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Overdoses from prescription opioid drugs now kill nearly seventeen thousand americans every year. Thats one overdose death every thirty minutes. The overdose rate which might have been 1 or 2 a month in our Emergency Department is now more like 3 or 4 or 5 if not more than that, in a 24hour period. Thats a massive increase. Massive. Over the past 10 years, weve had more than 125,000 americans lose their lives to painkiller Overdose Deaths. The food and Drug Administration recently approved a powerful new opioid painkiller called zohydro over the objections of its own medical advisors and dozens of lawmakers. I thought we had learned our lesson with oxycontin. How can you say with any degree of confidence that zohydro wont be abused . Youre going to have people die. This week fault lines looks at the battle over the most popular drugs in america opioid painkillers. There is big controversy tonight involving a new narcotic painkiller. The drug about to hit the market is called zohydro. But many are now asking is it even needed, and did the fda ignore warnings by approving it . At the heart of the debate, whether or not the drug may be too powerful and potentially addictive. In october 2013 the food and Drug Administration did something unusual. It approved a new painkiller called zohydro despite the fact that its own Advisory Committee had rejected the drug. I was quite surprised. You invite us in and then you tell us, forget it. Zohydro is a pure hydrocodone drug that comes in doses up to ten times higher than vicodin. The Advisory Committee feared that it could create a new generation of addicts. The entire Prescription Drug epidemic was launched basically from high dose oxycodone. Many of us felt that a high dose hydrocodone product would end up in the same place. Few areas have been more impacted by this epidemic than the state of maine. Here more longacting opioid painkillers are prescribed per capita than in any other state. Its led to one of the highest addiction rates in the country and a related surge in the use of heroin. In portland, this Ambulance Team responds to an opioidrelated call nearly every day. Its about 10 oclock on friday night. From what were hearing, theres a 25 yearold male in there, who could have had a seizure due to an overdose. The responders found this man lying on a bathroom floor, unconscious and barely breathing. A syringe and a small bag of heroin were at his bedside. They were able to revive him by administering a drug that counters the effects of opioid overdose. Now were seeing it so frequently and theyre people that youd never expect. Its not the junkie, its the 25 year old kid. What were finding is that they cant get the Prescription Medication that they used to get they cant get vicodin or oxy. So what they do instead is they buy heroin. Opioids are pretty much drugs that come from opium. You create oxycodone and hydrocodone from opium in the same way that you create heroin from opium. And when you look at the effect that hydrocodone or oxycodone or heroin produce. Its pretty much indistinguishable. Weve driven about 20 minutes out of portland, and were on our way to meet somebody who started using legal, prescription opioids as a teenager but quickly transitioned onto heroin. Jack asked us not to use his real name. He is 32 years old. Once youve done it. You know ive done it for so long that i need it to feel normal. You know what i mean . Once i start doing heroin, like i comprehend better. I can focus better. He has been using opioids first prescription painkillers and now heroin for more than half of his life. Its eleven in the morning and he is preparing his first injection of the day. Ah, that felt good. What does it feel like . Feels good. Big warm feeling right through your whole body. Like it just runs right through your whole body instantly. Makes you feel great. Forget about everything. Got any aches and pains, its gone instantly. Jack started taking painkillers when he was 13. He bought them from friends at school first vicodin, then oxycontin. They were so popular around here it wasnt even funny. You go anywhere and you get an oxy 80. And were you crushing them up . Started sniffing em first and then i started injecting em shortly right after. The transition from that, to taking heroin is that a pretty easy transition to make . Once somebody does oxys people that you would never ever think of doing drugs end up the same way i am, you know what i mean . Just went to the doctors, got it prescribed, and now theyre addicted to heroin. Have you met people like that . Oh yeah. I know a lot of people like that. People that you would never think of doing drugs ever. Ever. And now theyre just like me. In the last five years, heroin use has nearly doubled across the us. Four out of five heroin users switched to the drug after first taking prescription opioids. This is wellspring a recovery house in bangor maine for people struggling with Substance Abuse. So how many we could start from this side have moved from Prescription Drugs to heroin . [hands go up] everybody. But it actually with everyone started with a prescription from the doctor. Jamie had never used opioid painkillers until he was 21 years old, and he got injured. I got crushed over the stern of a lobster boat. I got released from the hospital with a script for dilaudid 8. So i started taking them and it was over. My life was completely gone after that i lost everything. My home, my vehicle you know all the money i had. Once people became dependent on painkillers they said theyd do almost anything to get them. One time, i was hurting so bad that i ended up punching a 4 x 4 and breaking all three of these fingers and this bone to get pain meds from my doctor. So you hurt yourself in order to go to a doctor . I had 9 teeth pulled out of my head for prescriptions. Ive been in groups of people where theyve taken like bats to their