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Tag: opioid epidemic

  • FDA Has "Cozy Relationship" With Pharmaceutical Companies, Says Adviser

    FDA Has "Cozy Relationship" With Pharmaceutical Companies, Says Adviser

    “The FDA has a lack of transparency. They use the advisory committees as cover,” said the head of the FDA’s opioid advisory council. 

    A Food and Drug Administration adviser says that the agency is putting the needs of pharmaceutical companies above the public by continuing to approve dangerous pain medications. 

    Speaking with The Guardian, Dr. Raeford Brown, head of the FDA’s opioid advisory council, said there are “cozy, cozy relationships between the pharmaceutical industry and various parts of the FDA.”

    Brown has been vocally opposed to the approval of the drug Dsuvia, an opioid more powerful than fentanyl that the FDA recently approved against the recommendation of the advisory committee. (The FDA is not bound by the recommendation of the committee.)

    Brown said that the committee voted to approve the drug while many committee members were away at a professional conference, which he believes was a willful manipulation of the system. 

    “There’s no question in my mind right that they did that on purpose. The FDA has a lack of transparency. They use the advisory committees as cover,” Brown said. 

    He pointed to Dsuvia’s approval as the latest sign that the FDA has allegiances to pharmaceutical companies. 

    He said, “I think that the FDA has learned nothing. The modus operandi of the agency is that they talk a good game and then nothing happens. Working directly with the agency for the last five years, as I sit and listen to them in meetings, all I can think about is the clock ticking and how many people are dying every moment that they’re not doing anything. The lack of insight that continues to be exhibited by the agency is in many ways a willful blindness that borders on the criminal.”

    This approach is fueling the rise in opioid-related deaths, he said. 

    “They should stop considering any new opioid evaluation. For every day and every week and every month that the FDA don’t do the right thing, people drop dead on the streets. What they do has a direct impact on the mortality rate from opioids in this country.”

    Brown pointed out that the FDA relies on pharmaceutical funding for 75% of the budget of the division that approves opioid medication. He explained that this allows pharmaceutical companies to unfairly influence the process, something that the FDA denies. Brown worries that despite the widespread deaths caused by the opioid epidemic and the resulting media coverage, little will change at the FDA.

    “Nothing is fundamentally being done to effect change in the regulation of opioids,” he said. “If the FDA continues to encourage the pharmaceutical industry to turn out opioid after opioid after opioid, and the regulation of those opioids is no better than it was in 1995, then we’ll be cleaning this up for a long time.”

    View the original article at thefix.com

  • Opioid Use May Be Tied To Intestinal Disorder In Newborns

    Opioid Use May Be Tied To Intestinal Disorder In Newborns

    A new report explores the connection between opioid use and the intestinal birth defect.

    Infants whose mothers use opioids during pregnancy are at risk for a host of issues from small head size to dependency on the drugs. Now, a new report suggests an additional health concern for babies exposed to opioids: a possible increased risk of gastroschisis, a birth defect that causes infants to be born with their intestines outside their bodies.  

    The report, published in the Morbidity and Mortality Weekly Report through the Centers for Disease Control and Prevention, confirmed that rates of gastroschisis are increasing around the globe, something that doctors had reported anecdotally. Instances of the condition rose 10% when researchers compared two periods, 2006 to 2010, and 2011 to 2015.

    During this time, the rates of infants born exposed to opioids also increased. The report authors found that gastroschisis was more common when the rate of opioid use was also more common. 

    “Gastroschisis prevalence was higher in areas with high and medium opioid prescription rates, compared with that in areas with low rates,” the authors of the review wrote. “This ecologic analysis supports the findings from a large case-control study, which suggested that self-reported prescription opioid use in the first trimester was associated with gastroschisis.”

    Although researchers looked at the rate of prescription opioids — not illicit opioids — the findings suggest a connection between opioid use and the birth defect, and researchers said there is a need for more information about how opioid use may contribute to gastroschisis.

    “These findings provide compelling evidence of the need to better understand the potential contribution of opioid exposure in the etiology of gastroschisis as well as the possible role opioids have played in the observed increases in gastroschisis,” the authors wrote. 

