Tagged opioids

Doling Out Pain Pills Post-Surgery: An Ingrown Toenail Not The Same As A Bypass

What’s the right painkiller prescription to send home with a patient after gallbladder surgery or a cesarean section?

That question is front and center as conventional approaches to pain control in the United States have led to what some see as a culture of overprescribing, helping spur the nation’s epidemic of opioid overuse and abuse.

The answer isn’t clear-cut.

Surgeon Marty Makary wondered why and what could be done.

So, Makary, a researcher and a professor of surgery and health policy at Johns Hopkins School of Medicine in Baltimore, took an innovative approach toward developing guidelines: matching the right number of opioid painkillers to specific procedures.

After all, most doctors usually make this decision based on one-size-fits-all recommendations, or what they learned long ago in med school.

Even Makary admitted that for most of his career he “gave [painkillers] out like candy.”

In December, he gathered a group of surgeons, nurses, patients and other leaders, asking them: What should we be prescribing for operation X?”

The answer was illuminating.

“No one should have 50 tabs sitting in their medicine cabinet” for acute pain, says Dr. Marty Makary, who’s leading an effort to curb overprescribing by offering procedure-specific guidelines for opioid painkillers. (Courtesy of Johns Hopkins Medicine)

“The head of the hospital’s pain services said, ‘You’re the surgeon, what do you think?’” recalled Makary.

Makary didn’t know. Nor did the resident. And the nurse practitioner, who often is the one who most closely follows up with patients, said it varies.

“Wow,” recalls Makary of that day when they first considered appropriate limits. “We’re the experts, the heads of this and that, and we don’t know.”

After a quick couple of weeks of intense discussion, Makary’s group reached consensus and gave its blessing to guidelines setting maximum numbers of opioid-containing pills for 20 different common surgical situations, from relatively minor procedures to coronary bypass surgery.

“We’re in a crisis,” said Makary, explaining why the group didn’t go a more traditional route and publish its findings in a medical journal first, which could take months.

Sometimes the right number of opioids is zero, concluded the group.

Indeed, it recommends no opioids for patients heading home after uncomplicated labor and delivery, or after cardiac catheterization, a procedure in which a thin, hollow tube is inserted into the heart through a blood vessel to check for blockages.

For certain types of knee surgery, such as arthroscopic meniscectomy, the guidelines recommend no more than 12 pills upon discharge, while a patient going home after an open hysterectomy could require as many as 20.

Optimally, “no one should be given more than five or 10 opioid tablets after a cesarean section,” Makary said.

Oh, and for cardiac bypass surgery? No more than 30 pills.

But What About The Pain?

Tens of thousands of Americans are dependent upon opioid medications. An increasing number are dying from overdoses, both from prescription medication and street drugs.

Knowing that, Makary, as well as other surgeons, hospitals and organizations, are taking steps to change how they practice medicine.

After all, many experts view the use of opioid prescription painkillers after surgery as a gateway to long-term use or dependence. A study published last year in the journal JAMA Surgery found that persistent use of opioids was “one of the most common complications after elective surgery.”

In that study, University of Michigan researchers found that 6 percent of people who had never taken opioids but received them after surgery were still taking the medications three to six months later.

With about 50 million surgeries that occur in the U.S. each year, “there are millions who may become newly dependent,” said Chad Brummett, the study’s lead author and an associate professor of anesthesiology at the University of Michigan Medical School.

Smokers, and those diagnosed with certain conditions such as depression, anxiety or chronic pain before their operations, were most at risk of long-term use.

Each refill or additional week of use makes for a greater risk of misuse, other studies have shown.

Additional research points to another reason for concern. If patients don’t take all the pills they are prescribed following an operation, those pills can be stolen or diverted to other people, who then run the risk of becoming dependent.

Still, there is debate in medical circles about just how effective recommendations and guidelines will be in stemming the epidemic.

For one thing, some experts worry that if the fight against opioids focuses only on safe prescribing at the expense of seeking alternatives, it may miss the bigger picture.

