Tagged Pharmaceuticals

Some N.H. Communities To Follow Lead Of State A.G. And Take Legal Action Against Opioid Company

In related news, the nation’s largest pharmacy benefit manager is taking the controversial step of limiting the number and strength of first-time prescriptions for opioids. And let’s not forget about drugged drivers’ risk of overdose and new statistics that indicate the nation is drinking more.

New Hampshire Public Radio: Manchester Likely To File Its Own Lawsuit Against Opioid Companies
Last week, the New Hampshire Attorney General’s Office took its first steps to sue an opioid company — Purdue Pharma — over its alleged role in the state’s addiction crisis. Now, some local communities may soon follow with lawsuits of their own. Back in May, Manchester officials signed a contract with a New York-based law firm — Napoli Shkolnik — to explore the possibility of legal action against drug manufacturers. (McDermott, 8/16)

The Associated Press: Express Scripts To Limit Opioids; Doctors Concerned
The nation’s largest pharmacy benefit manager will soon limit the number and strength of opioid drugs prescribed to first-time users as part of a wide-ranging effort to curb an epidemic affecting millions of Americans. But the new program from Express Scripts is drawing criticism from the American Medical Association, the largest association of physicians and medical students in the U.S., which believes treatment plans should be left to doctors and their patients. (Salter, 8/17)

The Associated Press: Overdoses On The Road: Drugged Driving Rises As A Menace
Car crashes caused by overdosing drivers are becoming so commonplace, authorities say, that some rescue crews immediately administer the antidote, naloxone, to any unresponsive driver they find at an accident scene. People who use heroin and related drugs are sometimes so eager to get high, or so sick from withdrawal, that they’ll shoot up in the car as soon as they get their hands on more, police say. Often they’re back on the road before the overdose takes hold, and they lose consciousness, a recipe for traffic accidents. (Stacy and Welsh-Huggins, 8/17)

NPR: With Heavy Drinking On The Rise, How Much Is Too Much?
If one glass of wine takes the edge off, why not drink a few more? This thinking may help explain the findings of a new study that points to an increase in drinking among adults in the U.S., especially women. “We found that both alcohol use and high-risk drinking, which is sometimes called binge-drinking, increased over time,” says Deborah Hasin, a professor of epidemiology at the Columbia University Medical Center and an author of the study. (Aubrey, 8/16)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Perspectives: Drug Companies Getting Stingy With Subsidies; Supreme Court Deals Blow To Consumers

Read recent commentaries about drug-cost issues.

Los Angeles Times: Drug Companies Are Growing Less Generous In Helping Patients Pay For Meds
Industry watchers say soaring drug prices have prompted many pharmaceutical companies to rethink long-standing programs to help subsidize purchases or even give meds away for free. “More and more people have become aware of these programs, and demand has gone up,” said David P. Wilson, president of PRAM Insurance Services, a Brea firm that helps employers with prescription-drug benefits. (David Lazarus, 8/15)

Stat: A Supreme Court Pharma Case Deals Consumers A Big Loss
The U.S. Supreme Court case of Bristol-Myers Squibb Co. vs. Superior Court of California, which was decided in favor of BMS in June, may seem like an arcane question of legal jurisdiction. It’s anything but.The case centered on a drug called Plavix that BMS developed. Plavix, also known by its generic name, clopidogrel, is an anti-platelet used to prevent blood from clotting inside blood vessels. Ever since the drug was approved by the FDA in 1997, thousands of people have claimed that it caused them gastrointestinal bleeding, severe bleeding from relatively minor cuts, and even brain damage. (Michael Burg, 8/14)

Stat: Eli Lilly’s Odyssey To Use A Fake Rule And Fake News To Protect Bad Patents
The story begins in 1991, when Eli Lilly applied for a Canadian patent for its antipsychotic drug, Zyprexa. Five years later, it applied for a Canadian patent for its attention deficit hyperactivity disorder drug, Strattera. In both cases, the company copied its U.S. patent applications without making changes to address the specificities of Canadian patent law, presumably as a cost-saving measure. (E. Richard Gold, 8/16)

JAMA: Value-Based Pricing And State Reform Of Prescription Drug Costs
Faced with increasing prescription drug costs and congressional gridlock, some states have enacted meaningful reforms. In April 2017, New York State became the first public payer in the United States to authorize limits on prescription drug costs based on their therapeutic benefits. Under its new budget legislation, the state can identify high-cost drugs, determine a value-based price, and use enhanced powers to negotiate supplemental rebates to achieve this target price for its Medicaid program. (Thomas J. Hwang, Aaron S. Kesselheim and Ameet Sarpatwari, 8/15)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Drugmakers ‘Game The System And Game The Rules,’ FDA Head Gottlieb Says

News outlets report on stories related to pharmaceutical pricing.

USA Today: FDA Chief Says Drug Makers Are Gaming The System To Slow Generic Competition; Vows Action
A day after President Trump lashed out at the black CEO of drug maker Merck on Twitter, his new Food and Drug Administration commissioner said brand name drug companies are “gaming the system” to block generic competition and vowed to do something about it. Physician and FDA chief Scott Gottlieb declined to comment on Trump’s tweet urging Merck’s Kenneth Frazier to lower drug prices after Trump’s response to the violent Charlottesville, Va., protests prompted Frazier to resign from the White House manufacturing council. However, in a meeting Tuesday with USA TODAY’s Editorial Board, Gottlieb didn’t mince words when it came to his plans to stop what he said are anti-competitive actions by brand-name pharmaceutical companies that keep prices high. (O’Donnell, 8/15)

Politico: Trump Tweets Up A Storm On Drug Prices But Delivers Little Change
Back in January, Trump had signaled his intention to go after powerful drugmakers at his very first news conference, accusing the industry of “getting away with murder.” The issue is top of mind for voters — a bigger health priority than repealing Obamacare. But the White House has invested little political capital in the issue, appointing industry insiders to key posts while abandoning key campaign pledges to allow Medicare to negotiate drug prices and import cheaper medicines from overseas. (Karlin-Smith, 8/15)

Stat: Who Gets All That Biopharma Lobbying Money?
As the winds shift in Washington, here’s something to depend on: Big pharma and health products companies will be the top spenders on lobbying, and the competition isn’t close. Since 1998, they have doled out $3.7 billion to convince, cajole, entice, or strong-arm Congress and federal agencies — more than $1 billion more than any other industry. That doesn’t count campaign contributions, donations to independent pressure groups, and outlays for politicking at the state level. Since January 2016, the industry has spent about $144 million on federal lobbying, according to data compiled by the Center for Responsive Politics. It can claim a big victory from last year’s passage of the 21st Century Cures Act, which is expected to speed up Food and Drug Administration drug approvals. (Piller, 8/16)

ProPublica and The New York Times: Generic Drug Prices Are Declining, But Many Consumers Aren’t Benefiting
Not all drug prices are going up. Amid the public fury over the escalating costs of brand-name medications, the prices of generic drugs have been falling, raising fears about the profitability of major generic manufacturers. Last week, Teva Pharmaceuticals reported that it had missed analysts’ earnings estimates in the second quarter and planned to lay off 7,000 workers. Its share price plummeted 24 percent in one day as investors worried there was no end in sight. (Ornstein and Thomas, 8/8)

Bloomberg: What’s Harder Than Making Copycat Biotech Drugs? Selling Them 
Big-name drugmakers want to profit from selling lower-priced copies of rivals’ expensive biotechnology drugs. Patients and doctors want to pay less for medicine. Getting those two sides together is harder than it looks. Part of the problem: a web of relationships between drug companies and insurers that shields incumbent drugs and often sidelines upstarts until the market becomes crowded. (Hopkins, 8/15)

Stat: High Drug Prices Loom Large At Gathering Of State Legislators
A representative of the Trump administration on Tuesday made a familiar promise to a crowd of state legislators here: We know high drug prices are a problem. And we’re working to solve it. Lowering drug costs is a “priority,” and the Department of Health and Human Services is “committed to doing all we can to increase affordability and accessibility,” said Jane Norton, HHS’s point person in dealing with state governments. (Robbins, 8/8)

Kaiser Health News: Climbing Cost Of Decades-Old Drugs Threatens To Break Medicaid Bank
Skyrocketing price tags for new drugs to treat rare diseases have stoked outrage nationwide. But hundreds of old, commonly used drugs cost the Medicaid program billions of extra dollars in 2016 vs. 2015, a Kaiser Health News data analysis shows. … Rising costs for 313 brand-name drugs lifted Medicaid’s spending by as much as $3.2 billion in 2016, the analysis shows. Nine of these brand-name drugs have been on the market since before 1970. In addition, the data reveal that Medicaid outlays for 67 generics and other non-branded drugs cost taxpayers an extra $258 million last year. (Lupkin, 8/14)

Stat: The FDA Made A ‘Grand Bargain’ On Fast Drug Approvals, But Pharma Isn’t Holding Up Its End
The FDA, in an effort to bring promising new therapies to patients as quickly as possible, has introduced a spate of shortcuts to speed up the approval process. Those programs are working as intended, new research finds, but drug companies are often loath to fulfill their obligations. The big idea behind the FDA’s accelerated drug approval program is that regulators will OK a promising drug based on clues that it will improve patient lives, so long as pharma companies later carry out larger trials to confirm those hints of efficacy. But looking at four years of data, a team of researchers found that only 50 percent of those trials actually took place within three years of approval. (Damian Garde, 8/15)

Cleveland Plain Dealer: Poll: Most Ohioans Unclear About Prescription Drug Issue 2
The forces for and against Issue 2 are spending so much money that they could set new records in Ohio in election spending. But six out of 10 registered Ohio voters told Survey USA they don’t know much, if anything about Issue 2, according to WOIO Cleveland 19 News, which commissioned the poll with WXIX 19 Cincinnati and WTOL 11 Toledo. (Hancock, 8/8)

The Wall Street Journal: England’s NHS Turns To Clinical Trial To Make Cheaper HIV Drug Available
A branded HIV drug that has been shown to reduce the risk of infection with the virus by 86% is proving too expensive for some at-risk European patients. England’s National Health Service thinks it has a solution. The high price of Gilead Sciences Inc .’s HIV drug Truvada has deterred many countries from providing the pill as a preventive treatment for people at high risk of contracting the AIDS-causing virus, doctors, activists and patients say. (Mancini, 8/11)

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First Edition: August 16, 2017

Aug 16 2017

Today’s early morning highlights from the major news organizations.

