The opioid epidemic: How we got in, how we can get out

Dear Reader,

No way around it: Pain, which accompanies so many diseases and injuries, demands attention. But recent attempts to ease chronic pain with powerful prescription narcotics have gone wrong, horribly so.

Big Pharma’s profiteering, physicians’ lax prescribing, and misguided good intentions all around have become a lethal prescription for tens of thousands of Americans who have been inundated with potent painkillers.

This has created an opioid drug abuse epidemic, one of the deadliest public health scourges to afflict the nation in recent times. We need to reckon with its carnage — and figure out how to stop it.

The path forward has many avenues. This month, we explore some of the most promising.

Opioid prescription drugs are killing tens of thousands

Mary Jo Curtis, 57, was found dead in her bed in June 2014. How she came to that tragic end, with a fatal mix of painkillers and alcohol, is just one example of the nation’s rampant opioid crisis.

Curtis, a Manassas, Virginia mom and insurance executive, had fallen down stairs at her home and broken her ankle three years before. She underwent multiple surgeries to try to repair her ankle, all with the same doctor, Christopher Highfill, who practices with Northern Virginia Orthopedic Specialists. He would have seen at the outset from her medical records that Curtis struggled with alcohol and other substance abuse and bipolar disorder.

And though he would note that she spoke only on occasion of “mild pain” from her injury, he prescribed for her Percocet. That’s a powerful and highly addictive painkiller, a branded form of the drug oxycodone. Percocet carries by federal regulators’ orders a “black box” warning — the strongest caution that can be offered to doctors that it can be risky, especially for “addiction, abuse, and misuse.”

The doctor, a jury hearing a wrongful death suit against him would find, wrote Curtis weekly Percocet prescriptions, and in the last 14 months of her care without ever seeing her. The number of such pills the doctor would push toward her in 40 months of his care would total more than 7,000.

The jury in Prince William County Circuit Court assessed against Highfill damages of $100,000 for Shea Curtis, 27, of Richmond (a client of our law firm). She is Curtis’s only child (shown in photo above with her mom). Dr. Highfill admitted he was negligent, but denied responsibility for his patient’s death, which he contended would have happened anyway if he had not prescribed the Percocet. He also was reprimanded by the Virginia Board of Medicine, the state licensing authority, for prescribing narcotics to the patient without seeing her, which is a violation of state prescribing law.

How many more families can we spare from tragedies like what befell Curtis? How many overdose deaths might we prevent, and how many patients with medical records free of drug or substance abuse might we save from addiction if the nation could better grapple with its epidemic of abuse involving opioids, drugs named for how they react with pain-signaling receptors in the brain?

I don’t typically write in this newsletter about cases in which our firm’s lawyers are involved. But the Curtis case offers a tough reminder that abuses and overdoses of prescribed opioids, including related drugs like the synthetic painkiller fentanyl and illicit heroin, have become the leading cause of death for Americans 50 and younger, killing more than 64,000 in 2016 alone. Those fatality figures exceed those for major widespread killers of recent times, including car crashes (which peaked in 1972), the HIV-AIDs epidemic (peaking in 1995), and gun homicides (which hit their highs in 1992).

Respected analysts, working with the health information site Stat, have projected that the worst-case death toll from the opioid epidemic could hit 650,000 or more in a decade, a number equivalent to the population of Baltimore.

Other experts now have put a price tag on this tragedy: More than $1 trillion since 2001 and more than $500 billion over the next three years. They attribute that cost to “lost earnings and productivity losses to employers. Early deaths and substance abuse disorders also take a toll on local, state and federal government through lost tax revenue,” NPR reported.

The public broadcaster also quoted Corey Rhyan, a senior analyst who helped calculate the epidemic’s giant tab, and he underscored its human cost: “The average age at which opioid deaths are occurring — you’re looking at something in the late 30s or early 40s. As a result, you’re looking at people that are in the prime of the productive years of their lives.”

