Taking on Tranq

From: POLITICO Pulse - Tuesday Jul 11,2023 02:02 pm
Presented by PhRMA: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy.
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By Megan R. Wilson and Daniel Payne

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With Carmen Paun and Ben Leonard 

Driving the Day

The Director of the US Office of National Drug Control Policy, Rahul Gupta, speaks during a press conference

Rahul Gupta, director of the Office of National Drug Control Policy, unveiled a plan to prevent deaths associated with xylazine, a horse tranquilizer often combined with fentanyl. | Juan Pablo Pino/AFP via Getty Images

WHITE HOUSE PLOTS ‘TRANQ DOPE’ PLAN — The Biden administration is rolling out a plan to curb deaths caused by a drug known as “Tranq Dope” — a combination of fentanyl, a powerful synthetic opioid, and the horse tranquilizer xylazine, Carmen reports.

The effort, unveiled by the White House’s Office of National Drug Control Policy this morning, focuses on improving testing and data collection and developing standards for prevention, harm reduction and treatment — in addition to obtaining more information about the xylazine supply chain and researching the drug’s impact.

“What I want everyone to understand is this: If we thought fentanyl was dangerous, fentanyl combined with xylazine is even deadlier,” said ONDCP Director Rahul Gupta.

The percentage of fatal opioid overdoses in which xylazine was detected rose by 276 percent between January 2019 through June 2022 — from 2.9 percent of overdoses to 10.9 percent, according to a recent CDC report. The agency noted that because the data represents 20 states and the District of Columbia, the “results might not be generalizable” nationwide and cautioned that disproportional testing among states may have led to an undercount of xylazine-connected deaths that potentially inflated the increase.

More than 4,800 people died of an overdose that included xylazine between January 2021 and June 2022, according to the report — likely an undercount because it contains data from 31 states and D.C.

The White House aims to achieve a 15 percent reduction by 2025 in the number of drug poisoning deaths in which xylazine is detected compared to 2022.

Xylazine doesn’t respond to naloxone, the opioid overdose reversal drug, which makes Tranq Dope even more lethal than fentanyl alone. But dealers mix the two because xylazine enhances fentanyl’s high.

Those who survive an overdose can end up with deep, hard-to-treat skin and soft-tissue wounds caused by xylazine. Dependence on either substance causes severe withdrawal symptoms and makes it difficult to treat people because there’s no consensus on the best protocol, according to the ONDCP.

WELCOME TO TUESDAY PULSE. This week, don’t forget: Drink water and get some sunlight — humans are basically just houseplants with more complicated emotions. But a new study furthers research of the sounds plants make when stressed — and shows they’re more complex than we’d thought.

I’m Megan Wilson, the health team’s lobbying reporter, and I’d love to hear all of your complicated thoughts and feelings. Email me at mwilson@politico.com, and don’t forget to tip dpayne@politico.com.

TODAY ON OUR PULSE CHECK PODCAST, Megan talks with host Ben Leonard and breaks down what lies in store for lawmakers returning from their July recess — with only 11 legislative days before their next. Expect high policy aspirations and partisan gridlock as deadlines approach for must-pass health care legislation.

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A message from PhRMA:

Research and development of cancer medicines after their initial FDA approval can help expand treatment populations, find new ways of treating a cancer or help patients earlier in their cancer battle. Unfortunately, provisions in the Inflation Reduction Act put this progress in jeopardy by selecting medicines for price setting before many of these critical advancements can be fully realized. Read the new report.

 
In Congress

Sens. Ron Wyden, left, and Mike Crapo, right, arrive at a Senate Finance hearing on Capitol Hill.

Finance Committee Chair Ron Wyden (l.) and ranking member Mike Crapo are cracking down on pharmacy benefit managers' business practices. | Andrew Harnik/AP Photo

MORE COMING ON PBMs — The Senate Finance Committee is moving forward with its promise to rein in pharmacy benefit managers, according to lobbyists and a Senate health aide granted anonymity to talk about the plans — telling Megan that additional proposals targeting the industry are expected to drop in the coming days.

Although it’s unclear what the PBM-focused bills would contain, it’s part of a broader attempt by Chair Ron Wyden (D-Ore.) and ranking member Mike Crapo (R-Idaho) to crack down on PBMs’ business practices. The duo released a roadmap in April that laid out the types of bipartisan policies they wanted to pursue.

PBMs negotiate discounts on medicines with drugmakers and decide which treatments health plans will cover and have faced bipartisan scrutiny in the House and Senate this year.

Several bills have already been released as part of the Senate Finance Committee effort, including one that would take aim at what critics say are misaligned incentives that drive up prescription drug costs for Americans.

The industry is fighting back, arguing that Congress should be focused on passing legislation that advanced out of the Senate Judiciary Committee this year that would crack down on how drugmakers use the patent system to prolong exclusivity over their products.

