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Opioid Litigation Daily Media Report 11/7/2017
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Opioid crisis leads local officials to contract D.C. law firm to sue pain pill makers
Nov 6, 2017 | Akron Beacon Journal (OH)
By Doug Livingston
Local governments reeling from the opioid crisis have selected a law firm and plan to file their suit against pharmaceutical companies later this month. -
‘This is just the beginning’: Scope of opioid lawsuits widens to include hospital accreditor
Nov 7, 2017 | STAT News
By Max Blau
Government officials grappling with the nationwide opioid crisis, from the sandy beaches of Florida to the far reaches of the Alaskan frontier, have filed lawsuits against drug companies at a steady clip this year. These suits seek to hold manufacturers and distributors financially responsible for the strain on public services that drug addiction has caused. -
U.S. senator investigating Waltham’s Alkermes over opioid addiction drug
Nov 6, 2017 | Boston Business Journal (MA)
By Max Stendahl
Alkermes, one of the state’s largest life sciences firms, came under fire this summer following reports about its aggressive sales practices for an opioid addiction drug. Now the company is facing an investigation by a prominent U.S. senator accusing it of profiting from a nationwide crisis. -
Kentucky AG Sues Endo For Alleged Role In Opioid Crisis
Nov 6, 2017 | Law360
By Rachel Graf
Endo Health Solutions Inc. has violated Kentucky law by misrepresenting the safety of the company's opioids to drive sales, contributing to almost 200 local deaths with its Opana ER drug, the state attorney general alleged in a suit filed Monday. -
Opioid Crisis Continues to Pressure Physicians, But Patients Bear the Pain
Nov 7, 2017 | Pain Medicine News
By David C. Holzman
The efforts to crack down on opioids are coming to a head. As a result, patients are hurting—literally.
Ohio Cities Suit
Commentary and FYI's
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Opioid crisis leads local officials to contract D.C. law firm to sue pain pill makers
Nov 6, 2017 | Akron Beacon Journal (OH)
By Doug Livingston
Local governments reeling from the opioid crisis have selected a law firm and plan to file their suit against pharmaceutical companies later this month.
County Executive Ilene Shapiro announced two weeks ago that she would lead Akron, Barberton and Cuyahoga Falls into court. Her office plans to file the lawsuit against a yet-to-be-disclosed list of drug companies by the end of November.
In a separate effort, Ohio Attorney General Mike DeWine — a year before being term-limited and now running for governor — is suing five drug companies on behalf of all Ohioans.
The two lawsuits, if successful, could result in millions of dollars in settlements redirected to fight the opioid crisis, which appears to be intensifying. In the first nine months of this year, emergency rooms have treated 2,049 patients for drug overdoses, mostly from Akron, Barberton and Cuyahoga Falls, according to Summit County Public Health.
Shapiro’s office has signed a legal retainer with Motley Price, a Washington, D.C., law firm with at least 15 other clients across the nation, each a state or local government suing drug companies for an addiction problem that is draining taxpayer-funded resources.
Brian Bremer, an attorney for the city of Akron, told City Council Monday that “this litigation will not cost the city any money,” explaining that the law firm doesn’t get paid unless Akron gets paid.
Wave of litigation
Across America, municipal and state governments are adding up the tax dollars burned on the opioid crisis, from education and prevention to miles traveled by ambulances to doses of naloxone that revive residents to mobile freezers that hold dead bodies until a coroner’s table becomes available.
Along with DeWine in Ohio, attorneys general in Mississippi, Missouri, New Jersey and West Virginia have filed suits against drug companies involved in marketing, making and distributing pain pills.
Motley Price’s opioid litigation division — led by Linda Singer, a former attorney general for the District of Columbia — is representing Alaska, Kentucky, New Hampshire and South Carolina as well as several cities, towns and counties, including Akron and Summit County.
Singer could not be reached for comment Monday afternoon.
In Chicago and Santa Clara County, Calif., her law firm filed the first opioid-related lawsuits in 2014 against the same five companies DeWine decided to sue in May. The companies are Purdue Pharma L.P., Cephalon Inc., Janssen Pharmaceuticals Inc., Endo Health Solutions Inc. and Actavis.
