Author: The Fix

  • FDA, DEA Partner For Probe Into Vaping Illnesses

    FDA, DEA Partner For Probe Into Vaping Illnesses

    The agencies are focusing on vaping manufacturers in order to “[follow] the supply chain to its source.”

    The Drug Enforcement Administration (DEA) will assist the Food and Drug Administration (FDA) in its investigation into the spate of vaping-related illnesses that have sickened more than 1,000 and claimed at least 18 lives.

    In testimony before a House Energy and Commerce subcommittee on September 25, acting FDA Commissioner Dr. Ned Sharpless said that the agencies will collaborate to determine “if someone is manufacturing or distributing illicit, adulterated products that caused illness or death for personal profit,” which would be considered a criminal act.

    FDA Waited Too Long To Review Vaping Products

    Sharpless acknowledged that the FDA should not have waited to review e-cigarette products, a decision which some lawmakers have said was a contributing factor in the rise of teen e-cigarette use.

    Sharpless’s testimony came on the heels of the FDA’s announcement of a criminal problem into the rash of vaping illnesses, which they announced on September 19. He mentioned that the decision to bring the DEA into the probe is due to the number of illnesses and deaths related to the use of vaping cartridges containing THC.

    As for the focus of the probe, Sharpless said that the agencies are focusing on vaping manufacturers in order to “[follow] the supply chain to its source.”

    Additionally, Sharpless said that the FDA plans to finalize a draft of new guidance for flavored vaping products. Warning letters will be sent to manufacturers that do not remove those products—save for those that are flavored like tobacco—from the market. Those that do not comply may be subjected to additional warning letters, as well as possible fines and injunctions.

    Why Did The FDA Take So Long to Act?

    But lawmakers on the subcommittee also wanted to know why the agency appeared to wait nearly three years in order to take action in regard to e-cigarettes.

    The FDA asked companies in 2016 to file applications to market products by August of 2018, but as STAT News noted, former FDA Commissioner Scott Gottlieb shifted the agency’s focus to curbing nicotine levels in traditional cigarettes, while also delaying the marketing applications to 2022 (the deadline has since been moved to May 2020).

    In response to the subcommittee’s inquiries, Sharpless said that the “FDA should’ve acted sooner,” but added that the probe, and the addition of the DEA to its efforts, should help them “catch up.”

    “We will not rest until we have answers to the questions in the investigation, and until we have dramatically reduced the access and appeal of e-cigarettes to kids,” he said.

    View the original article at thefix.com

  • Safe Injection Site In Philadelphia Ruled Federally Legal By Judge

    Safe Injection Site In Philadelphia Ruled Federally Legal By Judge

    The ruling goes against the wishes of the US Justice Department, which sued to stop the facility from opening.

    A federal judge has ruled that a planned supervised injection site, where individuals can go to use illicit drugs safely under medical supervision, does not violate U.S. federal law. This has opened the door for the city of Philadelphia, where the facility in question would be located, to host the first legal safe injection site in the country.

    “Crackhouse Statute” Does Not Apply

    According to the Philadelphia Inquirer, U.S. District Judge Gerald A. McHugh ruled on Wednesday that a 30-year-old law created to address what was commonly referred to as “crack houses” does not apply to the safe injection site proposed by the non-profit organization Safehouse.

    “The ultimate goal of Safehouse’s proposed operation is to reduce drug use, not facilitate it,” McHugh wrote in the document explaining his decision.

    The ruling goes against the wishes of the U.S. Justice Department, which sued to stop the facility from opening. The government argued that the drugs that would be used are dangerous and the act of using them is illegal.

    “This is in-your-face illegal activity using some of the most deadly, dangerous drugs that are on the streets. We have a responsibility to step in,” said U.S. attorney for the Eastern District of Pennsylvania William McSwain in February. “It’s saying, ‘Safehouse, we think this is illegal. Stop what you’re doing.’”

    Saving Lives, Not Encouraging Drug Use

    However, the Safehouse lawyers have argued that the purpose of a safe injection site, also referred to as overdose prevention sites, is to save lives and encourage the individuals who frequent it to get into addiction treatment.

    “I dispute the idea that we’re inviting people for drug use. We’re inviting people to stay to be proximal to medical support,” said Ilana Eisenstein, chief attorney for Safehouse, in September.

