Secret Opioid Memo

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A confidential government document containing evidence so critical it had the potential to change the course of an American tragedy was kept in the dark for more than a decade. The document, known as a “prosecution memo,” details how government lawyers believed that Purdue Pharma, the maker of the powerful opioid, OxyContin, knew early on that the drug was fueling a rise in abuse and addiction. They also gathered evidence indicating that the company’s executives had misled the public and Congress.

Bottles of Opiate Prescriptions

There has been a recent wave of lawsuits against opioid makers and members of the Sackler family, which owns Purdue Pharma. Opioid abuse has ravaged America over the past two decades. According to the Centers for Disease Control and Prevention (CDC), from 1999 to 2017 more than 700,000 Americans have died from a drug overdose. Approximately 68% of the more than 70,200 drug overdose deaths in 2017 involved an opioid. In 2017, the number of overdose deaths involving opioids (including prescription opioids and illegal opioids like heroin and illicitly manufactured fentanyl) was 6 times higher than in 1999. On average, 130 Americans die every day from an opioid overdose.

The confidential Justice Department “prosecution memo” represents a missed opportunity that might have changed the course of the opioid epidemic. It also suggests that Purdue Pharma and members of the Sackler family knew far earlier than they admitted that OxyContin was being abused. The memo had the potential to change the course of the opioid crisis but was kept from circulation for more than a decade. The report states that Purdue Pharma executives were implicated in the crisis.

The Department of Justice chose not to pursue felony charges against those executives, paving the way for a settlement that ended a four-year investigation. The settlement did not produce any vital changes to industry behavior regarding the prescribing of narcotic painkillers. Secrecy surrounding the memo is emblematic of a legal process that favors the suppression of corporate information. If disclosed, this information could benefit the public’s health and safety. It is truly extraordinary to see after all these years that the opioid industry is finally being held to account.

Analysis of the DEA database obtained by the Washington Post reveals that a relatively small number of pharmacies—15 percent—distributed roughly half of prescription opioids nationwide from 2006 to 2012. It seems the DEA wasn’t paying attention to its own data, instead relying on drug companies and pharmacies to police themselves. In one engaging multimedia story, the Post took a close look at a southwestern Virginia area that was flooded with 74 million opioid pills over seven years—enough for 106 pills per resident every year. Journalists from over 30 states have now published over 90 separate articles based on the previously undisclosed DEA data.

It’s unbelievable that millions of oxycodone and hydrocodone pills flooded poor communities in Appalachia as pharmaceutical companies and the DEA failed to heed signs of large-scale inappropriate prescribing. Yet there is a certain liberation in being able to point to specific data, which might help assign responsibility for what may be U.S. health care’s most fateful systemic failure in recent history.

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It is bad enough that many doctors and pharmacies were little more than “pill mills” supplying untreated addicts with their drug of choice rather than treating legitimate pain patients. It is quite another to know that nearly 35 billion opioids — about half of all distributed pills — were handled by just 15 percent of the nation’s pharmacies between 2006 and 2012. A single drugstore in tiny Albany, Kentucky purchased nearly 6.8 million hydrocodone and oxycodone pills during that period, equivalent to 96 a year for all 10,000 or so men, women and children in surrounding Clinton County. This was the most on a per capita, per county basis in the United States.

There is always a tension between discretion and disclosure—between keeping the public informed about the workings of large medical treatment systems and permitting specialists who operate them to handle delicate matters in private. Nowhere is that tension more relevant than in health care, where medical expertise, proprietary information and patient privacy are all at a premium. Like all good things, however, those may be taken to an extreme or turned into excuses for unwarranted concealment.

Any ordinary person who learned that a single pharmacy in small-town Kentucky was handling millions of potentially addictive pills over a seven-year period might have sounded an alarm, even if government bureaucracy, industry leaders, and doctors did not. Unfortunately, no ordinary person could know—until now.

For more information, click here: OxyKills.com

Hazelden Betty Ford Foundation Recovery Advocacy Update

Startling data recently made public show the details of how pharmaceutical companies saturated the country with opioids. In the seven years from 2006 to 2012, America’s biggest drug companies shipped 76 billion oxycodone and hydrocodone pain pills in the United States. The result? Opioid-related deaths soared in communities where the pills flowed most. These new revelations come from the Washington Post, which spent a year in court to gain access to a DEA database that tracks the path of every single pain pill sold in the United States.

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The database reveals what each company knew about the number of pills it was shipping and dispensing and precisely when they were aware of those volumes, year-by-year, town-by-town. The data will be valuable to the attorneys litigating cases to hold manufacturers accountable, including a huge multi-district case in Ohio, where thousands of documents were filed last Friday. The data show that opioid manufacturers and distributors knowingly flooded the market as the overdose crisis raged and red flags were everywhere.

