Preview Newsletter
Opioid Litigation Media Report 10/26/17
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Purdue Probed Over Opioid Relief Claim
Oct 25, 2017 | Bloomberg
By Esme E Deprez
Federal prosecutors in Connecticut began a criminal investigation into Purdue Pharma Inc., the maker of the controversial opioid painkiller OxyContin, according to a person familiar with the probe. -
Purdue Pharma under new investigation over opioid claims
Oct 25, 2017 | Reuters
Purdue Pharma Inc confirmed an earlier report on Wednesday that the drugmaker was under investigation related to the marketing of its opioid painkiller OxyContin. -
Purdue Is Under Investigation for Opioid Painkiller OxyContin
Oct 25, 2017 | Wall Street Journal
By Sara Randazzo and Jeanne Whalen
Purdue Pharma L.P. said it is the subject of a probe by federal prosecutors related to its opioid painkiller OxyContin, adding to the mounting litigation the company already faces over its marketing of the addictive drug. -
Summit County Declares an Opioid State of Emergency, Prepares to Sue Drug Companies and Distributors
Oct 25, 2017 | WKSU (OH)
By M.L. Schultze
Summit County is preparing to sue the companies that make and distribute addictive painkillers. WKSU’s M.L. Schultze has more on the lawsuit the county expects Akron, Barberton, Cuyahoga Falls and others will join -- on the declaration by the county of a state of emergency. -
County may join opioid lawsuit
Oct 26, 2017 | The WInchester Sun (KY)
By Fred Petke
Clark County magistrates are mulling whether to join a potential lawsuit to recoup costs related to the ongoing opioid crisis. -
Counties file lawsuits against opioid makers, distributors
Oct 25, 2017 | American City and County (GA)
By Jason Axelrod
As the opioid crisis worsens in their communities, counties are taking the fight to drugmakers themselves. American City & County previously reported that Everett, Wash. and two Ohio cities have initiated legal proceedings against opioid drug makers. Those cities accused the companies of flooding Everett’s black market with opioids and misleading the Ohio public on the benfits and risks of these medications, respectively. -
Milwaukee County taking steps to sue drugmakers & drug store chains in light of opioid epidemic
Oct 26, 2017 | TMJ4 (WI)
By Katie Crowther
Every sixteen hours someone in Milwaukee County dies from a probable overdose. The Milwaukee County Medical Examiner's Office expects at least 425 people to die from drug use this year. That's a 25 percent increase from last year. -
Counties lining up to sue opioid producers
Oct 26, 2017 | RIpon Press (WI)
By Maic D'Agostino
A lawsuit against opioid makers heralded by the Wisconsin Counties Association (WCA) could be joined by a county near you. -
Suffolk Doctor Facing Illegal Prescription Charges Loses Bid To Join Counties' Suit
Oct 25, 2017 | Law.com
By Andrew Denney
A Suffolk County doctor facing criminal charges for overprescribing pain meds who employed the novel defense of blaming his offenses on Big Pharma was unsuccessful in his effort to join a class action suit against the industry filed by a group of New York county governments. -
Trump Administration To Declare Opioid Crisis A Public Health Emergency
Oct 26, 2017 | NPR
By Greg Allen
The Trump administration will declare a public health emergency to deal with the opioid epidemic Thursday, freeing up some resources for treatment. More than 140 Americans die every day from an opioid overdose, according to the Centers for Disease Control and Prevention. -
WH officials: Trump will stop short of declaring opioid crisis a national emergency
Oct 26, 2017 | The Hill
By Nathaniel Wexel
The Trump administration on Thursday will stop short of calling the opioid epidemic a national emergency and declare it a public health emergency instead, White House officials said. -
FDA’s Gottlieb makes strong push to fight opioid crisis with medication-assisted treatment
Oct 25, 2017 | STAT News
By Lev Facher
Scott Gottlieb, commissioner of the Food and Drug Administration, announced new steps the agency would take to promote the use and development of medication-assisted treatmentfor substance use disorder at a House hearing on Wednesday. -
Walgreens to offer drug naloxone, which can reverse opioid overdoses (VIDEO)
Oct 25, 2017 | ABC News
In more than 8,000 pharmacies across the U.S., anyone will now be able to walk in and buy the most successful emergency overdose treatment available. -
Who Is to Blame for the Opioid Crisis?
Oct 25, 2017 | Pharmacy Times
By John Burke
I find it interesting that many people pin the blame for the opioid crisis on pharmaceutical manufacturers, wholesalers and distributors. -
Rhode Island doctor pleads guilty to opioid kickback scheme related to Insys
Oct 26, 2017 | Reuters
By Nate Raymond
A Rhode Island doctor pleaded guilty on Wednesday to charges he participated in a scheme to obtain kickbacks in exchange for writing prescriptions for an addictive fentanyl-based cancer pain drug produced by Insys Therapeutics Inc.