    Speaking with Live Science, Dr. Saima Aftab, medical director at the Fetal Care Center at Nicklaus Children’s Hospital in Miami, said “there’s something changing” in the prevalence of gastroschisis. Although the condition can be corrected with surgery, infants face risks with their digestion early on. Babies with the condition may have to be hospitalized for months following their delivery and surgery. 

    Because the CDC report does not provide any concrete answers about why and how opioids may contribute to gastroschisis, the authors said it will be important to conduct more research into the correlation.  

    “The findings … can be used to prioritize basic science, public health, and clinical research on opioid exposure during pregnancy and its potential impact on birth defects,” they wrote. “Having a better understanding of all possible effects of opioid use during pregnancy can help provide evidence-based information to health care providers and women about the potential risks to the developing fetus.”

    View the original article at thefix.com

  • How Big Pharma's Payments To Doctors Affected Overdose Deaths

    How Big Pharma's Payments To Doctors Affected Overdose Deaths

    A new study examined the link between large payments and gifts to doctors from pharma companies and overdose deaths.

    In counties and states where opioid manufacturers offered large payments or gifts to doctors to promote their product, a new study has suggested that both opioid prescriptions and opioid-related overdose deaths were higher than in other areas.

    Coverage of the study in The New York Times showed that the study culled information from a variety of sources, including the Open Payments database, which tracks payments by pharmaceutical companies to doctors, and data from the Centers for Disease Control (CDC).

    Information from these sources suggested that spending on physicians was most highly concentrated in the Northeastern United States, where certain cities and counties claim some of the highest overdose death rates in the country.

    The study, conducted by researchers from Boston University School of Medicine, Boston Medical Center and New York University School of Medicine, and published in the Journal of the American Medical Association, filtered data from the aforementioned national databases through three criteria: total dollar value of marketing efforts by companies spent on doctors, number of payments and number of physicians that received any marketing. 

    According to the researchers, the pharmaceutical industry spent approximately $40 million promoting their opioid products to nearly 68,000 doctors between 2013 and 2015. The marketing efforts included paid meals, trips and consulting fees.

    By referencing overdose data and opioid prescription numbers from the CDC, they determined that for every three additional payments made to doctors per 100,000 people in a county, overdose deaths involving prescription opioids would rise 18% over a year’s time.

    Marketing to doctors dropped significantly in the period immediately following the years included in the study by 33%, which The New York Times attributed to public pressure on companies after the opioid epidemic began reaching critical levels.

    Cities and counties in the Northeastern US that received some of the largest payments also had some of the highest overdose rates, including Salem and Fredericksburg in Virginia, Cabell County in West Virginia and Lackawanna County in Pennsylvania.

    As The New York Times noted, the study authors also suggested that the number of interactions such as free meals appeared to be more strongly linked to overdose deaths than the amount spent on such interactions. 

    “Each meal seems to be associated with more and more prescriptions,” said study lead author Dr. Scott Hadland of Boston Medical Center’s Grayken Center for Addiction. Hadland and his co-authors also wrote that the study did have limitations: They were unable to differentiate between overdose deaths involving prescribed opioids and those caused by painkillers obtained through illegal means.

    “We acknowledge that our work describes only one part of the very complex opioid overdose crisis in this country,” said Hadland. “Even still, prescription opioids remain involved in one-third of all opioid overdose deaths, and are commonly the first medications that people encounter before transitioning to heroin or fentanyl. It is critical that we take measures now to prevent marketing from unnecessarily exposing new people to opioids they may not need.”

    View the original article at thefix.com

  • Inside The Push For Over-The-Counter Naloxone

    Inside The Push For Over-The-Counter Naloxone

    The FDA has recently taken an unprecedented step to kickstart the development of over-the-counter naloxone products. 

    Last week the FDA took an unprecedented step to make the anti-overdose drug naloxone directly available to opioid users.

    Currently, naloxone requires a prescription. But in an effort to make approval for non-prescription versions of the drug easier for pharmaceutical companies to get, the FDA developed sample labels that would meet federal Drug-Facts Label requirements for over-the-counter products. It marks the first time the drug agency has ever proactively created labelling to expedite the process.

