THE PROGNOSIS

Ohio federal prosecutors indicted opioid distributor Miami-Luken and two of its top officials yesterday on charges of conspiring to pour millions of pain pills into communities in Ohio, West Virginia and Kentucky. The move marks an escalation by the federal government in its criminal offensive against the opioid epidemic plaguing the country — in April, prosecutors filed criminal charges against distributor Rochester Drug Cooperative.

“There’s a need, in my opinion, to devote sufficient charges right here and now to stop the dying,” U.S. Attorney Benjamin C. Glassman said about why the agency used criminal statutes, according to my Washington Post colleague Lenny Bernstein. “We have to devote the resources to cut off the supply of the drugs, whether it’s synthetics or it’s prescription opioids or both.”

Lenny writes: “The new indictment lists numerous violations by Miami-Luken, including ignoring 'obvious signs' that drugs were being diverted to illegal users and dealers between 2011 and 2015. Prosecutors said the company sent 2.3 million doses of oxycodone and 2.6 million doses of hydrocodone to Miller-West’s drugstore in Oceana, W.Va., with a population of 1,394.

“Under federal law, these wholesalers are required to monitor the flow of controlled substances and alert the Drug Enforcement Administration when they identify suspicious purchases that could indicate pills are being diverted to the black market. But many companies ignored that responsibility as profits soared, authorities allege.”

The federal action comes as the Drug Enforcement Administration recently released a database tracking the manufacture and sale of opioids across the nation. From 2006 to 2012, the DEA data shows that drug companies poured 76 billion hydrocodone and oxycodone pills into communities across the country.

“The data provides an unprecedented look at the surge of legal pain pills that fueled the prescription opioid epidemic, which has resulted in nearly 100,000 deaths from 2006 through 2012,” write Post reporters Scott Higham, Sari Horowitz and Steven Rich.

“Just six companies distributed 75 percent of the pills during this period: McKesson Corp., Walgreens, Cardinal Health, AmerisourceBergen, CVS and Walmart, according to an analysis of the database by The Washington Post. Three companies manufactured 88 percent of the opioids: SpecGx, a subsidiary of Mallinckrodt; ­Actavis Pharma; and Par Pharmaceutical, a subsidiary of Endo Pharmaceuticals.

“Purdue Pharma, which the plaintiffs allege sparked the epidemic in the 1990s with its introduction of OxyContin, its version of oxycodone, was ranked fourth among manufacturers with about 3 percent of the market.

“The volume of the pills handled by the companies skyrocketed as the epidemic surged, increasing about 51 percent from 8.4 billion in 2006 to 12.6 billion in 2012. By contrast, doses of morphine, a well-known treatment for severe pain, averaged slightly more than 500 million a year during the period.”

The Post's Joel Achenbach reported from one of the hardest-hit communities in Norton, Va., which is party to a lawsuit against drug companies seeking millions of damages.

“It’s outrageous,” Charles Slemp, the commonwealth’s attorney for the city of Norton and surrounding Wise County, told Joel. “It’s unfortunate that there’s that number of prescription drugs flooding the market. It is extremely disappointing that substances that are manufactured to help an individual are being sold and distributed at proportions that are poisoning not just individuals but an entire community.”

He talked to a foster mom who said the kids she's now caring for have been placed with her because of drug abuse in their families.

“The kids I’m taking in — it’s all due to drugs now. Before, it was neglect,” said Crystal Miller, 32.

It seems, however, that things might be changing, with two lawsuits at the federal level and every state — plus 2,000 towns and cities — filing charges against drug companies that they say sickened their communities and now must help to nurse them back to health.

But now the effort to hold someone to account for the worst drug crisis in U.S. history is narrowing to a few dozen drug companies whose day in court has come or will soon arrive,” write Lenny and Christopher Rowland.

" 'It is a drug company crisis, and it begins and should end with them,' Oklahoma attorney Bradley Beckworth told a judge this week in the first state drug trial of the opioid era. The state is seeking $17.5 billion from the health care conglomerate Johnson & Johnson to address the costs of addiction.”

The Oklahoma judge is expected to rule on the state case in August. But there are 48 more state trials to go.

Note to readers: Paige Winfield Cunningham is on vacation and will be back on Tuesday. Meanwhile, we have a lineup of Washington Post writers to keep you up-to-date on the health-care news of the day. Thanks for reading.

AHH, OOF and OUCH

AHH: In a victory for at least two families, UnitedHealthcare said it would reverse previous decisions to deny coverage for a $2.1 million gene therapy for spinal muscular atrophy, a rare and debilitating disease.

The insurance company approved coverage for six requests for the recently approved drug, our Post colleague Christopher Rowland reports, “four based on initial claims and now two more after the families appealed.” The drug Zolgensma, marketed by Novartis, is meant to be a one-time treatment for the disease -- it works by replacing the defective gene causing the spinal muscular atrophy with a good one, but it must be administered by the age of 2. Christopher wrote last week about the families who were battling to get approval, an example of a debate over insurance coverage for advanced gene treatments.

“Lauren Sullivan, whose 21-month-old daughter, Daryn, was running out of time to receive the drug before her second birthday in October, said she was deeply relieved when a UnitedHealthcare representative called to relay the decision Wednesday,” Christopher writes. Sullivan told him: "I was sobbing, calling everyone, and thanking everyone and sending emails. We couldn’t believe it." 

“The stressful appeals the Sullivan and Patgiri families undertook were described by The Washington Post last week. UnitedHealth Group’s chief medical officer, Richard Migliori, said in an interview Thursday that public attention on the families’ plight played no role in the reversal. He said the decisions were based on clinical evidence.”