Kaiser Health News: CBO: Killing Cost-Sharing Subsidies Would Hike Silver Plan Premiums And Deficit
KHN reporter Phil Galewitz writes: “If President Donald Trump were to follow through on his threats to cut federal cost-sharing subsidies, health insurance premiums for silver plans would soar by an average of 20 percent next year and the federal deficit would rise by $194 billion over the next decade, the nonpartisan Congressional Budget Office said Tuesday. The change would not be expected to have much long-term effect on the number of uninsured people, according to the analysis. But it could cause a shift in which plans are popular with marketplace customers as insurers realign some of their prices to defray the loss of the federal payments, the CBO said. Surprisingly, some customers might find better deals by looking at higher-end products.” (8/15)

Kaiser Health News: Doctors Warm To Single-Payer Health Care | Kaiser Health News
KHN reporter Rachel Bluth writes: “Single-payer health care is still a controversial idea in the U.S., but a majority of physicians are moving to support it, a new survey finds. Fifty-six percent of doctors registered either strong support or were somewhat supportive of a single-payer health system, according to the survey by Merritt Hawkins, a physician recruitment firm. In its 2008 survey, opinions ran the opposite way — 58 percent opposed single-payer. What’s changed?” (8/16)

The Associated Press: Report: Higher Premiums If Trump Halts ‘Obamacare’ Subsidies
Premiums for a popular type of individual health care plan would rise sharply, and more people would be left with no insurance options if President Donald Trump makes good on his threat to stop “Obamacare” payments to insurers, the Congressional Budget Office says. The nonpartisan number crunchers also estimated that cutting off payments that now reduce copays and deductibles for people of modest incomes would add $194 billion to federal deficits over a decade. That head-scratching outcome is because a different Affordable Care Act subsidy would automatically increase as premiums jump, more than wiping out any savings. (Alonso-Zaldivar, 8/15)

NPR: CBO Analysis Finds That Ending Reimbursements To Insurers Will Raise The Deficit
If President Trump decides to cut off payments to insurance companies called for under the Affordable Care Act, it’s going to cost him. Or, more accurately, it’s going to cost taxpayers — about $194 billion over 10 years. The cost is “eye-poppingly large,” says Nicholas Bagley, a professor of health law at the University of Michigan. “This single policy could effectively end up costing 20 percent of the entire bill of the ACA.” (Kodjak, 8/15)

The New York Times: Trump Threat To Obamacare Would Send Premiums And Deficits Higher
Even before efforts to repeal the Affordable Care Act collapsed in the Senate last month, Mr. Trump began threatening to stop paying the subsidies, known as cost-sharing reductions. He said the health care law would “implode” and Democrats would have no choice but to negotiate a replacement plan. Mr. Trump described his strategy as, “Let Obamacare implode, then deal.” Those threats continue, though the Trump administration has paid the subsidies each month. (Pear and Kaplan, 8/15)

The Wall Street Journal: What Are Insurance Subsidies And What Would Happen If They Were Cut?
As health insurers weigh their commitments to the Affordable Care Act’s exchanges for 2018, they point to a key issue that will affect the rates they would charge and indeed whether they will participate: Federal subsidies known as cost-sharing reductions. Those payments are likely to be a major story going forward, and on Tuesday, the Congressional Budget Office estimated that if President Donald Trump carried out his threat to halt the subsidies, it would boost premiums for middle-priced plans by 20% next year. (Wilde Mathews, 8/15)

The Wall Street Journal: Trump Targets McCain Over Health Vote
President Donald Trump continued his attacks against individual Senate Republicans, criticizing Sen. John McCain (R., Ariz.) and his pivotal health-care vote at a news conference Tuesday at Trump Tower in New York City. A week after Mr. Trump knocked Senate Majority Leader Mitch McConnell (R., Ky.) over the Senate’s failure to pass any legislation dismantling and replacing the Affordable Care Act, the president took aim at Mr. McCain, now in his sixth Senate term. (Peterson, 8/15)

The Hill: GOP Senator Meeting With White House On New ObamaCare Plan 
Sen. Bill Cassidy (R-La.) said he’s meeting with the White House and the Trump administration “two or three times per week” on a plan to repeal and replace ObamaCare. Cassidy has teamed up with Sens. Lindsey Graham (R-S.C.) and Dean Heller (R-Nev.) on a new proposal that would essentially block-grant ObamaCare funding to the states while repealing the law’s individual and employer mandates. (Hellmann, 8/15)

The Hill: White House To Pressure McConnell On ObamaCare
White House officials are exploring ways to pressure Senate Majority Leader Mitch McConnell (R-Ky.) to return to the controversial issue of ObamaCare repeal when the Senate returns to work in September. President Trump, who has repeatedly criticized McConnell in public, wants to hold the leader’s feet to the fire on the issue, say White House sources. (Bolton, 8/16)

The Wall Street Journal: Nevada And Centene Reach Agreement On Insurance Markets
Roughly 8,000 consumers in Nevada were at risk of losing access to health plans on the exchange after Anthem Inc. and Prominence Health Plan said in June they would exit markets in 14 counties. Insurers can hold off on final decisions to participate in exchanges until late September, but many have exited markets, citing volatility and prolonged uncertainty about the White House’s support for the markets. (Evans, 8/15)

The New York Times: Obamacare’s Bare County Problem Looks Mostly Solved, For Now
A few months ago, it looked as if large swaths of the country might end up without any insurers willing to sell Obamacare insurance in 2018. But in the last few weeks the “bare county” problem, which President Trump had cited as a sign the markets were failing, has nearly solved itself. On Tuesday, Gov. Brian Sandoval of Nevada announced that Centene would offer insurance in 14 rural counties of Nevada that had been bare. That leaves only two counties in the country without insurers saying they will sell coverage; fewer than 400 Obamacare customers live in those counties. (Sanger-Katz, 8/15)

Stat: CMS Moves To Cancel Medicare Programs Overhauling Some Hospital Payments
The Centers for Medicare and Medicaid Services moved to cancel pilot programs that would have paid certain hospitals a lump sum for all of the care associated with heart attacks, bypass surgeries, and some hip and femur fractures, including the initial visit, the surgery, and follow-up care. It’s canceling a similar program that targeted cardiac rehabilitation, and the agency is also proposing to drastically reduce the number of hospitals that have to participate in a separate program already underway that offers similar lump payments for hip and knee replacements. (Mershon, 8/15)

USA Today: FDA Chief Says Drug Makers Are Gaming The System To Slow Generic Competition; Vows Action
A day after President Trump lashed out at the black CEO of drug maker Merck on Twitter, his new Food and Drug Administration commissioner said brand name drug companies are “gaming the system” to block generic competition and vowed to do something about it. Physician and FDA chief Scott Gottlieb declined to comment on Trump’s tweet urging Merck’s Kenneth Frazier to lower drug prices after Trump’s response to the violent Charlottesville, Va., protests prompted Frazier to resign from the White House manufacturing council. However, in a meeting Tuesday with USA TODAY’s Editorial Board, Gottlieb didn’t mince words when it came to his plans to stop what he said are anti-competitive actions by brand-name pharmaceutical companies that keep prices high. (O’Donnell, 8/15)

Politico: Trump Tweets Up A Storm On Drug Prices But Delivers Little Change
Back in January, Trump had signaled his intention to go after powerful drugmakers at his very first news conference, accusing the industry of “getting away with murder.” The issue is top of mind for voters — a bigger health priority than repealing Obamacare. But the White House has invested little political capital in the issue, appointing industry insiders to key posts while abandoning key campaign pledges to allow Medicare to negotiate drug prices and import cheaper medicines from overseas. (Karlin-Smith, 8/15)

Stat: Congressional Democrats May Form Expert Panel On Trump’s Mental Health
Three congressional Democrats have asked a psychiatrist at Yale School of Medicine to consult with them about forming an expert panel to offer the legislators advice on assessing President Trump’s mental health. Yale’s Dr. Bandy Lee told STAT that over the last few weeks members of Congress or their staff have asked her to discuss how members might convene psychiatrists, psychologists, and other mental health professionals “to review the president’s mental health, and review it on a periodic basis.” The closed meeting is expected to take place in September, she said. (Begley, 8/16)

