Author: The Fix

Purdue Reaches $10 Billion Settlement In Opioid Lawsuits

The deal does not include any admission of wrongdoing by Purdue Pharma or the Sackler family.

Purdue Pharma, the most infamous manufacturer of prescription opioid pills, has reached a multi-billion dollar settlement with thousands of state, city and county governments that are suing the maker of OxyContin for its alleged role in the opioid epidemic.

The deal was first reported Wednesday evening (Sept. 11). The details were not immediately made public, but The New York Times reported the basics of the settlement: Purdue will declare bankruptcy.

What Happens To Purdue?

A new company will be formed to sell OxyContin, and the profits from those sales will go to Purdue’s settlement payout. The Sackler family, which owns Purdue, will contribute $3 million to the settlement over seven years. In addition, Purdue will donate prescriptions, including those for addiction treatment. NBC News reported that the settlement is worth $10-12 billion overall.

The deal does not include any admission of wrongdoing by Purdue Pharma or the Sackler family.

According to NBC News, as of Thursday (Sept. 12), at least 20 states have rejected the deal while legal officials in 27 states are reportedly in favor of the deal, which still needs to be approved by a bankruptcy judge and the board of Purdue Pharma.

“We are proud to participate in the nation’s most significant step in addressing this deadly crisis,” Texas attorney general Ken Paxton said through a spokesperson.

Tennessee Attorney General Herbert Slatery, who earlier this week predicted that Purdue would likely file for bankruptcy, said the settlement “would secure billions of dollars nationwide to go toward addressing the devastating effects of the opioid epidemic and will result in the Sackler family divesting themselves of their business interests in the pharmaceutical industry forever.”

Florida Attorney General Ashley Moody said that the settlement was historic and will help provide treatment.

“Sadly, this agreement cannot bring back those who have lost their lives to opioid abuse, but it will help Florida gain access to more life-saving resources and bolster our efforts to end this deadly epidemic,” Moody said.

The Opposition Calls The Settlement “An Insult”

However, not everyone was satisfied with the settlement. At least 20 states have opted not to sign on to the deal. New York Attorney General Letitia James had one of the strongest reactions, calling the settlement “an insult, plain and simple.”

Other states want to hold onto their right to sue the Sackler family personally.

“If Purdue cannot pay for the harm it inflicted, the Sacklers will,” said New Jersey Attorney General Gurbir S. Grewal.

Massachusetts Attorney General Maura Healey wanted to see Purdue Pharma and the Sackler family forced to admit wrongdoing.

“It’s critical that all the facts come out about what this company and its executives and directors did, that they apologize for the harm they caused, and that no one profits from breaking the law,” she said.

View the original article at thefix.com

12 September 2019
DEA Announces Plans To Expand Scientific Research For Marijuana

The agency also revealed plans to propose new regulations to evaluate these applications before reviewing and making possible approvals.

Clinical studies involving marijuana moved a substantial step forward with an announcement by the Drug Enforcement Administration (DEA) to “facilitate and expand” applications for research into medical and scientific applications of cannabis.

The agency intends to expand its review of applications from qualified growers who seek to cultivate marijuana for research. In doing so, the DEA noted that it will “increase the variety of marijuana available for these purposes.”

However, the agency also stated that it plans to propose new regulations to evaluate these applications before reviewing and making possible approvals. For researchers whose work has been hampered by marijuana’s status as a federally illegal Schedule I drug, the news has prompted a response tempered with cautious optimism, given the DEA’s slow response to change on this topic in the past.

A Monopoly on Marijuana for Research

For the past half-century, a single facility at the University of Mississippi was legally approved by the National Institute on Drug Abuse (NIDA) to grow marijuana for scientific and medical research.

As Think Progress noted, that scenario was a major roadblock to researchers; the facility produced only a handful of cannabis varieties and what was described as “low-grade” flower.

In 2016, the DEA announced its plans to expand research facilities, prompting numerous scientific and medical entities to apply for research grow licenses. However, as Think Progress noted, nothing came of the announcement.

According to the DEA announcement, the number of applicants registered to conduct research has increased by 40% (from 384 in 2017 to 542 in 2019), while product quoted for federally approved research projects has doubled. The announcement of expanded review for these applications is a step in the right direction, according to researchers who have been waiting for years for approval—albeit a step that they suggest should be taken with a grain of salt.

