Opioid Litigation Media Report 10/12/17

Litigation Focused Coverage

1. Sen. Claire McCaskill on the opioid epidemic: pharma “ought to begin looking over their shoulder”

   Oct 11, 2017 | Vox

   By German Lopez
   
   
   Sen. Claire McCaskill (D-MO) says it’s time for pharmaceutical companies to start worrying about their role in causing the opioid epidemic, the deadliest drug overdose crisis in US history.
2. Russell joins sheriffs’ suit against opioid manufacturers

   Oct 12, 2017 | Ouachita Citizen (LA)

   Ouachita Parish Sheriff Jay Russell joined four other sheriffs in the state in a lawsuit against pharmaceutical companies and physicians over the supposedly deceitful marketing of prescription opioid painkillers.
3. Kane County: Opioid drug manufacturers to blame for drug overdose deaths

   Oct 12, 2017 | Daily Herald

   By James Fuller
   
   
   Kane County will attempt to pin the blame for a growing number of opioid drug overdose deaths on the makers of a variety of prescription medications via a pending lawsuit.
4. Indy will take opioid manufacturers and distributors to court

   Oct 11, 2017 | NUVO (IN)

   By Fran Quigley
   
   
   In Dayton, Ohio, the opioid crisis achieved a grim milestone earlier this year: For the first time ever, the local coroner’s office ran out of space to hold the corpses of those who had overdosed. Funeral parlors had to be recruited to take on temporary storage duties.
5. The Cities Suing Big Pharma Over Opioids

   Oct 11, 2017 | CityLab

   By Sarah Holder
   
   
   It started with a few states, whose rural areas experienced the ravage of the opioid epidemic, and sought to hold pharmaceutical companies accountable with lawsuits. Now, the movement is spreading: New states are filing suits over the opioid crisis at a rapid clip. But so are cities and counties, aiming to halt potentially dangerous opioid distribution practices, and recoup the enormous past (and future) costs. That expense includes caring for, treating, and sometimes burying the addicted; supporting their children; and paying paramedics, police, and city officials.

Other Relevant Coverage

6. How the VA Fueled the National Opioid Crisis and Is Killing Thousands of Veterans

   Oct 12, 2017 | Newsweek

   By Art Levine
   
   
   Late one summer night in 2014, Kevin Keller broke into his best friend’s home. Keller was a U.S. Navy vet wracked with constant pain, and because his right arm had been crippled by a stroke, he had to use his left hand to scrawl a note of apology to his buddy: “Marty, Sorry I broke into your house and took your gun to end the pain! FU VA!!! Can’t take it anymore.” He then drove to his nearby Veterans Affairs outpatient clinic in Wytheville, Virginia, and pounded on the locked doors of the medical office, probably out of frustration or as a final protest, since the facility had been closed for hours. Keller then put the barrel of his friend’s 9 mm pistol to his head and shot himself.
7. Melania Trump Says She Aims to ‘Give a Voice’ to the Victims of Opioids

   Oct 10, 2017 | New York Times

   By Katie Rogers
   
   
   Melania Trump, a once-reluctant first lady who has lately been ramping up her travels as well as directing her aides to lash out at rivals, allowed the public a glimpse at her nascent platform on Tuesday at a clinic that treats infants born with addiction.
8. Tighter oversight of opioid prescriptions by Medicare could help stem epidemic

   Oct 10, 2017 | HealthDay News

   Medicare places few limits on opioid painkiller prescriptions, even in the face of recent U.S. government guidelines, researchers report.

Full Texts

Litigation Focused Coverage

1. Sen. Claire McCaskill on the opioid epidemic: pharma “ought to begin looking over their shoulder”

   Oct 11, 2017 | Vox

   By German Lopez

   Sen. Claire McCaskill (D-MO) says it’s time for pharmaceutical companies to start worrying about their role in causing the opioid epidemic, the deadliest drug overdose crisis in US history.

   “I believe we are reaching a tipping point where even pharma — which is legendary for its power on Capitol Hill — ought to begin looking over their shoulder and wondering whether or not they’ve gone too far in terms of some of their conduct,” McCaskill told me in an interview earlier this month about her investigation into the opioid epidemic.

   As she described it, drug companies aggressively marketed opioids — sometimes even committing fraud — to get doctors to prescribe the drugs. She could see it in her own life as the number of opioid prescriptions rose. And that inspired her to launch a formal investigation, via the Senate Homeland Security and Governmental Affairs Committee, for which she is a ranking member, into opioid makers and distributors earlier this year.

   For McCaskill, the key statistic is the disparity between how much the US prescribes opioids and other countries do. As Stanford drug policy expert Keith Humphreys noted in a recent talk, “Consider the amount of standard daily doses of opioids consumed in Japan. And then double it. And then double it again. And then double it again. And then double it again. And then double it a fifth time. That would make Japan No. 2 in the world, behind the United States.”

   The statistics really do back this up. Japan is one of the lowest prescribers of opioids in the developed world (for reasons outlined in a great piece by my colleague Ella Nilsen). And the US absolutely dwarfs anyone else in terms of opioid prescriptions, with Japan not even showing up in the top 25:

   (View graphic here.)

   McCaskill credits these kinds of numbers with animating her investigation into opioid companies.

   “I looked around,” she told me, “and nobody had really done a complete and thorough investigation in Congress about the role of both the manufacturers — in terms of their sales and marketing — and the distribution of these drugs, in terms of the ability of people to divert drugs from the prescription market into the black market.”

   The first report in her ongoing investigation came out last month, looking at the fentanyl producer Insys. It found that Insys misrepresented Subsys, its fentanyl product, to get insurers to pay for it, letting the company sell its product to people who didn’t need and shouldn’t have had access to such a powerful drug.

   McCaskill’s team even uncovered audio in which representatives from Insys posed as staff from a doctor’s office to get an insurance company to grant prior authorization — essentially, to agree to pay for — a patient’s fentanyl prescription. “The result, in the case of Ms. Fuller, was death due to allegedly improper and excessive Subsys use,” the report concluded.

   It’s unclear what will come out of McCaskill’s investigation. Some Insys executives had already been criminally charged for their conduct, and the company reportedly agreed to some reforms even before the report.

   But McCaskill hopes that even if her investigation doesn’t lead to full legislation, it will help shine a light on how pharmaceutical companies contributed to the opioid crisis — and deter other drug companies from misbehaving in a similar way in the future.

   “Sometimes you can even make a difference without legislation, and just shine the bright light of public attention on problems,” she said. “It makes a difference.”

   What follows is my conversation with McCaskill, lightly edited for length and clarity.

   German Lopez

   What got you interested in the opioid crisis?

   Claire McCaskill

   Well, I think, like many Americans, I’ve had family members that have been impacted by opioid addiction. My mother, near the end of her life, there’s no question in my mind that she had been prescribed opioids to the point that she was dependent. It was obvious to me as somebody who had been around drug treatment and prevention as a prosecutor many years before. I knew the signs. I could sense her dependency on the drug.

   I looked around, and nobody had really done a complete and thorough investigation in Congress about the role of both the manufacturers — in terms of their sales and marketing — and the distribution of these drugs, in terms of the ability of people to divert drugs from the prescription market into the black market.

   I thought it would be a good idea to take that aggressive, thorough look at how did we go from these drugs being developed to a country where we are consuming a much higher percentage of the world’s opioid supply than any other country in the world, by multiples. I wanted to try to get to the bottom of it. That’s why I began this investigation.

   German Lopez

   Why the focus on the pharmaceutical industry, the distributors, and the manufacturers? What made you think this is a good target for an investigation?

   Claire McCaskill

   When I had my wisdom tooth pulled out, I got an aspirin and Baskin-Robbins ice cream. When my children had the work done, they were prescribing opioids. And when I’ve had surgery, I’ve had opioids prescribed.

   And yes, the first few days that might be necessary, like when I had my knee replaced or when I had my breast cancer surgery. But after a few days, they’re no longer necessary. But I was prescribed 30 days and, in one instance, 30 days and a refill. So I’ve seen what appeared to me, just as a layperson watching what’s going on, that these prescriptions are increasing.

   I had a feeling it might be because they were being marketed extensively. And as it turns out, I believe that’s part of the problem. We have lots of different issues with opioids that we have to look at, but no question these drugs were aggressively marketed to the medical community.

   We have already issued one report on one company that went so far that they had an internal sales slogan, “Start them high and hope they don’t die.”

   So we are going to continue looking at all the documents that have been produced and continue asking questions until we get to the point that we completely understand why it is that these are so heavily prescribed in America, unlike other countries.

   German Lopez

   Speaking as a reporter who’s been looking at this issue, one of the things that’s surprised me is how some of the more irresponsible companies have behaved. I’m curious if there are things that have surprised you in the course of this investigation.

   Claire McCaskill

   Well, it is early yet. Now that we’ve expanded our investigation into the distribution of these products, we are at over a million and a half pages of documents and counting.

   But I will say that the brazenness of Insys and the fraud they were committing — masquerading as people in a doctor’s office in order to create prior authorization of a fentanyl product — that surprised me, that they would be that bold, that they would actually call and pretend they were with the doctor, calling from the doctor’s office. That was shocking to me that they would go that far.