Houston Chronicle: Doctors Have A Change Of Heart On Single Payer
A majority of doctors questioned nationwide now support a single-payer health care system – an almost exact reversal of their stance nine years ago. Fifty-six percent of the 1,033 physicians who responded to the Aug. 3 Merritt Hawkins survey said they either strongly supported or somewhat supported a single-payer system. (Deam, 8/14)

Politico: Colorado’s Gardner Faces Blowback At Home Over Obamacare Repeal
Sen. Cory Gardner was hammered for supporting Obamacare repeal during a series of raucous town halls on Tuesday, where constituents repeatedly criticized his role in a closed-door partisan process to draft the failed GOP health bill. Gardner, who’s responsible for protecting the GOP majority in the Senate in 2018, faced heated criticism over the repeal effort that collapsed just a few weeks ago, even as congressional leaders try to pivot to tax reform when they return from the lengthy recess next month. (Pradhan, 8/15)

NPR and ProPublica: They Got Hurt At Work — Then They Got Deported
To assess the impact of Florida’s law on undocumented workers, ProPublica and NPR analyzed 14 years of state insurance fraud data and thousands of pages of court records. We found nearly 800 cases statewide in which employees were arrested under the law, including at least 130 injured workers. An additional 125 workers were arrested after a workplace injury prompted the state to check the personnel records of other employees. Insurers have used the law to deny workers benefits after a litany of serious workplace injuries, from falls off roofs to severe electric shocks. A house painter was rejected after she was impaled on a wooden stake. (Grabell and Berkes, 8/16)

The New York Times: A Start-Up Suggests A Fix To The Health Care Morass
If you watched the drama in Washington last month, you may have come away with the impression that the American health care system is a hopeless mess. … So it is surprising that across the continent from Washington, investors and technology entrepreneurs in Silicon Valley see the American health care system as the next great market for reform. (Manjoo, 8/16)

The Washington Post: Oregon Approves Sweeping Bill Expanding Abortion Access
Called the Reproductive Health Equity Act, the measure requires health insurers to provide birth control and abortion without charging a co-pay. It also dedicates state funds to provide reproductive health care to noncitizens excluded from Medicaid. Antiabortion groups swiftly condemned the new law, saying it will force taxpayers to foot the bill for a procedure many consider to be a form of murder, and that it cements Oregon’s status as the most liberal state when it comes to abortion. (Somashekhar, 8/15)

Reuters: Texas Governor Signs Bill To Limit Insurance Coverage For Abortions
The Republican governor of Texas signed into law on Tuesday a measure that will restrict insurance coverage for abortions, compelling women to buy a supplemental plan if they want coverage for the procedure. Governor Greg Abbott said the measure known as House Bill 214 would protect abortion opponents from subsidizing the procedure. Democratic critics decried it as forcing people to buy “rape insurance.” (Herskovitz, 8/15)

The New York Times: A Changed Landscape For Abortion Rights In Texas
The drive between Del Rio and San Antonio consists of vast expanses of Texas farmland dotted with tiny towns. Along the route, a huge wooden sign in Hondo greets passers-by: “Welcome: This is God’s Country. Please don’t drive through it like hell.” By the time Kristen passed the sign on her way to get an abortion, she had been riding a Greyhound bus for four hours. The 150-mile trip was the shortest distance she could travel to visit an open clinic — Whole Woman’s Health in San Antonio. Her journey is not unique in Texas. (Van Houten, 8/16)

The Associated Press: Lawsuit Accuses Drug Manufacturer Of Worsening Opioid Crisis
South Carolina on Monday became the latest state to accuse a drug manufacturer of exacerbating its opioid drug crisis by using deceptive marketing. Attorney General Alan Wilson sued Purdue Pharma on Monday, accusing the maker of OxyContin and other opioid drugs of violating South Carolina’s Unfair Trade Practices Act. (Kinnard, 8/15)

The Wall Street Journal: South Carolina Sues Purdue Pharma, Alleging Deceptive Opioid Marketing
South Carolina’s suit follows efforts by several other jurisdictions to hold pharmaceutical companies accountable for what they call deceptive marketing of opioid painkillers. The states and others say that such marketing has led to an epidemic among residents, leading to addiction, overdose and deaths. The lawsuit, filed in South Carolina state court, focuses solely on Purdue Pharma, which manufactures OxyContin and other opioid drugs. New Hampshire last week filed a similar suit against Purdue. (Randazzo, 8/15)

The Associated Press: US Teen Drug Overdose Deaths Inch Up After Years Of Decline
After years of decline, teen deaths from drug overdoses have inched up, a new U.S. government report shows. The drop in teen deaths had been a rare bright spot in the opioid epidemic that has seen adult overdose deaths surge year after year — fueled by abuse of prescription painkillers, heroin and newer drugs like fentanyl. (Stobbe, 8/15)

NPR: People With Addictions Lured To Bogus Rehab Treatment Via ‘Body Brokers’
Some sober homes are good places. But others see a person who has an addiction as a payday. Amid the nation’s growing opioid crisis, South Florida has become a mecca for drug treatment. And as more people arrive looking for help, there’s more opportunity for corruption and insurance fraud. There are millions to be made in billing patients for unnecessary treatment and tests, according to officials investigating the problem. (Haden, 8/15)

The Associated Press: Colorful Portraits Show Faces Of New Hampshire Drug Crisis
At the New Hampshire State Library’s latest art exhibit, the bright smiles and bold colors of the canvases belied the broken hearts of those who attended its opening reception. More than 80 paintings are on display this month featuring the faces of the state’s opioid epidemic. What started as one mother’s private outlet for grief has grown into a larger effort to comfort others and reduce the stigma of addiction. (Ramer, 8/16)

The Wall Street Journal: How To Handle A Large, Unexpected Medical Bill
These days, not only are health-care costs climbing but individuals also often are bearing a greater portion of their medical bills than before, as many insurers cut back on payments and more companies expect employees to pay higher deductibles and copays.Meanwhile, many people don’t have sufficient emergency funds to pay for an unanticipated medical expense. … Against this backdrop, advisers such as Mr. Van Zutphen (who successfully negotiated a 25% reduction on his long-ago bill) are encouraging clients to negotiate medical costs, question charges and move quickly to resolve disputes or arrange payment plans. (Dagher, 8/15)

The Associated Press: Government Joins Food Fight Over Menu Labeling Requirements
The U.S. government has joined a food fight between New York City and a national group opposing new food labeling regulations for chain grocery and convenience stores. The Department of Justice filed legal papers this week on behalf of the Food and Drug Administration, asking a judge to block the city from enforcing a law requiring some stores serving prepared foods to post calorie information where the foods are sold. (Eltman, 8/16)

The Washington Post: There’s Plague In Arizona. Authorities Warn Of Fleas That Can Infect People And Pets.
Public health officials in two Arizona counties are warning residents about the discovery of plague bacteria, an endemic concern among those who live in the American Southwest but unsettling, nonetheless, given the disease’s devastating impact on human history. Navajo and Coconino counties are adjacent to one another, and in each community the findings are identical: Fleas carrying Yersinia pestis, the bacterium that causes plague, were discovered this month and pose a potentially grave threat to people and their pets, especially cats. (deGrandpre, 8/15)

The Washington Post: This Morbid Microbe’s Infection Strategy Is Gross But Genius
Pathogens are real jerks. As if infecting and killing plants and animals isn’t bad enough, they can also turn their hosts into zombies that spread the pathogens to their next victim. Now scientists report that bacteria make some victims summon other victims as their dying act. The bacteria hijack the chemical signaling pathway of insects, making them release a burst of hormones that serve as a beacon to attract friends and potential mates right before the bacteria kill off the host. Like malware marauding as an enticing link, the bacteria attract and then infect. (Gallegos, 8/16)

NPR: Homeland Security’s Nuclear Fallout Guidelines Include Warning About Conditioner
If, for some reason, you find yourself in a situation where you need to wash radioactive material from your body, don’t reach for the bottle of hair conditioner. Conditioner can bind radioactive particles to your hair. That warning was part of guidelines issued last Friday by Guam’s Office of Civil Defense, following threats from North Korea that it was preparing to test a missile that would create an “enveloping fire” around the U.S. territory. On Tuesday, North Korean state media reported it would not carry out the test after all. (Chen, 8/15)

News21: 63 Million Americans Exposed To Unsafe Drinking Water
As many as 63 million people — nearly a fifth of the United States — from rural central California to the boroughs of New York City, were exposed to potentially unsafe water more than once during the past decade, according to a News21 investigation of 680,000 water quality and monitoring violations from the Environmental Protection Agency. The findings highlight how six decades of industrial dumping, farming pollution, and water plant and distribution pipe deterioration have taken a toll on local water systems. (Philip, Sims, Houston and Konieczny, 8/15)

The Associated Press: Researchers To Study Chemical Contamination Of US Waters
University of Rhode Island and Harvard University professors are collaborating through a new research center to study chemicals that have contaminated water at sites nationwide. The chemicals, called perfluorinated chemicals, have been linked to cancer and other illnesses but aren’t federally regulated in drinking water. Water has been contaminated near sites of industrial facilities and U.S. military bases. (McDermott, 8/15)