Proceed With Caution

“DEA/DOJ can slow-roll this for many years to come, leaving progress of medical cannabis research in limbo indefinitely,” wrote Dr. Sue Sisley of the Scottsdale Research Institute in a statement.

Sisley, who conducted a federally approved study on cannabis as treatment for post-traumatic stress disorder in veterans, applied for a grow grant in 2016 based on the “sub-par” cannabis provided by the NIDA-approved facility. When she received no response for three years, she filed suit against the DEA. The agency’s announcement was delivered two days before a major deadline imposed by the suit.

“At least [the] door is now theoretically kicked open,” Dr. Sisley wrote. “Now we just need to keep the DEA’s feet to the fire.”

View the original article at thefix.com

12 September 2019
Telemedicine Closes Mental Health Treatment Gap For Rural Patients

“There’s just not enough mental health coverage across the state, but the rural areas are particularly hit hard,” said one doctor.

People living in rural areas face challenges that can take a toll on their mental health, including low wages, limited job opportunities and a lack of social capital. All of that is compounded by the fact that it can be harder to access mental health care in rural America.

From Months To Days

Now, telemedicine is helping to close the gap in treatments available in rural areas. At Meridian Health Services in Indiana, integrating telemedicine has reduced the wait time for new patient visits with a psychologist from months to days, according to NPR.

That makes a big difference for patient outcomes, said Meridian’s chief medical officer Dr. Sarfraz Khan.

“In my opinion, it’s lifesaving,” he said. Meridian was having trouble delivering mental health services because the organization couldn’t find doctors who were willing to work in rural areas.

“There was a time when we were seriously considering: Would it be viable for us to provide psychiatric services because nobody would like to come to small towns?” Khan said.

Now, doctors don’t need to come to small towns to work. They work out of a central location in Indianapolis. Patients, meanwhile, visit rural clinics for their appointments. There, a nurse takes their vitals and sets them up with a two-way computer screen, where they teleconference with a doctor from the city.

Patients Share Their Experiences

Some patients might balk at the idea of receiving health care through a screen, but a Meridian patient named Mariah said that telemedicine actually helps her be more honest with her providers.

“It’s easier because they’re not there, so I feel like I can tell more, and speak more and truly just be fully real. If they’re sitting right there, I might not want to say everything or say as much,” she said after finishing her first telemedicine appointment.

In Texas’s DeWitt County there are no practicing psychiatrists.

“We kept looking at what our needs were (in DeWitt County), and we did not have adequate access to mental health care,” Lynn Falcone, CEO of Cuero Health, told the Victoria Advocate.

Falcone knew that she was unlikely to be able to find a psychiatrist to come practice in the area, so she reached out to Access Physicians, a group that provides telemedicine services. Now, patients at Cuero Regional Hospital can have telemedicine appointments with psychiatrists.

Dr. Chris Gallagher, CEO of Access Physicians, said he is seeing more and more rural hospitals turning to telemedicine, especially for mental health services.

“Psychiatry is probably the most in-demand specialty,” he said. “There’s just not enough mental health coverage across the state, but the rural areas are particularly hit hard.”

View the original article at thefix.com

12 September 2019
Back to School: 5 Things You Should Know About Staying Sober in College

Avoiding drugs and alcohol can help you have a healthier, more productive college career.

College is a time to focus on building your career, and getting the most our of the huge investment that you’re making to get a degree. But too often, that focus gets lost among the pop culture messages that seem to scream that college is for one thing: partying.

Students who are sober can feel like fish out of water on campus. However, this doesn’t have to be the case. Although drinking — specifically binge drinking — is common on campus, more and more college students are opting to stay clean and sober. If you’re headed back to school this fall, here’s what you should know about sobriety on campus.

1. Being sober isn’t as unusual as you might think.

Often, it seems like everyone on campus is drinking, but that’s simply not true. Data from the National Institute of Drug Abuse found that in 2017 just over 56 percent of people age 18-25 reported using alcohol in the past month. That means that nearly half of all people in this age group are abstaining, at least temporarily.

Racheal Doll, admissions director at Asana Recovery, which offers detox and treatment in Costa Mesa, California, says that movies and television shows make drinking and partying look a lot more common than they actually are during college.