   The company knew they had no internal controls related to these problems because they had looked at it and determined they didn’t have internal controls as to what was being said and how these drugs were being pushed, particularly through this internal group that was trying to up the numbers of authorizations that people who were being prescribed this drug were getting.

   I’d say that was shocking — some of the evidence that came out on the report we’ve issued on Insys and their product.

   German Lopez

   Like you mentioned, it’s shocking that they thought it was okay and that they could get away with it. Why do you think they thought that? To me, it’s a question of what kind of culture are we cultivating as a country, where a drug company can feel it can do this.

   Claire McCaskill

   Well, these are companies that are driven by quarterly analyst calls. These are companies that are driven by profit. These are companies that are trying to harness drugs through a patent process and ride that horse as long as they can possibly ride it — in terms of having a monopoly. It’s profit, just dollars and cents, and not seeing, not stopping long enough to look at the bigger picture: “Is what we’re doing ethical? Is what we’re doing good for public health? Is what we’re doing going to be an ultimately terrible reflection on this company even if we make our number for the quarter?”

   And some of this is the pressure that the high costs of [research and development] impose on this country in order to make these things work.

   But some of the tactics that are being used within the pharmaceutical industry to go market these products and even other drugs and [to] protect patents, I believe we are reaching a tipping point where even pharma — which is legendary for its power on Capitol Hill — ought to begin looking over their shoulder and wondering whether or not they’ve gone too far in terms of some of their conduct.

   German Lopez

   How have your colleagues in the Senate reacted to this investigation so far?

   Claire McCaskill

   It’s interesting. It doesn’t feel like they’re reacting in any partisan way. I think that there may be some skepticism because this is an investigation that the chairman [Sen. Ron Johnson (R-WI)] has not chosen to join directly in.

   Although I would tell you that the chairman has not pushed back at all on the work we’re doing. And I am cautiously optimistic that if we got to the point that a company was stonewalling us — which we’re not to that point, but if we did get to that point — I think we’d get bipartisan cooperation in trying to move forward to get the information we need to understand exactly why we’ve had this boon in the prescription of these kinds of drugs.

   German Lopez

   Have you faced any resistance then?

   Claire McCaskill

   No, I haven’t. I think this is because this is legitimately the biggest public health crisis facing our country. We have more deaths now [from drug overdoses] than we had at the height of the AIDS crisis. This country was gripped with the public health issues surrounding AIDS, and this is surpassing that.

   The thing about this particular public health crisis is it isn’t limited to any geographical area or any socioeconomic strata. It hits the suburbs, it hits farming communities, it hits the cities, and everything in between — north, south, east, west.

   The nature of this problem is such that there is good bipartisan concern about what has happened in this space.

   German Lopez

   Are you concerned that the chair hasn’t officially joined the investigation?

   Claire McCaskill

   I’m not. As I said, I’ve gotten no pushback from the chairman. He and I have worked together on other issues well.

   I have done a lot of bipartisan investigations. [Sen.] Rob Portman [R-OH] and I did the Backpage investigation together. [Sen.] Susan Collins [R-ME] and I did the Valeant and the Turing investigation together.

   So I have a record of working with my Republican colleagues on important investigations that sometimes take a while and are labor-intensive and are paper-heavy. But in both of those investigations, we were able to make a difference when it was all said and done. Sometimes you can even make a difference without legislation, and just shine the bright light of public attention on problems. It makes a difference.

   In some instances, legislation is necessary. In others, it’s not. Too early to tell in this particular investigation whether any legislation would be appropriate.

   German Lopez

   Do you think we as a country are paying enough attention to the opioid crisis? It seems to me like it’s not getting the kind of all-consuming coverage and political attention that the crack cocaine and HIV/AIDS crises drew. Do you think that’s right? And if so, does that concern you?

   Claire McCaskill

   I certainly think it’s in the top tier of issues that is talked about in Washington. I will admit that in these times, a lot of the oxygen in the room is consumed by some of the partisan battles and the unusual nature of some of the things — I mean, we’ve never had a president using his Twitter handle as a method to mold public opinion. It’s a different time, where there are a lot of distractions in terms of the public attention.

   But there is a unifying thread around opioids in Washington. I feel it being here. I think most members feel it — that they know we have a responsibility to act and do more than just wring our hands and say, “What are we going to do?” We’ve passed legislation that’s comprehensive as it relates to the addiction of opioids. We are working every day to make sure treatment beds are available and make sure we’re getting a grasp of the problem of black-market fentanyl coming in through the mail, our ports.

   There are a lot of different parts of this problem that many different members of Congress have worked on. So I do feel that it is in the top tier of issues that is on everyone’s mind here. And I don’t think it’s getting kicked to the curb at all at this point.

   German Lopez

   But when I talk to addiction treatment facilities, they point to this statistic: Only 10 percent of people who have a drug use disorder get specialty treatment for it. And one of the major complaints in this crisis is that there’s still weeks- or months-long waiting periods.

   So do you think Congress has done enough to expand treatment to this point?

   Claire McCaskill

   No, I don’t.

   I think that people are familiar with substance abuse treatment know the moment of crisis is the key moment. It does make a difference if you can capture someone into a good treatment bed at the moment of crisis; it increases the likelihood of avoiding a relapse. And unfortunately, too many of the treatment beds in this country are dependent on having money or insurance that covers those treatments.

   There are way too many people who have burned every bridge in their family, are completely out of money, are completely dependent on the public health system for any treatment help they’re going to get. Which means that we’ve got to, under the category of worrying about opioid addiction in this country, continue worrying about Medicaid funding.

   The way the provisions, the budgets that have been proposed in order to pass the tax cuts that Republicans are talking about is proposing a trillion-dollar cut to Medicaid. Well, that’s a knife in the heart of addiction treatment in this country for a vast number of people who are hooked on opioids. So we’ve got to remember it’s not just talking a good game about, oh, we’ve got to do something about opioids; we’ve got to back it up with the public money that’s necessary to treat the addictions that are out there if we really want to save lives.

   German Lopez

   I’m trying to get an idea of what the endgame to this investigation is. You’ve already looked at Insys and found some pretty alarming things. What do you hope to achieve with this?

   Claire McCaskill

   It’s a bit like the Turing [and] Valeant investigations [which looked at drug pricing abuses].

   If there’s another pharmaceutical company that thinks it would be a good idea to put a unit inside the manufacturer of the drug to try to pose as if they are a doctor’s office getting prior authorization, I’m hoping that our investigation has already prevented that kind of behavior from happening.

   And there may be other behaviors that we uncover in this investigation that we can bring forward in a very public way. And that would be a cautionary moment for other pharmaceutical companies to engage in that same kind of behavior.

   German Lopez

   How are you following up on the findings on Insys in particular?

   Claire McCaskill

   They had a complete change in management. There are people that are being criminally prosecuted.

   But we’re continuing to follow both what the company is doing both in terms of the reforms they’ve instituted. Also, we’re following these criminal prosecutions, making sure we’re paying close attention so somehow those don’t go away, whatever pressures might be brought to bear on the people who might bring up those charges.

   German Lopez

   Do you think the regulatory structure has failed? There are all these stories about the overprescription of opioid painkillers for years and years and years. It seems the DEA, FDA, and so on should have caught some of these problems and stopped them before they got this out of hand.

   Claire McCaskill

   I wouldn’t shy away from that kind of criticism. It’s hard to imagine that we could have such an outsize level of prescriptions to this kind of drug in our country compared to other countries, and that people in leadership positions and regulatory positions didn’t see that and begin to ask themselves why. Why is everyone getting a bottle of opioids?

   I will say, too, that one of the things in the long list of things we need to look at in this phase is that we took a step in this epidemic that most countries have not — and that is making pain a vital [sign]. Most vitals in the hospital have to do with a numerical assessment. What is your blood pressure? What is your temperature?

   When they made pain a vital, all of a sudden we’re being asked constantly in the hospital, “Tell me what your pain level is from 1 to 10.” And doctors and medical personnel are evaluated by how well they manage their patients’ vitals. So it allowed the patient on a subjective basis to begin to weigh in on whether or not they had pain. I think that also has contributed to the overprescription of opioids. And I think it’s something we have to look at, along with all the other things we have to work on.

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2. Russell joins sheriffs’ suit against opioid manufacturers

   Oct 12, 2017 | Ouachita Citizen (LA)

   Ouachita Parish Sheriff Jay Russell joined four other sheriffs in the state in a lawsuit against pharmaceutical companies and physicians over the supposedly deceitful marketing of prescription opioid painkillers.

   Russell and the other sheriffs claim opioid painkillers have led to higher crime rates and trends of delinquency across Louisiana.

   “The opioid epidemic has touched every corner of this parish and every part of this state,” Russell . “I am proud to join with my fellow sheriffs to try to do something about this crisis for the people of Ouachita Parish.”

   Laborde Earles, a Lafayette accident and personal injury law firm, filed the lawsuit on behalf of the sheriffs last week. The lawsuit is similar to other lawsuits filed by Laborde Earles on behalf of the sheriffs of Avoyelles, Jefferson Davis, Rapides and Lafayette parishes in September.