The Post has also published the data at county and state levels in order to help the public understand the impact of years of prescription pill shipments has had on their communities. Hazelden Betty Ford Foundation says to expect many reports from local journalists using the data to explain the causes and impact of the opioid crisis in their communities. The Post did its own local deep-dive, taking a close look this weekend at two Ohio counties that soon will be at the center of the bug multi-district litigation. Barring a settlement, the two counties are scheduled to go to trial in October as the first case among the consolidated lawsuits brought by about 2,000 cities, counties, Native American tribes and other plaintiffs.

Meanwhile, the CDC posted preliminary data suggesting that the number of Americans who died from drug overdoses finally fell 5% in 2018 after years of significant increases. This new data, while still preliminary, covers all of 2018, so it is firmer. And it is a rare positive sign. But it’s only one year and no cause for celebration or complacency—especially with continued funding for opioid crisis grants are uncertain and the decline in deaths anything but uniform across the states. For example, 18 states still saw increases in 2018. Policymakers must be reminded that we’re still very much in the midst of the nation’s worst-ever addiction crisis—one from which it will take years to recover. Federal funding remains essential, as advocate Ryan Hampton points out in his latest piece making the case for the CARE Act, a Congressional bill that would invest $100 billion over the next 10 years.

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If you missed the premiere of  “The First Day,” a powerful, one-hour documentary that shows the evolved talk of former NBA-player-turned-recovery advocate Chris Herren, you can catch it again July 30 at 10:00 p.m. Eastern on ESPN. It is also now available for sale as a download. Herren has spoken to more than a million young people, and the film follows him on a dozen or so speaking engagements up and down the East Coast.

Delta Air Lines announced that naloxone, the medication used to treat (reverse) an opioid overdose, will be available in all emergency medical kits on flights beginning this Fall.

Delta’s decision comes after a passenger tweeted that a man died aboard a Delta flight last weekend from an opioid overdose. It’s unfathomable why naloxone isn’t already on all flights for all airlines. Last year, Hazelden Betty Ford Foundation joined the Association of Flight Attendants in urging the FAA to require it. No one should have to die before airlines take this common-sense step.

Oklahoma’s lawsuit against Johnson & Johnson went to the judge, who will decide later this summer whether to hold the drugmaker accountable for the state’s opioid epidemic. Oklahoma is seeking more than $17.5 billion to abate the costs of opioid addiction. Purdue Pharma and Teva Pharmaceutical settled their part of the Oklahoma case. But they and other drugmakers and distributors face some 2,000 similar lawsuits by states and local municipalities.

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Purdue Pharma, a pharmaceutical company owned by the Sackler family, invented the so-called non-addictive drug OxyContin. The company was found to have falsified the addiction rate at less than 1% when in fact it was over 10%. Raymond Sackler had a personal net worth of $13 billion in 2016. He passed away on July 17, 2017. The Louvre in Paris has removed the Sackler family name from its walls, becoming the first major museum to erase its public association with the philanthropist family linked with the opioid crisis in the United States.

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Dr. Nora Volkow, director of the National Institute on Drug Abuse, has written and spoken extensively about the importance of prevention in addressing the opioid crisis. NIDA studies have shown that teens who misuse prescription opioids are more likely to initiate heroin use. You can visit NIDA’s site by clicking here.

 

 

The Opioid Issue: Part 2

Part Two: Collateral Damage

As the nation grapples with opioid’s hold over millions, its smallest victims cry out to be heard, held, and healed. No Child Left Behind is a familiar battle cry. But to foster parents helping to care for children of parents addicted to drugs, those words have nothing to do with a political agenda or advertising campaign. One foster mom reported quietly watching another baby detox from opiates, its high-pitched wails unique with the sound of drug-induced anguish, and whispering, “A whole generation is being lost from the opioid epidemic. A whole generation.”

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That generation—with hundreds of thousands of America’s youngest feeling its physical, mental, and emotional impact, sometimes from the moment of conception—is staring down what doctors call Neonatal Abstinence Syndrome (NAS). The condition is not something that can be cured with a pill. There are so many children growing up without their parents that the long-term ramifications are still unforeseen. The United States has certainly faced its share of social and public health problems over the years, but when it comes to the opioid crisis, child advocates around the country warn, it’s a strange and scary new world.

Agony in the Womb

According to a study released by the University of Minnesota this spring, one baby struggling with NAS is born in America every 15 minutes. Furthermore, almost 90 percent of pregnancies among women struggling with opioid addiction are unintentional. When a woman takes opioids while pregnant—even exactly as a doctor might instruct, according to the March of Dimes—she runs the substantial risk of harming her unborn child.

