Answer Addiction

Tag: drug companies

  • Every 15 Minutes A Baby Dependent On Opioids Is Born

    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

  • 'Kingpin Within the Drug Cartel' Tries to Avoid Federal Opioid Trial

    '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

  • In Australia, Frustrations Rise As Opioid Crisis Takes Hold

    In Australia, Frustrations Rise As Opioid Crisis Takes Hold

    “We’re living in a country that is oblivious to what’s going on.”

    Jasmin Raggan watched as her brother developed addiction and died of an opioid overdose, and her brother-in-law became addicted to OxyContin.

    Raggan, who lives in Australia, began researching opioids and the toll they were having in the United States, and realized that no one was talking about the real dangers headed Down Under. 

    “If only Australia could understand how quickly this can get out of hand. We’re not immune to it,” Raggan told The Associated Press. “I was screaming from the mountaintops after Jon died and I’d started doing my research. And it was like I’m screaming and nobody wants to hear me.”

    Lack of Awareness

    In Australia, both opioid prescription rates and overdose rates have risen steeply in recent years, but the increase has been largely overlooked. Even Sydney pain specialist Dr. Jennifer Stevens, didn’t realize how bad it was until she tallied up data from her hospital and saw that prescriptions for one specific opioid had risen 500% in eight years. More alarmingly, 1 in 10 patients was still on opioids three months after a procedure, increasing their risk for dependence and addiction. 

    “We were just pumping this stuff out into our local community, thinking that that had no consequences, and now, of course, we realize that it does have huge consequences,” Stevens said. 

    Pharmaceutical Companies’ Aggressive Marketing

    Drug companies are in part to blame for the rise, pushing the same aggressive sales tactics that now have them in trouble in America. It’s illegal for pharmaceutical companies to advertise directly to consumers in Australia, but companies like Mundipharma, the international affiliate of Purdue, have skirted around the laws with “awareness campaigns” that don’t mention specific drugs by name, but still direct consumers to websites with information on the drugs. 

    Stevens recalls Mundipharma marketing aggressively to doctors at her hospital. 

    “Marketing, on the whole, is very clever and very successful — otherwise it wouldn’t be done,” she said. 

    At the same time, the country lacks programs like prescription monitoring databases, which can help prevent overdoses and “doctor shopping.”

    In 2012, Australian Matthew Tonkin came home after serving in Afghanistan alongside American troops. He had been injured, and was also dealing with PTSD after witnessing the death of his best friend. He proudly showed his father David Tonkin the Americans’ solution: a strip of powerful opioid pills. 

    Davis Tonkin recalls his son saying to him “Look, Dad, the Yanks really know how to look after you.”

    At home, Matthew started doctor shopping for powerful opioids, until he died of an overdose in 2014. 

    Not Learning from America’s Mistakes

    Sue Fisher, whose son died of an overdose in 2010, said it’s frustrating to see the lack of policies, especially since Australia can look to the US to see what solutions have worked to help stem overdose deaths — like prescription monitoring and Narcan programs.

    “We’re living in a country that is oblivious to what’s going on,” Fisher said. “Why aren’t we learning from America’s mistakes? Why don’t we learn?”

    View the original article at thefix.com

  • Report: Fentanyl Distribution Mishandled By Drug Companies, Feds

    Report: Fentanyl Distribution Mishandled By Drug Companies, Feds

    Nearly half of all patients who were prescribed fentanyl should have been denied the drug, according to a new report.

    A report published Tuesday in the Journal of the American Medical Association (JAMA) is alleging widespread failure to keep the extremely potent opioid fentanyl out of the hands of patients who were ineligible to receive it.

    Using the Freedom of Information Act, researchers obtained around 5,000 pages of documents from the US government that they say show that nearly half of all patients who were prescribed fentanyl should have been denied the drug.

    Fentanyl is a relatively new opioid painkiller that is 50 to 100 times more powerful than morphine. It is meant only for patients experiencing severe pain, including “breakthrough” pain so bad that opioids such as OxyContin or even morphine cannot control, and who have already developed a tolerance to these drugs. Without an established tolerance to opioids, taking fentanyl presents a high risk of overdose due to its extreme potency.

    Due to the dangers of fentanyl, the US government has established a strict protocol that was supposed to prevent anyone other than opioid-tolerant patients with severe pain, such as cancer patients, from being prescribed this drug.

    The researchers of this new report claim that this protocol has not been followed across the system, implicating the Food and Drug Administration, drug companies, and doctors.

    “The whole purpose of this distribution system was to prevent exactly what we found,” said study leader and co-director of the Center for Drug Safety and Effectiveness at Johns Hopkins Caleb Alexander. “It should never happen. It’s a never event. And yet we found it was happening in 50% [of cases reviewed].”

    According to the report, between 34.6% and 55.4% of patients surveyed who were given fentanyl were “opioid-nontolerant.” Researchers also found that a substantial amount of pharmacists and drug prescribers (7.9% and 11.6%, respectively) reported believing that they were allowed to give fentanyl to patients who had not developed a tolerance to opioids 12 months after the protocol was put in place.

    This number increased as time went on, reaching 18.4% among prescribers and close to 50% among patients.

    In spite of this, no substantial changes were made to the protocol by the FDA.

    “What we found was that several years after the program was started, there were alarming deficiencies identified, and yet little was done by the FDA and drug manufacturers to effectively address these problems,” said Alexander.

    Researchers and addiction experts are finding that fentanyl has played a large role in the opioid epidemic. A 2018 study found that deaths related to fentanyl use increased by 520% from 2009 to 2016, while deaths from other prescription opioids increased by 18% in the same time frame.

    The fentanyl deaths were primarily from illicit use, but the high rates of death from fentanyl overdose demonstrate just how dangerous the drug is to those who are not approved for its use.

    “These drugs are dangerous enough, they should never be used in patients who aren’t already on around-the-clock opioids,” said Alexander.

    View the original article at thefix.com