   “The pharmaceutical companies named in this suit ignored the devastating impact that their drugs were having on individuals and families across the nation, including right here at home,” said Derrick “Digger” Earles, Partner at Laborde Earles. “It’s time they were held accountable and pay for the damage they caused.”

   In the complaint, the five parish sheriffs seek relief, including compensatory and punitive damages, for the millions of dollars they spend each year to combat drug-related crimes and to ease the societal economic burden of opioid abuse created by the drug companies’ allegedly deceptive marketing touting safety and efficacy of long-term opioid use. Simmons Hanly Conroy, one of the nation’s leading law firms focused on consumer protection and mass tort actions, which is spearheading similar lawsuits on behalf of more than 30 governmental entities across the country,has joined Laborde Earles as co-counsel in the cases.

   The defendants in the lawsuit are: Purdue Pharma L.P.; Purdue Pharma, Inc.; The Purdue Frederick Company, Inc.; Teva Pharmaceuticals USA, Inc.; Cephalon, Inc.; Johnson & Johnson; Janssen Pharmaceuticals, Inc.; Ortho-McNeil-Janssen Pharmaceuticals, Inc.; Janssen Pharmaceutica, Inc.; Endo Health Solutions Inc.; Endo Pharmaceuticals, Inc.; Dr. Randall Brewer; Dr. Perry Fine; Dr. Scott Fishman and Dr. Lynn Webster.

   “We applaud our clients for standing up and saying, ‘enough is enough’ and trying to do something to stop the opioid epidemic sweeping our nation,” said David Laborde, Partner at Laborde Earles. “These sheriffs join a growing list of public entities around the country that have concluded that it’s time to hold the drug companies accountable for their fraudulent actions.”

   In a separate action, the Louisiana Department of Health also sued the major pharmaceutical companies, alleging in their complaint, “Drug manufacturers undertook an orchestrated campaign to flood Louisiana with highly addictive and dangerous opioids in an effort to maximize profits above the health and well-being of their customers.”

   According to the lawsuits, state data shows opioid-related deaths in Louisiana have nearly doubled from 155 in 2012 to 305 in 2016. Louisiana is one of eight states that has more opioid prescriptions than it has residents. In 2013, Louisiana ranked first in opioid prescriptions according to the Centers for Disease Control (CDC) Morbidity and Mortality Weekly Report and the Louisiana Department of Health and Hospitals. The state was found to have the sixth highest prescription-per-capita rate at 1.03 pain killer prescriptions written per Louisiana resident in 2015.

   According to the CDC, Washington Parish and Vernon Parish had rates of usage higher than the national average in 2015. Washington Parish’s usage rate was between 677 and 958 milligram equivalents (“MME”) per person in 2015, compared to 640 MME per person in 2015 nationally.

   The lawsuits allege the defendants aggressively sought to create a false perception in the minds of physicians, patients, health care providers and clients that using opioids to treat chronic pain was safe for most patients and that the drugs’ benefits outweighed the risks. This was allegedly perpetrated through a coordinated, sophisticated and highly deceptive promotion and marketing campaign that began in the late 1990s, became more aggressive around 2006, and is ongoing. Specifically, the complaint alleges that the defendants poured significant financial resources into generating articles, continuing medical education courses and other “educational” materials, conducting sales visits to doctors, and supporting a network of professional societies and advocacy groups – all of which were successful in the intended purpose of creating a new and phony “consensus” supporting the long-term use of opioids.

   In the Louisiana Department of Health lawsuit officials wrote, “Drug manufacturers undertook an orchestrated campaign to flood Louisiana with highly addictive and dangerous opioids in an effort to maximize profits above the health and well-being of their customer.”

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3. Kane County: Opioid drug manufacturers to blame for drug overdose deaths

   Oct 12, 2017 | Daily Herald

   By James Fuller

   Kane County will attempt to pin the blame for a growing number of opioid drug overdose deaths on the makers of a variety of prescription medications via a pending lawsuit.

   County board members spent about 90 minutes this week meeting behind closed doors with a team of lawyers from outside law firms. After, Kane County State's Attorney Joe McMahon confirmed he'd passed along a recommendation about the viability of a lawsuit against opioid drug manufacturers to the board. His office has not yet released the details of that advice.

   McMahon, however, did confirm the county board will move forward with a lawsuit.

   "The opioid epidemic across this region has been horrific," McMahon said. "I'm pleased the county board has agreed to move forward in holding the opioid industry accountable."

   The Kane County coroner's office handles about one opioid death per week, on average this year. That's already more drug deaths than the record total of 36 in 2016.

   The lawsuit will seek compensation for the impact to the coroner's office, costs for policing the drug trade by the sheriff and prevention and treatment efforts by the county health department.

   Guiding the various departments through the process of determining the damages are two firms McMahon described as "national experts in large, mass tort-type litigation."

   The Chicago-based law firm of Simmons Hanly Conroy LLC developed the initial lawsuit proposal. The firm won a $75 million settlement against Purdue Pharma LLP and Abbott Laboratories Inc. in 2006. The companies are the promoters and manufacturers of OxyContin. The lawsuit claimed fraudulent marketing to doctors and patients stating the drug was not as addictive as alternative drugs.

   Joining the effort is St. Charles-based Meyers & Flowers. The firm specializes in catastrophic injury, medical negligence, defective products and workplace injury lawsuits. Peter Flowers met with the county board this week. He was one of the lead plaintiff attorneys behind a $2.5 billion settlement from a unit of Johnson & Johnson in 2013. More than 8,000 people filed thousands of lawsuits claiming injury by defective artificial hip implants.

   Chicago and St. Clair County have similar pending lawsuits.

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4. Indy will take opioid manufacturers and distributors to court

   Oct 11, 2017 | NUVO (IN)

   By Fran Quigley

   In Dayton, Ohio, the opioid crisis achieved a grim milestone earlier this year: For the first time ever, the local coroner’s office ran out of space to hold the corpses of those who had overdosed. Funeral parlors had to be recruited to take on temporary storage duties.

   Indianapolis is not there yet. But the trend here is nearly as disturbing. Opioid addiction killed 345 people in Marion County last year. That was the highest number ever and four times more victims than all of the county’s traffic accidents put together.

   Mayor Joe Hogsett announced last week that the city would be taking opioid manufacturers and distributors to court.

   “Left unchecked, opioid addiction will continue to incite criminality, tear apart families, and take the lives of Indianapolis residents,” Hogsett said in a statement. “As we work to combat this epidemic of addiction and connect affected community members with the treatment they need, those who have contributed to this crisis should be held accountable.”

   The local crisis Hogsett refers to is part of a national problem. U.S. opioid overdose deaths (heroin plus prescription opioids) have quadrupled since 1999. By filing a lawsuit, the city of Indianapolis will follow the lead of dozens of states and cities that have already pointed the finger at the corporations that promoted and profited from the surge in pain medication prescriptions that preceded the addiction crisis. A Congressional investigation is also looking into the companies’ responsibility.

   When Ohio Attorney General Mike DeWine sued pharma corporations in May, he did not shy away from assigning blame. “These companies got thousands and thousands of Ohioans addicted to opioid pain medications, which has all too often led to use of the cheaper alternatives of heroin and synthetic opioids,” he said. “These drug manufacturers led prescribers to believe that opioids were not addictive, that addiction was an easy thing to overcome, or that addiction could actually be treated by taking even more opioids.

   “They knew they were wrong,” DeWine added. “But they did it anyway — and they continue to do it.”

   The manufacturers and distributors identified as the likely targets of the planned Indianapolis lawsuit gave statements to the Indianapolis Star denying responsibility for the crisis.

   But they will have a lot to answer for, as the epidemic followed on the heels of multiple companies spending billions of dollars pushing physicians and patients into a downward spiral of painkiller over-prescription and abuse.

   The promotions included lavish dinners and junkets for physicians, along with industry-produced literature that extolled the life-changing benefits of opioids while alleging multiple disadvantages of over- the-counter medications like ibuprofen. At the same time, the industry was using insider ties to rewrite medical guidelines to justify the rash of prescriptions.

   The result: In 2010 alone, physicians wrote 254 million prescriptions for opioids, and pharmaceutical corporations raked in $11 billion in opioid sales. In Ohio, almost 20 percent of the state’s population was prescribed an opioid in 2016.

   The most notorious marketing campaign centered around Purdue Pharma’s product OxyContin, which the company claimed would provide 12 hours of relief from each dose. (Purdue Pharma is not connected to Purdue University.) The lengthy duration distinguished OxyContin from cheaper alternatives, so it was the core of the company’s pitch to physicians and patients.

   Except multiple clinical trials and physician reports eventually revealed that the drug’s effects did not actually last that long for many patients. When OxyContin’s effects wore off before the next scheduled dose, searing pain returned, which patients were desperate to alleviate. It was “the perfect recipe for addiction,” Theodore J. Cicero, a neuropharmacologist at the Washington University School of Medicine in St. Louis told the Los Angeles Times.

