fun City Popcorn.
SPEAKER_05: Right, it's not a typical path, and it's really not a typical name for a biotech company. Fun City Popcorn sold popcorn and nacho cheese sauce to concessionaires all around Las Vegas.
SPEAKER_03: They had hundreds of clients — malls, ballparks, skating rinks, you name it. But of course Lev didn't pursue Fun City for their nacho cheese sauce recipe.
SPEAKER_08: It turned out Fun City's owners were getting out of the popcorn and concession business. And they were game to try something new. Fun City agreed to actually merge with Lev Pharmaceuticals, thus bestowing on Lev their status as a publicly traded company.
SPEAKER_03: Which made it easier for Lev to attract even more investors. But for a few months, until they could get the paperwork sorted out, they had to go by the name Fun City Popcorn.
SPEAKER_05: We felt we could overcome the name Fun City Popcorn and the jokes that might bring up. Did people kid you about it? Sure. Still do, apparently.
SPEAKER_03: Schein could laugh all the way to the bank. Over the next few years, Lev Pharmaceuticals raised about $75 million to pay for the clinical trials that would win FDA approval. Of course, Joshua Schein still had to get the trials done — and do it — before anyone else.
SPEAKER_08: After all, the Orphan Drug Act is set up to give a monopoly to whoever gets to the treatment first.
SPEAKER_03: Finishing second can mean losing the whole investment. It was a real horse race to see who could finish the trials first.
SPEAKER_08: And Schein won this particular race. Yeah, I'm very pleased with how this worked out. It worked out most importantly for patients.
SPEAKER_05: And of course, he's also glad it worked out for the shareholders.
SPEAKER_08: Most companies don't pan out. And so, you know, I'm pleased that as management of a company that we were able to provide a return for shareholders.
SPEAKER_03: It was a big return. In 2008, a couple weeks before the FDA gave the new drug its final approval, Lev Pharmaceuticals sold for $442 million. And within a few years, the new owner was making $400 million back from this one drug every year, thanks to a price tag that made this one of the world's most expensive drugs — more than half a million bucks a year per patient. And then that owner sold itself to a still bigger company for $4.2 billion.
SPEAKER_08: That company's CEO says that the company's entire strategy is to make money from the treatment of rare diseases. The Orphan Drug Act and the crazy pricing that is its legacy is this company's whole vision for making tons of money. This is why Abby Myers has mixed feelings about her legacy.
SPEAKER_04: Thirty, thirty-five years later, the Orphan Drug Act has been responsible for the most miraculous treatments on many, many diseases. But some of the companies that make these drugs have put prices on them that make the drugs absolutely unaffordable.
SPEAKER_08: In other words, it's like a ransom note for thousands of desperately ill people.
SPEAKER_03: Joshua Schein from Lev Pharmaceuticals has a different perspective. He says, it is hard enough to get money to develop these drugs, even with the Orphan Drug Act's incentive, but massive payout. These drugs are hugely expensive to develop, and the failures far, far outnumber the successes.
SPEAKER_05: And without a system in place like the Orphan Drug Act, the drugs would not come to market.
SPEAKER_08: Of course, it doesn't have to be this way. Abby Myers and others have their own proposals for how to balance incentives with reasonable prices. It's a giant debate.
SPEAKER_03: If you look at a list of the most expensive drugs, you'll notice two things. They are unbelievably expensive. Tens of thousands of dollars a month. And they are generally for rare conditions. Whoever pays an individual bill — insurance companies, patients — the whole thing contributes to the spiraling cost of health care.
SPEAKER_08: And it's going to take more than a fake TV march on Washington to fix the problem.
SPEAKER_08: If you'd like to know more about how the cost of health care has gotten so messed up, and what we may be able to do about it, or if you just like really good storytelling, check out Dan Weissman's new podcast. It's called An Arm and a Leg. We'll have more about that show after the break.
SPEAKER_08: The International Rescue Committee works in more than 40 countries to serve people whose lives have been upended by conflict and disaster. Over 110 million people are displaced around the world. And the IRC urgently needs your help to meet this unprecedented need. The IRC aims to respond within 72 hours after an emergency strikes, and they stay as long as they are needed. Some of the IRC's most important work is addressing the inequalities facing women and girls, ensuring safety from harm, improving health outcomes, increasing access to education, improving economic well-being, and ensuring women and girls have the power to influence decisions that affect their lives. Generous people around the world give to the IRC to help families affected by humanitarian crises with emergency supplies. Their generous donation will give the IRC steady, reliable support, allowing them to continue their ongoing humanitarian efforts even as they respond to emergencies. Donate today by visiting rescue.org slash rebuild. Donate now and help refugee families in need. Chances are you're listening to 99% Invisible on your phone, probably while you're on the go. Think of all that you do on your phone the moment you leave your front door, whether it's looking up directions, scrolling social media, or listening to your favorite podcast. It requires an amazing network. That's why you should switch to T-Mobile. T-Mobile covers more highway miles with 5G than anyone else and helps keep you connected with 5G from the driveway to the highway and the miles in between. Because your phone should just work where you are, it's your lifeline to pretty much everything you didn't bring with you. So next time you head out, whether you're taking a trip or going to work or just running errands, remember T-Mobile has got you covered. Find out more at T-Mobile dot com slash network and switch to the network that covers more highway miles with 5G than anyone else. Coverage is not available in some areas. See 5G details at T-Mobile dot com. This show is sponsored by BetterHelp.