“Society and mainstream media has a huge role to play in why we associate college years as the ‘wild’ or ‘experimental’ time in someone’s life, because for most people it may be the first time young adults haven’t lived under their parents’ roof,” she said. “This is what we see in movies and hear in songs but it doesn’t have to be the rule.”

2. There’s strength in numbers.

Hearing about the rates of drinking on campus can be reassuring, but it does little to improve your confidence if everyone around you is partying. That’s why Doll says it’s important to connect with other students who are in recovery.

“The important thing is to stick with the pack,” she says. “Find like-minded people, sober fellows, and stick with your routine. Continue to go to meetings and work with a sponsor.”

Recovery groups are common on campuses around the country. In addition, many colleges now offer sober dormitories, where students are committed to living in an environment without drugs or alcohol. Joining one of these communities can give you the confidence and framework to prioritize your recovery while you’re in school.

3. Set boundaries before you need them.

Especially when you’re new on campus, it can be easy to fall into a risky situation where people are using drugs or alcohol. Before you find yourself in a bind, take time to think about what you’ll do when these situations arise. Be honest with yourself, and set your boundaries ahead of time.

Saying that you won’t drink or use is easy. But it’s also important to think about what your boundaries are when people are using around you. If you’re socializing and people start drinking, will you leave? What if your roommate wants to drink or use in your room? Considering these questions ahead of time will leave you better able to respond in the moment.

4. Being sober can improve your college experience.

If you’re sober on campus you might initially feel like you’re missing out. However, that’s not the case. Living without drugs and alcohol can improve your college experience, academically and socially.

“Because you aren’t intoxicated or hungover you are aware and present, which allows you to fully absorb the knowledge you went there for in the first place,” Doll says. “It also allows you to really appreciate the experience with your friends. You will be able to remember and look back on all the great memories as opposed to having it all be a blur.”

Since you’re not prioritizing partying, you’ll be more likely to take advantage of sober events offered on campus, like concerts, art displays and other events.

5. Help is nearby, if you need it.

Although being sober on campus has perks, it can still be challenging. If you find yourself feeling overwhelmed or letting your recovery slip, reach out for help before things get out of control.

“There are many helpful resources/tools on campus which many students may not be aware of,” Doll says. “If you are struggling with drugs or alcohol just don’t be afraid to ask for help.”

One of the most important resources on campus is the student health center, which can connect you with professionals who can help support your sobriety. If you’re concerned about your mental or physical health, going to the health clinic is a great way to connect with resources that you may not have realized you had.

Asana Recovery offers residential and outpatient treatment in Costa Mesa, California. Learn more by calling 949-438-4504.

View the original article at thefix.com

12 September 2019
New York Considers Allowing Students To Take Mental Health Days

Proponents of the bill say that designating excused “mental health days” will help destigmatize mental illness and help start critical conversations.

New York state legislators are considering a bill that would allow students to take off from school to attend to their mental health.

Some call it coddling and a crutch. But proponents of the bill say that designating excused “mental health days” will help destigmatize mental illness and encourage young people to feel comfortable talking about what they are going through.

“No longer will a student have to lie about why they’re staying home from school, and this conversation, hopefully, will be forced out in the open—not just with their teachers, but with their parents and their family members, too,” said state Senator Brad Hoylman, who is sponsoring the bill.

Indeed there is a need to address young people’s mental health. About 70% of American teenagers view anxiety and depression as a major problem, according to a recent study from the Pew Research Center. And suicide is the second leading cause of death for young people aged 10-34, according to the CDC.

Mandatory Mental Health Education

Last September, New York became the first state to mandate mental health education in elementary through high school curricula.

Allowing days off from school to deal with mental or behavioral health would cement the state’s commitment to supporting young people’s mental well-being.

“I think that’s a really good idea, because teenagers go through a lot of issues, struggles internally that they might not show to everyone… or even talk about,” student Gabbi Hanna told CBS. “But inside they might be dealing with something they don’t know how to deal with. And having that day off… might help them decompress a little bit before going back into the school environment.”

Other States Are Also Prioritizing Mental Health Days

New York would not be the first state to enact such a policy. In 2018, Utah amended the definition of a student’s valid absence to include illness “which may be mental or physical.”

And in July, Oregon began allowing students five mental health days in a three-month period. Hailey Hardcastle, who helped pass the bill, said the bill was inspired by the national youth-led movement following the Parkland, Florida mass shooting in 2018.