In May, Motley Price achieved a $1.6 million settlement for the California county. The agreement instructs Cephalon and its subsidiaries to stop “engaging in false and misleading marketing practices,” according to the county government, which is still suing the other four companies.
At the top of most plaintiff’s hit lists is Purdue, which admitted to misleading prescribers about the addictive nature of its opioids. In 2007, three of its executives were criminally charged and the Connecticut company paid out one of the largest fines to date for mislabeling their infamous pain pill, OxyContin.
Troubling history
Purdue had once pushed a questionable study that said less than 1 percent of patients prescribed certain pain pills would become addicted.
In reality, 12 percent of users became addicted. Meanwhile, the company spent $200 million in 2001 alone to market OxyContin, according to the congressional testimony of one of its former executives.
The string of recent lawsuits often cite alarming statistics from the American Society of Addiction Medicine, which estimates nearly 80 percent of opioid addictions began with a doctor’s prescription. Between 1999 and 2008, America saw a four-fold increase in opioid prescriptions and deaths from taking too many of them. In 1996, the American Pain Society pushed for pain to be a vital sign, which was adopted by a federal regulatory body in 2001, ushering in an era of pain care management by pill.
Since 2008, the crackdown on the overprescribing of pain pills has turned to those with addictions to heroin or synthetic opiates like fentanyl and carfentanil, which are can kill in tiny doses.
Looking ahead
Akron At-large Councilwoman Veronica Sims — though unaware, like others on council, that the city had joined the county’s legal effort — stressed the importance of having Akron listed as a plaintiff if and when a settlement is issued.
Sims referenced the distribution of more than $5 billion from a settlement reached when the state of Ohio jointly sued with other states over the tobacco industry’s deceptive marketing practices and health claims. The money was distributed by the state, primarily to rebuild schools but also to fund tobacco cessation programs.
Thinking about the day drug companies might also pay up, Sims wants to have more local control over how the proceeds would be spent, “whether we’re talking about drug treatment or neonatal care for babies born addicted or support for first responders.”
Mayor Dan Horrigan agrees with Sims.
“This is not the end of these suits. There will be more,” said James Hardy, Horrigan’s chief of staff. “And Akron and Summit County will have a seat at the table.”
Sims successfully urged her council colleagues to adopt a resolution Monday “expressing support for the City of Akron to either initiate or join a lawsuit to hold drug manufacturers and distributors accountable for their role in the opioid epidemic.”
In other news, Ward 6 Councilman Bob Hoch did not attend the meeting. It was his fourth consecutive absence. On Oct. 16, council voted to discipline the Ellet councilman for telling other council members to shut up or sit down during public meetings.
His son Andy Hoch submitted a letter to council Monday in which he criticized members for encouraging what he said was division and hatred.
The younger Hoch said council members need to check their egos at the door. He went on to say his father has had health issues due to the stress of the past year.
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‘This is just the beginning’: Scope of opioid lawsuits widens to include hospital accreditor
Nov 7, 2017 | STAT News
By Max Blau
Government officials grappling with the nationwide opioid crisis, from the sandy beaches of Florida to the far reaches of the Alaskan frontier, have filed lawsuits against drug companies at a steady clip this year. These suits seek to hold manufacturers and distributors financially responsible for the strain on public services that drug addiction has caused.
Now local officials in West Virginia — the state with the nation’s highest drug death rate — have taken aim at a different target: the medical experts who recommended their use. This past week the cities and towns of Huntington, Charleston, Kenova, and Ceredo filed a class-action lawsuit against the Joint Commission, the influential nonprofit that both inspects hospitals’ performance and sets practice standards for their physicians. Hospitals must abide by the group’s standards, on opioids or anything else, in order to get reimbursed for care provided to Medicaid and Medicare patients.
The lawsuit claims the nonprofit — responsible for accrediting more than 20,000 health organizations nationwide — has spread “misinformation” about the risks of opioid addiction dating back to the early 2000s, including in published materials underwritten by opioid manufacturers.
And experts say the lawsuit could pave the way for many other municipalities to follow in West Virginia’s footsteps.
“Opioids are killing a generation of West Virginians,” Ceredo Mayor Paul Billups told STAT. “It’s had a tremendous impact. It appears that a number of medical providers were relying on directives from the Joint Commission that caused an increase on the number of opioids on the market.”
