Amid a rising toll of opioid overdoses, recommendations discouraging their use to treat pain seem to make sense. Yet the devil is in the details: how recommendations play out in real life can harm the very patients they purport to protect. A new proposal from the Centers for Medicare and Medicaid Services to enforce hard limits on opioid dosing is a dangerous case in point.

A controlled substance analogue (for example, a 'designer drug') is a substance which is structurally or pharmacologically similar to a Schedule I or Schedule II substance, specifically used for human consumption, and is not an approved medication in the United States. I personally don’t understand how depriving law abiding citizens treatment for severe pain is supposed to affect the behavior of criminals who put these medications to illegal use.

There’s no doubt that we needed to curtail the opioid supply. The decade of 2001-2011 saw a pattern of increasing prescriptions for these drugs, often without attention to risks of overdose or addiction. Some patients developed addictions to them; estimates from the Centers for Disease Control and Prevention range from 0.7 percent to 6 percent. Worse, opioid pills became ubiquitous in communities across the country, spread through sale, theft, and sharing with others, notably with young adults.

The prescribing tide has turned: Private and governmentaldata show that the number of prescriptions for opioids has been falling since 2012. Reassuringly, federal surveys show that misuse of pain relievers bottomed out in 2014-15.

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Nevertheless, the CDC produced a guideline in 2016 that recommended shorter durations for opioid prescriptions and the use of non-drug treatments for pain. It also suggested keeping opioid doses lower than the equivalent of 90 milligrams of morphine. As the guideline acknowledged, its recommendations reflected weak scientific evidence. Problematically, it was silent on how to care for patients already receiving doses higher than the 90 milligram threshold.

To its credit, the guideline endorsed treating patients as individuals, not numbers. A CDC official wrote to one patient that the guideline “is not a rule, regulation, or law. … It is not intended to take away physician discretion or decision-making.”

Unfortunately, these mitigating features were undermined by intemperate publicity that vilified opioids for pain. Opioids for pain “are just as addictive is heroin,” proclaimed CDC Director Dr. Tom Frieden. Such statements buttress a fantasy that the tragedy of opioid overdoses and deaths will be solved in doctors’ offices, primarily by upending the care of 5 to 8 million Americans who receive opioids for pain, even when most individuals with opioid addiction did not start as pain patients.

The progression of the guidelines from “voluntary” to “enforceable” has culminated in a draft policy from CMS. It would block all prescriptions above the CDC threshold of 90 milligrams unless complex bureaucratic barriers are surmounted. Urdu novels pdf free download. Many pharmacy plans are already enforcing this approach. Under that plan, many patients suffering with chronic pain would lose access to the medicines they are currently taking, all in the name of reversing a tide of death increasingly defined by non-prescribed opioids such as heroin and fentanyl.

The logic of doing this is untested. There have been no prospective clinical studies to show that discontinuing opioids for currently stable pain patients helps those patients or anyone else. While doing so could help some, it will destabilize others and likely promote the use of heroin or other drugs. In effect, pain patients currently taking opioids long-term have become involuntary participants in an experiment, with their lives at stake.

Turning the voluntary guidelines into strict policy is unfortunate for three reasons.

First, it reflects a myopic misunderstanding of addiction’s causes, one at odds with a landmark report issued by the US surgeon general in November 2016. While the supply of drugs matters, whether people develop addiction to opioids reflects diverse factors including age, biology, and whether their lives include opportunities for rewarding activities like work and family or lacks those opportunities. Restricting prescriptions through aggressive regulation invites the outcomes seen in Prohibition, 90 years ago. To be fair to Prohibition, cirrhosis deaths did decline. But echoing that era’s gangsters and moonshine, we now face a galloping criminal trade in drugs of greater potency and lethality. Overdoses have skyrocketed, mostly from heroin and illicit fentanyl. In a Massachusetts review of overdoses, just 8 percent of those who had overdosed had received opioid prescriptions in the prior month.

Second, we have alternatives to bureaucratic controls. These include promoting and paying for treatments that de-emphasize pills. Important work by the Department of Veterans Affairs shows how to identify patients with elevated risk for harm from opioids and how to mitigate the risks.