   In 2007, Purdue Pharma and top executives admitted to felony fraud in their OxyContin promotions, paying fines of $634 million. Purdue is not alone: sales representatives from other companies have pled guilty to bribing doctors to prescribe painkillers, using lures that included speaking fees.

   Yet the industry that has become one of the most profitable in modern history by exploiting the desperate needs of suffering people has been anything but chastened. In response to the spike in demand for the medicine naloxone to respond to overdoses, manufacturers increased its price by as much as 500 percent.

   The state of Indiana has not yet joined the opioid litigation push, although Attorney General Curtis Hill is one of 41 state attorneys general conducting an investigation of companies’ role in the epidemic.

   Widespread lawsuits aiming to recover government costs and deter unethical corporate behavior invoke comparisons to the 1990s claims against tobacco companies. In 1998, those suits concluded with the companies and 46 states reaching the largest civil litigation settlement in U.S. history.

   No doubt, Indianapolis taxpayers would be happy if the opioid litigation brings similar results. The city could use the financial boost to offset the increased public safety, health emergency and legal system costs caused by the epidemic. But it would be even better if the lawsuits succeed in reducing the burden on coroners’ offices — here and across the country.
   

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5. The Cities Suing Big Pharma Over Opioids

   Oct 11, 2017 | CityLab

   By Sarah Holder

   It started with a few states, whose rural areas experienced the ravage of the opioid epidemic, and sought to hold pharmaceutical companies accountable with lawsuits. Now, the movement is spreading: New states are filing suits over the opioid crisis at a rapid clip. But so are cities and counties, aiming to halt potentially dangerous opioid distribution practices, and recoup the enormous past (and future) costs. That expense includes caring for, treating, and sometimes burying the addicted; supporting their children; and paying paramedics, police, and city officials.

   Chicago was the first city to take legal action in 2014, but almost ten others have decided to file lawsuits in the past year—with Seattle, Indianapolis, and Cincinnati all filing in the past three months. Miami might soon join them.

   Drug companies marketed and sold too many prescription drugs to too many patients, they argue, without offering adequate and accurate information about their risks. As a result, thousands of users have become dependent, often turning to harder versions of those originally prescribed opioids.

   The cities developing the lawsuits listed below are bolstering the state effort in holding Big Pharma accountable, much in the way that 46 state and local attorneys worked together to take on Big Tobacco in 1998. Then, their efforts were successful: tobacco companies ended up paying out more than $200 billion in settlements for peddling addictive, harmful drugs. The opioid industry could be next.

   In most cases, the pharmaceutical companies in question have continued to vehemently deny wrongdoing, and reaffirmed their commitment to combatting the epidemic and promoting responsible use.

   Thus far, at least one state action has been successful. One of the first lawsuits brought by West Virginia against Cardinal Health and Amerisourcebergen ended in settlements of $20 million and $16 million, respectively.

   Here are some of the new, city-spearheaded lawsuits:

   Seattle, Washington: “Knowingly conducted an uncontrolled experiment”

   Since 2000, 10,000 people have died from opioid overdoses in Washington state; in King County, where Seattle is located, two-thirds of the 332 drug-use deaths in the last year were opioid-related. Each year, the numbers rise, according to University of Washington researchers.

   In September, the state of Washington and the city of Seattle both announced they would separately sue pharmaceutical companies for their role in that acceleration.

   Seattle’s case, led by city attorney Pete Holmes, targets Purdue Pharma and Teva Pharmaceuticals. It’s not just that the companies aggressively peddled opioids to doctors, attorneys argue: it’s that they downplayed—and in some cases failed to disclose entirely—the dangerous and addictive nature of the drugs in question. At the same time, they overstated the drugs’ benefits.

   They even introduced the new medical concept of “pseudo-addiction,” recommending that doctors respond to warning signs of opioid addiction by prescribing more opioids. If a patient asks for higher dosages of drugs, hoards drugs, or wants early refills of drugs, they’re not addicted—they really just need more drugs to quell their pain, Purdue claimed. Cities are calling the theory bogus—it’s based primarily on one cancer study—but Purdue has insisted it’s legally and medically valid: the FDA itself approved OxyContin labeling that “embodies the concept” of pseudo addiction, Purdue says.

   “Purdue Pharma has knowingly conducted an uncontrolled experiment on the people of Washington state,” said Washington Attorney General Bob Ferguson at a news conference. Teva and Purdue are denying these allegations, saying they are dedicated to balancing the dual priorities of providing crucial drugs and preventing drug abuse.  

   It was actually a much smaller locale that brought the first of Washington’s lawsuits. The city of Everett, located north of Seattle with a population of 108,000, alleged in January that Purdue knew their pills were being trafficked illegally within the city, but did not intervene or alert law enforcement. In September, a Seattle judge ruled that the city of Everett could proceed with the lawsuit, rejecting the pharmaceutical company’s March argument that the city’s case had no merit. Still, Purdue told CBS News that Everett’s narrative of their involvement in the Everett crisis is “flawed” and “inaccurate.”

   Indianapolis, Indiana: “They sought relief from pain and were administered addiction”

   Last year, 1,498 people died of an overdose across the state of Indiana, and 345 of them were within Indianapolis’ Marion County. In Indianapolis alone, overdose medication (the expensive and hard-to-administer drug, Narcan) has been deployed by paramedics 1,670 times so far in 2017.

   This fall, the city hired a private firm tasked with arguing that big Pharma conspired to increase sales by misrepresenting how addictive their drugs really were. The city also alleges that, when “unquestionably suspicious” opioid orders were requested, drug companies failed to report them. “They all sought relief from pain and were instead administered addiction,” said Mayor Hogsett in a news conference.

   Indianapolis hasn’t identified all the defendants yet, but the mayor and an attorney named Purdue Pharma, Endo, Teva and three distributors (Cardinal Health, McKesson Corporation and Amerisource Bergen) as likely targets—those who sold the bulk of the OxyContin and oxycodone to Indianapolis residents.

   Purdue “vigorously den[ies] these allegations”; Teva and Endo wrote of their commitment to making drugs accessible but keeping drug use safe and appropriate; and the representative for all three city distributors said that while they, too, want to be part of the solution, they “aren’t willing to be scapegoats.” It’s a bigger problem than just distribution, they insist.

   Cincinnati; Dayton; and Lorain, Ohio: “a year-and-a-half supply” for 802,000 residents

   In 2014, Ohio had the highest rate of overdose deaths in the nation—and in subsequent years, the number of deaths has risen. Along with taking lives, the crisis has sucked valuable public resources from cities in the state. So this summer, Cincinnati announced it would join its sister city Dayton, as well as their shared home state, in bringing suits against pharmaceutical companies.

   Both Cincinnati and Dayton are suing “Big Three” distributors AmerisourceBergen, Cardinal Health and McKesson Corporation; and Dayton is also suing five manufacturers (Purdue Pharma, Endo Health Solutions, Teva Pharmaceutical Industries, Johnson & Johnson, Janssen Pharmaceuticals and Allergan) and four physicians. “They profited by breaking the law and we want our money back," Cincinnati mayor John Cranley told WCPO. “We are in a state of emergency. We need action now,” Dayton mayor Nan Whaley said at a news conference.

    

   Both cities’ suits start with the common argument that drug distributors and manufacturers misled the public for profit. Both also hinge on the high volume of opioid shipments these companies approved—“enough for a year-and-a-half supply of opioids for Hamilton County's 802,000 residents,” officials estimate—which Cincinnati argues was in violation of the 1970 Controlled Substances Act. But Dayton’s suit extends the scope of responsibility to include individual doctors who acted as consultants to drug manufacturers, promoting and deceptively marketing opioids to patients.

   The Big Three distributors issued statements similar to those published in response to other cities’ suits: Cardinal Health writes that they “care deeply about the devastation opioid abuse has caused American families and communities” and they all want to find a solution—but, writes McKennan, because they “do not manufacture, promote or prescribe prescription medications to members of the public,” they “believe these copycat lawsuits filed against us are misguided.” AmerisourceBergen insists they do inform the DEA of suspicious orders, and comprehensively track and report the details of pharmacy orders. The manufacturers and physicians did not issue statements of their own.

   Another smaller Ohio city, Lorain, also filed a suit against more than 11 companies in late June.

   Princeton, West Virginia: “It’s a war”

   The small city of Princeton, located in southern West Virginia, voted this month to sue Amerisourcebergen Drug Corporation, Cardinal Health Inc, and other as-of-yet unnamed pharmacies within the city limits. The lawsuit has not been filed, and there has been no response from the companies the city did name.

   “It’s more than serious,” said Mayor Dewey Russell during the city council meeting, before the affirmative vote on whether to proceed with a legal case. “It’s an epidemic, it’s a war.”

   The state of West Virginia already settled one case against 14 drug distributors in 2016, from which they received around $40 million. Their success inspired Princeton and other West Virginian cities to follow suit.

   Chicago, Illinois: “Stop this deceptive and unlawful marketing”

   Chicago led the city-level charge in 2014, when they sued Purdue Pharma L.P., Cephalon, Inc., Janssen Pharmaceuticals, Inc., Endo Health Solutions Inc. and Actavis, for the same sort of misleading, manipulating, and overselling other cities have condemned them for.

