News – Flagler Open Arms Recovery Services

Join Our Support Mission

louie — Sun, 13 Oct 2024 17:11:26 +0000

We hope you are well after the hurricane! We are excited to announce a three-day mission to support vulnerable residents across Florida.

Starting Monday, October 14, a team of five dedicated individuals—affectionately known as 5 Guys—will travel from Hastings to Bunnell, Lady Lake, Eustis, Leesburg, Bushnell, Dade City, Tampa, and Sarasota, visiting areas that have been significantly impacted by Milton to help those facing homelessness, substance use disorder, mental health challenges, and other hardships. The team will distribute essential supplies, resources, and offer support services to individuals and families in need.

They encourage YOU to join by: 1) Donating funds or essential items 2) Volunteering your time 3) Spreading awareness of our mission

Want to give canned goods or essential items? We have four convenient drop-off locations available from today (10/12) until Monday (10/14):

DC Hair & Beauty Salon
29 Old Kings Rd N #3a, Palm Coast, FL 32137
Open Saturday & Monday 10am-5pm

Ileana Nail
160 Cypress Point Pkwy STE C215, Palm Coast, FL 32164
Open Saturday 10am-6pm, Sunday 8:30am-11am, & Monday 10am-6pm

Palm Coast Athletics
2323 N State St Unit 70, Bunnell, FL 32110
Open Sunday 1-10pm & Monday 5-9 pm

AMP Hardcore Gym
1 Willard Dr, St. Augustine, FL 32086
Open Saturday 10am-5pm & Monday 9am-8pm

Donate at https://secure.qgiv.com/for/flaopearmrec or email Pam Birtolo at pambirtolo@me.com to get involved. Let’s come together to lift each other up!

The 5 Guys Travel Route

Gangs mix another potent sedative into U.S. street drugs causing ‘mass overdoses’

louie — Fri, 07 Jun 2024 18:28:21 +0000

Source: www.northcountrypublicradio.org

People gather outside the Savage Sisters’ community outreach storefront in the Kensington neighborhood of Philadelphia. The area is being hit hard by Medetomidine and Xylazine, powerful sedatives most often used by veterinarians that are moving through the illicit drug supply triggering “mass overdose” events and causing gruesome skin wounds. Image: Matt Rourke/AP

Public health officials say Mexican cartels and drug gangs inside the U.S. are mixing a dangerous chemical sedative called medetomidine into fentanyl and other drugs sold on the street. The combination triggered a new wave of overdoses that began in late April and have accelerated in May.

“The numbers reported out of Philadelphia were 160 hospitalizations over a 3 or 4-day period,” said Alex Krotulski who heads an organization called NPS Discovery that studies illicit drugs sold in the U.S.

Medetomidine, most often used by veterinarians as an animal tranquilizer, but also formulated for use in human patients, has also been linked to a recent “mass overdose outbreaks in Chicago.

Preliminary data also suggested another mass overdose event linked to medetomidine in Pittsburgh, but those initial findings proved false, according to Krotulski.

Experts say the chemical, mixed into counterfeit pills and powders sold on the street, slows the human heart rate to dangerous levels. It’s impossible for drug users to detect.

Public health advisories have been issued in Illinois and Pennsylvania.

Dr. Brendan Hart at Temple University in Philadelphia says they first began hearing reports of street drug users exposed to the fentanyl-medetomidine mix in April.

“Some of our emergency medicine doctors started stopping me in the hallway,” Hart told NPR.

“They said ‘Something funny is going on with the overdoses.’ Patients were coming in with very low heart rates. As low as in the 20s. A normal heart-rate is sixty to a hundred [beats per minute] so 20s is extremely low.”

Laboratory tests of street drug samples came back positive for the powerful sedative, which is used in some formulations by doctors with human patients, but only in carefully controlled medical settings.

Medetomidine was previously detected in the illicit drug supply as early as 2022 but only rarely and in small amounts. This time experts say it appears to be spreading rapidly, with large-scale overdose events also reported earlier this year in Toronto, Canada.

U.S. drug supply grows more toxic
Last year the Biden administration issued a warning that street fentanyl was being mixed with another tranquilizer used by veterinarians called xylazine. That mix of drugs led to more overdoses and many users also experience terrible flesh wounds that can linger for months or years.

Medetomidine is even more powerful than xylazine, experts told NPR. As it spreads, Krotulski said no one knows what long-term health effects this new cocktail of chemicals will cause in the human body.

“Patients are being cared for as we speak in emergency rooms,” he said. “These are very complex drug products. You’ve got fentanyl adulterated with xylazine that now also contains medetomidine.”

Registered nurse Kathy Lalli treats Ellwood Warren’s injuries at the Kensington Hospital wound care outreach van, parked in the Kensington neighborhood of Philadelphia, on May 23, 2023. In humans, xylazine can cause breathing and heart rates to drop. It’s also linked to severe skin ulcers and abscesses, which can lead to infections, rotting tissue and amputations. Experts disagree on the exact cause of the wounds, which are much deeper than those seen with other injectable drugs. Image: Matt Rourke/AP

The presence of these chemical additives severely complicates the medical response to high-risk overdoses.

Xylazine and medetomidine don’t respond to naloxone, the medication used to reverse most fentanyl overdoses. There’s currently no way for street users to know when their drugs are laced with this chemical.

Dr. Bertha Madras, a drug researcher at Harvard Medical School and McLean Hospital, said it’s not clear why drug gangs are mixing these new chemicals with fentanyl. Some experts believe sedatives may prolong the opioid high, making the drugs more desirable on the street.

According to Madras, it’s urgent that first responders and emergency rooms be prepared to treat overdoses complicated by heart conditions triggered by medetomidine.

She also thinks people using drugs need to be warned that illicit pills and powders are more perilous than ever.

“It’s critical to alert street users,” Madras said. “They’re playing Russian roulette now with the drug supply.”

Madras said experts are also working to understand where the medetomidine appearing on U.S. streets is coming from.

It’s not yet clear whether the sedative is being illegally diverted from veterinarian supplies or from medications intended for use in hospitals and clinics.

It’s also possible drug gangs are formulating their own medetomidine compounds from precursor chemicals acquired illegally.

