Preview Newsletter

Opioid Litigation Daily Media Report - 3/12/18

Commentary and FYIs

CNN Exclusive: The more opioids doctors prescribe, the more money they make
Mar 12, 2018 | CNN
By Aaron Kessler, Elizabeth Cohen and Katherine Grise

As tens of thousands of Americans die from prescription opioid overdoses each year, an exclusive analysis by CNN and researchers at Harvard University found that opioid manufacturers are paying physicians huge sums of money -- and the more opioids a doctor prescribes, the more money he or she makes.
America's War on Pain Pills Is Killing Addicts and Leaving Patients in Agony
Mar 8, 2018 | Reason
By Jacob Sullum

Craig, a middle-aged banking consultant who was on his school's lacrosse team in college and played professionally for half a dozen years after graduating, began developing back problems in his early 30s. "Degenerative disc disease runs in my family, and the constant pounding on AstroTurf probably did not help," he says. One day, he recalls, "I was lifting a railroad tie out of the ground with a pick ax, straddled it, and felt the pop. That was my first herniation."
Another harsh truth about opioids: They’re not a better way to manage pain (Opinion)
Mar 12, 2018 | Washington Post
By Editorial Board

OPIOID OVERDOSES, both fatal and nonfatal, increased 30 percent from July 2016 through September 2017 in 52 areas in 45 states, according to the latest review of emergency-room admissions data by the Centers for Disease Control and Prevention, published Tuesday. On the same day, the Journal of the American Medical Association released the results of a year-long study from Minneapolis-area Veterans Affairs clinics showing that opioids were no more effective against common forms of back and joint pain than acetaminophen. These new findings underscore a tragic irony of the deadly epidemic: Though it has by now morphed into a problem of both licit substances, such as hydrocodone and oxycodone, and illicit ones, such as heroin, the opioid epidemic’s roots lie in a wave of permissive prescribing of opioids that turns out, in hindsight, to have been unjustifiable even as good pain-management practice.
Questions And Answers About Opioids And Chronic Pain
Mar 12, 2018 | NPR
By Ari Shapiro

Millions of Americans use opioids to relieve pain. But many also struggle with addiction.
McCaskill plans a bill to force pharma to disclose payments to nonprofits and advocacy groups
Mar 9, 2018 | STAT News
By Ed Silverman

Seeking to toughen the Sunshine Act, Sen. Claire McCaskill (D-Mo.) plans to introduce a bill that would require drug makers to report payments that are made to nonprofit organizations and patient advocacy groups, according to several sources familiar with the effort.
Trump officials study death penalty for drug dealers in opioid epidemic
Mar 9, 2018 | Washington Post
By Katie Zezima and Josh Dawsey

The Trump administration is studying new policy that could allow prosecutors to seek the death penalty for drug dealers, according to people with knowledge of the discussions, a sign that the White House wants to make a strong statement in addressing the opioid crisis.
Opioid Protest at Met Museum Targets Donors Connected to OxyContin
Mar 10, 2018 | The New York Times
By Colin Moynihan

Anti-opioid activists unfurled banners and scattered pill bottles on Saturday inside the Sackler Wing of the Metropolitan Museum of Art in New York, which is named for a family connected to the powerful painkilling drug OxyContin.

Northeast (MA, CT)

Cities and towns throughout the state joining opioid lawsuit
Mar 12, 2018 | Western News Mass.com (MA)
By Maggie Lohmiller & Naomi Wilson

The next battle in the war against opioid abuse is set to take place in the courtroom.
Local towns want drug companies to pay up to help fund addiction services
Mar 9, 2018 | Boston 25 News (MA)
By Bob Dumas

The human toll of the opioid crisis across the country is staggering -- resulting in more than 60,000 overdose deaths a year.
Lowell, Billerica join suit seeking opioid damages from Big Pharma
Mar 12, 2018 | Lowell Sun (MA)
By Rock Sobey

It's time for Big Pharma to pony up and take responsibility for flooding cities and towns with opioids.
Danbury Hires Ventura Law to Pursue Opioid Litigation
Mar 9, 2018 | Connecticut Law Tribune
By Robert Storace

The Danbury City Council voted this week to hire the Ventura Law firm to represent it in potential litigation against some of the nation’s largest pharmaceutical companies for their alleged role in causing the opioid crisis.
Directors may join lawsuit against drug companies
Mar 9, 2018 | Journal Inquirer (CT)
By Joseph T. O'Leary

The Board of Directors has asked the town attorney to compile information about lawsuits filed by hundreds of communities against pharmaceutical companies for their role in the opioid epidemic as it considers joining one.

Southeast (LA, FL)

BOSSIER PARISH FIRST TO FILE OPIOID LITIGATION..MORE ON THE WAY
Mar 12, 2018 | Shreveport News (LA)
By John Setlle

It’s really not that surprising that Bossier Parish was the first parish in Louisiana to join the hundreds of governmental entities nationwide to file litigation against the manufacturers and major distributors of opioids. Bossier elected officials generally leave the schoolyard politics at home when they assemble and just go about good government without too much fuss.
Opioid crisis: City suing drugmakers
Mar 12, 2018 | Jacksonville Daily Record (FL)
By Max Marbut

The City of Jacksonville has joined the national effort to hold drug manufacturers accountable, and financially liable, for the explosion of opioid abuse and overdoses.

West (UT)

Summit County plans to file suit against opioid manufacturers
Mar 11, 2018 | Park Record (UT)
By Angelique McNaughton

Summit County will soon be joining other counties and states across the country that have filed lawsuits against drug manufacturers and distributors for their role in the national opioid epidemic.
Lawmakers Pass Resolution Urging Utah AG to Sue Opioid Manufacturers Directly
Mar 12, 2018 | KSL.com (UT)
By Ben Lockart

Legislators emphasized their focus on opioid addiction this session with a Thursday vote passing a resolution urging Attorney General Sean Reyes to directly sue manufacturers of those drugs.

Broadcast Media Coverage

CNN Newsroom Live
Mar 12, 2018 | National Programming
By CNN

Video Link: http://app.criticalmention.com/app/#clip/view/33488604?token=e9790d32-382d-41f1-b1d8-f9fab9d02662
Politics and Public Policy Today
Mar 12, 2018 | National Programming
By CSPAN

Video Link: http://app.criticalmention.com/app/#clip/view/33488660?token=e9790d32-382d-41f1-b1d8-f9fab9d02662
18 News Today
Mar 12, 2018 | Elmira, NY
By WETM (NBC)

Video Link: http://app.criticalmention.com/app/#clip/view/33488588?token=e9790d32-382d-41f1-b1d8-f9fab9d02662
Boston 25 News at 6PM
Mar 9, 2018 | Boston, MA
By WFXT (FOX)

Video Link: http://app.criticalmention.com/app/#clip/view/33488682?token=e9790d32-382d-41f1-b1d8-f9fab9d02662
Chicago Tonight: The Week in Review
Mar 9, 2018 | Chicago, IL
By WTTW (PBS)

Video Link: http://app.criticalmention.com/app/#clip/view/33488861?token=e9790d32-382d-41f1-b1d8-f9fab9d02662

Commentary and FYIs

CNN Exclusive: The more opioids doctors prescribe, the more money they make

Mar 12, 2018 | CNN

By Aaron Kessler, Elizabeth Cohen and Katherine Grise

As tens of thousands of Americans die from prescription opioid overdoses each year, an exclusive analysis by CNN and researchers at Harvard University found that opioid manufacturers are paying physicians huge sums of money -- and the more opioids a doctor prescribes, the more money he or she makes.In 2014 and 2015, opioid manufacturers paid hundreds of doctors across the country six-figure sums for speaking, consulting and other services. Thousands of other doctors were paid over $25,000 during that time.
Physicians who prescribed particularly large amounts of the drugs were the most likely to get paid.
"This is the first time we've seen this, and it's really important," said Dr. Andrew Kolodny, a senior scientist at the Institute for Behavioral Health at the Heller School for Social Policy and Management at Brandeis University, where he is co-director of the Opioid Policy Research Collaborative.
"It smells like doctors being bribed to sell narcotics, and that's very disturbing," said Kolodny, who is also the executive director of Physicians for Responsible Opioid Prescribing.
The Harvard researchers said it's not clear whether the payments encourage doctors to prescribe a company's drug or whether pharmaceutical companies seek out and reward doctors who are already high prescribers.
"I don't know if the money is causing the prescribing or the prescribing led to the money, but in either case, it's potentially a vicious cycle. It's cementing the idea for these physicians that prescribing this many opioids is creating value," said Dr. Michael Barnett, assistant professor of health policy and management at the Harvard T.H. Chan School of Public Health.
CNN spoke with two women who've struggled with opioid addiction, and they described the sense of betrayal they felt when they learned that their doctors had received large sums of money from the manufacturers of the drugs that had created such havoc in their lives.
Carey Ballou said she trusted her doctor and figured that if he was prescribing opioids, it must be because they were the best option for her pain.Then she learned that opioid manufacturers paid her doctor more than a million dollars over two years.
"Once I found out he was being paid, I thought, 'was it really in my best interest, or was it in his best interest?' " she said.To do the analysis, CNN -- along with Barnett and Harvard's Dr. Anupam Jena -- examined two federal government databases. One tracks payments by drug companies to doctors, and the other tracks prescriptions that doctors write to Medicare recipients.
The CNN/Harvard analysis looked at 2014 and 2015, during which time more than 811,000 doctors wrote prescriptions to Medicare patients. Of those, nearly half wrote at least one prescription for opioids.Fifty-four percent of those doctors -- more than 200,000 physicians -- received a payment from pharmaceutical companies that make opioids.
Doctors were more likely to get paid by drug companies if they prescribed a lot of opioids -- and they were more likely to get paid a lot of money.Among doctors in the top 25th percentile of opioid prescribers by volume, 72% received payments. Among those in the top fifth percentile, 84% received payments. Among the very biggest prescribers -- those in the top 10th of 1% -- 95% received payments.
On average, doctors whose opioid prescription volume ranked among the top 5% nationally received twice as much money from the opioid manufacturers, compared with doctors whose prescription volume was in the median. Doctors in the top 1% of opioid prescribers received on average four times as much money as the typical doctor. Doctors in the top 10th of 1%, on average, received nine times more money than the typical doctor.
"The correlation you found is very powerful," said David Rothman, director of the Center on Medicine as a Profession at the Columbia University College of Physicians and Surgeons. "What's amazing about the findings is not simply that money counts but that more money counts even more.
"Paying doctors for speaking, consulting and other services is legal. It's defended as a way for experts in their fields to share important experience and information about medications, but it has long been a controversial practice.  Pharmaceutical company payments to doctors are not unique to opioids. Drug companies pay doctors billions of dollars for various services. In 2015, 48% of physicians received some pharmaceutical payment.It's illegal, however, for doctors to prescribe the drug in exchange for kickback payments from a manufacturer.
Dr. Steven Stanos, president of the American Academy of Pain Medicine, said he wasn't surprised that doctors who frequently prescribe a drug are often chosen and paid to give speeches about the drug to other doctors.
"They know those medicines, and so they're going to be more likely to prescribe those because they have a better understanding," Stanos said, adding that some of the money paid to doctors may have been to teach other doctors about new "abuse-deterrent" opioid drugs.
Stanos' group accepted nearly $1.2 million from five of the largest opioid manufacturers in the United States between 2012 and 2017, according to a recent report by the Senate Homeland Security and Governmental Affairs Committee.
Stanos said the money was used for various projects, including courses on safe opioid prescribing.
"I would obviously hope that a physician would not prescribe based on some type of kickback or anything like that, that they'd obviously be prescribing [in] the best interest of the patient," he said.But Dr. Daniel Carlat, former director of the Prescription Project at the Pew Charitable Trusts, said the CNN and Harvard findings are in line with other studies suggesting that money from drug companies does influence a doctor's prescribing habits.
"It's not proof positive, but it's another very significant data point in the growing evidence base that marketing payments from drug companies are not good for medicine and not good for patient care," said Carlat, a psychiatrist who blogs about conflicts of interest. "It makes me extremely concerned.
"Barnett, one of the Harvard researchers who worked with CNN, said pharmaceutical companies pay doctors for a reason."It's not like they're spending this money and just letting it go out into the ether," he said.
"They wouldn't be spending this money if it weren't effective."According to a statement by the Pharmaceutical Research and Manufacturers of America, drug companies support mandatory and ongoing training for prescribers on the appropriate treatment of pain.
"PhRMA supports a number of policies to ensure patients' legitimate medical needs are met, while establishing safeguards that prevent overprescribing," according to the statement from the group.
'I trusted my doctor'Angela Cantone says she wishes she had known that opioid manufacturers were paying her doctor hundreds of thousands of dollars; it might have prompted her to question his judgment.
She says Dr. Aathirayen Thiyagarajah, a pain specialist in Greenville, South Carolina, prescribed her an opioid called Subsys for abdominal pain from Crohn's disease for nearly 2½ years, from March 2013 through July 2015.
Subsys is an ultrapowerful form of fentanyl, which is 50 to 100 times more potent than morphine, according to the US Centers for Disease Control and Prevention."He said it would do wonders for me, and it was really simple and easy. You just spray it in your mouth," Cantone said.
She says Subsys helped her pain, but it left her in "a zombie-like" state. She couldn't be left alone with her three young children, two of whom have autism and other special needs."I blacked out all the time. I'd find myself on the kitchen floor or the front lawn," she said.
She says that if she missed even one day of the drug, she had uncontrollable diarrhea and vomiting.She said she brought her concerns to Thiyagarajah, but he assured her it couldn't be the Subsys that was causing her health problems.
"I trusted him. I trusted my doctor as you trust the police officer that's directing traffic when the light is out," she said.She says that when she eventually asked Thiyagarajah to switch her to a non-opioid medication, he became belligerent.
"He said it was Subsys or nothing," she said.Cantone would later learn that from August 2013 through December 2016, the company that makes Subsys paid Thiyagarajah more than $200,000, according to Open Payments, the federal government database that tracks payments from pharmaceutical companies to doctors.
CNN compared the $190,000 he received from 2014 to 2015 with other prescribers nationwide in the same medical specialty and found that he received magnitudes more than the average for his peers.Nearly all of the payments were for fees for speaking, training, education and consulting.
Cantone is now suing Thiyagarajah, accusing him of setting out to "defraud and deceive" her for "the sole purpose of increasing prescriptions, sales, and consumption of Subsys to increase ... profits."Through his attorney, Thiyagarajah denied any wrongdoing but declined to comment on this story due to the pending litigation.
In a court filing responding to Cantone's lawsuit, Thiyagarajah denied all of the allegations against him and said that all medical care provided to Cantone was "reasonable and appropriate and in keeping with the standard of care."His attorney, E. Brown
Parkinson, said the doctor is currently practicing medicine, alternating weeks between his practices in South Carolina and New York.Thiyagarajah might be expected to write a relatively high number of prescriptions for opioid painkillers, given that he's board-certified in physical medicine and rehabilitation with a subspecialty in pain medicine.
But he wrote an unusually high number of prescriptions for Subsys and other opioids even when compared with other doctors with the same certifications.In 2014 and 2015, physicians with Thiyagarajah's certifications wrote an average of 3.7 opioid prescriptions per Medicare patient per year, according to the analysis by CNN and Harvard.
Thiyagarajah, however, annually wrote more than seven opioid prescriptions per patient per year.
After about two years on Subsys, Cantone says, she took herself off the drug cold turkey.According to an affidavit by an investigator for the Drug Enforcement Administration, Thiyagarajah's office was inspected by the agency in June 2015 and found to be prescribing another opioid, buprenorphine, "for non-legitimate medical need" in violation of federal law.In March 2016, the agent conducted another inspection and seized 45 medical records related to Subsys.
The DEA did a compliance review and referred its findings to the Department of Health and Human Services, according to Robert Murphy, associate special agent in charge of the agency's Atlanta Field Division.
Cantone is also suing Insys, the company that makes Subsys. Insys denied allegations of wrongdoing in a court filing responding to Cantone's lawsuit.
Separate from Cantone's lawsuit, John Kapoor, the founder and largest shareholder of Insys, was arrested and arraigned in federal court in October on charges of bribing doctors to overprescribe the drug.
"Dr. Kapoor engaged in no wrongdoing and refutes all of the charges in the strongest possible terms," said Tom Becker, a spokesman for Kapoor. "He looks forward to being fully vindicated after having his day in court.
"Kapoor resigned from the Insys board of directors in October, according to a company news release.Several other Insys executives were arrested in connection with an alleged racketeering scheme.Separately, Sen. Claire McCaskill, a Democrat from Missouri, is conducting an investigation into the opioid industry.
According to her investigation and the federal indictment, Insys used a combination of tactics, such as falsifying medical records, misleading insurance companies and providing kickbacks to doctors in league with the company.
Saeed Motahari, president and CEO of Insys, wrote a letter in September to McCaskill, noting that he was "concerned about certain mistakes and unacceptable actions of former Insys employees." He added that most of the field-based sales staff were no longer with the company.
"I stand with you and share the desire to address the serious national challenge related to the misuse and abuse of opioids that has led to addiction and unnecessary deaths and has caused so much pain to families and communities around the country," Motahari added.
The analysis
Sometimes, pharmaceutical companies pay doctors to do medical research. They also pay doctors for promotional work: for example, to speak with other doctors about the benefits of a drug.
Among the doctors who prescribe the highest volume of opioids, the CNN/Harvard analysis found that the largest amount of money was paid for that second category, which includes speaking fees, consulting, travel and food.
Concerns about payments to doctors by opioid manufacturers were brought to light last year in a study by researchers at Boston University.Several studies published in medical journals in recent years have found an association between payments by pharmaceutical companies for various types of drugs and doctors' prescribing habits.
For example, researchers at the University of North Carolina examined the two government databases analyzed by CNN and Harvard and found that when doctors received payments from manufacturers of certain cancer drugs, they were more likely to prescribe those drugs to their patients.
"This study suggests that conflicts of interest with the pharmaceutical industry may influence oncologists in high-stakes treatment decisions for patients with cancer," the authors concluded.Some studies have looked at whether the amount of money a doctor receives makes a difference.
Studies by researchers at Yale University, the George Washington University Milken Institute of Public Health and Harvard Medical School have all found that the more money physicians are paid by pharmaceutical companies, the more likely they are to prescribe certain drugs.
Dr. Patrice Harris, a spokeswoman for the American Medical Association, said that the CNN and Harvard data raised "fair questions" but that such analyses show only an association between payments and prescribing habits and don't prove that one causes the other.
It's "not a cause and effect relationship," said Harris, chairwoman of the association's opioid task force, adding that more research should be done on the relationship between payments and prescriptions.
"[We] strongly oppose inappropriate, unethical interactions between physicians and industry," she added. "But we know that not all interactions are unethical or inappropriate."  
Harris added that relationships between doctors and industry are ethical and appropriate if they "can help drive innovation in patient care and provide significant resources for professional medical education that ultimately benefits patients.
"Stanos, the pain physician, said a doctor who gets paid by a pharmaceutical company and prescribes that company's drug might truly and legitimately believe that the drug is the best option for the patient.
"I hope physicians that do promotional talks prescribe because they think the medicine has a benefit," he said.
But Jena, one of the two Harvard researchers who collaborated on the CNN analysis, said he worries that money from opioid manufacturers -- especially large amounts of money -- could influence a doctor to prescribe opioids over less dangerous options.
"Every decision, every recommendation a physician makes, should be in the best interest of the patient and not a combination of the patient's interest and the financial interest of the doctor," said Jena, associate professor of health care policy at Harvard Medical School.
"If we lived in a different world where none of these payments to physicians occurred, how many fewer Americans would have [been prescribed] opioids, and how many fewer deaths would have occurred?" he asked.
From 1999 to 2015, more than 183,000 people in the United States died from overdoses related to prescription opioids, according to the CDC. In October, President Donald Trump declared the opioid epidemic a national public health emergency.
At least one company has decided to stop paying doctors for promotional activities such as speaking engagements.
Purdue Pharma discontinued its speakers program for the opioids OxyContin and Butrans at the end of 2016 and the program for Hysingla, another opioid, in November, according to company spokesman Robert Josephson.
"We have restructured and significantly reduced our commercial operation and will no longer be promoting opioids to prescribers," a company statement said.More than $1 million in three years
Though Thiyagarajah's opioid prescription rates were particularly high, many other doctors who have prescribed large amounts of opioids have also been paid large amounts of money by pharmaceutical companies that make the drugs.Several patients have filed lawsuits against these high prescribers.
From August 2013 through December 2016, Dr. Steven Simon of Overland Park, Kansas, was paid nearly $1.1 million by companies that make opioid painkillers, according to the federal Open Payments database.
Most of the payments were fees for speaking, training and education.Ballou, one of his patients, says she remembers Simon bragging about how drug companies were flying him across the country to give lectures to other doctors.
"He said he was going to Miami, and they were going to give him a convertible, and he was going to stay in the best hotel and eat the best Cuban food he'd ever had," said Ballou, who filed a lawsuit against Simon after she says she became addicted to opioids.
Simon's lawyer, James Wyrsch, said he would not comment on pending litigation.In court documents, he asked for the case to be dismissed, saying in part that Ballou's complaints that Simon improperly prescribed Subsys were "simply incorrect."
Bridget Patton, a spokeswoman for the FBI's Kansas City field office, said federal agents went to the office where Simon works, Mid-America PolyClinic, in July.
The clinic said in a statement that it is "fully and willingly cooperating with all investigations" and that Simon has not been employed there since July 24.
"We had a lawful presence at that facility," Patton said. She declined to say whether investigating Simon himself was the purpose of the FBI visit.
The owner of the pain clinic, Dr. Srinivas Nalamachu, told The Kansas City Star that the agents showed up with a search warrant for Simon's medical records involving fentanyl prescriptions.Simon and his lawyer told CNN they couldn't comment due to the pending litigation.
Ballou said that when she was Simon's patient, it didn't give her pause that the same doctor who was prescribing opioids to her was also taking money from the companies that made the drugs.But now she looks back with anger.