“Are there better methods than opioids in the first place?” asks Lewis Nelson, chair of emergency medicine at Rutgers New Jersey Medical School. “Could you put a lidocaine patch over the wound or is there a better way to immobilize a joint?”

Studies have shown that sometimes a combination of ibuprofen and acetaminophen can be just as good as or better than opioids.

Alternatives should always be considered first, agreed Makary.

Another concern is that guidelines for prescribing relief — even those aimed at short-duration, acute pain, such as that following surgery — have carryover effects on patients with long-term pain. Advocates say all the attention around prescribing limits have made it difficult for chronic pain patients to get the medications they need.

Some people even apply these concerns to recommendations about the treatment of acute pain.

“It’s important for a physician to have the ability, if they feel there’s a medical necessity, to write a prescription for a longer duration,” said Steven Santos, president of the American Academy of Pain Medicine. “It’s challenging to lump all patients into one basket.”

A Different Focus: Duration

Lawmakers — desperate to address overdose problems that are destroying families and communities — have gone where they usually don’t: setting specific rules for doctors.

Legislatures in more than a dozen states, including New Jersey, Massachusetts and New York, have set restrictions, often on the number of days’ worth of pills prescribed for acute pain.

“States said that since physicians haven’t self-regulated, we’re going to do it for them,” said Nelson at Rutgers.

Congress, too, is getting involved, holding a flurry of hearings this spring, and considering legislation that would, among other things, set limits on prescribing opioids for acute pain. The recently passed federal spending bill includes $3 billion in new funding to help states and local governments with opioid prevention, treatment and law enforcement efforts.

To be sure, the medical profession has also responded to the crisis — with medical societies and other expert groups offering a growing number of standards for prescribing opioids.

Some are fairly generic, recommending the lowest dose for the shortest period of time for acute pain. Some are more prescriptive.

None is meant to address the needs of chronic pain patients or those with cancer.

And state rules vary. New Jersey’s, for example, says patients with acute pain should, initially, get no more than a five-day supply, while Massachusetts sets the cap at seven days for a patient prescribed opiates for the first time.

The Centers for Disease Control and Prevention recommends three days.

Makary and some other experts say that, while well-intentioned, such durational rules are too blunt.

A day’s worth of pills can vary, depending on how often the doctor instructs patients to take them. Under many of the state rules, patients could still head home with more than 50 pills.

“No one should have 50 tabs sitting in their medicine cabinet” for acute pain, said Makary.

Andrew Kolodny, co-director of opioid policy research at the Heller School for Social Policy and Management, supports guidelines but wants states to take their rules a step further.

“I don’t think the way the states are going at this makes much sense because the issue with overprescribing was quantity, yet they’re passing laws around duration,” he said.

Instead, the laws should require that “if physicians are going to prescribe more than three days, they have to warn the patients that this is an addictive drug and that taking it every day for as little as five days may cause them to become physiologically dependent,” Kolodny said.

That would create a disincentive to prescribing more than three days’ worth of opioid painkillers, he added, and lead to more informed patients among those who need a longer supply.

Rutgers’ Nelson, who sat on the CDC panel that developed recommendations, said durational rules — like those adopted by the states — can be effective.

“I personally think three days is enough,” said Nelson. “That doesn’t mean pain goes away in three days, but most people get better within three to five days.”

That said, Nelson called the Hopkins’ approach an “excellent idea” and one he has tried to do. “It’s a lot harder than it sounds because of the large number of procedures and the diversity of patient needs,” he said.

To get around overprescribing — or setting one-size-fits-all guidelines — physicians at Dartmouth-Hitchcock Medical Center have a developed their own data-based approach.

Dr. Richard Barth, the chief of general surgery at Dartmouth, and colleagues studied 333 patients discharged from the hospital following six common surgeries that included bariatric procedures; operations on the stomach, liver, colon and pancreas; and hernia repair.

Surveying the patients, they asked how many opioid pills they went home with, how many they actually took, how many went unused and how much pain they experienced.