“We have a lot of kids that are dealing with [symptoms of mental illness] in silence because they’re embarrassed or they think people are going to judge them and not believe them,” said Jennifer Rothman, senior manager for youth and young adult initiatives for the National Alliance on Mental Illness.

Normalizing “mental health days” can help destigmatize mental illness and facilitate conversation about mental health, Rothman said.

View the original article at thefix.com

12 September 2019
FDA Rejects Petition For Moratorium On New Opioids

The FDA explained its decision to continue accepting applications for new opioids in a written response.

The Food and Drug Administration has rejected a request for a moratorium on the approval of new opioid drugs.

The petition for a moratorium was launched by the Public Citizen’s Health Research Group in April of this year. It requested that the FDA hold off on approving new opioids until the organization adopted recommendations made by the National Academies of Sciences, Engineering, and Medicine’s 2017 report, “Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use.”

The FDA issued a written response to the request last week, denying the petition.

Why The FDA Denied The Request

“While the FDA is committed to continuing its ongoing work of scrutinizing how it applies its benefit-risk framework to candidate opioids, and to exploring whether additional authority from Congress is needed, FDA must also continue to apply the existing statutory and regulatory framework to properly filed [new drug applications], including applications for new opioid drug products or opioid formulations,” the agency wrote.

“Furthermore, a moratorium on the approval of new opioid drug products could stifle the development and availability to patients of new opioids that could offer greater safety or other therapeutic advantages over products already on the market.”

The FDA went on to state that even after a new drug is approved, it is still closely monitored to make sure that its benefits outweigh its risks. The FDA has taken steps to mitigate the risk of opioids, including changing labeling, the agency says.

Approving A New Opioid That’s Stronger Than Fentanyl

Last year, the FDA ruffled feathers by approving a controversial new opioid that is 10 times stronger than fentanyl. The medicine, Dsuvia, is a version of sufentanil intended only for use in hospitals, the FDA said. Many people, including a member of the FDA’s own advisory committee, spoke out against the approval of the drug.

“It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly,” Dr. Sidney Wolfe of Public Citizen’s Health Research Group (the same group that requested the moratorium) said in a press release at the time. “It will be taken by medical personnel and others for whom it has not been prescribed. And many of those will overdose and die.”

Raeford Brown Jr., MD, chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee spoke strongly against the approval of the drug, even writing an open letter in opposition:

“It is my observation that once the FDA approves an opioid compound, there are no safeguards as to the population that will be exposed, the post-marketing analysis of prescribing behavior, or the ongoing analysis of the risks of the drug to the general population relative to its benefit to the public health,” he wrote.

“Briefly stated, for all of the opioids that have been marketed in the last 10 years, there has not been sufficient demonstration of safety, nor has there been post-marketing assessment of who is taking the drug, how often prescribing is inappropriate, and whether there was ever a reason to risk the health of the general population by having one more opioid on the market.”

View the original article at thefix.com

12 September 2019
Childhood Trauma, Body Dysmorphic Disorder, and Plastic Surgery Addiction

Many people who have multiple plastic surgeries are looking for self-worth, not correction of a deformity.

Most of the time when we talk about addiction, we’re referring to the compulsive or harmful use of substances. Only one behavioral addiction—gambling—is included in the Substance-Related and Addictive Disorders chapter of the DMS 5. Other behavioral addictions require further peer-reviewed research to become categorizable, diagnosable conditions. Addictive disorders involve a lack of ability to control substance use, social problems as a result of substance use, risk-taking to fulfill substance use urges, developing tolerance, and experiencing withdrawal symptoms when the substance is removed.

Behavioral Addictions

We no longer define addiction solely as physiological dependence on an ingested substance. We now have better categorizations for addictions, and the medical field is regularly adding more to the list, as society is constantly changing and addictive patterns become more apparent with time and research. The crux of what causes addiction is still an evolving conversation, one that keeps circling back to trauma.

New Hampshire-based plastic surgeon Mark Constantian believes plastic surgery can become an addiction in people who have experienced childhood trauma. Outside of moral judgements, issues of class and privilege, and other health implications, plastic surgery is a choice, and for many people it has no negative mental health effects. Then there are those who get plastic surgery and are profoundly upset even though they obtain the exact aesthetic results they originally desired. Constantian became interested in the experiences of patients who responded with profound anger and disappointment despite good results.