Return to headline | Return to top
America's War on Pain Pills Is Killing Addicts and Leaving Patients in Agony

Mar 8, 2018 | Reason

By Jacob Sullum

Craig, a middle-aged banking consultant who was on his school's lacrosse team in college and played professionally for half a dozen years after graduating, began developing back problems in his early 30s. "Degenerative disc disease runs in my family, and the constant pounding on AstroTurf probably did not help," he says. One day, he recalls, "I was lifting a railroad tie out of the ground with a pick ax, straddled it, and felt the pop. That was my first herniation."
After struggling with herniated discs and neuropathy, Craig consulted with "about 10 different surgeons" and decided to have his bottom three vertebrae fused. He continued to suffer from severe lower back pain, which he successfully treated for years with OxyContin, a timed-release version of the opioid analgesic oxycodone. He would take a 30-milligram OxyContin tablet twice a day, supplemented by immediate-release oxycodone for breakthrough pain when he needed it.
Then one day last May, Craig's pain clinic called him in for a pill count, a precaution designed to detect abuse of narcotics or diversion to nonpatients. The count was off by a week's worth of pills because Craig had just returned from a business trip and forgot that he had packed some medication in his briefcase. He tried to explain the discrepancy and offered to bring in the missing pills, to no avail. Because the pill count came up short, Craig's doctor would no longer prescribe opioids for him, and neither would any other pain specialist in town.
"I have lived my life by the rules," says Craig (whose name I've changed at his request). "I made one mistake, and they condemned me for it. They were basically saying that I'm a druggie when I have been fine for four years. My first pill count ever, and they boot me." He says a nurse at the practice told him "the doctors were getting tired of all the scrutiny, so they were booting all the opioid patients."
Without the OxyContin, Craig says, "every morning is a challenge to get out of bed." Even with liberal use of ice packs and Biofreeze, he says, "It's horrible. I can't expect to live a life like this. I'm not a junkie. I'm not a threat to society. I'm not a threat to myself. I simply want to live my life without pain."
Like other patients across the country, Craig is a victim of the recent crackdown on prescription opioids, which is based on a narrative that mistakenly blames pain treatment for a plague of addiction and death. Most Americans believe we are in the midst of an "opioid crisis" that began in the 1990s with the introduction of OxyContin. According to the generally accepted account, deceptive marketing encouraged reckless prescribing, which led to widespread addiction among patients and record numbers of opioid-related fatalities—a situation President Donald Trump has declared a public health emergency.
Former New Jersey Gov. Chris Christie, who chaired the President's Commission on Combating Drug Addiction and the Opioid Crisis, invokes that narrative when he talks about "the injured student-athlete who becomes addicted after [his] first prescription" or remembers the law school classmate who died of an overdose after getting hooked on the oxycodone he was taking for back pain. Such examples are misleading because they are rare, accounting for only a small percentage of opioid-related deaths.
Contrary to the impression left by most press coverage of the issue, opioid-related deaths do not usually involve drug-naive patients who accidentally get hooked while being treated for pain. Instead, they usually involve people with histories of substance abuse and psychological problems who use multiple drugs, not just opioids.
Conflating those two groups results in policies like the pill count that left Craig without the pain medication he needed to get out of bed in the morning, go to work, and lead a normal life. The rationale is that cutting people like him off will stop them from ending up dead of an overdose in a Walmart parking lot next to a baggie of fentanyl-laced heroin.
But the truth is that patients who take opioids for pain rarely become addicted. A 2018 study found that just 1 percent of people who took prescription pain medication following surgery showed signs of "opioid misuse," a broader category than addiction. Even when patients take opioids for chronic pain, only a small minority of them become addicted. The risk of fatal poisoning is even lower—on the order of two-hundredths of a percent annually, judging from a 2015 study.
Despite such reassuring numbers, the government is responding to the "opioid epidemic" as if opioid addiction were a disease caused by exposure to opioids, a simplistic view that ignores the personal, social, and economic factors that make these drugs attractive to some people. Treating pain medication as a disease vector, the government has restricted access to it by monitoring prescriptions, investigating doctors, and imposing new limits on how much can be prescribed, for how long, and under what circumstances. That approach hurts pain patients by depriving them of the analgesics they need to make their lives livable, and it hurts nonmedical users by driving them into a black market where the drugs are deadlier.
A large majority of opioid-related deaths now involve illicitly produced substances, primarily heroin and fentanyl. As usual, the government's efforts to get between people and the drugs they want have not prevented drug use, but they have made it more dangerous.
'Highly Addictive Drugs'
"We've known for millennia that opioids are highly addictive drugs," says Andrew Kolodny, executive director of Physicians for Responsible Opioid Prescribing. "We have an epidemic of people with the disease of opioid addiction in the United States. The reason it's become an epidemic is because opioids have been overprescribed by my colleagues, who were led to believe that we didn't have to worry about addiction."
Kolodny, who is also co-director of opioid policy research at Brandeis University's Heller School for Social Policy and Management, says the American Pain Society and the American Academy of Pain Medicine (AAPM) started to "advocate for opioids" in the late 1990s, taking the position that "the risk of addiction has been overblown, even that the risk of overdose death has been overblown, and that we should be prescribing much more for people with chronic pain." As a result, he says, "we got our patients addicted, and we stocked people's medicine chests with addiction, so their kids wound up getting addicted."
This gloss is superficially plausible. According to the U.S. Centers for Disease Control and Prevention (CDC), the amount of opioids prescribed in the United States more than quadrupled between 1999 and 2010, rising from 180 to 782 morphine milligram equivalents (MME) per capita. During the same period, according to CDC data, the annual number of deaths involving the kinds of opioids prescribed for pain also roughly quadrupled, from about 4,300 to about 18,500.
The relationship is not quite as straightforward as it might seem. Opioid prescriptions, measured by MME per capita, fell by nearly a fifth from 2010 to 2015, while deaths involving these drugs continued to rise. The CDC's numbers also indicate that deaths involving opioid pharmaceuticals are not always more common in states with higher prescription rates. In 2015, for instance, West Virginia's death rate was more than twice as high as Tennessee's, although it had fewer opioid prescriptions per capita. Rhode Island, New Mexico, and Utah had higher death rates than Oklahoma, where opioids were prescribed substantially more often.
Still, the expansion of the legal market for opioids obviously had something to do with the increase in illegal use of these drugs. Many of the pills were diverted to nonmedical users, either after they were prescribed or through theft from points higher in the distribution chain.
But greater availability of prescription opioids cannot by itself explain the rise in addiction and drug-related deaths. "The question is why so many communities were so vulnerable to developing problems with opioids in the first place," says Daniel Raymond, policy director at the Harm Reduction Coalition. Part of the answer, he thinks, can be found in the same factors that helped elect Donald Trump. "These pockets of the Rust Belt and Appalachia, with the loss of manufacturing jobs or traditional industry jobs, were extremely primed for developing a drug problem," he says. "It happened to be opioids, but it could have just as easily been—and arguably it has also been—alcohol or methamphetamine.
When Kolodny says "we got our patients addicted," he discounts the way unhappy circumstances, such as unemployment and dim economic prospects, make drug use more appealing. He also implies that pain treatment has been the main route to opioid addiction during the last two decades. But that is not what the evidence indicates.
According to a 2014 analysis of data from the National Survey on Drug Use and Health (NSDUH), 54 percent of nonmedical users got prescription opioids for free from friends or relatives. Another 16 percent bought or stole pills from friends or relatives, while 4 percent bought them from strangers. About 6 percent mentioned other sources, including online purchases, forged prescriptions, and theft from doctors' offices or pharmacies. Just 20 percent of nonmedical users said they obtained opioids through prescriptions written for them.
Although some people who now obtain opioids indirectly may have had prescriptions at some point, these results undercut the notion that nonmedical users typically start as bona fide patients. Even among the heaviest users, just 27 percent had prescriptions at the time of the survey, and it is not clear how many of those were legitimate at the outset. In most cases, says Sidney Schnoll, a physician specializing in addiction and pain treatment who works for the consulting firm Pinney Associates, "These are people who were drug-seeking. They are not people who went to a physician, got a prescription, and suddenly became addicted to the drug."
Stefan Kertesz, a University of Alabama at Birmingham internist who, like Schnoll, specializes in pain and addiction, agrees that the prevalence of iatrogenic opioid addiction (that is, addiction resulting from medical treatment) has been exaggerated. "I think a meaningful percentage did start in care of pain," he says, "but everything I've read leaves me with the sense that the overwhelming majority of the people who are dying of overdose began with diverted pills."
The NSDUH data reinforce the impression that doctors frequently prescribe more pain pills than their patients end up needing. People who take opioids after an injury or surgery might receive enough pills for two weeks but use only half of them. It seems likely that diverted opioids more often come from such short-term prescriptions than from medication prescribed for people suffering from severe chronic pain, who probably are not keen to share or sell the drugs that keep their agony at bay.
The fact that people frequently have leftover opioids that they give away, sell, or leave in their medicine cabinets to be swiped suggests these drugs are not quite as irresistible as they are reputed to be. According to NSDUH, 98 million Americans used prescription analgesics in 2015, legally and illegally. Judging from their responses to survey questions, about 2 million of them—slightly more than 2 percent—qualified for a diagnosis of "substance use disorder" (SUD) at some point during the previous year.
SUD is a catchall category that subsumes what used to be known as "substance abuse" and the more severe "substance dependence." The Substance Abuse and Mental Health Services Administration, which oversees NSDUH, does not report the breakdown between mild, moderate, and severe SUDs. But based on this survey, it looks like somewhere between 1 percent and 2 percent of prescription opioid users experience addiction in a given year. By comparison, NSDUH data indicate that 9 percent of past-year drinkers had an alcohol use disorder in 2015. That group was about evenly divided between "abuse" and "dependence."
'Narcotics Are Not That Appealing'
Stanton Peele, a psychologist and addiction expert, observes that, contrary to conventional wisdom, "narcotics are not that appealing" to most people. In addition to the NSDUH data, he cites research finding that hospital patients who are allowed to self-administer pain medication tend to take less than those who get it on a fixed schedule. "On their own," he says, "people only use it when they're in pain."
The notion that opioid addiction is "an equal-opportunity destroyer," as politicians and drug treatment boosters like to say—or that "everyone is at risk and every family prey to loss," as Mitchell Rosenthal, founder of the Phoenix House treatment centers, told the Christie commission—is "absolutely false," Peele says. To the contrary, opioid addiction is strongly associated with unemployment, poverty, family dysfunction, and pre-existing psychological issues. Well-adjusted people with supportive families, strong social ties, and good economic prospects are much less likely to seek refuge in opioids than people who lack those advantages. To put it another way, mere exposure to opioids does not produce addiction. A drug will become the focus of a tenacious habit only if it serves an important function in the user's life.
"I didn't realize how much I was trying to run away from myself," says Jill, a former heroin user from Ohio who has been anxious since childhood, received a diagnosis of obsessive compulsive disorder as an adult, and was a victim of sexual assault in college. "I wasn't really cognizant of how difficult it was to be in my own head. I'd had a lot of trauma that I wasn't dealing with, and everything was piling up. The appeal of heroin was it turned everything off. It was like a vacation." In rehab, Jill realized that other opioid users had similar issues. "They either have a trauma or a mental illness that they're trying to deal with," she says, "and nobody gave them the tools to do that."
Kolodny concedes that most people who use opioids do not develop an addiction. "You don't become addicted by using a highly addictive drug once or twice," he says. "You can use a highly addictive drug on an intermittent basis and not get addicted. It's repeated use that puts people at very high risk of becoming addicted."
But even in studies of patients who take pain medication repeatedly and regularly, sometimes for months or years, the addiction rates are generally modest. As Nora Volkow, director of the National Institute on Drug Abuse, and A. Thomas McLellan, a former deputy director of the Office of National Drug Control Policy, noted in a 2016 New England Journal of Medicine article, "Addiction occurs in only a small percentage of persons who are exposed to opioids—even among those with preexisting vulnerabilities."
A 2010 analysis in the Cochrane Database of Systematic Reviews found that less than 1 percent of patients taking opioids for chronic pain experienced addiction. A 2012 review in the journal Addiction likewise concluded that "opioid analgesics for chronic pain conditions are not associated with a major risk for developing dependence."
A study reported in The BMJ this year tracked 568,612 opioid-naive patients who took prescription pain medication following surgery and found that 5,906, or 1 percent, showed signs of "opioid misuse" during the course of the study, which included data from 2008 through 2016. Although some studies have described "rates of misuse, abuse, and addiction-related aberrant behaviors" as high as 26 percent among chronic pain patients, Volkow and McLellan reported, "rates of carefully diagnosed addiction" average less than 8 percent.
Fatal overdoses among patients are even rarer. A 2015 study reported in the journal PLOS One followed chronic pain patients treated with narcotics for up to 13 years and found that one in 550 died from an opioid-related overdose, which is a risk of less than 0.2 percent over the course of the study. A 2015 study of opioid-related deaths in North Carolina, reported in Pain Medicine, found 478 fatalities among 2.2 million residents who were prescribed opioids in 2010, an annual rate of 0.022 percent.
Kolodny cites a 2012 study of deaths involving prescription opioids in Utah, reported in the Journal of General Internal Medicine, to support his contention that iatrogenic addiction accounts for "the bulk of the overdose deaths." In 87 percent of the cases, relatives or other people who knew the decedents said they had received prescriptions for pain medication in the previous year.
Other studies, however, indicate that prescribed drugs play a smaller role in opioid-related fatalities than that number suggests. In the North Carolina study, only half of the decedents had active prescriptions for opioids when they died. A 2008 study of West Virginia deaths involving opioid analgesics, reported in the American Medical Association journal JAMA, found that most of the decedents had never been prescribed opioids. A 2012 study of opioid users in Maine, reported in Addictive Behaviors, found that two-fifths reported chronic pain, but more than three-quarters of those subjects said their opioid use preceded their symptoms. A 2014 study of people who were treated in emergency rooms for overdoses involving prescription opioids, reported in JAMA Internal Medicine, found that just 13 percent had a chronic pain diagnosis.