The data helped them land on a way to recommend a specific number of pills. “If they took none the day before discharge, then over 85 percent of patients did not take any when they went home,” said Barth.

Dartmouth-Hitchcock now uses that data as a recommended starting point for physicians.

Under the guidelines, patients taking no opioid pain pills the day before discharge go home with none. Those who take one to three pills get 15, an amount Barth’s study found satisfied 85 percent of patients, and those who took four or more get 30 pills.

“We came out with a very easy to implement and remember guideline,” said Barth. “We actually called patients and asked them how many [pills] they used. That’s what differentiates us from other places.”

Brummett, at Michigan, says the Opioid Prescribing Engagement Network, a collaboration of hospitals, insurers, physicians and others in his state, has used similar data methods to come up with procedure-specific guidelines.

“We’ve taken a data-driven approach,” he said. “We believe patient-reported outcomes are a better way to guide than expert consensus.”

For his part, Makary admitted it is harder to develop guidelines like those at Hopkins and Dartmouth, but he said the effort is vital.

“It’s mind-boggling to me” that so many opioid-prescribing guidelines do not specify the procedure, said Makary. “An ingrown toenail is not the same as cardiac bypass surgery.”

Must-Reads Of The Week From Brianna Labuskes

President Donald Trump’s summit with North Korean leader Kim Jong Un may have stolen a bit of the spotlight from health care this week, but there’s still plenty of news to go around in our corner of the world. Here’s what you may have missed.

Republicans are cringing at the administration’s decision not to defend the health law’s preexisting condition provision. The move is likely to serve as a tailor-made soundbite for Democrats as lawmakers hit the campaign trail for the midterms. In fact, Dems are already going after the decision as “a sick joke,” while Senate Majority Leader Mitch McConnell (R-Ky.) is doing damage control. “Everybody I know in the Senate — everybody — is in favor of maintaining coverage for preexisting conditions,” McConnell told reporters in the Capitol. “There is no difference in opinion about that whatsoever.”

Politico: Trump’s Latest Health Care Move Squeezes Republicans

The New York Times: A ‘Sick Joke’: Democrats Attack Health Secretary On Pre-Existing Conditions

Politico: McConnell: ‘Everybody’ In Senate Likes Pre-Existing Condition Safeguards


Insurers are less than pleased with a court’s decision that they are not owed billions of dollars from the government under the health law’s risk corridors program. The program was designed to entice insurers into the marketplace with promises of covering their financial risk. But the panel said the government doesn’t have to pay insurers the money because Congress had taken action — after the health law’s passage — requiring the program to be budget neutral year after year. Insurers complain the rug was pulled out from under them.

The Wall Street Journal: Federal Government Doesn’t Have To Pay Billions To Health Insurers, Court Rules


The big dogs in the insurance industry are slowly inching toward a model where they could deny emergency room claims — and hospitals, doctors and lawmakers are all livid imagining a world where patients worry about whether their visits are going to be covered before seeking emergency care. The companies, though, argue that unnecessary ER visits are a huge factor in driving up medical costs. They’re not wrong, but the subject has always been taboo before.

Politico: Insurers Spark Blowback By Reducing Emergency Room Coverage


CRISPR is so hot right now it even spawned a (canceled) TV show. But a report that found genes edited by the technology could essentially be cancer “ticking time bombs” sent stocks spiraling this week.

Stat: CRISPR-Edited Cells Might Cause Cancer, Two Studies Find


Lawmakers are gearing up to consider a whopping 57 measures in an opioid package that is sure to win both Democrats and Republicans political points — conveniently just before the midterms. But advocates say the bills may still fall short of what’s needed to battle the country’s epidemic.

Stat: Can Major Opioids Legislation Make A Dent In A National Epidemic?


And in the miscellaneous file this week: A report confirms that sexual harassment is rampant in the academic sciences (“Most of that harassment is not the Harvey Weinstein harassment. It’s the everyday put-downs, and exclusions and belittlings,” said one woman); an ALS scientist who was diagnosed with the disease after he started researching it says he finds reason to live by helping others fight the condition that has ravaged his body; a nationwide survey reports that the kids are not all right, with sadness and hopelessness on the rise in teens (they’re also drinking less milk for what it’s worth); and how being black in America can deeply affect your health.