He describes this category of patients as being unhappy to an irrational degree. They expressed feelings of being betrayed and felt deceived. Constantian explains that they behaved “the way people behave when they’re traumatized and then triggered back to their childhood, they start acting and saying things that would have been appropriate to their abusers when they’re five or six years old but they’re no longer appropriate when they’re 40.”

Constantian has been practicing since 1978 and has taught in his field with a focus on nasal surgery, particularly with people who have had prior nasal surgery. Patterns emerged, and he wrote a book chronicling his findings. He found that many people who have multiple plastic surgeries are looking for self-worth, not correction of a deformity.

Body Dysmorphic Disorder

Plastic surgery addiction, while not a diagnosable condition, seems to exist alongside body dysmorphic disorder, a mental illness defined in the DSM 5 as “preoccupation with one or more perceived defects or flaws in physical appearance that are not observable or appear slight to others.”

According to Dr. Constantian, “Body dysmorphic disorder is looked at as a problem that arises out of the blue.” But that’s incorrect. “[A]ll of this starts in childhood. The family problems, the self-esteem problems are already there and it just percolates. Then you get to the teenage years and you start to compensate in some way, and you medicate the pain and it can be medicating with an eating disorder, with obesity, depression, cutting, drug or alcohol abuse. The characteristics I’m seeing are shared by all kinds of addiction.”

People wanted to be different from who they were as children. “The original genesis of the original problem had nothing to do with the cosmetic issue.” The self-harming behaviors are fulfilling a need to soothe the loneliness and the isolation, which are the result of shame.

Adverse Childhood Experiences Survey

To test what he was seeing in his patients, Constantian surveyed patients using an adapted version of the Adverse Childhood Experiences survey (ACE). The ACE study is one of the biggest studies on childhood abuse and neglect and other difficult experiences, and how they affect health later in life. The ACE study has been found to be one of the best predictors of conditions in adulthood.

Through years of neglect, abuse, or other traumas during childhood, we learn what adults are like. We learn how important we are in the world, what kind of space we occupy and how safe we are. We learn how dangerous the world is. How much we’re loved. Children learn to cope with those environments.

Constantian’s working theory was that if trauma works on the brain long enough, eventually it develops enough damage to create a disorder that a mental health professional can diagnose. It takes time to damage the brain to that extent. Traumatic experiences in childhood can influence an entire lifetime of decisions and alter how a person perceives themselves and the world around them.

Chronic unpredictable stress in childhood and adolescence can echo into adulthood with reverberations that translate into mental and physical health conditions. In Constantian’s study, he found that overall, 80% of surveyed plastic surgery patients had one or more Adverse Childhood Experience (compared to about 64% in the original study). For those with more than one cosmetic surgery, 90% had higher ACE scores than those in the original study. Emotional neglect was about four times higher. Drug abuse or alcoholism in the family was almost double. He noticed that emotional abuse was common in his patients.

How to Prevent Plastic Surgery Addiction

Categorizing someone as a poor candidate for plastic surgery cannot be calculated with something like the ACE score, because it leaves out a key feature: resiliency. Life changes and stressful situations arise for everyone at some point or another. Most people are able to recover from these conditions and adapt to change.

“Having cosmetic surgery is not a bad thing, as long as the reason for that is body dissatisfaction. As long as the person feels he or she has self-worth,” Constantian says. Lack of resilience is a huge factor in whether someone is more at risk of using plastic surgery as a maladaptive coping tool. Using the ACE study cannot rule out people not suitable for plastic surgery. Constantian couldn’t predict a patient’s trauma score, no matter how well he knew them.

Resiliency is the ability to overcome challenges and bounce back from difficult, even traumatic, events. Resilience can be learned, although there is some evidence that suggests some people may develop resilience due to genetic and other natural factors. Children learn how to be resilient through their parents, or other caretakers. If those caretakers are unavailable, abusive, or otherwise neglectful, a child may not learn appropriate coping mechanisms and lack resiliency later in life.

Resilience is like the antidote to childhood trauma. Often people with strong resiliency and high ACE scores had someone in their life who created a sense of stability and support. It might have been a teacher, a religious leader, a friend’s parent, a coach. Someone who made them feel capable and loved, and could model healthy coping methods.

