THE PROGNOSIS

Now only six drug companies will go to trial later this month before a judge in Cleveland, Ohio, in a landmark case to decide who bears responsibility for the country's opioid abuse epidemic. 

There were seven companies until Johnson & Johnson announced yesterday it reached a $20.4 million settlement with Ohio's Cuyahoga and Summit counties, saying it can now "avoid the resource demands and uncertainty of a trial," my colleagues Scott Higham, Sari Horwitz and Lenny Bernstein report. The remaining companies include manufacturer Teva Pharmaceuticals, distributors McKesson, Cardinal Health, AmerisourceBergen and Henry Schein, and the pharmacy Walgreens, from whom the counties are seeking billions of dollars in damages and financial contributions for addiction treatment, emergency services and health care for people affected by opioid abuse.

"The deal would winnow to six the number of defendants scheduled to stand trial this month in a lawsuit brought by more than more than 2,500 counties, cities and Native American tribes," Scott, Sari and Lenny write. "The plaintiffs sued nearly two dozen drug manufacturers, distributors and pharmacies, alleging that they fueled the nation’s prescription opioid epidemic, which has claimed more than 200,000 lives since 1999."

Jury selection is set to begin on Oct. 16 and the trial is scheduled to start the following week. As the remaining companies defend themselves, they'll likely try to assign some blame on their own pointing the finger at federal authorities for not doing enough to stem the flow of opioids.

Their association, the Healthcare Distribution Alliance, yesterday seized upon a government watchdog report finding the Drug Enforcement Administration allowed opioid manufacturers to substantially increase the number of opioid painkillers they sold every year.

The report “highlights many concerns that distributors have consistently raised around the DEA’s oversight of the opioid epidemic, and, notably, the fact that previous DEA leadership consistently raised production quotas for opioids,” HDA senior vice president John Parker said in a statement.

The drug companies are up against allegations that they allowed billions of pills to be diverted to the streets. But these companies argue that they produced only as many pills as the DEA allowed each year. The new watchdog report may lend some credence to their claims, while certainly not absolving the companies of responsibility in the crisis.

The DEA, which sets annual quotas for narcotic painkillers produced in the United States, authorized an increase of more than 400 percent in oxycodone output between 2002 and 2013 — even as overdose deaths rose an average of 8 percent from 1999 to 2013. The agency didn’t start cutting back until 2017, well after the problem of opioid abuse and overdose was a widely recognized problem.

That’s not all the inspector general found. The report also said the DEA didn’t give immediate suspension orders — one of its best tools for making sure pills don’t end up in the wrong hands — nearly often enough. These orders allow the agency to instantly halt shipment of pain pills from a distributor. The DEA issued more of these orders in 2012 than it did from 2013 to 2017, according to the report.

“We found that DEA was slow to respond to the significant increase in the use and diversion of opioids since 2000,” the report says. “We found that DEA policies and regulations did not adequately hold registrants accountable or prevent the diversion of pharmaceutical opioids.”

My Post colleagues reported previously on this sharp decline in immediate suspension orders. Back in 2016, Lenny and Scott Higham detailed how the DEA’s legal office was seeking to prevent field offices from using that power. And in 2017, they explained how Congress made the use of such orders almost impossible, under heavy lobbying from the pharmaceutical industry.

The DEA responded yesterday to the new report, telling Lenny that it has sharply reduced production levels of opioids over the past three years. Spokeswoman Mary Brandenberger also said DEA “secured more than $194 million in civil penalties” in fiscal 2017, “more than the total of the prior seven years combined.”

Expect to hear an intense debate later this month over where the responsibility for the opioid crisis lays, as the showdown between counties and drug companies begins. Lawyers for the two counties wrote in court filings that they’ll prove that opioid manufacturers and distributors harmed public health and safety.

“The opioid epidemic…constitutes an unreasonable interference with public health, public safety, public peace or public comfort” that results from products distributed irresponsibly by the drug industry, they wrote.

