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Teaching kids about addiction and the opioid epidemic
If there is one thing we all know, it is that children are resilient, aware and often impacted by the actions and environments that surround them. And as America is still in the grips of the opioid epidemic, it was only a matter of time before a traditional and respected outlet like Sesame Street took the lead on making sure children could relate. According to Sesame Workshop, 5.7 million children under the age of 11 in the U.S. live with a parent battling a substance abuse disorder. That's one in eight kids and doesn't include children who have been separated from a parent due to circumstances like divorce, incarceration or death related to their addiction. "Addiction is often seen as a 'grown-up' issue, but it impacts children in ways that aren't always visible," said Sherrie Westin, President of Social Impact and Philanthropy at Sesame Workshop. "Having a parent battling addiction can be one of the most isolating and stressful situations young children and their families face." "'Sesame Street' has always been a source of comfort to children during the toughest of times, and our new resources are designed to break down the stigma of parental addiction and help families build hope for the future." CBS NEWS, October 10 Are you a journalist covering the opioid epidemic or addiction issues in America? If so, let our expert help with your questions and coverage. There are a lot of questions and that’s where we can help. Dr. Marc Sweeney is the Founding Dean of the School of Pharmacy at Cedarville University and is an expert in the fields of drug abuse, prescription drug abuse and Opioid addiction. Marc is available to speak with media regarding this growing issue. Simply click on his icon to arrange an interview.

As we approach the first anniversary of the legalization of cannabis and prepare for the introduction of legal edibles, CAA South Central Ontario (CAA SCO) is releasing new data that suggests that the dangers of cannabis-impaired driving are misunderstood by many. It shows that approximately 1.2 million Ontario drivers have, at some point, driven high after consuming cannabis. Seventy-two per cent report waiting three hours or less to get behind the wheel, with 27 per cent feeling very or somewhat high when they did. “We know that driving under the influence of cannabis affects your ability to drive safely and increases your risk of getting into a crash,” said Teresa Di Felice, assistant vice-president of government and community relations at CAA SCO. “The research has shown us that young Canadians are more at risk of a vehicle crash even five hours after inhaling cannabis.” The research also shows that over half of Ontario drivers who use cannabis are “poly-users,” meaning they typically pair cannabis with another substance. Alcohol is by far the most common substance paired with cannabis. Cannabis-infused edibles are another option that may further complicate matters when it comes to drug-impaired driving. Twelve per cent of non-users indicated they were very or somewhat likely to try edible cannabis products after it becomes legal. “It is crucial to continue to explore and understand what impact the legalization of edibles may have on Ontario’s roads. If Ontarians choose to consume edibles, they should be aware of its delayed psychoactive effects and the impact on their ability to drive,” said Di Felice. CAA’s focus is to ensure that road safety, public education and enforcement remain at the forefront of the management of cannabis legalization. The statistically representative study, commissioned by CAA and conducted by Dig Insights in late June 2019, surveyed 1,510 Ontarian between the ages of 19 and 70 who have a valid driver’s license. ��

Can Understanding the History of Drug Addiction Help Address the Opioid Epidemic?
According to the National Institute on Drug Abuse, more than 130 people die every day after overdosing on opioids. Lives have been lost, families shattered, and billions spent as experts, elected leaders, health care professionals, and law enforcement officials try to address the country's opioid epidemic. A professor at Rensselaer Polytechnic Institute can help shed light on the forces at work in this crisis and its history. Professor Nancy Campbell is an expert is in the history of science, technology, and medicine as it relates to drug policy and the social significance of drugs. She is a professor and head of the Department of Science and Technology Studies (STS) in the School of Humanities, Arts and Social Sciences at Rensselaer Polytechnic Institute. "We found her to be one of the most knowledgeable people on the history of opioids and how that history fits into the context of today’s problem," reporters for CBS 6 News in Albany wrote of Campbell. In a recent interview with the station, Campbell discussed her extensive research on the history of drug addiction, as well as her approach to educating students about it. “I actually want my students to go out of the class, knowing more about where our current opioid epidemic came from, the endemic that it built upon and also knowing more about drug markets and the social aspects,” Campbell said. August 15 – CBS 6 News Are you a reporter covering the opioid crisis and need to know what’s being done and what more needs to be done? Let our experts help with your questions. Campbell is available to speak to media regarding the opioid crisis and the history of drug addiction – simply click on her icon to arrange an interview.