wrists to snap them easily. How many people know of someone whos died of an overdose . [hands go up] everybody catch more faultlines episodes on demand or at aljazeera. Com faultlines. One purpose of painkiller drugs is to help the millions of americans who suffer from chronic pain. David duhrkoop is one them. For over 20 years, he has been in nearly constant discomfort since injuring his back in an accident. It becomes almost like a partner that you walk around with all day. And you dont like that partner very much. But uh youve got them there and theyre with you 24 hours a day. I think about being out of pain every day of my life. In the late 1990s david was part of the first wave of people prescribed oxycontin for chronic pain. I was told that there was a new medication that came out and it was primarily for Cancer Patients but they were trying it for chronic pain patients. You know if the doctor prescribed it, its got to be good. I remember on the bottle it says do not bite or crush this medication. well, why not . What happens if you do . Well i found out you get the full effect of 12 hours of medication you know in 15 minutes and from then on you know the devils gotcha. It was only after years of Addiction Treatment that david was able to drop oxycontin. He now gets by on two morphine pills a day. Thats the question on the table. Is how long should a doctor prescribe medication . and, at what point are you doing more harm than good . opioids are very important medications for easing suffering at the end of life. And theyre very good at relieving pain on a shortterm basis. But if you look at the bulk of the opioid prescribing in the united states, its for very common chronic conditions like lowback pain. Doctor Andrew Kolodny is an addiction specialist who advocates for reform in opioid drug policies. He says the manufacturers of oxycontin encouraged a shift in the medical thinking about opioids. Theres no need for anyone to suffer in pain anymore. This pill thats the timerelease pill solves all the problems. See what its like when youre not in pain anymore. Take these medications. When Purdue Pharma launched oxycontin, they launched a Marketing Campaign and an Educational Campaign to convince the medical community that we had been underprescribing opioids. Theres no question that our best strongest medicines are the opioids. To convince us that we had been allowing patients to suffer needlessly because of what they called an overblown fear of addiction. The culture actually of the time was lets treat everyone with opioids at whatever dose necessary and if some doesnt work well give a higher dose. Many of the patients i would have to keep increasing the dose that brought them up to doses that i didnt feel were safe. I consider it a populationwide experiment on american citizens that lets just give them all opiates. Here in seattle doctor david tauben is part of a group of physicians who are changing their approach to treating pain. Okay, so when i just slightly press does that hurt . Its a response to a staggering reality in 2010, doctors prescribed enough opioid painkillers to medicate every american adult around the clock for an entire month. Our oath as physicians is to do no harm and i think weve done harm. Okay, so youve been on opioids for how long . Uh, since august 08 how do i use opioids in my chronic pain practice . I use it occasionally. The primary treatment for chronic pain is management by the patient, management by the team using nondrugs, nonpharmacological and nontechnological solutions. We need to flip the paradigm to opioids being a late resort. But we certainly shouldnt introduce more patients into something that we recognize has been a bit of a failed experiment. Wayne merrill got caught up in the opioid painkiller experiment. Wayne was an exceptional father. He really was. Five years ago, Kathleen Bowley married wayne, and they started a family here in southern maine. I couldnt have asked for a better partner. We shared the same value system. We just felt into it very easily. It was easy. Wayne worked as a meat cutter at a butcher shop. One day he fell at work, and was prescribed vicodin and percoset for the pain. Several months later he injured his arm at work again, and his doctor prescribed him oxycontin. I was in the waiting room and the doctor came out and said we had to give him something stronger this time because hes built up a tolerance. And i thought that was peculiar, but i just nodded and responded to the doctor and that was that. Hes the doctor, hes in charge hes the expert. It took me about 9 months to figure out what was going on with him and the prescription pills. I was working from home one day and he came home around 2 oclock that afternoon and he was so messed up. I mean he couldnt even put a sentence together. And he told me later on that he took 10 vicodin that day. This was by 2 oclock. If he didnt have the opiates in his system, he could not function as a human being. He couldnt. Hed totally changed. He was so angry. Like the person i married and spent four or five years with was gone completely gone. Eventually, kathleen decided to separate from wayne. One month ago, she was contacted by his family. His mother picked up the phone and she said katie, waynes dead. It was very cut and dry. And, i said i have to go ill call you back. I dropped to the floor. She told me what she knew from the detectives that showed up at her work place and brought her into a back room and showed her pictures of wayne. Wayne was found dead in the backseat of a car, in the parking lot of a local hospital. I blamed him for a long time. I looked at it as a choice which was i think ignorant in my part. Hes like, but i have to have this medication to survive, to get through each day. In 2010 doctor michael von korff published the first study that directly linked high doses of prescribed opioids to increased risk of overdose. It may seem obvious, but it went