One Baby Every Half Hour

Prescription painkillers like codeine, fentanyl, hydrocodone, morphine, and oxycodone (as well as the street drug heroin) are all classified as opioids and all negatively affect children in the womb. Common risks of opioid use during pregnancy, the March of Dimes says, include miscarriage, preterm labor, premature birth, birth defects, low birth weight (defined as weighing less than five pounds, eight ounces), and NAS. NAS is its own beast. The completely preventable condition can grip babies with tremors, fever, chills, weight loss, seizures, and even death. Dr. W. David Hager, member of Focus on the Family’s Physicians Resource Council (PRC), believes 55-94% of newborns delivered to women who used opioids in pregnancy suffer from NAS.

Clearly, it is nearly impossible for an unborn child to skate past the consequences of his or her mother’s opioid use, no matter how slight. Yet damage isn’t usually intentional. Instead, Hager says, addiction to opioids reaches far beyond the initial physical pleasure to something much deeper.

It All Adds Up

That’s a familiar story for J. Scott Moody and Wendy Warcholik, a married pair of economists. As the directors of Family Prosperity Institute (FPI), a New Hampshire-based think tank focused on measuring the health of the American family, Moody and Warcholik frequently hear about opioid-related crises—and have watched their own loved ones succumb to substance abuse along the way. Warcholik, for example, grew up in a family fragmented by her parents’ collective five divorces. Of all her siblings, she was the only one to have fully escaped the negative consequences. The others have experienced unemployment, substance abuse, government dependency, low educational attainment, unwed childbirth, and divorce.

FPI has created a family prosperity index—a formula-driven rankings list that measures the strength and prosperity of families and the nation by combining the most important economic and social data into a single number and then ranking those states based on which create the best environment for families to thrive. The index fills in the gaps around other measures like the gross domestic product, assembling all the pieces of the prosperity puzzle into a complete picture of the economy. No other measure takes into consideration both the economic and social choices of people in a state to create a holistic measure of human behavior in the States.

The latest FPI index ranked Utah first and New Mexico last. FPI’s formula calculates things like average welfare utilization, children in married households, religious attendance and infant mortality rate. That last category is most disconcerting because as opioid use has risen, so has infant mortality rate. (The U.S. Centers for Disease Control and Prevention defines that as the death of an infant before his or her first birthday), while the infant mortality rate is the number of infant deaths for every 1,000 live births.

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Between 2010 and 2015 twenty-one states saw an increase in their infant mortality rate. So many states, in fact, that while the national average dropped 16 percent between 2000 and 2015, the last five years only saw a decrease of 1.6 percent. Clearly, if trends continue, the country could see an increase in the infant mortality rate in the near future. Keep in mind that a rising infant mortality rate is typically only found in Third World countries. Besides the physical, emotional and mental cost to America’s children, opioid addiction doesn’t come fiscally cheap, either. For example, in 2015 Ohio paid more than $133 million to care for approximately 2,000 NAS babies born that year.

The True Cost

Interestingly, FPI’s research shows that devout beliefs and behaviors (consistent church attendance, daily prayer, Bible reading, etc.) reduce illicit drug use. The converse holds true as well. Moody says, “It is clear that people in despair who don’t turn to God for help will try to numb their pain some other way, whether it be with drugs or sex. Unfortunately, at least for the last decade, we’ve been seeing more and more people turning to drugs and sex than God. We have to reverse this trend.”

Ultimately, America truly has no idea what the long-term consequences of opioid addiction on our most innocent citizens will be. “We read horrifying stories in New England about parents shooting up their own children just to keep them quiet, or left in a freezing car with their parents passed out in the front seat,” Warcholik says. How far are we, as a society, willing to go in elevating adult desires over the health and well being of our children?

That is a question far beyond the scope of any research team—but one the Church must rise up to help answer.

 

 

COUNTERFEIT OXYCODONE WARNING!

COUNTERFEIT PAIN PILLS CONTAINING DANGEROUS SYNTHETIC OPIOIDS!

Originally posted July 18, 2017
National Institute of Drug Abuse
https://www.drugabuse.gov/

Health and safety agencies in Iowa have issued an advisory to warn Iowans of counterfeit pain pills containing dangerous synthetic opioids. The Iowa Division of Criminal Investigation’s (DCI) laboratory analyzed pills made to resemble the prescription pain reliever oxycodone, finding them to contain more powerful and illicit synthetic fentanyl and U-47700, putting users at higher risk of opioid overdose. U-47700, also known as “Pink” or “U4” on the streets, is a synthetic opioid pain medication currently being distributed as a dangerous designer drug. Since 2015, reports have surfaced of numerous deaths due to street use of U-47700. Law enforcement agencies have traced illegal importation into the United States primarily from clandestine chemical labs in China. It is available through the Dark Web.

