Five more US states sue Purdue Pharma over its role in opioid crisis

Wisconsin, Iowa, Kansas, Maryland and West Virginia sign up with a number of lots other states, declaring business pressed incorrect claims

Five more US mentions took legal action against the pain reliever maker Purdue Pharma on Thursday, declaring misbehavior in the marketing and sales of opioids such as the business’s extremely rewarding OxyContin narcotic.

Wisconsin, Iowa, Kansas, Maryland and West Virginia submitted comparable however different claims, bringing the variety of states taking legal action against the pharmaceutical business to 45, over its supposed function in the United States opioids crisis that has actually triggered countless drug overdose deaths. Pennsylvania took legal action against the business 2 days back, while New York’s Metropolitan Museum of Art on Wednesday signed up with a host of scholastic and cultural organizations in revealing it would stop accepting philanthropy from the Sackler member of the family behind Purdue Pharma.

The 5 states that submitted on Thursday are likewise taking legal action against Richard Sackler , who was formerly Purdue’s co-chairman and president and is among the leading members of the Sackler household who entirely own the personal business.

Sackler has actually been taken legal action against in a number of other such suits in current months and Purdue is likewise being taken legal action against by more than 1,500 cities and counties from all throughout the United States.

West Virginia’s suit declares Purdue Pharma strongly pressed misleading practices and incorrect claims, even in the previous training brand-new marketing staff members with the marketing slogan: “We offer hope in a bottle.”

“This claim exposes several years of painstaking examination,” West Virginia’s chief law officer, Patrick Morrisey, stated. “The ridiculous death and destroyed lives of unknown thousands should stop.”

Purdue Pharma and Richard Sackler have consistently and strenuously rejected the claims in the different claims versus them, and all misdeed.

In Wisconsin, opioids cost 916 lives in the state in 2017, the state’s match stated.

“The opioid epidemic has actually shattered lives and stretched neighborhoods throughout the nation and the state,” stated Wisconsin’s chief law officer, Josh Kaul. “Today, we submitted fit … declaring that they misinformed the medical and public experts about both the advantages of and the threats postured by OxyContin and other opioids, which the opioid epidemic is partially attributable to their conduct.”

Wisconsin’s suit, submitted in Dane county circuit court, looks for an irreversible injunction, reduction of the general public annoyance, and civil charges. It declares that the business entities Purdue Pharma LP and Purdue Pharma Inc, and Sackler consistently made misleading and incorrect claims relating to opioids, consisting of OxyContin.

Purdue Pharma’s incorrect and misleading marketing produced a shift in the understanding of the efficiency and threat of opioids, the problem declares. “In order to fight the issues about opioids being mistreated, Purdue released an aggressive marketing project that looked for to increase sales of OxyContin, while altering the accepted standards about opioid prescribing.”

The Wisconsin problem even more declares that, after a 2007 settlement in a federal criminal case versus Purdue and a few of its leading executives, in a case that did not consist of any charges versus any members of the Sackler household, Purdue continued to take part in incorrect, deceptive and misleading marketing practices in relation to its prescription pain reliever and the threats of abuse, death and dependency.

Kaul declares that Purdue and Richard Sackler were completely familiar with the prospective earnings of OxyContin.

OxyContin was introduced in the mid-90s as an advancement in discomfort relief, due to the fact that of its formula for regulated, continual release of its active component, which is originated from the opium poppy.

Iowa’s chief law officer, Tom Miller, stated: “Purdue Pharma is accountable for a public health crisis that has actually exceptionally impacted clients, their households, our neighborhoods, and our health care system,” Miller stated. “The business and its executives were recklessly indifferent to the effect of their actions, regardless of ever-mounting proof that their deceptiveness were leading to an epidemic of dependency and death.”

Purdue Pharma released a declaration on Thursday, stating: “Purdue Pharma strongly rejects the claims in the claims submitted today and will continue to protect itself versus these deceptive attacks.”

The business indicated the substantial current advancement in its favor that North Dakota’s state claim versus it was tossed out previously this month, and kept in mind that: “As the judge mentioned in his choice, one business can not be held responsible for a complicated public health concern such as the opioid crisis.”

The North Dakota attorney general of the United States is appealing versus the choice.

On Thursday, in action to the current flurry of suits, Purdue included: “These problems become part of a continuing effort to attempt these cases in the court of popular opinion instead of the justice system. The states can not connect the conduct declared to the damage explained, therefore they have actually created strikingly over-broad legal theories, which if embraced by courts, will weaken the bedrock legal concept of causation.