The movement would come as questions still swirl about which measures will make it into Senate Majority Leader Chuck Schumer’s long-awaited insulin and drug pricing package.

FIGHTING COVID-ORIGIN COVER-UP ACCUSATIONS — Two authors of a 2020 scientific paper discussing the origin of the coronavirus pandemic will appear before a House panel Tuesday to fight accusations that their paper was meant to cover up a potential lab origin of Covid-19 orchestrated by Anthony Fauci, the former director of the National Institute of Allergy and Infectious Diseases.

Kristian Andersen, professor at Scripps Research, and Robert Garry, professor at Tulane University School of Medicine, will tell the Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic they genuinely attempted to consider the evidence available about the pandemic’s origins, according to their written testimonies.

Andersen will also testify that allegations from House Republicans that he drafted the paper after being prompted by Fauci to disprove a potential lab leak in exchange for a nearly $9 million grant are “absurd and false.”

Jeremy Farrar, now the World Health Organization’s chief scientist, organized the scientists who wrote the paper, according to Andersen. He will also say the $9 million grant was approved in November 2019, months before the start of the paper-drafting process.

The panel subpoenaed Andersen’s Slack messages with Fauci, Farrar and others to understand Fauci’s involvement in the process. Fauci told POLITICO in March that he wasn’t involved in writing or editing the paper.

Democrats strike back: A Democratic staff report released this morning aims to disprove Republicans’ accusations that Fauci and Francis Collins, the former NIH director, orchestrated the paper to hide NIH funding to the Wuhan virology lab, which is at the center of the lab leak hypothesis.

Panel Republicans have called the paper a cover-up, convinced that Fauci and other NIH officials have tried to distract from what the GOP believes was a lab accident in Wuhan triggering the pandemic, following experiments with coronaviruses partly funded by the U.S. government.

The report, which Democratic staff claims is based on more than 10,000 pages of email exchanges and transcribed interviews with Andersen and Garry, points to Farrar as having organized the paper, not Fauci nor Collins.

 

UNLEASH THE FUTURE OF HEALTHCARE WITH POLITICO, A 7/20 INTERACTIVE EVENT: Imagine a future where rare genetic diseases are not only treatable, but potentially curable. Where our approach to chronic illness takes a monumental leap forward. That future is already taking shape in the form of next-generation health care treatments such as gene therapy. Join POLITICO on Thursday, July 20 and delve into the burgeoning field of gene therapies, which hold the power to redefine our health care landscape. Are you ready to explore this new frontier in health care? Don't miss this chance to be part of the conversation. REGISTER NOW.

 
 
Around the Agencies

HACKERS MINE HEALTH DATA — Data breaches of Americans’ personal health data exploded in the first half of 2023, according to HHS data crunched by Ben.

Health care entities covered by the federal health privacy law HIPAA have reported more than 330 breaches affecting 41.4 million people to HHS’ Office for Civil Rights, already closing in on 2022’s total of more than 52 million, Ben found.

The targets are growing as the sector modernizes and health data increasingly goes digital.

Among the breaches, hackers accessed 8.9 million people’s data at Managed Care of North America, which offers dental plans, and 5.8 millions’ at pharmacy firm PharMerica.

What’s next: HHS has asked Congress to nearly double the Office for Civil Rights’ budget for fiscal year 2024 to cope with the increased workload. The office said earlier this year it was restructuring to better handle data breaches.

 

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Names in the News

Elizabeth Cherot has been named president and CEO of March of Dimes, a nonprofit that supports mothers and babies. Before that, she led the group’s Office of Maternal and Child Health Impact and is the first physician to lead the organization. She begins on July 17.

Richard Carbo, former top aide to Louisiana Gov. John Bel Edwards, has joined lobbying and public affairs firm Cornerstone. He most recently worked at S-3 Public Affairs.

Jonathan Jagoda is now senior policy adviser at Alston & Bird. He previously was a senior vice president at the Federation of American Hospitals.

 

LISTEN TO POLITICO'S ENERGY PODCAST: Check out our daily five-minute brief on the latest energy and environmental politics and policy news. Don't miss out on the must-know stories, candid insights, and analysis from POLITICO's energy team. Listen today.

 
 
What We're Reading

The Wall Street Journal reports that European regulators are looking into whether weight-loss drugs like Ozempic increase the risk of suicidal thoughts.

KFF Health News has a database of who’s overseeing the distribution of billions of dollars in opioid settlement money.

CNN reports on how tax-exempt hospitals are coming under more scrutiny for how they operate.

 

A message from PhRMA:

A new report showcases the vital role of post-approval R&D in nine critical oncology treatments. This research can help expand treatment populations, find new ways of treating a cancer or help patients earlier in their cancer battle. Unfortunately, provisions in the Inflation Reduction Act put this progress in jeopardy by selecting medicines for price setting before many of these critical advancements can be fully realized. See how post-approval R&D in cancer is at risk.

 
 

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