Here’s what some of the companies plan to argue based on their own court filings, as reviewed by Lenny:

— Walgreens says the counties “cannot show that any conduct by Walgreens resulted in the diversion of prescription opioid medications that could have caused the harms that plaintiffs allege.” 

— McKesson, the nation’s largest drug distributor, said it would “introduce evidence establishing that it complied with DEA’s shifting guidance regarding suspicious orders.”

— Teva said the counties cannot prove a causal link between drug sales by the company or its subsidiaries and any harms to Cuyahoga or Summit residents.

AHH, OOF and OUCH

AHH: President Trump is planning to tap Stephen Hahn, a radiation oncologist and senior official at MD Anderson Cancer Center, to be the next head of The Food and Drug Administration, Stat’s Lev Facher and Nicholas Florko report. He has until Nov. 1 to nominate a permanent FDA chief.

That decision will deviate from the advice of four former FDA commissioners and advocacy groups that urged the president to name Ned Sharpless, who has led the agency in an acting capacity since former FDA commissioner Scott Gottlieb left in April.

“Hahn, 59, is a longtime Republican donor who supported the presidential campaigns of GOP nominees Mitt Romney, John McCain, and George W. Bush, and numerous Republican lawmakers — but not Trump, according to STAT’s review of his campaign finance records,” they write. ‘…Under Hahn’s purview, both institutions encountered controversy, though he was not individually implicated in any high-profile misstep. This year, regulators found that MD Anderson had run afoul of federal rules so dramatically that the transgressions “substantially limit [the] hospital’s capacity to render adequate care.’”

Our Post colleague Laurie McGinley wrote last month that Hahn had emerged as a top candidate for the post.

OOF: The FDA tried four years ago under the Obama administration to ban flavored e-cigarette fluids, warning about a youth vaping crisis.

White House officials considered whether to include a ban as part of new tobacco rules, and over a period of 46 days, more than 100 tobacco industry lobbyists and small business advocates met with White House officials as they determined whether to do so, the Los Angeles Times’s Emily Baumgaertner reports.

Ultimately, top Obama administration officials chose to reject the ban, even though it had the support of scientists and public health experts. “The officials told The Times that a cost-benefit analysis suggested the economic burden on vape shops appeared to outweigh potential health benefits of the ban,” Emily writes.

Cecilia Muñoz, then a senior official heading the White House’s Domestic Policy Council, told the Los Angeles Times that the FDA and the Office of Management and Budget jointly made the decision but added that the FDA “struggled mightily” with determining the economic consequences of such a ban.

“We had deep respect for the science-based agencies. In this case, the science wasn’t clear,” she said. “The question was: Is it reasonable to effectively shut down all of these vape shops and businesses when the benefits and harms were still inconclusive?”

— Juul Labs will pull funding that was donated in support of Proposition C, a ballot measure in San Francisco meant to overturn a vaping law there, the Associated Press reports.

The company donated nearly $19 million to the Yes on C campaign and was essentially the campaign's only financial backer. 

"Matt Dorsey, spokesman for the No on C campaign, said so much money has been spent in support of the proposition that opponents have no choice but to continue educating voters on a measure that will appear on San Francisco’s Nov. 5 ballot," the AP reports. "...San Francisco’s proposition would overturn a city ordinance approved by supervisors in June, and set to start in January, to stop all sales of e-cigarettes and vape products in the city until the U.S. Food and Drug Administration reviewed and approved their use." 

The change comes as Juul has been the focus of a nationwide crisis over e-cigarette use. 

Authorities said Tuesday that a Virginia resident died in North Carolina due to a severe lung injury after vaping. It's one of the 31 lung injury cases in Virginia and one of 805 such cases across 46 states and one U.S. territory, our Post colleague Justin Wm. Moyer reports.

OUCH: A federal judge has blocked Georgia’s six-week abortion ban from going into effect while a challenge to the “heartbeat” bill plays out in court.