The Wall Street Journal: Some Companies Want You To Take A Mental-Health Day
Bosses want their workers to start taking mental-health days for the right reasons. Workers often say they are taking a mental-health day with a wink and a nudge, as it is commonly understood that they will be catching up on housework or going to the beach. Meanwhile, many people who genuinely need time off to see a therapist or recover from an anxiety attack say they are less than forthcoming with their managers about why they need a break. (Fontana, 8/15)

NPR: Osteoarthritis Is Much More Common Now Than In Ancient Knees, Study Suggests
American doctors have been noticing an increase in osteoarthritis of the knee. They have suspected two driving forces: more old people and more people who are overweight. A study published in this week’s Proceedings of the National Academy of Sciences argues that’s far from the whole story. Even correcting for body mass index and age, osteoarthritis of the knee is twice as common now as it was before the 1950s. (Harris, 8/15)

USA Today: Vitamin B3 May Play An Important Role In Preventing Miscarriages And Birth Defects
For some moms, taking vitamin B3 may help prevent miscarriages and certain birth defects, according to a study published last week in the New England Journal of Medicine. Researchers in Sydney, Australia, analyzed the DNA of four families where mothers had experienced multiple miscarriages or had babies with serious birth defects, usually involving the heart, kidney and spine. (Toy, 8/15)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Drug Manufacturers Face Looming Deadline To Track Medicines As U.S. Cracks Down On Counterfeits

In other pharma industry news, early clinical trial data prove to be a mixed blessing for investors, while the Food and Drug Administration issues new prescription advisories and recalls.

Stat: With Deadlines Looming, Pharma Companies Look To Tighten Drug Security
Most people trust that their medicine matches the description on the bottle. But what if it doesn’t? Counterfeit drugs look a lot like the real deal, but can contain too little or none of the active ingredients that make a drug work. Or worse, a counterfeit drug can have toxic compounds. (Wosen, 8/14)

The Wall Street Journal: Why Early Peeks At Drug Trials Are Giving Investors Whiplash
Roche Holding AG shares jumped 6.5% on a single day in early March when the drugmaker said its new breast-cancer treatment, Perjeta, helped prolong average patient survival in a clinical study. But the stock gave up nearly all those gains three months later, when the Swiss company disclosed full details of the trial at a medical conference. The study, dubbed Aphinity, showed what some doctors said was only a marginal benefit for Perjeta …. The episode throws light on the peculiar drip-feed way drug companies often disclose the results of clinical trials. (Loftus and Roland, 8/14)

Miami Herald: FDA Calls Out PharmaTech, 22 Liquid Drug Products Recalled
For the second time in 10 months, the FDA has issued an advisory to avoid liquid drug products made at Davie company PharmaTech after finding Burkholderia cepacia contamination in the products. And three drug companies issued a sweeping all-lots, all-expiration-dates wholesale and retail recall of 22 over the counter liquid medications made by PharmaTech. (Neal, 8/14)

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Trump Blasts Merck CEO After He Quits White House Panel Over Charlottesville Response

In a quick response to the announcement from Merck’s chief Kenneth Frazier, the president tweeted that the decision would give Frazier “more time to LOWER RIPOFF DRUG PRICES!”

Stat: 7 Things To Know About The Pharma CEO Who Incurred Trump’s Wrath
[Kenneth] Frazier, the CEO of drug giant Merck, announced that he was resigning from a council of business leaders advising Trump, citing “a responsibility to take a stand against violence and extremism” after Trump’s failure to denounce the actions of white nationalists in Charlottesville, Va., over the weekend. Within an hour, Trump personally rebuked him on Twitter, saying Frazier’s departure would give him “more time to LOWER RIPOFF DRUG PRICES!” And at the end of the day, in another tweet, Trump added another accusation: “taking jobs out of the U.S. Bring jobs back & LOWER PRICES!” (Robbins, 8/14)

The Washington Post: Merck CEO Takes A Stand And Draws Trump’s Ire
It is unclear whether Trump’s tweet could portend negative repercussions for Merck or the pharmaceutical industry generally. Trump has repeatedly promised to bring down drug prices and has used harsh language to describe the industry, but has not taken any strong actions. (Johnson and McGregor, 8/14)

The Wall Street Journal: Three CEOs Quit Trump Advisory Council After Charlottesville Violence
Drugmaker Merck issued a statement Monday morning on Twitter from Chairman and Chief Executive Kenneth Frazier, saying, “America’s leaders must honor our fundamental values by clearly rejecting expressions of hatred, bigotry and group supremacy, which run counter to the American ideal that all people are created equal.” … Almost an hour later, President Donald Trump posted on Twitter: “Now that Ken Frazier of Merck Pharma has resigned from President’s Manufacturing Council, he will have more time to LOWER RIPOFF DRUG PRICES!” (Loftus, 8/14)

The New York Times: Under Armour And Intel C.E.O.S Follow Merck Chief, Quitting Panel In Rebuke To Trump
On Sunday, Mr. Frazier, the son of a janitor and grandson of a man born into slavery, watched news coverage of white nationalists clashing with counterprotesters in Charlottesville, and of Mr. Trump’s ambiguous response to the violence. That evening, he informed his board members that he was preparing to resign from Mr. Trump’s American Manufacturing Council, one of several advisory groups the president formed in an effort to forge alliances with big business. (Gelles and Thomas, 8/14)

POLITICO Pro: Trump Gives Heartburn To American CEOs
[Kenneth] Frazier appeared at the White House on July 20 to celebrate a new jobs initiative, where the president hailed him as a “great, great business leader” and thanked Merck for investing in American jobs. But on Monday, the president blasted Frazier after the executive announced he was leaving a White House advisory council over Trump’s failure to condemn the hate groups that demonstrated in Charlottesville, Va. (Diamond, 8/14)

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House Expected To Hold Hearings On ‘Right-To-Try’ Bill That Senator Tied To FDA Funding

The Senate quickly passed the bill that would allow dying patients access to experimental drugs after Sen. Ron Johnson (R-Wis.) had threatened to slow down consideration of a separate bill to renew the FDA’s fee-collection authority. In other drug industry news, the FDA is implementing new rules about hiring foreign scientists, industry tightens controls to keep out counterfeit drugs, cancer trials are low on patients and costs of old drugs rising quickly for Medicaid.

Roll Call: ‘Right To Try’ Bill Could Face Slower Action In House
A Senate-passed bill intended to help dying patients access experimental drugs will likely face lengthier deliberations in the House. While the Senate fast-tracked the bill on Aug. 3, the House will likely subject it to a hearing and markup before bringing it up to a vote, according to congressional aides and a lobbyist. (Siddons, 8/14)

Stat: FDA Puts New Restrictions On Hiring Of Foreign Scientists, Documents Show
The Food and Drug Administration is implementing a new hiring protocol that could make it significantly harder for foreign scientists to find jobs and research opportunities at the agency, according to interviews and newly obtained documents. The FDA recently began directing hiring managers not to extend any employment offers — including for fellowship and contractor positions — to any individual who has not lived in the U.S. for at least three of the five previous years, according to briefing materials shared with STAT that have been presented to some agency employees. (Mershon, 8/11)

Stat: With Deadlines Looming, Pharma Companies Look To Tighten Drug Security
Most people trust that their medicine matches the description on the bottle. But what if it doesn’t? Counterfeit drugs look a lot like the real deal, but can contain too little or none of the active ingredients that make a drug work. Or worse, a counterfeit drug can have toxic compounds. (Wosen, 8/14)

The New York Times: A Cancer Conundrum: Too Many Drug Trials, Too Few Patients
With the arrival of two revolutionary treatment strategies, immunotherapy and personalized medicine, cancer researchers have found new hope — and a problem that is perhaps unprecedented in medical research. There are too many experimental cancer drugs in too many clinical trials, and not enough patients to test them on. The logjam is caused partly by companies hoping to rush profitable new cancer drugs to market, and partly by the nature of these therapies, which can be spectacularly effective but only in select patients. (Kolata, 8/12)

Kaiser Health News: Climbing Cost Of Decades-Old Drugs Threatens To Break Medicaid Bank
Skyrocketing price tags for new drugs to treat rare diseases have stoked outrage nationwide. But hundreds of old, commonly used drugs cost the Medicaid program billions of extra dollars in 2016 vs. 2015, a Kaiser Health News data analysis shows. … Rising costs for 313 brand-name drugs lifted Medicaid’s spending by as much as $3.2 billion in 2016, the analysis shows. Nine of these brand-name drugs have been on the market since before 1970. In addition, the data reveal that Medicaid outlays for 67 generics and other non-branded drugs cost taxpayers an extra $258 million last year. (Lupkin, 8/14)

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Climbing Cost Of Decades-Old Drugs Threatens To Break Medicaid Bank

Skyrocketing price tags for new drugs to treat rare diseases have stoked outrage nationwide. But hundreds of old, commonly used drugs cost the Medicaid program billions of extra dollars in 2016 vs. 2015, a Kaiser Health News data analysis shows. Eighty of the drugs — some generic and some still carrying brand names — proved more than two decades old.

Rising costs for 313 brand-name drugs lifted Medicaid’s spending by as much as $3.2 billion in 2016, the analysis shows. Nine of these brand-name drugs have been on the market since before 1970. In addition, the data reveal that Medicaid outlays for 67 generics and other non-branded drugs cost taxpayers an extra $258 million last year.