Read more: https://www.theguardian.com/us-news/2019/may/16/purdue-pharma-states-sue-opioids-crisis-role

‘I dont want to overdose and die:’ one woman’s death, one country’s shame

Saige Earley, who was found dead of a heroin overdose in a toilet stall at Syracuse airport, is the face of real people devastated by the worst drug epidemic in American history

Saige Earley was gone in stages.

To her mother, Ellen, the 22-year-old grew increasingly detached within weeks of returning from the dentist with a fateful prescription for opioid painkillers. The young woman with long dark hair and a broad toothy smile was gone physically a few months later when she walked out on her young son and left Ellen wondering if her daughter was even alive.

Then last September, Saige was gone for good, found dead of a heroin overdose in a toilet stall at Syracuse airport, clutching a plane ticket to drug rehab in California.

Whether she escaped in her insatiable appetite for books, dancing till exhausted, headphones blaring music, walks upon walks, or the drugs that cut her life so terribly short, she simply needed to run, Saiges father, Jason, wrote in a moving and frank obituary. But she always wanted to return, to make us laugh, to love her baby, to show us this cruel yet fascinating world through her eyes.

The obituary caught the eye of the New York attorney generals office as it built a sweeping lawsuit filed against the opioid industry last month. The legal action singled out Saige Earley as the face of real people devastated by the worst drug epidemic in American history.

An epidemic fomented in board rooms

The New York lawsuit drew a clear line between the dentist prescribing Saige Earley opioids after he removed her wisdom teeth in the spring of 2017 and the heroin overdose that claimed her life 18 months later. But her reality was messier, and in its own way a deeper indictment of the lengths the drug industry went to blame Saige and other victims of the epidemic for their deaths.

Topping a long list of accused in the New York action is Purdue Pharma, the maker of OxyContin, and those members of the Sackler family who owned and ran the company.

The lawsuit reveals an email written by Dr Richard Sackler, Purdues head of marketing who ramped up sales of OxyContin by downplaying the risks of addiction from its high dose of narcotic. As overdoses and deaths escalated, Sackler painted the victims as criminals to blame for their own condition.

They get themselves addicted over and over again, he wrote in a 2001 email. They engage in it with full, criminal intent. Why should they be entitled to our sympathies?

Sackler has apologised for using insensitive language in what he said was his frustration at illegal drug use. But it was more than a passing outburst. Blaming the victims evolved as a central strategy as Purdue and other opioid makers sought to keep the door open to the mass prescribing earning billions of dollars a year even as it fuelled an escalating human tragedy that has claimed about 400,000 lives over the past two decades.

The manufacturers, their lobbyists and well funded industry front organisations played on societys stigma against those sucked into addiction by powerful narcotic drugs to blame the person, not the pill. Addiction was painted as a lifestyle choice, and those who made it as degenerates.

But for Saige Earley, it was a struggle for survival.

At times she kept a diary. A year after she walked out of the dentists office, opioids were testing her will to live.

I dont want to overdose and die. Thats not for sure though because it changes all the time. Sometimes I do want to, she wrote.

Protesters
Protesters stage a die-in at the Solomon R Guggenheim Museum in Manhattan, New York, against its funding by the Sackler family, the owners of Oxycontin manufacturer Purdue Pharma. Photograph: Yana Paskova/The Guardian

When Richard Sackler spoke about criminal addicts, Saige was exactly who he had in mind. Her family too. Saiges mother, Ellen, was buying black market opioid painkillers in the 1990s before much more powerful and addictive OxyContin hit the market. Her father, Jason, was also struggling with substance abuse.

Ellen was able to walk away from the narcotics when she became pregnant with Saige. She taught dance and reckoned her daughter was a natural. The family lived in a roomy wooden house in Cazenovia, a prosperous upstate New York village with a sense of history and well-preserved 19th century architecture.But Saige struggled with mental health issues as a teenager, something Ellen links to a history of bipolar disorderon Jasons side of the family.

Saige began coming home drunk and then took to marijuana. She skipped school and cut herself. In time, Ellen noticed her daughter developing what she regarded as a less savoury set of friends. The two clashed. Ellen tried to get help but said counsellors put the confrontations down to mother daughter stuff.

I was relating it to my own teenagerhood and thinking I did some crazy things and I was hanging out with some absolutely wrong people, and I survived, said Ellen. But I have two other kids that Im trying to raise by myself and this chaos was too much. We had a year of just chaos.