   “The purpose of the lawsuit is simple,” said Chicago Corporation Counsel Stephen Patton in 2014. “To stop this deceptive and unlawful marketing and hold these companies responsible for the harm their deception has caused.”

   The case is still in the discovery phase in the U.S. District Court for the Northern District of Illinois.

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Other Relevant Coverage

6. How the VA Fueled the National Opioid Crisis and Is Killing Thousands of Veterans

   Oct 12, 2017 | Newsweek

   By Art Levine

   Late one summer night in 2014, Kevin Keller broke into his best friend’s home. Keller was a U.S. Navy vet wracked with constant pain, and because his right arm had been crippled by a stroke, he had to use his left hand to scrawl a note of apology to his buddy: “Marty, Sorry I broke into your house and took your gun to end the pain! FU VA!!! Can’t take it anymore.” He then drove to his nearby Veterans Affairs outpatient clinic in Wytheville, Virginia, and pounded on the locked doors of the medical office, probably out of frustration or as a final protest, since the facility had been closed for hours. Keller then put the barrel of his friend’s 9 mm pistol to his head and shot himself.

   Grieving friends told The Roanoke Times that Keller couldn’t handle how the VA was weaning him off painkillers. His doctors had told him cutting back would extend his life, but Marty Austin, whose gun Keller stole that night, told the paper, “He did not want a longer life if he was going to be miserable and couldn’t do anything because of the pain.”

   Suicides like Keller’s and the widespread despair behind them are yet another tragic element of a national opioid crisis blamed for most of the 64,000 fatal drug overdoses a year. Opioids, mostly illegally obtained counterfeit pills and heroin, now account for 63 percent of all drug deaths in the U.S., with fatalities climbing at an astounding rate of nearly 20 percent a year. In fact, the estimated number of drug deaths in 2016 topped the total number of soldiers killed in the Iraq and Vietnam wars. There’s a grim irony in that statistic, because the Department of Veterans Affairs has played a little-discussed role in fueling the opioid epidemic that is killing civilians and veterans alike. In 2011, veterans were twice as likely to die from accidental opioid overdoses as non-veterans. One reason, as an exhaustive Newsweek investigation—based on this reporter's book, Mental Health, Inc.—found, is that for over a decade, the VA recklessly overprescribed opiates and psychiatric medications. Since mid-2012, though, it has swung dangerously in the other direction, ordering a drastic cutback of opioids for chronic pain patients, but it is bungling that program and again putting veterans at risk. (It has also left untouched one of the riskiest classes of medications, antipsychotics—prescribed overwhelmingly for uses that aren’t approved by the Food and Drug Administration (FDA), such as with post-traumatic stress disorder.)

   A key role in spreading opiate use was played by Purdue Pharma, the OxyContin manufacturer convicted of hiding the drug's addictive properties. It gave $200,000 to the VA pain management team that essentially turned the VA into its propaganda arm, according to secret corporate documents obtained by Newsweek. The team helped develop the initial VA–Department of Defense guidelines that concluded opiates "rarely" cause addiction. A 2001 budget plan outlining Purdue’s marketing schemes hailed “additional corporate initiatives and partnering efforts [that] were very successful with the Veterans Administration” and other major health organizations in promoting the phony campaign, “Pain: The 5th Vital Sign.”MOST READNazi-Killing Video Game 'Wolfenstein II' Angers NazisRepublicans Are Kicking People Off Food StampsISIS May Still Have Proof It Did Las Vegas AttackSouth Korea Builds 'Blackout Bombs' against PyongyangTrump Was Racist on 'Apprentice' Set, Claims Producer

   Today, the number of patients affected by the VA’s swinging opiate pendulum is staggering: 60 percent of veterans who fought in the Middle East and 50 percent of older veterans have chronic pain. Since 2012, though, there has been a 56 percent drop to a mere 53,000 chronic pain VA patients receiving opioids—leading to swift, mandated cutoffs regardless of patient well-being and with virtually no evidence that it’s a safe approach. For a taste of the kind of indifferent care vets with chronic pain are getting, consider Marine veteran Robert Rose. He is now mostly confined to a wheelchair, suffering from severe spine, neck and knee injuries from his military service—but until he was cut off from opioid pain medications last year (despite not abusing them), he didn’t need a wheelchair and was able to play with his grandkids and build finely crafted woodworks. The primary care doctor at the Mountain Home, Tennessee, VA Medical Center told a hobbled, diabetic Rose and his wife during an office visit in May, “You should continue smoking, as it will help you with the stress and frustrations you are dealing with now. And you should continue to drink Mountain Dew, as the sugar molecules will attach to the pain receptors and block the pain you are experiencing without pain medications.”

   Rose is ignoring that advice and raging against how he and other veterans are being treated—and mistreated: “I am going crazy because of the pain and burning up with anger at the VA, the [Centers for Disease Control and Prevention] and [Drug Enforcement Administration (DEA)] for what they’re doing to so many Americans and veterans.”‘Don’t Fix the Problems’

   In a ceremony in the East Room of the White House in late June, President Donald Trump signed a law making it easier for the Department of Veterans Affairs to remove bad employees and protect whistleblowers. He was joined by his new Veterans Affairs secretary, Dr. David Shulkin, and Sergeant Michael Verado, who lost his left arm and leg to an improvised explosive device in Afghanistan in 2010, but had to wait 57 days for a properly fitted prosthetic, and over three years for the VA to correctly equip his home with accessibility equipment—making him a living symbol of the agency’s wait-time scandals.

   "In just a short time, we've already achieved transformative change at the VA—and believe me, we're just getting started," the president declared. "For many years, the government failed to keep its promise to our veterans. Veterans were put on secret waitlists, given the wrong medication, given the bad treatments and ignored in moments of crisis for them. Many veterans died waiting for a simple doctor's appointment. Yet some of the employees involved in those scandals remained on the payrolls…. Today, we are finally changing those laws to help make sure that the scandal of what we suffered so recently never, ever happens again—and that our veterans can get the care they so richly deserve.”SIGN UP FOR OUR NEWSLETTERSIGN UP
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   To some VA critics, Trump's selection of Shulkin to head the agency makes it unlikely that significant changes will be made. “For veterans who voted for Donald Trump, this is going to feel like a bait and switch,” says Benjamin Krause, founder of DisabledVeterans.org. “Keeping Shulkin will keep a host of flunkies and criminals who should have been part of the whole ‘drain the swamp’ promise.” (His own reputation as an ethically pure reformer was undercut by The Washington Postreport  in late September that he billed the government for his wife’s travel during a 10-day business jaunt that also included side-trips to the Wimbledon finals and a  visit to Copenhagen’s “Little Mermaid” statue; these  expenses were somehow approved by the VA’s ethics team but  are now under investigation by the department’s Inspector General.)

   The fetid VA swamp has been spreading for years under the last three VA secretaries, including Shulkin. It’s an institution long notorious for vicious retaliationagainst whistleblowers and a penchant for falsehoods, obfuscation and delay, as well as rampant cover-ups of unsafe and sometimes deadly conditions—or even fraud—by the VA's watchdog agencies. This is all kept from view by what some longtime employees call “the code”—the institutional silence and protection offered wrongdoers. Likening it to the mob’s “omertà,” one high-ranking VA administrator, who insisted on anonymity, tells Newsweek, “You don’t break ‘the code,’ or your career is over…. It’s a fearful environment.

   “The code,” that VA official says, “is designed to do this: don’t fix the problems.”

   Shulkin’s media office declined repeated requests for an interview with the VA secretary by this reporter to discuss the rampant problems at the VA, but he has made some progress in cleaning up the department—while demonstrating a shrewd feel for public relations. The Boston Globe reported in mid-July that the highly rated (by the VA) Manchester, New Hampshire, VA hospital had to close an operating room because exterminators couldn't get rid of flies, and thousands of patients couldn't make appointments for vital, sometimes life-saving, treatments because of a breakdown in scheduling specialized care outside the VA. Whistleblowers had been complaining about this for years, to no avail, but a few hours after the Globestory broke, Shulkin removed the two top administrators.

   But even this response was more symbolic than substantive. Many other shocking abuses have been ignored by Shulkin and his predecessors. In 2016, 34 whistleblowers turned to the Scripps News Washington Bureau and its Cincinnati TV affiliate, WCPO, to report such problems as surgeons allegedly being pressured to use blood- and bone-splattered instruments as "sterilized" by the Cincinnati VA hospital's then–acting chief of staff, Dr. Barbara Temeck. Those complaints were backed by hundreds of dangerous incidents chronicled in internal documents given to Scripps. (Temeck has denied the allegations, although she was demoted after Scripps reported that she improperly prescribed opiates to the wife of her regional supervisor.) The VA’s investigators didn’t interview any of the whistleblowers quoted in the press and concluded that there were no safety problems at that VA Medical Center, a position Shulkin’s VA still holds.RELATED STORIES

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   All told, nearly 2,000 VA whistleblowers were forced in fiscal year 2016 alone to appeal to an independent federal agency, the Office of Special Counsel (OSC), to protest retaliation while reporting fraud or unsafe conditions—more than the next four problematic federal departments combined. As The Boston Globe reported in September, these employee complaints included nursing home residents at the Bedford, Massachusetts, Veterans Affairs Medical Center allegedly being starved of food for hours or left to lie naked in bed amid the squalor of soiled sheets.