Litigation Coverage
Other Coverage
Broadcast Media Coverage
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Purdue Probed Over Opioid Relief Claim
Oct 25, 2017 | Bloomberg
By Esme E Deprez
Federal prosecutors in Connecticut began a criminal investigation into Purdue Pharma Inc., the maker of the controversial opioid painkiller OxyContin, according to a person familiar with the probe.
U.S. Attorney Deirdre Daly is gathering documents about Purdue’s claim that OxyContin provides 12 hours of pain relief, said the person, who requested anonymity to discuss the matter freely. That claim was the subject of a Los Angeles Times investigation published last year, which found that Purdue ignored evidence showing the drug’s effects failed to last that long in some patients, increasing the risk of withdrawal, abuse and addiction.
Purdue is cast as the main villain in a wave of government lawsuits seeking to hold opioid makers and distributors responsible for an epidemic now killing thousands of people and costing the U.S. economy billions of dollars annually. Ten states and dozens of cities and counties have sued companies including Purdue, Endo International Plc, and Johnson & Johnson’s Janssen Pharmaceuticals, alleging that they triggered the epidemic by minimizing the addiction and overdose risks of painkillers such as OxyContin and Percocet.
Stamford, Connecticut-based Purdue invented many of the aggressive marketing techniques that made OxyContin a blockbuster drug and which government lawsuits now seek to frame as unlawful.
Tom Carson, a spokesman for Daly, declined to comment on the investigation. Purdue didn’t immediately return a request for comment.
Purdue resolved a federal criminal prosecution in 2007. The company and three of its top executives pleaded guilty to “misbranding” OxyContin and collectively agreed to pay more than $630 million in civil and criminal penalties in one of the largest pharmaceutical settlements in U.S. history. The company specifically acknowledged that it trained its sales representatives to mislead physicians about opioid risks.
Purdue promoted the synthetic morphine substitute as a low-risk painkiller, according to court papers, although the drug is a habit-forming narcotic derived from the opium poppy.
The executives, former CEO Michael Friedman, General Counsel Howard Udell and Chief Medical Officer Paul Goldenheim, served no prison time and were sentenced to community service in drug rehabilitation centers.
Purdue emphasized that its plea covered misconduct only from 1995 through 2001. “We accept responsibility for those past misstatements and regret that they were made,” the company said at the time.
Purdue is closely held and doesn’t release financial information, but the brokerage Sanford C. Bernstein & Co. estimates OxyContin alone generated sales of $1.3 billion in 2016. Purdue is also the focus of a Congressional investigation led by Senator Claire McCaskill, a Missouri Democrat, who’s demanding documents and information related to the sales, marketing and education strategies that opioid manufacturers used to promote their painkillers.
Daly was one of the 46 U.S. Attorneys asked in March by Attorney General Jeff Sessions to submit letters of resignation and vacate their offices. She remained in order to complete two decades of service at the Justice Department. Her last day is Oct. 27.
Nominated by President Barack Obama in 2014, Daly has made the opioid epidemic a focus of her tenure. Last year, her office developed a statewide initiative with the Drug Enforcement Administration, probing overdose deaths and targeting dealers who sell heroin and synthetics like fentanyl.
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Purdue Pharma under new investigation over opioid claims
Oct 25, 2017 | Reuters
Purdue Pharma Inc confirmed an earlier report on Wednesday that the drugmaker was under investigation related to the marketing of its opioid painkiller OxyContin.
Federal prosecutors in Connecticut began a criminal investigation into Purdue Pharma's marketing of OxyContin, according to a Bloomberg report. (bloom.bg/2h7W9Ao)
“Purdue is committed to being part of the solution to our nation’s opioid crisis and has been cooperating with the U.S. Attorney’s investigation. We will continue to do so until this matter is resolved,” the drugmaker said in a statement.
U.S. Attorney Deirdre Daly is gathering documents about Purdue’s claim that OxyContin provides 12 hours of pain relief, Bloomberg reported.
A spokesman for the U.S. Attorney’s Office in Connecticut declined to comment.
The investigation would be the latest in a string of lawsuits filed by state or local governments seeking to hold pharmaceutical companies accountable for fanning the flames of a an opioid crisis, declared a national emergency by President Trump.
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Purdue Is Under Investigation for Opioid Painkiller OxyContin
Oct 25, 2017 | Wall Street Journal
By Sara Randazzo and Jeanne Whalen
Purdue Pharma L.P. said it is the subject of a probe by federal prosecutors related to its opioid painkiller OxyContin, adding to the mounting litigation the company already faces over its marketing of the addictive drug.
Purdue said it has been cooperating with an investigation by the U.S. Attorney’s Office in Connecticut and “will continue to do so until the matter is resolved.” It added that the company “is committed to being part of the solution to our nation’s opioid crisis.”
A spokesman for Connecticut U.S. Attorney Deirdre Daly declined to comment. Ms. Daly, nominated by former President Barack Obama, is ending her tenure as U.S. attorney on Friday.
Bloomberg first reported the probe Wednesday.
Purdue, a privately held company based in Stamford, Conn., has previously faced criminal scrutiny related to its opioid sales.