The Washington Post: Half Of Women In Science Experience Harassment, A Sweeping New Report Finds

The Washington Post: Devastated By ALS, Trying To Save Others

The New York Times: Sex And Drugs Decline Among Teens, But Depression And Suicidal Thoughts Grow

The Atlantic: Being Black In America Can Be Hazardous To Your Health


As you’re planning your weekend, you should probably know the oft-touted Mediterranean diet report has been retracted as flawed. But if you’re a fish, olive oil and nuts person, don’t worry, experts still think the diet is beneficial to heart health. Meanwhile, I’ll be over here worrying about my DNA’s digital footprint.

In New Hampshire, Even Mothers In Treatment For Opioids Struggle To Keep Children

Jillian Broomstein starts to cry when she talks about the day her newborn son Jeremy was taken from her by New Hampshire’s child welfare agency. He was 2 weeks old.

“They came into the house and said they would have to place him in foster care and I would get a call and we would set up visits,” she said. “It was scary.”

Broomstein, who was 26 at the time, had not used heroin for months and was on methadone treatment, trying to do what was safest for her child. The clinic social worker told her that since Jeremy would test positive for methadone when he was born, she would need to find safe housing or risk losing custody.

Broomstein moved in with a friend and her kids — but it turned out that friend had her own legal battles with the state’s Division of Children, Youth and Families, known as DCYF. The friend’s home would not pass muster as “safe housing” because of that.

Since Broomstein grew up in foster care and had no family to take her in, Jeremy was taken from her. She had 12 months to try to get her son back or lose her parental rights permanently.

To get their children back from the foster care system in New Hampshire, parents struggling with addiction are required to be compliant in drug treatment and have a safe place to live. If they can’t find housing or if they relapse, the clock does not stop ticking.

“I cannot stress enough that 12 months is a really short window for somebody who’s in early recovery,” said Courtney Tanner, who runs Hope On Haven Hill, one of the few places in New Hampshire where pregnant women and new mothers can live with their children and get treated for addiction. But with just eight beds here, the waitlists can be long.

There are more than 430,000 children in foster care in the U.S., according to the latest government figures. The opioid crisis is definitely a factor in an increasing trend of more children being removed from the home, but the scope of the problem is hard to measure due to poor tracking.

New Hampshire has some of the highest rates of opioid abuse in the country. One of the fastest-growing groups of heroin users is women of childbearing age. In the past few years the number of children taken into state custody has more than doubled, according to DCYF. Last year, New Hampshire spent $36 million for foster care.

“Here in New Hampshire, what I have seen is a mom can be enrolled in this program and compliant in treatment and they are giving birth to a child and that child is still being removed and put into foster care,” said Tanner.

In 2012 state legislators made major budget cuts to DCYF — and those dollars have not been restored. Child welfare workers in New Hampshire have more than triple the caseloads than in many other states, according to the agency’s director Joseph Rispam. Also as a result of the budget cuts, DCYF can only engage a family once case workers have opened a legal case of abuse and neglect. There’s little money to support parents before that happens.

“The result of that is … that more children coming into the foster care system that otherwise might not if we had the capacity to serve families more holistically up front,” said Ripsam.

After her son Jeremy was placed into foster care, Jillian Broomstein continued her methadone treatment and her parenting classes.

She was determined to get her son back. She finally got off a waiting list and got a bed at one of the residential treatment centers for young mothers. After a few months she was reunited with Jeremy. But she was told that her case was unusual.

“They said in court that it was an odd case that they gave me my child back so quickly,” Broomstein said. “It made me want to cry.”

“I knew it was going to be hard,” she said. “Not everybody tries to get their children back. A lot of people I’ve known just give up; they just resort back to drugs again.”

This story is part of a reporting partnership that includes NPR and Kaiser Health News.


