Drugmakers won't replace opioids anytime soon Presented by

With help from Adam Cancryn.

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Quick Fix

— New pain meds won't replace opioids any time soon, the head of the National Institute on Drug Abuse told POLITICO in an interview.

— A bill to protect people with pre-existing conditions is top of the agenda for West Virginia's attorney general, who's joined the red state lawsuit trying to overturn Obamacare.

— Grassley scolds his colleagues over drug pricing as he renews his push to pass his bipartisan measure in Congress' rapidly dwindling window of opportunity.

A message from PhRMA: Today, there are several promising vaccine candidates in stage three clinical trials. These trials have tens of thousands of participants, from every walk of life. From development to robust clinical trials, and throughout manufacturing, these vaccine candidates follow the same rigorous process of other vaccines that have saved millions of lives. More.

WELCOME TO WEDNESDAY PULSE — Where we are recovering from yet another Washington shutdown — the snowy kind. (Although this seemed more like a watery blizzard). Your regular PULSE author returns tonight. Send tips to Dan Diamond ([email protected]).

Driving the Day

LESS ADDICTIVE OPIOID REPLACEMENTS ARE STILL YEARS AWAY — We're still another five to 10 years away from new pain medications replacing today's opioids, NIDA Director Nora Volkow told POLITICO's Sarah Owermohle and Sarah Karlin-Smith. And that's the best-case scenario.

— The pharmaceutical industry is scrambling to bring opioid alternatives to market, but eager manufacturers have plenty of obstacles. Volkow told the Sarahs that her five-to-10-year timeframe assumes medicines currently in Phase II and III clinical trials prove effective and can secure FDA approval in the next several years. Novel molecules that are in earlier stages of drug research and development could take longer — if they work at all.

For a long time there was a dearth of interest in new painkillers because opioids were so commercially successful, Volkow said. Only now, amid the opioid crisis that kills an estimated 130 people a day, is the need and business potential clear.

Volkow also noted that any new medicines could be addictive, and regulators need to take precautions for how, where and when the drugs could be used to forestall a new crisis of overprescribing, addiction and misuse.

— Providers, take note: The NIDA director warned that hospitals also need to be careful when they administer potentially addictive drugs to their patients.

“I’m a little concerned about delivery systems that will enable the use of [addictive] drugs outside” of controlled settings, she said. This could open up a “Pandora’s box to allow a drug that could be diverted and abused.”

Obamacare

W.Va. ATTORNEY GENERAL CALLS FOR PRE-EXISTING CONDITIONS PROTECTIONS — West Virginia's GOP Attorney General Patrick Morrisey, who joined the red state lawsuit to shut down Obamacare, announced a forthcoming bill aimed at guaranteeing health care coverage for people with pre-existing conditions if that lawsuit succeeds.

Morrisey sought bipartisan support for the "no-brainer" proposal even as he defended his position on the Obamacare lawsuit, citing the "skyrocketing premiums" of the Affordable Care Act exchanges.

— The emphasis on pre-existing conditions underscores how even Republicans in West Virginia, where President Donald Trump won almost 70 percent of the vote, worry about Obamacare politics now that the lawsuit has jumped back into the public eye.

Morrisey and the measure's sponsor, Republican State Senate President Mitch Carmichael, previewed the proposal on Tuesday. The state legislature's 60-day session begins today.

There aren't many details about the "West Virginia Healthcare Continuity Act" since it hasn't yet been introduced. Morrisey's office says it would broadly prevent insurers from refusing coverage based on a person's pre-existing medical condition, while also "mitigating the risk faced by insurers with open enrollment and affiliation periods."

West Virginia Gov. Jim Justice, also a Republican, is set to mention the proposal in his "State of the State" address tonight.

— Deadline approaches: The fraught politics surrounding the Obamacare lawsuit could heat up even more this week, as the Supreme Court weighs whether to intercept the case from the conservative Texas judge who axed all of Obamacare in 2018 and was tasked by an appeals court to take another crack at the law. The Trump administration and Republican-led states challenging the law must respond to a petition at the high court by Friday.

In Congress

GRASSLEY RENEWS DRUG PRICING BATTLE WITH PHARMA, GOP — Sen. Chuck Grassley had sharp words for the pharmaceutical industry and some in his own party over the resistance to his drug pricing legislation, S. 2543 (116), pointing to recent price hikes as proof that Congress needs to crack down on drugmakers.

"People are fed up with big increases in drug prices," he told reporters on Tuesday. "There's 22 Republicans up for election, and they need an answer to that."

The cost of hundreds of drugs increased an average of 5 percent in the first days of 2020, giving Democrats an opening to hammer the Trump administration and Republicans for failing to control prices. Still, POLITICO's Adam Cancryn notes, Grassley has struggled to win support for his measure within the Republican caucus, largely due to the way it would penalize companies that raise prices faster than inflation — criticized by Republicans and the pharmaceutical industry as tantamount to price controls. Democrats, meanwhile, are trying to keep the focus on their sweeping drug price bill that passed the House last year, H.R. 3 (116).