In 2007, Purdue and three of its executives pleaded guilty in federal court to criminal charges of misleading the public about the addictive qualities of OxyContin between 1995 and 2001. Purdue and the executives agreed to pay $634.5 million in government penalties and costs to settle civil litigation.
Around the same time, Purdue agreed to pay $19.5 million to settle similar allegations made by 26 states and the District of Columbia.
Purdue has been at the center of recent litigation seeking to hold makers and distributors of opioids accountable for widespread drug addiction. The latest suits to name Purdue, including those brought by nine states and dozens of cities and counties, largely fault the company for allegedly misrepresenting the addiction risk of opioids in their marketing of the drugs.
The states that have sued include Ohio, New Hampshire, South Carolina, Missouri and Washington state. The majority of those that haven’t yet sued are collaborating on a multistate investigation that could result in additional lawsuits. That bipartisan group said in September that it had served subpoenas on Purdue and four other major opioid manufacturers, as well as three companies that account for about 90% of opioid distribution in the U.S.
Purdue has denied the allegations and is asking courts to dismiss the cases.
Several public companies have said in securities filings in recent months that they have received subpoenas from the U.S. Justice Department related to the marketing and sale of opioids. They include Mallinckrodt Pharmaceuticals , Depomed Inc. and Mylan NV. The Justice Department has declined to comment on the existence of the investigations.
In addition, Senator Claire McCaskill (D-Mo.), the top-ranking Democrat on the Senate Homeland Security and Governmental Affairs Committee, is leading a probe into opioid painkiller makers and pharmaceutical distributors, to determine whether their marketing and distribution of the drugs contributed to widespread opioid addiction.
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Summit County Declares an Opioid State of Emergency, Prepares to Sue Drug Companies and Distributors
Oct 25, 2017 | WKSU (OH)
By M.L. Schultze
Summit County is preparing to sue the companies that make and distribute addictive painkillers. WKSU’s M.L. Schultze has more on the lawsuit the county expects Akron, Barberton, Cuyahoga Falls and others will join -- on the declaration by the county of a state of emergency.
At her state of the county address, county Executive Ilene Shapiro announced the plans to file the suit in a few weeks. She says the opioid epidemic has cost local taxpayers nearly $112 million over the last five years, and is likely to cost as much as $165 million over the next five.
Shapiro says she became convinced the suit was warranted because of growing evidence that the drug companies “deceitfully and maliciously flooded our community.”
“When you realize and get the information and understand what has really been perpetrated -- letting our physicians believe these were non-addictive drugs and so forth, it gets your ire up. And if f we won’t step up and speak out, who will?”
Ohio Attorney General Mike DeWine has sued the manufacturers of the drugs, but not the wholesalers -- like Ohio-based Cardinal Health – that distribute them. Dayton and Lorain have already sued both groups.
Meanwhile, Shapiro today declared Summit County in a state of emergency caused by the opioid crisis.
Shapiro said the state of emergency will allow the county to be prepared when more federal money becomes available.
President Trump is expected to declare a national state of emergency tomorrow. It’s unclear what law enforcement and treatment changes will come with that.
Summit County also plans to allow two nonprofits to build an inpatient and aftercare facility on the now vacant land that was Edwin Shaw Rehabilitation Hospital. And it plans to sue the makers and distributors of the highly addictive painkillers.
Here's the complete address by County Executive Ilene Shapiro:
Listen to clip here: http://wksu.org/post/summit-county-declares-opioid-state-emergency-prepares-sue-drug-companies-and-distributors#stream/0
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County may join opioid lawsuit
Oct 26, 2017 | The WInchester Sun (KY)
By Fred Petke
Clark County magistrates are mulling whether to join a potential lawsuit to recoup costs related to the ongoing opioid crisis.
According to an email from the Kentucky Association of Counties, three dozen counties have already joined the lawsuit, which is being handled by a group of eight law firms.
The Clark County Fiscal Court discussed the matter in a previous meeting, but returned to the discussion Wednesday. The magistrates voted to take no action, but to take more time to review and research before the Nov. 8 meeting.
“I really don’t have a recommendation,” Clark County Judge-Executive Henry Branham said.
At this point, any funds awarded in the suit could be used for anything related to opiates, he said, including costs for law enforcement, court or incarceration.
County Attorney Brian Thomas said the lawsuit will be filed against the pharmaceutical companies that make drugs like Lortab, OxyContin and similar painkillers.
The city of Louisville has filed a similar suit against three medication wholesalers, he said.
Magistrate Robert Blanton said a potential settlement wasn’t as important as holding the pharmaceutical companies accountable.
Others were less sure.
“Who’s getting rich off this?” Magistrate Daniel Konstantopoulos said. “The attorneys are getting 30 percent off the top.”
The agreement calls for the attorneys to retain 30 percent of the gross settlement, but there will be no expense to the counties if there is no settlement.
“I’ve got mixed emotions about it,” Konstantopoulos said.
“It’s a very expensive situation,” Magistrate Greg Elkins said. “It’s a drain on our resources. I don’t know if the pharmaceutical companies are the right people to chase.”