    “Naloxone is a critical drug to help reduce opioid overdose deaths. Prevention and treatment of opioid overdose is an urgent priority,” the agency wrote in an unsigned statement. “Increased availability of naloxone for emergency treatment of overdoses is an important step.”

    The agency created two model labels, one for a nasal spray version of the drug and one for an auto-injector version. Both versions include a short information box about the drug and its uses, followed by an illustrated guide on how to administer the life-saving treatment and a warning about the drug’s expected effects.

    “These efforts should jumpstart the development of OTC naloxone products to promote wider access to this medicine,” the FDA wrote. The agency tested the labeling through a research contractor to verify that potential users could understand the images and warnings.

    “This work builds on our ongoing efforts to get this life-saving drug into the hands of those who need it most,” the statement continued. “In addition to the approval of injectable naloxone for use in a health care setting and both prescription auto-injector and intranasal forms of naloxone, which facilitate use by laypersons, we also released draft guidance to advance development of generic naloxone hydrochloride nasal spray.”

    The move comes amid a long-term rise in overdose deaths, as close to 48,000 people died from opioids in 2017 – double what the figure was seven years earlier, according to the federal agency. Overdoses can cause drug users to lose consciousness and stop breathing, but naloxone reverses those effects if given quickly enough. 

    Though the injectable version is pricier, a two-pack of the brand-name nasal spray version sells for about $125, according to CNBC. The generic is around $40 per dose. In theory, offering up a label that could make over-the-counter access easier might help lower those figures further by eliminating the need for would-be buyers to spend money on seeing a doctor for a prescription.

    “While the person administering naloxone should also seek immediate medical attention for the patient,” the agency said, “the bottom line is that wider availability of naloxone and quick action to administer it can save lives.”

    View the original article at thefix.com

  • How Opioids Hijack The Brain

    How Opioids Hijack The Brain

    Addiction experts and people who use opioids discuss how opioids impact their brains.

    Last year thousands of Americans died from opioid overdoses. Yet, despite the fact that the dangers of these drugs are well-publicized, new users continue to get hooked on opioids and succumb to their addictions. 

    To try to understand why, The New York Times spoke with addiction experts and users to understand just how opioids act on the brain, putting together a visual and text representation of what happens once someone tries opioids. 

    Twenty-four-year-old Amanda Ryan-Carr, of Pennsylvania, said that the first time she tried opioids was like a religious experience. 

    “It’s like being hugged by Jesus,” she said. 

    For Michigan resident Matt Statman, 48, the feeling was one of freedom from worry. 

    “I remember feeling like I was exhaling from holding my breath for my whole life. Just intense relief from suffering,” Statman said. 

    The Times pointed out that many opioid users remember where and when they were when they first used, and they end up chasing that euphoric feeling as addiction takes over their lives. 

    “It was like the high put on blinders to everything and made me not care about anything in the world, other than the heroin,” said Brandon N., a 26-year-old from Pennsylvania.

    Ivana Grahovac, 42, of California, said that opioids became her solution to any problem. 

    “Any time you start to feel like you’re getting antsy or anxious or a little stressed, your body says it knows exactly how to get out of this, and it’s telling you to just go get a little bit more of that heroin,” Grahovac said. 

    Once their bodies become used to having an opioid fix, users face painful withdrawals if they don’t take opioids. 

    Michigan resident Raj Mehta, 51, felt a sense of “doom and anxiety,” when withdrawals loomed, while Pennsylvania resident Jasmine Johnson, 29, said withdrawal was overwhelming. 

    “It’s like a demon crawling out of you. You’d rather just die and be done with it than go through that,” she said. 

    Eventually, users are no longer chasing a high, but just trying to hold off withdrawal symptoms. 

    “It’s like a time bomb,” Mehta said. “You’ve got 24 hours to get heroin, or you’re going to be really sick. You wake up, and your whole life is just based around it.”

    The lucky people are able to get access to treatment and begin a life in recovery. 

    “There was a push factor, which was the misery and the self-hatred and the depression and the cops, and then there was a pull factor, which was this amazing hope from this community of people who I knew understood me in a way nobody else in the world could,” Statman said. 