View the original article at thefix.com

12 September 2019
Every 15 Minutes A Baby Dependent On Opioids Is Born

New York Times columnist Nicholas Kristof says drug executives should be held accountable for the growing number of infants born addicted to opioids.

Instead of being lovingly swaddled and rocked in the first day of life, thousands of American infants are being treated for opioid withdrawal almost immediately after birth, a condition caused by exposure to opioids when they were in the womb.

At Charleston Area Medical Center in Charleston, West Virginia, neonatologist Stefan Maxwell says that up to 14 percent of babies are born dependent on opioids, according to The New York Times. Often, these infants experience painful and dangerous withdrawal symptoms that themselves need to be treated with opioids like methadone or morphine that can be tapered over the course of weeks.

“He’s frantic,” Maxwell said of one infant. “Baby isn’t sleeping, isn’t eating, isn’t growing. It’s a disaster.”

Neonatal Abstinence Syndrome (NAS)

Writing for the Times, columnist Nicholas Kristof detailed the prevalence of neonatal abstinence syndrome. The rise in rates of the condition can’t just be blamed on women who use drugs while pregnant. A system that peddled opioids and a healthcare system that woefully underfunds treatment are also to blame, he writes.

“Pharmaceutical executives are battling lawsuits by blaming drug users. I wish those executives had to cuddle these infants who, partly because of their reckless greed, suffer so much,” Kristof writes. “These drug-addicted newborns are suffering partly because of Johnson & Johnson, McKinsey, Purdue Pharma, McKesson and many other companies; these babies are a reminder of why corporate regulation is essential.”

Neonatologist Cody Smith, who practices at Ruby Memorial Hospital in Morgantown, West Virginia, said most mothers are helpless in the face of addiction. Nearly all of them have unplanned pregnancies, and few have the resources to deal with their own trauma and mental health conditions, so they continue to use opioids while pregnant.

“Lots of these moms are very well meaning,” he said. “The vast majority of these moms love their babies, and they feel a tremendous amount of guilt.”

Toll on Healthcare Providers

Maxwell said that caring for infants in such destress can take a toll on healthcare providers. “Nurses are in tears at the end of a shift,” he said.

Kristof calls for punishing those at the root of the addiction epidemic, as well as providing support for vulnerable women and babies.

“We need accountability, as well as deterrence,” he writes. “That means sending executives to prison along with other big drug dealers, and ensuring that shareholders in these companies suffer as well.”

He continues, “Anyone doubting the need for tougher accountability, and for a far more robust public health approach to address drug use, should visit one of these nurseries and see babies suffering withdrawal.”

View the original article at thefix.com

12 September 2019
Small-Town Ohio Physician Ordered 1.6M Pain Pills in Four Years

According to her attorney, Dr. Margaret Temponeras’ inappropriate prescribing was the result of being misled by pharmaceutical companies.

A feature in the online edition of the Cleveland Plain Dealer examines the circumstances behind a family physician in a southern Ohio suburb who, by ordering more than 1.6 million opioid pills, was credited by federal and state authorities for allegedly helping to fuel the state’s opioid overdose crisis.

The State Medical Board has accused Dr. Margaret Temponeras of prescribing painkillers for “other than a legitimate medical reason” and to patients who showed clear signs of dependency between 2006 and 2011 from a pain clinic and dispensary she operated.

Guilty Plea

After federal authorities raided her offices in 2015, Temponeras pled guilty to a charge of drug conspiracy in 2017, and is currently awaiting sentencing. Her attorney was quoted in the Plain Dealer as saying that the doctor was misled by pharmaceutical firms, which according to the article, have paid millions of dollars to settle lawsuits over their alleged contributions to the opioid crisis in Ohio, which ranked fourth on a list of the states that received the highest amount of prescription painkillers between 2006 and 2012.

It Was a Family Affair

According to the Statement of Facts cited by the Department of Justice press release, Temponeras, who operated a family practice in Wheelersburg, Ohio, also opened a pain management clinic in the town, her father, gynecologist Dr. John Temponeras, also worked at the clinic. From 2005 until 2011, the pair saw more than 20 patients a day, who paid $200 and $225 in cash for examinations. Federal records indicated that in some cases, patients drove to the clinic from Kentucky and West Virginia.

