Who’s responsible for the opioid epidemic? Doctors or pharmaceutical companies?

Dr. Barry Schultz is serving 157 years in prison after he prescribed enough opioids for a prosecutor to call him one of Florida’s, “most notorious drug dealers.” In his only interview, Schultz says he’s a scapegoat.

In the annals of 60 Minutes, we have rarely come across a doctor like Florida physician Barry Schultz. Prosecutors say he wantonly prescribed and sold massive quantities of highly addictive opioids. In July, Schultz was sentenced to 157 years for his role in fueling the most devastating public health crisis of the 21 century. Last year more Americans died of drug overdoses than in the entire Vietnam War. While Schultz ended up in jail, Mallinckrodt, the pharmaceutical company that flooded Florida with hundreds of millions of oxycodone pills, paid a relatively small penalty. The question now being debated in Congress and in federal court is: who is responsible for the opioid epidemic? The doctors who prescribed the pills or the opioid manufacturers and distributors who supplied them?

Dr. Barry Schultz is an inmate at Florida State Prison, where he will likely be incarcerated until the day he dies.

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Clean, Sober and $41,000 Deep in Out-of-Pocket Addiction Recovery Costs

Tess Henry with her rescue dogs, in a photo taken by her mother. Ms. Henry was the subject of a recent Sunday Review essay, which generated over 400 reader comments.
Credit Patricia Mehrmann

People recovering from opioid addiction and their families discuss the financial and emotional costs of treatment.

Tess Henry’s family paid $12,000 for 30 days of rehab from opioid addiction. She had done two more cycles of treatment without achieving sobriety. So her family agreed to pay $20,000 for 28 days of more rehab. But they never got the chance.

A few days after assuring her mother that she planned to fly to Virginia to resume treatment, Ms. Henry was murdered.

The tragic end of Ms. Henry’s six-year struggle to recover from an opioid addiction that began with a prescription for cough syrup was chronicled last week in The New York Times by Beth Macy, a journalist who covers the opioid crisis.

It takes eight years, and four to five attempts at treatment, for the average person addicted to opioids to achieve one year of remission, according to John Kelly, a researcher and professor of psychiatry at Harvard Medical School, whom Ms. Macy cited in her Sunday Review essay.

Some people manage to achieve recovery through free 12-step programs, while others spend hundreds of thousands of dollars.

Ms. Henry’s story prompted readers to share with us in our comments section their own struggles with recovery or the struggles of their family members.

Here is a selection of the comments that cite costs — in out-of-pocket expenses, as well as in time, insurance payouts and human patience — of recovery. They are condensed and lightly edited.

‘I’m lucky it didn’t cost me more’

$25,000 for Suboxone, $16,000 of doctor appointments, $200,000 paid by insurance

I abused opiates for four years. I quit one-time and have been sober for five years. I’ve been on Suboxone [a drug that helps prevent opioid withdrawal symptoms] for five years as well. Luckily I make enough money to spend $400/month on Suboxone. I also moved 1,500 miles away from where I bought OxyContin when I quit, went to a $100,000 rehab on private insurance, and then stayed for 10 more months working as a nighttime janitor and going to A.A. like 10 times a week.

Recovering from opiates has cost me over $25,000 for Suboxone, $16,000 of doctor appointments, and it’s cost my insurance about $200,000. It cost me five years of my life. I’m lucky it didn’t cost me more.

David Cassidy claimed he didn’t have dementia — he just lied about getting sober

A few weeks before his death in November, David Cassidy confessed that the sudden decline in his health was brought on by alcohol abuse — not dementia, as he previously claimed.

The revelation comes courtesy of A&E Networks, which is airing a two-hour documentary next week originally intended to chronicle the onetime teen idol as he recorded a tribute record to his late father, Jack Cassidy. Instead, David Cassidy fell gravely ill and struggled with what he first said was the onset of dementia.

The truth was just as bad. After becoming ill and being hospitalized during production, Cassidy was told that he had liver disease, which would ultimately become multiple organ failure.

“The head doctor at the hospital, she said, ‘I believe that your dementia was directly related to your alcoholism,’” Cassidy told A&E producer Saralena Weinfield in a taped phone call from a Fort Lauderdale, Fla., hospital.

“I did it to myself, man. I did it to myself, to cover up the sadness and the emptiness,” he said.