U.S. District Judge Steve Jones sided with abortion rights advocates that have sued the state over the law that restricts the procedure as early as six weeks into pregnancy and that was meant to go into effect on Jan. 1.

"Jones wrote the plaintiffs met their burden of showing the ban would cause 'irreparable harm' and violate a woman’s constitutional right to privacy. He also stated that the U.S. Supreme Court has 'repeatedly and unequivocally' held that a state cannot ban abortion before viability," our Post colleague Samantha Schmidt reports. 

“What is clearly defined, however, is that under no circumstances whatsoever may a state prohibit or ban abortions at any point prior to viability, no matter what interests the state asserts to support it,” Jones wrote in the ruling. “By banning abortions after a fetal heartbeat is detected, HB 481 prohibits women from making the ultimate decision to terminate her pregnancy at a point before viability.”

HEALTH ON THE HILL

— House Democratic leaders are calling on the National Institutes of Health to conduct more research into how using e-cigarettes affect people’s health.

Rep. Raja Krishnamoorthi (D-Ill.), chairman of the House Oversight and Reform subcommittee on economic and consumer policy, sent a letter to NIH Director Francis Collins, saying “Action by NIH now to support more scientific research into the risks associated with e-cigarette usage and vaping could save countless lives.”

He called on the agency to “allocate new research grants and to announce the availability of supplements to current grants to fund research into the human health impact of vaping. … Strong scientific research into the long-term health risks of vaping is needed now by government, physicians and consumers; lives depend on it.”

REPRODUCTIVE WARS

— Town councils in East Texas have been passing abortion bans and calling themselves “sanctuary cities for the unborn,” our Post colleague Emily Wax-Thibodeaux reportsFive towns have adopted an ordinance that outlaws emergency contraception such as Plan B, criminalizes abortion rights groups and fines doctors $2,000 for performing abortions, she writes. A sixth East Texas town has adopted a more lenient version of the ordinance.

Mark Lee Dickson, who works with antiabortion group Texas Right to Life to pitch the bans in municipalities throughout Texas, said he plans to travel to more than 400 Texas municipalities to pitch the ban.

“This is a local issue because it impacts the most vulnerable — the unborn child,” Dickson told Emily. “If we could do this in Texas, we can do this in cities and towns in Arizona, in Florida, in Iowa. It could happen all over the country.”

Hundreds of miles west, the Austin City Council is working in the opposite direction. Last month, it approved $150,000 to be used for transportation, hotels and other costs for women seeking an abortion. 

—  And here are a few more good reads: 

The four-term Republican, who resigned from the House on Monday, shared inside information about a company with his son.
New York Times
State borders can highlight Medicaid’s arbitrary coverage. On the Missouri side of the Mississippi River, low-income people struggle with untreated health issues. But on the Illinois side, people i…
Kaiser Health News
INDUSTRY RX
Juul's Switch Network is designed to have the look and feel of a grassroots movement where citizens are emboldened by a shared cause to lobby lawmakers for change. But Juul's campaign is what politicos call an Astroturf campaign.
CNBC
AGENCY ALERT
Smoking was already prohibited inside VA medical buildings, but now patients, employees and visitors will not be able to puff away anywhere on the grounds. Previously, smoking was allowed in designated shelters dotting the grounds of VA medical facilities. Posters and banners promoting the ban have been put up in facilities and the VA is alerting veterans through social media and letters.
Associated Press
MEDICAL MISSIVES
This was a “verbal autopsy” — an interview in which a trained health worker asks a close relative or caretaker about a recently deceased person. Increasingly, health officials are using these tools and their computer algorithms to learn more about the global course of human disease.
Associated Press
DAYBOOK

Today

  • The CATO Institute holds an event on naloxone policy an training.

Coming Up

  • The Center for Strategic and International Studies hosts an event on the outcomes of the UN high-level meeting on health coverage on Thursday.
  • The CATO Institute holds an event on patients, privacy and prescription drug monitoring programs on Thursday.
SUGAR RUSH

Watch Chris Collins submit his resignation to the House of Representatives: