nearly 70,000 Americans die each year from drug overdoses mostly from opioids as 60-minutes has reported the explosion in both the demand and supply of pharmaceutical opioids began with the aggressive marketing of narcotics to treat chronic pain tonight we reveal the story of the powerfully addictive fast-acting opioid fentanyl our year-long investigation which concluded just as the corona virus was spreading uncovered the PlayBook of sales practices that triggered an explosion of prescriptions we will introduce you to two insiders on different sides of the law a top opioid salesman whose rise and fall spanned the epidemic but first federal agent Greg trauma Leo who in 2003 saw the crisis coming and tried to stop it the story will continue in a moment if you're gonna intentionally knowingly break the law your profits have to be so significant that when the FDA comes knocking and they hit you with a 425 million dollar penalty you're still smiling you're sad in front of them but when you walk out the door you're smiling you're smiling because you just made a billion dollars worth of profit and it's worth it to them it's worth it when Greg tremolo looks back at the carnage caused by the rise in the use and abuse of opioids one early case sticks in his mind in 2003 he was the senior special agent assigned to the undercover arm of the Food & Drug Administration's DC office of Criminal Investigations his target Cephalon one of several drug companies doing business in ways that brazenly floated FDA regulations they weren't afraid of the FDA why would they be back then you only received a misdemeanor nobody was prosecuted so they're willing to take that slap on the wrist because the benefits are so great yes profits are too big way too big at the time when a drug company was caught violating FDA regulations federal prosecutors typically would negotiate corporate settlement agreements without holding individual pharmaceutical executives accountable but agent Greg tremolo hoped this time would be different his investigation revealed Cephalon was violating strict FDA laws on drug promotion with three drugs including a synthetic opioid act eek a dangerous fast-acting fentanyl sold in lollipop form for easy absorption through the mouth the drug is 100 times more powerful than morphine intended for severe cancer pain only these drugs are so powerful that they received approval by FDA for their indicated use which was strictly for cancer patients with severe pain that have a tolerance level to other opioids so morphine's not working for them anymore and their instill and severe pain and they need something that's going to give them a recovery immediately that's what this lollipop is for people in end-stage cancer yes a doctor can prescribe things off-label so what was wrong with what they were doing yes in the FDA we call that the practice of medicine we give medical doctors the ability to prescribe whatever they think is going to help treat their patients but that's what the understanding that the medical doctor is getting presented with accurate factual information from the drug sales rep they're not being groomed to promote drugs off-label the FDA approved labeling for Cephalon fentanyl drug act ich also called the package insert tells doctors and patients who should take act ich and how it should be used the document carries the weight of a legally binding agreement between the FDA and drug companies limiting how sales reps can promote a drug pushing a drug for patient groups not listed on the label spreading misleading information or publicizing a potentially deadly drug as less dangerous than FDA evaluations indicate is called off-label promotion and it's against the law profit / patient health we call it doesn't matter what the drugs indicated uses if I'm a sales rep I'm hustling it I'm slinging it as fast as I can if not for cancer what else would they be pushing this drug to be used for pain is pain that's their motto so whether you have a migraine pappa fentanyl lollipop whether you have a back injury take a fentanyl lollipop it didn't matter alik Berlocq off was a star sales representative at Cephalon he told us he would say almost anything to convince doctors to prescribe act ich on or off label before joining Cephalon he was a standout sales rep at Eli Lilly & Johnson & Johnson wherever he worked he says the sales tactics were the same ignore the FDA's off-label promotion laws I was taught to forget the patient to not think about the patient take the human aspect out of it it's like selling widgets were you not aware of what these opioids were doing to communities around the country what is your job what is your title sales sell do you understand either understand or pack your bags what's the key to being a successful salesman in the pharmaceutical especially the opioid end of the business the key to success the less of a conscious you had the better 60 minutes went to court in Oklahoma to get Cephalon internal documents unsealed the drug makers master plan for promoting its powerful drug act eke a virtual how-to for breaking federal law the documents reveal Cephalon strategy was to broaden the use of the opioid beyond cancer patients with severe pain to the general pain market including but not limited to osteoarthritis rheumatoid arthritis chronic back pain migraine headaches getting doctors to prescribe the drug off-label was quote the most critical component of the Act ich tactical plan they push you right