    Multiple studies on safe injection sites, including those that have opened across Europe and in Canada, show that they reduce the number of overdose deaths in the area without resulting in an increase in overall illicit drug use.

    They also lessen the spread of dangerous viruses such as HIV and hepatitis by offering clean needles and a place to safely dispose of used ones. These successes have led the American Medical Association to endorse the bringing of these sites to the U.S. However, the Justice Department is determined to continue the fight.

    “The Department of Justice remains committed to preventing illegal drug injection sites from opening,” said McSwain. “Today’s opinion is merely the first step in a much longer legal process that will play out. This case is obviously far from over.”

    View the original article at thefix.com

  • Johnson & Johnson Settles Opioid Lawsuits With Two Ohio Counties

    Johnson & Johnson Settles Opioid Lawsuits With Two Ohio Counties

    The settlement is tiny compared to a recent $572 million ruling against Johnson & Johnson for its role in the opioid epidemic in Oklahoma.

    Johnson & Johnson has reached a settlement deal with two Ohio counties in the “bellwether” case for the national opioid lawsuits. 

    Johnson & Johnson has agreed to pay a $20.4 million settlement to Summit and Cuyahoga counties. That includes $10 million in cash and $5 million in legal fee reimbursement. Another $5.4 million will be donated to addiction treatment and opioid-related programs in the counties. 

    “This settlement represents yet another milestone in this litigation as it gets much-needed funding into the community while at the same time providing support for programs addressing opioid-exposed babies and their families,” the counties’ attorney, Frank L. Gallucci, told The Washington Post

    Johnson & Johnson argued previously that its opioid products made up fewer than 1% of opioid sales in the two counties, and therefore could not be held responsible for addiction in the counties. However, it decided not to take that argument to trial. 

    “The settlement allows the company to avoid the resource demands and uncertainty of a trial as it continues to seek meaningful progress in addressing the nation’s opioid crisis,” the company said in a statement. “The company recognizes the opioid crisis is a complex public health challenge and is working collaboratively to help communities and people in need.”

    A Small Price To Pay

    The settlement is tiny compared to a recent $572 million ruling against Johnson & Johnson for its role in the opioid epidemic in Oklahoma. The company was one of the only defendants in that case that did not reach a settlement before trial. The company is appealing that ruling.

    Johnson & Johnson’s stock rose after the Ohio settlement was announced, indicating that investors see this as a win for the company. 

    Purdue Pharma and Mallinckrodt Pharmaceuticals have also reached settlements in the bellwether case, which is meant to set the stage for more than 2,000 opioid-related lawsuits from around the country. So far, the two counties reached settlements worth a total of $60 million, The New York Times reported. However, six defendants are still slated to go to trial, which will begin at the end of the month. The jury selection will begin within two weeks. 

    More Counties To Come

    Attorneys for the counties said that they are preparing for the trial. “We continue our preparation ahead of the October 21st trial where we plan to hold the remaining opioid makers and distributors accountable for fueling the crisis that has led to thousands of deaths in Ohio and across the country.”

    View the original article at thefix.com

  • DEA Was "Slow To Respond" To Opioid Crisis, Report Reveals

    DEA Was "Slow To Respond" To Opioid Crisis, Report Reveals

    According to a watchdog report, the DEA allowed the drug crisis to reach a level that could have been prevented.

    The DEA could have done more to blunt the impact of the national opioid crisis, which has claimed more than 300,000 lives in the U.S. since 2000, according to a new report.

    The “harsh” report—released by the Justice Department’s Office of the Inspector General, which is responsible for auditing the DEA—found that despite rising opioid abuse being reported early on before the full-blown epidemic emerged, the DEA failed to act in a timely manner, allowing the drug crisis to reach a level that could have been prevented.

    “DEA is responsible for regulating opioid production quotas and investigating its illegal diversion,” said inspector general Michael E. Horowitz in a video summarizing the report’s findings. “We found that DEA was slow to respond to this growing public health crisis and that its regulatory and enforcement efforts could have been more effective.”

    Opioid Manufacturing Skyrocketed From 1999 To 2016

    The report noted that from 1999-2016, despite increasing reports of opioid abuse, the amount of opioid manufacturing authorized by the agency “also increased dramatically during that same time.”