Evolving street drug supply outpaces public health, law enforcement

Madras said Mexican cartels and U.S. drug gangs are moving fast to create new combinations of powerful synthetic drugs, often using chemicals like medetomidine which aren’t yet regulated or tightly controlled under U.S. law.

She said it’s nearly impossible for U.S. law enforcement and public health to keep up.

“There is an almost endless supply of new psychoactive substances and there are literally thousands and thousands of drugs that can be made,” she said.

Experts say the decision to experiment with xylazine, medetomidine or other chemicals in illicit street drug combinations likely reflect which substances are cheap, poorly regulated and readily available.

Some critics, including Dr. Jeffrey Singer, a drug policy analyst at the libertarian Cato Institute, believe law enforcement efforts aimed at regulating chemicals used in street drugs are actually encouraging the cartels to experiment with more readily available substances that may be more harmful, including medetomidine.

“Law enforcement is trying harder and harder to crack down on xylazine,” Singer said. “If the drug trafficking organizations are interested in adding a sedative [to their street drug mixes] they can always add medetomidine.”

Singer believes interdiction of synthetic drugs is so difficult that U.S. policy-makers should focus resources on helping drug users find medical treatment instead of funding more law enforcement efforts.

Efforts to tightly regulate medetomidine could be complicated by the fact that a version of the sedative called dexmedetomidine is widely used by physicians as well as veterinarians.

“That medicine is used everywhere along the lifespan, from [neonatal intensive care units] to sedate babies that need to be on respirators, to elderly patients who can’t breathe on their own,” said Dr. Nabarun Dasgupta, a street drug expert at the University of North Carolina at Chapel Hill.

“[Restricting access to] medetomidine like xylazine or even fentanyl will have major impact on every hospital in the country,” he said.

Fatal overdoses in the U.S. dropped 3 percent last year, but roughly 107,000 people in the U.S. still died after using street drugs.

Addiction experts worry modest gains in saving lives of drug users could be reversed as more toxic chemicals like medetomidine and xylazine hit the streets.

Upcoming Trainings this Week!

louie — Mon, 15 Apr 2024 12:58:14 +0000

Trainings by BMC Grayken Center for Addiction TTA

Wednesday, 4/17

Essentials of Treating Stimulant Use Disorder

10:00 AM – 1:00 PM ET via Zoom

Led by Justin Alves, MSN, FNP-BC, ACRN, CARN, CNE and Vanessa Loukas MSN, FNP-C, CARN-AP, this course is designed to be a guide for addiction providers interested in providing and caring for people who use stimulants, namely cocaine and methamphetamines. Topics include neurobiology and physiology of addiction, identifying health risks of stimulant use, practical application of evidence-based treatment for patients who use stimulants in an office-based addiction treatment setting, management of overamping and acute stimulant intoxication, and harm reduction interventions. All disciplines are welcome.

Thursday, 4/18

Long-Acting Injectable Buprenorphine Treatments for Opioid Use Disorder

12:00 PM – 1:00 PM ET via Zoom

Led by Jessica Kemp, RN, CARN and Emery Marcus, MSN, FNP-C, PMHNP-BC, CARN-AP, this training is designed to provide healthcare teams with information on all the available FDA-approved monthly/weekly injectable buprenorphine formulations used to treat opioid use disorder, as well as how to incorporate them into clinical practice. All disciplines are welcome.

Note: This training is 60 minutes long. There will be an optional 30-minute Q&A session following the training, which will not count for credit.

Overdose Deaths in 2022 Were at Record High, But Rate May be Levelling Off: Report

louie — Sun, 31 Mar 2024 21:20:23 +0000

Source: drugfree.org

The rate of overdose deaths in the United States in 2022 were at a record high, but there are signs the overdose rate may be leveling off after years of a steady rise, according to new government data.

The Centers for Disease Control and Prevention (CDC) reported 107,941 overdose deaths in 2022. This is only a slight increase from the number of overdose deaths the previous year, STAT reports. A large majority of overdose deaths were linked with fentanyl. As the number of fentanyl-related deaths have skyrocketed, the share of deaths involving other opioids such as heroin, prescription painkillers and methadone have decreased.

Overdose deaths involving cocaine increased 12.3% from 2021 to 2022, while deaths involving methamphetamine rose 4%, the CDC found. There are also increasing racial disparities in overdose death rates. The report showed signs of overdose rates decreasing among young people, but increasing in older populations.

When it comes to addiction, Americans’ word choices are part of the problem

louie — Wed, 02 Nov 2022 19:35:18 +0000

Who gets better medical care in the United States: “addicts,” or “people with substance use disorders”?

The terms, of course, mean functionally the same thing. But in the field of addiction medicine, the question presents something of a crisis. Even as drugs and alcohol claim 200,000 lives each year, many who seek addiction treatment are greeted by the harsh, stigmatizing labels that many Americans don’t think twice about: Words like addict, alcoholic, junkie, abuser, or worse.

Even as the nation’s substance use crisis has escalated, however, new research has emerged showing that simple word choices can have a big impact on the way health professionals view their patients and, accordingly, the care they receive. And in recent years, a coalition of doctors, recovery advocates, researchers, and even government officials has pushed to swap out stigmatizing terms like “addict” in favor of language that recognizes addiction as a medical condition — and acknowledges those who suffer from it as human beings.

“Words matter tremendously, and much of the language we use when we talk about addiction is very dissimilar from the language we use for other health conditions,” said Sarah Wakeman, the medical director of the Massachusetts General Hospital Substance Use Disorder Initiative. “Many of the words that are commonplace when talking about addiction are incredibly pejorative and stigmatizing.”

Advocates say that changing the country’s addiction vocabulary would represent a major step toward advancing compassion and evidence-based care — and, more broadly, advancing Americans’ understanding of addiction as a disease, not a moral failing.

The effort, they are quick to stress, is not just rooted in political correctness. Research shows that health workers who use terms like “substance abuser” or “addict,” as opposed to more neutral language, are more likely to exhibit bias against patients struggling with addiction.

“Language has an impact — it influences the way people feel, the way they think, the decisions they’re likely to make,” said Robert Ashford, a researcher who has written extensively about the language used in addiction-care settings. “We’re just asking people to modify the type of language they use so that we can set people up in our systems for success.”