Opioid abuse has savaged some parts of the country, notably poorer, rural areas. The federal Centers for Disease Control and Prevention reported that the five states with the highest rates of death in 2016 due to drug overdoses were: West Virginia, Ohio, New Hampshire, Pennsylvania, and Kentucky.

The CDC says significant increases in overdose death rates from 2015 to 2016 were seen in the Northeast, Midwest and South Census Regions. The were a total of 27 states with notable increases in drug overdose death rates, the CDC found, including Maryland and Virginia.

News reports have told how this crisis has been:

• contributing to new outbreaks of syphilis, a destructive sexually transmitted disease that is tough to contain and whose cases had dwindled until recently;

• leading hospices to crack down on how they handle powerful painkillers because a growing number of family members and friends may be stealing the meds from the dying and dead;

• causing dentists and even veterinarians to reconsider their pill-control protocols;

• prompting federal officials to fret about the current dosages of the key ingredient in common, over-the-counter anti-diarrhea medications like Imodium. It turns out that the substance known generically as loperamide, useful in stopping the runs, happens to be part of the opioid family, an addictive drug class that includes morphine and oxycodone. Drug users have turned now to abusing anti-diarrhea meds, which are sold in high-count packages and at dosages that authorities want reduced.

The opioid crisis has become so pervasive that it has for two years running resulted in unheard of reductions in white Americans’ overall life expectancy, with analysts finding that poor, less-educated, and middle-class Americans are dying earlier these days, even as the wealthiest are enjoying unprecedented longevity. The disparities are big. In the District of Columbia, the poorest quarter of men die on average at age 75, while those in the richest quarter live 11 years longer to 86. In Virginia, the poorest men on average die at 76, while the richest live to 86. In Maryland, the numbers are 76 and 85.

And while prescription painkillers may have sparked the crisis, they also re-ignited abuses and overdoses of heroin and fentanyl, a lab-created painkiller that packs a huge wallop at dosages as tiny as a few grains. This has meant that African Americans, who for various reasons had been spared opioids’ harms, now are getting hit as they hadn’t been before with drug deaths among urban blacks, especially in areas like Baltimore and Washington, D.C., increasing by 41 percent in 2016, far outpacing any other racial or ethnic group.

Big Pharma and doctors got this epidemic started

Just how did the nation get so deep into such a mess with opioids?

At least two groups must shoulder considerable blame: Big Pharma and physicians. The links between the two are puzzling and disturbing.

Let’s start with doctors, who long have wrestled with  their patients’ pain, including pain caused by necessary treatments.

Surgery was a grisly practice before scientific advances like sterile environments, antibiotics — and, of course, anesthesia. Oncology continues to be a challenging specialty because of the pain that can accompany many of its key therapies, including radiation and chemotherapy. And obstetrics-gynecology and pediatrics have been sometimes unpleasant fields to work in, with practitioners steeling themselves to suffering that women and children can endure while receiving medical care.

A major push to treat pain

But in the 1990s, doctors and hospitals — many say with a covert shove from Big Pharma — shifted their thinking about pain, slowly but surely elevating it as a central concern, with a rapidly rising group of specialists, calling themselves pain experts, pushing it as a “fifth vital sign.” It inarguably was something that doctors could and should have dealt better with. Still, patient advocates got so caught up in the push for pain management that they would make it a key quality measurement affecting the bottom line for doctors and hospitals.

Big Pharma watchdogs, including investigative journalists and medical experts, also have retrospectively scrutinized how drug makers fueled philosophical and practical changes in the way doctors and hospitals changed their views on pain and its treatment.

These findings, taken in total, offer a view of a big, pernicious campaign for the relentless promotion and sale of pain killers, often with counter-factual arguments and by taking advantage of doctors’ surprising weakness in their wishing just to be liked by their patients. Yes, others, such as insurers, played big parts, too. But only now, decades later, has deep digging by investigative reporters at media outlets like the Los Angeles Times disclosed the major perfidy, for example, of Purdue Pharma, which built a multi-billion-dollar enterprise for the philanthropic Sackler family, what the New Yorker magazine has termed an “Empire of Pain.”