   Shulkin has established a new office given a mandate to protect whistleblowers, but that hasn’t yet halted the retaliation. “I don't know of a single instance when a VA employee has been held accountable for harassing whistleblowers," says Krause.

   This turf-protecting has perhaps been most apparent in the VA's belated response to the national opiate crisis it helped usher in. The VA doesn't even keep an accurate count of how many veterans have died of legal or illegal drug overdoses, even though it officially launched an Opioid Safety Initiative in 2013 that has brought the VA's opiate prescribing down 30 percent. Nor does it regularly monitor opiate use by its patients who seek legal or illegal drugs outside the VA.

   The VA's overmedication epidemic, which wasn't on the list of reform prioritiesShulkin released in May, has become especially urgent because of its apparent link to the 20 suicides a day of veterans in the U.S.

   Even those earlier VA figures may be a gross understatement. When the VA released in September state-by-state data, it showed, for example, that Arizona had a suicide rate as high as 53.6 per 100,000 across all age groups, nearly 40 percent higher than what the VA was reporting nationally. These troubling suicide rates—at least double the civilian rate—haven’t been stemmed by all the VA’s suicide-prevention efforts (including the slowly improving crisis line, 1-800-723-8255). For Arizona veterans between 18 and 34, the suicide rate was an astonishing 76.8 per 100,000, twice as high as the national rate for all veterans. The average suicide rates were especially high in some rural areas across the country, the new VA report said.

   Even if the VA has done relatively little to reform prescribing, it’s becoming more evident that medications play some role in all these tragedies. For instance, a 2016 study by researchers at the South Texas Veterans Healthcare System found a nearly 400 percent increase in overdoses and suicidal behavior by Iraq and Afghanistan war veterans given too many psychotropic and opiate medications, a practice known as “polypharmacy”—receiving five or more drugs affecting the central nervous system. Another recent study of veterans’ suicides between 2004 and 2009 found that the suicide rate was twice as high for those patients receiving the highest doses of opioids compared to low doses, although no causal link was established for the meds.

   This drug free-for-all has gotten so bad that Republican Senator John McCain of Arizona reintroduced a bill called the Veterans Overmedication Prevention Act. It demands that the VA commission an independent study to analyze all the suicides and accidental overdoses of veterans who have died in the last five years, and itemize all medications they received. McCain said in May that the ultimate goal is to "ensure doctors develop safe and effective treatment plans for their veteran patients." Given the reality of today’s VA and its past failures, that worthy goal seems unlikely to be achieved anytime soon.

   The VA hasn’t fully acknowledged its role in the alarming opiate addiction rates among veterans. A 2012 JAMA (formerly the Journal of the American Medical Association) study showed that veterans with mental health disorders and PTSD were three times more likely to receive opioids for pain diagnoses than other veterans. “They are essentially prescribing heroin pills; the effects of these opiates are indistinguishable from heroin, and the VA jumped on this campaign to encourage highly addictive prescribing,” says Dr. Andrew Kolodny, co-director of Brandeis University’s Opioid Policy Research Collaborative. In Huntington, West Virginia, a city so gripped by addiction that 28 people overdosed from heroin in a four-hour period last year, the local VA prescribes take-home opiates to roughly 18 percent of its patients—a rate that’s about 230 percent higher than the national average for all adult male patients. When told about this figure, Kolodny said, after a shocked pause, “Wow! That’s very problematic.” He then added, “These are iatrogenic—medically caused—addictions by the VA. The chickens are coming home to roost.”

   n West Virginia and most other states, the VA worsened the nation’s opioid crisis by essentially ignoring it—the VA didn’t even start reporting all patients getting opiates to state databases until the end of 2015, a delay that allowed those patients to do more doctor-shopping and drug-dealing to and with civilians. VA pharmacies were finally compelled to share prescribing records by a federal opioid abuse law passed in July 2016, but by the end of last year, 18 state VA programs still weren’t reporting.

   In May 2016, the board chairman of the American Academy of Family Physicians wrote a letter to Shulkin, then head of the VA’s health agency, the Veterans Health Administration, pleading for the department to impose mandatory opiate reporting on all VA programs. Speaking more than a year later, the AAFP’s president, Dr. John Meigs, tells Newsweek his organization has still not heard back from Shulkin or anyone else at the VA. “Prescription drug–monitoring programs are among the important vehicles for preventing patients from abusing opioid medications and, as such, are a cornerstone of the American Academy of Family Physicians' advocacy on dealing with this epidemic,” he declares.

   The disaster is likely to worsen under the Trump administration because of its assaults on Medicaid and Obamacare; this affects veterans as well, since fewer than half of the nation’s 22 million veterans receive their care from the VA. (In late August, the administration left no doubt it wanted to destroy the Obamacare marketplaces by announcing it would cut by 90 percent the advertising needed to promote enrollment and slash funds by 40 percent for helpful “navigators” to help people sign up for the program.) Nearly as troubling, the looming denial of care is aggravated by the suicides, overdoses and illegal use of opioids that are all compounded by draconian new federal pain medication restrictions on chronic pain patients. So when New Jersey Governor Chris Christie’s federal opioid commission released its initial report at the end of July calling for swift federal action, his home state newspaper, the Newark Star-Ledger, pointed to the "elephant in the room.… The obvious fact that Donald Trump’s team is striving as hard as it can to gut Medicaid and make it even more difficult to get treatment.” (Trump referred to the opioid crisis as a “national emergency” on August 10, but the federal government hasn’t yet taken the steps needed to invoke emergency powers that could allow for more spending or loosen bureaucratic restrictions on providing medication-assisted addiction treatment, such as Suboxone, which cuts overdose fatalities.)‘What if He Were Your Son?’

   In 2013, after the Center for Investigative Reporting (CIR) exposed skyrocketing rates of opiate prescribing by the VA, some of its physicians told a House veterans subcommittee they were pressured to prescribe the addictive painkillers—even to patients they hadn't examined. Dr. Pamela Gray, a primary care physician fired from the Hampton, Virginia, VA hospital, said, "There are multiple instances when I have been coerced or even ordered to write for Schedule 2 narcotics when it was against my medical judgment." VA officials deny there were any systemic problems in their prescribing practices, yet in May 2014, the VA inspector general found that clinicians were ignoring guidelines for safe take-home opiate prescribing, with one out of 10 chronic pain opioid users also receiving benzodiazepines in the course of a year—and 92 percent got them at the same time. This is a flagrantly dangerousmixture that the federal government flagged as a lethal combination—while the FDA has recently added new warnings that it could cause "respiratory depression, coma and death."

   And that’s what happened to Marine Corps veteran Jason Simcakoski, who was taking 16 different VA-prescribed opiates, benzodiazepines, an antipsychotic and other sedating drugs before he died. By the time he checked himself into the Tomah, Wisconsin, VA's inpatient psychiatric unit in the summer of 2014 for help with anxiety and a pill addiction, VA leadership had known for years that there were deadly overprescribing problems there. But they didn't begin to address the crisis until the CIR broke this story in January 2015: "Opiates handed out like candy to ‘doped-up’ veterans at Wisconsin VA," leading to the deaths of over 30 veterans. The story laid out how opiate prescribing had quintupled since Dr. Michael Houlihan—nicknamed by vets “the Candy Man”—became chief of staff in 2005, while the number of patients served dropped. Nationwide, opiate prescribing increased 270 percent across the VA system since 9/11, CIR discovered, while the patient load had increased less than 40 percent by 2013. The latest guidelines at the time for sensible opiate prescribing were routinely ignored at Tomah and many other VA facilities, and Houlihan's reckless prescribing was exacerbated by his penchant for terrorizing any clinician and staffer who opposed him. This was especially notable in his firing of a psychologist who had objected to the excessive doping of patients, then faced relentless harassment from his supervisor—and later killed himself after he lost his job.

   Noelle Johnson, a Veterans Affairs pharmacist fired from Tomah after she refused to fill high-dosage opiate prescriptions, notes that the VA's archaic software didn't flag any dosage or interaction warnings for the 1,080 morphine pills in 30 days she was pressured to prescribe a patient with "psychological pain." She says, “My bosses tried to strong-arm pharmacists.” She adds that she got the same kind of pressure at her new post with the Des Moines, Iowa, VA.

   Although it was obvious that Jason Simcakoski was an addict, the VA kept shipping him bagfuls of opiates and benzos and antipsychotics, and he was also dosed with the stimulants Adderall and Ritalin, which worsened his mood, behavior and insomnia. His doctors prescribed those for a questionable diagnosis of attention deficit hyperactivity disorder, just one of at least a dozen or so diagnoses slapped on him over the years, along with bipolar personality disorder and PTSD.

   “With all these medications, he went downhill real fast,” says Jason’s father, Marvin Simcakoski. His weight ballooned from 180 to 250 pounds, and he was too ashamed to go into a restaurant on those rare days he went into town—he’d only order food from drive-thru windows. Near the end, he couldn’t even bend down to tie his shoes.