So far, results have been mixed.

Some highly pejorative terms, like “crackhead” or “junkie,” are now widely viewed as unacceptable.

But other judgmental terminology remains pervasive, advocates say, including words as commonplace as “alcoholic” or “addict,” which they argue reduces people’s identity to the name of their medical condition.

Indeed, when it comes to language, the field of addiction medicine largely stands alone. Cancer patients are not referred to as cancers. People who experience strokes or heart attacks aren’t referred to by the name of their disease, either. The same is true even in the highly stigmatized world of mental health: People with depression are not depressives, and people with schizophrenia are no longer commonly referred to as schizophrenics.

Even terms as simple as “substance abuse,” advocates say, imply that people are always making willful, considered choices to consume drugs or alcohol, leveling a moral judgment against them instead of recognizing the medical reality of addiction.

“Relapse,” too, is out of vogue. Many researchers and clinicians now favor terms like “return to use” or “resumption of use,” saying that the former term can feel judgmental and that people often experience ups and downs in their recovery.

The use of “clean” to denote abstinence from drug use is also becoming less popular, largely because it implies people currently using drugs or alcohol are “dirty.”

“This isn’t about being politically correct, it’s not about being nice or polite,” said Michael Botticelli, the former director of the White House Office of National Drug Control Policy who wrote a 2017 memo directing federal agencies to use more neutral language when referring to people with addiction. “Our language really colors how we think about people, and colors policy.”

Even the everyday terminology of addiction medicine is out of step with that of other specialities, many doctors argue. One pillar of addiction care, Wakeman said, is fundamentally mislabeled: medication-assisted treatment, or the practice of prescribing drugs like methadone or buprenorphine to reduce opioid cravings and withdrawal symptoms.

Patients who take methadone and buprenorphine are 59% and 38% less likely to die of overdose, respectively, than those not prescribed medication — meaning that in the context of almost any other epidemic, they’d be seen as extraordinarily effective.

“‘Medication-assisted treatment’ implies that medication is not treatment in its own right, and that it’s a corollary to something else, when in fact we know that medication is incredibly effective and saves lives,” Wakeman said. “We don’t talk about insulin-assisted diabetes treatment, or chemotherapy-assisted cancer treatment. So to just use language as we would with any other condition is a good litmus test.”

Some doctors now use terms like “medications for opioid use disorder” or “pharmacotherapy,” though the term “medication-assisted treatment” is still commonly used in official government language and in research papers.

Yet even within their own field, doctors seeking to change the vocabulary of addiction face an uphill battle.

“Those that use the most stigmatizing language, and also have the strongest negative associations [about people with substance use disorders], are health care professionals,” Ashford said. “There are no ifs, ands, or buts about it. It prevents opportunities to have meaningful conversations about getting help, because nobody wants to put themselves in a situation where they’ll be further discriminated against.”

There’s at least one community in which terms like “addict” and “alcoholic” are commonplace: People with substance use disorders, or people in recovery.

In particular, some people who participate in peer support groups like Alcoholics Anonymous or Narcotics Anonymous have at least partially “reclaimed” the terms. It’s not uncommon, either, for patients in addiction-treatment settings and other people who use drugs to refer to themselves as addicts — a choice that experts say health workers should respect but not necessarily emulate.

“When you’re a member of a community, you have certain liberties in terms of what you call yourself, and those liberties are not extended, necessarily, to other people,” said Botticelli, who was the first ONDCP director to identify as a person in recovery.

Even within the recovery community, however, it’s a sensitive topic. While some use the terms proudly, others have cautioned that even though people in recovery are free to refer to themselves however they like, using terms like “addict” or “alcoholic” can still take a toll.

One Alcoholics Anonymous chapter even added a page to its website in 2020 addressing the concerns of those who don’t wish to introduce themselves with the now-famous line: Their name, followed by “and I’m an alcoholic.”

“Even with that reclamation, there’s a level of internalized stigma and shame which does impact people’s sense of self-worth, which is directly associated with whether they believe they’re worth helping or can recover,” Ashford said.

Most institutions have been slow to change: Phrases like “opioid addicts” still regularly appear on major news sites like the Washington Post and Wall Street Journal, though the New York Times appears to have mostly moved toward the comparatively neutral term “drug users.”

Another large exception is the Associated Press, which in 2017 cautioned its reporters against using terms like “addict” or “abuser” — largely in response to research by John Kelly, a Harvard psychiatry professor and frequent collaborator of Ashford and Wakeman.

Even at the highest levels of government, efforts to use more neutral language have yet to move forward. The country’s largest research institute focusing on drug use is known as the National Institute on Drug Abuse; the institute focused on alcohol is known as the National Institute on Alcohol Abuse and Alcoholism; and the health agency responsible for addiction and mental health care is known as the Substance Abuse and Mental Health Services Administration.

Efforts to change the names date back over 15 years — the first bill introduced in Congress, in fact, was authored in 2007 by Senator Joe Biden of Delaware.

“The pejorative term ‘abuse’ used in connection with diseases of addiction has the adverse effect of increasing social stigma and personal shame, both of which are so often barriers to an individual’s decision to seek treatment,” Biden wrote then.

With Biden now serving as president, there have been more signs of change: This year, for the first time, the White House proposed changing NIDA’s name to the National Institute on Drugs and Addiction, and changing the word “abuse” in SAMHSA’s name to “use.”

Lawmakers from the House and Senate included the changes in spending bills for 2023, but Congress has failed to reach agreement on a final version — meaning that for now, the agencies’ names remain the same.

“We’ve come a pretty significant way in a short period,” Botticelli said. “But I still think there’s a long way to go — it’s still indicative of the level of stigma we have in our society.”

Inside The Sales Machine Of The “Kingpin” Of Opioid Makers

louie — Sat, 21 May 2022 16:09:09 +0000

A cache of more than 1.4 million newly released records exposes the inner workings of the nation’s largest opioid manufacturer.

Source: Washington Post

The largest manufacturer of opioids in the United States once cultivated a reliable stable of hundreds of doctors it could count on to write a steady stream of prescriptions for pain pills.