    However, many people feel like relapse is always looming. 

    “A lot of times in your addiction, things are getting better. You see a light at the end of the tunnel. And it ends up being the freight train coming at you,” Johnson said. 

    Even with bumps along the road, people in long-term recovery say that the work is worth it, allowing them to regain control of their lives and enjoy life without being fixated on their next high.

    “Colors get brighter and smells are more intense and emotions just are much more powerful, because opiates numb them,” said Dove Henry, a 26-year-old from Montana.

    View the original article at thefix.com

  • Mass Overdose In California Leaves One Dead, 12 Hospitalized

    Mass Overdose In California Leaves One Dead, 12 Hospitalized

    “Every indication is that this mass overdose incident was caused from the ingestion of some form of fentanyl in combination with another substance,” said a police chief at the scene.

    The synthetic opioid fentanyl is most likely responsible for a cluster of overdoses in one Chico, California house. One person died after overdosing and four are in critical condition; a total of 12 people were taken to the hospital. 

    According to NPR, Chico police are fairly sure the mass overdose was caused by the use of fentanyl, in combination with another substance.

    “Every indication is that this mass overdose incident was caused from the ingestion of some form of fentanyl in combination with another substance. That is yet to be confirmed, but we do anticipate confirmation in the coming days,” Chico Police Chief Michael O’Brien said.

    According to Anna Lembke, MD, fentanyl (a synthetic opioid pain reliever) can be 50 to 100 times more potent than heroin. Lembke gives this chilling example: “If you ingest a ‘bag of heroin,’ which is typically 100 mg of heroin, and that bag contains 20% pure fentanyl in place of heroin, you will be ingesting the rough equivalent of 2,000 mg of heroin, enough to kill even a highly tolerant user.”

    Chico Fire Department Division Chief Jesse Alexander said it was the largest mass casualty incident he had seen in years, with six people receiving CPR simultaneously.

    Chief O’Brien reported on the crime scene. “Upon arrival, Chico police officers found multiple individuals in what appeared to be life-threatening, overdose conditions. . . . Officers began to both administer CPR and also naloxone to those individuals. . . . Unfortunately one male individual was pronounced dead at the scene.”

    Chico officers began carrying naloxone on their person one year ago, according to CNN, and in this case lives were saved with the opioid-reversing drug. Police Chief O’Brien reported that officers administered CPR and six doses of naloxone.

    After working the crime scene, two officers reported feeling fentanyl-like symptoms from possible exposure and were treated and later released from a local hospital.

    The Chico Enterprise-Record reported that all of the people hospitalized were over the age of 18, with most of them appearing to be in their 20s. The National Institute on Drug Abuse reports that in 2017 there were more than 72,000 drug overdose deaths, with the sharpest increase seen among deaths related to fentanyl and fentanyl analogs (synthetic opioids) for a staggering total of nearly 30,000 overdose deaths. 

    View the original article at thefix.com

  • Opioid Overdose Deaths Surpass Vehicle Crash Deaths For First Time

    Opioid Overdose Deaths Surpass Vehicle Crash Deaths For First Time

    According to a new report from the National Safety Council, Americans are more likely to die from an opioid overdoses than a car crash.

    An opioid overdose is now a more likely cause of death than even vehicle crashes, according to a recent report. 

    The report on preventable deaths from the National Safety Council found that Americans have a 1 in 96 chance of death due to an opioid overdose, based on 2017 accidental death data. 

    “Drug poisoning is now the No. 1 cause of unintentional death in the United States,” the report reads. “Every day, more than 100 people die from opioid drugs –  37,814 people every year – and many of these overdoses are from prescription opioid medicine.”

    In comparison, NPR states, the chance of death in a motor vehicle crash is 1 in 103. 

    “We’ve made significant strides in overall longevity in the United States, but we are dying from things typically called accidents at rates we haven’t seen in half a century,” Ken Kolosh, manager of statistics at the National Safety Council, said, according to PR Newswire. “We cannot be complacent about 466 lives lost every day. This new analysis reinforces that we must consistently prioritize safety at work, at home and on the road to prevent these dire outcomes.”