   When Jason died in August 2014 of what the local medical examiner called “mixed drug toxicity,” he had just been obeying his doctors’ orders: He was already taking 14 different medications, including high-risk opiates, benzodiazepine tranquilizers and the sedating antipsychotic Seroquel. Yet just two days before his death, Jason was also given Suboxone, an opiate typically used to reduce dependence on other narcotics. This was soon followed by a powerful migraine medication, Fioricet, that posed a risk of respiratory failure or death when combined with Suboxone and several of his other drugs. He was ingesting this drug cornucopia despite the well-known dangers of potentially fatal interactions between Suboxone and all three benzodiazepines he was taking—Valium, Restoril and Serax—and with some of his other high-risk medications.

   Marvin Simcakoski told a joint congressional field hearing on the Tomah scandal in March 2015 that he’d spent years trying to save his son, but says his fears were dismissed by VA doctors as ignorant second-guessing. “I was always told that I wasn’t their patient, even though I was his dad, who truly cared about him a lot more than they did!” His voice quaking with an anger, he added, “What I would like to know is, if Jason was their son, would they have had him on all of these meds?”

   After that congressional hearing, the VA announced it was conducting a criminal investigation; that probe and other investigations led to a few Tomah medical officials getting vilified in the press, and eventually facing employment sanctions. Houlihan was fired more than a year after Jason died, but he was practicing medicine until January 2017, when he agreed to surrender his license as part of a deal with state regulators to drop their investigation of him.

   Jason’s father and widow took their campaign against the VA’s medication practices to D.C. They worked with Democratic Senator Tammy Baldwin of Wisconsin on legislation to curb and monitor opiate overprescribing, and appeared at a news conference in June 2015. The Jason Simcakoski Memorial Opioid Safety Act was signed into law in July 2016.

   Heather hopes the bill will save lives, but she and other VA critics know there are critical weaknesses in the new plan to rein in overmedication: weak oversight of staff, worsened by the VA’s electronic records and drug-interaction alerts that too often fail to work, and on-screen drug warnings that are widely ignored. In 2015, the VA paid over $1 million to the widow of former paratrooper Ricky Green, who died after getting his opiates and tranquilizer dosages cranked way up after back surgery. The VA pharmacists admitted under oath that their software hadn’t flagged either the higher dosages or that Green had a sleep apnea condition that fatally interacts with those drugs.

   The VA’s entire make-shift health software system—known as VistA—is so bad Shulkin announced in June that the VA was purchasing a brand-new commercial system at an estimated cost of $16 billion; it’s based on one recently bought by the Defense Department so that, in part, as their electronic health records are rolled outthey could be shared seamlessly, but that won’t necessarily fix the problems with the VA’s pharmacy software. Even more troubling, Chris Miller, the department’s executive in charge of modernizing the Pentagon’s software using the same contractor as the one hired by the VA was then sent over to advise the VA, but he fled, appalled over mismanagement, within weeks of his appointment in early June. “The people problems are not resolved and the user problems are not resolved just because you have a new tool coming on board,” a VA official says. “The people problems are at the core of the demise of the VA.”

   That’s one reason no one knows how many vets have been killed by accidental prescription overdoses in the past decade, although a handful of rigorous studies suggest the death toll is in the thousands. One of the very few scholarly reports on accidental overdose deaths of veterans, done by University of Michigan and VA researcher Amy Bohnert in 2011, used 2005 data to conclude that 1,013 patients receiving VA services died annually through unintentional overdoses, mostly from prescription medications. At that time, legal opioids, present in nearly a third of the accidental overdose deaths, were the most common substances involved, while non-narcotic psychiatric drugs and sedatives were involved in 22 percent of the deaths she studied. (Across all civilian and military populations, legitimately manufactured opioid medications account now for only 15 percent of opioid fatalities.) When the Austin-American Statesman looked at Texas records in 2012, nearly 20 percent of all deaths of veterans getting VA benefits they studied were due to mostly accidental overdoses of prescription drugs—not from suicides.

   Despite the Tomah and other tragedies, veterans continued to die from overdoses in VA hospitals and residential treatment facilities, sometimes abetted by drug-peddling employees—while the agency failed to accurately track the drug-related deaths of veterans. The Lowell Sun reported last year that two veterans grappling with addictions who lived in VA residential facilities in Massachusetts died of opiate overdoses within weeks of each other. Their deaths are now the focus of a VA criminal investigation into drug dealing by a ring of employees and patients at the hospital. Administrators initially denied anything was amiss, and the African-American whistleblower who helped expose the alleged drug ring revealed in February that he had been demoted, and harassed by colleagues—including finding on his desk a teddy bear with a noose around its neck and the sign, "Go home or die.”Lethal Cutbacks

   Following the Tomah overprescribing scandal, the VA said it would follow tougher new DEA guidelines on opiate prescribing that, some advocates say, harm patients with legitimate pain issues. That’s in part because those patients are now required to see their doctors in person once a month for refills—a near-impossible task because of the backlog and delays throughout the VA system. Equally troubling, the crackdown on opiate prescribing—a swing from one dangerous extreme to another—may be contributing to an increase in heroin and illegal opiate medication use among veterans, as well as suicides from pain-wracked veterans going through poorly monitored withdrawal. (Even with new opioid guidelines, the number of veterans with opioid-use disorders increased 55 percent from 2010 to 2015.)

   Although the VA boasts that those tougher guidelines have led to a decline of nearly a third in opiate prescribing, it doesn't track veterans who have turned to heroin and illegal prescriptions as a result of the cutbacks—or notice the devastation this crackdown is causing. It has become increasingly clear that too many VA doctors are focusing on taking patients off opioids without offering appropriate addiction counseling or addressing how they’re needlessly hurting all the chronic pain patients they’re taking off these meds. “They’re not focusing on patient-centered care; they’re focusing on numbers,” one VA staffer says. At one point, this employee says, a doctor in a major VA medical center was spotted crying in the hallway because he was obligated by administrative fiat to kick a chronic pain patient off opioids in a way that he knew would hurt his patient.

   Even when patients realize they’re endangering themselves, the VA’s clinicians too often don’t offer much meaningful help. Take Mallory Dinkel, an Air Force infantry soldier who had her leg and hips severely damaged in an attack on her Humvee in Kuwait in 2004, but returned for multiple combat tours in Iraq before being medically discharged in 2013. Grappling with PTSD and a poorly understood form of chronic pain, complex regional pain syndrome, she stepped up her rotating use of prescription morphine, Percocet and other drugs until she was forced in January 2016 to quickly unwind all opioids. “It was awful: I was constantly vomiting, sweating, having migraines and getting the shakes,” she says, unable to move from her couch for two weeks except to crawl to the bathroom. “Nothing was mentioned about addiction, and I didn’t get treatment.” All she got before going cold turkey on her own—despite the risks of sudden withdrawal without medically supervised tapering—were two one-hour classes on the dangers of opiates and how to inject herself with naloxone to prevent overdoses. “The VA didn’t do a thing,” she says, turning to costly, unproven ketamine infusion treatment for depression and pain relief through a family friend’s center that she can no longer afford. “I’m battling on my own now.”Can’t Stop, Won’t Stop

   The callous indifference of both the VA and Congress to the overmedication crisis has only recently started to change, and that’s just for opiates, not antipsychotics. What has gotten worse in the last decade is the VA’s determination to hide the truth. The Senate governmental affairs committee’s Republican majority, for instance, concluded in May 2016 about the Tomah VA Medical Center debacle: “The overprescription, retaliation, veterans’ deaths, and abuse of authority at the Tomah VAMC did not occur in a vacuum. Veterans, employees, and whistleblowers tried for years to get someone to address the problems. The Tomah VAMC is a microcosm of both the VA’s cultural problems with respect to whistleblower retaliation and the VA Office of Inspector General’s disregard for whistleblowers."

   These whistleblowers are notably skeptical about the various reform and accountability gestures such as public waiting lists offered by Shulkin. Take Shea Wilkes, then a mental health administrator at the Shreveport, Louisiana, VA hospital who was busted back down to social worker after, in 2014, he exposed 37 wait-time deaths among those people on a secret mental health waiting list of 2,700 patients. While noting that the VA has now seemingly been able to provide some same-day crisis mental health services, as promised, he says that all too often patients can’t get prompt, regular counseling: “The one thing the VA is very good at is throwing pills at the problem.”

   In VA hospitals all over the country, dissidents such as Brandon Coleman are still punished for trying to save lives or fight fraud. He is a bearded, blunt-talking addiction therapist formerly with the Phoenix VA and a disabled Marine Corps veteran who severely shattered the bones of his left foot during a training accident at Camp Pendleton that led to nine failed surgeries, and he felt he had to file a formal federal whistleblower complaint in December 2014 over the maltreatment of veterans at that notorious VA hospital. With his past as a meth addict who came close to shooting himself in 2005, he was alarmed that the understaffed ER was allowing suicidal or homicidal patients in crisis—often brought over by addiction counselors—to simply wander off. One patient killed himself in the parking lot after being ignored by the staff.