Building an ‘Empire of Pain’

Purdue displayed a marketing, advertising, and sales mastery, campaigning over a quarter of a century to overcome doctors’ resistance to prescribing powerful painkillers like its own powerhouse version of oxycodone, a drug branded as OxyContin. The company insists it has abided by the law and business ethics, though only recently, it has decided to curb its quarter-century of aggressive and controversial drug marketing — efforts that critics and lawsuits say helped fuel the nation’s opioid drug abuse epidemic.

Reporters, meantime, have detailed how, as the Los Angeles Times described it: “Purdue had extensive evidence pointing to illegal trafficking of its [OxyContin] pills but in many cases did not share it with local law enforcement agencies or cut off the flow of the drugs.”

Cities, counties, and states, including most recently Alabama, have sued Purdue, accusing it of pushing addictive painkillers through deceptive marketing. Plaintiffs assert the firm pooh-poohed the significant risk of OxyContin addiction, while vastly overstating opioids’ benefits in treating chronic rather than short-term pain, Reuters reported::

“Purdue and three of its executives pleaded guilty in 2007 to federal charges related to the misbranding of OxyContin and agreed to pay a total of $634.5 million to resolve a Justice Department investigation. That year, Purdue also reached a $19.5 million settlement with 26 states and the District of Columbia. It agreed in 2015 to pay $24 million to resolve a lawsuit filed by Kentucky.”

Purdue long has asserted that it sold drugs approved by the federal Food and Drug Administration, and it pointed to its efforts to reformulate its painkiller to make it less susceptible to abuse. But the Los Angeles Times noted that the independent, nonpartisan RAND Corp. and the Wharton School of Business at the University of Pennsylvania scrutinized data on Purdue’s much-touted product switch.

The company changed OxyContin, so the pills were tougher to crush up, and therefore became more difficult to snort, smoke, or inject. Wharton and RAND found that move didn’t stem the opioid drug abuse epidemic but sent it, instead, in a new direction — prescription painkillers became a gateway, but abusers then moved on to illicit alternatives, including heroin and fentanyl.

Purdue’s rise as a big-time Big Pharma enterprise stems from its start with the entrepreneurial Sackler family and their marketing savvy, the Los Angeles Times reported:

“Purdue was a small New York City pharmaceutical firm when brothers Mortimer and Raymond Sackler, both psychiatrists, bought it in 1952. The spectacular success of OxyContin has generated tens of billions of dollars in revenue over the last two decades and made the Sacklers one of the nation’s wealthiest families. Three generations of the family now help oversee the Purdue and Mundipharma corporations. The family is known for giving tens of millions of dollars through its foundations to such renowned arts institutions as the Victoria and Albert Museum in London, the Dia Art Foundation and the Solomon R. Guggenheim Museum in New York.”

The New Yorker magazine also did a deep dive into the Sackler’s philanthropic ties across the country, raising questions about the family’s ascent into the cultural elite and big institutions’ willingness to accept gifts from an enterprise built on hype and patients’ pain. The magazine also reported how a Sackler scion, now a documentary film maker, is shooting a project rife with irony, as it records the travails of Indiana prison inmates, many of whom are incarcerated due to crimes tied to opioid abuse. Nan Goldin, a respected photographer, has chronicled in a tony art magazine her own struggles with OxyContin addiction after a wrist injury and ripped the Sackler family, accusing them of abetting the opioid crisis.

Bloomberg news service, which first reported Purdue’s marketing shift, reminded in its report that Purdue’s pushy and innovative marketing for oxycontin hit a surprisingly gullible audience in supposedly well-educated, smart doctors. Its hype included its own music tracks, as well as silly swag like fishing hats and stuffed toys.