to the line and if you go to that line every single day what happens eventually you start to cross the line and they want you to cross that line I guess you would have to run through the risks of abuse when you're talking to the doctors about the drugs but with a wink and a nod not even if you go through training like me as a young man you drink the kool-aid you drink it like a fire hose and I'll never forget you can go as high as you want as long as they're still in pain the federal investigation of Cephalon began in January 2003 when a sales rep with a troubled conscience got in touch with Greg chromoly old telling him Cephalon was pushing its sales team to break the law to gather hard evidence agent trauma leo got approval from federal prosecutors to wire up the sales rep and conduct a surveillance operation of company employees at this Nevada Hotel site of the drug makers annual sales conference and training sessions set it up right out of the hotel room where we manage the source as we wired him up and we sent a man and we listened to the conversations you were listening in we're listening to the techniques of how to train somebody to sell drugs and they're being encouraged by senior drug reps I like the way you've steered the doctor away from the label and you talked about severe migraine sufferers how to groom a doctor yes what is your reaction to what you're hearing I was disgusted it was just so open the conversations about disregarding the label and breaking the law it's almost like a game it's a lot of the sales reps how many doctors do I have under my control and how many prescriptions are what we call scripts how many are they issuing every single week Asian trimalleolar chorded days of damning conversations between sales reps providing accounts of their strategies it sounded to him more like the corrupt tactics of an organized criminal operation they targeted what we call pill mill doctors first do they go visit the doctor to see if he has a glint in his eye let's see if he seems willing to play starts there it's it's a long process you've got those that are established pill mills what we call them pain clinics that the doctors that just had no conscience and then he had the ones that you're slowly grooming and developing and where they feel comfortable prescribing the drug off-label the internal Cephalon document 60 minutes obtained showed just how Cephalon roped in willing or vulnerable physicians it funded advocacy groups to promote opioids spread deceptive information about addiction and offered incentives for doctors to prescribe opioids including medical education programs conference junkets free dining and drain King and lucrative peer-to-peer speaking engagements the master plan noted that quote these programs generate immediate script impact in other words they've got doctors to write more prescriptions and if they can't convince you they have other doctors that they've already paid that they can reach out to you don't believe me talk to your peer except they don't tell the doctor oh your peer has been to for vacation spots over the last year and we paid them approximately two hundred thousand dollars or some astronomical consulting fee it's garbage it's no different than a bribe no different from a bribe we're just calling it what it is instead of bribing doctors recorded educational consulting medical education program fancy words on the street they just call it something different whether they call it on the street it's just a straight hustle the only difference is they're in a suit and tie it when they do they're also that's the only difference when agent Romano approached other sales reps at the 2003 Cephalon conference to cooperate as informants word of the surveillance operation leaked out after word got out that you were there all week listening in to their training they scrambled like cockroaches literally within 30 minutes there was probably a hundred taxi cabs out front and we were sitting out our window watching the drug reps running out to get into the cabs to leave so what happens before I even got back to Washington DC my phone was already ringing it was a senior official in his FDA division who was unaware of the extent of the operation which was authorized by federal prosecutors Greg trauma Leo told us the official objected to the aggressive investigative procedures agent Romano was immediately pulled off the case my boss did not appreciate that FDA did not appreciate that was a tactic that they were not comfortable with why was that because it's a white collar case you can't treat him like a drug cartel you should treat them differently with respect because they're legitimate pharmaceutical company they're breaking the law people are becoming addicted dying from their practices why would the FDA the government want a sort of tiptoe around them the FDA was afraid of the Big Pharma's but you were providing them with the proof I had to proof were they duped or were they complicit I just think they stuck their head in the sand what were you going for the kingpin the head of the snake the executives at the top of Cephalon we never got that far the case ended in 2008 when Cephalon pleaded guilty to a misdemeanor for illegal promotion and paid four hundred twenty five million dollars in fines and settlements less than a quarter of what Cephalon made in one year the company was eventually sold for six point eight billion dollars Alec Birla cough found a new job at a company called