Even when someone who dies from drug poisoning has an opioid prescription, it does not necessarily mean he was a bona fide patient. Patients can fool doctors, and some doctors are eager to be fooled. "Pill mill" cases in Florida and West Virginia have involved doctors who saw as many as 70 patients a day, each of whom paid $100 to $300 in cash, and doctors who wrote prescriptions without meeting patients or looking at their files. Such examples do not tell us much, if anything, about legitimate patients who become addicted while being treated for pain.
Whatever share of people who die from drug poisoning began using opioids as legitimate patients, the share of patients taking opioids who die from drug poisoning is tiny—and the risk is not random. In the Utah study cited by Kolodny, 61 percent of the decedents had used illegal drugs, 80 percent had been hospitalized for substance abuse (including abuse of alcohol and illegal drugs as well as prescription medications), 56 percent had a history of mental illness, and 45 percent had been hospitalized for psychiatric reasons other than substance abuse.
NSDUH data indicate that most nonmedical users of prescription opioids use other drugs as well, a fact that is reflected in mortality data. In the West Virginia study, 79 percent of the deaths involved combinations of drugs. In North Carolina, benzodiazepines such as Valium and Xanax were detected in 61 percent of the people whose deaths were attributed to prescription opioids, and that's just one class of depressants. In New York City, which has one of the country's most thorough systems for recording causes of death, 97 percent of drug-related deaths involve more than one substance. A 2003 study of 919 deaths attributed to oxycodone, reported in the Journal of Analytical Toxicology, likewise found that 97 percent involved combinations of drugs.
It seems clear that people by and large are not dying simply by taking too many pain pills. Even Chris Christie's law-school friend washed down his Percocet with vodka.
What's true of prescription analgesics is also true of illegal opioids. So-called overdose deaths generally involve mixtures of drugs, as reflected in the toxicology results for celebrities such as John Belushi (heroin and cocaine), River Phoenix (heroin, cocaine, and diazepam), Chris Farley (heroin and cocaine), Cory Monteith (heroin and alcohol), and Philip Seymour Hoffman (heroin, cocaine, amphetamines, and benzodiazepines). It is misleading to call such deaths "overdoses" (as opposed to, say, "mixed drug intoxication," the phrase used by the medical examiner who handled Hoffman's case), since people who die after taking an opioid along with other substances might still be alive if they had taken the opioid by itself.
Heroin Gets Deadlier
As these examples suggest, attributing deaths to particular drugs can be tricky, especially since methods for making that determination vary widely from one jurisdiction to another. But one thing is clear: Prescription analgesics are no longer the main factor in opioid-related deaths. In 2013 and 2014, according to an analysis by the Massachusetts Department of Public Health, 85 percent of opioid-related fatalities in that state involved heroin and/or fentanyl. A prescription analgesic was the deadliest drug in just 5 percent of the cases.
National data show a similar pattern. The CDC says there were more than 42,000 opioid-related deaths in 2016, including about 15,500 deaths involving heroin. About 19,400 deaths involved "synthetic opioids other than methadone," a category that consists mainly of fentanyl and its analogues, which nowadays are generally manufactured by drug traffickers rather than pharmaceutical companies. Prescription analgesics were implicated in about 17,900 drug poisoning fatalities.
Since some deaths involve more than one opioid, the total is smaller than the sum of the subcategories. But the CDC's numbers indicate that just two-fifths of opioid-related deaths in 2016 involved prescription analgesics, and some of those deaths also involved heroin, fentanyl, or its analogues.
Fentanyl is roughly 40 times as potent as heroin, which helps explain its appeal to drug dealers, who can use it to smuggle more doses in the same volume and to boost the impact of heroin that has been diluted by cutting agents. The increased use of fentanyl makes the potency of black-market heroin, which was always unpredictable, even more variable, raising the risk of fatal drug poisoning.
Indeed, heroin-related deaths, which began rising gradually in 2005, quintupled between 2010 and 2016. Deaths involving the category of opioids that includes fentanyl more than tripled between 2010 and 2015, then doubled in 2016 alone.
During the same period when heroin-related deaths rose by 400 percent, the number of heroin users counted by NSDUH rose by just 53 percent. NSDUH probably misses a lot of heroin users, both because respondents are especially reluctant to admit using that drug and because the survey sample does not include people who are institutionalized or have no fixed residence. But the NSDUH data still should give us a pretty good sense of how much the group of heroin users has expanded, if not its absolute size. And those data indicate that the number of heroin deaths has increased roughly eight times as fast as the number of heroin users.
To put it another way, heroin was eight times deadlier in 2016 than it was in 2010. The proliferation of fentanyl-fortified heroin is the most obvious explanation.
A research team headed by Brown University medical anthropologist Jennifer Carroll found that fear of fentanyl was common among the Rhode Island opioid users they interviewed for a study reported in The International Journal of Drug Policy last year. "Participants who were aware of fentanyl universally described it as dangerous and potentially deadly," Carroll and her colleagues write. "People are dropping like flies," one heroin user said. "I don't want to die," said another, explaining why he buys heroin only from a dealer he trusts not to sell him fentanyl-laced powder. Others said they try to avoid fentanyl and take "test hits"—small trial doses—whenever they suspect it is present.
Many of the people who are dealing with black-market powders of unknown composition were previously accustomed to the predictable doses of legally manufactured analgesics. "I used to take just the pills, and then I started doing dope, the heroin, only when I could get it, when it was cheaper," said a female opioid user quoted by Carroll and her collaborators. "But I don't prefer it because you never know what you're getting. It's scary, so I'm more into pills."
She was right to be scared. Comparing deaths counted by the CDC to users counted by NSDUH indicates that heroin is more than 10 times as lethal as prescription opioids. Even if that calculation exaggerates the difference because NSDUH undercounts heroin users, it seems clear that switching from prescription opioids to black-market substitutes dramatically increases the risks that users face.
Despite the dangers, that sort of switch is much more common today than it used to be. A 2014 study of heroin users entering treatment, reported in JAMA Psychiatry, found that 80 percent of those who began using opioids in the 1960s started with heroin. By contrast, Washington University neuropharmacologist Theodore Cicero and three other researchers noted, 75 percent of those whose opioid abuse began in the 2000s "reported that their first regular opioid was a prescription drug." (That does not necessarily mean it was prescribed for them.)
A more recent study led by Cicero, reported last year in the journal Addictive Behaviors, suggests that trend has reversed. Cicero and his co-authors report that a 2015 survey of people entering treatment for opioid use disorder found 33 percent had started with heroin, up from 9 percent in 2005. That finding is consistent with the hypothesis that troubled people who find emotional relief in drugs will turn to whatever options are most readily available. During the period when Cicero found that more and more opioid users were starting with heroin, pain pills were becoming harder to obtain thanks to surveillance, tighter regulations, and investigations of doctors.
"As the most commonly prescribed opioids—hydrocodone and oxycodone—became less accessible due to supply-side interventions, the use of heroin as an initiating opioid has grown at an alarming rate," Cicero and his co-authors conclude. "Given that opioid novices have limited tolerance to opioids," they add, the variability in potency typical of the black market poses a special risk to them, which is "likely to be an important factor contributing to the growth in heroin-related overdose fatalities in recent years."
'You Have to Start Somewhere'
To the extent that the crackdown on prescription analgesics has made them more expensive and harder to get, it has pushed opioid users toward more dangerous drugs. That helps explain why total opioid-related fatalities more than tripled from 2002 to 2016, even as illegal use of pain pills declined.
"We're funneling them from those drugs that were FDA-approved, you know what the dose was, they were predictable, towards drugs that are less predictable and more likely to cause overdose," says Daniel Raymond, whose work at the Harm Reduction Coalition involves finding ways to make drug use less lethal. With legally produced opioids, he says, "I have this zone that I stay in, and that's anchored by the fact that I know exactly what dose is in each pill. If I'm buying heroin every day…I never know the relative potency and concentration that I'm getting. I might be going to different dealers, and one week there's fentanyl in my heroin, and the next week there's not. I cannot self-titrate. I cannot optimize my dosing to stay within that window where I'm not going through withdrawal but I'm not at risk of overdose."
In a 2017 interview with the Carlisle Sentinel, Carrie DeLone, Pennsylvania's former physician general, confessed that "we knew that this was going to be an issue, that we were going to push addicts in a direction that was going to be more deadly." Her justification: "You have to start somewhere."
For a sense of where that attitude can lead, consider what happened after the reformulation of OxyContin. Introduced in 1996, the drug was widely blamed for the subsequent rise in opioid-related deaths, even though most of those deaths actually involved short-acting pain pills.
In 2007, Purdue Pharma, the company that makes OxyContin, pleaded guilty to "misbranding" the product by minimizing its abuse potential. Three years later, the Food and Drug Administration approved a new, "abuse-deterrent" formulation of the drug, which was designed to make it harder to crush and snort or inject. When the reformulated OxyContin is mixed with water, it forms a gel.
The old version of OxyContin was withdrawn from the market when the new one was introduced, a switch that coincided with the post-2010 spike in heroin-related deaths. In a 2017 paper published by the National Bureau of Economic Research, Wharton School health economist Abby Alpert and two RAND Corp. researchers investigate whether those developments were related by comparing states with different pre-2010 rates of nonmedical OxyContin use.
"We estimate large differential increases in heroin deaths immediately after reformulation in states with the highest initial rates of OxyContin misuse," Alpert and her colleagues write. "Our results imply that a substantial share of the dramatic increase in heroin deaths since 2010"—perhaps as much as 80 percent—"can be attributed to the reformulation of OxyContin." They conclude that the increase in heroin-related fatalities offset any decrease in OxyContin-related fatalities, "leading to no net reduction in overall overdose deaths."
There is some evidence that prescription drug monitoring programs, which allow regulators and law enforcement agencies to track the controlled substances a doctor prescribes, also have led people to substitute illicitly produced drugs for pills. A 2017 study reported in The American Journal of Managed Care found that such programs, which by 2015 had been adopted by every state except Missouri, "were not associated with reductions in drug overdose mortality rates and may be related to increased mortality from illicit drugs and other, unspecified drugs."
Harm Maximization
Responding to the shift from prescription analgesics to heroin and fentanyl, drug warriors have further magnified the dangers opioid users face by cracking down on those markets. A heroin user who tries to avoid fentanyl by sticking with a dealer he deems trustworthy may face increased risks if that dealer is arrested. Similarly, the FBI may be endangering drug users when it shuts down websites that help reduce hazards to consumers by selling fentanyl-free heroin or offering opioids in uniform liquids that make dosing easier.
Arresting opioid users also increases the risk of a fatal drug reaction, since abstinence imposed by jail or mandatory treatment reduces their tolerance. Once they get out, the doses to which they were accustomed before they were arrested may prove lethal. "There's one study that shows that someone's risk of overdose in the two weeks following their release from incarceration is up to 25 times higher than it is normally," says Carroll, the Brown University medical anthropologist. "People are overdosing right after they get out of prison."
Another policy that almost seems designed to make fatal poisoning more common is charging people with homicide if someone dies after taking a drug they supplied. Because prompt medical attention is crucial in saving people from potentially lethal opioid reactions, 40 states and the District Columbia have enacted "911 Good Samaritan" laws that shield bystanders from certain drug-related charges when they call for help. But if those bystanders know they might be prosecuted for murder should rescue attempts fail, they will think twice before dialing 911.
According to a 2017 report from the Drug Policy Alliance (DPA), 20 states have laws that specifically address drug-induced homicide, while others "charge the offense of drug delivery resulting in death under various felony-murder, depraved heart, or involuntary or voluntary manslaughter laws." Potential prison sentences range from two years to life, which is the minimum penalty in six states; the death penalty is possible in Colorado and Florida. Under federal law, drug distribution resulting in death or serious injury is punishable by 20 years to life. These statutes have been on the books since the 1980s, but prosecutions seem to have risen sharply in recent years, judging from mentions in news stories, which by the DPA's count more than tripled between 2011 and 2016, from 363 to 1,178 per year.
Although politicians may claim that drug-induced homicide prosecutions are aimed at high-level dealers, the targets are usually people close to the decedents. Someone's role in "distributing" the drug may be limited to buying it for someone else or sharing a stash. Even when money changes hands, the dealers are often selling just enough to finance their own habits. Cases cited by the DPA include a small-time New Hampshire dealer who did not realize the heroin he sold a friend contained fentanyl but got 10 to 30 years anyway, an Ohio woman who got three years after she took heroin with her father and woke up to find him dead, and a Minnesota woman who got six years because her husband died after taking methadone prescribed for her, even though she called 911 and tried to save his life.
"The vast majority of charges," the DPA says, "are sought against those in the best positions to seek medical assistance for overdose victims—family, friends, acquaintances, and people who sell small amounts of drugs, often to support their own drug dependence." The report concludes that "the only behavior that is deterred by drug-induced homicide prosecutions is the seeking of life-saving medical assistance."
One widely endorsed policy that actually holds promise for reducing drug-related deaths is easier access to naloxone, a.k.a. Narcan, an overdose-reversing opioid antagonist that can be administered by injection or nasal spray. Dispensing naloxone along with pain medications, making it available without a prescription (which 41 states currently allow), supplying it to first responders, and distributing it to friends and relatives of opioid users are ways to increase the odds that it will be used promptly when someone needs it. Speed is especially important when a person overdoses on fentanyl, which can cause lethal respiratory depression faster than heroin.
"I have a four-milligram Narcan in my purse right now," says Jill, the former heroin user in Ohio, who adds that she has "Narcanned" friends "probably dozens" of times. "You hope you don't have to use it, but you might have to. Everyone should have one. That is the only way that I can see the epidemic being managed at all."
For some drug warriors, naloxone's lifesaving potential is a bug, not a feature. In 2016 Maine Gov. Paul LePage, a Republican, vetoed a bill allowing pharmacists to dispense naloxone without a prescription. "Naloxone does not truly save lives; it merely extends them until the next overdose," he wrote in his veto letter. "Creating a situation where an addict has a heroin needle in one hand and a shot of naloxone in the other produces a sense of normalcy and security around heroin use that serves only to perpetuate the cycle of addiction."