Credulous caregivers

Can it really be that doctors, with decades of advanced education and well-paying and highly respected positions, were gulled by trinkets and armies of fast-talking sales representatives into whipping out their prescription pads and ordering risky and costly meds for the vulnerable patients in their care?

The influential medical journal JAMA Internal Medicine published a study that finds that Big Pharma can sway doctors’ drug prescribing practices for about the cost of a large pizza and a few sodas, roughly $20. Just to be clear, this scrutiny involved more than 275,000 MDs, and more than 65,000 payments over four medications. The research doesn’t purport to demonstrate cause-and-effect but shows a troubling correlation.

And, as the Washington Post summarized of this study: “Doctors who ate a single meal on a drug company’s tab had a higher likelihood of writing a prescription for the name-brand drug that was being promoted instead of equivalent drugs that were cheaper. … And the more meals — or the more expensive the meals — the greater the rate of prescribing the pitched drug.”

The New Yorker, referring to investigations by the Los Angeles Times and others, as well as its own reporting, also found that Purdue for years paid doctors speaker and other fees to get them to convince medical peers that OxyContin should be prescribed widely for many different types of pain. The company also made a claim, later shown to be unsupported, that its drug’s effects lasted longer and so required fewer pills to be taken. But documents later were forced out, showing that many patients did not get the promised durational pain relief, causing them to abuse the drug instead.

A U.S. Senate Committee has just released a report assailing Big Pharma for quietly making millions of dollars of payments to patient advocacy groups so they could help to legitimize and assist in promoting powerful prescription painkillers, a practice that investigators say helped fuel the opioid drug abuse epidemic.

Inundated with addictive pills

Big Pharma’s incessant flooding of not just the United States but the globe with prescription painkillers hit in ways that are still hard to fathom.

West Virginia officials and the Charleston Gazette-Mail, a small newspaper, used civil lawsuits to force Big Pharma to start to show how it flooded poor, desperate small towns across the state with tens of millions of painkiller pills.

The paper, in one of several excellent reports, found that, “In six years, drug wholesalers showered the state with 780 million hydrocodone and oxycodone pills, while 1,728 West Virginians fatally overdosed on those two painkillers.” The paper points out the obvious: There was zero chance that Big Pharma had any reason to think the powerful and addictive drugs were in appropriate use—and the Charleston Gazette-Mail questions why more pharmacists and state regulators did little as a tsunami of potent and suspect medications inundated small towns and turned lethal.

Early this year, the newspaper followed up some of its pathbreaking work, reporting about inquiries now by congressional investigators. They are demanding to know why Miami-Luken and H.D. Smith, two regional drug wholesalers, shipped 20.8 million prescription painkillers to two pharmacies four blocks apart in a southern West Virginia town with 2,900 people. The supplies of hydrocodone and oxycodone flooded Williamson, a small town in Mingo County.

Company employees also blew the whistle on purported pain doctors who were prescribing big shares of the tidal wave of oxycodone (sold under the brand names OxyContin and Percocet) and hydrocodone (Vicodin and Lortab) washing over the poor, rural area.

But even as companies like Purdue confronted a growing backlash against its seemingly ubiquitous painkillers and took steps to move more of their business to lucrative, even less regulated overseas markets, federal watchdogs, notably the Drug Enforcement Administration, seemed to be a step behind in responding to the opioid crisis.

A Washington Post investigation may provide insight why: The paper says that since 2005, when the DEA began to attack illicit sales of painkillers like oxycodone, Big Pharma has targeted the drug cops’ top echelons, recruiting and hiring away 42 of the agency’s brass. The  DEA division that seeks to curb illegal medication sales got picked clean by Big Pharma of 31 of its leaders, the Post says, detailing how the agency’s aggressive attack on prescription painkillers slowed as it leadership ranks thinned.

Will the nation suffer the effects of that talent depletion even more as the opioid crisis increasingly turns to trafficking and overdose deaths due to illicit drugs like street heroin and fentanyl manufactured overseas, notably in China?