    It should be noted that during this time period, a number of high-profile events occurred that established opioid abuse as a national public health crisis. From 1997-2002, OxyContin prescriptions for non-cancer related pain increased from 670,000 in 1997 (a year after OxyContin went on the market) to about 6.2 million in 2002, according to a timeline provided in the report.

    In 2007, Purdue Pharma and three company executives pleaded guilty to charges of false branding of OxyContin and were fined $634 million. Meanwhile, the rate of drug overdoses, fueled by opioid abuse, surged.

    Too Little, Too Late

    The agency waited until recent years to scale back opioid production. “It wasn’t until 2017 that DEA significantly reduced the production quota for oxycodone by 25%,” the report noted.

    The report did acknowledge the agency’s recent efforts to tighten up enforcement of drug diversion (when prescription drugs end up being abused in a way it was not intended) but said that more work is needed overall.

    The inspector general offered a list of nine recommendations to improve the DEA’s opioid response. They include developing a comprehensive national strategy that involves better cooperation between federal and local authorities and timely monitoring of emerging drug abuse trends, among others.

    View the original article at thefix.com

  • Jesse Eisenberg Talks Childhood Anxiety

    Jesse Eisenberg Talks Childhood Anxiety

    Eisenberg described how the anticipation of being bullied caused him to feel extremely anxious growing up. 

    Actor Jesse Eisenberg struggled with anxiety as a child, making it difficult for him to relax around other children, he said in a conversation with Dr. Harold S. Koplewicz, president of the Child Mind Institute.

    The conversation was titled “Great Minds Think Unalike 2.0” and was a part of Advertising Week, a gathering of media professionals. Eisenberg, who has his Zombieland sequel coming out on October 18, said that he anticipated being bullied as a child, putting him on edge around other children.

    “I kept one tissue for crying and one for bleeding,” he told Koplewicz. “I was prepared for battle, but nothing ever happened, which was almost worse.”

    Acting Offered Eisenberg A Safe Space

    He also described how acting has been cathartic by providing a controlled space to experience emotion.

    “Acting is a very visceral experience,” he said. “It is a cathartic way to have an emotional experience that is safe and contextualized. [It’s] different form real-life experiences [like] when I ran out of middle school hysterically crying due to my anxiety.”

    The Academy Award-nominated actor, who says his anxiety surfaces “just in the morning, afternoon and evening,” said that if his younger self had witnessed the increasing discussion of mental health awareness that we are seeing today, it would have provided him some sense of relief. “If 12-year-old me was able to see something like this, it would show me that life ebbs and flows. It helps destigmatize something that is incorrectly stigmatized,” he said.

    Being Mindful Around His Son

    Speaking about his two-year-old son, Eisenberg said he tries not to project his anxiety around him. “To me, there’s nothing better for one’s mental health than to worry about things that are real, and when you have a child, you can only worry about something that’s real,” he said.

    “I resist all of the temptations I have to make [my son] neurotic because I know it’s not helpful. I know that what might feel good in the moment of consoling a kid who appears nervous may be detrimental in the long term,” he added.

    In 2017, Eisenberg shared a video for the Child Mind Institute’s #MyYoungerSelf series, in which he shared what he would tell his younger self about dealing with anxiety and nervousness.

    “I think I would probably tell myself two things. One is that it’s not the worst thing in the world to have those feelings. Even though it might feel like the worst thing in the world… actually having that anxiety might be indicative of other beneficial positive characteristics like sensitivity to the world or an empathy or maybe a kind of interesting or unusual perception of life that could benefit you over the long term,” he said.

    He said the second thing he would tell his younger self is to get involved with charitable work sooner than later.

    “I worked with people with terminal illnesses and volunteered at a domestic violence shelter, and you realize very quickly that other people have bigger problems than you and it puts your life in perspective in a healthy way. And it also gets you out of your own bad, cyclical thinking patterns. And of course, more importantly, it’s helping somebody else.”

    View the original article at thefix.com

  • Nicotine and Self-Recrimination: Kicking My Last Addiction

    Nicotine and Self-Recrimination: Kicking My Last Addiction

    I had four months smoke free under my still loosely fitting belt and had been patchless for over 30 days. Hours passed without any thought of a cigarette. I felt confident. And then one day, I stepped on the scale.