LePage's argument is familiar from the debate over needle exchange programs: For the sake of deterrence, he thinks, drug use should be as dangerous as possible. Maine legislators, who overrode LePage's veto, apparently disagreed.
How to Not Die
Drug testing is another promising form of self-help. Test strips and reagent kits that cost a dollar or two each can tell opioid users if the powder they just bought contains fentanyl. Some tests also detect common fentanyl analogues. A recent pilot study in Vancouver found that 83 percent of drugs thought to be heroin tested positive for fentanyl. Drug users were 10 times as likely to take less than usual and 25 percent less likely to overdose if they tested their drugs before injecting.
"It becomes this concrete, physical manifestation that opens up a conversation about fentanyl risks," the Harm Reduction Coalition's Raymond says. "If we've got fentanyl in our community, whatever you've been doing to minimize or avoid overdose, you need to up your game because it might not be enough against fentanyl. If you're careful about how much you use, if you're careful about what dealers you buy from, you might need to start thinking about not using alone and making sure you've got extra naloxone on hand."
The fact that drug mixtures figure in the vast majority of deaths involving heroin and other opioids suggests that discouraging particularly dangerous combinations could save lives—assuming it actually has an impact on people's behavior. "I think there's a huge role for education around that," Carroll says, citing a spate of heroin-related deaths in the late 1990s among high school students in Plano, Texas, some of whom died after snorting the drug while drinking. "It was just a pure educational gap, because I don't think there was any reason to believe that anyone was being deliberately cavalier. Educating people about how to not die is always worth our time."
Jill, the former heroin user, is less sanguine. "You're telling somebody, 'Don't mix benzos with heroin because it potentiates the heroin,'" she says. "They will mix the benzos with the heroin because they want to potentiate the heroin. One of the earliest things I learned was that if you take benzos it'll make your high better."
Raymond agrees that people who like to mix drugs and have done it repeatedly without any close calls won't be very receptive to the message that they are being reckless. "What we want to address is the environment of risk," he says. "And we can do that by saying, 'Hey, make sure that you have naloxone available. Don't use alone.' We can do that by talking about things like supervised injection facilities."
Such facilities provide a safe environment where people can take drugs they bring with them under medical supervision and get help immediately if they need it. The facilities may also offer services such as drug testing, syringe exchange, and assistance finding treatment. Studies of Insite, a supervised injection facility that has been operating since 2003 in Vancouver, have found that it boosted treatment admissions and reduced public drug use, needle sharing, and opioid-related deaths without raising local crime rates.
As a risk reduction strategy, letting people inject drugs at a place like Insite represents a distinct improvement over having them do it in the restroom at the public library in the hope that if they overdose they'll be discovered before it's too late. The first government-sanctioned supervised injection facilities in the United States are expected to open this summer in San Francisco. Officials in Seattle and Philadelphia are also interested in the idea.
Raymond notes that naloxone and needle exchanges "have gained increasing acceptability and, to varying degrees, lost their aura of controversy." But now that policy makers are beginning to talk about allowing supervised injection facilities, he says, "it's almost like a flashback to the '90s," when opponents of syringe exchanges argued that they should not be allowed because they encourage drug use. "It forces people to confront the question of how we feel about people using drugs and what are we willing to do to save their lives," he says. "The fact that it's even on the table is a testament to how far we've come."
So-called medication-assisted treatment, which combines counseling and behavioral therapy with substitute opioids, is not as controversial as supervised injection facilities. Research indicates that methadone, which has been used as a treatment for heroin addiction since the 1960s, reduces treatment dropout rates, heroin use, drug-related fatalities, and criminal activity. Buprenorphine seems to be about as effective as methadone at keeping users in treatment, reducing heroin use, and preventing premature death. Methadone is very strictly regulated, available only at special clinics that enrollees must visit to consume their daily doses. Buprenorphine is more widely available, but caps on the number of people a doctor can treat and conditions for prescribing it, including at least eight hours of special training and a federal waiver, make it harder to get than it should be.
Methadone and buprenorphine are the only opioids that can legally be prescribed for addiction treatment or maintenance in the United States. A wider range of options, including analgesics such as hydromorphone (a.k.a. Dilaudid) or diacetylmorphine (a.k.a. pharmaceutical heroin), probably would make treatment more attractive and therefore more effective for a wider range of people. Heroin is banned for all uses in the United States, but heroin maintenance is legal in Belgium, Canada, Denmark, Germany, Great Britain, the Netherlands, and Switzerland. Studies show it is more effective than methadone at promoting retention, reducing illicit drug use, and improving health outcomes.
Heroin maintenance "can be effective for people who have not had success with something like methadone," Raymond says. Even for people who eventually end up on methadone, "it may be an intermediate step to transition people off of a street supply of heroin." That switch alone would improve the odds of survival, since the potency of legally produced opioids is consistent and predictable.
"It's not clear at all, when we review the data, that there's a painkiller epidemic or a heroin addiction epidemic," Peele, the psychologist, says. "There's a death epidemic, and the way to address that is to guarantee the best, most regular, and purest supplies of drugs." Schnoll, the pain and addiction specialist, agrees that "if people can get their drug at a reasonable cost, knowing the purity of it, being able to use it safely, people are going to migrate to that."
Punishing Patients
In contrast with these harm reduction tactics, continuing attempts to discourage the use of prescription pain medication promise to cause a lot of needless suffering without making a noticeable dent in opioid-related deaths. Prescription guidelines that the CDC issued in March 2016, which minimize the benefits of opioids, exaggerate their risks, and encourage doctors to be stingy with them, exemplify this misguided strategy.
A 2016 critique published by the journal Pain Practice challenges several key aspects of the CDC document, including its recommended dose ceilings, its general declaration that nonopioid treatment is "preferred for chronic pain," its suggestion that opioid prescriptions for acute pain last no longer than seven days, and its statement that doctors who decide to prescribe opioids should begin with immediate-release products rather than extended-release or long-acting (ER/LA) analgesics.
The criticism of that last recommendation sums up what is wrong with the guidelines in general. "It appears that this statement is asking physicians to make prescribing choices based on public health concerns…rather than the most appropriate course of therapy for the individual patient," write pain specialist Joseph Pergolizzi and the six other authors of the Pain Practice article. "If prescribers must forego the use of ER/LA opioids in patients who could possibly benefit from them, it essentially punishes the chronic pain patient for offenses committed by drug abusers."
The CDC guidelines in themselves are not legally binding. But Congress has imposed them on the Department of Veterans Affairs (V.A.), and at least 18 states have enacted elements of them. In 2016 and 2017, according to a tally by the National Conference of State Legislatures, 14 states imposed limits on the duration of initial prescriptions for acute pain, ranging from three days (Kentucky) to two weeks (Nevada), with seven days the most common. Arizona enacted a similar law in January. Four states (Arizona, Maine, Nevada, and Rhode Island) have imposed daily dose ceilings, while Maryland limited opioid prescriptions to "the lowest effective dose" and a quantity "not greater than needed for the expected duration of pain." The legislatures of seven other states directed or authorized other bodies to impose limits on opioid prescriptions.
In addition to these statutory changes, the CDC guidelines are shaping the policies and practices of regulators, insurers, and law enforcement agencies. Doctors face "pressure from many directions," the University of Alabama at Birmingham's Kertesz notes. That includes "scrutiny from state officials," "barriers from insurance and pharmacy benefit plans," "more restrictive guidelines from state licensing boards," "stories of some physicians losing their livelihoods and being shut down," and "super-intense rhetoric from thought leaders and journalists," who tend to blame physicians for causing the "opioid epidemic" through careless prescribing. "Under that kind of pressure," Kertesz says, "who wouldn't change what they're doing, even if it hurts a few patients?"
Some physicians have decided the safest course is to stop prescribing opioids altogether. "There are many pain clinics flooded with patients who have been treated previously by their primary care physician," says Jianguo Cheng, president-elect of the AAPM. These refugees include patients who "have been functional" and "responding well" to opioids for "many years."
Schnoll sees similar problems. "Pain is still undertreated, and unfortunately it's getting worse because of the backlash that's occurring," he says. "I still get calls from patients whom I treated years ago, who were on stable doses of medication, doing very well, who have chronic pain conditions, and they can't get medication to treat their pain. They're being taken off medication on which they had done very well for years."
One such patient, a former cable company salesman named John, successfully used OxyContin to treat the back pain caused by injuries sustained during a mugging in 2011. Before he found a medication that worked for him, he recalls, "my wife was about to leave me, because I was a miserable bastard. When you're in that much pain, you want to just go to sleep and not wake up."
After the CDC guidelines came out, John was told that his daily dosage had to be cut in half. "My whole life turned upside down in a matter of 30 days," he says. "I'm back in bed now. I can't really get up very much, and I'm right back where I started in 2011."
'Can't Take It Anymore'
Maxx Lamb, a Kansas college student, became a pain treatment activist as a result of his experience with Ehlers-Danlos syndrome, a hereditary connective tissue disorder. He sent me a photograph of a sign at a doctor's office in Washington state that reflects the impact of the CDC's guidelines. "Beginning February 2017," it says, "Morphine Equivalency Dosing WILL decrease until CDC guidelines are met by June 2017. Target is 90mg of Morphine equivalency per day, or less. All medication adjustments will be based on this new clinic policy."
The CDC guidelines do not explicitly say patients should never exceed 90 morphine milligram equivalents a day, but they do suggest that such doses are hard to defend. "Clinicians should use caution when prescribing opioids at any dosage," the CDC says, and "should carefully reassess evidence of individual benefits and risks when considering increasing dosage" to 50 MME per day or more. The guidance adds that doctors "should avoid increasing dosage" above 90 MME per day, or at least "carefully justify a decision to titrate dosage" above that level.
Although the CDC implies there is something special about these numbers, the study of opioid-related deaths in North Carolina found that "dose-dependent opioid overdose risk among patients increased gradually and did not show evidence of a distinct risk threshold." Critics see the CDC's cutoffs as arbitrary, since patients vary widely in the way they metabolize and respond to opioids, especially if they have developed tolerance after years of treatment.
"There seems to be no clear clinical evidence that opioid risks increase with 50 MME/day or that doses should never exceed 90 MME/day in any patient," Pergolizzi et al. write. "It seems unnecessary and counterproductive to decrease a patient's dose of opioids just to achieve an arbitrary limit."
CDC officials say they do not want doctors to impose dose reductions on patients. "We do hear stories about people being involuntarily taken off opioids," Deborah Dowell, a co-author of the guidelines, said at an April 2017 conference. "We specifically advise against that in the guidelines."
That's not exactly true, but the guidelines do describe tapering as a consensual process. The CDC says "clinicians should work with patients to reduce opioid dosage or to discontinue opioids" if they determine that the risks outweigh the benefits. It notes that "tapering opioids can be especially challenging after years on high dosages" but says "these patients should be offered the opportunity to re-evaluate their continued use of opioids at high dosages."
In many cases, that "opportunity" has become a unilateral decision. "Even though it is not specified in the CDC guidelines to do this," Kertesz says, "I am seeing many physicians in my region and across the country taper patients against their will. They're tapering stable patients who were not violating the rules of the practice, who were basically functional. Physicians are tapering them without consent, often in a draconian fashion, and in many cases simply discharging the patient from the practice and just ending the clinical relationship."
Lynn Webster, a pain researcher and former AAPM president, says he gets emails almost every day from desperate patients. Many had been taking doses of opioids that controlled their pain well enough for them to work and "have a reasonable life…maybe for a decade or more." Now, "because they're being forced to take a dose far less than what has been necessary to keep them functional," they are bedridden.
Other patients "have been told by their doctors that they're taking them off all of their medicines," Webster says. Many of them "don't have any idea where to go to get help." Some say "the only option they have is suicide."
Kertesz quotes a doctor at "a large integrated care system" who reported that "the situation of chaotic and involuntary tapers was brought home to me by a patient who shot himself in our parking lot." That patient survived. Others have not.
Lamb, the pain treatment activist, has compiled a list of two dozen patients who have committed suicide in the last few years after they were denied adequate pain treatment. They include Allison Kimberly, a 30-year-old Colorado woman with interstitial cystitis, who killed herself in June 2017 after an emergency room turned her away.
"I was rushed to the ER because my pain was so out of control I couldn't take it anymore," Kimberly wrote on Instagram. "I got ZERO help. After 7 hours I was discharged. The nurse has the nerve to say that my kind of pain shouldn't be that bad and basically I was faking for medication. I am so beside myself I am shaking as I type this. Screaming and begging in pain, needing any kind of help they'd give me and I was just sent home."
Kevin Keller, a 52-year-old Navy veteran with severe pain following a stroke, shot himself in the head with a friend's gun in July 2014 after the local V.A. hospital cut his opioid dose. "SORRY I BROKE INTO YOUR HOUSE AND TOOK YOUR GUN TO END THE PAIN!" he wrote in a note to his friend. "FU VA!!! CAN'T TAKE IT ANYMORE."
Keller's dose reduction seems to have been part of the department's so-called Opioid Safety Initiative, which began in October 2013. A Veterans Affairs "fact sheet" brags that the program reduced the number of patients receiving opioids by a third. According to a V.A. analysis, "opioid discontinuation was not associated with overdose mortality but was associated with increased suicide mortality."
Lamb says the medication he uses to control his pain, fentanyl patches supplemented by hydromorphone pills, is "the difference between wanting to put a bullet in your brain and enjoying life." Despite the huge improvement opioids have made for him, Lamb had a hard time finding someone to continue his treatment after his doctor curtailed his pain practice in 2017. Most physicians in his area "explicitly state they do not do medication management," he says. "I've been having lots and lots of trouble finding another physician. If I can't find one, the natural physiological consequences of severe pain will kill me."