iNSYS that story when we return when Alec Birkhoff and former Cephalon sales reps found a new home in 2012 working for a pharmaceutical mogul named John Kapur they would rack up huge profits selling subsys a new formulation of fentanyl like act eek it was fda-approved for cancer pain only and on the strength of subsys sales Kapoor's company became a Wall Street sensation one fueled by unbelievable greed and depravity in the midst of the deadly epidemic incest sales reps got doctors to prescribe opioids for unapproved uses enticing them with all expenses paid visits to strip clubs fancy dinners and with money which federal prosecutors say corrupted the practice of medicine this time there would be no settlement iNSYS was targeted as an organized criminal enterprise and its top executives were prosecuted the story will continue in a moment in January John Kapur billionaire entrepreneur and former CEO of iNSYS therapeutics arrived at a federal courthouse in Boston for sentencing a jury had found him along with several of his top executives guilty of racketeering mail and wire fraud conspiring to recklessly and illegally boost profits from the opioid painkiller subsys a fentanyl spray designed to be absorbed under the tongue Kapoor received five-and-a-half years his lieutenants received from 12 to 33 months in part because of the testimony of the government's star witness Alec Birla cough the senior vice president of sales at iNSYS who had pled guilty and cooperated with prosecutors we talked with Alec burlock off with the consent of federal prosecutors before he was sentenced in January but after he had testified about illegal sales tactics at iNSYS including bribing physicians the doctors are they an easy mark no most doctors would throw you out absolutely and the faster you get thrown out the better get thrown out move on to the next guy keep going keep going leave and eventually somebody is gonna stop and talk to you and you start to wonder why I'm cells representative I'm not a doctor the doctor is looking at you and he's saying to himself what's in it for me wifm we call it the with the with them with them if they're saying what's in it for me then you know you've got one on the hook you got one on the hook it doesn't mean you're gonna be successful but you're gonna figure out real quick that the more you pay that doctor the more he's gonna prescribe John Kapur was a pharmaceutical industry success story he immigrated to the United States from India and as an executive and investor made a fortune with a series of drug companies you has a entrepreneur have to have a dream and then you work with passion to make that dream come John Kapur hired Alec burlock off after the salesman regaled him with stories from his days at Safwan bribing doctors he said paying them for speaking engagements he pounded the table and he said that's our next VP of Sales Kapur asked him to start a similar speaker program at iNSYS I felt like I finally made it to the big leagues and John Kapur was asking you to do this yes he wanted me to pay doctors to prescribe substance I could do that I've done it before I can do it again and you had talked about bribery oh yeah use that word if I think that he's gonna be intimidated by the word bribery or that he hasn't been involved in that before on numerous occasions thoughtful iNSYS would pay some doctors sales reps called them whales as much as 125 thousand dollars a year in bribes camouflaged as insists speaker program fees all that money caught the attention of federal prosecutors in Boston Nathaniel Yaeger and David Lazarus these doctors these whales were getting paid to speak 40 50 times a year so when you think about a speaker you think of them going to say a ballroom and you have other doctors there and the speaker gets up and makes a speech about the benefits of this drug right that's not what was going on no no what was going on they say was illegal and the to prosecutors launched what would become the first criminal case to bring pharmaceutical executives to trial for fuelling the opioid epidemic they indicted 7 insists executives including CEO John Kapoor and sales vice president Alec Birla cough it's not something that people think about but the reality is that doctors are licensed drug dealers and the pharmaceutical companies know that at the heart of the indictment was the insist speaker's program and this is what it looked like posted by one New York doctor on Instagram it isn't easy being me hashtagged friends sales reps hired to recruit doctors for the speaker's program didn't need to be experienced pharmaceutical salesman like Alec Birla cough here in this picture he gave us of his management team but it did help if they had charm and sex appeal they had people whose previous jobs were being a waitress at Hooters people who worked at strip clubs camp counselors Jaeger and Lazarus called the speaker's program a sham the doctor would just repeatedly invite her friends or his friends just a night out paid by insist right rack up a big bar bill and then get a check in the mail for it was it that blatant it was that blatant the sale staff was taught to look for doctors who might be going through a rough time and they would literally list what their strengths and weaknesses were and one of things they would say is divorced needs money former senior vice president of sales Alec Birla cough says the terms of the bribe were clearly spelled out to the doctor increased the number and