    According to the QuitNow! app glowing from the glossy face of my phone, I’ve been smoke-free for 294 days. I have saved almost $3,000 and “won” back three weeks that otherwise would have been squandered away standing in the rain sucking on a Basic Menthol Light. 

    This almost unthinkable achievement, this formerly unattainable goal, is a boast I have bellowed to and fro for the last eight months to anyone who does or doesn’t give a shit. In support groups with quitters swimming in self-pity and weakness, I have proclaimed myself the victor over nicotine and tobacco; an easy battle because I am committed. Though 42 years of smoking may have damaged my body in ways yet to be revealed, I have managed to silence the relentless chatter of the irrational addict and return logic to the part of my brain that runs every other program of my life.

    That is, until a month ago.

    During my four tours in rehab, counselors and addicts alike proposed the theory that the last substance an addict quits will be the most difficult. I have 16 years clean and sober from drugs and alcohol but it was not without many slips along the way. 

    Whatever made me think I could quit smoking and get it right on the first try? The hubris of the addict.

    Using the NicoDerm patch system, the first few months of my quit were reminiscent of my first stay in rehab at age 26. The pink cloud, as it’s called, evidently happens no matter what drug you kick and it buoyed me through those initial weeks of cigarette cravings. I lived and breathed the Facebook quit smoking groups (there are dozens!) where I could experience all the regret, heartache, and depression of relapsing by reading of others’ failures while still remaining smoke-free.

    I weathered internet and cable outages and the subsequent maddening phone calls to Comcast that I thought I couldn’t endure, and I considered lighting up and smoking my Williams Sonoma Wintergreen candles to deal with the stress. I survived a devastating family fight that left me bent in half on the couch for a week, my tears spilling onto the floor until they crested over the cushions. I couldn’t write because I didn’t smoke and those two activities were knit together like a friendship bracelet. 

    But I persevered. I went on walks, something I hadn’t done for, well, ever. With my grandchildren, the nucleus of my motivation, I trotted along as they biked or scootered; again, unprecedented. 

    “Gwammy, you’re going to walk us to school?!” they would squeal, their incredulity expressing a maturity unheard of for a seven- and five-year-old.

    “Why yes, my darlings,” I would declare with the wisdom and assurance of Yoda. “Gwammy can walk now!”

    I had spent so many years anticipating the sudden fatal heart attack that would befall me should I exert myself even a wee bit, and now I felt a freedom I had not known since my teenage years, when I first started smoking but thought myself immortal. 

    And I gloated. I admit it. I went to the groups and while they whined and cried about gaining weight, I lectured about exercise and eating right and how it’s all about choices. Eat fruit and popcorn, like me! Drink lots of water, like me! Walk to the store, like me!

    I had not had a problem with my weight for, well, ever. At five feet and 105 pounds, I felt very positive about how I looked – in clothes. I was hypervigilant about maintaining my weight because at my height, even a few extra pounds could mean an unwelcome eight-hour shopping excursion to Nordstrom Rack for a wardrobe in the next size up. That’s not happy shopping. 

    I had four months smoke free under my still loosely fitting belt and had been patchless for over 30 days. Hours passed without any thought of a cigarette and most of the habitual smoking associations like driving, talking on the phone, writing, eating, cooking, breathing, living, had been broken effectively enough for me to feel like an actual non-smoker. I steered clear of the last few friendly smoking circles I’d once been a part of (people, places, and things) and reveled in my success. I felt confident. I didn’t need support.

    And then one morning, I stepped on the scale. And it was different. VERY different. 

    I had read accounts of ex-smokers who claimed to gain ten pounds overnight. I thought them daft. I accused them of looking for excuses to smoke. I showed them no mercy.

    And the scale continued to climb. 

    Suddenly everything that seemed manageable fell into chaos. Work became untenable. I seethed with HATRED for my boss, who had the unmitigated gall to ask me to do things. I purple-screamed in traffic at other drivers. I muttered in the grocery store like a sociopath when the deli clerk sliced honey ham instead of Black Forest. I stopped eating plain, dry, Styrofoam-like popcorn at night because clearly that was the culprit behind the weight gain. I cried on the kitchen floor because I could no longer have popcorn. I cried because I grew a muffin top overnight. I cried because I hate fruit and now it was my only treat. I cried because my thighs were about to…touch.