Kertesz says "our focus on pill control" is driven partly by "a recognition that there was a failure to prescribe carefully" but also by "institutional and legal interests seizing on what looks like a simple answer to a complex problem," heedless of the human costs. "We're engaged in a stampede that is trampling people to death," he says, "and those people need to be protected."

Return to headline | Return to top
Another harsh truth about opioids: They’re not a better way to manage pain (Opinion)

Mar 12, 2018 | Washington Post

By Editorial Board

OPIOID OVERDOSES, both fatal and nonfatal, increased 30 percent from July 2016 through September 2017 in 52 areas in 45 states, according to the latest review of emergency-room admissions data by the Centers for Disease Control and Prevention, published Tuesday. On the same day, the Journal of the American Medical Association released the results of a year-long study from Minneapolis-area Veterans Affairs clinics showing that opioids were no more effective against common forms of back and joint pain than acetaminophen. These new findings underscore a tragic irony of the deadly epidemic: Though it has by now morphed into a problem of both licit substances, such as hydrocodone and oxycodone, and illicit ones, such as heroin, the opioid epidemic’s roots lie in a wave of permissive prescribing of opioids that turns out, in hindsight, to have been unjustifiable even as good pain-management practice.
That permissiveness did not just happen. Long-standing medical caution, based on fears of addiction, had to be overcome if pharmaceutical companies were to boost sales. About two decades ago, firms began aggressively marketing opioids, including funding ostensibly expert medical opinion and ostensibly grass-roots “patient advocacy,” with names such as the American Academy of Pain Management and the U.S. Pain Foundation.
Which brings us to a recent report on chronic-pain advocacy organizations, published by Claire McCaskill (Mo.), the ranking Democrat on the Senate Homeland Security and Governmental Affairs Committee. The report shows that nearly $9 million flowed from opioid manufacturers to some 14 nonprofits between January 2012 and March 2017. Individual doctors affiliated with these groups accepted more than $1.6 million in speaking fees and other payments from the opioid industry between 2013 and the present. Most of the groups touted the benefits of opioid prescriptions and raised objections to the most significant recent federal effort to rein in excessive opioid prescribing, the CDC’s 2016 guidelines.
Useful as it is, the McCaskill study arrives after a quarter-century in which opioids have already killed hundreds of thousands of people. As the backlash has grown, including with class-action lawsuits, opioid makers have shied away from the most aggressive marketing tactics, such as support for ostensibly neutral patient and professional groups. PurduePharma , maker of OxyContin, recently announced it will no longer market the drug directly to doctors. The flow of funds documented by Ms. McCaskill probably represents only a fraction of what went on before 2012, when opioid prescribing seems to have peaked.
There is still no legal requirement to disclose industry connections, only an ethical one. And the 14 organizations in the study tend to interpret that duty minimally. Before Ms. McCaskill’s staff inquired, some disclosed no information on a regular basis; others listed companies by name, indicating that they gave “at least” a certain amount; but none provided full disclosure of names, specific amounts and purposes of the donations. The opioid-makers and the nonprofits they supported, ostensibly on behalf of pain patients, have lost credibility in recent years. If they want to recover it, they are going to have to do better.

Return to headline | Return to top
Questions And Answers About Opioids And Chronic Pain

Mar 12, 2018 | NPR

By Ari Shapiro

Millions of Americans use opioids to relieve pain. But many also struggle with addiction.
This week, a report in JAMA, the journal of the American Medical Association, found that nonopioid painkillers — like acetaminophen and ibuprofen — were as effective as opioids at treating chronic back, hip and knee pain, and with fewer side effects.
The findings raise a lot of questions about the right approach to managing pain, particularly chronic pain. So earlier this week, we asked listeners on Facebook and Twitter to share their questions about treating chronic pain.
For answers, NPR's Ari Shapiro turned to Dr. Ajay Wasan, professor and vice chair for pain medicine at the University of Pittsburgh Medical Center.
Questions and answers have been edited for length and clarity.
Isn't it true that ... acetaminophen can be very damaging to the liver, particularly with daily long-term use? — Emma Juneau
For treatment of chronic pain, especially arthritis pain, higher doses of acetaminophen have been recommended, and there are good studies supporting that it can be quite effective for pain. You get a cumulative effect with the higher doses.
Those can also be associated with a rise in liver enzymes for some people. It would be very rare for those enzymes to reach a toxic level that would cause liver damage, but we don't know what percent of people get that little rise in liver enzymes, or the chances that a slight increase in liver enzymes will lead to liver damage.
It raises a very excellent point, that nonopiate medications have some side effects as well. We know anti-inflammatories can have significant side effects — in general the side effects of opioids are greater — but both nonopioids and opioids do have side effects.
Why isn't acupuncture part of the discussion as an alternative for opioids? It seems like a simple, noninvasive, nonaddictive alternative to painkillers, but most insurance plans don't cover it for this purpose. Is there any work being done to evaluate its effectiveness? — Rachel Esser of Tampa, Fla.
There's a lot of research going on for the effectiveness and the mechanisms for acupuncture. The literature suggests that for chronic low back pain, and chronic knee arthritis pain, acupuncture can be effective. Just like many treatments for chronic pain, it tends to be a subset of people, approximately 20-30 percent, that get significant improvement with acupuncture.
And it's a good point as to why it's not better covered, because many of our treatments for chronic pain really only confer improvement to 20 to 30 percent of people. We often have to try different things and combine different treatments — the term we use is multimodal pain treatment.
The other thing is this issue of insurance coverage. A lot of physicians, like myself, have pushed for that, and there are a few more progressive insurance companies that are starting to cover acupuncture. University of Pittsburgh medical center does have some coverage for acupuncture in their health plan, but it's an outlier.
Another listener points out that physical therapy, which can help ease pain, is far more expensive than an opioid prescription. Is there an important role for insurers here?
This is a wonderful point, and it's such a vexing issue for anyone who treats chronic pain. Some of the treatments that have been proven more effective, and safer, and have better outcomes, such as physical therapy, may have a $20 to $40 copay, for each visit, versus an opioid which might have a $5 copay for an entire month's supply.
So it's a huge problem that insurance companies, I think, need to contend with across the country. There are all sorts of hidden additional costs with prescribing an opioid, and in the long run, it may be that using these nonopioid approaches, like physical therapy, and other medications, really provides the best improvement in chronic pain but also lowers costs.
I used to take up to three Percocets a day for pain related to surgeries and injuries, but a couple years ago my doctor told me he was being pressured to stop prescribing opioids for chronic pain. So I switched to medical marijuana, and it's working fine. How widely is this being discussed in pain medicine — marijuana instead of opioids? — Gary Price, Colorado
This is a really hot topic in the field of chronic pain. Very recently, the state of Pennsylvania has a medical marijuana law, and it's starting to be available here in Pittsburgh. When you look at all the studies, you see some of the same patterns for the effectiveness of medical marijuana as you see for a lot of our other chronic pain treatments.
For neuropathic pain, which is pain related to nerve damage, or nerves not functioning properly, you can see some evidence for medical marijuana's effectiveness. Some patients do respond, and do get better, but it's only about 20 or 30 percent on average. It's amazing how that figure creeps up on many of the chronic pain treatments we have — 20 to 30 percent of patients will get a significant response.
The other point is this idea of using medical marijuana instead of opioids. There's very little data on that, but it's an issue that many pain specialists are starting to explore. If it's reasonable to certify someone on medical marijuana, can you use that as a way to decrease the use of opioids?
Since there's a wide menu of options besides opioids, why do you think millions of Americans every year use opioids — and likely a much smaller number of people are using all of these other things that we're talking about?
The recent study in JAMA gets to this issue nicely.
A key message from that study is that if you're treating chronic pain, and you prescribe opioids or nonopioids, both groups of patients get significantly better. More than 50 percent in both groups had significant improvements in pain or function.
So you can understand why opioids might be prescribed first, because they still are, and always will be, regarded as some of the most powerful analgesics that we have.
There's a second part to this: If the nonopioid medications and modalities, like physical therapy, aren't readily available to patients, and the resources aren't there for comprehensive pain treatment, then you can imagine that the default option becomes opioids. Patients do get better on them. It may not be a very long lasting effect, we don't know. But that may be the only tool, sadly, that many physicians have available to them at the time.
After my husband had surgery, the discharge doctor wrote him a 30-day opioid prescription. When I asked her, "Why are you prescribing 30 days?" she said, "Well, that's just how it's done."
I was pretty shocked by this. What kind of education or policy or procedures are being put in place for discharging physicians or others? — Linda, North Carolina, who asked that we not use her last name to protect her family's privacy
This is a really hot topic in the fields of surgery and anesthesiology, and there have been a number of studies that have come out in the past few years looking exactly at this issue, and trying to get at the exact amount of time that someone should be prescribed opioids after surgery. It may vary by surgery.
It's an issue that many, many health care systems, including ours, are really tackling to avoid prolonged opioid use after surgery.
Now that the opioid crisis is on everyone's mind, why do I feel like a bad person? Why am I looked at suspiciously by medical personnel? Am I wrong to want to continue taking the drug that alleviates my torturous pain? — Barbara Huffman, Lawrenceville, Ga.
We see this so much as pain specialists, that patients who have been on appropriate doses of opioids, for appropriate time, and doing very well, having good pain control, do get stigmatized. And that's an important negative consequence of the opioid epidemic and the increased scrutiny.
Patients that are prescribed opioids for pain are not the same as people who use opioids for the psychoactive effect, such as using them to get high.
Of course there are people with chronic pain who can become addicted, but that is a very tiny subset, really, of patients.
I've taken prescription opioids for 15 years, after trying many other options. Opiates have been a godsend to a certain factor of the population that suffers horrible pain. We are not terminal cancer patients; we are people with a life ahead of us if only we could live it. We, the patients, are terrified of being swept up in the storm of opiate rejection and having our medicines taken away from us. Should people be worried? — Helen Stevens, Hagerstown, Md.
One of the key things that the recent study in JAMA, and others, try and can't answer ... is ... what do you do if the nonopioids don't work? Is it reasonable to put people on opioids?
And there is literature that suggests yes. All pain specialists have patients in their practice who do well on opioids for many years; many of them are on lower doses and do not have tolerance.
It's all about this issue of responders and nonresponders. When you read studies, they average everyone together. So some people do well on opioids and some people do poorly, but there's always a spread. And that's a key thing that's missing from the debate, and the controversy.
There are responders and nonresponders, and we need to do a better job of identifying them, and also spreading that word to physicians, that there are people who can be on opioids for many years without having any problems with addiction or abuse.
My mother has been taking hydrocodone for the last five years for everything from back pain from a car accident to chronic migraines. Aside from IBS, what long-term health effects are there to consider? — Ryan McMillan, Texas
So there are a lot of long-term side effects, potentially. Some of them are dose related, but there aren't that many studies tracking people who are on opioids for more than 12 months.
Besides the gastrointestinal effects, decreased testosterone can affect men and women, and that might lead to early osteoporosis. You can have other effects on your adrenal gland, and your ability to make cortisol. It can affect the immune system, so the immune system doesn't get compromised, but immunity as a whole does not seem as strong. These are associations, so there's no causality, but long-term opioid use is associated with a slightly higher risk of cancer.
Opioids can increase the chances that people can become depressed, if they have chronic pain. That's a difficult thing to tease out, but even when you account for all these various associations between pain and depression, it does seem that the opioids themselves are associated with a higher rate of developing depression. Because they are, as a class of drugs, depressants.