Heroin and a Handgun

U-47700 has been seized by law enforcement on the street in powder form and as tablets. Typically, it appears as a white or light pinkish, chalky powder. It may be sold in glassine bags stamped with logos imitating heroin, in envelopes and inside knotted corners of plastic bags. In Ohio, authorities seized 500 pills resembling a manufacturer’s oxycodone immediate-release tablets, but they were confirmed by chemical analysis to contain “Pink.” U-47770 has also been identified and sold on the Internet misleadingly as a “research chemical” at roughly $30 per gram.

Pink is very toxic or deadly in even small doses. Labels on the packaging may state NOT FOR HUMAN CONSUMPTION or FOR RESEARCH PURPOSES ONLY, most likely to avoid legal detection. Fatalities due to U-47770 in the United States join the growing incidents of drug overdose deaths from opioid pain medication. Those who abuse U-47770 may be at high risk of addiction and substance abuse disorder, overdose and death. Fatalities have been reported in New York, New Hampshire, Ohio, Texas, Wisconsin and North Carolina.

In July 2016, a toxicology case report was published in the Annals of Emergency Medicine that detailed events in which fentanyl and U-47700 were being sold misleadingly as the prescription opioid pain medication Norco or Vicodin (acetaminophen and hydrocodone) on the streets of Northern and Central California. In one patient who presented to the emergency room, nalaxone (Narcan) was administered which reversed respiratory depression and pinpoint pupils. After additional chemical analysis, it was found the Norco contained hydrocodone, fentanyl, and U-47700.

Reports indicated that Pink and prescription fentanyl may have been contained in the drug cocktail that led to the death of pop star legend Prince in April 2016. In Utah, two 13-year old boys died in September 2016 reportedly due to use of U-47770 purchased from an Internet website. U-47700 (“Pink”) is a novel synthetic opioid agonist with selective action at the mu-opioid receptors in the brain and on the spinal column. It was originally developed by chemists at Upjohn Pharmaceuticals in the 1970’s as a potent pain reliever for use with cancer patients, post-operative patients with intractable pain, or extremely painful trauma injuries. Although it was never commercially made available, the patent and chemical details remained available, and have been produced on the black market.

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U-47700 has a similar chemical profile as morphine and other mu-opioid receptor agonists; however, it has been reported by the National Institute of Drug Abuse (NIDA) that Pink is “far more potent than morphine” –  possibly by seven to eight times. Unfortunately, the strength of the product can never be assured, and may be much stronger, especially when manufactured overseas in illicit labs as a designer drug. On November 14, 2016, the DEA placed U-47700, as well as its related isomers, esters, ethers, and salts into Schedule I of the Controlled Substances Act due to an imminent hazard to public safety and health. Substances in Schedule I have a high potential for abuse, no currently accepted medical use, and a lack of accepted safety for use under medical supervision.

Temporary emergency scheduling of dangerous illicit drugs is one tool the DEA uses to help restrict potentially fatal and new street drugs. Scheduling will last at least 24 months, with a possible 12-month extension if the DEA needs more time to determine whether the chemical should remain permanently as a Schedule I drug. According to the Federal Register, there are no current experimental or approved new drug applications for U-47700, which can typically hinder its permanent placement in Schedule I if approved. DEA’s Final Order is available in the Federal Register with details on threats to public safety. Prior to DEA’s scheduling, several states had already outlawed the drug under emergency orders, including Florida, Ohio, Wyoming and Georgia.

BOTTOM LINE

U-47700, known on the streets as “Pink” or “U4”, is a dangerous designer drug exported from illegal labs in China to the U.S. It is a strong opioid analgesic, reportedly 7 to 8 times more potent than morphine. Authorities in many U.S. cities have reported that Pink is sold on the streets or over the Internet, often falsely promoted as a prescription opioid like Norco or Percocet, or as heroin. In fact, many of these products have contained the potent designer drug Pink, as well as fentanyl. U-47700 is now illegal in all forms, and the DEA has temporarily placed the substance into Schedule I of the Controlled Substances Act, pending further review, due to an imminent hazard to public safety and health. It is considered not safe for human consumption, and has no acceptable medical use.

Clusters of overdoses and deaths of Pink were reported in U.S. cities in 2015 and 2016. Some of these deaths involved children. According to one case report, the use of naloxone (Narcan) in an emergency setting reversed the effects of U-47700, but this may not always be the case. Emergency physicians should contact their local poison control center, medical toxicologist or public health department in cases where there is a reasonable suspicion of ingestion of designer drugs to help protect the surrounding community. Special lab analysis is typically needed to identify drugs like “Pink,” leaving communities at risk.

The public should be aware that drugs obtained on the street, even though they look like an authentic prescription medication, may be fake and deadly. Don’t take any prescription drug, legal or otherwise, unless it is prescribed specifically for you by a doctor and is dispensed by a reliable pharmacy.