“I don’t see this helping the crisis,” Konstantopoulos said. “You can’t sue them out of business.”
In other action, the fiscal court:
— approved a contract to replace a bridge on Morris Road from Triple C Contracting from Cynthiana for $82,190. Branham said the project would be part of the state’s bridge replacement program which funds 80 percent of the project. The county would be responsible for the remaining 20 percent.
— approved employee benefit insurance for 2018. Health insurance premiums are down 4 percent, while life, dental and vision insurance remained the same.
— approved hiring Lincoln Arnold as a full-time county firefighter.
— approved hiring Noah Covington, Jerry Goosey, Calvin Parker and Kenneth Poole as volunteer firefighters.
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Counties file lawsuits against opioid makers, distributors
Oct 25, 2017 | American City and County (GA)
By Jason Axelrod
As the opioid crisis worsens in their communities, counties are taking the fight to drugmakers themselves.
American City & County previously reported that Everett, Wash. and two Ohio cities have initiated legal proceedings against opioid drug makers. Those cities accused the companies of flooding Everett’s black market with opioids and misleading the Ohio public on the benfits and risks of these medications, respectively.
Multiple cities have since followed suit, but counties are now jumping into the fray as well. On Oct. 23, Fulton County, Ga., became the first Georgia county to file a lawsuit against over 30 opioid manufacturers and distributors and individuals, according to the Marietta Daily Journal. The lawsuit claims that these entities have filled the county with addictive medications that contributed to the county’s opioid epidemic.
In a news conference, Fulton County Board of Commissioners Vice President Bob Ellis said the opioid crisis and these entities’ desire for profits has affected the county in numerous ways.
“[Addicts] have left our courts filled with an explosion of drug-related offenders, and our jails have become de facto mental-health and addiction-treatment facilities,” Ellis said, per the Daily Journal. “The cost to provide those services has exploded as a result. The impact is pushed down into our youth and children, and they have newfound challenges they are facing in our middle and high schools as a result.”
Some counties are opting for class-action suits. Two Michigan counties — Wayne and Oakland counties — filed a class-action lawsuit against 12 drug distributors and manufacturers, accusing them of deceptively marketing and selling opioids. according to Crain’s Detroit Business.
"We want to do to the opioid manufacturers and distributors the same thing we did 30-40 years ago to the tobacco industry," Oakland County Administrator L. Brooks Patterson told Crain's. "We see that they really have taken a page out of the tobacco era — false advertising, false claims, people becoming dependent on these drugs without the fair notice of what could happen to their lives."
In New Jersey, Licking County commissioners have agreed to pursue legal action against drugmakers as well, the Columbus Dispatch reports. Licking County Commissioner Tim Bubb expects their lawsuit to be absorbed into a larger class action lawsuit. “This isn’t going to be some quick fix,” Licking County Commissioner Duane Flowers told the Dispatch. “And it’s just once piece of a puzzle. There are a thousand pieces out there.”
But not all officials in these counties agree with joining these lawsuits. The St. Lawrence County, N.Y. Services Committee voted 10-3 on Oct. 23 in favor of joining a class-action lawsuit filed against several opioid manufacturing companies, the Watertown Daily Times reports. St. Lawrence would be one of 15 counties that would have joined the filing firm Simmons, Hanly, Conroy P.C. to sue opioid manufacturers, New York North Country TV station WWNY reports.
The county won’t be charged for the lawsuit unless it results in a financial settlement, per the Daily Times. While the county will hold its final vote on the matter on Nov. 6, Legislature Chairman Kevin Acres made his opposition known.
“I don’t want to be any part of this,” he said, per the Daily Times. “The fact that we’re signing on, just because it’s free, I find absurd.” He added, “the drugs are all legal and regulated by the federal government. Trying to bring litigation against these companies that are all legal is going to be very difficult.”
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Milwaukee County taking steps to sue drugmakers & drug store chains in light of opioid epidemic
Oct 26, 2017 | TMJ4 (WI)
By Katie Crowther
Every sixteen hours someone in Milwaukee County dies from a probable overdose.
The Milwaukee County Medical Examiner's Office expects at least 425 people to die from drug use this year. That's a 25 percent increase from last year.
A TODAY'S TMJ4 camera crew walked with volunteers Wednesday as they picked up used needles on Milwaukee's south side. Milwaukee County officials say it's such a problem, they are now taking steps to potentially sue drugmakers.
"People expect to get high, and they end up dead," say Bill Lauer, a recovering addict turned advocate. He now runs the organization Friends of Recovery.
"It tears families apart and ruins people's lives faster than anything I've ever seen or experienced before."
Lauer says it's time to hold the people and corporations that make, supply, and give out prescription painkillers, more accountable.
"They have huge responsibility in cleaning up the problem that they helped to create," he says. "There is an underlying pressure to prescribe, with incentives for doctors and hospitals to prescribe this drug over that drug, and so on. There are companies and families that have hugely profited from this epidemic."
That's why Milwaukee County might soon join dozens of others across the country, in filing lawsuits against the drug companies and drug store chains, that make opioids so easy to get, and without adequate warning.