But one left the United States for Pakistan months before he was indicted on federal drug conspiracy and money laundering charges. Another was barred from practicing medicine after several of his patients died of drug overdoses. Another tried to leave the country in the face of charges that he was operating illegal pill dispensing operations, or pill mills, in two states. He was arrested and sent to prison for eight years.

These doctors were among 239 medical professionals ranked by Mallinckrodt Pharmaceuticals as its top prescribers of opioids during the height of the pain pill epidemic, in 2013. That year, more than 14,000 Americans died of prescription opioid overdoses.

More than a quarter of those prescribers — 65 — were later convicted of crimes related to their medical practices, had their medical licenses suspended or revoked, or paid state or federal fines after being accused of wrongdoing, according to a Washington Post analysis of previously confidential Mallinckrodt documents and emails, along with criminal and civil background checks of the doctors. Between April and September of that year, Mallinckrodt’s sales representatives contacted those 239 prescribers more than 7,000 times.

The documents, made public after years of litigation and bankruptcy proceedings, shed new light on how aggressively Mallinckrodt sought to increase its market share as the epidemic was raging.

The Mallinckrodt documents are part of a cache of 1.4 million records, emails, audio recordings, videotaped depositions and other materials the company turned over as part of its $1.7 billion bankruptcy settlement in 2020. Several state officials with claims against the company, led by Massachusetts Attorney General Maura Healey (D), urged that the documents be made public.

While most Americans may have never heard of Mallinckrodt, the Drug Enforcement Administration called the company in 2010 “the kingpin within the drug cartel” of legitimate companies driving the opioid epidemic. Between 2006 and 2014, Mallinckrodt accounted for 27 percent of the opioid market compared with 18 percent for Purdue Pharma, measured by the potency of the pills they produced, according to an analysis by The Post. While the Sackler family, which owned Purdue, attracted intense national attention and became a cynosure of criticism after the company’s introduction of its blockbuster pill OxyContin, the Mallinckrodt brand slipped under the radar.

“Everybody thinks of Purdue when they think about the opioid epidemic, but Mallinckrodt was far worse,” said Jim Geldhof, a DEA supervisor who investigated Mallinckrodt before retiring in 2016 after four decades with the agency and now works as a consultant to cities suing the opioid industry. “They were up to their eyeballs in oxycodone, and they knew exactly what they were doing. Their drugs had become the most popular on the street and they jumped in with both feet.”

Between 2000 and 2020, more than 270,000 people died of prescription opioid overdoses in the United States.

As the opioid epidemic took hold of the nation, Mallinckrodt’s 30 mg oxycodone tablet became the preferred drug on the street, according to the DEA. The baby-blue-colored pills, the equivalent to a hit of heroin, became so ubiquitous that the smuggling route from Florida to Appalachia became known as the “Blue Highway.”

In Massachusetts, Mallinckrodt’s pain pills were supplied to more than half of those who died of opioid-related overdoses during the past 12 years: 9,673 people, according to an analysis of prescription and overdose death data by the Massachusetts Attorney General’s Office. By comparison, Purdue and its affiliate Rhodes Pharmaceuticals supplied opioids to 2,967 people who died in the state.

“For the first time in a long time, industry secrets are going to be turned over to the public and millions of documents will live online in an archive forever,” Healey said. “Making this evidence available to the public will hopefully pave the way for important reforms that will stop dangerous conduct and save lives.”

Massachusetts resident Cheryl Juaire, who lost two of her three sons to opioid overdoses, 23-year-old Corey and 42-year-old Sean Merrill, applauded the release of the documents.

“It helps to heal the families to know what really happened and to know that their child had a disease and where it started and who caused it,” she said. “There is a healing in knowing.”

In videotaped depositions taken between 2018 and 2020 as part of a national lawsuit against Mallinckrodt, top company executives took little or no responsibility for the opioid epidemic. Several skirted questions about whether an opioid epidemic even existed.

The Mallinckrodt files are being made available through the Opioid Industry Documents Archive, a digital repository of material generated by state and federal lawsuits against drug companies and managed by Johns Hopkins University and the University of California at San Francisco. The Post was provided exclusive access to the files, the largest disclosure of its kind by an opioid company to date.

Among the documents was the company’s promotional material, including a reggae song with the chorus: “You can start at the middle, you can start at the top. You can start with very little but that’s not where you should stop. Your patient needs relief, mon, so please do what you should.”

For years, drug companies have argued they were simply filling orders written by medical professionals for legitimate patients. But the Mallinckrodt files show that the company had detailed knowledge of the prescribing patterns of doctors and bemoaned their loss when they fell into trouble with regulators.

Other key findings from the files:

Company managers pressured sales representatives to find doctors who would write large numbers of prescriptions and then targeted them for continued business. They rewarded top performers with bonuses and overseas vacations; and fired those failing to meet quarterly sales goals.
Three years after one sales rep cautioned that a dozen doctors in his region were running pill mills, illegal pain clinics that dispense large amounts of narcotics, five of them remained on the company’s preferred list of prescribers.
Mallinckrodt paid top prescribers thousands of dollars to extol the virtues of the company’s drugs to fellow doctors at “speaker programs” held at fine restaurants and resorts. All it took “was a speaker program to get them writing,” one sales rep wrote.
Mallinckrodt played a key role in an industry-wide effort to convince the health-care industry that addiction was rare among opioid users and marketed its drugs to specific segments of society. “With older adults, start dose low, go slow,” the company wrote in marketing material for drug industry trade shows. “But go!!”

“While Mallinckrodt does not agree with the allegations regarding decade-old issues, it has spent the past three years negotiating a comprehensive, complete and final settlement that resolves the opioid litigation against it, provides $1.725 billion to a trust serving affected communities, and allows Mallinckrodt to continue to serve patients with critical health needs under an independently monitored compliance program,” a company spokesperson said in a statement .

Although generics made up the majority of Mallinckrodt’s business, the company also produced and marketed its own brand of time-release narcotics to remain relevant in the increasingly competitive opioid market. One of the drugs the company made and marketed directly to doctors was called Exalgo, a hydromorphone tablet and a close cousin of the pill manufactured and marketed by Purdue, OxyContin.