Did you know? 18.8 million women and girls are living with HIV AIDS-related illnesses are the leading cause of death among females between the age of 15 and 49 1.8 million children are born with HIV, contracted from their mothers In sub-Saharan Africa, 3 in 4 new HIV infections in teenagers are among girls There are 5,000 new HIV infections per day Women continue to be disproportionally affected by HIV around the world, but particularly in sub-Saharan Africa, where three in four new HIV infections are among young girls. For women seeking care in developing countries, preventing and managing HIV is an expensive proposition. Truvada, the pre-exposure HIV treatment drug commonly known as PrEP, costs about $1,500 a month and must be taken daily for continual HIV protection. Likewise, the antiretroviral therapies that attempt to control HIV infection are costly at nearly $20,000 a year. These oral medications as therapy are a non-starter in developing nations like Africa, where nearly 30 million people are infected with HIV. But Phil Santangelo, biomedical engineering professor at Georgia Tech, has another approach in mind. He’s working on an aerosolized RNA-based HIV preventative that eventually could protect women against the disease. It’s applied vaginally and, currently, the aerosol has been tested in pre-clinical trials. The early results are promising; it’s been shown to create HIV antibodies that ward off the infection. It also has the potential to protect against genital herpes and other pathogens, depending on what protein the RNA encodes for. “A single administration of this aerosol is showing expression of antibodies against HIV for up to three months in pre-clinical trials,” said Santangelo. “Our hope is that this will be more affordable, granting easier access to women in developing countries, especially. With women’s health at the forefront of many conversations today, this has the potential to revolutionize disease prevention.” Eventually, Santangelo says RNA could be used for contraception as well – the RNA would express antibodies that inhibit sperm. Again, if birth control can’t be accessed in developing countries, a self-administered, inexpensive aerosol could change the lives of many women. Are you a journalist covering this very important topic? If you have questions or would like to know more about the research being conducted at the Georgia Tech College of Engineering – then let our experts help. Dr. Philip J. Santangelo is an Assistant Professor in the Wallace H. Coulter Department of Biomedical Engineering. Dr. Santangelo is an expert in the areas of therapeutics and vaccines and HIV/SIV and hRSV. He is available to speak with media regarding this emerging discovery - simply click on his icon to arrange an interview.

It was a historic decision yesterday that may play a role in America’s opioid crisis. "On Monday, Cleveland County Judge Thad Balkman made his judgment in the lawsuit brought by the Oklahoma attorney general against the company for what the state alleges it did to fuel the U.S. opioid crisis. In reading out his settlement decision, Balman said that "the opioid crisis has ravaged the state of Oklahoma." The nine-figure settlement, while hefty, pales in comparison to what the attorney general's office originally asked for, as they reportedly asked for in excess of $17 billion in damages.” August 26 – ABC News But what will this decision mean for the future of big-pharma? What will the money go to? Can or should companies be held accountable for addictions? There are a lot of questions and logistics still to be figured out and if you are a reporter covering this lawsuit – let our experts help. Dr. Marc Sweeney is the Founding Dean of the School of Pharmacy at Cedarville University and is an expert in the fields of drug abuse, prescription drug abuse and Opioid addiction. Justin Cole is an expert in clinical pharmacy, Pharmacogenomics, and the pharmacy industry. Marc and Justin and has been following this issue closely and is available to speak with media. Simply click on their icons to arrange an interview with either Marc or Justin.