Return to headline | Return to top
McCaskill plans a bill to force pharma to disclose payments to nonprofits and advocacy groups

Mar 9, 2018 | STAT News

By Ed Silverman

Seeking to toughen the Sunshine Act, Sen. Claire McCaskill (D-Mo.) plans to introduce a bill that would require drug makers to report payments that are made to nonprofit organizations and patient advocacy groups, according to several sources familiar with the effort.
The move comes eight years after the Sunshine Act was created in response to concerns that industry payments were unduly influencing medical research and practice, an issue that arose after a Senate Finance Committee probe. The law was subsequently folded into the Affordable Care Act and a federal database was launched in 2014 to which companies must report payments to physicians.
The remainder of this article is under paywall: https://www.statnews.com/pharmalot/2018/03/09/mccaskill-pharma-payments-opioids/

Return to headline | Return to top
Trump officials study death penalty for drug dealers in opioid epidemic

Mar 9, 2018 | Washington Post

By Katie Zezima and Josh Dawsey

The Trump administration is studying new policy that could allow prosecutors to seek the death penalty for drug dealers, according to people with knowledge of the discussions, a sign that the White House wants to make a strong statement in addressing the opioid crisis.
President Donald Trump last week suggested executing drug dealers as a way to make a dent in opioid addiction. Opioids killed nearly 64,000 people in 2016, and the crisis is straining local health and emergency services.
People familiar with the discussions said that the president's Domestic Policy Council and the Department of Justice are studying potential policy changes and that a final announcement could come within weeks. The White House has said one approach it might take is to make trafficking large quantities of fentanyl - a powerful synthetic opioid - a capital crime because even small amounts of the drug can be fatal. White House officials also are studying tougher noncapital penalties for large-scale dealers.
Trump said last week that the administration would soon roll out unspecified "strong" policies on opioids. White House officials said Trump has privately expressed interest in Singapore's policy of executing drug dealers.
"Some countries have a very tough penalty, the ultimate penalty, and they have much less of a drug problem than we do," Trump said during an appearance at a White House summit on opioids last week.
Trump also has endorsed Philippine President Rodrigo Duterte's approach to the issue; Duterte's "drug war" has led to the deaths of thousands of people by extrajudicial police killings. Last year, Trump praised Duterte in a phone call for doing an "unbelievable job on the drug problem," according to the New York Times.
Kellyanne Conway, counselor to the president, is leading much of the work on opioids for the White House. Singaporean representatives have briefed senior White House officials on their country's drug policies, which include treatment and education, but also the death penalty, and they provided a PowerPoint presentation on that country's laws.
Singapore's model is more in line with the administration's goals for drug policy than some other countries, a senior administration official said.
"That is seen as the holistic approach that approximates what this White House is trying to do," a senior administration official said.
The Department of Justice declined to comment on the policy discussion. A White House spokesman did not respond to a request for comment Friday.
Federal law currently allows for the death penalty to be applied in four types of drug-related cases, according to the Death Penalty Information Center: murder committed during a drug-related drive-by shooting, murder committed with the use of a firearm during a drug trafficking crime, murder related to drug trafficking and the death of a law enforcement officer that relates to drugs.
Peter Meyers, a professor at the George Washington University School of Law, said he doesn't agree with the idea of adding more capital crimes for drug dealers, but he said it could be a legal approach: "It very likely would be constitutional if they want to do it."
The administration's directives come as prosecutors nationwide are cracking down on higher-level drug dealers and law enforcement officials are looking at increased penalties for fentanyl trafficking and dealing. But at the same time, public health officials - including those in the Trump administration - and many in law enforcement are emphasizing treatment rather than punitive measures for low-level users and those addicted to drugs.
Attorney General Jeff Sessions has directed federal prosecutors to pursue the most severe penalties for drug offenses. The Department of Justice said last year it will aggressively prosecute traffickers of any fentanyl-related substance.
Some argue executing drug dealers could have a raft of unintended consequences, such as deterring people from calling police when they know someone is overdosing.
While news of capital charges against a drug dealer would spread quickly and possibly be a deterrent, said Daniel Ciccarone, a professor of family and community medicine at the University of California at San Francisco, it could also drive drug users underground.
"It will keep people from any positive interface with police, any positive interface with public health, any interface with doctors," he said, noting that it could lead to fewer people receiving treatment for their addictions. "People will become afraid and hide. They won't trust the police, and they won't trust the doctor either."
Ciccarone said there is also concern that the laws could ensnare low-level drug dealers, many of whom do not know that their products contain lethal amounts of opioids and some of whom are battling addiction.
"We're not talking El Chapo-level people," he said, referring to Joaquín "El Chapo" Guzmán, the former leader of the Sinaloa cartel who was extradited to the United States last year. U.S. officials had to assure their Mexican counterparts that Guzmán would not face the death penalty as part of extradition negotiations.
"The closer you get to the ground, the closer you get to people who are easy to capture and the more unknown the fentanyl issue is," Ciccarone said. "I don't believe that expanding the drug penalty further for other trafficking offenses is going to solve the opioid epidemic," she said.
Regina LaBelle, deputy chief of staff at the Office of National Drug Control Policy in the Obama administration, said that current laws that allow for drug dealers to be charged with a capital offense haven't had a deterrent effect.

Return to headline | Return to top
Opioid Protest at Met Museum Targets Donors Connected to OxyContin

Mar 10, 2018 | The New York Times

By Colin Moynihan

Anti-opioid activists unfurled banners and scattered pill bottles on Saturday inside the Sackler Wing of the Metropolitan Museum of Art in New York, which is named for a family connected to the powerful painkilling drug OxyContin.
The protest, which was organized by a group started by the celebrated photographer Nan Goldin, started just after 4 p.m., when several dozen people converged at the Temple of Dendur inside the wing.
The wing is named after Arthur, Mortimer and Raymond Sackler, brothers who in the 1970s donated $3.5 million toward its construction. Their scientific and marketing skills also transformed a small business into what became Purdue Pharma, the company that developed OxyContin, which has been widely prescribed and abused. The drug’s active ingredient, oxycodone, is among the most common painkillers involved in prescription opioid overdose deaths, which have become an unrelenting crisis in the United States.
On Saturday the protesters called for cultural institutions to reject moneyfrom the Sackler family. They also demanded, among other things, that Purdue, which has been accused of using deceptive and aggressive tactics to market OxyContin, fund addiction treatment.
As onlookers watched, protesters brandished black banners with the phrases “Shame on Sackler” and “Fund Rehab” and hurled yellow pill bottles with white labels that read “OxyContin” and “prescribed to you by the Sacklers” into the wing’s reflecting pool.Continue reading the main story
Ms. Goldin announced a series of demands in the form of short statements, including “harm reduction” and “treatment,” that were repeated loudly by the crowd.
“We are artists, activists, addicts,” she shouted. “We are fed up.”
Ms. Goldin — whose intimate photographs documenting drug use, violence and deaths from AIDS are displayed in numerous museums, including the Metropolitan — started an anti-opioid group called Prescription Addiction Intervention Now, or PAIN, after being addicted to OxyContin from 2014 to 2017. She has called withdrawal from OxyContin the darkest experience of her life.
A spokesman for the museum declined to comment, and a spokeswoman for the Sackler family did not respond to a request for comment. A Purdue spokesman, Robert Josephson, said the company is “deeply troubled by the prescription and illicit opioid abuse crisis” and is dedicated to helping solve it by paying for prescription-drug monitoring programs and collaborating with law enforcement.
OxyContin has accounted for tens of billions of dollars in sales since entering the market in 1996.
In 2007, Purdue’s parent company pleaded guilty to a federal felony charge of misbranding the drug, which prosecutors said was marketed as less addictive, less subject to abuse and less likely to cause withdrawal than other painkillers. Since then, states have accused Purdue in lawsuits of misrepresenting the risks and benefits of OxyContin, allegations the company has denied.
Arthur Sackler died before OxyContin was developed, and his descendants say they have not profited from the drug. Among them is Elizabeth A. Sackler, who founded a center for feminist art at the Brooklyn Museum, and said recently that she admired Ms. Goldin’s activism while describing Purdue’s role in the opioid epidemic as “morally abhorrent.”
Since 1998, foundations run by Mortimer and Raymond Sackler, who died in 2010 and in 2017, and their families have given tens of millions of dollars to cultural institutions including the Dia Art Foundation and the Guggenheim in New York, and the Victoria and Albert Museum in London.
In recent years the Metropolitan Museum appears to have received comparatively modest amounts from the Sacklers. For instance, the museum is listed on tax documents as having received a total of $190,000 from 2012 to 2016 from the Mortimer D. Sackler Foundation.
Still, Ms. Goldin said she and her group had chosen the museum as the site of their protest because of its high profile in the art world and because they see it as symbolic of the fact that Sackler family members are often viewed primarily as art patrons rather than as owners of a pharmaceutical company.
Inside the Temple of Dendur on Saturday, security guards implored the protesters to quiet down and move on. About 50 protesters lay on the ground in a symbolic “die-in.” Then, about 20 minutes after the protest had begun, the crowd marched through the museum’s halls, brandishing their banners and chanting, “Sacklers lie; people die.”
They then gathered outside, clapping and chanting. Ms. Goldin addressed the crowd and, perhaps, the museum.
“We’re just getting started,” she said. “We’ll be back.”

Return to headline | Return to top

Northeast (MA, CT)

Cities and towns throughout the state joining opioid lawsuit

Mar 12, 2018 | Western News Mass.com (MA)

By Maggie Lohmiller & Naomi Wilson

The next battle in the war against opioid abuse is set to take place in the courtroom.
About sixty cities and towns from The Bay State are already taking on pharmaceutical giants that distribute opioids.
Cities and towns across the country are taking the matter to court.
One attorney representing several towns estimates that as many as two hundred communities will join the lawsuit when all is said and done.
Springfield and Greenfield have been hit hard with the opioid epidemic and they are not alone.
Attorney Richard Sandman is representing several communities taking on big pharma.
“There’s a shared responsibility that I think really needs to come across," Sandman said.
About sixty communities have already joined the lawsuit and Sandman thinks about 140 more will soon take part as well.
“Opioids are supposed to treat an acute pain issue,” Sandman said. “They are not supposed to be used for chronic pain over time, and manufacturers dismissed addiction along the way.”
The idea is to raise awareness of opioid addiction and defray the rising costs of treatment.
Boston Mayor, Marty Walsh, said, “They have made billions and billions and billions of dollars pushing opioids out into the public, in a legal way, but they are as dangerous as drug dealers.”
Auburn is one of the most recent to join and likely not the last.
“Let's not pretend every single one of us hasn't been touched by this personally, whether it’s a mother or father, daughter or son, sister or brother, a neighbor, a close friend,” Walsh said.
Just this week U.S. Attorney General, Jeff Sessions, said the Justice Department will consider legal action as well.
It’s not entirely clear who else may join the lawsuit in the coming months.

Return to headline | Return to top
Local towns want drug companies to pay up to help fund addiction services

Mar 9, 2018 | Boston 25 News (MA)

By Bob Dumas

The human toll of the opioid crisis across the country is staggering -- resulting in more than 60,000 overdose deaths a year.
It’s also causing a financial emergency in many cities and towns as they try to fund all the services drug addiction puts a strain on.
Now many of those communities want the drug companies to pay up as they join a lawsuit which seeks to have the drug companies reimburse them.
Auburn is one of about 60 Massachusetts municipalities joining the suit.
“Let's not pretend every single one of us hasn't been touched by this personally, whether it’s a mother or father, daughter or son, sister or brother, a neighbor, a close friend,” Doreen Goodrich, chairman of the Board of Selectman, said.
As the epidemic claims about 120 people each day, the town feels the strain of answering the call for help.
“We are seeing an increase in the number of ambulance calls,” Auburn Town Manager Julie Jacobson, said. “There were impacts in the schools. There were impacts on our work force. There were impacts on the human service agencies that service this community, and the whole county, Worcester county.”
“There’s a shared responsibility that I think really needs to come across," Malden attorney Richard Sandman said.
This means going after both the manufacturers and the distributors.
Sandman said the distributors have one primary responsibility which is to look for red flags and suspicious transactions.
“And what the manufacturers did,” Sandman explained, “is opioids are supposed to treat an acute pain issue. They are not supposed to be used for chronic pain over time, and manufacturers dismissed addiction along the way.”
Jacobson recommended the town get involved because there are no upfront costs. Everything is on a contingency basis.
Goodrich quickly agreed.
“There's no cost to the taxpayers which is a plus," Goodman said. I think that we just need to send a strong message and a clear message to the pharmaceutical companies that you are destroying small communities.”
Boston Mayor Marty Walsh said communities of all sizes are dealing with the same consequences and that’s it’s time for the drug companies to pay up.
“They have made billions and billions and billions of dollars pushing opioids out into the public, in a legal way, but they are as dangerous as drug dealers," Walsh said. "They’re as dangerous as heroin dealers.”
The effort against drug companies is picking up steam.
Just this week, U.S Attorney General Jeff Sessions said the Justice Department will consider legal action as well.
Sandman thinks he could end up with 200 Massachusetts communities as part of the lawsuit.
As for the drug companies, an industry spokesperson said they don’t comment on lawsuits against their members.
Some legal experts are comparing this case to the tobacco lawsuit, when those companies were held accountable for the public health problems associated with smoking.