    The chatter returned. Quiet, reluctant, and shy at first, it built up steam quickly, as I fought with all the strength I could muster to shut it down.

    “Fatty. Fatso. FAT GIRL. You’re going to get so fat, it won’t matter if you live longer because you’re going to hate yourself.”

    “Shut it.”

    “Look how depressed you are! Is that how you want to feel the rest of your life? Don’t you know you could feel BETTER, happier, skinnier, right now?”

    “Feel better momentarily and then feel horrible because I failed? No thanks.”

    “Who says you’ll feel bad? All those other fat people? Who cares! You’re the one alone, depressed and getting larger with every clean, deep breath you take. And there’s nothing you can do about it. Walk, cut back on popcorn – it’s inevitable. Your metabolism is in a coma.”

    “That’s rubbish. Leave me alone. I don’t want to die.”

    “Drama queen.”

    I’d quiet myself down, still the noise with an audiobook or some raucous comedy on Spotify. But always waiting in the silence: the nicotine Night King, ready to strike…and I felt ill-equipped for the battle.

    “Hey, you know it took you four tries to kick drugs and alcohol.”

    “That’s true.”

    “Theoretically, you’ve got a few more years of smoking to go before you really quit.”

    “As illogical as that is, I’m listening.”

    And so it goes.

    I bought a pack of fake, herbal smokes made of marshmallows, rose petals, and the flatulence of unicorns. And I told EVERYONE. I brought the unopened pack to my therapist’s office and slammed them down on the couch. 

    “Let’s talk about these fake cigarettes,” I stated.

    And we did, but I still wanted to smoke them. I told my older sisters, my greatest champions in this quit, and they both implored me to refrain from lighting them. I told my son, who shrugged and mumbled “slippery slope.”

    I’ve smoked a few a day for about a week. The menthol flavor is not terrible, as the reviews on Amazon claimed. They help when a strong craving steers my car into the 7-11 with only one objective that has nothing to do with Slurpees. Already, my lungs feel uncomfortably full and I’m concerned about the long term effects of marshmallow leaf and unicorn farts.

    But for now, I’m still nicotine and tobacco free. I can’t say smoke-free anymore because that’s dishonest. I hope I don’t go back. It would be miserable AF to have to start a quit again. I hope I don’t gain any more weight. I’ve already dropped a grand at Nordstrom’s for a wardrobe to fit my new bountiful 115 pound frame. But mostly, I hope that whatever happens, I can cut out the self-recrimination as successfully as I cut out the popcorn. That, I suspect, is the deadliest extra weight I now carry.

    View the original article at thefix.com

  • Google Honors Addiction Treatment Pioneer Dr. Herbert D. Kleber

    Google Honors Addiction Treatment Pioneer Dr. Herbert D. Kleber

    Kleber, who died last year, was honored with a very special Google Doodle on Tuesday. 

    If you used the Google search engine on Tuesday, you would have seen a Google Doodle honoring Dr. Herbert D. Kleber, who spent more than 50 years pioneering addiction treatment, including the use of medication-assisted treatment for substance use disorder. 

    Kleber, who died last year at the age of 84, began his medical career in 1964, with an assignment to the Public Health Service Prison Hospital at Lexington, Kentucky. There, he was saw firsthand how people with substance use disorder were treated, according to CNN

    “Most people didn’t get therapy. Most people had work therapy,” Kleber said in an oral history for Columbia University, where he later worked. “They’d be assigned to the kitchen. They’d be assigned to the farm. They’d be assigned to the woodshop, which made furniture. They’d be assigned to the laundry, whatever, whatever.”

    A Thought Leader Who Knew Early On That Treating Addiction As A Moral Failing Was Wrong

    At the time, most saw addiction as a moral failing, but Kleber could see that it was actually the treatment system that was failing patients. 

    “There was about a 90% relapse rate within the first 90 days,” he said. 

    Two years later, Kleber returned to Yale.  

    “The last thing in the world I wanted to do was to treat addiction,” he said. “But once you had been at Lexington, you were a marked man. That is, people sought you out who thought you might know something about treating addiction.”