Cassidy explained that after a few days where he was unconscious and near death, his memory came back.

“That’s such a blessing,” he told the producer, beginning to laugh as if he were telling a wry joke. “That means I’m cognizant of my surroundings, that I’m alive and it’s daytime and I know what day of the week it is. There is no sign of me having dementia at this stage of my life. It was complete alcohol poisoning. And the fact is, I lied about my drinking.”

After he was arrested for DUI in 2014 — his wife filed for divorce the next week — Cassidy was sentenced to rehab and put on probation. In early February 2017, he told People that he was suffering from dementia and would stop touring to focus on his private life.

The former star of “The Partridge Family” died soon after at age 67 from organ failure, including his liver and kidneys.

Although Their Introductions as Treatment are Different, Two Top Medications for Opioid Addiction are Equally Effective

With opioid addiction officially declared a public health emergency in the U.S., medical intervention to treat the illness is increasingly important in responding to the epidemic. Now, a new study concludes that two of the top medications available for outpatient, office-based treatment, once initiated, are equally safe and effective in curtailing opioid use, relapse, treatment drop-out and overdose.

Researchers in the Departments of Psychiatry and Population Health at NYU School of Medicine, who led the study sponsored by the National Institute on Drug Abuse (NIDA) and published online November 14, 2017 in The Lancet, conclude that extended-release naltrexone (an opioid antagonist marketed as Vivitrol) demonstrated similar safety and clinical effectiveness to more commonly prescribed buprenorphine-naloxone (an opioid agonist marketed both generically and as Suboxone).

However, the study also points out differences that have previously been known: Patients being treated with naltrexone must detoxify before it can be administered. (This is commonly referred to as the “detox hurdle.”) On the other hand, buprenorphine allows individuals to transition relatively seamlessly from opioid use to medication maintenance without needing to detoxify.

Agonist (buprenorphine) and antagonist (naltrexone) treatment are pharmacologically, conceptually and logistically near-opposites — allowing patients, families and providers to choose an approach in line with their goals and preferences. Among the differences:

  • Agonists activate opioid receptors, have opioid-like effects, and maintain physical dependence on opioids, while antagonists have no effects on their own and block the effects of opioids
  • Agonists can be started while a patient is still opioid dependent or detoxifying, but antagonists only can be administered after full detoxification to avoid opioid withdrawals
  • When discontinued, agonists are associated with withdrawal symptoms; antagonists are not
  • Agonists have abuse potential and diversion risks; antagonists do not
  • There are differences in prescribing regulations and community acceptance between the two forms of treatment

Despite these differences, the researchers say, until now there had been no comparative data on the effectiveness of both treatments. “As the epidemic has escalated, and hundreds of people in the U.S. and elsewhere are dying every day, there is an increased urgency to provide immediate and effective medical treatment,” says John Rotrosen, MD, professor in the Department of Psychiatry at NYU School of Medicine and the study’s senior author. “Our findings should dispel some commonly held misconceptions and help patients choose between these different approaches to treatment.”

What the Study Examined

The clinical trial took place from 2014 to 2017 at eight community treatment programs affiliated with NIDA’s Clinical Trials Network across the U.S. The patient cohort involved 570 opioid dependent adults, approximately two-thirds of whom were men and 82% primarily using heroin. They were recruited during admission for detoxification and randomly assigned to two study groups for up to 24 weeks of treatment. One group received a monthly injection of naltrexone initiated after completing detoxification, and the other self-administered a daily oral dose of buprenorphine initiated as early as possible after randomization.

Among those treated, 24-week relapse rates were similar — 52% for naltrexone and 55.6% for buprenorphine, as were other measures of opioid use. In addition, craving for opioids was lower with naltrexone, though by the end of 24 weeks, the buprenorphine group had caught up. Other than mild to moderate injection site reactions with naltrexone, adverse events, including fatal and non-fatal overdoses, were similar across the two study groups.

The study also examined the detox hurdle — a critical point of initiation for active users (though a non-issue for those who are already fully detoxed). Approximately 25% of participants assigned to the naltrexone group were unable to complete detox and get a first dose of naltrexone — though for those assigned to naltrexone later in the detox process, the hurdle wasn’t so insurmountable. In contrast, only 6%, of patients were unable to start buprenorphine.