Even after a medicine has gone generic, the branded version often remains on the market. Medicaid recipients might choose to purchase it because they’re brand loyalists or because state laws prevent pharmacists from automatically substituting generics. Drugs driving Medicaid spending increases ranged from common asthma medicines like Ventolin to over-the-counter painkillers like the generic form of Aleve to generic antidepressants and heartburn medicines.

Among the stark examples:

  • Ventolin, originally approved in 1981, treats and prevents spasms that constrict patients’ airways and make it difficult to breathe. When a gram of it went from $2.58 to $2.90 on average, Medicaid paid out an extra $54.5 million for the drug.
  • Naproxen sodium, a painkiller originally approved in 1994 as brand-name Aleve, went from costing Medicaid an average of $0.72 to $1.70 a pill, an increase of 136 percent. Overall, the change cost the program an extra $10 million in 2016.
  • Generic metformin hydrochloride, an oral Type 2 diabetes drug that’s been around since the 1990s, went from an average 10 cents to 13 cents a pill from 2015 to 2016. Those extra three pennies per pill cost Medicaid a combined $8.3 million in 2016. And cost increases for the extended-release, authorized generic version cost the program another $6.5 million.

“People always thought, ‘They’re generics. They’re cheap,’” said Matt Salo, who runs the National Association of Medicaid Directors. But with drug prices going up “across the board,” generics are far from immune.

Historically, generics tend to drive costs lower over time, and Medicaid’s overall spending on generics dropped $1.6 billion last year because many generics did get cheaper. But the per-unit cost of dozens of generics doubled or even tripled from 2015 to 2016. Manufacturers of branded drugs tend to lower prices once several comparable generics enter a market.

Medicaid tracks drug sales by “units” and a unit can be a milliliter or a gram, or refer to a tablet, vial or kit.

Old drugs that became far more expensive included those used to treat ear infections, psychosis, cancer and other ailments:

  • Fluphenazine hydrochloride, an antipsychotic drug approved in 1988 to treat schizophrenia, cost Medicaid an extra $8.5 million in 2016. Medicaid spent an average $1.39 per unit in 2016, an increase of 347 percent vs. the year before.
  • Depo-Provera was first approved in 1960 as a cancer drug and is often used now as birth control. It cost Medicaid an extra $4.5 million after its cost more than doubled to $37 per unit in 2016.
  • Potassium phosphates — on the market since the 1980s and used for renal failure patients, preemies and patients undergoing chemotherapy — cost Medicaid an extra $1.8 million in 2016. Its average cost to Medicaid jumped 290 percent, to $6.70 per unit.

A shortage of potassium phosphates began in 2015 after manufacturer American Regent closed its facility to address quality concerns, according to Erin Fox, who directs the Drug Information Center at the University of Utah and tracks shortages for the American Society of Health-System Pharmacists.

When generics enter a market, competition can drive prices lower initially. But when prices sink, some companies inevitably stop making their drugs.

“One manufacturer is left standing … [so] guess who now has a monopoly?” Salo said. “Guess who can bring prices as far up as they want?”

According to a Food and Drug Administration analysis, drug prices decline to about half of their original price with two generic competitors on the market and to about a third of the original price with five generics available. But if there’s only one generic, a drug’s price drops just 6 percentage points.

The increases paid by Medicaid ultimately fall on taxpayers, who pay for the drugs taken by its 68.9 million beneficiaries. And those costs eat “into states’ ability to pay for other stuff that matters to [every] resident,” said economist Rena Conti, a professor at the University of Chicago who co-authored a National Bureau of Economics paper about generic price hikes in July. The manufacturers’ list prices for the drugs named here also rose in 2016, according to Truven Health Analytics, which means customers outside Medicaid also paid more.

Conti said that about 30 percent of generic drugs had price increases of 100 percent or more the past five years.

Medicaid spending per unit doesn’t include rebates, which drug manufacturers return to states after they pay for the drugs upfront. Such rebates are extremely complicated, but generally start at the federally required 23.1 percent for brand-name drugs, plus supplemental rebates that vary by state, Salo said. Final rebate amounts are considered proprietary, he noted. “All rebates are completely opaque … [it’s] “black-box stuff.”

Fox said drug prices could also jump when a pharmaceutical product changes ownership, gets new packaging or just hasn’t had a price increase in a long time.

Recently named FDA Commissioner Scott Gottlieb has made increasing generic competition a core mission. Plans include publishing lists of off-patent drugs made by one manufacturer and preventing brand-name drugmakers from using anti-competitive tactics to stave off competition.

Doctors, pharmacists and patients don’t always receive warning when a price hike is about to occur, Fox said.

“Sometimes, we will get notices. Other times, it’s like a bad surprise,” she said, adding that the amount of wiggle room for alternatives depends on the drug and the patient.

Following some price hikes, doctors can use fewer units of a drug or switch it out entirely, she said.

Ofloxacin otic, long used to treat swimmer’s ear, became so expensive when generic manufacturers exited the market that doctors started using eye drops in patients’ ears, Fox said.

When old drugs get more expensive, hospitals try to eliminate waste by making smaller infusion bags and keeping really expensive drugs in the pharmacy instead of stocked in readily available shelves and drawers. But that’s not always possible.

“These drugs do have a place in daily therapy. Sometimes they’re life-sustaining and sometimes they’re lifesaving,” said Michael O’Neal, a pharmacist at Vanderbilt University Medical Center. “In this case, you just need to take it on the chin, and you hope one day for competition.”

Methodology Note:

The KHN analysis is based on drugs whose per-unit spending increases drove Medicaid costs up by at least $1 million in 2016. 

We calculated extra expenditures for each drug by first determining how much it would have cost Medicaid to reimburse the number of units purchased in 2016 at the 2015 unit cost. We subtracted this from the actual total cost in 2016. 

The total extra expenditure for a drug includes the sum of the extra expenditures for all its versions (represented by NDC codes), accounting for various strengths, package sizes, routes and labelers. Reimbursement levels vary by state and are typically based on a drug’s list price.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Categories: Cost and Quality, Medicaid, Pharmaceuticals

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Viewpoints: Why The Ohio A.G. Decided To Take Legal Action Against The Big 5 Opioid Manufacturers; Health Reforms Advance Without Congress

A selection of opinions on health care from around the country.

The Washington Post: This Is Why I’m Suing Five Opioid Manufacturers In My State
Opioid addiction has become all too familiar in my home state of Ohio. The man-made public health-care disaster has spread to every county in the state. This is why, as state attorney general, I have filed suit against five of the largest manufacturers of brand-name and generic opioids. We believe evidence will show that they flooded the market with prescription opioids, such as OxyContin and Percocet, and grossly misleading information about the risks and benefits of these drugs. And as a result, we believe countless Ohioans and other Americans have become hooked on opioid pain medications, all too often leading to the use of cheaper alternatives such as heroin and synthetic opioids. Almost 80 percent of heroin users start with prescription opioids. (Ohio Attorney General Mike DeWine, 8/10)

The New York Times: On Health Care, Who Needs Congress?
Regardless of whether Congress enacts health care reform, the private sector isn’t waiting. Health care for our employees is too expensive, and the employer-based system must be reformed. More Americans — 146 million people, or 57 percent of the country — get health insurance through their employers than they do through Medicare or Medicaid, each with more than 50 million enrollees. But for years, premiums and co-payments have been rising for the workers at America’s private-sector companies. (Robert Andrews, 8/11)

The New England Journal Of Medicine: Repeal, Replace, Repair, Retreat — Republicans’ Health Care Quagmire
Republicans have been bedeviled by internal party divisions, strategic miscalculations, the absence of a viable replacement plan, the resilience of the status quo, and the constraints of American political institutions. Given their slim 52–48 majority, passing health care legislation in the Senate required forging a near-consensus among GOP lawmakers. Conservative and centrist Republicans could not, however, agree on whether the party’s repeal proposals went too far or not far enough. While Speaker Paul Ryan and GOP leaders found a way to navigate such tensions in the House of Representatives, they had a larger majority to work with and could afford more defections (even then, House repeal efforts initially imploded before a remarkable turnaround led to passage of the American Health Care Act [AHCA] on May 4 by a 217–213 vote). (Jonathan Oberlander, 8/9)

The Wall Street Journal: The Trump-McConnell Spat
The damage from the GOP’s health-care debacle has only just begun, and the latest evidence is this week’s public spat between President Trump and Senate Majority Leader Mitch McConnell. The big potential winner here is Democratic leader Chuck Schumer. Mr. McConnell has been getting the Kim Jong Un treatment this week, as Mr. Trump has pounded away for the Senate’s recent failure to reform ObamaCare. “Can you believe that Mitch McConnell, who has screamed Repeal & Replace for 7 years, couldn’t get it done. Must Repeal & Replace ObamaCare!,” the President tweeted Thursday morning from his vacation redoubt in Bedminster, N.J. (8/10)

The Wall Street Journal: John McCain’s Defense Cut
There is no more passionate and principled advocate for greater military spending than Senator John McCain, so we wonder if the Arizona Republican appreciates that he recently voted to guarantee weaker U.S. defenses. To wit, his vote to kill health reform means that entitlements like Medicaid will continue to squeeze the Pentagon like an ever-tightening vise long after he has retired. (8/10)