SPEAKER_08: Do you ever find that just as you're trying to fall asleep, your brain suddenly won't stop talking? Your thoughts are just racing around. I call this just going to bed. It basically happens every night. It turns out one great way to make those racing thoughts go away is to talk them through. Therapy gives you a place to do that. So you can get out of your negative thought cycles and find some mental and emotional peace. If you're thinking of starting therapy, give BetterHelp a try. It's entirely online, designed to be convenient, flexible and suited to your schedule. Just fill out a brief questionnaire to get matched with a licensed therapist and switch therapists at any time for no additional charge. Get a break from your thoughts with BetterHelp. Visit BetterHelp dot com slash invisible today to get 10 percent off your first month. That's BetterHelp. H-E-L-P dot com slash invisible. Dan Weissman is a journalist based in Chicago. You may remember that he reported a couple of stories with us over the years about the reversing of the Chicago River and how the popularity of billiards drove the development of plastics. And as we mentioned, he now has a show about health care called An Arm and a Leg. I asked him why he was compelled to create a podcast about this particular subject. I've kind of been interested in this topic for a long time and partly for personal reasons.
SPEAKER_03: You know, I had thought about going out on my own as a reporter instead of having working for somebody else for a while, something I wanted to do. But who's going to buy the health insurance for our family? My wife has her own business. And so it just seemed unthinkable. And I found myself kind of having left one job thinking like, oh, crap, I might need a new career. Which was really sad for me. Then I was like, well, there is this one thing that's kind of running my life. And I know I'm not the only person, which is the cost of health care and the need for health insurance and the expense of that just drives so many decisions for so many people. I don't see a conversation about that or a kind of accessible conversation about like, how do we get here? Is there anything any of us can do about it?
SPEAKER_08: And is how did we get here the driving question? Or is it how do we solve it? Like, where do you place the emphasis in the show?
SPEAKER_03: That is a super good question. It's a good question. I think because of my disposition, there are some good stories in how we got here. And I think that there's two good things about that. One is that understanding how we got here might help us understand a little bit about how we could make things a little better. And also that one of the things, in some ways, the thing that I most want the show to do is that it allows us to be company for each other. That we're all kind of scared and angry and confused. And telling some interesting, maybe fun stories is also just a way to pass the time and bring our blood pressure down to the point where we actually could see our way clear to doing something else about it.
SPEAKER_08: As you've been gathering the stories, is there an underlying theme that's emerged that surprised you?
SPEAKER_03: The thing that surprised me first was just from talking to people about the idea of doing this show that like every single person I would talk to, and this has, I'd say, pretty much remained true. We'll either write off the bat or as we get to talking be like, oh yeah, well, this is a story that happened to me. But that was probably the single biggest surprise was like everybody. Everybody.
SPEAKER_08: So you have one of these examples in your pilot with your friend Peter. Could you describe the situation with Peter? Yeah, Peter is a real estate developer and he makes a perfectly good salary.
SPEAKER_03: And when I tell him I'm doing this show, he's like, oh, yeah, you know, the health insurance at my job just keeps getting worse and worse. And last year my deductible was like $13,000 and this year it's worse. And yeah, and he's like, oh wait, and did I tell you about when I had the kidney stone last year? And I'm like, no, he's like, well, you know, I put off going to get help for as long as I possibly could. Because he was like, they're just going to charge him money and not people that do anything for him. And he finally breaks down and his wife makes him go to the hospital and they give him an MRI and he is kicking himself. And they told me exactly what I knew that I had a kidney stone and that it was passing.
SPEAKER_06: And I'm like, thank you very much. And then I get the bill. Well, it was $6,500. Oh my God. And you had it was all on you.
SPEAKER_06: It was all on me. It didn't help me in any way, shape or form. And then I'm left with this bill.
SPEAKER_03: Peter, one of the things that I find, you know, awful and delicious about this story is like, it's not just you're a real estate developer, you know, you're making good salaries. You're a real estate developer, like negotiating with people like, say, contractors who most people would never think they were slick enough to do is what you actually do for a living.
SPEAKER_06: Right. And I can't negotiate this system.
SPEAKER_08: And so if you want to hear that story in its entirety, you have to subscribe to an arm and a leg. Thank you, Dan. I appreciate it. Oh, Roman, thank you so much.
SPEAKER_08: Ninety nine percent invisible was produced this week by Dan Weissman and edited by Avery Truffleman mix and tech production by Sharif Yousif music by Sean Real. Katie Mingle is the senior producer. Kurt Kohlstedt is the digital director. The rest of the team includes Emmett Fitzgerald, senior editor Delaney Hall, Joe Rosenberg, Vivian Lee, Taron Mazza and me, Roman Mars. We are a project of ninety one point seven KALW in San Francisco and produced on Radio Row in beautiful downtown Oakland, California. Ninety nine percent invisible is a member of radio topia from PRX, a fiercely independent collective of the most innovative shows in all of podcasting. Find more at radio topia.com. You can find the show and join discussions about the show on Facebook. You can tweet at me at Roman Mars and the show at ninety nine P.I. org. We're on Instagram, Tumblr and Reddit, too. But this week, I think it's a good idea to check out Dan Weissman's other 99 P.I. stories on our Web site. Just use the handy search function and ninety nine P.I. dot org.
SPEAKER_07:
SPEAKER_08: Radio topia.
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