The study could have immediate implications for how the U.S. responds to a crisis that has already claimed 300,000 lives since 2000, according to the U.S. Centers for Disease Control and Prevention.

“Both medications are effective treatments for opioid use disorders versus counseling-only approaches or compared to placebo,” says Joshua D. Lee, MD, MSc, associate professor in the Departments of Medicine and Population Health at NYU School of Medicine and the study’s lead author. “What is now clear is how similar the outcomes are for those initiating treatment with either medication.”

The researchers also point out that the study sheds light on the likelihood that those dropping out of detox will rapidly relapse. “Patients wanting naltrexone, but who are unable to complete detox,” Lee adds, “should be encouraged to start an agonist-based treatment like buprenorphine.”

A smaller (total cohort of 159 patients) and shorter (up to 12 weeks of treatment) parallel study conducted in Norway over the same period found naltrexone and buprenorphine to be equally effective in retaining patients in treatment and reducing opioid use. However, all participants in that study were randomized late in detox so there was no “hurdle” to clear. Prior to these two studies, the field had no comparative effectiveness data. An earlier multi-site clinical trial led by NYU School of Medicine found in 2016 that extended-release Naltrexone was effective at preventing opioid relapse in criminal justice offenders.

Opioid Epidemic Leaving grandparents to Raise Grandchildren

A million children now live with their grandparents primarily due to their parents’ addictions, increasingly because of opioids.

The growing opioid crisis has been declared a public health emergency. It’s sparked a parallel crisis you rarely hear about: the impact on children neglected by addicted parents. More than one million American children now live with grandparents, primarily because of their parent’s addiction to opioids and other drugs: heroin, crack, meth and alcohol. Grandparents are putting off retirement and plowing through savings to rescue their grandchildren from dangerous situations.

To see how widespread this is, we went to one of the healthiest states in the country, Utah. Tonight, we’ll introduce you to a few families around Salt Lake City, and meet children, raised in the wreckage of the opioid crisis, getting a chance at a normal life.

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Woman lost 2 sons in one night to opioids; fighting the crisis is now her life’s work

Everything just kind of seemed like a blur that day,” Becky Savage said. “Your mind is not really meant to process something that extreme.” The day Savage is describing is June 14, 2015.

The Indiana mom’s two oldest sons, Nick and Jack, were celebrating at high school graduation parties the night before. The boys came home about 12:30 a.m. and checked in with their mom, who had been waiting up.

The next morning, as Savage was picking up laundry in Jack’s room, she noticed that he wasn’t stirring as she tried to wake him.
“He was unresponsive. I called 911, and I remember hollering for Nick, for him to come up, and how he never came.”

Nick, her eldest son, was downstairs sleeping in the basement with friends.

The first responders arrived and tried to resuscitate Jack, and then Savage noticed one of them going downstairs to the basement.

“I had no idea at that point what they were doing in our basement. And then I remember one of them coming up and asking for a coroner. That’s the last thing that I remember that day.”

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Worried about your alcohol consumption? Sober moms share their advice

If you think alcohol may be affecting your life or serving as a crutch, it’s time to get curious about your behavior. That’s one of several tips from three women who decided to stop drinking. “I want the women who are watching to know that we are never alone. There needs to be no shame attached to this,” mother and psychotherapist Kelley Kitley told Megyn Kelly.

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Substance Abuse in Older Adults – Topic Overview

Many people think alcohol and drug abuse happen only to teens and younger adults. But all ages can have problems with drugs and alcohol, including older adults.

Older adults may use illegal drugs, use prescription or over-the-counter medicines in harmful ways, drink too much alcohol, or mix alcohol and medicines. Doing any of these can cause serious health problems and problems with money and the law. It also can harm relationships with family and friends.

Substance abuse in older adults may be overlooked, because:

Older adults are more likely to drink or use drugs at home rather than in public.
Older adults may not have duties that are affected by substance abuse, such as going to school or work.
Signs of abuse are similar to those found in health problems that many older adults have, such as depression and dementia.
Caregivers of older adults may be aware of the problem but may not want to talk about it.