The lawsuit centers on the Joint Commission’s pain management standards, first issued in 2001, and the alleged cozy financial ties the nonprofit had with pharmaceutical firms. According to the lawsuit, the nonprofit produced materials that downplayed the evidence “that addiction is a significant issue when persons are given opioids for pain control.” It also says that similar materials claimed that patients who used opioids rarely became addicted, even though that was underpinned by scant evidence.
And those standards were developed in collaboration with the very drug makers positioned to profit from them, the suit alleges. Dr. Gary Franklin, a neurology professor at the University of Washington and vice president of state regulatory affairs for the advocacy group Physicians for Responsible Opioid Prescribing, said the research supporting the original standards was “developed in collaboration with University of Wisconsin” pain researchers who accepted drug company funding while pushing the industry’s agenda.
Industry involvement also went beyond the standards. In the early 2000s, pharmaceutical firms — including Purdue Pharma, maker of OxyContin — underwrote educational Joint Commission programing and paid for its own events to train hospital physicians about the accreditation standards, the lawsuit said. Even after the Food and Drug Administration warned Purdue in 2003 about overstating OxyContin’s effectiveness in ads, the Joint Commission kept producing materials that urged doctors to treat patients until they were “free from pain.” According to the lawsuit, the pattern continued for years, leading to the promotion of pain as the “fifth vital sign” in articles, as well as published education materials funded by Janssen Pharmaceuticals, maker of Duragesic, a skin patch that contains fentanyl.
The Joint Commission declined STAT’s request for an interview, but a spokesperson said in a statement that the nonprofit is “deeply troubled by a lawsuit that contains blatantly false accusations that have been thoroughly debunked.”‘It’s not a lawsuit I would’ve brought’
This latest tack signals a new chapter in the legal war brewing around the opioid crisis. Earlier this year, West Virginia settled suits against a pair of drug distributors for a combined $36 million; a collection of the state’s cities and counties have since taken wholesalers and pharmacy owners to court. Following West Virginia’s lead, a coalition of about three dozen state attorneys general have launched an opioid investigation that’s earned comparisons to the tobacco litigation of the ’90s.
“This is just the beginning,” said Dr. Andrew Kolodny, executive director of PROP, which is not involved in the lawsuit. “They’re going to start to get named more frequently. Other complaints are going to include the Joint Commission.”
But Paul Hanly, a New York-based attorney helping local governments sue opioid makers in five states, doesn’t think the lawsuit “advances the ball” beyond sending a symbolic message. He sees two key limitations of the legal strategy. First, he said the Joint Commission — which made nearly $13 million in 2015, leaving it with total assets of $147 million, according to nonprofit filings — lacks the deep pockets of pharmaceutical industry. He’s also skeptical that a judge will “substitute his or her non-expert opinion for what purportedly is the consensus of physician and hospital groups” involved with the Joint Commission.
“Let me put this way: I’ve been doing this for a very long time, and it’s not a lawsuit I would’ve brought,” Hanly said.Related Story: A veteran New York litigator is taking on opioid makers. They have a history
Former Mississippi Attorney General Mike Moore, a pioneer of the tobacco litigation who’s now advising states to sue drug companies, sizes up the accreditor suit as follows: “The state cases now in litigation — the strongest, most compelling cases — are the A-team; the city and county cases suing the manufacturers and distributors are the B-team; the C-team is the investigations from the other attorneys general. Cases like this one fall into rank after that.”
“Having said that,” Moore noted, “it’s important that innovative trial lawyers come up with new and novel ways to solve this problem. I don’t know if it’ll succeed or not — after all, I was told my tobacco suit wouldn’t succeed.”A cautionary tale
The attorneys filing the class-action suit point to end goals beyond just financial ones. Ultimately, they say, they hope that nearly a dozen hospitals in their region — perhaps more depending on what other governments join the suit — will no longer be forced to choose between keeping their accreditation or prescribing fewer opioids. Two lawyers behind the suit, Scott Damron and Paul Ellis, the city attorneys with Huntington and Charleston respectively, told STAT in a statement that stronger control over prescribing practices would be a “choke point” for reducing future addiction.
“There hasn’t been a focus on The Joint Commission in part because few municipalities have the depth of understanding of the opioid problem that we do in West Virginia and in part because The Joint Commission is a not for profit entity,” they wrote. “But being not for profit does not allow you to overwhelm our communities with addiction.”