"It would help us recuperate the loss that we've suffered as a county, and better assist addicts going forward," says Milwaukee County Supervisor Peggy West.
"We have to have some kind of money or funding to rebuild our communities," Lauer adds. "What's needed is not going to come from the government or tax money. Sure, a lawsuit wouldn't solve the root cause of addiction, but it would at least raise some awareness and set a precedent that this is an aspect of our culture that needs to be healed."
Proof of that is in the loss of lives, and the millions of dollars spent trying to curb this crisis, as highlighted in Milwaukee County's proposed 2018 budget.
"We've put in somewhere around $330,000 for a piece of equipment that will help us identify much earlier what exactly it is that someone has died from, whether it be fentanyl or heroin," West says. "So we can have better insight into what's circulating throughout our community at all times."
That money could be used for many other things, if this epidemic was not overpowering our area.
West says Milwaukee County is looking to hire an attorney to handle this, and it's not alone. Sheboygan County also moving toward a potential lawsuit against national drug companies.
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Counties lining up to sue opioid producers
Oct 26, 2017 | RIpon Press (WI)
By Maic D'Agostino
A lawsuit against opioid makers heralded by the Wisconsin Counties Association (WCA) could be joined by a county near you.
Fond du Lac County’s finance committee unanimously voted Tuesday to authorize county officials to engage legal representation for the lawsuit.
The county board as a whole likely will vote on the resolution at its meeting Tuesday, Oct. 31 at 6 p.m., according to Fond du Lac County Clerk Lisa Freiberg.
If the resolution passes, the county would join a litigation movement that is picking up steam nationally.
A rising number of counties across the country are pursuing legal action against opioid manufactures in the wake of a nationwide surge in addictions and overdose deaths, often referred to as the opioid “crisis” or “epidemic.”
Fond du Lac County Executive Al Buechel is the second vice chair of WCA’s board and explained last week that the organization is following the lead of other states and counties.
“It didn’t start in Wisconsin. It started in a couple of other states, where they decided to take a stand on the opioid issue because of the availability of it and the fact that many people were not aware of how addicted they could become and how quickly they’d become addicted,” he said last week Friday over the phone.
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Suffolk Doctor Facing Illegal Prescription Charges Loses Bid To Join Counties' Suit
Oct 25, 2017 | Law.com
By Andrew Denney
A Suffolk County doctor facing criminal charges for overprescribing pain meds who employed the novel defense of blaming his offenses on Big Pharma was unsuccessful in his effort to join a class action suit against the industry filed by a group of New York county governments.
Dr. Michael Belfiore, who is charged in the U.S. District Court for the Eastern District of New York with 26 counts of illegal distribution of oxycodone and two counts of oxycodone distribution that resulted in a person’s death, had filed to intervene in suits filed by nine New York counties that have been consolidated in a Suffolk County court.
Belfiore argues that he and other doctors were misled by pharmaceutical companies by way of false advertising that the companies’ painkillers could be freely prescribed without concern of the products’ addictive qualities.
But Suffolk County Justice Jerry Garguilo said it is anticipated that more than 50 additional New York counties are expected to join in on the suit and noted that, while Belfiore is the only doctor who filed to join the suit, there could be a “flood” of other New York health care professionals who would file to join in the fray.
The defendants named in the counties’ suits include Purdue Pharma, Teva Pharmaceuticals USA, Cephalon, Johnson & Johnson, Janssen Pharmaceuticals Inc. and Endo Pharmaceuticals Inc.
Thomas Liotti, Belfiore’s lawyer, said in an email that denial of the request shows the “complicity of Big Pharma and the government in creating the opioid crisis.”
“The public has to be made aware of their actions so that innocent physicians like my client are not wrongfully charged,” Liotti said.
Paul Hanly, Jayne Conroy, Andrea Bierstein, Sarah Burns and Thomas Sheridan III of Simmons Hanly Conroy represent the counties.
In papers filed in opposition to Belfiore’s motion to intervene, Hanly argued that the outcome of the class action would not affect Belfiore’s criminal case and that allowing him to intervene would have prejudiced the county plaintiffs.
“It would not have been appropriate for him to be part of our litigation,” Hanly said in an interview.
As for Belfiore’s criminal case, on Oct. 12, U.S. District Judge Joseph Bianco of the Eastern District of New York ruled from the bench to deny Belfiore’s motion to dismiss the criminal charges.
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Trump Administration To Declare Opioid Crisis A Public Health Emergency
Oct 26, 2017 | NPR
By Greg Allen
The Trump administration will declare a public health emergency to deal with the opioid epidemic Thursday, freeing up some resources for treatment. More than 140 Americans die every day from an opioid overdose, according to the Centers for Disease Control and Prevention.
President Trump is also expected to direct agency and department heads to use all appropriate emergency authorities to reduce number of deaths caused by the opioid crisis, according to senior administration officials.
The move stops short of declaring the crisis a national emergency, which Trump first said he'd declare in August. He repeated that pledge this week. The White House said it determined that declaring a public health emergency was more appropriate than a national emergency.