against the conventional thinking about painkiller addiction. The problem was posed as theres good patients and bad patients. This sort of thinking persists today, that if you can sort out who the good patients are, that have legitimate pain, from the bad patients who are drug seekers and uh and, and addicts, then that longterm use of opioids can be safe. And i think what weve learned is that life isnt that simple. The last thing the Drug Companies wanted anybody to think was that this was a prescribing problem. They were okay with thinking its a Substance Abuse problem. That the problem is in the patient. Doctor Gary Franklin is a medical official in washington state. He was one of the first people to sound the alarm about the adverse effects of opioid prescribing. Somebody would come into our system with a low back sprain, and be dead three years later from an unintentional overdose of opioids. I was shocked. I mean it was the saddest thing i had ever seen in many years in my job. Franklin has worked to implement guidelines that limit the prescribing of opioid drugs in washington. Since the rules went into effect Overdose Deaths in the state have dropped by more than a quarter. These are avoidable deaths. Theres a sea change going on in practice and i think that the regulatory agent the fda in particular, rather than being out in front of the sea change, is being carried along. We would not be dealing with this problem today had the fda been doing its job properly going back to 1996. With well over 100,000 deaths this is the worst manmade epidemic in history. When i say manmade i mean made by organized medicine. Catch more faultlines episodes on demand or at aljazeera. Com faultlines. Theres more to finical news than the ups and downs of the dow. For instance, could striking workers in greece delay your retirement . Im here to make the connections to your money real. As the painkiller epidemic has spread drug Company Profits from opioids have soared. Over the last ten years revenues from opioid painkillers have more than doubled. In 2012, the figure was over nine billion dollars. As the market for opioids grew so did the incentive to get new, more lucrative painkillers approved by this federal agency, the fda. In 2002, a group of academics and fda staff began hosting private meetings with Drug Companies to develop new ways of testing the safety and effectiveness of painkillers. The meetings were held in fivestar hotels in the washington dc area and funded by over a dozen pharmaceutical companies, who paid hundreds of thousands of dollars to attend. The benefit for the Drug Companies who participated was enormous. Getting a drug approved can result in billions of dollars for that company that gets the drug on the market. Details about the meetings became public only in 2013 after emails were obtained in a public records request. In one of the emails you have one of the Drug Companies sort of questioning the fee that they had to pay. And the response to the drug company was youre getting a lot for your money. You get to influence fda thinking. You get to sit at a small table with fda. One key person who sat on the Steering Committee for these meetings was doctor Bob Rappaport the head of the fda division that regulates painkiller drugs. This is the voice of doctor rappaport at the fda hearing on the drug application for zohydro. Throughout the hearing, rappaport repeatedly instructed the committee to focus narrowly on whether zohydro worked to relieve pain rather than whether it would worsen the opioid epidemic. They did redirect us a few times when we were getting a little more concerned about individual safety. When the committee voted against approval rappaport rebuked them for unfairly penalizing the drug company. Its hard not to learn from history. Were supposed to learn from history and try not to repeat our mistakes. There is not a legal basis by which fda can say we dont need another opioid because weve already had a lot of bad experience. Doctor Judith Kramer voted against zohydro. But she says the fdas powers are limited. The fda is required by law to fairly and uniformly apply the law. The people that were saying safetys not adequate, were saying oim no longer comfortable just following what you have to follow by the law. You have to do it, but weve got to have more information. fault lines repeatedly requested an interview with the fda about the opioid epidemic. Weve been speaking to the fda for weeks now, trying to get an interview that theyll make available and we just received a response. They say unfortunately, we are going to have to take a pass on your oncamera interview request at this time. In an email the agency said it approved zohydro because the medical benefits of a pure hydrocodone product outweigh its risks. It said that it takes the issue of opioid addiction seriously, but that removing Treatment Options from the market would unfairly penalize pain patients. Since the fda approved zohydro twentyeight state attorney generals and dozens of members of congress have asked the agency to reverse its decision. All six new england governors have called for zohydro to be blocked. As a mother of teenagers, as a clinician its the young kids, its the new its the new exposures that im worried about. This is probably a lost generation of people who have been on opioids and have become dependent. We still have a huge way to go. Weve only begun to dig out of this thing. Not one more person should be dying from an unintentional overdose of painkillers prescribed by your doctor. Welcome to the news hour live from doha. These are the main stories this hour. The president ial compound and Prime Minister convey attacked in yemen. We may have a new yemen by the end of the day. Hundreds attended the funerals for six hezbollah fighters killed in an israeli air strike. After six weeks of no new infections declared free from the

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