There’s a challenging path forward to end this lethal public health scourge

Reasons for concern about anti-anxiety drugs, too

Too many Americans aren’t just abusing opioid painkillers, close behind may be benzodiazepines.

Don’t know benzos? You may be more familiar with their branded versions like Xanax and Valium.
These medications are often prescribed to treat anxiety, insomnia, and seizures.

But, as a recent commentary in the New England Journal of Medicine observed, too many doctors and patients are unaware or ignore that these drugs can be addictive and lethal, just like opioids.

As the Chicago Tribune reported:

“Prescriptions for benzodiazepines increased by 67 percent between 1996 and 2013, from 8.1 million to 13.5 million. The quantities of drugs obtained with these prescriptions more than tripled during that same period. … As a result, more people are becoming addicted to benzodiazepines and falling victim to overdose. Overdoses involving the drugs multiplied sevenfold between 1999 and 2015, increasing from 1,135 to 8,791 deaths.”

Federal authorities already have issued a stern warning that benzos must not be mixed with alcohol or opioid painkillers because the results can be deadly.

Researchers say the nation must do much more to document and deal with the harms of these drugs, which, like opioids, are starting to show up more often in illicit manufacture and sale.

Drugs like Xanax and Valium should be given for short periods of a few weeks and should not be used long-term, the experts have advised, writing:

“Other risks associated with benzodiazepines include cognitive decline, accidental injuries and falls, and increased rates of hospital admission and emergency department visits. Fortunately, there are safer treatment alternatives for anxiety and insomnia, including selective serotonin-reuptake inhibitors and behavioral interventions. Just as with opioids, some patients benefit from long-term use of benzodiazepines. But even in low-risk patients, it is best to avoid daily dosing to mitigate the development of tolerance, dependence, and withdrawal.”

Fentanyl: a lab-produced pain reliever turned potent killer

As prescription painkiller abuse became more common and widespread, fentanyl, a synthetic opioid developed in the late 1950s, burst into public notoriety.

As the CDC says of the drug: “Pharmaceutical fentanyl is a synthetic opioid pain reliever, approved for treating severe pain, typically advanced cancer pain. It is 50 to 100 times more potent than morphine. It is prescribed in the form of transdermal patches or lozenges and can be diverted for misuse and abuse in the United States.”

The drug, which also can be 30 to 50 times more powerful than heroin, has posed accidental overdose risks to police, fire fighters, and other first-responders who encounter it as part of their official duties, sufficiently so that the DEA has issued special warnings about how it should be handled. Post-mortem investigations have shown that the drug played a part in the deaths of celebrity musicians Prince and Tom Petty.

Fentanyl, sadly, is relatively easily made, with its chemical components accessible and interchangeable. Organized crime has seized on it as a lucrative commodity, though it also is manufactured overseas, notably in China, by lightly regulated chemical companies.

The drug packs a wallop in tiny doses (the photo above shows comparative amounts to overdose on heroin vs. fentanyl), so it can and often is ordered with shocking ease online, then shipped through the international arm of the U.S. Postal Service.

As with other opioids, Big Pharma has sketchy ties to fentanyl’s spread. Federal prosecutors have charged John Kapoor, the controversial founder of drug maker Insys, and other company executives with participation in a wide scheme to bribe doctors to prescribe Subsys, a fentanyl-containing drug sprayed under the tongue as a painkiller for cancer patients.
Prosecutors assert that Insys paid doctors speaker and other fees to get them not only to promote Subsys but also to see it used for other types of pain, besides in cancer, for which it has been federally approved.

A U.S. Senate Committee also has chastised Insys for its sneaky tactics with prescription-drug benefit management companies to promote sales of its fentanyl-based product.

Photo credit: NH state police forensic lab

HERE’S TO A HEALTHY 2018!

Sincerely,

Patrick Malone
Patrick Malone & Associates