Big trouble for big pharma – let our expert explain
Things are sunny and bright for the usually family-friendly image of Johnson & Johnson. In fact, as more and more evidence and details are presented in a landmark lawsuit between the corporate giant and the State of Oklahoma. The company could be facing financial calamity and its reputation might be a near impossible mission for any PR expert to recover. “As the state of Oklahoma’s multibillion-dollar lawsuit against Johnson & Johnson has unfolded over the past month, the company has struggled to explain marketing strategies its accusers say dangerously misrepresented the risk of opioid addiction to doctors, manipulated medical research, and helped drive an epidemic that has claimed 400,000 lives over the past two decades. Johnson & Johnson profited further as demand for opioids surged by buying poppy growing companies in Australia to supply the raw narcotic for its own medicines and other American drug makers. One expert witness at the forefront of combatting the epidemic, Dr Andrew Kolodny, told the court he had little idea about Johnson & Johnson’s role until he saw the evidence in the case. “I think it’s fair to characterize Johnson & Johnson as a kingpin in our opioid crisis,” he said. – The Guardian, June 19 But what is next? Will this lawsuit be duplicated in other states? Are other big-pharma companies liable or in similar trouble? And is this the gamechanger the industry needs? There are a lot of questions and that’s where we can help. Dr. Marc Sweeney is the Founding Dean of the School of Pharmacy at Cedarville University and is an expert in the fields of drug abuse, prescription drug abuse and Opioid addiction. Marc is available to speak with media regarding this growing issue. Simply click on his icon to arrange an interview.

Phasing out opioids – can it be done?
It’s a crisis that’s gripped America and has hit epidemic levels. More and more Americans are hooked on prescription painkillers, in fact, in 2017 close to 50,000 people in the United States died due to overdose from pills. And recently, it’s been suggested that perhaps phasing out and replacing these pills with less addictive and dangerous options is the only way to solve this issue? “FDA Commissioner Scott Gottlieb, who plans to leave his job at the agency next week, wants companies to develop pain drugs that could eventually allow older opioids to be restricted or to come off the market entirely. “Given the public health crisis we face, and that American families are still being destroyed by the opioids epidemic, I believe that the FDA should treat opioids, as a class, differently from other drugs,” Gottlieb told a Senate appropriations subcommittee on Thursday.” - Denver Post It's a bold statement from a bureaucrat leaving his post – but is it possible? · Will big pharma comply? · Is it a matter of money over morality or are more rigids rules required? · Or is the only aspect left legal and government intervention? There are a lot of questions to be answered and that’s where an expert from Cedarville University help. Dr. Marc Sweeney is the Founding Dean of the School of Pharmacy at Cedarville University and is an expert in the fields of drug abuse, prescription drug abuse and Opioid addiction. Marc is available to speak with media regarding this growing issue. Simply click on his icon to arrange an interview.

MEDIA RELEASE: CAA launches cannabis education campaign, geared towards a younger demographic
This holiday season will be the first time Ontarians will consume cannabis legally. Many of those experimenting will be young adults, who according to our research, are more likely to mix alcohol and cannabis together. In response to the new laws and research, CAA has launched a cannabis education campaign called #DontDriveHigh. The campaign is geared towards novice drivers to remind them that even though cannabis is legal, it’s not harmless, especially in situations where reaction time, motor skills and judgment are critical. Driving high is driving impaired. “Just because you think you may be able to drive while high, doesn’t mean you should,” said Teresa Di Felice, assistant vice president, government relations, CAA SCO. “It’s important to remember that if you are going to consume alcohol or cannabis, find an alternative to driving so you can arrive where you’re going safely.” CAA’s research shows that there is a gap in awareness of the effects of using cannabis, specifically, in young men. Men aged 25 to 34 are the most likely to drive under the influence of cannabis. Many are novice drivers who live in busy, urban areas. “Our research shows that many Ontario drivers believe that there is a strong need for public education around cannabis legislation,” said Teresa Di Felice. “Our campaign aims to educate young drivers with fun yet thought-provoking videos.” CAA SCO worked with The Turn Lab, to create a series of videos demonstrating the impact cannabis has on concentration, coordination, reaction time, and decision making. CAA believes that education is one of the most critical elements to help Ontarians understand the issues surrounding cannabis legislations and safety. If you are writing about cannabis and road safety – we can help. Teresa Di Felice is the Assistant Vice President of Government & Community Relations at CAA South Central Ontario (CAA SCO), Canada's largest CAA Club. She has been with CAA since 2005. She is responsible for the overall direction and execution of the organization’s advocacy strategies and programs, representing and raising awareness on relevant issues to CAA’s over 2 million Members and with policymakers in Ontario.