Some in the field, like Dr. Andrew Kolodny, say it's been frustrating to wait for the administration to respond to a crisis Trump first acknowledged on the campaign trail when he was running for president.
Kolodny, who is co-director of the Opioid Policy Research Collaboration at Brandeis University's Heller School, says he expected immediate action after the president's August statement. "If you're calling something an emergency, you expect people to act urgently and respond as if it's an emergency."
After taking office, President Trump appointed a commission to study the opioid crisis, headed by New Jersey Gov. Chris Christie. In an interim report, the commission called on the president to declare a national emergency. Doing so would free up funds for treatment, ensure wider access to the anti-overdose drug naloxone and improve monitoring of opioid prescriptions to prevent abuse.
In August, days before the president promised to declare a national emergency, Health and Human Services Secretary Tom Price said he didn't think one was necessary. Flash forward two months, though, and Tom Price is gone.
Dr. Keith Humphreys, a professor of psychiatry at Stanford University and a former adviser in the Obama administration says that Price was not a friend to addiction treatment programs. "When he was a congressman, he opposed the parity law which required insurers to cover addiction treatment," Humphreys says. "He was very skeptical of methadone maintenance which is a very good treatment for heroin addiction. So having him out of the way is a potential plus."
In a policy change this week, the director of the Food and Drug Administration told a congressional committee the agency will begin working to promote medication assisted treatment—using methadone, buprenorphine or naltrexone to help addicts in recovery. That's significant because some states currently won't pay for some of those treatments. Advocates will be listening for what, if anything, the president says about that.
Humphreys says he's interested in what measures the president proposes as part of an emergency declaration. For example, he could announce he'll use his authority to negotiate cheaper prices for drugs. Humphreys says the president could say, "In an emergency, we're going to use our power as a big purchaser to say to naloxone manufacturers that ... we want 40 percent off or whatever, to use that leverage which currently we can't do legally."
But, when the president speaks on the opioid epidemic Thursday, advocates say the key issue will be what he says about funding. Congress is currently spending $500 million a year on addiction treatment programs. Dr. Kolodny says to help the more that 27 million Americans abusing opioids, much more is needed. He puts the price tag at $6 billion each year. "You want that opioid addicted individual to be able to access effective outpatient treatment more easily than they can get pills, heroin, or fentanyl," Dr. Kolody says.
Kolodny criticizes the Obama administration for being slow to acknowledge opioids, a crisis that he says that began in 1996 and which the CDC declared an epidemic in 2011. President Obama's health secretary Kathleen Sebelius agrees. "Did we do enough? Probably not," Sebelius says. "Recognizing how widespread this was, what factors were contributing to it, would have been helpful a number of years ago." And she says, it might have prevented many overdose deaths.
Sebelius notes that the Affordable Care Act and the expansion of Medicaid greatly increased coverage for addiction treatment. If President Trump is serious about tackling opioids, she says his first step should be to stop fighting to repeal Obamacare.
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WH officials: Trump will stop short of declaring opioid crisis a national emergency
Oct 26, 2017 | The Hill
By Nathaniel Wexel
The Trump administration on Thursday will stop short of calling the opioid epidemic a national emergency and declare it a public health emergency instead, White House officials said.
The announcement has been months in the making but will stop short of declaring a presidential emergency under the Stafford Act or National Emergencies Act — which the administration's opioid commission had previously recommended.
Trump will formally make the announcement during a White House event Thursday. Officials previewed the actions with the press on condition of anonymity Thursday morning.
On Aug. 10, Trump said his administration was drafting paperwork to officially declare the epidemic a national emergency, which was the “first and most urgent” recommendation in an interim report from his commission to combat the crisis.
But administration officials said they felt that a public health emergency was a better use of resources.
A public health emergency declaration would allow Acting HHS Secretary Eric Hargan to loosen certain regulations and issue grants and spend money that he otherwise would not be able to access.
A Stafford Act emergency is typically reserved for a terror attack or natural disaster and officials said the National Emergencies Act wouldn’t allow for the kinds of regulatory flexibilities that will be required to fight the epidemic.
Three agencies that will play a role in the federal response to the epidemic currently have acting directors instead of Senate confirmed-leaders: the White House Office of National Drug Control Policy, the Department of Health and Human Services, and the Drug Enforcement Administration.
Rep. Tom Marino (R-Pa.) — an early backer of Trump — withdrew as the ONDCP nominee last week following a Washington Post-”60 Minutes” joint investigation reporting a bill he sponsored weakened the policing of the nation’s drug laws. Marino has vigorously defended himself.
White House officials said Trump will be submitting names to lead HHS and ONDCP soon, but pointed to “obstructionists” in the Senate for slowing down confirmation of lower level agency appointees who could help implement the action.
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FDA’s Gottlieb makes strong push to fight opioid crisis with medication-assisted treatment
Oct 25, 2017 | STAT News
By Lev Facher
Scott Gottlieb, commissioner of the Food and Drug Administration, announced new steps the agency would take to promote the use and development of medication-assisted treatmentfor substance use disorder at a House hearing on Wednesday.