By then Ellen and Jason were divorced and she gave Saige an ultimatum: get help or go live with your father. At 17, Saige moved in with Jason. She continued to use alcohol and marijuana, and didnt speak to her mother much for a couple of years. But then Saige became pregnant and asked to move back home. Ellen agreed.

I was young when I was pregnant too and I thought Ill never greet a pregnancy with negativity. So thats great. She said she was very happy about it but she was young and she knew from my life experience that single parenthood is difficult, she said.

Saige asked if she could move back in because heres a safe place. There is no drinking or drugging. She was absolutely sober for the entire pregnancy. She found a new focus.

Ellen describes the birth as whacky because it took a while for Saige to realise she was in labour and they only made it to the hospital with minutes to spare.

Saige was clean for a while after her son Julian was born but was still troubled and was drawn back to alcohol. Months later she wrote about it in her diary.

When I picked up that first drink after having my son I did not think I was chasing alcohol over loving Julian. I really figured I could just drink some nights to relieve stress like other people do. Like other moms do all the time. 1 turned to 3 turned to every single night, she wrote.

Still, Ellen said Saige largely kept it together and was focussed on her baby.

Then came the dentist. Saiges wisdom teeth were impacted and causing pain. Ellen thought it was contributing to her daughters general unhappiness and encouraged her to have them removed. But she advised against having all four teeth extracted at once because it would be so painful.

Photographs
Photographs of Saige with her family in Julians room. Photograph: Maranie R Staab/The Guardian

The dentist said the insurance company would only pay for Saige to have the teeth removed in one sitting. He said it would be fine. He would give her painkillers to take home.

By the time Saige went to the dentist two years ago, the extent of the opioid crisis was beyond doubt. The Centers for Disease Control and Prevention (CDC) established the close link between the sharp rise in opioid prescribing and increasing overdose deaths more than a decade ago. In 2012 alone, doctors and dentists wrote 255m opioid prescriptions enough to supply every American adult with a month of pills.

But even as the epidemic revealed itself, the drugmakers worked hard to keep the door to mass prescribing open.

In 2005, Burt Rosen, a vice-president of government affairs at Purdue Pharma and the companys chief lobbyist in Washington, co-founded the Pain Care Forum (PCF) with other opioid manufacturers. The forum spent close to three-quarters of a billion dollars over the following decade pushing opioid friendly policies, writing legislation, and funding elected officials across the country.

The PCF exploited the longstanding stigma against those who become addicted to opioids, particularly heroin, to tell congressional briefings and Food and Drug Administration hearings that there must be no curbs on prescribing because the people Sackler portrayed as criminals should not be allowed to deprive legitimate patients of desperately needed opioids.

Very often though, they were one and the same. People like Saige Earley who began on a prescription and ended up buying on the black market to feed their addiction.

The PCF claimed opioids were safe for those who took them as prescribed and had no history of addiction. To Congress and the FDA, the industry painted a picture of doctors closely interrogating their patients about their vulnerability to addiction and monitoring for evidence of dependence. But most primary care physicians had little training in using narcotics for pain relief, and the drugmakers were instrumental in shaping a medical policy in which hospitals and insurance companies pressured doctors and dentists to default to opioids.

Ellen
Ellen holds a family photograph taken on their last vacation together in Myrtle Beach. It was the greatest vacation I think any of us have ever had. Photograph: Maranie R Staab/The Guardian

Dr Russell Portenoy, the Purdue-funded pain specialist who led the way in breaking down the medical professions decades-long caution about prescribing narcotics, recently said in a court deposition that drug manufacturers deliberately understated the risks of opioids, particularly the risk of abuse, addiction and overdose to boost sales. Opioid makers even told doctors that it was safe to ratchet up doses without risk of addiction.

Saiges history of addiction, and that of her parents, should have been a red flag to any medical professional prescribing opioids. But Ellen said her daughter was not asked if she might be vulnerable. Instead she was sent home with a weeks worth of the opioid hydrocodone hydros with a refill for another week. There would be no monitoring.

Ellen saw that the drugs would be pushing against an open door with Saige.

I felt awful because she was an adult. In the middle of the night I was thinking how can I switch those pills so that she wouldnt know, so that she wouldnt feel like I was trying to control the situation? she said.

Ellen gave her daughter the drugs and cautioned her. Saige shrugged it off.