KHN’s coverage of these topics is supported by
Heising-Simons Foundation
and
The David and Lucile Packard Foundation

How America Got Hooked On A Deadly Drug

(Maria Fabrizio for KHN)

Purdue Pharma left almost nothing to chance in its whirlwind marketing of its new painkiller OxyContin.

From 1996 to 2002, Purdue pursued nearly every avenue in the drug supply and prescription sales chain — a strategy now cast as reckless and illegal in more than 1,500 federal civil lawsuits from communities in Florida to Wisconsin to California that allege the drug has fueled a national epidemic of addiction.

Kaiser Health News is releasing years of Purdue’s internal budget documents and other records to offer readers a chance to evaluate how the privately held Connecticut company spent hundreds of millions of dollars to launch and promote the drug, a trove of information made publicly available here for the first time.

All of these internal Purdue records were obtained from a Florida attorney general’s office investigation of Purdue’s sales efforts that ended late in 2002.

I have had copies of those records in my basement for years. I was a reporter at the South Florida Sun-Sentinel, which, along with the Orlando Sentinel, won a court battle to force the attorney general to release the company files in 2003. At the time, the Sun-Sentinel was writing extensively about a growing tide of deaths from prescription drugs such as OxyContin.

We drew on the marketing files to write two articles, including one that exposed possible deceptive marketing of the drug. Now, given the disastrous arc of prescription drug abuse over the past decade and the stream of suits being filed — more than a dozen on some days — it seemed time for me to share these seminal documents that reveal the breadth and detail of Purdue’s efforts.

Asked by Kaiser Health News for comment on the OxyContin marketing files and the suits against the company, Purdue Pharma spokesman Robert Josephson issued a statement that reads in part:

“Suggesting activities that last occurred more than 16 years ago, for which the company accepted responsibility, helped contribute to today’s complex and multi-faceted opioid crisis is deeply flawed. The bulk of opioid prescriptions are not, and have never been, for OxyContin, which represents less than 2% of current opioid prescriptions.”

Purdue first marketed OxyContin for cancer pain but planned to expand that use to meet its multimillion-dollar sales goals.(John Ewing/Portland Press Herald via Getty Images)

The marketing files show that about 75 percent of more than $400 million in promotional spending occurred after the start of 2000, the year Purdue officials told Congress they learned of growing OxyContin abuse and drug-related deaths from media reports and regulators. These internal Purdue marketing records show the drugmaker financed activities across nearly every quarter of medicine, from awarding grants to health care groups that set standards for opioid use to reminding reluctant pharmacists how they could profit from stocking OxyContin pills on their shelves.

Purdue bought more than $18 million worth of advertising in major medical journals that cheerily touted OxyContin. Some of the ads, federal officials said in 2003, “grossly overstated” the drug’s safety.

The Purdue records show that the company poured more than $8 million into a website and venture called “Partners Against Pain,” which helped connect patients to doctors willing to treat their pain, presumably with OxyContin or other opioids.

It made and distributed 14,000 copies of a video that claimed opioids caused addiction in fewer than 1 percent of patients, a claim Food and Drug Administration officials later said “has not been substantiated.”

Purdue hoped to grow into one of the nation’s top 10 drug companies, both in sales and “image or professional standing,” according to the documents; OxyContin was the means to that end.

Purdue first marketed the drug for cancer pain but planned to expand that use to meet its multimillion-dollar sales goals. In 1998, the market for treating cancer with opioids stood at $261 million, compared with $1.3 billion for treating other types of pain, the Purdue reports note.

Purdue’s OxyContin sales objectives were clearly stated in the earliest marketing plan in the records, for 1996. It sought $25 million in sales and to generate 205,000 prescriptions. By the next year, its goals had tripled: $77.9 million in sales and to generate 600,000 prescriptions.

Purdue bombarded doctors and other health workers with literature and sales calls. Records show that in 1997 the company budgeted $300,000 for mailings to doctors who prescribed opioids liberally, based on sales data that drug companies purchase. The mailers recommended OxyContin for “pain syndromes,” including osteoarthritis and back pain. It added $75,000 for mailings “to keep in touch with our best customers for OxyContin to ensure they continue prescribing it.”