Gottlieb also rapped the insurance industry for what he called “often inadequate” coverage of existing therapies that combine counseling and medication-assisted treatment.
“To tackle the treatment gap, FDA is planning to convene experts and stakeholders to discuss the evidence of treatment benefits at the population level — such as studies that show community-wide reductions in overdose following expansion of access to therapy,” Gottlieb said.
Widely viewed as one of the Trump administration’s most effective and popular political appointees, Gottlieb has made efforts to address the opioid crisis a signature issue since winning confirmation to lead the FDA in May.
He continued that emphasis during the hearing before the House Committee on Energy and Commerce, outlining a three-pronged approach to encouraging greater MAT use.
The FDA, Gottlieb said, will issue guidance for development of new MAT options, promote efforts to decrease stigma surrounding use of medication in treating substance use disorder, and take further steps to promote use of existing therapies.
“There’s a wealth of information supporting the use of these medications,” Gottlieb said. “We’re focusing on the data in the drug labeling that can help drive broader and appropriate prescribing. So one concept that FDA is actively pursuing is the research necessary to support a label indication for medication-assisted treatment for everyone who presents with an overdose, based on data showing a reduction in death at a broader population-level. Such an effort would be a first for FDA.”
Gottlieb at one point referred to “all three” options for medication-assisted treatment, presumably referring to methadone, buprenorphine, and naltrexone, a newer formulation for a monthly injectable treatment that blocks many of the sedative or euphoric effects of opioid use.
Many addiction treatment experts, however, are not fully convinced by the results of an early study indicating naltrexone is as effective as more traditional, daily administered MAT.
Expanding access to medication-assisted treatment was among the key recommendations of a White House panel when it released its interim report in late July. That commission’s final report is expected next week.
President Trump pledged last week to declare the opioid crisis a national emergency, and an email from the Office of National Drug Control Policy obtained by STAT invited policy stakeholders to “an event on the nationwide opioid crisis” at the White House on Thursday afternoon.
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Walgreens to offer drug naloxone, which can reverse opioid overdoses (VIDEO)
Oct 25, 2017 | ABC News
In more than 8,000 pharmacies across the U.S., anyone will now be able to walk in and buy the most successful emergency overdose treatment available.
Known commercially as Narcan, the drug is administered through a nasal spray and is an FDA-approved form of naxolone.
“This is an incredibly safe and effective medication,” ABC News chief medical correspondent Dr. Jennifer Ashton said today on “Good Morning America.” “We’ve been using it in the hospital for decades, usually with a needle, intravenous or in a muscle.”
Narcan works to counteract respiratory depression, in which a large dose of opioid stops the body’s signals to continue breathing. Overdoses from prescription painkillers, heroin and its derivatives cause this frequent cause of overdose death.
AmerisourceBergen, a pharmaceutical wholesaler, has distributed Narcan demonstration devices for free to Walgreens pharmacists so they can instruct patients on how to administer the medication, Walgreens said in a statement.
The drug will be available to patients and caregivers without a prescription in 45 states. Walgreens said it is "eager and willing" to work with more states to make naloxone easier to obtain.
“As a pharmacy we are committed to making Narcan more accessible in the communities we serve,” the statement added.
Ashton spoke about the risks and benefits of making Narcan so widely available.
“I think the risk here," she said, "is that people could say, ‘Will this give people a false sense of security and have them use opioids more if they know that they can use this immediate antidote?’”
But the benefits of making Narcan available on a wider basis, Ashton said, are incredibly important.
“This drug saves lives," she said. "Think of this maybe as defibrillator, EpiPen, another piece of lifesaving medical equipment that probably is going to be pretty widespread now.”
The announcement that Walgreens will carry naloxone comes as experts agree the opioid epidemic has become a critical emergency on a national scale.
In Connecticut, the Milford School District is making Narcan available in all of its 14 public schools, including eight elementary schools, a district spokeswoman told ABC News.
President Donald Trump has called the opioid crisis a "national emergency" and said he will officially declare it as such. Two months after his inauguration, he signed an Executive Order launching a commission to explore ways to curb opioid abuse and overdoses, led by New Jersey Gov. Chris Christie.
The number of overdose deaths involving opioids has quadrupled since 1999, according to the U.S. Centers for Disease Control and Prevention(CDC).
The agency reported that 91 Americans die every day from an opioid overdoses.
Ashton said the move by Walgreens shows the U.S. is in a "critical and unstable condition" battling the opioid crisis.
"We have to tackle this at the prescriber level, at the dispensing level and at the user level, and that’s what this is," she said.
View clip here: http://abcnews.go.com/Health/walgreens-offer-drug-naloxone-reverse-opioid-overdoses/story?id=50703736
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Who Is to Blame for the Opioid Crisis?
Oct 25, 2017 | Pharmacy Times
By John Burke
I find it interesting that many people pin the blame for the opioid crisis on pharmaceutical manufacturers, wholesalers and distributors.