Overhaul of FDA's approval process for medical devices overdue, but balanced approached needed
The Food and Drug Administration has announced plans to overhaul its system for approving a certain category of medical devices, which critics have said fails to protect consumers from risky implants and medical instruments. George Ball, assistant professor of operations and decision technologies and the ArcelorMittal Supply Chain Faculty Fellow, at the Indiana University Kelley School of Business, studies the medical device industry, in particular medical device recalls. There are two primary approval pathways for medical devices. “510(k)” clearances are reserved for products that demonstrate substantial equivalence to a previously approved device. Clinical trials are normally not required and this method is much faster and cheaper than the other pathway, a “Pre-Market Approval (PMA).” PMA new product submissions are reserved for those products that are new or substantially modified from previously approved devices. Clinical trials in humans and laboratory study data are normally required to demonstrate safety and efficacy. In comparison to 510(k) clearances, PMA approval pathways are time-consuming and expensive. “The FDA’s announcement regarding an overhaul of the 510(k) approval process seems to be warranted, as medical device product approvals are currently on two ends of an extreme spectrum,” Ball said. “New PMA products can require years and millions of dollars to successfully obtain approval by the FDA. Conversely, 510(k) clearances are significantly faster and cheaper, as the manufacturer has to simply demonstrate equivalence with similar, already approved products. “As 510(k) products represent the bulk of new product approvals, they also represent the bulk of medical device recalls, unsurprisingly,” Ball said. “In the last decade, 510(k) products were recalled at a ratio of 17-to-1, compared to PMA products.” “However, the method of approval currently practiced for 510(k) products has many benefits for manufacturers as well,” he said. “Demonstrating equivalence with prior approved similar devices makes the development time exponentially faster compared to PMA product approval times. “A middle-ground here seems logical and advisable. For example, the FDA approves products using a two-pronged approach: safety and efficacy. While efficacy may be easily established by demonstrating similarity to prior products, evidence of safety for 510(k) products may require additional verifications and tests. Doing so may help ensure that new 510(k) products, which are often much more technologically advanced than the ones they are compared against for approval purposes, are also safe for patients.” Ball can be reached at 812-856-0625 or gpball@indiana.edu

Pressure to lower drug prices may lead to recalls, particularly of generics
The pressure being placed on drug companies to reduce prices as a result of President Donald Trump’s recent proposals, likely will intensify with the Democrats’ taking control of the House of Representatives in the mid-term elections. Research by George Ball, assistant professor of operations and decision technologies at the Indiana University Kelley School of Business, highlights why consumers should be concerned beyond the high prices of their prescriptions. Ball is the lead author of a recent paper in the Journal of Operations Management which found that extreme price competition in the generic pharmaceutical market -- designed to make medications more affordable -- may be putting more patients at serious health risk. This was evidenced by a higher number of product recalls caused by manufacturing-related problems. "Extreme price competition in the generic pharmaceutical market has some unexpected risks that regulators and lawmakers may not have foreseen when pushing for cheaper drugs," Ball said. “There's a downside to cheaper drugs: You can't guarantee that they're going to be of the exact same quality," Ball said. "This research demonstrates that regulators and insurers may want to temper their intense public pressure placed upon pharmaceutical companies to bring prices down. Such pressure may come at a cost: poorly manufactured drugs." Ball can point to examples of recent generic drug recalls that occurred because of manufacturing problems. He is available at 812-856-0625 and gpball@indiana.edu. Copies of the paper are available.