Mallinckrodt deployed a national sales team in an effort to turn Exalgo into a blockbuster of its own. Despite the company’s ambitions, Exalgo never caught on. It represented less than 1 percent of the company’s overall opioid sales. The Exalgo sales force was disbanded in 2015.

The internal documents show that the company’s sales managers grew deeply concerned about falling sales numbers when their top prescribers lost their medical licenses or went to prison.

The managers frequently checked in with their regional sales reps, asking them which prescribers had moved, died, lost their licenses or been arrested. The sales team also lamented the loss of doctors who were under investigation and tried to find a way to make up for those sales by recruiting physicians who could write prescriptions.

In April 2013, Mallinckrodt’s sales managers told one of their reps about a productive “target,” Fathalla Mashali, a pain management specialist who operated four busy clinics in Massachusetts and Rhode Island. Sales rep Dean Boissy reported back that Mashali pledged to start writing Exalgo prescriptions for his patients.

Mashali and his clinics were already under investigation by the FBI and the DEA. The previous year, four of his employees had complained to law enforcement about his “unprofessional, unethical, and unlawful behavior.”

Prosecutors would later find that “Mashali used the proceeds derived from his fraudulent billing to fund a lavish lifestyle, spending money on his extravagant Dover [Mass.] residence and a condominium in Florida. For example, he ordered the construction of a carriage house and outfitted his Dover home with a squash court and movie theater.”

A month before Boissy approached Mashali, federal agents had served search warrants on the doctor’s pain clinics, demanding patient and prescribing records. Mashali was arrested in 2014 while trying to board a flight bound for Egypt. He later pleaded guilty to health-care fraud, conspiracy to commit mail fraud and money laundering.

“Losing Dr Mashali hurt to say the least. Not only did he literally produce half my Exalgo scripts but his opioid market output was incomparable to any other practice in my territory,” Boissy wrote to a manager. “A large portion of my time was spent w him so I’ve been trying to use that time to increase my number of writers even more to try to make up for his production.”

A company sales manager reviewing the prescribing patterns for the New England region agreed. The manager noted that the “absence of Dr. Mashali in the Worcester territory had a significant negative impact on this territory, the Boston District and likely the Northeast Region.”

In a phone interview from a federal prison in Massachusetts, where he is serving out his eight-year sentence, Mashali said he was a responsible prescriber who was unfairly targeted by prosecutors. He said it was the companies who influenced doctors’ prescribing patterns, yet none of the executives faced the same repercussions as he did.

“We got prosecuted criminally and we lost all our money, lost everything,” Mashali said. “The Sacklers get to keep their money, Mallinckrodt to keep their money. All the companies get to keep their money.”

Another doctor favored by Mallinckrodt was George Griffin, an orthopedic surgeon who practiced in Cincinnati. The company placed him at the top of the list of doctors to recruit in the region, quarter after quarter.

“Griffin had 29 Exalgo [prescriptions] this week,” Ohio district sales manager Kevin Becker wrote to the rep handling Griffin, Matthew Hook, in March 2012. “Holy cow!”

In 2015, another sales manager wrote to Hook to highlight Griffin’s prescribing, suggesting that Hook had a shot at being included in the company’s President’s Club, a prestigious award for top-selling reps that came with free trips to destinations like Hawaii and Europe.

But Griffin was in trouble and the company knew it. Previously, the State Medical Board of Ohio had determined in 2010 that Griffin had overprescribed pain pills to more than a dozen patients. Griffin was able to appeal and continue to prescribe. For one patient, he prescribed 640 mg a day of OxyContin — despite warnings from a pharmacist that the patient was a drug dealer with a history of drug-related felonies, according to the board.

“It appears that as of November 22, 2011, Dr. Griffin lost his license,” Becker, the sales manager, wrote in an email to his supervisor three weeks later. “He is the districts 10th largest prescriber and Matt’s #2 writer of Exalgo.

“Crap.”

“Oops,” the supervisor responded. “We’ll figure something out.”

In 2019, Griffin was arrested along with 10 other doctors, charged with running suspected pill mills. A year later, he was convicted of unlawful distribution of controlled substances and sentenced to 40 months in prison.

Griffin, who has since been released from prison, did not respond to requests for comment. His attorney argued during his sentencing hearing that Griffin “broke the law with good intentions” to help people return to work after injuries.

Mallinckrodt sometimes kept working with doctors even though they were suspected of sending narcotics to the black market. In 2010, Michael Burgmeier, a sales rep assigned to the Pennsylvania region, flagged 11 local doctors among the company’s highest prescribers for running pill mills. Three years later, five of them remained on Mallinckrodt’s list of preferred doctors. No records in the trove indicated the company vetted the doctors on the list. Burgmeier did not respond to requests for comment.

Syed Jawed Akhtar-Zaidi was a popular pain doctor in Solon, Ohio, who Mallinckrodt ranked as one of their top prospects. While sales reps were bringing him Starbucks coffee and catered meals from Panera Bread in September 2013, according to expense records, three undercover DEA agents were posing as his patients. They left his office with opioid prescriptions, even though they were not diagnosed with pain problems, prosecutors later alleged.

Less than a year later, a federal grand jury indicted Akhtar-Zaidi, charging him with conspiracy to distribute controlled substances, health-care fraud, distribution of controlled substances and money laundering. The indictment accused the doctor of overprescribing opioids to people who didn’t need them, and directing his clinical staff not to report to law enforcement the patients suspected of selling their pills.

Before Akhtar-Zaidi was indicted, he left for Pakistan. Akhtar-Zaidi remains a fugitive. His former lawyer declined to comment.

After identifying top prescribers, Mallinckrodt sales reps worked hard to expand the circle. Relying on a select group, one sales rep wrote, is like putting “a lot of eggs in just a few baskets.”

Mallinckrodt sales reps were delighted to sign up Eugene M. Gosy. It was hard to miss him in Buffalo. His pain clinic boasted as many as 40,000 patients and he drove around town in high-end sports cars, including a Ford GT Coupe and a Ferrari 360 Moderna F1. In 2010, he was targeted by Mallinckrodt as someone who could be a reliable writer of Exalgo prescriptions.