   “It crushes me when a veteran successfully commits suicide,” he says—and since 2011, at least six of the addicts he counseled killed themselves before he was pushed out of his job early in 2015. “There are dozens and dozens who commit suicide in the Phoenix area each year,” Coleman says. After going public with his concerns in January 2015, a specialized yearlong outpatient program he ran in the evenings for addicted veterans with criminal convictions was shut down by Phoenix VA administrators, he was forced to take administrative leave, and he was investigated for purportedly threatening a colleague.

   In May 2016, the independent OSC sided with Coleman. It gave him a generous financial settlement that allowed him to pay off all his debts and help his kids buy a home and cars. He was reinstated as an addiction specialist at an outpatient clinic unaffiliated with the Phoenix system, and he was able to restart his life-changing program for addicted vets. During more than a year of forced leave, he became an informal leader of the nation’s countless VA whistleblowers. He sums up his travails this way: “I kicked the VA in the nuts, and I won my case.” Today, he rides around in a prized new classic car, a blue 1968 Mustang, with a license plate that reads, “THX VA.”

   Coleman may now be in a position to stop the abuse of whistleblowers—he’s a staff member of the new VA whistleblower protection office. While his appointment is perhaps the most positive indicator yet that the VA might try to reform, that’s a heavy burden to place on his broad shoulders. He’s gotten well over 50 calls and emails from desperate staffers turning to him for help since his appointment was announced.

   For example, one new test case Coleman and his colleagues are reviewing involves an MIT-trained Tomah VA engineer, Jae Pak, who was fired after trying to halt an allegedly shoddy, unsafe series of delayed hospital repair projects—by a company friendly with administrators—that were way over budget. He faced a spurious disorderly conduct charge (the case was dismissed). Equally troubling, critics say, he was forced out under the watch of a new Tomah hospital director, Victoria Brahm, and a new regional VA chief, Renee Oshinski, who both, while at regional headquarters, allegedly downplayed for nearly a decade the deadly prescribing and retaliation campaign led by Houlihan, Senate investigators found; the officials claimed they responded appropriately.

   One added weapon for reform could be a new bill moving slowly through Congressdesigned to quickly discipline or remove administrators who harass whistleblowers. It is named after Christopher Kirkpatrick, the psychologist who killed himself after being driven out of his job at Tomah for protesting deadly prescribing.

   For now, patients at VA sites such as the Phoenix and St. Louis hospitals (where the chief of psychiatry, Dr. Jose Mathews, was forced out in 2013 after reporting that suicidal patients were ignored by staff) continue to see honest, dedicated clinicians and other employees get punished.

   What Coleman will do about such alleged retaliation and cover-ups remains to be seen. With a quick search on Google News, it seems there’s a new retaliation or health scandal reported every few days, although most never get much media attention. So even before Coleman’s appointment was publicly announced, he told Newsweek: “I still get two to four calls a week from VA whistleblowers I have never met who are crying, scared and losing their careers all for merely telling the truth. It has not stopped because the VA has never been made to stop.”

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7. Melania Trump Says She Aims to ‘Give a Voice’ to the Victims of Opioids

   Oct 10, 2017 | New York Times

   By Katie Rogers

   Melania Trump, a once-reluctant first lady who has lately been ramping up her travels as well as directing her aides to lash out at rivals, allowed the public a glimpse at her nascent platform on Tuesday at a clinic that treats infants born with addiction.

   Mrs. Trump flew about 400 miles to this western edge of the state. Her visit is a signal that her interests — so far stated broadly as helping children and combating cyberbullying — have narrowed, at least for now, to focus on learning more about the opioid epidemic.

   More than two million Americans are estimated to have problems with opioids, and Appalachia has some of the highest overdose rates in the country.

   “Please tell me how I can help,” Mrs. Trump told staff members and former clients of Lily’s Place, which was established in 2014 and has so far treated around 190 babies suffering from neonatal abstinence syndrome. “That’s why I’m here. I want to listen to your stories; I want to hear what I can do to help.”

   The short answer, according Rebecca Crowder, the clinic’s executive director: money.

   “We still battle with funding, obviously,” Ms. Crowder told the first lady. “We haven’t gotten to that point where they recognize us through Medicaid.”

   The brief exchange raises questions about how Mrs. Trump could help address the issue. The latest Republican-driven effort to repeal the Affordable Care Act would have dismantled the Medicaid expansion and capped open-ended funding of the program, an entitlement that covers one in five Americans.

   In an eight-minute appearance in front of reporters, Mrs. Trump said her goal for the visit, which lasted about an hour, was to help “give a voice” to families facing addiction.

   “We need to open the conversation and teach children and young mothers that it’s dangerous to use drugs,” Mrs. Trump said.

   Accompanying the first lady to Lily’s Place was Kellyanne Conway, counselor to the president, and Dr. Elinore F. McCance-Katz, the assistant secretary of health and human services for mental health and substance use.

   Mrs. Trump’s visit could be seen as a boost to Representative Evan Jenkins, a Republican who helped found the clinic and who is challenging Senator Joe Manchin III, a former governor of the state, for his seat in 2018.

   Mr. Jenkins, who greeted the first lady after she landed in West Virginia, said in an interview that he had met several times with White House aides to talk about Lily’s Place, and that he personally discussed the clinic with Mr. Trump aboard Air Force One.

   Having the first lady’s attention, Mr. Jenkins said, was “particularly impactful” to his cause. In May, Mr. Jenkins wrote and introduced the Caring Recovery for Infants and Babies Act that would allow families needing treatment at a clinic like Lily’s Place to be covered through Medicaid.

   “Having her voice behind it will be very, very important,” he said.

   Stephanie Grisham, the first lady’s communications director, said that Mrs. Trump had chosen Lily’s Place because it was brought up often in the “many conversations she’s had on the topic.”

   Others who are hoping for the White House to push for more resources and policy changes watched Mrs. Trump’s visit with interest. Jessica Hulsey Nickel, the president and chief executive of the Addiction Policy Forum, a group of organizations working to elevate awareness of the opioid crisis, said that a visit from the first lady — even a brief one — could help her cause.

   “The more awareness and the brighter spotlight that we shine on this issue,” she said, “the more likely we are to get the resources and new strategies that we need.”

   The Centers for Disease Control and Prevention found in a report released last year that the incidence of neonatal abstinence syndrome climbed to six per 1,000 hospital births in 2013, up from 1.5 per 1,000 in 1999. In 2012, one infant with the illness was born every 25 minutes.

   Mrs. Trump has not unveiled concrete plans to move forward with her platform, and many observers are still trying to read the tea leaves regarding her comfort with White House life.

   She is, apparently, at least comfortable with her title. On Monday, Mrs. Trump found herself in a tangle with her husband’s first wife, Ivana Trump, who jokingly referred to herself as “first lady” while promoting her new memoir.

   “Mrs. Trump has made the White House a home for Barron and the President. She loves living in Washington, D.C., and is honored by her role as first lady of the United States,” Ms. Grisham said in an email on Monday. “She plans to use her title and role to help children, not sell books.”

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8. Tighter oversight of opioid prescriptions by Medicare could help stem epidemic

   Oct 10, 2017 | HealthDay News

   Medicare places few limits on opioid painkiller prescriptions, even in the face of recent U.S. government guidelines, researchers report.

   Yale University scientists say Medicare plans for people 65 and older are untapped resources for curbing the unnecessary use and abuse of drugs such as oxycodone, or OxyContin, and hydrocodone, or Vicodin.

   "People are looking for any way to control the increase in opioid-use disorder. This is one strategy," said study first author Dr. Elizabeth Samuels. She's a postdoctoral fellow in Yale's National Clinical Scholars Program.

   A previous study involving private insurers showed that certain practices can help curb use of addictive painkillers, the researchers said. Such measures include requiring prior authorization from insurers and setting quantity limits.

   For this study, Samuels and her colleagues analyzed the "formulary files" -- lists of allowable medicines -- of the Centers for Medicare and Medicaid Services in 2006, 2011 and 2015. They zeroed in on Medicare coverage for all opioids except methadone.

   In 2006, two-thirds of opioids were prescribed with no restrictions. That dropped to one-third by 2015, but too many of these drugs were still prescribed without limitations, the researchers found.

   The risk for overdose increases with high doses of the powerful painkillers. Also, it's widely believed that many Americans who became addicted to painkillers and heroin were initially prescribed opioids for pain relief, the researchers said.

   In 2016 the U.S. Centers for Disease Control and Prevention released new guidelines for prescribing opioids. Doctors were urged to prescribe addictive painkillers at the lowest dose possible and preferably just for short-term pain relief, among other recommendations.

   But Medicare is often the standard for other insurers, the study authors noted.

   Despite some improvements in prescribing practices, the researchers said restrictions like those supported by the CDC accounted for just 13 percent of Medicare-covered prescriptions in 2015.

   Meanwhile, Medicare coverage of opioids increased slightly between 2006 and 2015. "An increasing number of opiates were added to the formulary list," Samuels said in a university news release.

   The study was published Oct. 9 in the Annals of Internal Medicine.

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