And then she was gone

The CDC warns that opioid painkillers can get a grip on a person in as little as five days.

I had oral surgery, under anesthetic felt great, Saige told her diary. Then got some dumb hydros that I really thought nothing of and like without a second thought I had abused them and was looking for more pain pills. Huge consequence for this.

On the back of her history of other addictions, Saige rapidly fell into dependence on opioids. When the prescription ran out, she found a new set of friends to supply her with pills. Within a few weeks she hooked up with a man with a long history of heroin use.

And then she was gone, said Ellen.

It was very quick. Her personality changed. Up until that point, even with the pain from the wisdom teeth, she had a lot of patience with Julian. She was working. But then she was just miserable, consistently miserable. She didnt want to be around us. The baby all of a sudden became really difficult for her. Can you just take him? I cant deal with it.

Saige walked out of her mothers house on Independence Day 2017, three months after the visit to the dentist. Julian was 16 months old.

We had our big July 4th party and then she left with this man and left the baby here, said Ellen.

Desperate to at least know her daughter was alive, each night Ellen checked Saiges cell phone billing for evidence she was sending text messages.

Then the texts stopped. No nothing. No activity on her phone. It was terrifying, she said.

Ellen has been able to reconstruct only a part of the picture of the life Saige was living at that moment.

There was some really bad stuff involving sex trafficking. She wound up in Poughkeepsie, New York. She called her best friend who called me and said I cant really understand what shes saying. Shes being kept by some guy, said Ellen. There was something really bad that happened and it was fast.

Saiges father, Jason, finally tracked her down and got her into rehab in Florida that October. She made it through the initial programme and into a halfway house. Six months later, Saige went out drinking.

Came home to halfway black out drunk and got kicked out, she told her diary. I had spent the night in the hospital and was sober and couldve gotten into 1/2way but instead I continued drinking and drugging for a week til I ran out of resources.

A month later, she was back in rehab.

divider

In his emails, Richard Sackler said that it was necessary to hammer on the abusers in every way possible. They are the culprits and the problem.

Sackler was angry that OxyContin was getting the blame for rising overdoses This vilification is shit and claimed that it was factually untrue that addicts dont want to be addicted.

For Saige, it was not nearly so straightforward. A single page of her diary lays bare her struggle to resist being sucked back into using opioids. In rehab in Florida, she wrote: Ive accomplished a lot. Ive changed a lot.

But a few lines later, she is resisting the drag of the past.

I feel like going back to the same people, places, things at this point Ill relapse on old behaviors and thought patterns which will lead to a relapse on drugs, she wrote.

I
I miss my baby boy so much. My soul aches for him. Its like a missing limb. But more important. Like missing an organ. Photograph: Courtesy of the Earley family

She writes about how she just really wanted to get high and the pull of just one more fix against medical advice, or AMA.

Monday I ran into dirty Mike and was like triggered af (as fuck) whatever that means but like I was seriously considering AMAing right then and there.

Saige was also struggling with life without Julian.

I miss my baby boy so much. My soul literally aches for him. Its like a missing limb. But more important. Like missing an organ. Like my body cant function without him. I cant function without him. Yet here I am. Living life, without Julian. Happy a lot of the time, she told her diary.

Finally in August 2018, Saige said she had a handle on her addiction and wanted to come home. Ellen wasnt sure it was a good idea. She thought her daughter needed more time under the direct oversight of rehab but it would mean Julian would have his mother back and so she agreed.

In Cazenovia, Saige joined Alcoholics Anonymous and recorded her daily struggle.

Showered, got dressed. Stayed sober. Theres so much more I need to be doing and I could have done today but thinking about how much I failed does absolutely nothing. So Im trying to focus on the good I did accomplish. Loving my son, being here for him. Meetings every night, she recorded in the diary.

For the first time in years, Ellen and Saige took a holiday together to Myrtle Beach with their children.

It was the greatest vacation I think any of us have ever had. We had a lot of fun. Came back and within five days she was gone, said Ellen.

While she was away, one of Saiges friends overdosed and died. On her return she went to the calling hours to view the body. As the evening wore on, and Saige failed to return home, her mother grew anxious. Ellen shot Saige a text. However hard it is, she said, focus on Julian. You have him and he needs you.

Days later, Saige contacted friends from rehab in Florida who helped get her into a recovery programme in California. A friend in Syracuse bought the plane ticket.

With it, he gifted her a bag of heroin. A last hit before she made another attempt to get clean.