“How can we make a difference?” Mallinckrodt’s Eastern regional sales director Gavin J. McGowan wrote to his team on Nov. 18, 2010. “Doing the same thing day after day doesn’t seem to be cutting it.”

McGowan had some advice for his sales reps.

“BIG IDEAS. GAME CHANGERS. BETTER MOUSETRAPS if we want to be on a different plane,” he wrote. “As you all know I am a little competitive, and don’t think second place is an option. One area where I see immediate opportunity is with our top identified physicians.”

McGowan placed Gosy at the top of his list, according to the documents.

Within three years, Gosy’s prescription practices had also drawn the attention of federal investigators, who ultimately charged him in 2016 with running a criminal operation by issuing prescriptions for pain medications between 2006 and 2016 that were “without a legitimate medical purpose.” Federal prosecutors said he continued to write prescriptions “in flagrant disregard of warning signs of patient addiction and abuse and despite notice that patients of the practice had overdosed and/or died.”

On Oct. 15, 2020, Gosy was sentenced to 70 months in prison for conspiracy to distribute controlled substances and health-care fraud. Gosy’s defense lawyer said at the time that his client’s practice had become too overwhelming. The judge who oversaw the case agreed. “We’re not talking about a drug dealer here, but a doctor who lost control of his office,” Chief U.S. District Judge Frank P. Geraci Jr. said.

Gosy did not respond to a letter requesting an interview sent to FCI McKean, a medium-security prison in Pennsylvania where he is serving his sentence. Neither his attorney nor McGowan returned calls for comment.

Like other companies, Mallinckrodt touted its paid speakers’ program for doctors, hosting dinners and speeches at pharmaceutical conventions. The company advertised these get-togethers as an opportunity to provide educational resources for prescribers.

Steve Fanto, a Scottsdale, Ariz.-based pain management doctor, was on Mallinckrodt’s list of favorite prescribers. A company sales rep once described him in an email to a colleague as a “character” who drove a white Maserati with a license plate that read “PAINMD.” He and other doctors attended speaker’s programs at Dominick’s Steakhouse, a high-end, red-carpeted restaurant in Scottsdale, where a hand-cut New York strip costs $67, a la carte.

Sales rep Shelly Sheldahl called one of the events a success.

“I am confident that they will all give Exalgo some extra thought from here on out,” she wrote to her colleagues. “I used to call on these docs with a previous pharma company and all it ever took was a speaker program to get them writing, so I am hopeful to say the least.”

Fanto ran into trouble with regulators for accepting money from Insys Therapeutics, an opioid company that manufactured fentanyl products. Insys became infamous for sales videos that included rap songs urging doctors to prescribe high doses of the dangerous drug. Seven of its executives went to prison following their convictions on bribery and fraud.

In 2021, Arizona Attorney General Mark Brnovich (R) announced his office had settled a case it had brought against Fanto, accusing him of taking hundreds of thousands of dollars in “sham educational speaker fees” from Insys in exchange for prescribing the company’s fentanyl drug, Subsys. Fanto paid $400,000 to settle the case, Brnovich said.

Fanto said in a brief interview with The Post that he was targeted as a prescriber by drug companies because of his expertise in the pain management field.

“This is very typical in health care. It’s no different than being a mechanic, using a certain tool,” he said. “It’s like any other business. It’s not a negative thing.”

When asked about the speaker fees he was ordered to surrender and the status of his medical license, Fanto ended the interview. Fanto’s medical license was suspended in Arizona.

Mallinckrodt sales rep Shannon Cramer considered Frank Danger Li, a pain management specialist based in Seattle, to be one of her success stories. Li ran a chain of eight pain clinics and served thousands of patients in the 2000s and 2010s.

“Dr. Li is one of your high prescribing Exalgo targets and is also your largest prescriber of pain medications,” district manager Sean Wilmert wrote in Cramer’s 2011 evaluation.

But two years later, the state’s Labor Department refused to renew Li’s contract for worker compensation insurance after determining that two of his patients had overdosed, according to a memo from the state’s attorney general.

“Witness interviews indicate that Seattle Pain Center is well known amongst opioid addicts and other drug seekers as an easy place to get drugs,” investigators for the attorney general wrote in a memo. Between 2010 and 2015, 15 Medicaid patients died of opioid drug overdoses within three months of filling prescriptions obtained from Li’s clinics, the investigators said.

Li’s medical license was suspended in 2016. Four years later, he agreed to pay a $2.85 million fine to settle state and federal claims that his clinics ordered unnecessary medical tests. Li, who did not return calls for comment, did not admit any wrongdoing.

Some medical professionals pushed back against Mallinckrodt’s marketing. Dante Langston, a physician assistant in Colorado Springs, wrote an email to the Exalgo sales team in March 2011, urging the company to stop sending out opioid promotional material. He compared members of the company’s sales team to “the stereotypical used-car salesmen.”

The Mallinckrodt reps who small-talked their way into doctors’ offices were no different than those from Purdue Pharma, Langston wrote. He said they resorted to the same tactics of free food and “good ol’ boy kinds of talk,” he recalled in a recent interview.

“It just reminded me of the way that if you walk onto a car lot, it feels like you’re a piece of fruit that’s attracting a lot of flies,” he said.

Not long before Langston wrote to Mallinckrodt, DEA investigators had begun examining the drugmaker after a South Florida doctor was charged with drug trafficking and manslaughter because one of his patients had died of an overdose.

The doctor, Barry Schultz, who was later convicted, received most of his oxycodone through wholesale companies that worked directly with Mallinckrodt. In one year alone, Schultz received more than 20,000 tablets of Mallinckrodt-made oxycodone tablets through one of the company’s middlemen, Sunrise Wholesale of Broward County, Fla.

DEA investigators also noticed that another wholesale drug company, KeySource Medical, operating out of Cincinnati, was pouring massive amounts of oxycodone into Florida. In 2010, it sent 41 million tablets of Mallinckrodt-made oxycodone to the state — nearly 2.5 pills for every man, woman and child. The DEA eventually revoked the registrations of Sunrise and KeySource, barring them from distributing controlled substances.