Detroit News: Medicaid Bridges Care Gap For Disabled Kids
The first time services were cut for my disabled daughter, I cried in the restroom at work. … Watching the most recent debates to dismantle the Affordable Care Act, or Obamacare, I remembered those feelings as I watched the Senate debate massive cuts to Medicaid that would’ve potentially left millions without insurance. I wondered how many of those same senators had ever spent time with someone who relies on Medicaid, especially children with serious disabilities. There’s a perception that Medicaid is only for low-income families. It isn’t. It’s also for families like mine — two working parents trying desperately to give their daughter the life she deserves. (Maureen Feighan, 8/10)

The New England Journal Of Medicine: Small Change, Big Consequences — Partial Medicaid Expansions Under The ACA
Though congressional efforts to repeal and replace the Affordable Care Act (ACA) seem to have stalled, the Trump administration retains broad executive authority to reshape the health care landscape. Perhaps the most consequential choices that the administration will make pertain to Medicaid, which today covers more than 1 in 5 Americans. Much has been made of proposals to introduce work requirements or cost sharing to the program. But another decision of arguably greater long-term significance has been overlooked: whether to allow “partial expansions” pursuant to a state Medicaid waiver. Arkansas has already submitted a waiver request for a partial expansion, and other states may well follow its lead. (Adrianna McIntyre, Allan M. Joseph and Nicholas Bagley, 8/9)

Bloomberg: Sugar Is Finally More Popular Than Corn Syrup Again
All of that decline, as is apparent from the chart, has been in corn sweeteners — consumption of sugar made from cane or beets is actually up a bit since the 1990s. And the overall drop in sweetener use seems to have stalled over the past four years. The biggest story in the data, really, is the rise and fall of high-fructose corn syrup, which came from nowhere in the 1960s to become a ubiquitous sweetener of soft drinks and other things. Then, around the turn of the millennium, it was identified as a prime suspect in the country’s obesity epidemic. (Justin Fox, 8/10)

Bloomberg: Amazon Could Probably Conquer Drugstores, Too
Can Amazon do to the pharmacy business what it’s done to … well, everything else? Rumor has it they’re thinking about doing just that. They’ve reportedly created a new general manager position to look into such an expansion. In May, when those rumors started floating, Bloomberg’s own Max Nisen explained why they might find the business attractive. (Megan McArdle, 8/10)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Research Roundup: FDA Expedited Drug Approvals; Effectiveness Of Flu Vaccines

Each week, KHN compiles a selection of recently released health policy studies and briefs.

Health Affairs: Drugs Cleared Through The FDA’s Expedited Review Offer Greater Gains Than Drugs Approved By Conventional Process
We investigated whether drugs approved by the Food and Drug Administration (FDA) through expedited review have offered larger health gains, compared to drugs approved through conventional review processes. …We found that drugs in at least one expedited review program offered greater gains than drugs reviewed through conventional processes (0.182 versus 0.003 QALYs). (Chambers, Thorat, Wilkinson, et. al., 8/1)

JAMA Internal Medicine: Social Determinants Of Health In Managed Care Payment Formulas 
Using data from MassHealth, the Massachusetts Medicaid and Children’s Health Insurance Program, we estimated regression models predicting Medicaid spending using a diagnosis-based and SDH-expanded model, and compared the accuracy of their cost predictions overall and for vulnerable populations. …Overall, the SDH model performed well, but only slightly better than the diagnosis-based model, explaining most of the spending variation in the managed care population (validated R2 = 62.4) and reducing underpayments for several vulnerable populations. (Ash, Mick, Ellis, et. al., 8/7)

New England Journal of Medicine: Influenza Vaccine Effectiveness In The United States During The 2015–2016 Season 
The A(H1N1)pdm09 virus strain used in the live attenuated influenza vaccine was changed for the 2015–2016 influenza season because of its lack of effectiveness in young children in 2013–2014.  …Influenza vaccines reduced the risk of influenza illness in 2015–2016. However, the live attenuated vaccine was found to be ineffective among children in a year with substantial inactivated vaccine effectiveness. (Jackson, Chung, Jackson, et. al., 8/10)

Annals Of Internal Medicine: HCV Infection Treatment By Nonspecialist Providers 
In a real-world cohort of patients at urban FQHCs, HCV treatment administered by nonspecialist providers was as safe and effective as that provided by specialists. Nurse practitioners and PCPs with compact didactic training could substantially expand the availability of community-based providers to escalate HCV therapy, bridging existing gaps in the continuum of care for patients with HCV infection. (Kattakuzhy, Gross, Emmanuel, et. al., 8/8)

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State Highlights: Arizona’s Ambulance Wars; Conn. Budget Cuts Undo Investments In School Mental Health Services

Media outlets report on news from Arizona, Connecticut, Florida, Washignton, Texas, Missouri, New York, Delaware, Ohio, Wisconsin and Maryland.

The CT Mirror: Budget Cuts May Erode Gains In School Mental Health Services
Since the horrific shooting of children and faculty at Sandy Hook Elementary School in December 2012, Connecticut has made significant investments in school mental health services and specifically in identifying and treating victims of trauma. But with no state budget and school beginning in less than a month, many Connecticut districts may have to cut back on recently expanded mental health services or make room for them in their own budgets. (Werth, 8/11)

Miami Herald: A Mental-Health Facility 13 Years In The Making Is One Vote Away From Becoming Reality
Leifman, a Miami-Dade circuit judge who has spent much of his life working to change state laws for mentally ill inmates, will lead the effort to take the former South Florida Evaluation and Treatment Center and turn it into a state-of-the-art mental health diversion facility. If they meet certain criteria, people can be housed, treated and taught to manage their illnesses and their lives. (Bordas, 8/10)

Seattle Times: Investigators Find ‘Numerous’ Issues Related To Patient Safety At Swedish’s Cherry Hill Site
Hospital regulators have identified a wide range of recent troubles at Swedish Health’s Cherry Hill facility, including failures of oversight and “numerous” issues related to patient safety, according to records released Thursday. Federal officials said the Cherry Hill site will be terminated from the Medicare program in 90 days unless Swedish can bring itself into compliance on a couple of key issues. (Baker, 8/10)

San Antonio Press Express: Superior HealthPlan Scales Back Medical Supply Contract With Illinois Company After Complaint
Superior HealthPlan, which operates Medicaid and Medicare programs in Texas, is delaying its switch to a new medical supplier and notifying patients that they can choose another company for glucose monitors, catheters and other supplies. Superior originally awarded a sole source contract to Illinois company Medline starting on Sept. 1, but decided to delay the agreement until Oct. 1 after a San Antonio medical supplier sent a protest letter last month to the Texas Health and Human Services Commission. (Pound, 8/10)

Kansas City Star: Hospital Firm Disputes Missouri Audit Alleging Billing Scheme
A Florida company is pushing back on a report from Missouri Auditor Nicole Galloway’s office that says the company engaged in a $90 million billing scheme in the course of managing a small Missouri hospital. The audit, released by Galloway’s office Wednesday, found that Putnam County Memorial Hospital in north-central Missouri had accepted millions in questionable insurance payments for patients who were treated across the country. (Lowry, 8/10)

The Wall Street Journal: New York To Broaden Medical Marijuana Program
The state of New York is about to make it more convenient for patients to use medical marijuana. The drug will be available in lotions, lozenges, patches and chewable tablets for the first time this fall. Currently, patients have to use an inhaler, a vaporizer or ingest capsules. Smoking marijuana remains prohibited under the new rules. (Alfaro, 8/10)

The Associated Press: Police Continuing Probe Into Alleged Prescription Fraud
Delaware State Police say more arrests are expected in an investigation involving a Philadelphia woman accused of distributing fraudulent prescriptions for controlled substances. Police said Thursday that 49-year-old Annette Scott stole blank prescription pads from a Wilmington-area doctor’s office where she worked and forged the doctor’s signature. Investigators say she then distributed 23 prescriptions to several individuals, who would fill the prescriptions at area pharmacies and use their Medicaid insurance to pay for them. (8/10)

Columbus Dispatch: Pot Growers Worry Ohio Will Miss Deadline For Finished Product
Ohioans were promised medical marijuana would be available by September 2018, but that legal deadline is in jeopardy because the state is taking so long to review the applications of potential cultivators. …<span id=”OwLYZawz” class=”lAwSztylkM”>That means the nascent cannabis industry will have only about 10 months to build growing facilities, grow and process a crop, go through inspections and permitting processes and get products in the hands of patients. </span>(Keiper, 8/10)

Milwaukee Journal Sentinel: OSHA Inspects Wisconsin Barrel Plant
The federal agency charged with workplace safety has opened an inspection of an industrial drum refurbishing plant in St. Francis — but only months after reports of dangerous working conditions and action by environmental regulators uncovered numerous violations. Inspectors from the U.S. Occupational Safety and Health Administration opened an inspection of Mid-America Steel Drum last week — on the same day the Milwaukee Journal Sentinel posted a story examining why the agency had inspected just one of six plants in the chain. (Diedrich, 8/10)

The Baltimore Sun: University Of Maryland Adds Inpatient Floors To Planned Midtown Tower
The University of Maryland Medical Center plans to add three inpatient floors atop a planned 10-story outpatient center at its Midtown campus, center officials said Thursday. The hospital is adding the floors in anticipation of future patient care needs and an expected expansion of services offered at the Midtown campus, according to Karen Lancaster, a spokeswoman for the center. (Cohn, 8/10)

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‘Things Must Be Bad’: Mylan’s Stumbles Over Generic Drugs Indicative Of Larger Industry Trouble

The company is the latest to slash their forecast due to generic drugs.