This past summer the Joint Commission announced it would issue new pain management standards. Those revisions – which urge hospitals to identify high-risk patients, embrace prescription drug monitoring programs, and help train doctors to refer at-risk patients to addiction treatment programs – won’t go into effect until 2018.
Gary Mendell, founder of Shatterproof, a national advocacy group pushing to improve substance use disorder treatment, believes that placing the spotlight on the Joint Commission through these lawsuits will remind the nation that drug companies aren’t the only groups potentially culpable in the opioid crisis. In his mind, the nonprofit offers a cautionary tale of what happens when the medical practice is influenced by giant drug companies.
“Accrediting agencies need to be held accountable to the families who’ve lost loved ones and the health care costs of those suffering from an opioid use disorder,” Mendell told STAT. “This will change behavior, not only for this situation with opioids, but for other drugs in the future.”
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U.S. senator investigating Waltham’s Alkermes over opioid addiction drug
Nov 6, 2017 | Boston Business Journal (MA)
By Max Stendahl
Alkermes, one of the state’s largest life sciences firms, came under fire this summer following reports about its aggressive sales practices for an opioid addiction drug. Now the company is facing an investigation by a prominent U.S. senator accusing it of profiting from a nationwide crisis.
Kamala Harris, a Democrat from California, said Monday that she has launched an investigation into Alkermes (Nasdaq: ALKS), which has around 650 employees in Waltham. The probe focuses on the company’s practice of marketing Vivitrol directly to judges and corrections officers — rather than to physicians — as a treatment for inmates and parolees with opioid addiction. Those efforts were the subject of stories in The New York Times, NPR and ProPublica in recent months.
In a statement announcing the investigation, Harris said that Vivitrol is more expensive but less effective than other FDA-approved treatments for opioid addiction, including methadone and buprenorphine.
While methadone and buprenorphine are both opioids, the FDA has deemed them safe and has sought to destigmatize their use. Even so, Alkermes has misleadingly sought to portray Vivitrol as the only non-addictive option for patients, Harris said Monday.
“We are at the height of a crisis, and companies are taking advantage of pain in order to profit,” Harris said. “We must hold these companies accountable for their deliberate actions that magnify the opioid epidemic and drive up the cost of drugs for Americans.”
Harris also made public a letter that she sent to Alkermes CEO Richard Pops on Monday. It requests information related to the company’s federal lobbying activities, its practice of assigning sales representatives to judges and drug courts, and its practice of providing free Vivitrol shots at prisons.
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In a lengthy statement, Alkermes said it "strongly disagrees" with Harris' claims, and called Vivitrol "a disruptive approach that challenges the treatment status quo."
"Alkermes has dedicated itself to addressing the scourge of opioid addiction through our medicine, our science, our advocacy and our commitment," the company said. "We will continue to be a strong voice in modernizing and advancing the treatment of opioid addiction, and encourage the examination of the addiction treatment system."
Harris' probe comes as U.S. and state lawmakers are investigating whether other companies that make opioids contributed to the crisis through aggressive sales tactics. The firms facing scrutiny include Depomed, Purdue Pharma, Mylan, Janssen and Insys.
The crisis has hit Massachusetts particularly hard. According to the state public health department, more than 2,000 people died from opioid-related overdoses last year, a record number.
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Kentucky AG Sues Endo For Alleged Role In Opioid Crisis
Nov 6, 2017 | Law360
By Rachel Graf
Endo Health Solutions Inc. has violated Kentucky law by misrepresenting the safety of the company's opioids to drive sales, contributing to almost 200 local deaths with its Opana ER drug, the state attorney general alleged in a suit filed Monday.
Kentucky AG Andy Beshear alleges in state court that Endo marketed opioids initially developed for short-term pain to a wider swath of patients with longer-term, minor pain in an effort to increase the drugmaker's revenue. Endo consequently helped further a drug epidemic that took the lives of 1,404 Kentucky residents last year, 191 of which were due to Endo’s Opana ER prescription opioid, the suit claims.
“My office refuses to sit back and watch families be torn apart while opioid manufacturers like Endo line their pockets at the expense of our communities and our future,” Beshear said in a statement.