Sales agents made thousands of visits to general practice doctors and others who had little training or experience using potent opioids, according to a 2003 Government Accountability Office audit. The OxyContin slogan in 1999 was: “The One to Start With and the One to Stay With.” OxyContin earned Purdue about $2.8 billion in revenue from the start of 1996 through June 2001, according to the Justice Department.

In May 2000, Purdue’s hope to conquer the arthritis market hit a snag when the FDA criticized an ad for OxyContin in the New England Journal of Medicine. The FDA said the ad, which Purdue Pharma agreed to stop using, overstated the drug’s benefits for treating all types of arthritis without pointing out risks.

News reports of abuse and overdose deaths also were surfacing. Purdue’s 2001 marketing document noted that OxyContin had “experienced significant challenges” the year before because of abuse and unlawful diversion in Maine, Ohio, Virginia, Louisiana and Florida.

OxyContin pills contain oxycodone, an opioid as potent as morphine and maybe more so. Abusers quickly figured out they could crush the pills and snort or inject the dust

In response, Purdue’s 2001 marketing budget included funding to help doctors recognize patients who were in need of “substance abuse counseling” and do more to “prevent abuse and diversion.” It added $1.2 million in spending for what it called “anti-diversion” efforts in 2002, according to the internal records.

Potent Sales Force

In 2002, The Florida attorney general’s office was one of the first law enforcement agencies to investigate Purdue. The state ended its probe after Purdue agreed to pay Florida $2 million to help fund a data system to monitor narcotics prescriptions. It did not admit to any wrongdoing in the settlement.

Yet handwritten notes of a state investigator’s interview with a former Purdue sales manager for West Virginia and western Pennsylvania named Bill Gergely, then 58, suggested otherwise. The notes were part of the documents released by the state.

Gergely, who worked for the company from 1972 until 2000, said Purdue executives told sales staff at a launch meeting that OxyContin “was non-habit forming,” according to the undated investigator’s notes. Gergely said Purdue gave its sales force material — some of which was not approved by the FDA — for “education,” the notes show. He told the investigator that Purdue had a bonus system and paid well; the last year he worked for Purdue, Gergely earned $238,000.

(Story continues below.)

As Purdue charged ahead with OxyContin, prescription pills overtook illegal drugs like heroin and cocaine as killers in Florida, according to medical examiner files. In May 2002, the South Florida Sun-Sentinel documented nearly 400 pill deaths in three South Florida counties the previous two years, based on an examination of autopsy and police records.

Half the deaths involved drugs that contained oxycodone, according to medical examiner records. But it was not always clear in these records that it was OxyContin because oxycodone was an ingredient in many other narcotic pills. In 70 of the deaths, however, police or medical examiner records specifically identified OxyContin as one of the drugs. Though some people who died bought pills on a thriving black market, many were under the care of doctors for what appeared, at least at some point, to be legitimate injuries, according to medical examiner files.

Purdue did not challenge the accuracy of the newspaper’s reporting. It countered that the articles “did a disservice” to the company and patients who take their medicine “according to the directions of their doctors.” While the company said its executives “deeply regret the tragic consequences that have resulted from the misuse and abuse of our pain medicine … advances in the treatment of pain should not be limited or reversed because some people illegally divert, abuse or misuse these drugs.”

To its sales force, the internal Purdue records show, Purdue blamed bad press for cutting into sales. “The media’s attention to abuse and diversion of OxyContin tablets has provided state Medicaid plans and some HMOs, concerned about the effect the product is having on their budget, an excuse to look for ways to limit the prescribing of OxyContin tablets,” the 2002 marketing document said.

But five years after its legal battle with Florida officials, Purdue made a startling admission in federal court in Virginia. The company pleaded guilty in 2007 to felony charges of “misbranding” OxyContin “with the intent to defraud or mislead.” The company paid $600 million in fines and other penalties. Among the deceptions it confessed to was directing its salespeople to tell doctors the drug was less addictive than other opioids.