In addition to the internal emails and documents, the Mallinckrodt files released Tuesday contain numerous videotaped depositions of the company’s top executives. The depositions were taken by plaintiffs’ attorneys as they prepared for a possible trial against Mallinckrodt.

Karen Harper held a variety of compliance positions during her 44-year career with the company. She was responsible for ensuring that Mallinckrodt complied with federal laws regulating narcotics. Drug companies are required to “maintain effective controls” over controlled substances to make sure they do not reach the black market. If companies receive suspicious or peculiar orders and they can’t determine why they are so large or frequent, they are supposed to halt those orders and notify the DEA.

“You did not always perform due diligence on peculiar orders before shipping them, correct?” plaintiffs’ attorney David Ko asked Harper during her deposition on Jan. 15, 2019.

“Correct,” she said.

In another deposition, a national sales account manager for the company, Steven Becker, was asked about the amount of oxycodone he sold to drug distributors while he was working for Mallinckrodt.

“You understand that a significant number of people died overdosing on oxycodone?” plaintiffs’ attorney Derek W. Loeser asked.

“I don’t know how many people passed away — or died from this epidemic,” Becker replied.

Loeser showed Becker a number of news articles documenting the rising death toll from oxycodone overdoses.

“But you know from the articles that we’ve gone over and you’ve read at the time that you were selling oxycodone that a significant number of people were, in fact, dying because of overdoses on oxycodone?”

“I believe so,” Becker said.

“Mr. Becker, can you please tell the jury if you have any regrets regarding your involvement in the sale and distribution of opioids during the time that you worked for Mallinckrodt?”

“No,” he said.

Flagler OARS brings drug and alcohol recovery ‘out of the shadows’ with inaugural festival

louie — Thu, 30 Sep 2021 18:07:35 +0000

Source: The Daytona Beach News-Journal 09/29/2021

The 25-year-old musician was once an up-and-coming rapper, playing clubs in New York City and making a name for himself.

But when he took the stage on a Saturday afternoon at Veterans Park in Flagler Beach, it was the first time he performed in over a year. And the first time he’s ever performed sober.

Wirth, and his burgeoning music career, took a detour in 2020 that eventually landed him in Palm Coast.

“I started drinking too much,” he said. “And that became more important to me.”

It took a while for Wirth to come to that realization, but once he did, he sought help.

“There’s a huge stigma that comes with alcohol abuse,” he said. “I thought I had to be a 62-year-old living under a bridge.”

And it’s that stigma that brought Wirth and hundreds of others to Veterans Park on Sept. 18 for Flagler Open Arms Recovery Services’ inaugural National Recovery Month Festival.

The event was designed to build community awareness around substance abuse disorders, according to Pam Birtolo, executive director of Flagler OARS.

“Part of our goal is to bring recovery out of the shadows,” she said.

Birtolo, who is in recovery herself, said the stigma surrounding addiction and recovery prevents many people from seeking the help they need. But she’s seen a change over the years.

“The kids don’t have much of a problem bringing it out into the open, and the more we do that, the more people will recover.”

Around 35 exhibitors attended the event, each one providing a service for people suffering from addiction.

Birtolo said Flagler County offers a lot of services for people looking to stop using drugs or drinking alcohol, but the festival was an opportunity to put all of those services in one place.

This year’s National Recovery Month theme is “Recovery is for Everyone,” which serves Flagler OARS quite well.

“We honor and respect multiple pathways to recovery,” Birtolo said. “Some people follow total abstinence, some still drink, some are in Alcoholics Anonymous, some are in Narcotics Anonymous. We celebrate and honor all of that.”

The event kicked off at noon with a yoga class and continued through 8 p.m. with live music and stories of recovery from drug and alcohol addiction.

Exhibitors included drug and rehabilitation centers; transitional and recovery housing; Focus on Flagler Youth; Flagler Cares; One Love Yoga; Care Connect; and more.

Kim Carney, Flagler OARS board president, said when the local recovery community heard about the festival, they worked hard to make it happen.

“These people want to be loved. They want to come out, they want to be part of a community,” she said. “Once they get the chance to connect, they are remarkable.”

Wirth, whose lyrics share his story of recovery, has no regrets about starting over in Palm Coast. He made the move in July 2020 after spending 30 days in rehab. He entered Palm Coast Transitions, a sober living house for people in recovery.

“I was only coming for two months, but I decided to stay,” he said. “I love it here.”

He credits the facility with getting him back on his feet and for introducing him to a strong support system of people in various stages of recovery.

“I had to learn how to redo everything sober,” he said.

He said he made strong connections with his housemates — a “brotherhood,” as he described it.

“I had a nice group of guys to do fun stuff with without having alcohol,” he said.

After six months in Palm Coast Transitions, Wirth got his own place. And his Realtor’s license.

“I’m so grateful to be an alcoholic,” he said. “Today I wouldn’t have what I have without it.”

Local drug overdoses and the availability of Narcan

Narcan also had a booth at the event and provided free doses of the overdose-reversal drug.

Carney said carrying Narcan should be as commonplace as learning CPR.

“I believe it should be in every house and carried by every person,” she said.

Carney said she has doses in her home, even though opioid addiction isn’t present.

“You just never know,” she said.

According to the federal Centers for Disease Control and Prevention, 70% of the nearly 71,000 drug overdose deaths in 2019 involved an opioid. Opioid drugs include prescription pain relievers such as OxyContin and Vicodin; heroin; and fentanyl, a synthetic opioid pain reliever.

Fentanyl is 80 to 100 times stronger than morphine, according to the U.S. Drug Enforcement Administration. Fentanyl is added to heroin to increase its potency, or to disguise the drug as highly potent heroin. This has posed a threat to drug users for years.

When the pandemic hit in 2020, Between March and July, 148 people died from drug overdoses in Flagler and Volusia counties. That’s a 54% increase over the 96 drug overdose deaths during the same period in 2019, data from medical examiners’ offices shows.

Local health-care systems also have observed a sharp increase in non-fatal overdoses.

Nationwide, drug overdose deaths rose 30.9% in 2020, according to preliminary data compiled in August by the federal Centers for Disease Control and Prevention.

About Flagler OARS

Flagler Open Arms Recovery Services is a nonprofit 501(c)(3) organization devoted to removing the stigma of substance use disorder through education, advocacy and peer support services to individuals and families affected by addiction.