States, cities, and even small municipalities have jumped on board to sue the manufacturers and/or wholesalers of prescription drugs.
The lure of no-cost attorneys who only take a portion if a suit is successful has drawn many governmental entities into the legal arena. Of course, some of the politicians initiating the suits are up for re-election soon, which is probably not a coincidence.
One thing I have learned is that complex and difficult problems seldom have quick and easy solutions. The opioid crisis came about for multiple reasons, and identifying one cause as the primary or only culprit is wrong and counterproductive.
Pharmaceutical manufacturers and wholesalers and distributors, which send those drugs onto retail entities, are thought to have deep pockets, and many of them do. But smaller wholesalers, which are also vulnerable, are not necessarily as well off financially, and these suits could potentially bankrupt them. These companies are painted as the villains, and they garner little sympathy. Hating big companies, especially pharmaceutical manufacturers that charge a lot of money, is common and well-justified in the minds of many.
Pharmaceutical manufacturers, like all for-profit companies, are certainly driven by making money. However, making money in the pharmaceutical industry also comes with significant risk. Non-generic manufacturers develop new drugs to address a plethora of diseases, symptoms, and health problems. Bringing a new product to the marketplace is not a simple process. There are many steps required by the FDA that include clinical trials before final approval is given. Although lengthy and very expensive for pharmaceutical companies, this process is the best way to assure that a new drug won’t be worse than the disease itself.
I remember one CII pain reliever that was removed the market in less than a year after its launch because of the potential dangers for overdose death if taken with copious amounts of alcohol. I always considered it common sense to not drink alcohol when taking opioid pain medications, and I am sure it was on the warning label, but nonetheless the drug was squashed. I am sure millions of dollars were lost with no chance of recovering the investment. As I recall, no tears were shed for the company when that happened.
The point is that if pharmaceutical companies can no longer see the profit potential for a drug or the risk outweighs the possibility of gains, it will affect the number of ground-breaking medications that are released. Research and development for other pain relievers such as the opioid abuse-deterrent formulations that are effective, will not occur or will be greatly reduced. To put it bluntly, a disease or other condition that any of us could develop over the next few years may not have a treatment or cure due to the pressure put on these companies.
If pharmaceutical companies were to blame for the opioid crisis and it would go away if we simply clamped down on them even harder, I would be all for it. The truth is that the fault and remedy is much more complex, and fixing this scourge takes all of us. I sincerely doubt that these companies are being sued with the thought that this will solve the opioid crisis but more so to solve the governmental entities’ fiscal crisis and/or to be a feather in the cap of politicians seeking re-election. -
Rhode Island doctor pleads guilty to opioid kickback scheme related to Insys
Oct 26, 2017 | Reuters
By Nate Raymond
A Rhode Island doctor pleaded guilty on Wednesday to charges he participated in a scheme to obtain kickbacks in exchange for writing prescriptions for an addictive fentanyl-based cancer pain drug produced by Insys Therapeutics Inc.
The plea by Jerrold Rosenberg came amid ongoing investigations of Insys related to Subsys, an under-the-tongue spray that contains fentanyl, a synthetic opioid.
Rosenberg, 63, pleaded guilty in federal court in Providence, Rhode Island, to charges that he committed healthcare fraud and conspired to receive kickbacks to prescribe Subsys.
Prosecutors said that from 2012 to 2015, Rosenberg schemed to receive $188,000 in kickbacks in the form of speaker fees from Insys, which were a major factor in his decision to prescribe Subsys to patients.
He also fraudulently indicated that his patients suffered from cancer pain when they did not in order to secure insurance approvals for Subsys, prosecutors said.
Under a plea agreement, Rosenberg agreed to pay $754,736 in restitution to healthcare benefit programs. He faces a maximum prison sentence of 15 years and is scheduled to be sentenced on Jan. 16.
Rosenberg’s lawyer did not respond to a request for comment. Chandler, Arizona-based Insys in a statement said it has “taken necessary and appropriate steps to prevent past mistakes from happening in the future.”
The investigations into Insys have come during a national epidemic of opioid abuse. According to the U.S. Centers for Disease Control and Prevention, opioids were involved in more than 33,000 deaths in 2015. The death rate has continued to rise, according to estimates.
In December, federal prosecutors in Boston charged six former Insys executives and managers, including ex-Chief Executive Michael Babich, with engaging in a scheme to bribe doctors to prescribe Subsys and defraud insurers.
All six have pleaded not guilty. Federal charges have also been filed in several other states against other ex-Insys employees and medical practitioners who prescribed Subsys.
Insys has been in settlement talks with the U.S. Justice Department. It said on Wednesday it is working “with relevant authorities to resolve issues related to the misdeeds of former employees.”
Insys also faces lawsuits by attorneys general in Arizona and New Jersey. It previously paid $9.45 million to resolve investigations by attorneys general in Oregon, New Hampshire, Illinois and Massachusetts.
The case is U.S. v. Rosenberg, U.S. District Court, District of Rhode Island, No. 17-cr-00009.
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