Three Purdue Pharma executives pleaded guilty to misdemeanor criminal charges for their roles in the marketing scheme. The three men paid a total of $34 million in fines and penalties, court records show. Accepting Purdue’s plea deal, U.S. District Judge James P. Jones noted that federal prosecutors believed the Purdue case of 2007 would send a “strong deterrent message to the pharmaceutical industry.”

A Costly Reckoning?

Ten years on, the 1,500-plus lawsuits, filed mostly on behalf of cities, counties and states, could prove to be a costly reckoning for the opioid industry. The suits are demanding payback from Purdue and other drugmakers for the sky-high costs of treating addiction and other compensation, much as the litigation against Big Tobacco in the late 1990s.

Other drug makers named as defendants in most of the suits include those that Purdue considered to be its top competitors in the pain sector: Janssen Pharmaceuticals, Teva Pharmaceutical Industries, Endo International PLC and Mallinckrodt PLC.

Federal officials estimate the economic cost of opioid abuse topped $500 billion in 2015 alone. Since 1999, at least 200,000 people have died in the U.S. from these overdoses, according to the Centers for Disease Control and Prevention. More than 52,000 of those died in 2015 alone, more than were killed in car crashes and gun homicides combined, the suits contend.

A case filed in April by Baltimore County in Maryland makes an argument common to many of the suits:

“From the mid-’90s to the present, manufacturing defendants aggressively marketed and falsely promoted liberal opioid prescribing as presenting little to no risk of addiction, even when used long term for chronic pain. They infiltrated academic medicine and regulatory agencies to convince doctors that treating chronic pain with long-term opioids was evidence-based medicine when, in fact, it was not.

“Huge profits resulted from these efforts — as did the present addiction and overdose crisis.”

Purdue has not yet filed a response to the allegations in the suit.

Other drug manufacturers “emulated Purdue’s false marketing strategy” and sold billions of dollars of prescription opioids “as safe and efficacious for long term use, knowing full well that they were not,” Wisconsin’s Oneida County alleges in its November 2017 federal court suit. Purdue also has not yet filed a response to the allegations in this suit.

But Purdue spokesman Josephson told KHN: “We share public officials’ concern about the opioid crisis, and we are committed to working collaboratively toward meaningful solutions. We vigorously deny these allegations and look forward to the opportunity to present our defense.”

One California doctor who was sentenced to 25 years in prison for overprescribing OxyContin is also suing Purdue. Masoud Bamdad alleges that the company’s representatives made sales calls and gave him “deceitful, misleading and over-hyped information,” which he relied on to prescribe the drug, in some cases with deadly consequences for his patients, according to the suit, which is pending. Purdue has asked that the case be stayed while judges decide if it should be consolidated with others filed against the company. In February, Purdue announced that it would no longer promote opioids to doctors.

(Story continues below.)

Because the lawsuits from across the U.S. contain similar allegations, many of them have been consolidated in Ohio – as a multi-district litigation. Some days, federal court dockets log a dozen or more new cases. Many of the suits run a hundred pages or more and allege that deceptive opioid marketing schemes continue to this day.

The manufacturers, in a joint court motion late last year, contend that opioids “serve a critical public health role in providing relief to patients suffering from pain that is often debilitating” and that they are being wrongly blamed.

They also point out that the FDA approved all of their products as “safe and effective.”

This month, the manufacturers filed motions to dismiss several of the cases, arguing that the county governments lack a legal basis for their claims. In seeking to blame the drugmakers, these lawsuits ignore “the criminal acts of third parties, the crucial role of health care providers, and the thorny public policy questions surrounding the problem of opioid abuse,” reads a motion to dismiss a case filed by Monroe County, Mich., against Purdue Pharma and other drug companies.

Dan Polster, the federal judge handling the cases, told an overflow crowd in his courtroom that the opioid epidemic has become so severe, that it is cutting the average life expectancy of Americans.

“I’m pretty ashamed that this has occurred while I have been around,” he said in January, adding “I think we all should be.”


KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Must Reads Of The Week From Brianna Labuskes

A distinctly sad and sobering week: days of suicide stories follow the deaths of Anthony Bourdain and Kate Spade. The events, and a devastating report about spiking suicide rates across the country, threw self-harm and mental health awareness into the spotlight. Advocates took to social media to spread the message: Depression “doesn’t discriminate.”

Here’s what else you may have missed this week.

The Justice Department is refusing to defend the health law in court, leaving a coalition of blue-state attorneys general to do the heavy lifting. It’s a political gamble for the administration as it could rattle an already unstable marketplace as the midterm elections creep up on us.

“Of all the things the Trump administration has done to destabilize the market, this may be the most major,” said Timothy Jost, a professor emeritus at Washington and Lee University and a health law supporter. Also, meet the Texas plaintiffs at the heart of the case who feel compelled to follow the letter of the law, despite the lack of penalty.

In a compelling profile, they’re likened to people who don’t “take a tag off of their mattress” because of the legal warning.

The New York Times: Justice Dept. Says Crucial Provisions of Obamacare Are Unconstitutional

Politico: Texas Plaintiffs Personalize Uphill Legal Challenge to Overturn Obamacare

And, these insurers say they don’t expect to lose customers next year, but they’re still planning on raising premiums by the double digits. At first that might warrant a “huh?” moment, but it all comes down to a business calculation. The insurers know when one company loses customers that can have a ripple effect though the marketplace. So, they’re all in a defensive crouch.

Modern Healthcare: Insurers Downplay Mandate Repeal’s Effect, But Still Raise Premiums


Other big news is the grim outlook for Medicare’s trust fund — it’s now expected to be depleted in 2026 instead of 2029, as was projected last year. To be clear, though, the money that’s running out is used to pay for hospital visits. Other services are supported primarily through general funds.

The New York Times: Medicare’s Trust Fund Is Set to Run Out in 8 Years. Social Security, 16.


Single-payer, single-payer, single-payer. You’ve probably heard that phrase a lot in the past year or so, especially this week when the California gubernatorial race was at center stage. But Democrats are being warned not to actually utter those words on the trail, leadership being worried that it could divide the party and make progressive candidates vulnerable to attacks from the GOP. That doesn’t mean talk about universal coverage is verboten, it’s just that the hot buzzword won’t be on too many candidates’ lips this summer and fall.

Politico: The 2 Words You Can’t Say in a Democratic Ad

The New York Times: In Fight for California Governor, Candidates Head to Ideological Corners


Thanks, but no thanks: Pharma companies aren’t all that interested in taking advantage of the relaxed provisions included in the “Right-to-Try” legislation that lawmakers passed recently after a series of fits and starts. It turns out, Big Pharma likes to go through the FDA anyway … which opponents have been saying all along.

The Wall Street Journal: The ‘Right to Try’ Law Says Yes, The Drug Company Says No

And, you think it’s hard to control drug prices for popular, lifesaving medications? What about when the treatment is for a problem no one wants to talk about?

The New York Times: Prices Keep Rising for Drugs Treating Painful Sex in Women


In our miscellaneous file for the week: In somewhat-rare good news, a study found that many women with a common form of breast cancer can skip chemotherapy; a court is weighing whether punishing an offender for having a drug relapse counts as “cruel and unusual punishment”; marijuana addiction is surging, but experts are having a hard time convincing people it even exists; and remember Brazil’s Zika babies? They’re growing up.

The Associated Press: Many Breast Cancer Patients Can Skip Chemo, Big Study Finds

The New York Times: She Went to Jail for a Drug Relapse. Tough Love or Too Harsh?

Stateline: Yes, You Can Become Addicted to Marijuana. and the Problem Is Growing.

The Associated Press: From Shrieks in Bucket to Laughs, Brazil Zika Baby Improves


I also feel duty-bound to point out that the U.S. has now issued a health alert over the unexplained brain injuries that have cropped up in diplomats serving in China. The mystery — make of it what you will — continues! Lots to read this weekend!