Return to headline | Return to top
Lowell, Billerica join suit seeking opioid damages from Big Pharma

Mar 12, 2018 | Lowell Sun (MA)

By Rock Sobey

It's time for Big Pharma to pony up and take responsibility for flooding cities and towns with opioids.
That's the message from lawyers with Massachusetts Opioid Litigation Attorneys, a group representing communities in a class-action lawsuit against prescription opioid manufacturers and distributors.
The MOLA lawsuit seeks monetary damages for past and future costs of emergency response, emergency services training, law-enforcement actions, Narcan, workers' compensation, education campaigns, treatment and more.
Lowell and Billerica have recently signed on to the effort, which officials hope will bring about meaningful change in the pharmaceutical industry.
The litigation has already resulted in positive movement, according to Richard Sandman, a lawyer with MOLA.
He pointed to one of the major pharmaceutical companies, Purdue Pharma, announcing recently that the company slashed its sales force by more than 50 percent. The company will no longer promote opioids to prescribers.
"It's from the pressure of all these lawsuits," said Sandman, of the firm Rodman, Rodman & Sandman in Malden.
"You get the sense that we're going to see a significant response at how we administer or prescribe painkillers," added Sandman, who will brief the Lowell City Council on the lawsuit Tuesday evening.
The lawsuits are not limited to Massachusetts.
It has been a nationwide movement to sue Big Pharma for costs resulting from the opioid crisis.
The pharmaceutical companies committed fraud by marketing opioids as a treatment for chronic pain, according to the lawsuits. It has resulted in opioids pouring into cities and towns, causing this public-health crisis, MOLA states.
In addition, the distributors failed to detect and report suspicious opioid orders to authorities as required under the Controlled Substances Act, Sandman said. Instead, they shipped large amounts of pills to pharmacies, he said.
"You had millions of pills going to a community of fewer than 1,000 people in two years," Sandman said. "That's what you would call a suspicious order."
Since the litigation started, there has been an incredible difference in the number of suspicious orders getting reported, he added.
In addition to Purdue Pharma, the pharmaceutical companies involved in these lawsuits are Endo Health Solutions, Teva Pharmaceutical Industries and subsidiary Cephalon, Johnson & Johnson and subsidiary Janssen Pharmaceuticals and Allergan.
The distributors connected to these lawsuits are McKesson Corp., AmerisourceBergen Drug Corp., and Cardinal Health Inc.
"We are deeply troubled by the prescription and illicit opioid abuse crisis, and we are dedicated to being part of the solution," Purdue Pharma said in a statement last week. "As a company grounded in science, we must balance patient access to FDA-approved medicines, while working collaboratively to solve this public health challenge.
"Although our products account for less than 2 percent of the total opioid prescriptions, as a company, we've distributed the CDC Guideline for Prescribing Opioids for Chronic Pain, developed three of the first four FDA-approved opioid medications with abuse-deterrent properties and partner with law enforcement to ensure access to naloxone," the company added. "We vigorously deny these allegations and look forward to the opportunity to present our defense."
Some have compared these lawsuits to the Tobacco Master Settlement Agreement in 1998. Tobacco companies ended up reimbursing states for Medicaid funds they spent on treating patients with lung cancer and emphysema.
With these opioid lawsuits, the money would directly help out cities and towns, Sandman pointed out.
"Certainly it worked well with the cigarette lawsuits, with a lot of prevention money to help in the battle against smoking," Lowell House CEO Bill Garr said. "Any resources we can get in this community in our battle against the opioid crisis would be more than welcome."
Billerica officials signed on to the lawsuit last week.
Selectmen Chairman Andrew Deslaurier said it was an "obligation" to join.
"We have to do something. We need to take our own action," he said. "There's no one not touched by this."

Return to headline | Return to top
Danbury Hires Ventura Law to Pursue Opioid Litigation

Mar 9, 2018 | Connecticut Law Tribune

By Robert Storace

The Danbury City Council voted this week to hire the Ventura Law firm to represent it in potential litigation against some of the nation’s largest pharmaceutical companies for their alleged role in causing the opioid crisis.
Ventura Law’s Chief Executive Officer Augie Ribeiro told the Connecticut Law Tribune Friday that he expects to file a lawsuit in Danbury Superior Court by year’s end. The council’s move comes on the heels of two other law firms—Scott + Scott and Simmons Hanly Conroy—filing opioid lawsuits on behalf of more than 20 Connecticut municipalities over the past six months.
The Danbury lawsuit would be the firm’s first foray into the ongoing opioid litigation. The firm will partner with Branstetter, Stranch & Jennings, a Tennessee-based firm that has filed opioid-related lawsuits on behalf of 47 counties in that state.
“We will be working side-by-side with Branstetter,” Ribeiro said. “They, like us, are in for the long haul. We will be 50-50 partners. We will both be sharing the risk, the expenses and the time down the middle.”
Ventura Law’s Kelly Fitzpatrick, who will be lead co-counsel with Ribeiro, said the lawsuit will be similar to those filed on behalf of municipalities such as Waterbury, New Haven and New Britain.
“I think we will be successful because there is plenty of evidence out there that the manufacturers convinced the medical community, and society in general, that there was a pain crisis, thereby creating the opioid crisis,” Fitzpatrick said. “They misled the medical community be claiming opioids were not addictive and downplayed the addictive nature of opioids by promoting opioids for long-term use and chronic pain for decades.”
To date, there are about 180 government plaintiffs suing Big Pharma in multidistrict litigation consolidated in Ohio.
Fitzpatrick said the firm will fight any attempt to move its litigation into the MDL. Fitzpatrick said it’s unlikely the case will be removed from the Nutmeg State since one of the defendants, Purdue Pharma, is from Connecticut.
It’s also important that the case be heard in Danbury, Fitzpatrick said, “because our communities here in Connecticut are being affected by the opioid crisis. Our juries should be the ones who are hearing the case.”
Part of the delay in filing the lawsuit, Fitzpatrick said, is the need to sit down and talk with city officials and do research on the costs and manpower associated with the epidemic.
Fitzpatrick, who said her firm will begin talking to city officials next week, added, “We will be talking to departments from finance to risk management to discuss what the expenses related to the opioid crisis have been. We also want to plan to forecast and predict what future damages might be.” Other conversations, she said, will take place with fire, police and EMS officials. The two firms, Fitzpatrick said, hope to have an estimated financial number on the toll the crisis has had on the city by the time the suit is filed.
According to the state medical examiner, the total number of overdose deaths, which include opioid deaths, jumped for the first time ever to more than 1,000 in 2017.
While Scott+Scott and Simmons Hanly Conroy will collect up to 33.3 percent of any award under their fee agreements if they win, Ribeiro said his firm is capping the amount at 25 percent.
Ventura Law was founded in 1957 and has been involved in several mass tort and complex litigation claims, including against British Petroleum for its role in one of the world’s worst environmental oil disasters.
Danbury Mayor Mark Boughton did not respond to a request for comment Friday.
Purdue Pharma also did not respond to a request for comment Friday. But, in past statements to the Connecticut Law Tribune, the company has said it wants to be part of the opioid solution, and have vowed to fight any allegations.

Return to headline | Return to top
Directors may join lawsuit against drug companies

Mar 9, 2018 | Journal Inquirer (CT)

By Joseph T. O'Leary

The Board of Directors has asked the town attorney to compile information about lawsuits filed by hundreds of communities against pharmaceutical companies for their role in the opioid epidemic as it considers joining one.
Directors heard an impassioned plea in support Tuesday from a local leader of anti-addiction efforts.
Sarah Howroyd of the Police Department’s HOPE Initiative spoke to the board about opioid addiction and the lawsuits’ significance.
“If this is not a disease, I don’t know what a disease looks like,” she said of opioid addiction.
The lawsuits contend drug makers used an elaborate campaign to increase sales of opioid medications, downplaying the risks of addiction and overselling the drugs’ benefits.
In Connecticut, she said, more than 1,000 “mothers, brothers, sisters, and fathers” died last year of overdoses, caused by both heroin and prescription opioid painkillers, she said.
In Manchester, she continued, 66 residents — 49 men and 17 women — have died of opioid overdoses in the last six years.
With a personal connection to the crisis — “this is killing my generation,” Howroyd said — the town should pursue litigation, she said.
Several municipalities, including Coventry and Tolland, have joined lawsuits already. Howroyd said Waterbury is a leader in its efforts as well.
With half a million deaths in America in the opioid crisis, helped along by pharmaceutical companies’ expansion of access to painkillers, Howroyd said they “need to be held accountable civilly and criminally.”
Mayor Jay Moran said the current opioid epidemic reminds him of cigarette companies’ actions decades ago, before similar lawsuits held them accountable for concealing the risks of smoking.
In response to a question from Minority Leader Cheri Ann Eckbreth, Howroyd said the lawsuit would have no upfront costs. Law firms are bearing the initial costs in drawing up the lawsuit and will seek compensation with a positive judgement.
In discussions, board members deferred to Town Attorney Ryan Barry, who said there are several law firms who have brought lawsuits for various reasons. Before the board’s April meeting, directors asked him to review different options for the town.

Return to headline | Return to top

Southeast (LA, FL)

BOSSIER PARISH FIRST TO FILE OPIOID LITIGATION..MORE ON THE WAY

Mar 12, 2018 | Shreveport News (LA)

By John Setlle

The City of Shreveport has hired counsel for opioid litigation and Webster Parish has just followed suit. It is anticipated that the Caddo Commission will soon retain counsel.
Opioid addiction has become a national epidemic and it results in an estimated 150 deaths per day. In what could become the next “big tobacco” litigation, elected officials are reviewing the governmental costs of opioid addiction and treatment on taxpayers.
Opioid abuse has resulted in substantial increases in hospital visits for drug overdoses. Additionally, infants born to opioid users are often born addicted to these drugs.
Local courts have experienced large increases in criminal defendants charged with illegal opioid possession and/or addiction. Local jails have become more crowded with those arrested for opioid offenses as well as those sentenced to serve time for opioid-related offenses. And for those convicted but not jailed, the caseload of probation officers have also swollen with opioid cases.
The litigation seeks recovery for the additional costs to the government entities for medical care, counseling and rehab service, law enforcement and public safety and child care for children whose parents suffer from opioid-related disabilities or incapacitation.
The lawsuits are based on multiple legal theories. These include public nuisance laws; fraud, racketeering, and corruption; violations of federal and state laws on controlled substances.
Opioid manufacturers are accused of grossly overstating the benefits of chronic opioid therapy as well as fraudulently concealing the harms of opioids.
Both the manufacturers and the distributors of opioids are accused of failing to properly monitor and report suspicious orders of opioids (unusual size, frequency and abnormal patterns) as required by federal law and misrepresentation of compliance with these requirements.
The list of opioid drugs is lengthy and includes OxyContin, Dilaudid, Butrans, Actiq, Fentora, Percodan, and Percocet.
The number of cities, counties, and parishes that have filed suits is over 400, and climbing weekly. The suits are filed in local federal courts and then transferred to a district court in Ohio as part of multiple district litigation. This process will streamline discovery that will be common for all the suits. After the common discovery, the cases will be sent back to the court in which suit was filed.
These lawsuits are handled on a contingent fee basis which means any payment to the attorneys will be from the suit proceeds.

Return to headline | Return to top
Opioid crisis: City suing drugmakers

Mar 12, 2018 | Jacksonville Daily Record (FL)

By Max Marbut

The City of Jacksonville has joined the national effort to hold drug manufacturers accountable, and financially liable, for the explosion of opioid abuse and overdoses.
In a 144-page complaint filed Feb. 27 in the 4th Judicial Circuit Court, the city names as defendants 16 drug manufacturers, four pharmaceutical distribution and sales companies, and as individuals, five former executives of the companies.
The city has engaged as outside specialized counsel the services of Scott+Scott Attorneys at Law LLP, a New York City-based law firm that is representing numerous other municipalities nationwide in similar actions, as co-counsel.
Scott+Scott will receive 15 percent of the net recovery if the case is settled before trial; 20 percent if the case proceeds through trial and appeal.
The costs and expenses of litigation will be deducted prior to the calculation of the fee. The city will not be responsible for payment of any attorneys’ fees, expenses or costs of litigation associated with Scott+Scott’s services unless a recovery is achieved during the course of litigation.
The city Office of General Counsel will supervise all litigation and direct Scott+Scott in the discharge of its respective duties.
The complaint alleges that opioid manufacturers engaged in a systematic plan to deceive doctors and patients about the addictive nature of their products and the products’ efficacy in the management of chronic pain.
It also alleges that the defendants employed physicians who published misleading articles in medical journals aimed at doctors who treat chronic pain; created false and unsupported literature that appeared to be independent and objective, but was not; and sponsored continuing medical education courses that persuaded doctors who prescribed opioids that the drugs were appropriate for pain relief and posed little or no serious threat of addiction.
Misuse and abuse of opioids is a national issue and data indicates it also is having a growing local impact.
According to the Medical Examiners Commission of the Florida Department of Law Enforcement, in 2016, 489 people died of overdose in Jacksonville after using prescription opioids, compared to 81 who died from overdose after using heroin.
There also is an escalating economic impact related to opioid overdose intervention.
According to data compiled by the Jacksonville Fire and Rescue Department, personnel responded to 2,114 overdose calls in 2015, to 3,411 in 2016 and 3,686 in 2017.
The number of patients who are taken to the hospital for treatment of overdose and the costs of transporting overdose patients also are escalating.
In 2015, JFRD transported 1,903 overdose patients at a cost of $1.9 million. In 2016, 3,156 patients were transported at a cost of $3.1 million; and last year, 3,505 overdose patients were transported at a cost of $3.6 million.
In addition, JFRD administered nearly $96,000 worth of Naloxone — the antidote for opioid overdose — last year, representing more than 7 percent of the department’s medical supplies budget.
The complaint contends the city has incurred, and continues to incur, costs related to opioid addiction; escalated overdose rates; criminal justice and victimization costs; social costs; lost productivity costs; loss of quality of life; increase in blighted areas; costs incurred to protect abused; abandoned, neglected and at-risk children; as well as escalating costs from increased foster care.
The complaint also alleges that the city has been directly damaged through its payment for inappropriate chronic opioid therapy and ensuing payments for addiction-related treatment for its employees, retirees and their families by partially funding a medical insurance plan and the city workers’ compensation program.
Jacksonville attorney W.C. Gentry, who was a member of the Florida legal team that secured a settlement for the state when it sued tobacco companies, said the cases are similar in terms of the allegations and the complaint filed by the city.
“This is a huge public health crisis that parallels the tobacco litigation,” he said.
Gentry said the likely next step will be for each of the 25 defendants to file motions to dismiss. Hearings before a judge will have to be heard on each motion.
“I expect that each preliminary motion hearing will take days,” he said, based on the volume of evidence.
Gentry also said the defendants are likely to attempt to have the case removed to federal court, since the manufacturers are headquartered outside the state. That might not happen, he said, because two of the individual defendants are residents of Florida.
“If they can stay in circuit court, it would put Jacksonville in a strong position to move the case quickly,” he said.