After Endo began to market its opioids to a wider group of patients, evidence that people were abusing Opana ER began to accumulate, the suit says. The company subsequently received approval in 2011 for a reformulated version of the drug that claimed to be crush-resistant, but the FDA nonetheless told Endo it could not market this new version as abuse-deterrent, according to the complaint.
An FDA advisory committee recommended in March 2017 that Opana ER be removed from the market because it could be “readily prepared for injection,” and the FDA officially recommended the drug’s withdrawal in June, the suit says.
The next month, Endo revealed that it would stop selling the drug, according to the complaint.
“However, by this point, the damage had been done,” the suit says.
The uptick in opioid abuse also put about 25 percent of Kentucky counties at risk of an increase in HIV cases, with the Centers for Disease Control and Prevention linking the 2015 HIV outbreak with the injection of Opana ER, Beshear says.
He alleges violations of the state's Consumer Protection Act, Medicaid fraud statute, assistance program fraud statute, and fraudulent insurance acts statute. The AG seeks reimbursement for Kentucky’s opioid-related expenditures, disgorgement of profits, civil penalties, compensatory and punitive damages, injunctive relief, and “abatement of the public nuisance Endo has helped create.”
Matthew J. Maletta, Endo’s executive vice president and chief legal officer, said in a statement Monday that the drugmaker will “vigorously” defend itself against the allegations.
“The public statement made by Kentucky Attorney General Andy Beshear today in connection with filing suit against Endo that this organization and its dedicated employees seek to ‘line their pockets at the expense of communities’ is patently offensive,” Maletta said.
Beshear is represented by LeeAnne Applegate, Elizabeth U. Natter, Charlie Rowland, C. David Johnstone and Brian C. Thomas of the Commonwealth of Kentucky's Office of the Attorney General.
Counsel information for Endo was not available Monday.The case is Kentucky ex rel. Beshear v. Endo Health Solutions Inc. et al., in the Franklin Circuit Court of the Commonwealth of Kentucky. The case number was not immediately available.
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Opioid Crisis Continues to Pressure Physicians, But Patients Bear the Pain
Nov 7, 2017 | Pain Medicine News
By David C. Holzman
The efforts to crack down on opioids are coming to a head. As a result, patients are hurting—literally.
Payors and legislators are limiting physicians’ ability to prescribe, said Joseph Ranieri, DO, an addiction medicine and pain specialist who is medical director of Seabrook House, in Newell, N.J. Moreover, even where rules are absent, the specter of monitoring has many physicians caught between protecting their practices and protecting their patients.
“The pressure on physicians is already intense,” Stefan G. Kertesz, MD, wrote in The Hill (http://thehill.com/?blogs/?pundits-blog/?healthcare/?326095-as-a-physician-i-urge-other-doctors-to-cut-back-on-prescribing). Dr. Kertesz described a 60-year-old chronic arthritis patient who had had a kidney transplant, when her opioid dose was reduced without her consent—an all too common result of the crackdown. “Predictably, she fell apart, as did her adherence to other medications, including ones to protect her kidney. … The threat of losing her kidney compounded the uncontrolled pain of her arthritis,” wrote Dr. Kertesz, associate professor in the Division of Preventive Medicine at the University of Alabama School of Medicine, in Birmingham.
The crackdown had been brewing for most of the decade, but things heated up in the spring of 2016, when the Centers for Disease Control and Prevention (CDC) issued the “Guideline for Prescribing Opioids for Chronic Pain” (MMWR Recomm Rep 2016;65:1-49). The recommendations, the pain physicians who commented on this article mostly agree, were not unreasonable, although the evidence for many was scant, by the CDC’s own admission. The problem was that they were oft interpreted to be rules, rather than guidelines.
For example, a proposal from the National Committee for Quality Assurance followed last winter that was seen as creating an incentive for physicians to unilaterally reduce doses among patients receiving more than 120 morphine milligram equivalents (MME) of opioids. Eighty pain physicians, including Dr. Kertesz, responded to that agency, stating that such dose reductions had “never been tested in prospective trials and … could actually increase risk to individual patients, as illustrated by scholarly and popular reports of acute withdrawal (with death) … and suicide associated with incautious unilateral opioid discontinuation or unrelenting pain.”