Alcohol

Alcohol abuse is dangerous for all people, and it can be very dangerous for older adults. Older adults:1

  • Usually need less alcohol to become drunk (intoxicated) than someone younger.
  • Stay drunk longer, because their bodies process alcohol more slowly.
  • May have vision and hearing problems and slower reaction times. Alcohol can make these problems worse, which means alcohol-related falls, car crashes, and other kinds of accidents are more likely.
  • May be more likely to mix alcohol and medicine because they are taking so many medicines. Mixing alcohol with many over-the-counter and prescription medicines can be dangerous or even fatal.

In older adults, alcohol can trigger some health problems or make them worse. These health problems include high blood pressure, ulcers, liver disease, anxiety, sleep problems, and depression.1

Experts suggest that adults 65 and older have:1

  • No more than 1 standard drink camera.gif a day.
  • No more than 2 drinks on any drinking occasion, such as New Year’s Eve or weddings.

Some older adults should not drink alcohol. Women who are small may want to ask their doctors what amount of alcohol is safe for them.

Long-awaited study finds monthly Vivitrol as effective as daily pill for opioid addiction

The largest head-to-head study to date between two leading drugs to treat opioid addiction has found them roughly equivalent — an outcome that could dramatically change prescribing habits and boost the fortunes of the newer drug, Vivitrol.

The study, sponsored by the National Institute on Drug Abuse, found that a monthly shot of naltrexone (sold as Vivitrol) is as effective as its main competitor, the daily pill of buprenorphine and naloxone (sold as Suboxone). Researchers found that about half of people with opioid addiction who took either drug remained free from relapse six months later.

Previously, there’s been a “widespread belief” that patients “don’t do as well on naltrexone as they do on buprenorphine,” said Dr. Nora Volkow, director of NIDA. “We’re hopeful this changes the prejudice.”

The finding, however, comes with a major caveat. A large number of people were unable to even start treatment with Vivitrol. That’s because participants had to thoroughly wean themselves off opioids for a period of three days before they could start taking Vivitrol, to avoid sudden symptoms of opioid withdrawal. Because of that hurdle, patients failed to start on Vivitrol at four times the rate that they did Suboxone.

Vivitrol, which received Food and Drug Administration approval in 2010 for opioid treatment, is seen as attractive option because patients only have to take it once a month, and it doesn’t contain opioids. Suboxone, by contrast, has been treated with skepticism by some physicians and officials — including former Health and Human Services Secretary Tom Price — because it’s “substituting” one opioid for another. But Vivitrol, which costs about $1,000 a shot, is also much more expensive than Suboxone, and up until now has had limited evidence showing how well it works.

Addiction experts say this study, which confirms the results of a smaller head-to-head trial recently published, offer more clarity at a time where misconceptions have clouded the public’s judgment about treatments for opioid addiction.

Costs and benefits

The research was conducted between 2014 and 2017 at eight community-based inpatient treatment facilities across the U.S. A group of 570 opioid-dependent adults — the majority of whom were white men between the ages of 25 and 45 — received one of the two medication-assisted treatments.

Over the subsequent six months, researchers both solicited self-reports of opioid use as well as weekly urine samples. Participants also reported side effects and their level of opioid craving. At the end of six months, 52 percent of those who had received Vivitrol had relapsed, compared with 56 percent of those receiving Suboxone. However, 28 percent of participants assigned to Vivitrol couldn’t make it through the detox period, as compared to 6 percent of people who quit the study before initiating Suboxone dosage. Taking into account all the participants, Suboxone had a lower rate of relapse than Vivitrol.

Dr. Joshua Lee, an associate professor with New York University’s School of Medicine and a leading author of the study, which published in the Lancet on Tuesday, said the findings indicate that each drug can help certain patients, rather than one simply being better than the other.

“Both medications worked quite similarly and, therefore, both should be discussed as treatment options,” Lee told STAT. “The problem is not enough people are getting into treatment anyway, and when they do go into treatment, they don’t get any of these treatment options. Enough of the circular firing squad among the addiction treatment providers, and the war amongst all these different medications.”

But other addiction doctors said that the gap in rates of people who successfully started each treatment was an alarming sign.

“The take-home from this study is that buprenorphine [Suboxone] is more effective” than Vivitrol, said Dr. Sarah Wakeman, the medical director of the Substance Use Disorders Initiative at Massachusetts General Hospital. She said the study confirmed what she sees at her clinical practice — that it is easier to initiate Suboxone treatment with patients, and patients stay with the treatment longer.

She also pointed out that many of the overdoses in the study occurred after detox — a phase that isn’t required if patients are given Suboxone.

