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Thursday, April 29, 2021

Overnight Health Care — Presented by Gilead Sciences — FDA unveils plan to ban menthol cigarettes | Joe Rogan clarifies vaccine comments

 
 
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Welcome to Thursday's Overnight Health Care. Need a palate cleanser? Here's a video of a hero helping a mother duck and her ducklings cross a busy D.C. street. 

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Follow us on Twitter at @NateWeixel, @PeterSullivan4, and @JustineColeman8 .

Today: The FDA pledged to ban menthol cigarettes within the next year, but the tobacco industry has won this fight before. Law firms representing Purdue Pharma will pay the government $1 million, and the State Department is urging U.S. citizens to leave India. 

We'll start with menthol:

FDA unveils plan to ban menthol cigarettes, flavored cigars

Menthol-flavored cigarettes and all flavored cigars would be banned in the U.S. under a new plan unveiled Thursday by federal health officials. 

The Food and Drug Administration (FDA) said it will issue a proposal "within the next year" to ban menthol in cigarettes and ban all flavors, including menthol, in cigars. 

The ban has long been sought by public health advocacy groups, and the administration was facing a Thursday deadline to respond to a lawsuit filed by antismoking and public health groups intended to force the FDA into action.

"Banning menthol — the last allowable flavor — in cigarettes and banning all flavors in cigars will help save lives, particularly among those disproportionately affected by these deadly products," acting FDA Commissioner Janet Woodcock said in a statement. 

Timing: On a call with reporters, officials were vague about when they might publish a proposal, because the process can be time consuming. The last time the federal government proposed banning menthol cigarettes, in 2013, it received more than 174,000 public comments. The lawsuit is still ongoing though, and a judge may order them to set a deadline.

Significance: The move is one of the most aggressive actions against tobacco the FDA has taken since it gained regulatory authority in 2009. Public health and civil rights groups have long argued Black Americans have been disproportionately harmed by menthol cigarettes, as the tobacco industry deliberately targeted Black communities for decades.

Backstory: Congress banned flavored cigarettes as part of the 2009 law giving the FDA authority to regulate tobacco products, but a loophole negotiated by industry lobbyists exempted menthol. Instead, lawmakers at the time directed the FDA to determine whether continued sale of menthol cigarettes was "appropriate for public health."

Read more here.

 
 
A MESSAGE FROM GILEAD SCIENCES

From HIV to viral hepatitis to today's battle with COVID-19, Gilead scientists have been pushing boundaries for over 30 years. So that we can bring tomorrow's life-changing therapies forward today. Learn more

 
 

Eyes on long COVID-19: Former health officials launch alliance on COVID-19's long-term health effects 

Former U.S. health officials launched an alliance on Wednesday that plans to advocate for research into and care for those suffering the long-term side effects of a COVID-19 infection, commonly known as "long COVID-19." 

Former Utah Gov. Mike Leavitt (R) and Nancy-Ann DeParle, the former deputy chief of staff for policy under former President Obama, unveiled their COVID Patient Recovery Alliance, which they plan to use to help health care professionals and policymakers address long-haul COVID-19.

DeParle and Leavitt, who also served as the HHS secretary under former President George W. Bush, began formulating the group of health care providers, researchers, patient advocates, data scientists, service providers and other experts in the fall of 2020.

Why is this important: Little is known so far about long COVID-19, which is when symptoms like fatigue, brain fog, disturbed sleep, shortness of breath, palpitations, depression, loss of taste and smell and muscle and joint pain persist four weeks or more after diagnosis and might impede one's ability to work.

Preliminary research has estimated that between 10 percent and 30 percent of people who had COVID-19 may endure long-haul COVID-19. With more than 32 million confirmed cases in the U.S. in the past year, that could amount to millions dealing with long-term effects of the viral infection.

What the alliance calls for: The alliance aims to support collecting coordinated data and research on long COVID-19, developing models of care for health care workers to help long-hauler patients and creating private sector and federal payment models for long haulers. 

Read more here

 

IMPORTANT CLARIFICATION: Joe Rogan says he's not "a respected source of information" on vaccines

Popular Spotify podcast host Joe Rogan on Thursday sought to clarify his recent controversial comments that young, healthy people don't need a COVID-19 vaccine.