dose of prescriptions or the speaker spigot would be turned off if you don't produce a return on investment of at least two to one via prescriptions of substance not only will you disappear from the speaker's bureau but your representative will be gone as well and you flat-out told the doctor this yes one the more you write the more you're gonna earn the more you increase the strength the more you're gonna earn and doctor if you don't like it we walk away his friends no big deal but in the case against John Kapur the ROI return on investment was a big deal Kapoor used real-time data from an FDA patient safety program to track the doctors they were bribing pouring over patient dosages and prescriptions at the sales meeting held every morning calling out his executives when they missed their targets he's looking at the chart and he sees perhaps a doctor is not prescribing as much as he thinks he should be how would he react well it would be irate within 24 hours that rep was demanded to be in that doctor's office and basically enforcing that they increased a dose he was requiring you to push doses higher than the patient actually needed he made it mandatory that we launch what what he called an effective dose campaign and what is that it's a fancy way of basically saying let's make sure that the patient will come back and want more others might say let's make sure we get the patients addicted you're preying on these people yeah because they're desperate they'll try anything and they may get relief from substance initially but we all know what's gonna happen we know we've been doing this long enough we know how it ends and that is it ends in addiction withdrawal pain suffering and even death and you didn't care about that back then I was numb to that I was flabbergasted as the trial approached Fred wyshak joined the prosecution team to prepare the racketeering case he pressured Alec Birkhoff to flip and testify against Kapoor best known for bringing down the Boston mafia and crime boss Whitey Bulger wyshak thought he had seen it all until this his first pharmaceutical case and this is coming from a man who's going after the mob yep yeah I mean the mob does have to some extent a code of conduct and usually they're only physically harming other bad guys these people they didn't care wasn't just bad guys who getting hurt and what was the impact the criminal activity was having on the consumers the patients most of the patients who received this drug were non cancer patients taking sub says essentially overmedicated them it ruined their lives many of them lost their jobs their families fell apart some were hallucinating they all became addicted teeth falling out becoming zombie light as a result of being given a medication this powerful that you don't need it was very compelling testimony some of them were showing insurance records that claimed that they had diagnosis that they'd never had and reacted to the fact that I didn't have cancer I didn't have that diagnosis prosecutors call that insurance fraud insist CEO John Kapoor set up a scam to get insurance companies to pay for the drugs that were prescribed he had incest employees poses doctors office staff to dupe the insurers prosecutors obtained recordings of the calls and played them for the jury what medication are we speaking up today this is perception so they're sitting in in a windowless room in Arizona saying all the way there's beautiful here in Houston today or oh it's cold up here in New York they would outright lie they would say the patient had cancer when they didn't have cancer and they knew they kept track at iNSYS of what answers would work with individual insurance companies Ince's executives prepared a script for call center workers that almost assured the insurance companies would pay and the patient's diagnosis it's for the breakthrough tinea malignant cancer pain yes ma'am nine times out of ten that drugs getting approved and this worked it worked for years it helped make incest so lucrative that when the company went public in 2013 it became the number one IPO in the country worth more than a billion dollars in court prosecutors exposed a culture of greed to make their case they played for the jury an in-house company video about titration a medical technique used to increase a patient's dosage I think the jury was disgusted when they saw that I I know I was disgusted in says sales reps rapping boasting about doctors under their control up in patients dosage of subsys in costume the biggest dose 1600 micrograms this was shown to a packed annual sales convention in Arizona in 2015 well ending with a cameo by Alec Birla cough everybody laugh I'm sorry to say everybody laughed yes the opioid crisis is raging outside the doors and you're inside joking about it yes we were all desensitized to what was going on On January 23rd a federal judge sentenced Alec Birla cough to 26 months observed and ordered him to turn over the 4.3 million dollars he had made at the company a dozen doctors were also convicted of crimes in connection with incest the company went bankrupt and CEO John Kapoor is to report to federal prison in July to begin serving his sentence of five and a half years as for wyshak and the federal prosecution team this case launched a new tougher approach to corporate crime I think sometimes white-collar criminals are more dangerous than violent criminals and more often than not they get a kid glove treatment and I think that needs to stop