Third and most troubling is the increasingly inhumane treatment of patients with chronic pain. Fearing investigation or sanction, physicians caring for patients on long-term opioids face a dire choice: to involuntarily terminate prescriptions for patients who are otherwise stable, or to carry on as embattled, unprotected professionals, subject to bureaucratic muscle and public shaming from every direction.

In this context, we cannot be surprised by a flurry of reports, in the press, social media, and the medical literature describing pain patients entering acute withdrawal, losing function, committing suicide, or dying in jail. The CMS policy, if adopted, will accelerate this trend.

Many of our colleagues in addiction medicine tell us they are alarmed by the widespread mistreatment of pain patients. We receive anecdotes every week from physicians and pharmacists, most of them expert in addictions, describing pain patients who have involuntarily lost access to their pain medications and as a result have been reduced from working to bedridden adults, or who have become suicidal.

This loss of access occurs several ways. A pharmacy benefit program may refuse to cover the prescription because it has already enacted the changes that CMS is proposing to make mandatory. A physician may feel threatened by employers or regulators, and believes his or her professional survival depends on reducing opioid doses — involuntarily and without the patient’s consent — to thresholds that the CDC itself described as voluntary and not mandatory. Or state regulators have imposed such burdensome requirements that no physician in a given region can sustain prescriptions for their patients. Such patients are then “orphaned,” compelled to seek treatment from other physicians across the country.

Given the expertise in addiction among these physicians, it should be particularly worrisome that they believe the present pill-control campaign has gone too far. And yet, the ethics are clear: It should never be acceptable for us to countenance the death of one patient in the avowed service of protecting others, even more so when the projected benefit is unproven.

Surgeon General Dr. Vivek Murthy made an underappreciated declaration in a recent interview with the New England Journal of Medicine. “We cannot allow the pendulum to swing to the other extreme here, where we deny people who need opioid medications those actual medications. … We are trying to find an appropriate middle ground,” he said.

As addiction professionals, we agree wholeheartedly.

Stefan G. Kertesz, MD, and Adam J. Gordon, MD, are physicians in both internal medicine and addiction medicine. Dr. Kertesz is an associate professor of preventive medicine at the University of Alabama at Birmingham School of Medicine; Dr. Gordon is a professor of medicine at the University of Pittsburgh School of Medicine and editor of the journal Substance Abuse. The views expressed here are their own and do not reflect positions held by their employers.

Many victims of America's opioid epidemic are filing lawsuits against physicians, pharmacists, and drug wholesalers. They claim that these doctors and entities caused or contributed to their addictions to prescription painkillers.

(Updated Jan. 5, 2018)

Since 1999, the number of prescription opioids sold in America has almost quadrupled. Over the same period, prescription opioid deaths have more than quadrupled.

West Virginia is the site of dozens of lawsuits filed against physicians, pharmacists, and drug wholesalers who may have caused or contributed to opioid addictions.

West Virginia has the highest overdose death rate in the nation—35 per every 100,000 people. It is the heart of coal country and has the second-highest unemployment rate in the country (after Alaska). This is a recipe for pain.

It’s not surprising, then, that West Virginia is also the site of dozens of lawsuits filed against physicians, pharmacists, and drug wholesalers. These lawsuits claim that doctors, drug companies, and “pill mills” exploited patients, got them hooked on pills, and cost individuals and the state millions of dollars.

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Lawsuits Allege Unjust Enrichment

A separate lawsuit filed by McDowell County, West Virginia with our attorneys aims to hold three drug wholesalers accountable: McKesson Corp., Cardinal Health, and AmerisourceBergen Drug Co. These three companies supplied more than half of West Virginia’s opioids.

The complaint alleges negligence, state code violations, and unjust enrichment” on the part of defendants. It claims that, in addition to spreading “addiction and destruction,” these companies drained McDowell County’s finances, stating:

Defendants have caused and will continue to cause McDowell County to expand substantial sums of public funds to deal with the significant consequences of the opioid epidemic that was fueled by defendants’ illegal, reckless and malicious actions in flooding the state with highly addictive prescription medications without regard for the adverse consequences to McDowell County or its residents.