    He realized that studying addiction might be his “fate,” and received funding from the National Institutes of Health to devise a treatment program that would help people stay sober. Kleber integrated methadone treatment with a community-based behavioral model. Over the years he tried many medications for treating addiction to a variety of substances. 

    He Oversaw The National Policy Center on Addiction and Substance Abuse With His Wife

    Kleber became the Deputy Director for Demand Reduction at the Office of National Drug Control Policy in 1989, despite the fact that some people opposed his appointment. He was seen as “soft on drugs” because he favored medication-assisted treatment. After that, Kleber worked at Columbia University, overseeing the National Policy Center on Addiction and Substance Abuse with his wife, Marian Fischman.

    Kleber said in his oral history, which was recorded in 2015, that there’s still strife between 12-step and medication-assisted treatment models, but he believed that would change as long-acting and non-addictive treatments for substance use disorder, like Vivitrol, became more widely available.

    “As those get perfected, you’re going to see important changes in how treatment is carried out,” he said. 

    Tuesday (Oct. 1) marked the 23rd anniversary of Kleber’s election to the National Academy of Medicine.

    View the original article at thefix.com

  • What Vaping Statistics Tell Us About The New Epidemic

    What Vaping Statistics Tell Us About The New Epidemic

    The statistics highlight just how popular the smoking trend is among adolescents and young adults. 

    Vaping has recently become headline news, as the national scrambles to figure out the cause of vaping-related illnesses that have killed 18 people as of Thursday (Oct. 3). Looking at the numbers around vaping can help people understand the issue. Here are some things to consider:

    Vaping is relatively rare among adults

    Although everyone seems to have an opinion on vaping, not too many adults are actually using e-cigarettes. According to the Truth Initiative, 4.2% of adults ages 25 to 44 were using e-cigarettes in 2016. That was an increase from 2013, when just 2.4% of adults were using them, but is still a relatively low rate.

    Most adults who use e-cigarettes are doing so to replace traditional tobacco products. Nearly 59% of adult users said they smoked both traditional and electronic cigarettes in 2015. An additional 30% of adult users were previous smokers, and just 11.4% of adult e-cigarette users had never smoked cigarettes.

    Vaping is very popular among teens, young adults

    Unfortunately, vaping has become super popular among teens and young adults, many of whom have never used traditional cigarettes. Although it’s illegal for people younger than 18 (or in some states, 21) to purchase or use vape products, 40% of 12th-graders surveyed in 2019 reported that they’ve used nicotine vapes, according to U.S. News and World Report.

    More than a quarter reported using nicotine vapes within the past 30 days. That’s a massive rise from 2017, when just 13% of 12th-graders had used vapes within the past month. Now, 12% of high school seniors say they use nicotine vapes every day.

    Unlike adult users, who seem to use e-cigarettes to replace traditional nicotine products, young people are using e-cigs as their first exposure to nicotine. Experts are concerned that teens who otherwise would not get hooked on nicotine are becoming dependent on it because of their vape use. For example, in 2018, 7.6% of high school seniors had smoked a cigarette within the past month, but 26.7% had used a vape, according to the Monitoring the Future survey.

    In adults, it’s associated with tobacco use

    Data shows that states with higher rates of tobacco use also have higher rates of e-cigarette use. For example, Kentucky had some of the highest smoking rates, with 24.6% of adults using traditional cigarettes in 2017 and 6.1% using vapes. In California, where just 11.3% of adults smoke tobacco, just 3% used vapes.

    The adult use trends are uneven. In fact, half of the states saw adult vaping rates decrease from between 2016 and 2017, while half saw an increase in adult use. Despite this, teen and young adult vaping rates continue to rise across the board.

    View the original article at thefix.com

  • FDA, DEA Warn Sites To Stop Selling Opioids

    FDA, DEA Warn Sites To Stop Selling Opioids

    The government agencies partnered to issue a joint warning to rogue online pharmacies. 

    The Food and Drug Administration and the Drug Enforcement Administration have issued formal warning letters to websites that illegally sold opioid pain pills, including pills given to people without prescriptions. 