Bloomberg: Generic Drug Price Slump’s Latest Victim: Mylan Profit Goal 
For the last five years, Mylan NV executives have gotten up in front of investors every year and said they could bet on one thing — that the maker of generic drugs would hit at least $6 in earnings per share in 2018. That’s not gonna happen. On Wednesday, Mylan cut its adjusted earnings forecast for next year to $5.40 a share. It’s the latest stumble in the generic-drugs industry during a period of falling drug prices, political scrutiny and takeovers by Mylan and its competitors that either couldn’t be consummated or turned out not to work as well as hoped. (Hopkins and Melin, 8/9)

Bloomberg: Mylan Pares Losses As Path To Generic Advair Approval Smoothed 
Mylan shares briefly pulled out of an early-morning swoon after executives tempered concern about regulatory roadblocks for some of its new drugs. Approval of a highly anticipated generic version of the asthma treatment Advair, which was delayed, won’t require additional clinical or device approvals, Mylan President Rajiv Malik said on a conference call. That helped placate investors who had driven Mylan down as much as 7 percent early Wednesday after the company cut its forecast for this year and the next. The shares rose as much as 2.8 percent during the call and were down 2 percent to $31.16 at 12:05 p.m. in New York. (Hopkins, 8/9)

In other pharmaceutical news —

The Washington Post: Md. Drug Company Sues Federal Government To Fend Off Competition From Generics
One of Maryland’s largest drug manufacturers is suing the federal government to fend off competition on one of its key drugs, saying its right to exclusively sell the medication should continue an additinoal three years. The suit comes as the company, United Therapeutics, faces new competition from other firms trying to sell similar treatments on the generic market. Silver Spring-based United Therapeutics filed suit Aug. 4 in U.S. District Court for the District of Columbia, alleging the firm is entitled to a seven-year period of exclusive sale of the drug’s oral formulation. (Gregg, 8/9)

Kaiser Health News: Hospitals Slashed Use Of Two Heart Drugs After Huge Price Hikes
Even before media reports and a congressional hearing vilified Valeant Pharmaceuticals International for raising prices on a pair of lifesaving heart drugs, Dr. Umesh Khot knew something was very wrong. Khot is a cardiologist at the Cleveland Clinic, which prides itself on outstanding heart care. The health system’s pharmacists had alerted doctors about the skyrocketing cost of the drugs, nitroprusside and isoproterenol. But these two older drugs, frequently used in emergency and intensive care situations, have no direct alternatives. (Tribble, 8/9)

Bloomberg: Teva Ramps Up Sales With Medis, Respiratory Units 
Teva Pharmaceutical Industries Ltd. is ramping up asset sales as the troubled Israeli drug maker works to preserve its credit rating and cut debt, people familiar with the matter said. The company is considering a disposal of Medis, an Icelandic unit that develops generics for other companies, a representative for Teva said, confirming Bloomberg’s earlier report. The company is also weighing a sale of some of its respiratory treatment assets, the people said, asking not to be identified because deliberations are private. Teva hasn’t made a final decision about the assets and considerations are at an early stage, they said. (Baigorri, David and Bemeleh, 8/9)

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Hospitals Slashed Use Of Two Heart Drugs After Huge Price Hikes

Even before media reports and a congressional hearing vilified Valeant Pharmaceuticals International for raising prices on a pair of lifesaving heart drugs, Dr. Umesh Khot knew something was very wrong.

Khot is a cardiologist at the Cleveland Clinic, which prides itself on outstanding heart care. The health system’s pharmacists had alerted doctors about the skyrocketing cost of the drugs, nitroprusside and isoproterenol. But these two older drugs, frequently used in emergency and intensive care situations, have no direct alternatives.

“If we are having concerns, what is happening nationally?” Khot wondered.

As it turned out, a lot was happening.

Following major price increases, use of the two cardiac medicines has dramatically decreased at 47 hospitals, according to a research letter Khot and two others published Wednesday in the New England Journal of Medicine.

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The number of patients getting nitroprusside, which is given intravenously when a patient’s blood pressure is dangerously high, decreased 53 percent from 2012 to 2015. At the same time, its price per 50 milligrams jumped thirtyfold, from $27.46 in 2012 to $880.88 in 2015.

The use of isoproterenol, key in monitoring and treating heart-rhythm problems during surgery, decreased 35 percent as the price per milligram rose from $26.20 to $1,790.11.

The drugs, which are off patent, have long been go-to medicines for doctors.

“This isn’t like a cholesterol medicine, these are really, very specialized drugs,” said Khot, who is lead author on the peer-reviewed research letter. When patients get the drugs, “they are either sick beyond sick in intensive care or they’re under anesthesia [during] a procedure.”

Valeant bought the drugs in early 2015 from Marathon Pharmaceuticals. Last year, Valeant announced a rebate program to lower the price hospitals paid for the drugs. And Valeant’s Lainie Keller, a vice president of communications, said the company is committed to limiting price increases.

“The current management team is committed to ensuring that past decisions with respect to product pricing are not repeated,” Keller wrote.

Erin Fox, who directs drug information at the University of Utah Health Care, said the letter reveals “exactly what a lot of pharmacists have been talking about. When prices are unsustainable, you have to stop using the drug whenever you can. You just can’t afford it.”

Fox said her Utah health system removed isoproterenol from its bright-red crash carts, which are stocked for emergencies like heart attacks. Nitroprusside is more difficult to replace.

“It is one if you need it, you need it,” Fox said. “That’s exactly why the usage has not gone down to zero even with the huge price increases.”

Cleveland Clinic leaders spent months investigating each drug’s use and potential alternatives, Khot said.

“We’re not going to ration or restrict this drug in any way that would negatively impact these patients,” Khot said, adding that he hopes to do more research on how the decreased use of both drugs affected patients.

Dr. Richard Fogel, a cardiologist and electrophysiologist at Ascension, a large nonprofit hospital chain with facilities in 22 states and the District of Columbia, told a Senate committee last year that the cost of the two drugs alone drove a nearly $12 million increase in Ascension’s spending over one year.

“While we understand a steady, rational increase in prices, it is the sudden, unfounded price explosions in select older drugs that hinder us in caring for patients,” Fogel said.

The NEJM letter also analyzed two other drugs — nitroglycerin and dobutamine — that remained stable in price as a control group. The number of patients treated with nitroglycerin, a drug used for chest pain and heart failure, increased by 89 percent, but Khot warned that the drugs can’t always be used as substitutes.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Categories: Cost and Quality, Pharmaceuticals

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Shkreli Gave The Public A Face To Blame For Price Gouging. Now He’s A Convicted Felon

Martin Shkreli was found guilty of three counts of fraud and faces a possible prison sentence. But how has his case affected the pharmaceutical industry?

Stat: The Shkreli Saga: What’s Changed? What Hasn’t? And What’s Next?
Martin Shkreli, the hoodie-clad bete noire that pharma uses as a moral yardstick, is now a convicted felon. … And in the years since the scandal surrounding Shkreli’s Turing Pharmaceuticals, the tone around drug pricing has gone from peripatetic frustration to ongoing outrage. Each new drug approval is met with “Yes, but how much will it cost?” Headlines that once heralded medical innovation are now sure to include words like “pricey,” “costly,” or “expensive.” Companies that withhold pricing information upon approval are only prolonging the inevitable. (Garde, 8/4)

Stat: Shkreli Is Convicted Of Fraud. Can Pharma Finally Slam The Door On Him?
Is this the end of the line for the “pharma bro” with the perpetual smirk? Martin Skhreli was found guilty on Friday of three counts of fraud after a five-week trial in federal court in Brooklyn, N.Y. He faces a prison sentence that could stretch years. … The big question now: Can the pharma industry finally slam the door on Shkreli, after complaining for nearly two years that his price-hiking antics tainted the reputation of the entire field? (Keshavan, 8/4)

The Associated Press: Convicted ‘Pharma Bro’ Has An Image Problem, Lawyer Concedes
Martin Shkreli, the eccentric former pharmaceutical CEO notorious for a price-gouging scandal and for his snide “Pharma Bro” persona on social media, was convicted Friday on federal charges he deceived investors in a pair of failed hedge funds. A Brooklyn jury deliberated five days before finding Shkreli guilty on three of eight counts. He had been charged with securities fraud, conspiracy to commit securities fraud and conspiracy to commit wire fraud. (Hays and Neumeister, 8/4)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

To Grow Market Share, A Drugmaker Pitches Its Product To Judges

Philip Kirby said he first used heroin during a stint in a halfway house a few years ago, when he was 21 years old. He quickly formed a habit.

“You can’t really dabble in it,” he said.

Late last year, Kirby was driving with drugs and a syringe in his car when he got pulled over. He went to jail for a few months on a separate charge before entering a drug court program in Hamilton County, Ind., north of Indianapolis. But before Kirby started, he says the court pressured him to get a shot of a drug called Vivitrol.

Vivitrol is a monthly injection of naltrexone, which blocks opioid receptors in the brain. It’s one of three medications approved by the Food and Drug Administration for treating opioid addiction. While it’s effective in some people, it’s not for everyone. Patients have to be ready to be opioid-free, and some patients won’t do well on it. It can also have side effects, which Kirby says he experienced.