Attorney John Yanchunis said, “McDowell County was once a thriving community, now laid to waste by drug addictions which have destroyed lives, broken up families and caused a dramatic increase in crime, addiction-related social and health issues, overdose and even death.”

McDowell County’s drug overdose fatality rate is nearly three times higher than West Virginia’s, which is highest in the nation.

McDowell County’s fatality rate from drug overdoses is nearly three times higher than West Virginia’s.

According to the Charleston Gazette-Mail, over a six-year period West Virginia was flooded with 780 million hydrocodone and oxycodone pills. The McDowell complaint states that the defendants were responsible for the majority of these pills—more than 423 million.

The lawsuit alleges that from 2007 to 2012, the defendants supplied pills for 1.8 million people, earning revenues of more than $17 billion.

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Lawsuits Claim Physicians and Pharmacies Caused Addictions

Meanwhile, dozens of groundbreaking lawsuits filed in West Virginia allege that “a veritable rogue’s gallery of pill-pushing doctors and pharmacies” caused or contributed to the plaintiffs’ (or their loved ones’) addictions to controlled substances.

Some plaintiffs are filing lawsuits because they had loved ones who overdosed on opioids and died.

The complaints claim that by prescribing and supplying these powerfully addictive drugs, the physicians and pharmacies in question caused the plaintiffs to abuse the opioids and even engage in criminal activity to obtain them. In many cases, plaintiffs lost jobs or wages as a result of their addictions.

Some plaintiffs are filing lawsuits because they had loved ones who overdosed on opioids and died.

Three pharmacies (Tug Valley Pharmacy, Strosnider Drug Store, and B&K Pharmacies at Mountain Medical Center) and four Mountain Medical Center doctors (Katherine Hoover, William Ryckman, Diane Shafer, and Victorino Teleron) are listed as defendants in those 29 lawsuits.

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Painkillers Include Oxycodone, Hydrocodone

Opioid narcotics are drugs that bind to opioid receptors to block or reduce feelings of pain. They are often prescribed for patients who have just had surgery or experienced physical trauma such as a car accident or serious sports injury.

The most commonly prescribed opioids include:

• Oxycodone (brand names: OxyContin, Roxicodone, Oxecta)
• Hydrocodone
• Methadone
• Fentanyl
• Morphine

Though doctors no longer prescribe it, heroin produces a similar effect as the above drugs. When the government finally cracked down on opioid prescriptions, many people who had become addicted to them switched over to heroin to achieve a similar feeling—often with deadly results.

Opioid Lawsuits Are Groundbreaking

There is no exact precedent for these opioid lawsuits, but that doesn’t make them any less legitimate. A defense attorney recently challenged Wilbert Hatcher’s lawsuit, asking the West Virginia Supreme Court if plaintiffs who admittedly had engaged in criminal behavior to obtain and use drugs had the right to sue. The Court upheld the lawsuit, with Chief Justice Margaret Workman writing in the majority opinion:

This court finds that our system of comparative negligence offers the most legally sound and well-reasoned approach to dealing with a plaintiff who has engaged in immoral or illegal conduct.

Furthermore, Senator Joe Manchin (D-WV) has endorsed the lawsuit, saying prescription painkillers are handed out in his home state “like M&Ms.”

Opioid Lawsuit Compensation

Our lawsuit lists the following damages on behalf of McDowell County:

• Increased expenses of drug treatment programs
• Medical care/hospitalizations
• Emergency medical transportation
• Costs of law enforcement response/investigations
• Costs of prosecutions and incarcerations
• Costs of repair for property damage

Meanwhile, Wilbert Hatcher and the 28 other plaintiffs in that lawsuit seek relief for the following damages:

• Medical expenses, including money (often thousands of dollars) spent on the prescription drugs in question
• Costs for drug treatment programs
• Lost wages
• Pain and suffering
• Funeral expenses (if they lost a loved one to overdose)
• Any other relief the Court deems fair and just

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