Return to headline | Return to top

West (UT)

Summit County plans to file suit against opioid manufacturers

Mar 11, 2018 | Park Record (UT)

By Angelique McNaughton

Summit County will soon be joining other counties and states across the country that have filed lawsuits against drug manufacturers and distributors for their role in the national opioid epidemic.
The County Council unanimously approved a resolution on Wednesday that recognizes the damaging effects of opioid addiction while authorizing the county to file a suit on behalf of the public. County Council member Chris Robinson was absent from the discussion.
County Attorney Margaret Olson drafted the resolution and presented it to the County Council after learning that other counties along the Wasatch Front were considering filing similar suits.
"Opioid addiction has touched every family, and we all know someone who has struggled with this or even have a family member who became addicted," she said in an interview on Thursday. "I have been working in the Drug Court and saw that nationwide there were counties that were pursuing Big Pharma so I decided to present a resolution."
More than 16 states and dozens of counties have filed more than 250 lawsuits in federal court against opioid manufactures seeking damages for the cost communities have incurred as a result of the opioid crisis, according to the resolution. Olson said she believes other counties are also planning to file suits.
"I do anticipate that other Utah counties will be joining or following in the near future," she said. "No county in Utah has filed suit yet, but I expect something to be filed on behalf of the larger counties very soon and I wanted to move on it. I think it is very important and timely, and I see no reason for our county to not try and recoup some of its costs."
More than three out of five drug overdose deaths involve opioids, according to the Center for Disease Control and Prevention. More than 42,000 people died from overdoses involving opioids in 2016.
Utah has the seventh-highest drug overdose rate in the country, with an average of six people dying per week, according to the resolution. Deaths from drug overdoses have outpaced deaths from firearms, falls and motor vehicle crashes since 2002.
The resolution alleges that prescription opioid manufactures have "systematically engaged in deceptive marketing practices and fraudulent cover-ups to advance the sale of prescription opioids."
"Beginning in the 1990s, opioid manufactures lied to both doctors and the public about the risks of opioids," the resolution states. "Opioid distributors injected millions upon millions of opioid pills into small communities, far in excess of any reasonable need."
Counties continue to incur the costs associated with the opioid epidemic through treatment and incarceration of addicted persons, increased law enforcement and social services.
"It is my hope that the county is able to recover money it has lost and be able to put that into abatement for education programs, substance abuse treatment and creating public awareness and solutions for opioid addiction," Olson said.
Several large firms have offered their services to the county to pursue a lawsuit on its behalf so the county would not be responsible for any costs associated with the litigation, Olson said. She added that the county attorney's office is not equipped to take on litigation of this kind. The county will soon begin the search for outside counsel.
Olson said a lawsuit targeting pharmaceutical companies for their role in the opioid epidemic is consistent with the county's strategic plan, which has identified mental wellness as a priority.
As part of the lawsuit and recognition of the crisis, the resolution stated the county would also work on a "sustainable, comprehensive public health approach to the opioid crisis in order to address preventable drug overdose deaths."
"Big lawsuits don't solve problems, but it will allow us to hold Big Pharma accountable for their role in this public health crisis," Olson said.
County Council Chair Kim Carson said a lawsuit would be another step forward in the county's efforts to combat mental health issues, such as substance abuse. She said the county hasn't experienced as many deaths as other communities, but "even one isn't acceptable."
"It is something that is being looked at on a national basis and I think the timing is right," she said. "With or without winning the money, I think it will help increase awareness, and hopefully we can provide some more education on opioids and alternatives to opioids."

Return to headline | Return to top
Lawmakers Pass Resolution Urging Utah AG to Sue Opioid Manufacturers Directly

Mar 12, 2018 | KSL.com (UT)

By Ben Lockart

Legislators emphasized their focus on opioid addiction this session with a Thursday vote passing a resolution urging Attorney General Sean Reyes to directly sue manufacturers of those drugs.
House Joint Resolution 12 urges Reyes to "immediately and publicly commit to directly filing suit against prescription opioid manufacturers, instead of joining a suit with other plaintiffs, in order to seek the maximum award for damages from prescription opioid manufacturers for the citizens of the state."
The resolution states that opioid manufacturers have played a "clear and reckless role in perpetuating the crisis" of addiction to the substances.
Sen. Jim Dabakis, the resolution's floor sponsor, said Thursday that it is meant as "a wake up call" to Reyes with regard to suing manufacturers directly.
"Right now we find an opioid crisis that I need not describe to you that is wreaking havoc in or state," Dabakis said.
The Senate passed the resolution 26 to 1. Sen. Lincoln Fillmore, R-South Jordan, cast the only dissenting vote.
The House of Representatives passed HJR12 unanimously last month.
Reyes said at the beginning of the session that Utah is among 41 states involved in combined ongoing civil action, but is also "ready to pull the trigger" on its own lawsuit in case manufacturers are properly cooperating.
Despite HJR12's easy passage, a pair of bills which would have significant policy implications related to opioid prescriptions failed to get enough support during the session.
HB260, which would allow specified law enforcement officers to request doctor prescribing data from the state Division of Professional Licensing without a warrant, was defeated in the Senate this week a few days after heated debate in committee over whether it violated the Fourth Amendment of the U.S. Constitution. The Senate vote was 9-18.
HB446, which would make it a class B misdemeanor for a person not to report that a "health practitioner is involved in diversion and knowingly fails to report the diversion to (police)," stalled in committee late last month after several concerns were raised about how it could be interpreted.
HB400, which instructs doctors to discuss the risk of opioid addiction with patients prior to prescribing, passed the House but got demoted from the reading calendar at the Senate to that body's Rules Committee.
However, HB399, which requires that pharmacists affix opioid addiction warning labels to prescriptions, passed both the Senate and the House unanimously.
Senate Concurrent Resolution 4, which warns about the potential for prescribed opioids to fatally depress breathing as a side effect and calls on hospitals and researchers "to collect more data about the risks of taking an opioid after surgery," passed the Legislature without any dissenting votes.

Return to headline | Return to top

Broadcast Media Coverage

CNN Newsroom Live

Mar 12, 2018 | National Programming

By CNN

Video Link: http://app.criticalmention.com/app/#clip/view/33488604?token=e9790d32-382d-41f1-b1d8-f9fab9d02662
Rough Transcript: the u.s. opioid epidemic has killed tens of thousands of americans. we teamed up with harvard investigators to investigate. the investigation follows the money from opioid manufacturers to the doctors who prescribe them. the bottom line is there is a distinct correlation. cnn's elizabeth cohen reports that the more prescriptions physicians write for these addictive and deadly drugs, the more money they make. >> you would take the cartridge and you would spray under your tongue like this. >> reporter: this is subsis, an opioid 50 times more powerful than heroin more more than two years angela's doctor prescribed it. >> it completely destroyed my life. i was not able to function for my family. it was a zombie-like state. 3:44 AMi suffered for over two years thinking that i was dying. i made arrangements for my children if something were to happen to me. >> reporter: when you told the doctor you didn't feel very well on this medication, what did he say? >> the response that i got floored me. it was opioids are nothing. >> reporter: and in particular this opioid? >> subsis, yes. >> reporter: he didn't give you other alternatives? >> nope. >> reporter: she then learned that her doctor had receive in order than $200,000 from the company that makes subsis for speaking and consulting other services. >> the medication that was prescribed to me was for his benefit, not my own. >> reporter: as the nation's opioid rages, the harvard schools of medicine and public health did a new analysis of government data. this a s a pretty dramatic line. >> i agree. >> reporter: what we found is stunning. >> the big picture is that the more money a physician receives from an opioid manufacturer, the 3:45 AMmore likely they are to prescribe opioids. >> reporter: as you can see here, the doctors who get paid the most money that. >> prescribe the most opioids. >> we don't know which way that relationship goes. is it that the payments motived the physician to prescribe more, or did the high prescriber attract the money? >> if there is the possibility that paying doctors leads to increases in inappropriate prescribing of these drugs, that's something that we have to take seriously. >> reporter: we showed opioid researcher our findings. >> it shows that the drug companies are really getting what they pay for. in effect, they're almost bribing doctors to prescribe their drugs aggressively. >> reporter: but pain specialist dr. steven stanos says pharmaceutical companies are paying doctors to educate other doctor. >> i hope they would choose physician bhas have an understanding of job, and can speak objectively about that. >> reporter: it works to make sure patients' needs are met while working to prevent overprescribing. she is suing the company that makes the drug and her doctor. saying their product marketing conformed with industry standards. and her doctor said the medical care he was gave was reasonable and appropriate and in keeping with the standard of care. but she says her doctor did proefr prescribe opioids for money. >> i was used as a pawn in a chest game which ended up making him and the pharmaceutical company a ton of money.

Return to headline | Return to top
Politics and Public Policy Today

Mar 12, 2018 | National Programming

By CSPAN

Video Link: http://app.criticalmention.com/app/#clip/view/33488660?token=e9790d32-382d-41f1-b1d8-f9fab9d02662
Rough Transcript: thank you, mr. chairman. thank you both for being here today. far too many families in massachusetts and all across the country have had to bury swn they love because of this opioid crisis. more deaths, more funerals. this crisis didn't happen overnight and it didn't happen on its own. and a big reason it happened is because the biggest drug companies in the -- a billion 1:58 AMdollars doing it. i think it is time to start talking about holding these companies accountable and holding their executives accountable for the crisis they helped create. in massachusetts attorney general healy is helping lead a bipartisan coalition of 41 states investigating drug manufacturing distributors for their role in the opioidepidemic. cities and towns in massachusetts have already filed lawsuits and a number of native tribes including the cherokee nation have also seen in both tribal and federal court. so let me ask this. governor hogan, maryland is also part of this investigation. baltimore and several county governments in maryland have filed lawsuits against manufacturers and distributors. you agree that part of tackling this crisis is holding these 1:59 AMcompanies accountable? >> there is no question about that. we have directed our attorney general to sue some of these manufacturing companies. there is liability, some of them knowingly pushing the sale of some of these drugs, knowing they had these addictive capabilities and did not disclose it. you can't paint all of the people trying to help people with pain with a broad brush but those doing these things should definitely be held accountable. i agree with you absolutely. unfortunately we can take those actions and we should but it is not going to stop the people dying on the streets. >> i understand. i understand. the investigation is ongoing and we should let the attorneys general do their work on this. if it turned out the drug companies broke the law, lied about it, and hurt people to rake in profits it won't be the 2:00 AMfirst time on this. few years ago a corporation made a spray out of fentanyl, powerful opioid. the fda told the company that its spray was approved only for use in cancer patients who were in such pain that other drugs like morphine just weren't enough to control that pain. but it turns out there just weren't enough of these cancer patients for the company to make buckets of money. and so it started illegally marketing the drug to people with milder forms of pain and bribing doctors to over prescribe it. a lot of states sued the company including massachusetts. oregon was the first state in the country to reach a settlement and it forced the company to pay up. so, governor brown, that settlement occurred a few months 2:01 AMafter you took office in 2015. has the money that oregon recovered from the company helped the state fight the opioid epidemic? >> absolutely. thank you for the question, senator warren. we received a little over a million dollars. over half of it went directly to opioid, substance abuse, treatment, and recovery. a portion went to oregon health sciences university. they're well renowned, a research medical university. they're doing incredible work. i was very pleased with how the dollars were targeted. >> good. im' glad to hear it. here's the thing. when a company breaks the law it is because the people running the country broke the law. a short time ago the department of justice announced the founder and owner of the company along with six top executives had been indicted for fraud and racketeering because of their actions. let me ask you this, governor brown. do you agree that c.e.o.'s deserve to be held personally accountable when the companies they run break the law and hurt people? >> senator warren, in egregious cases loo ick this, absolutely. but obviously these cases need to be taken on a case by case approach. this was a particularly egregious case and people should be held personally accountable. >> i agree on this one. this is not a democratic or republican issue and neither is holding drug companies accountable. the department of justice announced last week they are forming a task force to target opioidmanufacturers and distributors that contributed to the epidemic and i am glad to see it. families and communities have already paid an enormous price for this crisis and it is time to start holding companies and their c.e.o.'s available. -- accountable. thank you both.

Return to headline | Return to top
18 News Today

Mar 12, 2018 | Elmira, NY

By WETM (NBC)

Video Link: http://app.criticalmention.com/app/#clip/view/33488588?token=e9790d32-382d-41f1-b1d8-f9fab9d02662
Rough Transcript: schuyler county is holding a public hearing today to review a proposed local law declaring the opioid epidemic and its effects on the county a public nuisance. the county's attorney says the local law is the next step in the county's lawsuit against the manufacturers and distributors of opioid pain killers.

Return to headline | Return to top
Boston 25 News at 6PM

Mar 9, 2018 | Boston, MA

By WFXT (FOX)

Video Link: http://app.criticalmention.com/app/#clip/view/33488682?token=e9790d32-382d-41f1-b1d8-f9fab9d02662
Rough Transcript: drug manufacturers and distributors. companies that make millions per year to help cover all of these units will cost. >> the distributors have one primary responsibility, that is to be gatekeepers. to look for the red flags. opioids are supposed to treat him acute pain issue. they are not supposed to be used for chronic pain. they keep marketing them for chronic pain. 6:45 PMthe manufacturers dismissed addiction along the way. >> this manager recommended the child get involved because there are no upfront costs and everything is on a contingency basis. derain, quickly agreed. >> we just need to send a strong message and a clear message to the masuda quote companies. >> it is taking a big toll on every community. >> it is time for the drug companies to pay up. >> they have made billions off pushing opioids out into the public. they did a legal way. however they are as dangerous as drug dealers or heron deal is. >> jeff session said they will look into legal action as well. he thinks he could end up with many communities as part of his lawsuit. as for the drug companies, they said they don't comment on lawsuits. back to you. >>> some legal experts are comparing this case to the tobacco lawsuit went those companies were held accountable.

Return to headline | Return to top
Chicago Tonight: The Week in Review

Mar 9, 2018 | Chicago, IL

By WTTW (PBS)

Video Link: http://app.criticalmention.com/app/#clip/view/33488861?token=e9790d32-382d-41f1-b1d8-f9fab9d02662
Rough Transcript:
city of chicago sues major opioid manufacturers. the judge orders the mayor and top cop to answer questions in the lawsuit over the police shooting death of benny jones. a new report said tobacco company represented by the lobbying firm owned by joe barios got a huge tax break. laura washington, the city suing opioid pharmaceutical distributors. anything going to come of this? >> i don't know. it's a major lawsuit. i think it's kind of an unusual approach. the mayor is doing this because the crisis touched so many people and is so widespread. i think he wants to show he's taking some action. >> is it fair to blame pharmaceutical distributors for 8:13 PMthe opioid crisis? >> they're the ones that produce it. they're the ones that market these drugs. i think on the front end of this played down the fact that these were addictive, these pain killers. didn't affect people the way they do. we've seen people like tom petty and prince and, you know, you just see all of these people that have had lives ruined from it. >> i'm from near the border of west virginia is where i grew up. that's a state that's been highlighted. they're getting millions of pills into these tiny towns in these little pharmacies. i have seen what's happened in my home town with it, which is a smaller way you can look at it. it's not -- everyone wants to blame the addicts. it isn't their fault. i'm glad emanuel is trying. >> the knowledge that this has been a problem has been out there for a long time. and so that will help in a lawsuit in gathering evidence that -- if it will come to, same with the tobacco companies. when did they know this and how long did they know this? i think that will play into the suit.

Return to headline | Return to top

Add recipients

Suggested