“I had sinus problems, chest problems for the whole month I was on it,” Kirby said. “I couldn’t shake it.”

He says he also got a rash — another possible reaction to Vivitrol, according to the product’s warnings. Months after he had the shot, he still had white splotches on his arms, which he attributed to the drug. But even with those symptoms, Kirby said the court urged him to stick with the medication for a couple more months. “They were way too pushy about it,” he said.

More than 130,000 Americans will go through drug courts this year, according to the National Association of Drug Court Professionals. Drug courts are designed to allow some people whose crimes stem from addiction to get treatment instead of jail time. But the treatment that is offered varies from court to court and is entirely at the judge’s discretion.

Some courts offer participants a full range of evidence-based treatment, including medication-assisted treatment. Others don’t allow addiction medications at all. And some permit just one: Vivitrol.

Prime targets for marketing

One reason for this preference is that Alkermes, Vivitrol’s manufacturer, is doing something nearly unheard of for a pharmaceutical company: It is marketing directly to drug court judges and other officials.

The strategy capitalizes on a market primed to prefer their product. Judges, prosecutors and other criminal justice officials can be suspicious of the other FDA-approved addiction medications, buprenorphine and methadone, because they are themselves opioids. Alkermes promotes its product as “nonaddictive.”

The argument worked for Judge Lewis Gregory, who heads the city court in Greenwood, Ind. About a year and a half ago, Gregory didn’t allow participants to start on addiction medications while in the program. “We were failing miserably with the heroin population,” he said.

Judge Lewis Gregory, head of the city court in Greenwood, Ind., began allowing drug court participants to begin taking Vivitrol after meeting with an Alkermes sales representative. (Jake Harper/Side Effects Public Media)

At the time, Gregory was only familiar with buprenorphine and methadone. Both are opioid medications that can prevent withdrawals, reduce cravings and ultimately help people maintain a stable recovery. When they are properly prescribed and administered, patients don’t get a euphoric feeling or a “high.”

Buprenorphine and methadone have been the standard of care for opioid addiction for years, but because they’re opioids, it is possible to misuse them. They’re also sold illegally on the street.

“I was certainly not going to do a medication-assisted treatment program with drugs which people use to get high,” Gregory said, adding that he would not order someone to stop buprenorphine treatment if it were legally prescribed by a physician, a situation he rarely sees.

Then he received some Vivitrol literature in the mail and a phone call from an Alkermes sales representative. “So we ended up meeting in the early part of 2016, and she began educating me a bit,” he said.

Six months later, his court began a Vivitrol program, permitting some participants to use the drug. A sales representative sometimes sits in on the court’s treatment team meetings, Gregory said.

Many treatment specialists say allowing judges and other criminal justice officials with no medical training to exert influence over medical decisions is problematic. The power makes them prime targets for Vivitrol marketing, they say.

“You would think it would be more appropriate to go after physicians,” said Basia Andraka-Christou, who researches drug courts at the Fairbanks School of Public Health at Indiana University.

“What this is implying is that the judges in these cases are actually making a lot of the medical decisions, and that should be very concerning to everyone,” she said.

Adriane Fugh-Berman, who researches pharmaceutical marketing at Georgetown University, said she has not heard of another drug company going after judges. She says it’s not just unique — it’s inappropriate and could ultimately be damaging to patients. “They’re not health care providers. They don’t know data. They don’t know research,” she says.

A company strategy

The drug court Kirby went through doesn’t allow medications other than Vivitrol for treating addiction. In fact, NPR and Side Effects Public Media have identified at least eight courts out of the several dozen in Indiana that say they only allow Vivitrol treatment.

NPR and Side Effects Public Media have learned that Alkermes sales reps have also marketed the drug to court officials in Missouri and Ohio. A report from ProPublica found that extensive marketing is leading judges to favor Vivitrol around the country.

The company is open about this part of its sales strategy. At an investor event last year, policy director Jeff Harris said that drug courts are a huge market for Vivitrol.

“We’re making progress but still just barely scratching the surface on the need that exists across the country,” Harris said in a presentation. “There are over 3,000 counties in the United States, and there are over 3,000 drug courts.”

A shot of Vivitrol costs around $1,000, making it pricier than the other addiction treatments. In many cases, the drug is paid for through Medicaid or other public funds. And marketing to criminal justice settings seems to have paid off for the company, whose earnings have grown significantly since its introduction. Vivitrol sales reached $209 million in 2016 — up from just $30 million in 2011. Sales have continued to climb this year.

Alkermes goes beyond marketing to judges. It also lobbies state and national policymakers to write laws that favor Vivitrol — and in some cases, hamper access to other addiction medications. The company has said it supports the use of all medications for addiction, but in practice, it doesn’t.

The company supported one law in Indiana that encourages the use of Vivitrol in drug courts. Signed in 2015, the bill allows judges to require medication as a condition of participating in a drug court, and the language specifically highlights Vivitrol treatment.

Alkermes declined repeated interview requests. In a written statement, the company defended the practice of marketing in criminal justice settings by noting that judges don’t actually prescribe their product.

No one-size-fits-all solution

Drug court judges interviewed for this story say they don’t mandate Vivitrol treatment, and that people can say no.

“We encourage it, but we never force anybody,” said Judge Gail Bardach of the Hamilton County, Ind., drug court, where Philip Kirby was a participant.

But facing potential jail time and court officials who really believe in Vivitrol, participants say getting the shot doesn’t always feel like a choice.

“They made it seem like they were forcing it upon me, like I couldn’t come into the program until I got it,” Kirby said.

For some patients, Vivitrol does help. Jeremy Templin went through the Hamilton County drug court program a few years ago after he was arrested for theft. He said the decision to go on Vivitrol seemed like it was made without him, but he credits his recovery, in large part, to the drug.

“I don’t know what it would have been like without it, but I know that I did have it, and here I am today,” he said. “I’m still alive.”

But Vivitrol is far from a one-size-fits-all solution. It’s not ideal for patients who are dealing with chronic pain on top of their addiction, or for pregnant women. It’s expensive. Furthermore, relapse rates for all kinds of opioid addiction treatment are high, and after a period of not using, tolerance for opioids is low. Treatment with Vivitrol, which contains no opioid ingredients, could make someone more likely to overdose if they relapse, addiction specialists warn.

Dan Mistak, an attorney with Community Oriented Correctional Health Services, said courts should allow all medication options and let doctors make treatment decisions — including whether or not someone should use medication in their recovery.

“We rely on outside experts all the time in the judicial system. We don’t ask a judge to come in and be an expert in arson,” for example, he said. “This is a responsibility that a judge doesn’t want.”

The federal government and the National Association of Drug Court Professionals agree that courts should allow all three FDA-approved opioid addiction medication options.

“Especially with this exploding opioid use epidemic, we have to make available, as much as we can, whatever interventions are out there that are likely to be effective,” said Dr. Terrence Walton, chief operating officer for the NADCP, which lists Alkermes as one of its biggest donors.

For some judges, limited access to buprenorphine and methadone shapes their decisions about what to allow in drug court programs. The medications are heavily regulated, and many communities lack providers who can prescribe and dispense the drugs. Judge Bardach says she would consider allowing participants to use methadone if there were a provider closer to the court.

A need for regulation?

Currently, there is no regulatory agency that can ensure that judges follow best practices.

“There are not that many ways to leverage accountability over these courts,” said Christine Mehta, a researcher at Physicians for Human Rights. Mehta recently authored a report on drug courts, focusing on three states. “Really the key is attaching restrictions and requirements to funding,” she said.

The federal government has put some requirements in place for courts receiving grants from the Bureau of Justice Assistance. They have to show that they “will not deny any eligible client access to the program because of their use of FDA-approved medications for the treatment of substance use disorders.” But only about 200 of the more than 3,000 drug courts nationwide operate with help from a BJA grant.

The Substance Abuse and Mental Health Services Administration has similar grant-making guidelines in place, but it currently funds only 172 courts.

Mehta says states and counties need to implement similar requirements and work to educate drug court officials about all addiction medication options. She argues that until drug courts allow all of the medications, they’re not fulfilling their promise.

“If drug courts say that they provide access to treatment instead of prison, they are inherently violating that by saying, ‘Well, we only provide Vivitrol,’ ” she said.

Mehta says Alkermes’ marketing would be less effective if judges were compelled to follow best practices.

Georgetown researcher Fugh-Berman thinks that pharmaceutical companies like Alkermes should be barred from marketing to court officials and lawmakers.

“It would be great if the [FDA] went after this,” she said. “I think it does fall under their jurisdiction, but I wouldn’t rely on that being enough.” She says Congress could pass a law preventing such marketing, as well.

Philip Kirby says his probation officer finally relented when he lifted his shirt and showed that his rash was covering his whole body.

That rash has since cleared up, but it has left a pattern of white spots on his arms.

“I don’t know if they’ll go away,” he said. “I hope they go away eventually.”

He says he wishes he’d never taken Vivitrol in the first place.

This story is part of a partnership that includes WFYI, Side Effects Public MediaNPR and Kaiser Health News. Esther Honig of WOSU in Columbus, Ohio, and Bram Sable-Smith of KBIA in Columbia, Mo., contributed reporting.

Categories: Courts, Mental Health, Pharmaceuticals

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