Patients received monthly prescriptions for oxycodone and Xanax, some of which were filled by her father; records show that their office ordered more than 107,000 pills in 2008, which rose to more than 655,000 the following year and to more than 800,000 in 2010. Medi-Mart Pharmacy in Portsmouth, Ohio, initially filled many of the prescriptions but when DEA officials began warning local pharmacists about Temponeras’s prescribing habits, she began filling prescriptions at her clinic, where employees – none of whom were pharmacists – handled medication. The Plain Dealer noted that state law at the time did not require a solo practitioner’s office to have a license to dispense drugs.

Top Opioid Prescriber

By 2012, Temponeras ranked 18th on a national list of practitioners who ordered opioids between 2006 and 2012, with some 1.66 million pain pills placed by her office. The Plain Dealer noted that more than 1.4 million were obtained from Miami-Luken, a pharmaceutical wholesale distributor in southwest Ohio that was indicted on drug conspiracy charges in 2018 for selling millions of opioids throughout southern Ohio, Kentucky and West Virginia while also failing to report suspicious orders to the DEA. During testimony before a U.S House subcommittee, Miami-Luken’s chairman of the board mentioned Temponeras as someone they “never should have supplied” with medication due to the large amounts she had ordered.

In 2011, state and federal agents raided Temponeras’s offices, resulting in the permanent loss of both her and her father’s medical licenses. Both were also indicted, along with Medi-Mart Pharmacy owner Raymond Fankell, by a federal grand jury.

All three pled guilty to conspiracy to distribute a controlled substance, which carries a possible jail sentence of up to 20 years. As of the publication of the Plain Dealer article on September 1st, all three are free on bond.

View the original article at thefix.com

11 September 2019
'Kingpin Within the Drug Cartel' Tries to Avoid Federal Opioid Trial

Mallinckrodt has proposed to settle with two Ohio counties, which would allow the drug maker to avoid a forthcoming federal opioid trial in October.

Mallinckrodt Pharmaceuticals, a lesser known but still a major player in opioid manufacturing, has reached a tentative settlement with two Ohio counties as part of federal opioid litigation.

Mallinckrodt agreed to pay $24 million to Cuyahoga and Summit Counties and donate $6 million in pharmaceuticals, including addiction treatment drugs, to those counties, The New York Times reported.

The Proposed Settlement

The settlement would allow Mallinckrodt to avoid being part of the first federal bellwether trial of drug makers, distributors and retailers, which is slated to begin in October. The agreement “gives us the necessary time to continue to work towards a global resolution of the opioid lawsuits,” Mallinckrodt’s General Counsel Mark Casey said in a statement.

Judge Dan Polster has pushed for a settlement in the opioid lawsuits, which include more than 2,300 suits from cities, states and counties.

Although it is common in settlements for documents relating to the case to be sealed, most of the documentation in the federal opioid cases will remain open. That’s significant, said Adam Zimmerman, a law professor in Los Angeles.

“It means that all of this information in the federal litigation, which is so vital to our understanding about what happened, how we got here, will remain open,” he said.

DEA Called It the ‘Kingpin Within the Drug Cartel’

Mallinckrodt Pharmaceuticals isn’t as well known as Purdue Pharma or Johnson & Johnson, but the company played a massive role in the opioid epidemic, authorities say. The company controlled 38% of opioid sales between 2006 and 2012. Purdue, for comparison, held just 3% of the market during that time.

Barbara J. Boockholdt, former chief of the regulatory section at DEA’s Office of Diversion, said even she didn’t realize how massive Mallinckrodt’s hold was until she checked the data.

“I was shocked; I couldn’t believe it, Mallinckrodt was the biggest, and then there was Actavis,” she told The Washington Post. “Everyone had been talking about Purdue, but they weren’t even close.”

The details of the settlement have not yet been finalized. However, the funds and the pharmaceuticals will give “both counties critically needed resources in the ongoing response to the opioid crisis as well as protection in any future insolvency proceeding by Mallinckrodt,” lawyers for the counties said in a statement.

The company’s stock fell up to 40% after reports emerged saying that Mallinckrodt was exploring bankruptcy, but president and CEO Mark Trudeau said those reports were unfounded. That caused stock to rebound partially. Trudeau added that his company will likely stop selling opioids.

He said, “Fundamentally we are just not the best owners of this business.”

View the original article at thefix.com

11 September 2019