OOF: Here’s the latest obstacle in the Trump administration’s ongoing effort to tackle drug prices: Canada is warning U.S. officials that any effort to import cheaper prescription drugs into the United States could create shortages or raise costs for its own residents, Reuters’s Caroline Humer reports.

“Canada does not support actions that could adversely affect the supply of prescription drugs in Canada and potentially raise costs of prescription drugs for Canadians,” reads an April briefing obtained by Reuters.

The memo comes as the Trump administration has signaled support for efforts to import less expensive prescriptions and U.S. lawmakers have introduced legislation and called for approving Canadian imports. At least 10 states have passed or proposed such laws but they require federal approval.

“The talking points, prepared by Canada’s foreign ministry for use by Canadian officials who speak with U.S. officials, cite research suggesting shipments to the United States could cause shortages in Canada," Caroline adds. "...The ministry said officials have ‘made Canada’s position clear’ to both federal and state officials in the United States and it stood ready to take action to ensure Canadians have uninterrupted access to the prescription drugs they need."

OUCH: The World Health Organization declared the Ebola outbreak in Congo a global health emergency this week, nearly a year after the outbreak began in Congo's conflict-ridden North Kivu province.

What does that mean and why has the declaration been controversial? WHO has made the declaration for a "public health emergency of international concern" just four times in the past, and it’s one that lets other countries know to be on alert and help in the response, as our Post colleague Claire Parker reports. The other declarations involved the 2009 swine flu epidemic, the 2014 spread of polio in numerous countries, the 2014 Ebola outbreak in West Africa and the 2016 Zika epidemic.

“The WHO declined to label the Ebola outbreak in Congo a global health emergency three times before it finally did so Wednesday,” Claire writes. “It’s unclear what tipped the scales, but the WHO emergency committee cited a recent case confirmed in the city of Goma as one catalyst, according to a WHO news release.”

Some, including the Congo government, worry the label could create paranoia and negatively impact trade and travel. And while the label is mostly symoblic, because the designation doesn’t lead to automatic funding or responses, some international players have already pledged support. 

TRUMP TEMPERATURE

— The White House has reportedly sent a list of savings options to House Speaker Nancy Pelosi (D-Calif.) as leaders look to pair a budget agreement with a debt limit deal -- and one of those options is the $115 billion in savings from the Trump administration’s drug pricing proposal.

“The Trump administration is giving Democrats a menu of savings equaling at least $574 billion to offset the costs of a two-year budget cap agreement. The White House is seeking to pay for at least $150 billion of the cost for raising the caps and the next step would be for Pelosi to accept or reject items on the list of proposed cuts,” Bloomberg’s Jennifer Jacobs and Erik Wasson report. “Roughly half of the proposals are cuts and the others come from reforms…One of the suggested reforms is the drug pricing plan from the White House’s 2020 budget, which would save $115 billion, one of the people said.”

HEALTH ON THE HILL

— Sen. Bernie Sanders (I-Vt.) is not backing down from his quarrel with former vice president Joe Biden, telling the New York Times’s Sydney Ember and Katie Glueck that Biden is “sounding like Donald Trump” and “sounding like the health care industry” in the way that he’s criticized Medicare-for-all.

“I am disappointed, I have to say, in Joe, who is a friend of mine, really distorting what Medicare for All is about,” Sanders told them in an interview. “And unfortunately, he is sounding like Donald Trump. He is sounding like the health care industry in that regard.”

“Tensions between Sanders and Biden have been rising for several days over health care,” our Post colleagues Sean Sullivan and Robert Costa wrote earlier this week. “Biden released a plan this week that would expand the Affordable Care Act with an optional public insurance program, and he warned that shifting to a more sweeping Medicare-for-all initiative, as Sanders advocates, is risky and could hurt patients.”

Sanders has himself been ramping up those attacks, Sydney and Katie write: “His campaign called Mr. Biden’s health care plan ‘Bidencare’ and even released a video that accuses him of ‘lying’ about Medicare for All. But Mr. Biden, too, has been a more-than-willing participant, openly criticizing Medicare for All on multiple campaign swings over the last week.”

—  And here are a few more good reads: 

Politics
Paul and Lee held up the measure Wednesday as they pressed for votes on their proposed amendments. It’s now set for a vote next week.;
Felicia Sonmez and Devlin Barrett
AGENCY ALERT
Climate and Environment
The EPA rejected a petition by environmental and public health groups to ban a widely used pesticide that has been linked to neurological damage in children, though a federal court said last year there was “no justification” for rejecting the ban.
Brady Dennis and Juliet Eilperin
REPRODUCTIVE WARS
The departure of Dr. Wen, Planned Parenthood’s president, underscored a central tension: Is it a political organization first, or a health organization? And can it be both?
New York Times
MEDICAL MISSIVES
Capital Weather Gang
Heat advisories and warnings affect 154 million Americans as temperatures are forecast to reach at least 95 degrees for over half the population. The humidity will make it feel even hotter.
Andrew Freedman and Jason Samenow
Business
As grieving parents called for action, industry argued against warning, recall
Todd Frankel
INDUSTRY RX
A deal would give Novartis a much-needed opportunity to dispense with a string of well-publicized cases involving bribes paid in the U.S. and elsewhere.
Stat
DAYBOOK

Coming Up

  • The House Homeland Security Subcommittee on Emergency Preparedness, Response and Recovery holds a hearing on "Assessing Emergency Preparedness for Underserved Populations" on July 23. 
  • The House Oversight and Reform Subcommittee on Economic and Consumer Policy holds hearings on "Examining Juul's Role in the Youth Nicotine Epidemic" on July 24 and July 25. 
SUGAR RUSH

Rep. Ilhan Omar (D-Minn.) was greeted at the airport in her home state with welome chants after the crowd at President Trump's rally this week chanted “send her back":