The local branch, one of 12 in the state, started in October 2019 with a grant from the Florida Alcohol and Drug Abuse Association. The all-volunteer organization was up and running in April 2020, just as the COVID pandemic was shutting everything down.

But instead of putting services on hold until the pandemic eased up, members went full speed ahead.

“We could have circled back (after COVID), but we had a lot of committed people,” Carney said.

So like most organizations, they began offering programs through Zoom, such as Lunch & Learns and educational pieces, Birtolo said.

Carney said the organization met its strategic plan goals this year and is working on next year’s goals.

For information on services, visit flagleroars.org.

Flagler OARS hosts festival in support of National Recovery Month

louie — Mon, 20 Sep 2021 17:55:47 +0000

Original Post: www.palmcoastobserver.com 09/20/2021

Flagler Open Arms Recovery Services is a 2-year-old nonprofit that provides peer support services, public education on substance use disorder, community outreach and policy advocacy

Shaun Skelton stood against a palm tree at Veterans Park in Flagler Beach. He was shirtless, displaying tattoos on his arms and torso, and taking in the sites at a Sept. 18 festival.

This festival was put on by Flagler Open Arms Recovery Services to build awareness for National Recovery Month.

Skelton said he attended the event to connect with others who are taking positive steps toward recovery from alcoholism and substance abuse.

“You meet more people who are recovering,” he said. “It’s like gazelles. The ones on the outside are picked off by lions. The ones on the inside thrive.”

Skelton said he has been in many recovery programs over the years and hasn’t been able to stop using. He said he is currently participating in a program through Palm Coast Transitions and has a sponsor through Alcoholics Anonymous.

“Now I’m 30 days clean,” he said. “I really can’t put a price on recovery. Addiction has taken everything from me. My kids. My freedom.”

The event was a fund raiser for Flagler OARS with 33 booths in addition to musicians, speakers and a food truck.

Booths ranged from numerous recovery centers and treatment programs to other health-related programs to business such as a yoga studio and a landscaping company.

“Everybody here who has a booth serves people in recovery in some shape or form,” said Flagler OARS Executive Director Pam Birtolo. “Maybe people in recovery go to yoga. Maybe people in recovery use Flagler Cares services. It’s a whole array of mostly social services and some business that serve people in recovery.”

Flagler OARS was founded in 2019. It was the 12th recovery community organization in Florida, and now there are 30, Birtolo said.

She said there are about 12,000 people in the county who are currently in some stage of recovery and Flagler OARS is one of the organizations assisting them.

“Our mission is public education, policy advocacy and peer support,” she said.

Through grants and gifts Flagler OARS was able to hire certified recovery peer specialist Danielle Moye-Auriemma this year.

Birtolo said as a recovery community organization, at least 51 percent of Flagler OARS’ board of directors and staff are required to be in recovery. Of its 10 board members, six are in recovery, she said.

While on stage Moye-Auriemma told the festival goers that she is recovering from a 10-year addiction.

“I was afraid to seek help,” she said. “But so many people in my life supported me and helped me believe I can do this, and that’s what it takes. If anyone is struggling with alcoholism or addiction, what you need to know is there is help.”

Moye-Auriemma provides peer support, life coaching and counseling. She visits the Flagler County jail and provides support to people getting out of jail or out of rehab.

The festival was created to not only build awareness for Flagler OARS and recovery avenues available in the county, but to educate the public on what substance use disorder is, Birtolo said.

“It’s a disease of the brain,” she said. “It’s no different than any other disease. There’s a lot misunderstanding about that.”

Birtolo said Flagler OARS does not provide clinical treatment but helps support people in whatever recovery path they decide is best for them.

“Some people don’t believe in total abstinence. Some people just stay away from the drug that they abused,” she said. “Some people do total abstinence. Some people do NA, some people do AA, some people do different faith-based things and some people do their own thing. We believe in all pathways to recovery.”

Flagler OARS Festival This Weekend in Flagler Beach

louie — Fri, 17 Sep 2021 17:47:37 +0000

Original Post: www.flaglernewsweekly.com 09/17/2021

Flagler County’s Recovery Community Organization, Flagler Open Arms Recovery Services (OARS), will host its inaugural National Recovery Month Festival on Saturday, September 18, at Veteran’s Memorial Park in Flagler Beach from noon until 8:00 PM. This year’s theme is “Recovery is for EVERYONE: every person; every family; every community”. The festival event includes live bands, recovery speakers, food trucks, NARCAN distribution, area recovery partners and exhibitors … all coming together to celebrate recovery in Flagler County.

“Our entire community is impacted by substance use disorder which includes legal drugs, illegal drugs, and alcohol. Over 12,000 people in Flagler are in some stage of recovery, and about half the families here are affected by relatives and friends with substance use disorders,” said OARS Executive Director Pam Birtolo. “We are a free resource for peer support, public education and policy advocacy.”

Pam and Danielle Moye-Auriemma, OARS Certified Peer Support Specialist, are both passionate about helping the recovery community because they are living recovery, and they know it works. “In 2021 OARS has helped create new opportunities, as we connect individuals and families in recovery to needed services and current education,” explains Danielle.

Faces and Voices of Recovery, FAVOR, sponsors National Recovery Month in September every year. They encourage local communities across the nation to join in. This festival demonstrates that recovery works in Flagler County. OARS encourages all families and friends to participate and learn more about our mission, enjoy the music, and celebrate recovery in our community.

Bring a yoga mat if you want to participate in an easy stress free yoga class at the beginning of the festivities and bring a lawn chair to sit back and enjoy music the rest of the day.

For more information about the event, or how to become involved with Flagler OARS, please contact Pam Birtolo, (386)569-4310, pambirtolo@me.com or link to #flagleroars.

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Flagler OARS’ mission is to provide education, support and peer services to individuals and families impacted by substance use disorder. Founded in 2020 by concerned citizens in Flagler County who want to make a difference and who believe “Recovery is for Everyone!” For more information or to pick up free NARCAN, our office is located at 4750 East Moody Blvd, #220, Bunnell, FL 32110; 386-233-3444.