The Centers for Medicare & Medicaid Services proposed similar measures concurrently. However, that proposal appears to have been softened. An agency press release in the spring stated that a requirement to deny coverage above certain dose limits would not be implemented for 2018, contrary to the initial proposal. This change appears to be in response to a letter signed by 83 professionals, including four who worked on the CDC guideline.
Ironically, the ratcheting down of opioid prescriptions may be aggravating the problems it was meant to reduce. From 2010 to 2015, overdose deaths involving natural and semisynthetic opioids fell from 29% to 24% of all overdoses. But these were swamped by the rise of overdose deaths from heroin and synthetic opioids, excluding methadone, which tripled to 25% and doubled to 18% of the total, respectively.
Unfortunately, suicide and medical harm after an involuntary dose reduction “are not usually recorded in any database, and therefore, it is very hard for health authorities to measure the size of this new problem,” Dr. Kertesz said. “All we have now are anecdotes.”
But pain patients are particularly vulnerable. They die by suicide at twice the rate of the general population. In 2014, 28,000 took their lives.
Patients Hurting
In March, a year after release of the CDC guideline, an online survey of more than 3,000 patients, physicians and health care providers conducted by Pain News Network found that the guideline had “harmed pain patients, reduced access to pain care, and failed to reduce drug abuse and overdoses,” commented Lynn R. Webster, MD, vice president of scientific affairs at PRA Health Sciences, in Salt Lake City, past president of the American Academy of Pain Medicine, and a Pain Medicine News editorial advisory board member.
That survey, Dr. Webster noted in his comments to Pain News Network, found that “over 70% of pain patients say they are no longer prescribed opioid medication or are getting a lower dose. … Eight out of 10 patients say their pain and quality of life are worse.”
In a survey of 72 patients with arachnoiditis or Tarlov cyst disease, conducted by the Arachnoiditis Society for Awareness and Prevention, slightly more than half said they’d been completely cut off from their opioids.
In another portent, in articles published with comments sections, such as one in the Boston Globe health publication STAT by Dr. Kertesz and Adam J. Gordon, MD, some commenters have expressed a desire to die by suicide, or have described considering it, in the wake of the crackdown. “That suggests we are in some really dangerous territory,” Dr. Kertesz said (www.statnews.com/?2017/?02/?24/?opioids-prescribing-limits-pain-patients/?).
Attempts at Control
The medical community had long undertreated pain. In the early 1990s, physicians, finally recognizing the problem, turned to opioids in an effort to mitigate that epidemic. Prescriptions rose steadily, tripling at 219 million in 2011.
As prescriptions rose, so did overdoses and deaths from overdoses. “Excessive prescribing without sufficient close monitoring meant that prescriptions received by patients often wound up in others’ hands, through sales, theft or giving them away,” Dr. Kertesz said. Federal data indicate that 12.5 million people misused opioids at least once in 2015, and that 2 million would qualify as having an addiction diagnosis.
By 2010, the profession had become concerned, and in 2012, the number of prescriptions for opioids fell.
The March 2016 CDC guideline hit the media with a splash. Former CDC Director Tom Frieden, MD, was quoted saying that “opioids are just as addictive as heroin,” a statement widely interpreted as implying that most opioid addiction originates in pain patients, a controversial view.
The guideline is flawed by low-quality evidence, said Jeffrey Fudin, PharmD, owner and managing editor of PainDr.com, founder and chair of Professionals for Rational Opioid Monitoring & Pharmacotherapy, and co-editor of the Opioids, Substance Abuse and Addictions section of Pain Medicine.
Nonetheless, the CDC was “extremely careful” not to directly mandate dose reductions in patients “evaluated as benefiting from opioid prescriptions,” Dr. Kertesz said.
The guideline suggests a 90-MME ceiling, and states that for treatment of acute pain, three days or less often suffices, and that more than seven days is rarely necessary.
However, legislators are enshrining these provisions as law, and many insurers are using them to determine coverage.
Ohio, for example, has proposed legislation restricting primary care physicians and dentists to prescribe no more than 50 MME per day, in no more than three-day increments, unless they complete eight hours of training about opioids and addiction, and can provide treatment for the latter. The bill presently awaits committee hearings.