Dr. Andrew Kolodny, co-director of the Opioid Policy Research Collaborative at Brandeis University, agreed. “Buprenorphine outperformed naltrexone, period,” he said.

The need for evidence

One charge the study does settle is that there is a lack of evidence supporting Vivitrol’s touted effects. Alkermes, which manufactures the drug, was dinged by a number of investigative reports earlier this year highlighting the company’s expansive claims about the drug’s potential to investors and its aggressive lobbying of federal lawmakers.

Alkermes did not donate drugs to this trial. But two of study’s senior authors — Lee and Dr. John Rotrosen, a psychiatry professor at NYU’s School of Medicine — had received free drugs from Alkermes for an unrelated trial. Two other researchers involved in the study disclosed receiving either research support or consulting fees from Alkermes in the past. In a statement, Alkermes CEO Richard Pops said the “data from the study reinforce the value of [medication-assisted treatment] and the distinct differences between two important options” for opioid-use disorder.

Indivior, the company that makes Suboxone, donated drugs to this trial and “had access to periodic safety data only, with no input or review of this manuscript,” according to the study.

Volkow, for her part, believes physicians should be prescribing medication out of a series of choices. For instance, Vivitrol might be a better treatment for someone in a rural area because he or she wouldn’t have to drive as frequently to a faraway clinic; chronic pain patients might respond better to Suboxone, as it blocks pain receptors.

Ultimately, Volkow feels more long-term research and development of opioid addiction treatments — including extended-release buprenorphine — is needed now to truly know what works best for patients.

“They’re not perfect — in this trial 50 percent of the patients relapsed after six months,” Volkow said. “So it behooves us to research more and develop more medications.”

OxyContin maker stops promoting opioids, cuts sales staff

OxyContin maker Purdue Pharma LP said on Saturday that it has cut its sales force in half and will stop promoting opioids to physicians, following widespread criticism of the ways that drugmakers market addictive painkillers.

The drugmaker said it will inform doctors on Monday that its sales representatives will no longer visit physician offices to discuss its opioid products. It will now have about 200 sales representatives, Purdue said.

  • The drugmaker said it will inform doctors on Monday that its sales representatives will no longer visit physician offices to discuss its opioid products.
  • Doctors with opioid-related questions will be directed to its medical affairs department.
  • Opioids were involved in more than 42,000 overdose deaths in 2016, according to the U.S. Centers for Disease Control and Prevention.

“We have restructured and significantly reduced our commercial operation and will no longer be promoting opioids to prescribers,” the Stamford, Connecticut-based company said in a statement.

Doctors with opioid-related questions will be directed to its medical affairs department. Its sales representatives will now focus on Symproic, a drug for treating opioid-induced constipation, and other potential non-opioid products, Purdue said.

Opioids were involved in more than 42,000 overdose deaths in 2016, according to the U.S. Centers for Disease Control and Prevention.

Among other opioid producers, Endo International Plc agreed in July to pull its Opana ER painkiller after the Food and Drug Administration called for its withdrawal.

Purdue and other drugmakers have been fighting lawsuits by states, counties and cities that have accused them of pushing addictive painkillers through deceptive marketing.

The lawsuits have generally accused Purdue of downplaying OxyContin’s addiction risk and of misleading marketing that overstated the benefits of opioids for treating chronic, rather than short-term, pain.

At least 14 states have sued privately held Purdue. Alabama Attorney General Steve Marshall filed a lawsuit on Tuesday accusing Purdue of deceptively marketing prescription opioids.

Purdue is also facing a federal investigation by the U.S. Attorney’s Office in Connecticut.

Purdue has denied the allegations in the various lawsuits. It has said its drugs are approved by the U.S. Food and Drug Administration and account for only 2 percent of all opioid prescriptions.

Purdue and three executives pleaded guilty in 2007 to federal charges related to the misbranding of OxyContin and agreed to pay $634.5 million to resolve a U.S. Justice Department probe.

That year, Purdue also reached a $19.5-million settlement with 26 states and the District of Columbia. It agreed in 2015 to pay $24 million to resolve a lawsuit by Kentucky.

U.S. President Donald Trump has drawn criticism for his response to the opioid crisis. He has yet to declare it a national emergency as he pledged to do in August following a recommendation by a presidential commission.