During a conversation on his most recent episode of "The Joe Rogan Experience," the comedian made it clear that he wasn't anti-vaccine, and people should not necessarily be looking to him for medical advice.

"I'm not a doctor, I'm a f---ing moron, and I'm a cage fighting commentator ... I'm not a respected source of information, even for me. But I at least try to be honest about what I'm saying," Rogan said.

Read more here.

 
 
A MESSAGE FROM GILEAD SCIENCES

From HIV to viral hepatitis to today's battle with COVID-19, Gilead scientists have been pushing boundaries for over 30 years. So that we can bring tomorrow's life-changing therapies forward today. Learn more

 
 

"Vacc to normal": Whitmer links eased COVID-19 restrictions to vaccination rates in Michigan

Michigan Gov. Gretchen Whitmer (D) on Thursday unveiled a reopening plan that links eased COVID-19 restrictions to increased vaccination rates in a state that's been one of the hardest hit by the coronavirus in recent months.

The governor's initiative, titled "Vacc to Normal," would gradually loosen restrictions as more residents get their shots. The goal is to get the first vaccine shot to 5.67 million people, about 70 percent of residents 16 and older, while scaling back orders along the way.

So far, slightly more than 4 million residents have gotten their first COVID-19 vaccine shot, and 2.9 million are fully vaccinated, Whitmer said on Thursday.

What's next: Two weeks after 55 percent of the eligible population, or about 4.5 million residents, has had at least one vaccine shot, the state plans to remove its requirement on businesses to allow remote work, letting workplaces operate in-person.

The state is currently on pace to reach the 55 percent threshold before the end of May.

For the final phase at 70 percent, the state would end requirements for masks or limitations on public or private gatherings.

Read more here

 

FAMILY BUSINESS: Purdue Pharma law firms relinquishing $1M in fees to settle concerns about disclosures

The Department of Justice (DOJ) has ordered three law firms for Purdue Pharma to relinquish $1 million in fees earned in the drugmakers' opioid epidemic-related bankruptcy cases due to concerns about the firms' disclosures to the court.

The DOJ's U.S. Trustee Program (USTP) announced on Thursday the settlement with the three law firms: Skadden, Arps, Slate, Meagher & Flom LLP; Wilmer Cutler Pickering Hale and Dorr LLP; and Dechert LLP. 

The USTP alleges that the three firms did not "adequately disclose" a joint defense and common interest agreement between Purdue Pharma and members of the Sackler family who own the company. That agreement "created obligations" for the firms pertaining to the defense against hundreds of lawsuits related to its drug OxyContin.

Why this matters: USTP Director Cliff White described the disclosure "violations" as "particularly concerning because a central question in these cases has been the independence of Purdue from the Sackler families."

What the law firms say: The firms' position in the settlement said, "Although the Firms do not believe that the Common Interest Agreement is a 'connection' that was required to be disclosed … they have agreed to resolve the matter in the interest of expediency."

What's next: The agreement still requires approval from the Bankruptcy Court for the Southern District of New York.  

Read more here

 

LEVEL FOUR: State Department urging Americans to leave India as COVID-19 cases surge

The State Department is urging all Americans to leave India as the country grapples with a devastating wave of coronavirus cases that is pushing its health system to a breaking point.

In a level 4 travel alert, the highest level that can be issued by the State Department, the U.S. Embassy in India sounded the alarm over the availability of medical care and pressed Americans to take advantage of the daily flights that are available out of India back to the U.S.

"Access to all types of medical care is becoming severely limited in India due to the surge in Covid-19 cases. U.S. citizens who wish to depart India should take advantage of available commercial transportation options now," the embassy said.

Read more here

  

What we're reading

People seeking coronavirus vaccine appear eager to receive Johnson & Johnson (Washington Post

No, other people's Covid vaccines can't disrupt your menstrual cycle (New York Times)

CVS to offer in-store mental health counseling (NPR)

As forgeries spread, CDC tells states to pull vaccination card templates from web (NBC)

 

State by state

Washington state officials propose toolkit to help people with mental health, addiction issues find housing (Seattle Times)

What a difference a year makes in Colorado's case for a public option plan (Kaiser Health News)

Missouri falls behind in nationwide effort to track COVID-19 infections in fully vaccinated people (St. Louis Post-Dispatch

 

Op-eds in The Hill 

We urgently need a COVID-level response to the US drug crisis

 
 
 
 
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