Maine legislation capped doses at 100 MME, requiring patients already on higher doses to be tapered to that level by July 1, 2017. An estimated 16,000 Mainers are prescribed higher doses, and Patrick Mellor, a lawyer in Rockland representing two chronic pain patients, said they “would lose substantial functionality by having to taper down,” as would around 1,500 of the 16,000.
But the real problem, Mr. Mellor said, lies in the legal language, not in the law itself. The Maine legislation includes a “palliative care exception” to the tapering requirement, Mr. Mellor said. Under the statute, “palliative care” is not limited to end of life, as a nonlawyer might reasonably assume, but includes treating “a physical injury or condition that substantially affects a patient’s quality of life.”
Nonetheless, the July 1 deadline for tapering is problematic because “the doctors in the state haven’t been adequately informed as to the exceptions to the new law,” Mr. Mellor said. Whereas the physician of one of his clients knew to apply the palliative care exception, the other client’s physician did not. Therefore, that client’s dose—450 MME for the last 16 years—has already been tapered to 300 MME, much to the client’s distress.
Among other states that have enacted legislation, seven—California, Colorado, Indiana, New Hampshire, Ohio, South Carolina and Vermont—have soft limits on doses, which lack force of law, but can be used to assess a physician’s practice. Besides Maine, Massachusetts and Washington have hard limits.
Even under soft limits, “doctors feel it increases liability,” Dr. Fudin said. “And even if the prescriber has documentation, they are being scrutinized. ... They can be called on by state regulatory agencies to explain any patients with morphine equivalent daily dosages (MEDD) that fall [beyond] a predetermined limit. … The clinician may reduce the dosage to meet the state MEDD limit because they don’t want to deal with it.”
In Massachusetts, former Gov. Deval Patrick banned Zohydro ER (Pernix), the first extended-release, single-entity hydrocodone. “Eventually, the federal government overturned Gov. Patrick’s ruling, but doctors were still afraid to prescribe it,” Dr. Fudin said.
Washington requires patients to be referred to pain specialists if the prescribed MEDD exceeds 120 mg per day. “The trouble is, there aren’t enough pain specialists to go around, and … most prefer interventional procedures and shy away from or refuse to prescribe medication therapies,” Dr. Fudin said.
Payors
Meanwhile, “insurance companies are incorporating guidelines into what they’re willing to pay for under any circumstance, thus driving a lot of clinical decision making on what are supposed to be guidelines applying only to primary care doctors,” said Edward Michna, MD, director of the Pain Trials Center, Brigham and Women’s Hospital, in Boston, and a board member of the American Pain Society. All this is done “under the guise of patient safety, but it’s really about saving money.”
“Health plans are addressing a very serious crisis, the opioid epidemic,” said Cathryn Donaldson, director of communications for America’s Health Insurance Plans. Payors, she added, “are focusing on fighting the epidemic, while ensuring that people have a proven pathway to manage their pain.”
“It has been my experience that … some commercial plans have already been imposing [dosage ceilings] when it’s not currently required,” said James DeMicco, PharmD, of J&J State Street Pharmacy, in Hackensack, N.J. “Anything above 90 mg of MEDD becomes problematic.” Dr. DeMicco added that despite changes in some plans allowing soft edits and enabling pharmacist overrides at the point of sale, “it is still very challenging.”
Similarly, some insurance companies will not pay for extended release, or “have created incredibly lengthy red tape” that must be navigated before payment, in response to the CDC guideline’s fourth recommendation to avoid extended-release opioids when starting therapy, said Sanford Silverman, MD, director-at-large of the American Society of Interventional Pain Physicians. These strictures apply even when these opioids are prescribed by pain specialists, although the CDC guideline only applies to primary care physicians, he noted.
Worse, insurance companies often require prior authorization anew when a patient already on opioids switches physicians, Dr. Silverman said.
“Some insurance companies—WellCare in Florida is one—don’t even cover extended release, long acting in the formulary,” despite the fact that it often works better for patients, and it is less prone to diversion, Dr. Silverman said. (WellCare did not return phone calls for this story.)
Big Pharmacy Chains
Even when an insurance company covers a high dose, a pharmacy may refuse to dispense the dose or the drug. Pharmacies have grown wary following instances when the authorities have legitimately clamped down on them.