    “As the FDA works to forcefully tackle the opioid crisis on all fronts, we cannot allow rogue online pharmacies to continue to fuel the crisis by illegally offering opioids for sale and circumventing the important safeguards that have been put in place for opioids to help protect the public health,” said acting FDA Commissioner Ned Sharpless in a press release

    Joint Warnings

    Sharpless pointed out that the letters were the first of their kind because they brought the two federal agencies together. 

    “Today’s effort is also noteworthy because while the FDA partners regularly with the DEA, this is the first time we have issued joint warning letters with them,” he said. “This action further strengthens the warning to the operators of these websites. We remain committed to using all available regulatory and enforcement tools to stop the illicit flow of opioids online.”

    According to the press release, the 10 websites that received warnings were selling opioids online without following federal regulations. 

    “The products, while being marketed as authentic, may be counterfeit, contaminated, expired or otherwise unsafe,” the agencies said in the news release. 

    Other Types Of Fraud

    Although authorities are most concerned about the physical harm that these websites can cause, doing business with them can expose consumers to a host of other issues as well. 

    “In addition to health risks, illegal online pharmacies can pose other risks to consumers, including credit card fraud, identity theft and computer viruses,” the agencies warned. 

    The letters demanded that the pharmacies stop selling products to American consumers immediately. They also required the companies to respond within 15 days detailing the steps that they will take to curb the violations that were outlined in the letters. If the companies fail to respond, they could face legal action. 

    Issuing warning letters is a way for the FDA to intervene when a company is doing something illegal or harmful. Earlier this year the agency issued a warning letter to the drug manufacturer McKesson after it shipped “illegitimate” opioids.

    Acting DEA Administrator Uttam Dhillon said that by working together, the DEA and FDA are able to increase their enforcement capabilities. 

    “Issuing these warning letters is not only an effort to deter the availability of dangerous illegal opioids, but it is also a testament to the close cooperation between DEA and FDA,” he said. “We will continue to attack organizations that facilitate the sale of dangerous drugs, putting profit over public safety.”

    View the original article at thefix.com

  • Selena Gomez Honored With McLean Award For Mental Health Advocacy

    Selena Gomez Honored With McLean Award For Mental Health Advocacy

    The pop star has been open about her struggles with depression and anxiety throughout her career. 

    Selena Gomez is being honored for her willingness to speak out about her own mental health, as the singer and actress recently was awarded the 2019 McLean Award from McLean Hospital in Massachusetts. 

    According to Today, the 27-year-old accepted the award on September 13 and in doing so, shared her own personal experiences with depression and anxiety. 

    Getting Mental Health Treatment

    Last October, Gomez checked into a treatment facility for her own mental health. 

    “It felt as though all of my pain, anxiety and fear washed over me all at once, and it was one of the scariest times of my life,” Gomez said upon accepting the award. 

    Checking into treatment came a year after Gomez received a kidney transplant, a result of her battle with the autoimmune disease lupus. Gomez said that receiving her diagnosis lead her to feel “equal parts terrified and relieved.”

    She added that she felt “terrified because the veil was lifted but relieved that I finally had the knowledge of why I had suffered with various depressions and anxieties for so many years. I never had full awareness or answers about this condition.”

    For the past year, Gomez has been working to regain control of her emotions and learn how to put her health first. 

    “Although this does not mean that it has all gone away, I can say that after a year of a lot of intense work I am happier, I am healthier and I’m in control of my emotions and thoughts more than I have ever been,” she said.

    Talking About Mental Health In The Public Eye

    In speaking at the award ceremony, Gomez said it  “feels right to share” about her experience with depression and anxiety, but added that it’s not necessarily easy to do so. 

    Others expressed appreciation for Gomez’s transparency, including Jay Ruderman, president of the Ruderman Family Foundation. 

    “Thank you @selenagomez for being so open about your #mentalhealth,” he tweeted. “Your bravery in seeking help and speaking out will inspire others to do the same. @RudermanFdn was honored to hear your story last Friday at @McLeanHospital.”

    “I have feared being misunderstood and judged,” Gomez said. “I know that I have been given experiences and people and opportunities that have made my life exceptionally beautiful and sweet — and yet I struggle with my own thoughts and feelings at times. But this doesn’t make me faulty. This does not make me weak. This does not make me less than. This makes me human. We need help, and we need each other.”

    View the original article at thefix.com