Grassley opted for a more nuanced appeal to both parties, arguing that his bill is the only one with any shot at the 60 votes needed to pass the Senate, while also noting it wouldn't fix prices because companies could still introduce drugs at any initial price needed to recoup their investment. "We're only saying, once you get your money back, you have to keep your prices reasonable," he said.

Public Health

LOWER SUICIDE RATE LINKED TO SLIGHT MINIMUM WAGE HIKES: A new study links a $1 increase in the minimum wage to a 3.5 percent to 6 percent decline in the suicide rate among people who have a high school education or less.

The study, newly published in the Journal of Epidemiology and Community Health, followed the economy's upturns and declines from 1990 through 2015 and in all 50 states and D.C.

The research indicates that when unemployment is up, even minimal differences in minimum wage levels can change someone's risk of suicide.

— In sobering estimates, the authors calculated that between 2009 and 2015, a $1 increase to the minimum wage could have prevented nearly 14,000 suicides among people with lower education levels.

That said, far fewer states are matching the federal minimum rate: Twenty-one states were in 2015, compared to 36 states in 1990.

— Meanwhile, suicides are on the rise. In 2017, nearly one in five deaths among people aged 18 and 24 were by suicide. Between 1999 and 2017, suicide rates rates increased more than 30 percent in half of the states.

2020 Watch

MAYOR PETE ATTACKS MEDICARE FOR ALL — In a new ad in Nevada, Democratic presidential hopeful Pete Buttigieg targets Medicare for All as an idea that risks “further polarizing Americans.”

The South Bend, Ind., mayor touted his public option plan as one that doesn’t “dictate” people’s choice.

— The move isn't quelling progressive criticism. Rep. Pramila Jayapal (D-Wash.), who co-chairs the Congressional Progressive Caucus, responded by calling the Buttigieg plan a “misleading half-measure that will not fully address the enormous health care crisis in America.”

She and CPC co-chair Rep. Mark Pocan (D-Wis.) head to Iowa this weekend to host a Medicare for All town hall in Des Moines.

Opioids

CLASS ACTION STATUS SOUGHT FOR INFANTS BORN WITH OPIOID DEPENDENCY: Attorneys asked a federal judge in Ohio on Tuesday to grant class certification for children born with neonatal abstinence syndrome, or drug dependency.

The petition was filed to U.S. District Judge Dan Polster, who’s presiding over mass litigation against drug firms for their alleged role in fueling the opioid crisis.

“These children are the most vulnerable and blameless victims of the opioid crisis and will need lifelong medical monitoring and surveillance, as well as medical and social support services,” said Marc Dann, a former Ohio attorney general who submitted the brief.

Medicaid

FLORIDA LAWMAKERS SEEK TO QUELL MEDICAID EXPANSION PUSH — The Republican-controlled Florida Senate asked the state's Supreme Court to kill a petition to put Medicaid expansion on the ballot, POLITICO's Alexandra Glorioso reports.

The group Florida Decides Healthcare Inc. wants voters to decide whether to expand Medicaid for poor adults through a constitutional amendment. They're making their case to the Supreme Court on Feb. 6.

The Senate contends that Florida Decides Healthcare failed to get enough signatures to include the question on the ballot this year. The group is planning to apply the collected signatures and the state Supreme Court's opinion to the ballot process for 2022, as signatures are valid for two years.

A message from PhRMA: America’s biopharmaceutical companies are making great progress against a common enemy – COVID-19. They’re learning from successful vaccines for other diseases, developing new treatments and collaborating like never before. Today, there are several promising vaccine candidates in stage three clinical trials. These trials have tens of thousands of participants, from every walk of life. From development to robust clinical trials, and throughout manufacturing, these vaccine candidates follow the same rigorous process of other vaccines that have saved millions of lives. America’s biopharmaceutical companies are working day and night until they defeat COVID-19. Because science is how we get back to normal.

What We're Reading

Two economists including a Nobel Prize winner had blistering words for the expensive U.S. health care system, the Washington Post's Heather Long reports, calling it "like a tribute to a foreign power, but we're doing it to ourselves."

603 hours: that’s how long a 15-year-old and his parents had to wait for his bed in an inpatient psychiatric ward. Read more of their “Kafkaesque” experience of the nationwide psychiatric bed shortage, as reported by MedPage Today’s Elizabeth Hlavinka.

Human trials are underway for 89 versions of an elusive cancer therapy that pairs antibodies with toxic agents to attack tumors with far more ammunition than chemo can, according to Reuters’ Ludwig Burger and John Miller.

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