For example, in 2013, Walgreens paid $80 million in civil penalties, and was prohibited from dispensing controlled substances for two years. The giant pharmacy chain had failed to comply with Drug Enforcement Administration regulations requiring reporting of suspicious prescription drug orders that its Jupiter distribution center received from six Florida Walgreens retail pharmacies. During that time (2009-2011), all six stores saw skyrocketing increases in orders for controlled substances, the greatest of which was 21-fold.
Numerous fines have been levied elsewhere in the United States, such as an $8 million levy on CVS in Maryland earlier this year for similar violations of the Controlled Substances Act.
As a result, pharmacies are often reluctant to fill opioid prescriptions. Patients frequently are forced to drive to numerous pharmacies to find one that will fill such a prescription, Dr. Silverman noted. This is called the “pharmacy crawl.”
In one instance, Dr. Silverman had to spend 20 minutes convincing a pharmacy staff member that it was legal to give an opioid-naive patient a short-acting opioid. “This is only one of millions of stories,” he added.
Walgreens created a lengthy checklist that staff members must use when filling opioid prescriptions, which includes 11 items (e.g., “quantity is 120 units or less; or 60 units or less if paid by cash or cash discount card”) and more than two pages of “procedures,” in small type. (Walgreens’ media relations did not respond to a phone call and email.)
Dr. Silverman called the checklist “ridiculous,” pointing out that the pharmacist can check the state prescription drug monitoring program to see whether the patient in question has obtained drugs elsewhere.
Physicians in the Middle
“For physicians wishing to stay out of the firing line, the implicitly encouraged step is involuntary dose reduction, even if the patient is functionally stable on their current dose,” Dr. Kertesz said. “That course of action has absolutely no trial data to support it,” he added.
But with the growing medical-legal liabilities, “more and more primary care practices are saying they won’t offer opioids for any reason,” Dr. Michna said. The restrictions “have driven up the amount of time you need to spend, and with all these laws and regulations, there hasn’t been a concurrent increase in reimbursement.”
“I have cared for a few patients in the immediate aftermath of involuntary tapers introduced by others,” Dr. Kertesz said. “We have a rising tide of concerning reports. I am aware of hospital legal teams that are concerned about the liability implications of such practices.”
Crisis/Opportunity
All this notwithstanding, the opioid crackdown represents an opportunity to educate pain physicians to approach mitigating chronic pain more creatively, said Melanie Rosenblatt, MD, director of pain management at Broward Health North, in Pompano Beach, Fla.
For many patients, doses sufficient to numb the pain frequently numb the rest of living, Dr. Rosenblatt noted. But both physicians and patients frequently prefer to do what they know, rather than try something new, she said.
“I say to all my patients, ‘I promise I can help you.’ It just may not be exactly what they want.”
Dr. Rosenblatt has spent years adjusting treatments to make them more effective, with fewer side effects. For the patient who faces tapering from a high dose of opioids, “maybe a spinal cord stimulator would work better,” she said.
“Many patients might be better managed with newer alternatives, and maybe a fresh set of eyes,” she added. One patient came to her miserable with pain from metastatic prostate cancer. “The pain meds he was taking were making him sleepy, and nauseous, and they weren’t working,” she said. “I put an intrathecal pump into him that delivers opioid to the spine.” He came into his follow-up appointment, “walking, saying I had given him his life back.”
Dr. Rosenblatt has developed a protocol for treating pain patients that de-emphasizes opioids, which is being distributed by her new company, Melrose Pain Solutions.
Conclusion
As the opioid crackdown continues, two ironies remain. First, “this is the safest time in recent history to prescribe opioids,” said Steven Passik, PhD, vice president of scientific affairs, education and policy at Collegium Pharmaceuticals, in Canton, Mass. “We have potentially safer drugs, abuse-deterrent drugs, buprenorphine, etc. We also have prescription drug monitoring in almost every state. And urine drug tests now come back in 24 hours, with accurate results. Give-back programs and counseling programs have shown efficacy in clinical trials in helping people to avoid abusing. And screening tools are available to ascertain someone’s risk of abusing.”
The second irony: Although opioid prescriptions have dropped tremendously, abuse and overdoses continue to rise. The primary drugs of abuse are no longer prescription opioids but heroin and illicit fentanyl, and their abuse is driven partly by desperate patients who have lost access to opioids.
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