Get Even More Visitors To Your Blog, Upgrade To A Business Listing >>

After Covid, some states see more TB cases

Presented by CVS Health: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.
Oct 24, 2023 View in browser
 

By Katherine Ellen Foley and David Lim

Presented by

Driving The Day

The number of cases of tuberculosis, which mainly affects the lungs, are creeping up in some states. | Spencer Platt/Getty Images

HEALTH EXPERTS WATCH TB CASES POST-PANDEMIC — After 30 years of slow but steady declines, tuberculosis cases in the U.S. plunged in 2020 at the height of the pandemic. But they’re rebounding, a worrisome development, public health experts say.  

In 2022, the Centers for Disease Control and Prevention tallied 8,300 cases of tuberculosis, up from 7,874 the year before. Preliminary data shows 19 states and the District of Columbia already have higher case counts than they did all of last year.

While this year’s increase likely won’t surpass 2019 numbers, experts say the steep drop-off in TB cases during the pandemic could be misleading because people who were sick, hospitals and doctors have been so focused on testing for Covid-19.

TB is “one of the types of diseases that reflects our ability to manage complex health problems,” Dr. Amita Gupta, director of the infectious diseases division at Johns Hopkins University School of Medicine, told Prescription Pulse. And some public health departments — particularly those with high concentrations of at-risk populations like migrants or people experiencing homelessness — say they struggle to meet patient demand.

As the top global infectious disease killer, it’s been impossible to eradicate in the U.S.

“One thing that probably a lot of the public is not aware of [is that] TB is still here in the United States,” Dr. Philip LoBue, director of the CDC’s division of tuberculosis elimination, told Prescription Pulse.

LoBue said it’s premature to conclude the Covid-19 pandemic led to fewer cases. Some experts hypothesize that TB cases appeared artificially depressed as many people did not seek treatment or moved around less during federal, state and local shutdowns.

The disease is airborne and travels well in environments in which individuals live in close proximity, such as in prisons or shelters. Even if others don’t get sick right away, they could develop latent TB — which can emerge later if a person’s immune system becomes compromised.

Delays in diagnosis lead to dangerous delays in treatment, which requires several months of specialized antibiotics. Two of the first-line antibiotics for TB were in shortage or limited supply as of March. If patients don’t complete their antibiotic treatment, they risk developing drug-resistant TB, which is even more difficult to treat.

IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Katherine will be a panelist at the Food and Drug Law Institute meeting later this week — come say hello!

Send news and tips to Lauren Gardner ([email protected] or @Gardner_LM), David Lim ([email protected] or @davidalim) and Katherine Ellen Foley ([email protected] or @katherineefoley).

TODAY ON OUR PULSE CHECK PODCAST, host Ben Leonard talks with POLITICO health care reporter Robert King, who explains why some state insurance commissioners want Congress to restore their authority to regulate Medicare Advantage marketing.

Listen to today’s Pulse Check podcast

A message from CVS Health:

Learn how we’re delivering the future of health care. More here.

 
In Congress

Bernie Sanders wants to know why the NIH proposed awarding an exclusive patent license for a cancer therapy to a little-known company. | Francis Chung/POLITICO

SANDERS TARGETS NIH — Senate HELP Chair Bernie Sanders (I-Vt.) is requesting that HHS Inspector General Christi Grimm investigate the NIH’s process for granting a monopoly patent license for a cervical cancer treatment he said could be worth up to billions of dollars in revenue. The request comes two days ahead of the committee’s vote on President Joe Biden’s nominee to lead the NIH.

The NIH proposed in September to award the exclusive patent license to a little-known company that employs a former NIH researcher who worked on the drug’s development while at NIH, POLITICO’s Erin Schumaker reports.

The lawmaker said he is concerned that a former NIH researcher “appears to have a direct relationship” with the company that is on track to get the valuable patent license.

“There does not appear to be anything reasonable and necessary about granting a monopoly for a treatment that was invented, manufactured and tested by the NIH, is already in late-stage trials and could potentially enrich a former NIH employee who was one of the major government researchers of this treatment,” Sanders wrote in a letter.

Sanders said he is growing increasingly alarmed that the NIH appears to have abdicated what he argues is its authority to ensure drugs it helps develop are reasonably priced. His letter highlighted a story the American Prospect published last week, characterizing the exclusive patent licensing system’s alleged misuse as a “how-to-become-a-billionaire” program run by the NIH.

An NIH spokesperson didn’t respond to a request for comment.

 

GO INSIDE THE MILKEN INSTITUTE FUTURE OF HEALTH SUMMIT: POLITICO is proud to partner with the Milken Institute to feature a special edition of our Future Pulse newsletter at the 2023 Milken Institute Future of Health Summit from November 6-8. The newsletter takes readers inside one of the most influential gatherings of global health industry leaders and innovators solving the biggest public health issues to ensure a healthier, more resilient future for all. SUBSCRIBE TODAY TO RECEIVE EXCLUSIVE COVERAGE.

 
 
Tobacco

FDA HOSTS INFO MEETING FOR INDUSTRY — The agency’s Center for Tobacco Products is hosting a two-day public meeting through today on best practices when asking the regulator to authorize new tobacco products — including e-cigarettes.

It is only the second public meeting on the tobacco regulatory process in four years, including a tobacco product advisory committee meeting held in June. In opening remarks Monday, CTP Director Brian King said the meeting was called partly to respond to independent experts convened by the Reagan-Udall Foundation, which released a report on the FDA’s tobacco regulation that found transparency on regulatory decisions needed improvement.

FDA officials gave detailed presentations Monday on how to submit applications but declined to answer specific questions about individual product reviews. Instead, they addressed broader concerns raised by attendees, including how long it takes for application decisions.

Agency officials said it should take “180 active FDA review days” to issue a decision on a marketing authorization application, though several products have been under review for multiple years.

“We have not necessarily hit that timeframe in the past. It’s our goal to hit it in the future,” said Cristi Stark, director of the division of regulatory project management in the CTP’s Office of Science.

Not everyone is convinced. “You can learn all you need to know about the FDA based on the way we ordered lunch,” griped one meeting attendee Monday, referencing a lengthy process that required attendees to order with a paper form that had to be physically carried through a long line. The attendee was granted anonymity due to his company’s pending marketing applications.

Meanwhile, the CTP is considering a modified-risk product that could offer tobacco users a safer alternative to cigarettes. On Friday, tobacco giant Philip Morris International completed its application for IQOS ILUMA, which heats, though doesn’t burn, tobacco sticks, producing fewer harmful chemicals than smoking.

The original IQOS is one of the few tobacco products that has received modified-risk clearance from the FDA but is available only internationally due to a patent dispute with British American Tobacco. U.S. sales are expected to resume in April.

Industry Intel

ROCHE DROPS SOME $$$ — Roche struck a $7.1 billion deal on Monday to acquire Telavant from Vivek Ramaswamy-founded Roivant for the development, manufacturing and commercialization rights to an inflammatory bowel disease therapy for the U.S. and Japan. The deal is expected to close in the fourth-quarter or the first-quarter of next year.

Roche said it wants to start a global Phase III trial for Televant’s inflammatory bowel disease therapy “as soon as possible.”

Ramaswamy stepped down from Roivant’s board of directors in February to focus on his 2024 presidential campaign. He stepped down as CEO in January 2021.

 

A message from CVS Health:

 
WHAT WE'RE READING

Millennials are unprepared to care for their aging Baby Boomer relatives, Anna North reports for Vox.

The CDC told health care providers to ration newly approved shots from Sanofi and AstraZeneca that provide infants with some immunity through their first respiratory virus season after the companies underestimated demand from doctors and patients, POLITICO’s Chelsea Cirruzzo reports.

 

A NEW POLITICO PODCAST: POLITICO Tech is an authoritative insider briefing on the politics and policy of technology. From crypto and the metaverse to cybersecurity and AI, we explore the who, what and how of policy shaping future industries. We’re kicking off with a series exploring darknet marketplaces, the virtual platforms that enable actors from all corners of the online world to traffic illicit goods. As malware and cybercrime attacks become increasingly frequent, regulators and law enforcement agencies work different angles to shut these platforms down, but new, often more unassailable marketplaces pop up. SUBSCRIBE AND START LISTENING TODAY.

 
 
Pharma Moves

Johnson & Johnson announced Ashley McEvoy, executive vice president and worldwide chair of its medtech unit, will leave the company in the first quarter of 2024 to pursue another opportunity. Tim Schmid has been appointed to her role.

Document Drawer

The FDA published draft guidance for companies communicating scientific information to health care providers about unapproved uses of medical devices on the market.

A message from CVS Health:

Whether in the community, at home or virtually, consumers want health care that is convenient, personalized and affordable. And we’re delivering. By connecting each step of your care – from a medical appointment to a trip to the pharmacy to ongoing check-ins with your care team – we’re making healthier happen together.

Learn more.

 
 

Follow us on Twitter

David Lim @davidalim

Lauren Gardner @Gardner_LM

Katherine Ellen Foley @katherineefoley

 

Follow us

 

To change your alert settings, please log in at https://www.politico.com/_login?base=https%3A%2F%2Fwww.politico.com/settings

This email was sent to [email protected] by: POLITICO, LLC 1000 Wilson Blvd. Arlington, VA, 22209, USA

Please click here and follow the steps to unsubscribe.



This post first appeared on Test Sandbox Updates, please read the originial post: here

Share the post

After Covid, some states see more TB cases

×

Subscribe to Test Sandbox Updates

Get updates delivered right to your inbox!

Thank you for your subscription

×