On 16 September 2018, Ellen opened the door to a policeman she happened to know.

I had just sat down. Saige and I were watching Shameless together. There was a new episode on and I almost picked up the phone to text her and say youre missing the new Shameless and we got a knock on the door, she said.

He said you need to sit down. I knew what was coming. I didnt want to know but I knew. He said, we believe that we have Saige at the airport and she isnt alive anymore.

Chris McGreal is the author of American Overdose, The Opioid Tragedy in Three Acts

Read more: https://www.theguardian.com/us-news/2019/apr/29/i-dont-want-to-overdose-and-die-one-womans-death-one-countrys-shame

Opioid crisis: FDA’s own staff demand agency halt approval of new painkillers

Top professionals state firms precariously lacking oversight is continuing to sustain an epidemic that claims 150 lives a day

The United States Food and Drug Administration is dealing with a need from a few of its own experts to stop the approval of brand-new narcotic pain relievers since they state the firm’s “precariously lacking oversight” is continuing to sustain the opioid epidemic.

Dr Sidney Wolfe, a previous member of the FDA’s drug security committee, and Dr Raeford Brown, today chair of the company’s opioid advisory committee, on Thursday started an official procedure to require the FDA to discuss or suspend opioid approvals why not.

The 2 experts stated the FDA stopped working to appraise the general public health crisis and intensifying death toll brought on by the flood of opioid prescriptions over the previous 20 years even as the company authorized lots of brand-new narcotics. Wolfe and Brown have actually sent a petition to the FDA, a relocation that needs the firm to react, requiring it put in location a procedure that thinks about the effect of pain relievers on the opioid epidemic prior to anymore are authorized.

“It is a nationwide emergency situation,” stated Wolfe. “There’s not one opioid that’s been authorized in the last 10 or 20 years that has any substantial benefit in discomfort relief over existing ones and does not simply contribute to the likelihood of individuals getting addicted and abusing the drug.”

The call for a moratorium on brand-new opioid approvals shows aggravation and anger within parts of the medical neighborhood over what is viewed as the FDA’s consistent failure to confront its part in an epidemic declaring about 150 lives a day.

The company authorized 27 brand-new opioids for sale in between 2009 and 2015. Among those drugs, Opana ER, was at the centre of an HIV and liver disease C break out amongst individuals who injected it, requiring the FDA to press the producer to pull it from sale. Brown stated that Opana expense countless lives.

Wolfe stated the FDA declines to take obligation for its errors and goes on making them.

“When Opana was removed the marketplace, the FDA did not acknowledge any blame, any duty, for having actually enabled it to go on the marketplace in the very first location,” he stated.

The outbound FDA commissioner, Scott Gottlieb, has actually consistently promised to reform the approvals procedure however has yet to carry out a brand-new system. The company’s approval of an extremely high strength opioid, Dsuvia, in November triggered a new age of criticism. Brown, a teacher of anesthesiology at the University of Kentucky, implicated the FDA of compromising American lives.

Wolfe, a creator of the general public Citizen Health Research Group, stated the FDA had actually been provided every chance to act however “can no longer be relied on” since it is greatly swayed by the drug market which offers the bulk of the financing for the FDA’s drug approval department.

In 2016, the FDA asked the National Academy of Medicine for suggestions on how to control opioids due to the epidemic. A year later on, the academy released a report stating that the FDA had too narrow a view of the opioid approval procedure which stopped working to consider problems such as dependency and the truth that great deals of prescription narcotics wind up on the black market.

It noted a series of actions towards tightening up the approval of opioids in the future and suggested that the FDA evaluation whether those currently on the marketplace ought to still be offered. The academy stated it was “extremely not likely that all of these items would be evaluated reliable and safe under the brand-new drug approval structure” being proposed.

Two years later on, the FDA has yet to carry out the suggestions or to pull existing drugs off the marketplace.

“The FDA should enforce a moratorium on approval of opioids up until the regulative structure imagined by the National Academies remains in location,” Wolfe and Brown stated in a letter to Gottlieb and the health and human services secretary, Alex Azar, accompanying the petition.

The FDA is required to react to the petition and Wolfe and Brown strategy to utilize it to create assistance from within the medical occupation and Congress to put pressure on the FDA.

The FDA stated it is evaluating the petition and will react straight to Wolfe and Brown.

Read more: https://www.theguardian.com/us-news/2019/mar/21/fda-opioid-approvals-halt