    According to the Centers for Disease Control and Prevention, the drug at the forefront of overdose deaths is now fentanyl, which the council addressed in a statement. 

    “The nation’s opioid crisis is fueling the Council’s grim probabilities, and that crisis is worsening with an influx of illicit fentanyl,” the statement read. 

    Causes of death such as motor vehicle crashes and overdoses are different from heart disease and cancer deaths in that they are considered “a preventable, unintentional injury” — a statistic that has increased in the last 15 years, according to NPR. Falls also top the list of preventable causes of death, at 1 in 114, compared to 1 in 119 a year ago. 

    “It is impacting our workforce, it is impacting our fathers and mothers who are still raising their children,” Kolosh said. 

    He added that such deaths often impact people in the “core of their life.”

    “As human beings, we’re terrible at assessing our own risk,” Kolosh said. “We typically focus on the unusual or scary events … and assume that those are the riskiest.”

    Though everyone will die at some point, Kolosh says, action can still be taken to prevent unnecessary deaths. 

    “Your odds of dying are 1 in 1,” Kolosh added. “But that doesn’t mean we can’t do something. If, as a society, we put the appropriate rules and regulations in place we can prevent all accidental deaths in the future.”

    View the original article at thefix.com

  • What Does 2019 Hold For Opioid Lawsuits?

    What Does 2019 Hold For Opioid Lawsuits?

    Many are looking at the settlements with Big Tobacco to see how the opioid settlements—if there are any—might take shape.

    During 2018, as opioid overdose rates continued to soar, municipalities from around the country vowed to hold drug manufacturers and distributors accountable. This year, 2019, will show how many of the lawsuits around the opioid epidemic will pan out. 

    The plaintiffs — mostly local and county governments from around the country — hope that settlements from the lawsuits will help them recoup some of the costs of treating people addicted to opioids and maybe even help finance better treatment options going forward.

    “We are still in the throes of a public health crisis in Summit County,” Greta Johnson, a county official in Akron, Ohio, told NPR. In order to respond to that crisis, she said, the county needs funds from the major companies that caused or contributed to the epidemic. “We’re confident the court will see it that way as well.”

    Johnson’s argument, echoed in dozens of lawsuits, may sit well with Federal Judge Dan Polster, who is presiding over the largest group of lawsuits out of his Cleveland courtroom. Polster has called the opioid epidemic a “man-made plague,” and called for comprehensive solutions to the issues of addiction and recovery. 

    While defendants will likely try to have certain allegations dismissed on legal technicalities — like the statutes of limitations being up — Richard Ausness, a law professor at the University of Kentucky, told NPR that effort is unlikely to succeed entirely.

    “The judge has made it clear that he wants a settlement ultimately from this, along the lines of the tobacco settlement,” Ausness said. “If that is indeed the way that he feels, he is probably not going to let the defendants off the hook.”

    As the court cases proceed, the public could learn even more about practices that led to millions of Americans becoming hooked on opioids. Attorney Joe Rice, who represents some governments suing Big Pharma, said that he would like to see the information about misleading advertising and other unscrupulous practices become common knowledge. 

    “Our next battle is to get the documents that are being produced made available to the public instead of everything being filed under confidentiality agreements so we can get the facts out,” he said. 

    Many people are looking at the settlements with big tobacco to see how the opioid settlements — if there are any — might take shape. Tobacco companies have paid more than $100 billion in damages to Americans, some of which have been used to fund anti-smoking public health campaigns. A similar settlement with manufacturers and distributors could impact how future generations are educated about drug use.  

    View the original article at thefix.com

  • Maine's First Female Governor Targets Opioids

    Maine's First Female Governor Targets Opioids

    Governor Janet Mills is making the opioid epidemic in her state her top priority.

    Democratic Governor Janet Mills is making the opioid crisis in her state her top priority. Going the complete opposite direction of her predecessor, she has expanded Medicaid and made plans to appoint an opioid czar in her first days in office.

    Her Medicaid expansion would allow thousands of additional Maine citizens into the program, including those who need assistance in fighting opioid addictions.

    “A major part of the health care crisis is the opioid epidemic,” Governor Mills said in her inaugural address. To combat the epidemic in Maine, Mills said on Twitter she wants to appoint a czar to “marshal the collective power and resources of state government,” hoping to prevent deaths such as the 418 overdose deaths in Maine last year.

    Mills’ predecessor, former Republican Governor Paul LePage, was not constructive in approaching the drug crisis, suggesting the problem had something to do with race. In August 2016, LePage claimed he had a binder that showed a massive majority of busted drug dealers were black or Hispanic. 

    “I don’t ask them to come to Maine and sell their poison, but they come,” LePage said. “And I will tell you that 90-plus percent of those pictures in my book, and it’s a three-ringed binder, are black and Hispanic people from Waterbury, Connecticut, the Bronx and Brooklyn.”

    An audit of the binder revealed roughly half of the offenders in the binder appeared to be white. After being accused of being a racist, LePage denied the charges and claimed he was just stating facts.

    “You’ve been in uniform? You shoot at the enemy,” he once said at a statehouse press conference. “You try to identify the enemy and the enemy right now, the overwhelming majority of people coming in, are people of color or people of Hispanic origin.”

    Treatment advocates have high hopes for Mills’ plan.

    Gust Stringos is the medical director of a family practice in Skowhegan, a small town in Maine with a population of 8,000. He said half of his patients are battling opioid addiction.

    “Many of them were on Medicaid and then lost it in the era of LePage,” he said.

    He recalls one 21-year-old female who relapsed after losing coverage and dropping out of the treatment program. When she got pregnant, she requalified and was readmitted.

    “If she had been able to stay on Medicaid in the first place, she wouldn’t have gotten pregnant and wouldn’t have relapsed,” said Stringos. “That’s a typical story of people losing insurance and what happens.”

    View the original article at thefix.com

  • Grant Provides Medication-Assisted Treatment To Inmates Leaving Jail

    Grant Provides Medication-Assisted Treatment To Inmates Leaving Jail

    Inmates in the treatment program also leave jail with counseling appointments in place and other sobriety supports.

    The Wisconsin legislature is giving out $1.3 million in grant money that counties around the state will use to provide medication-assisted treatment for inmates who are leaving jails. 

    The grants, administered through the Wisconsin Department of Health Services, allow people who are ready to be released to receive an injection of Vivitrol, which can block opioid receptors in the brain and make people less likely to abuse opioids. Inmates in the program also leave jail with counseling appointments in place and other sobriety supports, according to Action News. 

    “This is another great opportunity for an individual who wants to make a change to have the resources to be able to do it, and do it at a cost that they can afford,” said Todd Delain, sheriff-elect in Brown County, Wisconsin, which includes Green Bay. “The Vivitrol is one piece of it. The counseling and ongoing monitoring treatment is the other part of it, because if you don’t have both, they’re probably not developing the skills and tools necessary to overcome it long-term.”

    The program aims to help address the vulnerabilities of people who have just been released from a correctional facility, said Paul Krupski, director of opioid initiatives at the Department of Health Services.

    “Specifically to the criminal justice population, they have a very high rate of opioid overdose and opioid overdose deaths upon release in the first 60-90 day period that they are out,” he said.

    Inmates seem eager to take advantage of the program, according to Correct Care Solutions, which provides health care services to jails. 

    Jessica Jones, the company’s regional operations manager, said, “It really needs to be something the patient wants to do. It needs to be a lifestyle change they’re ready to make. The medication is really 50 percent of this. The psych-social component is what they really need to be ready to dedicate themselves to.”

    A pilot program has been taking place at the Brown County Jail, in partnership with Prevea Health. Over the past 18 months, that program has shown success, said Prevea Health President and CEO Dr. Ashok Rai.

    “I remember the first person, when one of our physicians came to me and said, we had our first graduate and that person got a job,” Rai said. “The whole intent here was to try to help people.” 

    Vivitrol, in combination with therapy, can be a powerful tool for people looking to get into recovery, he said. 

    “To get to the heart of addiction is really to get to counseling and what psychological aspect, as part of that disease, led to the addiction,” Rai said. 

    View the original article at thefix.com